Sustainable reduction of antibiotic-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomised trial.

BACKGROUND: Despite many initiatives to enhance the rational use of antibiotics, there remains substantial room for improvement. The overall aim of this study is to optimise the appropriate use of antibiotics in German ambulatory care in patients with acute non-complicated infections (respiratory tract infections, such as bronchitis, sinusitis, tonsillitis and otitis media), community-acquired pneumonia and non-complicated cystitis, in order to counter the advancing antimicrobial resistance development. METHODS: A three-armed cluster randomised trial will be conducted in 14 practice networks in two German federal states (Bavaria and North Rhine-Westphalia) and an added cohort that reflects standard care. The trial is accompanied by a process evaluation. Each arm will receive a different set of implementation strategies. Arm A receives a standard set, comprising of e-learning on communication with patients and quality circles with data-based feedback for physicians, information campaigns for the public, patient information material and performance-based additional reimbursement. Arm B receives this standard set plus e-learning on communication with patients and quality circles with data-based feedback tailored for non-physician health professionals of the practice team and information material for tablet computers (culture sensitive). Arm C receives the standard set as well as a computerised decision support system and quality circles in local multidisciplinary groups. The study aims to recruit 193 practices which will provide data on 23,934 patients each year (47,867 patients in total). The outcome evaluation is based on claims data and refers to established indicators of the European Surveillance of Antimicrobial Consumption Network (ESAC-Net). Primary and secondary outcomes relate to prescribing of antibiotics, which will be analysed in multivariate regression models. The process evaluation is based on interviews with surveys among physicians, non-physician health professionals of the practice team and stakeholders. A patient survey is conducted in one of the study arms. Interview data will be qualitatively analysed using thematic framework analysis. Survey data of physicians, non-physician health professionals of the practice team and patients will use descriptive and exploratory statistics for analysis. DISCUSSION: The ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046 . Registered 24 August 2017.

[Antihypertensive pharmacotherapy of patients in primary care with either a statutory or private health insurance]. / Antihypertensive medikamentöse Therapie von gesetzlich und privat versicherten Patienten in der Primärversorgung.

BACKGROUND AND PURPOSE: In Germany, hypertension has a prevalence of about 20%. Cardiovascular morbidity and mortality are closely associated with hypertension. Therefore, antihypertensive medical treatment is of crucial importance. Currently, five groups of drugs for the medical treatment of hypertension are available: diuretics, beta-receptor blockers, calcium antagonists, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers. Besides medical considerations for the treatment of hypertension costs of treatment and other economic aspects become more and more important. Within this article, the antihypertensive treatment of insurants of the statutory health insurance and the private health insurance is compared with regard to the medical treatment and associated costs. METHODS: The analyzed data derive from the general practice morbidity research network CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork). The implementation of this network is funded by the German Federal Ministry of Research and Education (BMBF) for a continuous registration of health-care utilization, morbidity, course of disease, and outcome parameters within primary care. RESULTS: Altogether 4,842 patients from the participating general practitioners were regularly treated with antihypertensive drugs in 2007 and corresponding episodes were documented within electronic medical records. The proportion of insurants of the private health insurance was 7.6%. The costs of the antihypertensive medical treatment within the total sample in 2007 constituted 1.03 million Euros overall and per patient on average 212.82 Euros. Although the regarded sample of private health insurants was less morbid and the sum of defined daily doses (DDDs) within the observation period was notably lower (582.6 vs. 703.1; p < 0.0001), the annual therapy costs of the private health insurants compared to the statutory health insurants were 35.2% higher (280.29 Euros vs. 207.29 Euros; p < 0.0001). Hence, costs per DDD for antihypertensive medical treatment for private health insurants were 63.2% higher than for statutory health insurants. This refers to the great proportion of angiotensin II receptor blockers as well as the low proportion of generic drugs prescribed for private health insurants. CONCLUSION: Antihypertensive treatment with original drugs and/or angiotensin II receptor blockers is an expensive option. Based on the actual state of knowledge it must be questioned critically whether this constitutes a superior treatment option concerning the potential for lowering high blood pressure levels and organ protection.