Cardiovascular risk factors, exercise capacity and health literacy in patients with chronic ischaemic heart disease and type 2 diabetes mellitus in Germany: Baseline characteristics of the Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes study.

BACKGROUND: Lifestyle interventions are a cornerstone in the treatment of chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). This study aimed at identifying differences in clinical characteristics between categories of the common lifestyle intervention targets BMI, exercise capacity (peak V̇O2) and health literacy (HL). METHODS: Cross-sectional baseline characteristics of patients enrolled in the LeIKD trial (Clinicaltrials.gov NCT03835923) are presented in total, grouped by BMI, %-predicted peak V̇O2 and HL (HLS-EU-Q16), and compared to other clinical trials with similar populations. RESULTS: Among 499 patients (68.3±7.7 years; 16.2% female; HbA1c, 6.9±0.9%), baseline characteristics were similar to other trials and revealed insufficient treatment of several risk factors (LDL-C 92±34 mg/dl; BMI, 30.1±4.8 kg/m2; 69.6% with peak V̇O2<90% predicted). Patients with lower peak V̇O2 showed significantly higher (p < 0.05) CIHD and T2DM disease severity (HbA1c, CIHD symptoms, coronary artery bypass graft). Obese patients had a significantly higher prevalence of hypertension and higher triglyceride levels, whereas in patients with low HL both quality of life components (physical, mental) were significantly reduced. CONCLUSIONS: In patients with CIHD and T2DM, peak V̇O2, BMI and HL are important indicators of disease severity, risk factor burden and quality of life, which reinforces the relevance of lifestyle interventions.

Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial.

INTRODUCTION: Guidelines recommend lifestyle intervention in chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). However, evidence from randomised controlled trials is scarce in patients with combined entities. METHODS AND ANALYSIS: The Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (LeIKD) trial is a prospective, multicentre study that will randomise (1:1) patients with CIHD (ICD-10: I20-I25) and T2DM (ICD-10: E11) from one health insurance company into a lifestyle intervention (LS) or usual care (UC). Active LS consists of an individual combined exercise programme of strength and endurance training and nutritional counselling with regular feedback for 6 months. Intervention is supported by telemedicine. Follow-up without individualised feedback will continue for 6 months. The study aims to investigate whether an individualised telemedical supported LS intervention is superior to UC in improving cardiovascular risk factors, physical activity, quality of life, health literacy, major cardiovascular events and health economics in patients with both CIHD and T2DM. Primary endpoint is the change in HbA1c from baseline to 6 months. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Technical University of Munich (registration number: 144/18-S) and at each study site. The study will be conducted according to the World Medical Association Declaration of Helsinki, and results will be published in articles and reports. It is funded by the Federal Joint Committee (www.innovationsfonds.g-ba.de), reference number 01NVF17015, which has no impact on data collection, analysis or interpretation. Dissemination is independent of the funding source. TRIAL REGISTRATION NUMBER: Clinical trials.gov identifier: NCT03835923. German registry for clinical studies (DRKS): DRKS00015140.

[Guideline-Orientated Prescription of Disease-Modifying Drugs in Patients with Rheumatoid Arthritis - an Analysis Based on Social Health Insurance Claims Data]. / Leitliniengerechte Verordnung von krankheitsmodifizierenden Arzneimitteln bei Patienten mit rheumatoider Arthritis ­ eine Analyse auf Basis von GKV-Routinedaten.

BACKGROUND: With the market entry of biologics, the treatment of rheumatoid arthritis (RA) has changed fundamentally in terms of efficacy and costs. THE AIM: of this study is to analyse the treatment according the guideline of the German society of rheumatology for RA patients with disease-modifying anti-rheumatic drugs (DMARDs) using claims data from the statutory health insurance. MATERIALS AND METHODS: The claims data of the Techniker Krankenkasse were analysed retrospectively for the years 2011 - 2014. Subgroup analyses were used to conduct prescription and treatment differences with respect to guideline-recommended conventional DMARDs and biologics. RESULTS: The study population included 55,538 RA patients (29.7 % incidence, 70.3 % prevalence, 22.3 % M05: Seropositive rheumatoid arthritis, 77.7 % M06: Other rheumatoid arthritis). Only 21,616 insured patients (38.9 %) were prescribed a guideline-recommended conventional DMARD or biologic at least once within one year of/after the first diagnosis. Among incident patients, the coverage rate with disease-modifying drugs was below the prevalence patients (31.5 % vs. 42.1 %). 60.9 % of M05 patients and only 29.7 % of M06 patients received a single DMARD after index diagnosis. If a DMARD has been prescribed, then it was prescribed, on average, within the first quarter of the initial diagnosis. The leading role in the prescription of basic therapies for index medication is provided by the rheumatologist. Nevertheless, 68.3 % of patients consulted a specialist in rheumatology at least once within a year of the first diagnosis. CONCLUSION: The results of this large sample show differences in the guideline recommended prescription of disease-modifying drugs for different subgroups of RA as well as an undersupply in patients not treated by the rheumatologist.

Continuity of treatment with benzodiazepines in dementia patients: an analysis of German health insurance claims data.

Long-term treatment with benzodiazepines (BZD) should be avoided in dementia patients because of an increased risk of adverse events. We evaluated how continuously dementia patients were prescribed BZD over 12 months. For this observational study, we used claims data from a large German public sickness fund for 2014 and 2015, including patients with an incident diagnosis of dementia in 2014. The aim was to evaluate the continuity of treatment, the frequency of BZD prescriptions and defined daily doses were evaluated. In total, 1298 (5.6%) patients received 4.7±5.2 BZD prescriptions in 2015 on average. Thereof, lorazepam (47.5%), oxazepam (18.6%), diazepam (14.5%), and bromazepam (12.2%) were most often prescribed. 30.7% of the patients received at least one BZD prescription in each quarter of 2015. Although the total number of patients receiving BZD decreased in 2015, defined daily doses for single substances remained mainly unchanged. The incident diagnosis of dementia was not associated with modifications of prescription behavior. The treatment with BZD was not discontinued in a large proportion of dementia patients, increasing the risk of adverse events. Physicians' awareness of avoiding BZD should be improved and further evidence for the appropriate treatment of psychiatric symptoms in dementia (e.g. sleep disturbances, anxiety) is required.

Status and perspectives of claims data analyses in Germany-A systematic review.

BACKGROUND: The aim of this article is to evaluate the status, development, and perspectives of German claims data analyses in the international and health political context. METHODS: We conducted a comprehensive literature search in PubMed, Scopus, and DIMDI to identify empirical and methodological articles focusing on health insurance claims data studies published between 2000 and 2014. Inclusion criteria were (1) English/German full text articles or chapters in edited books that (2) focused on the claims data of statutory health insurance funds. FINDINGS: In total, 435 articles were included. Over time, the number of claims data studies has increased strongly and the frequency of policy-relevant research types increased. Along with the historical improvement path of claims data in Germany, we observed a rising percentage of international publications and an increase in the average quality of publications. In contrast to the US or Canada where comprehensive databases have been established, the most common data source in this search was data from a single SHI fund, while databases were rarely used. CONCLUSIONS: Claims data are an important source of information for healthcare stakeholders, and their use for research purposes has further increased during recent years in Germany. Despite its potential in optimising the health system, we found a lack of German comprehensive all-payer claims databases compared to the US and Canada.

Regional differences in health care of patients with inflammatory bowel disease in Germany.

BACKGROUND: The regional availability of specialized physicians is an important aspect in healthcare of patients with IBD. The association between physician density and healthcare is not yet clear. Most studies did not consider district type, which reflects population density. Our research question was, "Do specialist density and district type influence the healthcare of IBD patients in Germany?" METHODS: We combined a claims dataset from a German health insurance fund with population and physician data. Four main aspects were investigated: regular specialist visits, drug therapies, surveillance colonoscopy, and IBD-related hospitalizations. Various regression analyses were performed. RESULTS: The study cohort was comprised of 21,771 individuals, including 9282 patients with Crohn disease and 12,489 patients with ulcerative colitis. Patients who were living in districts with higher specialist densities were more likely to attend specialist visits on a regular basis. No difference in the frequencies of TNF-alpha inhibitor therapies was found. However, individuals from urban areas were more likely to receive a permanent immunosuppressive therapy with continuous specialist support. CONCLUSIONS: The results revealed that some aspects had positive effects on the probability of implementing healthcare in accordance with pathways and guidelines. No clear evidence of a general healthcare undersupply in rural areas was found.

Biologic TNF inhibiting agents for treatment of rheumatoid arthritis: persistence and dosing patterns in Germany.

OBJECTIVE: To obtain detailed real-world data on persistence and dosing patterns in the utilisation of the TNF inhibitors adalimumab, etanercept, and infliximab in rheumatoid arthritis (RA) patients treated in Germany. METHODS: In this retrospective observational study claims data of a major German health insurance fund between 2005 and 2008 were analysed. Patients receiving at least one prescription of adalimumab, etanercept or infliximab were identified and categorised as "TNF inhibitor naive" or "TNF inhibitor continuing". For the calculation of TNF inhibitor persistence a survival analysis with the Kaplan-Meier estimator was used. A Cox regression was used to analyse, if any relevant factors were influencing persistence. Dosage increase rates were analysed for adalimumab, etanercept and infliximab. Sensitivity analyses based on variations in gap length were conducted. RESULTS: A total of 2,201 RA patients were identified. 1,468 of these patients were TNF inhibitor naive patients and 733 were defined as TNF inhibitor continuing patients. There were no significant differences in the treatment persistence rates between adalimumab, etanercept and infliximab for TNF inhibitor naive and continuing patients. The persistence rate after three years was 22.47% for adalimumab, 24.27% for etanercept and 21.49% for infliximab naive patients. For continuing patients, the persistence rate after three years was 32.88% for adalimumab, 30.95% for etanercept, and 33.90% for infliximab, respectively. Gender, medication and Charlson Comorbidities Index did not influence the persistence significantly. Dosage increase occurred in 7.3% adalimumab, 1.4% etanercept, and 17.2% infliximab naive patients and 5.8%, 1.1% and 11.9% respectively in the continuing patients. CONCLUSIONS: In this study, there were no significant differences in persistence among adalimumab, etanercept and infliximab treated patients. Consistent with previous research, there was a higher dose escalation for infliximab than for the two subcutaneous treatments, adalimumab or etanercept.