Renal Replacement Therapy in People With and Without Diabetes in Germany, 2010-2016: An Analysis of More Than 25 Million Inhabitants.

OBJECTIVE: Epidemiological studies have shown contradictory results regarding the time trend of end-stage renal disease (ESRD) in people with diabetes. This study aims to analyze the incidence of ESRD, defined as chronic renal replacement therapy (RRT), to investigate time trends among people with and without diabetes in Germany and to examine whether these patterns differ by age and sex. RESEARCH DESIGN AND METHODS: The data were sourced from nationwide data pooled from two German branches of statutory health insurances covering ∼25 million inhabitants. We estimated age- and sex-standardized incidence rates (IRs) for chronic RRT among people with and without diabetes in 2010-2016 and the corresponding relative risks. Time trends were analyzed using Poisson regression. RESULTS: We identified 73,638 people with a first chronic RRT (male 60.0%, diabetes 60.6%, mean age 71.3 years). The IR of chronic RRT among people with diabetes (114.1 per 100,000 person-years [95% CI 110.0-117.2]) was almost six times higher than among people without diabetes (19.6 [19.4-19.8]). A consistent decline in IR was observed among people with diabetes (3% annual reduction, P < 0.0001) for both sexes and all age classes. In contrast, no consistent change of IR was identified in people without diabetes. Only among women aged <40 years (P = 0.0003) and people aged ≥80 years (P < 0.0001) did this IR decrease significantly. CONCLUSIONS: Incidence of chronic RRT remained significantly higher among people with diabetes. The IR decreased significantly in people with diabetes independent of age and sex. Time trends were inconsistent in people without diabetes.

The Burden of Systemic Lupus Erythematosus in Germany: Incidence, Prevalence, and Healthcare Resource Utilization.

INTRODUCTION: We evaluated incidence, prevalence, costs, and healthcare utilization associated with systemic lupus erythematosus (SLE) in patients in Germany. METHODS: Adult patients with SLE were identified from the German Betriebskrankenkassen (BKK) health insurance fund database between 2009 and 2014. SLE incidence and prevalence were calculated for each year and extrapolated (age and sex adjusted) to the German population. The 2009 SLE population was followed through 2014. Healthcare utilization and costs for patients with SLE were calculated and compared with controls matched by age, sex, and baseline Charlson Comorbidity Index scores. RESULTS: This analysis included 1160 patients with SLE. Estimated SLE incidence between 2009 and 2014 ranged from 4.59 to 6.89 per 100,000 persons and prevalence ranged from 37.32 to 47.36 per 100,000. SLE incidence in Germany in 2014 was 8.82 per 100,000 persons; prevalence was 55.80 (corrected for right-censored data). At baseline, 12.8, 41.7, and 45.5% of patients were categorized as having mild, moderate, and severe SLE, respectively. Patients with SLE had greater mean (standard deviation [SD]) annual medical costs compared with matched controls 1 year after index diagnosis (€6895 [14,424] vs. €3692 [3994]; P < 0.0001) and in subsequent years. Patients with moderate or severe SLE had significantly more hospitalizations, outpatient visits, and prescription medication use compared with matched controls. Mean annual costs for 5 years ranged from €1890 to 3010, €4867 to 5876, and €8396 to 10,001 for patients with mild, moderate, and severe SLE, respectively. CONCLUSIONS: SLE incidence in Germany increased 1.4-fold over 5 years. Patients with SLE have higher healthcare costs, and costs increase with baseline severity. Early and effective treatments may delay progression and reduce the burden of SLE.

Effects of Implementing a Brief Family Nursing Intervention With Hospitalized Oncology Patients and Their Families in Germany: A Quasi-Experimental Study.

Family nursing, based on the Calgary Family and Intervention Models, was implemented in a German oncological inpatient unit to promote effective family functioning in the context of cancer care. The objective of this study was to investigate the effects of implementing family nursing care on several psychological and physical outcomes of patients and their family members. A quasi-experimental study with 214 patients with a cancer diagnosis and 122 family members was conducted. Findings indicate that the superiority of family nursing, when compared to traditional care, could not be confirmed with respect to patients' outcomes (psychological burden, social support, satisfaction with care) and family members' outcomes (psychological burden, physical complaints, satisfaction with care). Various factors, such as country-specific structures and challenges in implementing family nursing care on an inpatient unit, may have contributed to these findings. Further replication attempts in similar settings in other countries are needed to shed light on the factors impairing or promoting the implementation of family nursing in practice settings.

Administrative prevalence and incidence, characteristics and prescription patterns of patients with migraine in Germany: a retrospective claims data analysis.

BACKGROUND: Migraine is a frequent headache disorder with high disease burden. The aims of this study were to determine the administrative prevalence and incidence of migraine in Germany; and to elucidate disease characteristics, prescription patterns and the patient journey through the German healthcare system. METHODS: In this retrospective, observational study, adult patients with migraine (International Classification of Diseases, 10th revision, German modification G43) were identified in the anonymised German Company Sickness Fund database (CSFD) from 2008 through 2016. The administrative prevalence and incidence of migraine were calculated for the total CSFD study population and extrapolated to the German Statutory Health Insurance (SHI) population. Migraine subtypes, concurrent diagnoses, prescription patterns and visited healthcare professional groups were analysed. RESULTS: A total of 243,471 patients with migraine were identified in the CSFD (2008-2016); 78.0% were female and 45.3% were aged 35-54 years. The administrative prevalence of migraine, extrapolated to the SHI population, ranged between 2.89% in 2008 and 3.98% in 2016; administrative incidence ranged from 0.587% in 2009 to 0.267% in 2016, and varied between 0.399% and 0.442% during 2011 to 2015. Overall, 29.1% of patients received at least one prescription for any preventive medication listed in the German guideline. Only 7.9% received the same preventive medication for more than 1 year, with 82.9% of these patients discontinuing the medication before study end. Regarding acute medications, 74.2% of prescriptions were for analgesics/non-steroidal anti-inflammatory drugs and 21.2% were for triptans. General practitioners most commonly diagnosed and treated migraine in the CSFD population. Patients with prescriptions for two or more different preventive therapy classes had higher use of acute and emergency medications, and visited healthcare professionals and hospitals more frequently than patients with no prescriptions or prescriptions for only one preventive therapy class. CONCLUSIONS: The administrative prevalence of migraine in this claims database suggests many patients with migraine did not seek medical care. Of those who did, fewer than one-third received preventive medication, with most patients having been prescribed only one such medication and few having continued treatment beyond 1 year. These outcomes suggest there is scope for improvement in migraine management in Germany.

Perianal fistulas in adult patients with Crohn's disease in Germany - a retrospective cross-sectional analysis of claims data from German sickness funds.

INTRODUCTION: Perianal fistulas (PF) are presumably a frequent extraintestinal manifestation of Crohn's disease (CD), causing significant functional impairment. This study aims to gain representative data on the prevalence, characteristics, and treatment of CD patients suffering from PF in Germany. MATERIALS AND METHODS: A retrospective cross-sectional analysis of claims data from several German company health insurance funds included adult patients with CD and PF in 2015. The dataset comprised in- and outpatient services with diagnoses, drug prescriptions, and other patient data. It is representative for age, gender, and region and allows extrapolation to the total German statutory health insurance (SHI) population. A systematic literature review was conducted to discuss these results in the international context. RESULTS: A CD prevalence of 299 per 100 000 and a PF prevalence in CD patients of 3.4 % was observed in this cross-sectional study. PF are most prevalent in young age groups (< 24 to 39). One-third of patients with PF received biologics and surgery. Surgical procedures were performed in 31.3 % of PF patients in the inpatient setting and in 4.4 % of PF patients in the outpatient setting. All complicated perianal fistula patients received at least 1 inpatient surgery and 44.8 % received biologic therapy. DISCUSSION: This claims data analysis in German patients estimates a CD prevalence in the SHI population that corresponds well to previously reported data. The prevalence rate for PF in CD patients is comparable with a previous cross-sectional German claims data analysis but is markedly lower than cumulative risks reported in longitudinal cohort studies. PF patients are young and treatment intensive with one-third requiring biologic treatment or inpatient surgery.

Hepatocellular carcinoma after prior sorafenib treatment: incidence, healthcare utilisation and costs from German statutory health insurance claims data.

OBJECTIVE: To estimate both the number of patients with hepatocellular carcinoma (HCC) eligible annually for second-line therapy following sorafenib in Germany and the healthcare costs accrued by patients meeting eligibility criteria. METHODS: Patients with an HCC diagnosis and one or more sorafenib prescription were identified from samples of > 3 million insured persons in each of 2012, 2013 and 2014 using the anonymised Betriebskrankenkasse health insurance scheme database. Incidence rates from 2013 were extrapolated to the German population using data from the statutory health insurance system database and Robert Koch Institute. Resource use and cost data were collected for a subset of patients with follow-up data post-sorafenib. RESULTS: Between 1032 and 1484 patients with HCC in Germany (893-1390 publicly insured patients) were estimated as likely to be eligible for second-line therapy after sorafenib annually. For post-sorafenib analyses, 117 patients were identified with HCC, one or more sorafenib prescription and considered potentially eligible for second-line treatment, 15 of whom were alive after 12 months' follow-up. Total mean costs per patient accrued in the 12 months after sorafenib treatment ended were €11,152 (hospital care, €6483 [58.1%]; outpatient prescriptions, €3137 [28.1%]). CONCLUSION: The estimated number of publicly insured HCC patients annually eligible for second-line therapy in Germany was < 1400 and mean total costs accrued in the year after completion of sorafenib therapy were approximately €11,000 per patient for the German statutory healthcare system. These estimates can be used when evaluating the budgetary impact of new second-line therapies for advanced HCC in Germany.

Lower-extremity amputations in people with and without diabetes in Germany, 2008-2012 - an analysis of more than 30 million inhabitants.

BACKGROUND AND PURPOSE: Lower-extremity amputations (LEAs) in people with diabetes are associated with reduced quality of life and increased health care costs. Detailed knowledge on amputation rates (ARs) is of utmost importance for future health care and economics strategies. We conducted the present cohort study in order to estimate the incidences of LEA as well as relative and attributable risk due to diabetes and to investigate time trends for the period 2008-2012. METHODS: On the basis of the administrative data from three large branches of German statutory health insurers, covering ~34 million insured people nationwide (about 40% of the German population), we estimated age-sex-standardized AR (first amputation per year) in the populations with and without diabetes for any, major, and minor LEAs. Time trends were analyzed using Poisson regression. RESULTS: A total of 108,208 individuals (diabetes: 67.3%; mean age 72.6 years) had at least one amputation. Among people with diabetes, we observed a significant reduction in major and minor ARs during 2008-2012 from 81.2 (95% CI 77.5-84.9) to 58.4 (55.0-61.7), and from 206.1 (197.3-214.8) to 177.0 (169.7-184.4) per 100,000 person-years, respectively. Among people without diabetes, the major AR decreased significantly from 14.3 (13.9-14.8) to 11.6 ([11.2-12.0], 12.0), whereas the minor AR increased from 15.8 (15.3-16.3) to 17.0 (16.5-17.5) per 100,000 person-years. The relative risk (RR) comparing the diabetic with the nondiabetic populations decreased significantly for both major and minor LEAs (4% and 5% annual reduction, respectively). CONCLUSION: In this large nationwide population, we still found higher major and minor ARs among people with diabetes compared with those without diabetes. However, AR and RR of major and minor LEAs in the diabetic compared with the nondiabetic population decreased significantly during the study period, confirming a positive trend that has been observed in smaller and regional studies in recent years.

The impact of non-persistence on the direct and indirect costs in patients treated with subcutaneous tumour necrosis factor-alpha inhibitors in Germany.

OBJECTIVE: The goal of the present study was to estimate the treatment costs in immune-mediated rheumatic disease patients initiating treatment with an s.c. biologic agent based on treatment persistence. METHODS: This is a retrospective cohort study based on the German statutory health insurance funds database. Patients ⩾18 years of age with a diagnosis of AS, PsA or RA treated with s.c. TNF-α inhibitors (TNFis) were included. Persistence was estimated as the duration of time from s.c. TNFi therapy initiation to discontinuation, which was defined as at least 60 days without therapy. We performed 1:1 matching based on a propensity score that was constructed as the conditional probability of being persistent as a function of age, gender, index year, physician specialty and Charlson comorbidity index. Finally, the cost differences between the matched pairs were estimated using the Wilcoxon test. RESULTS: After 1:1 matching, 678 persistent and 678 non-persistent patients were available for cost analyses. Using a 2-year time period, the costs for office-based visits per patient were €2319 in the persistent cohort compared with €3094 in the non-persistent cohort (P < 0.001). Co-medication costs were €2828 in the persistent cohort compared with €5498 in the non-persistent cohort, hospitalization costs were €3551 in the persistent cohort compared with €5890 in the non-persistent cohort and sick leave costs were €717 in the persistent cohort compared with €1241 in the non-persistent cohort (all P < 0.001). CONCLUSION: The results of this study indicate that persistence with s.c. TNFi treatment can be associated with several cost offsets for immune-mediated rheumatic disease patients.

The number of patients with chronic hepatitis C in times of new therapy options: a retrospective observational study on German health insurance funds data.

AIM/OBJECTIVES/BACKGROUND: Chronic hepatitis C (CHC) virus infection is a leading cause of liver-related morbidity and mortality. In Germany, as in many other countries, there is a lack of comprehensive epidemiological data. Routine data from sickness funds can support the estimation of the true prevalence and incidence of CHC. METHODS: In this article, the results of annual and quarterly analyses of prevalence and incidence for the years 2007-2013 are presented using data of several German sickness funds. RESULTS: Overall, the prevalence rate remained relatively stable at 0.2%, which is lower than the general assumption for Germany of 0.3%. CONCLUSION: We found that despite the introduction of the breakthrough designated triple therapies with telaprevir or boceprevir in 2011, there was no increase of prevalence or incidence between 2010 and 2011.

Frequency of computed tomography examinations in the follow-up care of testicular cancer patients - an evaluation of patterns of care in Germany.

BACKGROUND: Exposure to radiation resulting from diagnostic imaging procedures probably increases late cancer risk. Patterns of care regarding the application of computed tomography (CT) imaging in testicular cancer patients were investigated. METHODS: The database of a large German health insurance company comprising 850,000 insured men was searched for cases of testicular cancer arising in the years 2005 and 2006. The number of CT scans applied during a 3-year period of follow-up was noted for each individual patient and the resulting cumulative radiation dose was estimated. The number of CT scans actually observed was compared to guideline recommendations. RESULTS: 177 patients were identified. Within the 3-year observation period, patients received a mean of 4.4 CT scans (standard error: 0.4) whereas a number of 6.2 would have been expected according to contemporary guidelines. Patients were exposed to an estimated total median diagnostic radiation dose of 30 millisieverts (mSv) (interquartile range: 10-54 mSv). CONCLUSION: There is a considerable gap between recommendation and actual performance regarding the number of CT scans applied to testicular cancer patients. Unfamiliarity of clinicians with guidelines as well as poor acceptance of high numbers of CT scans scheduled may have contributed to create this particular pattern of care.

Expenditures of the German statutory health insurance system for patients suffering from acute coronary syndrome and treated with percutaneous coronary intervention.

Patients with acute coronary syndrome (ACS) are in need of cost-intensive treatment involving different aspects of the German Health System. Percutaneous coronary intervention (PCI) is the treatment of choice for a large proportion of cases. In the present study, an analysis of the cost impact of ACS with focus on PCI therapy was conducted across-the-board for the German Health System. Results indicated that 85% of all costs arising from treatment of ACS with a trial of PCI are due to in-patient care. Projection of results onto the entire insurant collective of the statutory health system estimated a total of Euro 954,995,603-a proportional 0.7% of all expenditure by statutory health insurance in 2005.

Predisposing factors for early retirement in patients with schizophrenia in Germany.

Although early retirement causes major changes in the life of schizophrenic patients and is among the major cost factors to be covered by payers, the causes leading to early retirement of schizophrenic patients have not been investigated in detail. Therefore, the objective of this retrospective non-interventional case-control study was to generate hypotheses on predisposing factors for early retirement in schizophrenia. Logistic regression was used to explore potential predisposing parameters with regard to their effect on the outcome early retirement. As the study results indicate, schizophrenia severity, assistance or care in the patient's everyday life, age and antipsychotic treatment with typical antipsychotics are linked to the occurrence of early retirement. Further research should be planned to confirm or refute the hypotheses determined in this retrospective analysis and to determine whether atypical antipsychotics could help to avoid early retirement and to improve the situation of schizophrenic patients.