Statutory Health Insurance Providers Research Articles

INTEGRATE-ADHD: Comparison and Integration of Administrative and Epidemiological ADHD Diagnosis Data through Clinical Assessment - Presentation of the Project

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.

Secondary Prevention via Case Managers in Stroke Patients: A Cost-Effectiveness Analysis of Claims Data from German Statutory Health Insurance Providers.

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.

Type 2 diabetes in the employed population: do rates and trends differ among nine occupational sectors? An analysis using German health insurance claims data

BackgroundSocioeconomic inequalities in type 2 diabetes (T2D) are well established in the literature. However, within the background of changing work contexts associated with digitalization and its effect on lifestyle and sedentary behavior, little is known on T2D prevalence and trends among different occupational groups. This study aims to examine occupational sector differences in T2D prevalence and trends thereof between 2012 and 2019.MethodsThe study was done on 1.683.644 employed individuals using data from the German statutory health insurance provider in Lower Saxony, the “Allgemeine Ortskrankenkasse Niedersachsen” (AOKN). Predicted probabilities for T2D prevalence in four two-year periods between 2012 and 2019 were estimated based on logistic regression analyses for nine occupational sectors. Prevalence ratios were calculated to illustrate the effect of time period on the prevalence of T2D among the nine occupational sectors. Analyses were stratified by gender and two age groups.ResultsResults showed differences among occupational sectors in the predicted probabilities for T2D. The occupational sectors “Transport, logistics, protection and security” and “Health sector, social work, teaching & education” had the highest predicted probabilities, while those working in the sector “Agriculture” had by far the lowest predicted probabilities for T2D. Over all, there appeared to be a rising trend in T2D prevalence among younger employed individuals, with gender differences among occupational sectors.ConclusionThe study displayed different vulnerability levels among occupational sectors with respect to T2D prevalence overall and for its rising trend among the younger age group. Specific occupations within the vulnerable sectors need to be focused upon in further research to define specific target groups to which T2D prevention interventions should be tailored.

Länger gesund im Beruf? Trends in den Lebensjahren frei von Herz-Kreislauf- und Muskel-Skelett-Erkrankungen in GKV-Daten für die Erwerbstätigen- und Allgemeinbevölkerung

ZusammenfassungHintergrundUnsere Studie fokussiert auf die Entwicklung der erkrankungsfreien Lebensjahre in Bezug auf 2 Erkrankungsgruppen mit hoher Public-Health-Relevanz: Muskel-Skelett- (MSE) und Herz-Kreislauf-Erkrankungen (HKE). Vor dem Hintergrund der steigenden Lebensarbeitszeit wird die Entwicklung der erkrankungsfreien Jahre der Bevölkerung im erwerbsfähigen Alter und der Erwerbstätigen verglichen und Unterschiede zwischen den Berufsgruppen beleuchtet.MethodenDie Studie basiert auf den Daten der AOK Niedersachsen (N = 2.001.225). Die Erkrankungsfälle werden anhand der Diagnosedaten ermittelt. Die erwarteten Jahre frei von MSE und HKE werden mit Multistate-Life-Table-Analysen für 3 Perioden zwischen 2006 und 2018 berechnet. Die Berufsgruppe wird über den Berufsschlüssel definiert und in 3 Gruppen unterteilt: 1) Un- und Angelernte, 2) Fachkräfte und Spezialisten, 3) Hochqualifizierte.ErgebnisseDie Lebensjahre frei von MSE nahmen in der Allgemeinbevölkerung und unter den Erwerbstätigen deutlich ab. Die stärkste Verringerung zeigte sich in der höherqualifizierten Berufsgruppe. Die Lebensjahre frei von HKE stiegen in der Allgemeinbevölkerung im Zeitverlauf. Die Zunahmen waren unter den Erwerbstätigen geringer, sie wurden nur bei Männern in un- und angelernter Tätigkeit verzeichnet.DiskussionDie Studie zeigt, dass sich die erkrankungsfreien Jahre unter den Erwerbstätigen teilweise schlechter als in der Allgemeinbevölkerung entwickelten. Für die untersuchten Erkrankungsgruppen MSE und HKE bestehen deutliche Ungleichheiten zwischen den Berufsgruppen, die sich im Zeitverlauf etwas verringerten. Die Ungleichheiten und die Abnahme der Jahre frei von MSE belegen die hohe Public-Health-Relevanz und den Bedarf an Präventionsmaßnahmen zur Vermeidung von HKE und MSE im erwerbsfähigen Alter.

Type 2 diabetes severity in the workforce: An occupational sector analysis using German claims data.

Individuals of working age spend a significant amount of time at the workplace making it an important context for disease prevention and management. The temporal development and prevalence of T2D have been shown to differ in the working population based on gender, age group and occupational sector regardless of socioeconomic status. Given potential differences in risk factors associated with different work environments, this study aims to define vulnerable occupational groups by examining T2D severity and its trends in working men and women with T2D of two age groups and among nine occupational sectors. The study is based on claims data of the statutory health insurance provider AOKN. The study population consisted of all insured working individuals with T2D. T2D severity was measured using the adapted diabetes complications severity index-complication count (DCSI-CC). Mean DCSI-CC scores were calculated over four time periods between 2012 and 2019 for men and women of the age groups 18-45 and 46+ years and among nine occupational sectors. Trends of DCSI-CC were investigated using ordinal logistic regression analyses to examine the effect of time-period on the odds of having higher DCSI scores. Overall, there was a significant rise in T2D severity over time in working men and women of the older age group. Moreover, the study displayed occupational sector differences in T2D severity and its trends. Over all, working men of all sectors had higher DCSI-CC scores compared to working women. Individuals working in the sector "Transport, logistics, protection and security" and "Construction, architecture, measuring and building technology" had higher T2D severity, while those working in the "Health sector, social work, teaching & education" had relatively lower T2D severity. There was a gender-specific significant increase over time in T2D severity in the above-mentioned occupational sectors. The study displayed gender, age group and occupational sector differences in T2D severity and its trends. Working individuals could thus benefit from personalized prevention interventions that consider occupational contexts. As a next step, examining T2D trends and severity in specific occupations within the vulnerable occupational sectors is needed.

Healthy enough to work up to age 67 and beyond? A longitudinal population-based study on time trends in working life expectancy free of cardiovascular diseases based on German health insurance data

BackgroundDue to the rising life expectancy in Western countries, the discussion about the increase in the retirement age is becoming more important. However, the prolongation of working lives cannot be...

EE634 Resource Utilization and Costs Related to Inflammatory Bowel Disease: A Longitudinal Analysis Based on Routine Data from Two German Statutory Health Insurance Providers

EE634 Resource Utilization and Costs Related to Inflammatory Bowel Disease: A Longitudinal Analysis Based on Routine Data from Two German Statutory Health Insurance Providers

Record Linkage of secondary data in the NAKO: Overview of data sources with focus on health insurance claims data

Abstract Background The collected primary data are enriched with secondary and registry data from different data owners to support morbidity follow-up and to obtain important exposure and progression data that could not be obtained otherwise. Goal A sophisticated data protection procedure had to be developed and agreed upon with hundreds of data owners. The outlines of this procedure and the various data bodies to be linked are presented, and consent behavior is described. Furthermore, it is discussed which hurdles still have to be overcome for a successful implementation of record linkage in Germany. Methods Study participants were asked for informed written consent to link their secondary and registry data. Confidentiality was ensured, among other things, by means of a complex pseudonymization procedure by an independent trust center. Legal and technical requirements for annual transmission and long-term use of their data were established with the data owners. Results At baseline, a total of 205,000 study participants were screened and interviewed in 18 study centers distributed across Germany starting in 2014. A second study wave followed from 2019, with a third starting in 2024. A high willingness to consent of 90.5% to use health insurance data was achieved. Willingness to consent is higher in the west than in the east of Germany, with 88.1% of consenters insured by one of the 113 statutory health insurance providers and 11.9% insured by one of the 46 private health insurance providers. Conclusions Large-scale record linkage of secondary data is a novelty in Germany. In addition to the identification of incident diseases, an almost complete medication history can be collected for the majority of study participants, independent of health insurance. However, linking is associated with a high administrative and technical effort, and some of the required data protection regulations will have a negative impact on data quality if improvements are not made here.

Effects of the Pandemic on the Care of Patients With Colorectal Cancer.

During the COVID-19 pandemic, there was a decrease in the rates of diagnosis and treatment of cancer. However, only a few detailed analyses have been made to date regarding the effect of the pandemic on the care of cancer patients in Germany. Such studies are needed as the basis for well-founded recommendations on health-care delivery priorities during pandemics and other, comparable situations of crisis. This review is based on publications that were retrieved by a selective search of the literature for controlled studies from Germany on the effects of the pandemic on colonoscopies, first diagnoses of colorectal cancer (CRC), surgical procedures for CRC, and CRC-related mortality. Compared to 2019, the rate of screening colonoscopies performed by physicians in private practice was 1.6% higher in 2020 and 4.3% higher in 2021. On the other hand, the rate of diagnostic colonoscopies in the inpatient setting was 15,7% lower in 2020, while that of therapeutic colonoscopies was 11.7% lower. According to the data evaluated here, first diagnoses of CRC were 2.1% less common in January to September in 2020 than they had been in 2019; according to routine data collected by the statutory health insurance provider GRK, surgery for CRC was 10% less common in 2020 than in 2019. With regard to mortality, sufficient data from Germany were lacking to draw definite conclusions. International modeling data suggest an increase in mortality due to decreased colorectal screening rates during the pandemic that may at least be partially compensated for by intensified screening strategies following the pandemic. Three years after the onset of the COVID-19 pandemic, there is still only a limited evidence base for an evaluation of the effects of the pandemic on medical care and on the outcomes of patients with CRC in Germany. The implementation of central data and research infrastructures will be necessary for further study of the long-term effects of this pandemic, as well as to enable optimal preparedness for future crisis situations.

Factors influencing adherence to clinical practice guidelines in patients with suspected chronic coronary syndrome: a qualitative interview study in the ambulatory care sector in Germany

BackgroundChronic coronary syndrome (CCS) is a potentially progressive clinical presentation of coronary artery disease (CAD). Clinical practice guidelines (CPGs) are available for prevention, diagnosis, and treatment. Embedded in the “ENLIGHT-KHK” healthcare project, a qualitative study was conducted to identify factors that influence guideline adherence from the perspective of general practitioners (GPs) and cardiologists (CA) in the ambulatory care sector in Germany.MethodsGPs and CAs were surveyed via telephone using an interview guide. The respondents were first asked about their individual approach to caring for patients with suspected CCS. Subsequently, the accordance of their approach with guideline recommendations was addressed. Finally, potential measures for assisting with guideline adherence were discussed. The semi-structured interviews were transcribed verbatim and analysed using a qualitative content analysis in accordance with Kuckartz and Rädiker. Factors influencing adherence to CPGs were categorised by assessing whether they (i) inhibited or facilitated guideline adherence, (ii) played a role in patients at risk of CCS or with suspected or known CCS, (iii) were mentioned in implicit or explicit thematic reference to CPGs, and (iv) were declared a practical problem.ResultsBased on interviews with ten GPs and five CAs, 35 potential influencing factors were identified. These emerged at four levels: patients, healthcare providers, CPGs, and the healthcare system. The most commonly cited barrier to guideline adherence among the respondents was structural aspects at the system level, including reachability of providers and services, waiting times, reimbursement through statutory health insurance (SHI) providers, and contract offers. There was a strong emphasis on interdependencies between factors acting at different levels. For instance, poor reachability of providers and services at the system level may result in inexpedience of guideline recommendations at the CPG level. Likewise, poor reachability of providers and services at the system level may be aggravated or alleviated by factors such as diagnostic preferences at the patient level or collaborations at the provider level.ConclusionsTo assist with adherence to CPGs regarding CCS, promoting measures may be needed that account for interdependencies between barriers and facilitators at various healthcare levels. Respective measures should consider medically justified deviations from guideline recommendations in individual cases.Trial registrationGerman Clinical Trials Register: DRKS00015638; Universal Trial Number (UTN): U1111-1227-8055.

M2Q or Something else? The Impact of Varying Case Selection Criteria on the Prevalence Estimation of Chronic Diseases Based on Outpatient Diagnoses in German Claims Data

To determine the prevalence of chronic disease conditions based on outpatient health insurance data, we often rely on repeated occurrence of a diagnosis over the course of a year, usually in two or more quarters (M2Q). It remains unclear whether prevalence estimates change after adapting repeated occurrence of a diagnosis in different quarters of a year compared to a single occurrence or to some other case selection criteria. This study applies different case selection criteria and analyses their impact on the prevalence estimation based on outpatient diagnoses. Administrative prevalence for 2019 was estimated for eight chronic conditions based on outpatient physician diagnoses. We applied five case selection criteria: (1) single occurrence, (2) repeated occurrence (including in the same quarter or treatment case), (3) repeated occurrence in at least two different treatment cases (including in the same quarter), (4) occurrence in two quarters and (5) occurrence in two consecutive quarters. Only information on persons with continuous insurance history within the statutory health insurance provider AOK Niedersachsen in 2019 was used (n=2,168,173). Prevalence estimates differed quite strongly depending on the diagnosis and on age group if a criterion with repeated occurrence of a diagnosis was applied compared to a single occurrence. These differences turned out to be higher among men and younger patients. The application of a repeated occurrence (criterion 2) did not show different results compared to the repeated occurrence in at least two treatment cases (criterion 3) or in two quarters (criterion 4). The application of the strict criterion of two consecutive quarters (criterion 5) resulted in further reduction of the prevalence estimates. Repeated occurrence is increasingly becoming the standard for diagnosis validation in health insurance claims data. Applying such criteria results partly in a distinct reduction of prevalence estimates. The definition of the study population (e. g., repeated visits to a physician in two consecutive quarters as a mandatory condition) can also strongly influence the prevalence estimates.

In atrial fibrillation epilepsy risk differs between oral anticoagulants: active comparator, nested case-control study.

Atrial fibrillation (AF) is a risk factor for brain infarction, which can lead to epilepsy. We aimed to investigate whether treatment of AF with direct oral anticoagulants (DOACs) affects the risk of epilepsy in comparison to treatment with the vitamin K antagonist phenprocoumon (PPC). We performed an active comparator, nested case-control study based on the German Pharmacoepidemiological Research Database that includes claims data from statutory health insurance providers of about 25 million persons since 2004. In 2011-17, 227 707 AF patients initiated treatment with a DOAC or PPC, of which 1828 cases developed epilepsy on current treatment with an oral anticoagulant. They were matched to 19 084 controls without epilepsy. Patients with DOAC treatment for AF had an overall higher risk of epilepsy with an odds ratio of 1.39, 95% CI (1.24; 1.55) compared to current PPC treatment. Cases had higher baseline CHA2DS2-VASc scores and more frequently a history of stroke than controls. After excluding patients with ischaemic stroke prior to the diagnosis of epilepsy, the risk of epilepsy was still higher on DOACs than on PPC. In contrast, within a cohort of patients with venous thromboembolism, the risk of epilepsy on treatment with DOACs was less elevated [adjusted odds ratio 1.15, 95% CI (0.98; 1.34)]. In patients with AF initiating oral anticoagulation, treatment with a DOAC was associated with an increased risk of epilepsy compared to the vitamin K antagonist PPC. Covert brain infarction may explain the observed elevated risk of epilepsy.

Trends of Antidiabetic and Cardiovascular Diseases Medication Prescriptions in Type 2 Diabetes between 2005 and 2017—A German Longitudinal Study Based on Claims Data

With an attempt to understand possible mechanisms behind the severity-dependent development of type 2 diabetes (T2D) comorbidities, this study examines the trends of antidiabetic and cardiovascular diseases (CVD) medication prescriptions in individuals with T2D. The study is based on claims data from a statutory health insurance provider in Lower Saxony, Germany. The period prevalence of antidiabetic and CVD medication prescriptions was examined for the periods 2005-2007, 2010-2012, and 2015-2017 in 240,241, 295,868, and 308,134 individuals with T2D, respectively. (Ordered) logistic regression analyses were applied to examine the effect of time period on the number and prevalence of prescribed medications. Analyses were stratified by gender and three age groups. The number of prescribed medications per person has increased significantly for all examined subgroups. For the two younger age groups, insulin prescriptions decreased but those of non-insulin medications increased, while both increased significantly over time for the age group of 65+ years. Except for glycosides and antiarrhythmic medications, the predicted probabilities for CVD medications increased over the examined periods, with lipid-lowering agents demonstrating the highest increase. Results point towards an increase in medication prescriptions in T2D, which is in line with the evidence of the increase in most comorbidities indicating morbidity expansion. The increase in CVD medication prescriptions, especially lipid-lowering agents, could explain the specific development of severe and less severe T2D comorbidities observed in this population.

Prevalence of malocclusions in 8- and 9-year-old children in Germany-Results of the Sixth German Oral Health Study (DMS6).

Current population-wide data on the prevalence of malocclusions in 8‑ and 9‑year-old children in Germany are not available. Therefore, the primary objective of this study was to collect data on the prevalence of malocclusions in 8‑ and 9‑year-old children in Germany. The secondary objective of this study was to use this information to derive the need for orthodontic care provision. This is an oral-epidemiological investigation and social science survey at the national level with afocus on tooth and jaw misalignment. The investigation took place between January and March 2021 at 16study centers across Germany. All relevant data were available for the 705study participants and were included in the statistical analysis. Overbite was the most common finding with 88.9%. Also widespread were crowding, with at least 60.9%, and lack of space, with ashare of 30.9%. All other indication groups had ashare below 10%. Rare (< 1%) were buccal and lingual occlusions and craniofacial abnormalities. The most severe forms of disease (Orthodontic Indication Group [Kieferorthopädische Indikationsgruppen, KIG] grade5) were overbite (3.2%), open bite malocclusion (1.0%), undershot (0.6%), and craniofacial abnormalities (0.4%). The proportion of study participants who required orthodontic treatment, in accordance with statutory health insurance provider guidelines, was 40.4%. The proportion of study participants in principle requiring orthodontic treatment for medical reasons was 97.5%. Systemic differences in the need for orthodontic care provision relating to gender, region, or social status were not identified. In general, the need for care provision identified in the orthodontic indication groups corresponds to that shown in previous studies. This suggests that the need for orthodontic treatment in Germany has remained stable over the years.

HTA183 AMNOG Benefit Assessment in Germany: Outcomes From 2011 to 2022

Since the enactment of the AMNOG in Germany in 2011, pharmaceutical companies are required to prove the benefit of newly approved drugs within the therapeutic area(s) of interest. The potential benefit is evaluated by G-BA/IQWiG forming the basis for price negotiations with the statutory health insurance providers. Aim of this study was to investigate the distribution and the outcomes of the assessments from 2011 to May 2022.

Effectiveness of Mammography Screening on Breast Cancer Mortality - A Study Protocol for Emulation of Target Trials Using German Health Claims Data.

The efficacy of mammography screening in reducing breast cancer mortality has been demonstrated in randomized trials. However, treatment options - and hence prognosis - for advanced tumor stages as well as mammography techniques have considerably improved since completion of these trials. Consequently, the effectiveness of mammography screening under current conditions is unclear and controversial. The German mammography screening program (MSP), an organized population-based screening program, was gradually introduced between 2005 and 2008 and achieved nation-wide coverage in 2009. We describe in detail a study protocol for investigating the effectiveness of the German MSP in reducing breast cancer mortality in women aged 50 to 69 years based on health claims data. Specifically, the proposed study aims at estimating per-protocol effects of several screening strategies on cumulative breast cancer mortality. The first analysis will be conducted once 10-year follow-up data are available. We will use claims data from five statutory health insurance providers in Germany, covering approximately 37.6 million individuals. To estimate the effectiveness of the MSP, hypothetical target trials will be emulated across time, an approach that has been demonstrated to minimize design-related biases. Specifically, the primary contrast will be in terms of the cumulative breast cancer mortality comparing the screening strategies of "never screen" versus "regular screening as intended by the MSP". In Germany, the utilization of data from health insurances for scientific research is regulated by the Code of Social Law. All involved health insurance providers as well as the responsible authorities approved the use of the health claims data for this study. The Ethics Committee of the University of Bremen determined that studies based on claims data are exempt from institutional review. The findings of the proposed study will be published in peer-reviewed journals.

Prescription of opioid analgesics for non-cancer pain in Germany: study protocol for a mixed methods analysis

AimLong-term therapy with opioid analgesics bears the risk of complications, such as misuse, abuse, and dependence. An evidence-based guideline addresses the long-term use of opioid analgesics for non-cancer pain. Recent studies observed an increase in opioid prescriptions over the past two decades in Germany. However, the exact circumstances of this increase and if long-term therapy adheres to these guidelines in practice remains unknown. Therefore, this study aimed to evaluate the provision of opioid analgesics for adults with non-cancer pain from patients’ and physicians’ perspectives. Based on the results, recommendations for care strategies for the patient groups at risk of misuse, abuse, and dependence were developed.MethodsBuilt on a mixed methods approach, this evaluation combines (i) interviews with primary care physicians and specialists, (ii) surveys of patients and physicians, (iii) analyses based on administrative claims data from a German statutory health insurance provider. Proceeding from the analysis of the evaluation results, the development of care strategies included (iv) semi-structured interviews with stakeholders and (v) expert workshops.ConclusionTo our knowledge, this is the first attempt to analyze opioid prescriptions from the combined perspectives of patients and practitioners in Germany. The results are intended to facilitate the development of target group-specific care strategies and recommendations to establish a general framework for the implementation of care strategies.

Ten-Year Evaluation of the Population-Based Integrated Health Care System "Gesundes Kinzigtal".

The population-based integrated health care system called "Gesundes Kinzigtal" (Integrierte Versorgung Gesundes Kinzigtal, IVGK) was initiated more than 10 years ago in the Kinzig River Valley region, which is located in the Black Forest in the German state of Baden-Württemberg. IVGK is intended to optimize health care while maximizing cost-effectiveness. It consists of programs for promoting health and for enabling cooperation among service providers, as well as of a shared-savings contract that has enabled resources to be saved every year. The goal of the present study was to investigate trends in the quality of care provided by IVGK over the past ten years in comparison to conventional care. This is a non-randomized observational study with a control-group design (Kinzig River Valley versus 13 structurally comparable control regions), employing data collected by AOK, a large statutory health-insurance provider in Germany, over the period 2006-2015. Quality assessment was conducted with the aid of a set of indicators, developed by the authors, that was based exclusively on claims data. The statistical analysis of the trends in these indicators over time was conducted with preset criteria for the relevance of any observed changes, as well as preset mechanisms of controlling for confounding factors. For 88 of the 101 evaluable indicators, no relevant difference was seen between the trend over time in the region of the intervention and the average trend in the control regions. Relevant differences in favor of the IVGK were observed for six indicators, and negatively divergent trends compared to the controls were observed for seven indicators. In the main summarizing statistical analysis, no positive or negative difference was found between the Kinzig River Valley and the other regions with respect to trends in the health-care indicators over time. An evaluation based on 101 indicators derived from health-insurance data did not reveal any improvement of the quality of care by IVGK and the totality of the programs that were implemented under it. However, under the conditions of the shared-savings contract, no relevant diminution in the quality of care was observed over a period of 10 years either, compared with structurally similar control regions without an integrated care model.

Exploring the status of and demand for palliative day-care clinics and day hospices in Germany: a protocol for a mixed-methods study

BackgroundTo date, the establishment and development of palliative day-care clinics and day hospices in Germany have been completely unsystematic. Research is needed to gain insight into these services and to ensure their accessibility and quality. Accordingly, the ABPATITE research project aims at: (1) identifying the characteristics of palliative day-care clinics and day hospices in Germany, (2) determining demand and preferences for these services, and (3) proposing recommendations (with expert agreement) for the needs-based establishment and development of these services.MethodsThe research is a multi-perspective, prospective, observational study following a mixed-methods approach across three study phases. In phase 1a, qualitative expert interviews will be conducted to capture the facility-related characteristics of palliative day-care clinics and day hospices in Germany; the results will feed into a questionnaire sent to all such institutions identified nationwide. In phase 1b, a questionnaire will be sent to local statutory health insurance providers, to gain insight into their contracts and accounting and remuneration models. In phase 2a, a service preference survey will be conducted with patients and family caregivers. In phase 2b, semi-structured interviews with management staff will explore the factors that promote and hinder the provision of service. In phase 2c, the external perspective will be surveyed via focus groups with local actors involved in hospice and palliative care. In phase 3a, focus groups with representatives from relevant areas will be conducted to develop recommendations. Finally, in phase 3b, recommendations will be agreed upon through a Delphi survey.DiscussionThe empirically developed recommendations should enable the establishment and development of day hospices and palliative day-care clinics in Germany to be better managed, more oriented to actual demand, and more effectively integrated into wider health care services. Importantly, the findings are expected to optimize the overall development of hospice and palliative care services.Trial registration:The study was prospectively registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien) (Registration N° DRKS00021446; date of registration: April 20, 2020). The study is searchable under the International Clinical Trials Registry Platform Search Portal of the World Health Organization, under the German Clinical Trials Register number.

N-Nitrosodimethylamine-Contaminated Valsartan and the Risk of Cancer—A Longitudinal Cohort Study Based on German Health Insurance Data.

N-Nitrosodimethylamine (NDMA), classified as a probable human carcinogen, has been found as a contaminant in the antihypertensive drug valsartan. Potentially carcinogenic effects associated with the consumption of NDMAcontaminated valsartan have not yet been analyzed in large-scale cohort studies. We therefore carried out the study reported here to explore the association between NDMA-contaminated valsartan and the risk of cancer. This cohort study was based on longitudinal routine data obtained from a large German statutory health insurance provider serving approximately 25 million insurees. The cohort comprised patients who had filled a prescription for valsartan in the period 2012-2017. The endpoint was an incident diagnosis of cancer. Hazard ratios (HR) for cancer in general and for certain specific types of cancer were calculated by means of Cox regression models with time-dependent variables and adjustment for potential confounders. A total of 780 871 persons who had filled a prescription for valsartan between 2012 and 2017 were included in the study. There was no association between exposure to NDMA-contaminated valsartan and the overall risk of cancer. A statistically significant association was found, however, between exposure to NDMA-contaminated valsartan and hepatic cancer (adjusted HR 1.16; 95% confidence interval [1.03; 1.31]). These findings suggest that the consumption of NDMA-contaminated valsartan is associated with a slightly increased risk of hepatic cancer; no association was found with the risk of cancer overall. Close observation of the potential long-term effects of NDMA-contaminated valsartan seems advisable.