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For decreasing the risk of coronary heart disease (CHD) it has been proposed to enrich food such as margarine with plant sterol esters which have been shown to reduce total and LDL cholesterol concentrations, two of the major risk factors. A Markov model was developed to assess the costs and benefits of consuming a low-fat plant sterol containing margarine (PS margarine). A health insurer's perspective was taken with a time frame of 10 years. Transition probabilities for CHD and CHD-related death were calculated on the basis of the Framingham risk equations. These were applied to a representative sample of the German population. The alteration in cholesterol levels after intake of PS margarine was estimated based on a meta-analysis of ten randomized controlled trials with parallel or crossover design that found a reduction of 5.7% in total cholesterol. Average annual costs of CHD were assumed to be at 3,000 euro. Costs for "no CHD" and "CHD-related death" were set to 0 euro since the intervention would solely be paid by the consumers. Sensitivity analyses were performed with regard to annual costs, risk estimation, PS margarine reduction in total cholesterol, discount factor, and risk of CHD-related death. The 10-year CHD risks are 6.1% (PS margarine) vs. 6.5% (control). Thus expected 10-year CHD costs are 696 euro (PS margarine) vs. 748 euro (control). The cost savings of 52 euro varied between 32 euro and 74 euro in the sensitivity analysis. A projection at the level of the population for which evidence (randomized controlled trials) exists that plant sterols lower cholesterol (25.35 million) leads to a reduction of 117,000 CHD cases over 10 years and a cost reduction of 1.3 billion euro for this time period (sensitivity analysis 0.8-1.9 billion euro).

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The purpose of this study is to analyse the recent development of tobacco taxes and demand for cigarettes in Germany and to describe consequences for health policy. A descriptive analysis of aggregated data of the Federal Statistical Office is used to show the development of tax income and consumer behaviour with regard to the degree of substitution between differently taxed tobacco products. From 1993 to 2002 the demand for cigarettes increased nearly continuously. In 2003 the demand for industrial cigarettes went down by 8.6% and in 2004 by 15.8%. The difference between taxes and prices of industrial cigarettes and substitutes increased over the time period and still continues to increase. Tax and price differences between tobacco products led to partial compensation of the decreasing demand for industrial cigarettes. Therefore a tax increase on substitute products like fine cut tobacco is recommended. There is still a lack of longitudinal epidemiological data on smoking behaviour in Germany that could affirm effects of tobacco taxation.

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OBJECTIVE: This population-based study assesses the prevalence and cost of illness as a result of diabetes mellitus in Germany by retrospectively analysing routine health insurance data. Prevalence and costs were analysed from statutory health insurance (GKV) and societal perspectives. RESEARCH DESIGN AND METHODS: The analysis comprises data of all insured persons of six large sickness funds. The insured with diabetes were identified via ICD-9 diagnosis and Anatomical Therapeutic Chemical Classification System (ATC) code for regular medication prescriptions. Costs for inpatient stay, medication and sickness benefits were taken from claims data. Costs for rehabilitation, premature death and early retirement were calculated using the human capital approach and data from national statistics. RESULTS: Overall diabetes prevalence in this age and sex standardized census of six large sickness funds was 6.45%. The cost of illness for sickness funds including hospital cost, medication and sickness benefits, and excluding ambulatory doctor care, were Euro 3.69bn . The total cost of diabetes from a societal perspective was calculated at Euro 5.71bn for the year 1999. CONCLUSION: In accordance with the results of recent studies using routinely collected health insurance data, our study suggests that the prevalence of diabetes mellitus has increased steadily in the past years. The prevalence in our population of 14.7 million insured was 6.45%. Total costs of diabetes mellitus amounted to Euro 5.71bn.

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It is generally accepted that the incidence of coronary heart disease can effectively be reduced by strengthening prevention. At the same time, it is still unclear how large the effects of life-style oriented preventive measurements such as diet and exercising are in everyday life. Furthermore, there is an ongoing debate on what measurements are effective. Thus, against the background of dwindling financial resources in health care the input of health economic evaluation is explicated. General issues of health economic evaluation are presented. After that, an overview on the current findings of cost-effectiveness in primary prevention of coronary heart disease is given. Risk factors are separately discussed. It is demonstrated that preventive measurements dealing especially with hypertension and hypercholesterolemia can be cost-effective.

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There is quite some ethical controversy on Evidence-based Medicine (EbM) with regard to issues of physician autonomy as well as its allocative implications. Yet, there are some shortcomings in the current debate. First of all, some of the arguments brought up against EbM are similarly defaults of "classical medicine" as well, for instance its negligence of social aspects of medicine. Second, it is often maintained that EbM is just a tool to attain cost containment. This argument is false in two regards for neither is there any idea of cutting costs in the roots of EbM nor does EbM once practiced necessarily lead to less costs as there can be underuse as well as overuse. Third, both opponents and proponents of EbM come up with the same arguments against each other. Both maintain that the other way of practicing medicine does not allow for physicians' autonomy and free judgment. Therefore, we are going to search for the different presuppositions on which these "reproaches" rely. In this way we can demonstrate that both opponents and proponents rely on different notions of autonomy and free judgment in their argument. Finally, we hope to show that some of the ethical criticism may be raised against classical medicine as well and that allocation in terms of costs is not primarily an aim of EbM.

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The purpose of this study was to estimate the prevalence and cost of illness of asthma in Germany by retrospectively analysing routine health insurance data. This analysis investigated claims data from all insured persons of six large sickness funds. Insurants with asthma were identified via the International Classification of Diseases (ninth revision) diagnosis and the Anatomical Therapeutic Chemical Classification System Code for regular medication prescriptions. Costs for hospital care, medication and sick benefit were taken from claims data. Costs for rehabilitation, premature death and early retirement were estimated using the human capital approach and data from national statistics. Prevalence of asthma in the German statutory health insurance was 6.34%. Total costs for asthma, including direct and indirect costs, were calculated at euro 2.74 billion during 1999. The prevalence of asthma in the German statutory health insurance has previously been estimated to be 4-6%. The results of this large study show the prevalence of asthma in the German social insurance system to be approximately 6%. The study also indicates that there is room for substantial savings in the German social insurance system, with indirect costs amounting to 74.8% of total costs and payment of sick benefits through the sickness funds amounting to 58.3% of indirect costs. These costs may be reduced with better asthma control in patients.

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OBJECTIVE: Germany has the highest per capita rate of percutaneous transluminal coronary angioplasties (PTCAs) in Europe and the third highest per capita rate of heart surgeries requiring a heart-lung machine. The goal of this study was to evaluate the appropriateness of PTCA, coronary artery bypass graft (CABG), and carotid endarterectomy (CEA) in German hospitals using RAND appropriateness criteria. METHODS: A retrospective study in 121 randomly selected German hospitals (52 % of all hospitals contacted) was performed from December 2000 to August 2001. A total of 361 patients were enrolled providing information on the appropriateness of 128 PTCAs, 92 CABGs, and 141 CEAs. RESULTS: Inappropriateness rates were 2 % (95 % CI 0 - 5 %), 4 % (95 % CI 1 - 9 %), and 3 % (95 % CI 1 - 7 %) for PTCA, CABG, and CEA, respectively. The overall rate of uncertain procedures was 42 % (95 % CI 36 - 47 %). Only 38 % (95 % CI 32 - 45 %) of patients who received a coronary intervention had had a pre-interventional stress test. CONCLUSIONS: The study yielded little overt overuse in the performance of PTCAs, CABGs, and CEAs, but potentially large underuse of stress tests. Despite a high per capita rate of invasive cardiovascular interventions in Germany, the rate of inappropriate procedures was not larger than in other countries.

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BACKGROUND: Outpatient clinics of university hospitals (Hochschulambulanzen) play a significant role in the German health care system. Universities have in contrast to other hospitals the right to implement an outpatient clinic, but the health care services they can render are restricted to clinical research and teaching activities. The university outpatient clinic study evaluates the intensity of medical care, teaching, research activities, and the related costs. METHOD AND DATABASE: 6 university hospitals with 51 outpatient departments in Germany were included. The prospective documentation of consultations was restricted to 800 visits per department. A total of 26,312 consultations with approximately 40,000 diagnoses and 150,000 services were documented. Furthermore, data concerning costs, teaching activities and research facilities were documented. RESULTS: Clinical treatment without any correlation to research or teaching activities amounted to about 81 % of the working time in the outpatient department (research 11 %; teaching 8 %). The primary task of the university outpatient clinics takes up less than 20 % of the working time. The physicians documented that the disease of every fourth visit was in accordance with their main field of research. 6.9 % of the visits were asked to take part in clinical trials, of these 1.25 % were included for the first time, 3.7 % were already included. 6.5 % of the visits were addressed to participate in specific teaching activities. The average total costs per case added up to 149 Euro. No outpatient clinic could cover the total per case costs with the lump sum payments. On the average 31 % of these costs were covered by lump sum payments (without cases concerning research and teaching). CONCLUSION: Treatment in outpatient departments of university clinics is far beyond research and teaching activities required by law. However, the ability of outpatient departments of universities to provide excellent outpatient services should have a more dominant role in the health care system. Therefore access to care should be deregulated for the patients and reimbursement schemes should be adjusted to adjust for the present losses.

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Increasing medical complexity, centrifugal forces of medical subspecialization and growing economic constraints are the key reasons for the introduction of quality management into routine care processes such as dialysis. Adequate quality assurance and improvement must be implemented in order to supply medical staff, care providers, and patients with the necessary information on critical issues of clinical management of dialysis patients. QiN (Quality in Nephrology), the quality management program of the largest German dialysis provider, is outlined here as a practicable example. The first of 2 parts provides information on the structure, implementation of QiN and achieved clinical improvement in routine care. The second part (quotation) analyzes longitudinal data in order to differentiate whether observed improvements during more than 5 years of QiN can be ascribed to the intervention (application of QiN) or whether they are due to other factors such as generally improved medical knowledge.

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BACKGROUND: Sibutramine is a selective serotonin and noradrenaline reuptake inhibitor that is known to reduce body weight. The efficacy of this drug in primary care medicine is currently unknown. OBJECTIVE: To study, in a primary healthcare setting, the effect of a standardized non-pharmacological treatment program and 15 mg sibutramine or placebo on long-term weight reduction in obese subjects with a body mass index >or= 30 and < 40 kg/m(2). DESIGN: A multicentre, double-blind, placebo-controlled, randomized, parallel group comparison over 54 weeks of continuous therapy. SETTING: 33 general practitioners in Germany. SUBJECTS: 389 obese patients were recruited of whom 362 were randomized. MEASUREMENTS: Primary measure was weight reduction at week 54; others included reduction in BMI, waist circumference, waist-hip ratio, blood pressure and blood lipids. RESULTS: 348 obese subjects were analyzed using an intention-to-treat analysis. Mean weight loss in the sibutramine (S) group was 8.1 +/- 8.2 kg vs. 5.1 +/- 6.5 kg in the placebo (P) group (p < 0.001; Intent-to-treat analysis). More subjects lost more than 5 % and 10 % of initial weight with sibutramine than with placebo (5 %, S: 62.6 %, P: 41.4 %, p < 0.001; 10 %, S: 40.8, P: 19.0 %, p < 0.001). Weight loss was accompanied by an improvement in the lipid profile, in particular, an increase in HDL-cholesterol and a decrease in fasting triglycerides. In both groups, systolic and diastolic blood pressure decreased in those with moderate hypertension and remained unchanged in those with normal blood pressure at baseline. There was a modest increase in heart rate in S (1.9 beats/min) vs. P (- 0.9 beats/min) (p < 0.05). CONCLUSIONS: Under primary care conditions, sibutramine 15 mg daily proved to be a safe and effective drug for additional weight loss in obese subjects undergoing a comprehensive weight reduction program.

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Ambulatory and short-stay surgery in Germany are regulated by two different political committees with different members. Currently, hospitals are permitted to practice ambulatory surgery on the basis of a mere notification sent to the health insurance companies. The details for access, reimbursement, and quality assurance are negotiated between the hospitals' association, the health insurance companies, and the association of the physicians. Compared to other fields of ambulatory care, the legislation for ambulatory surgery is rather loose concerning hospitals' access to this field of health care provision. Short-stay surgery is designated under inpatient care. With the introduction of so-called diagnosis-related groups (DRG) in 2003, a steep decline in length of stay is expected. Further efforts of the government and health insurance companies to extend ambulatory surgery to further indications are expected, too. However, the hurdle of transferring services from the inpatient sector to the ambulatory sector is a major challenge in Germany. We recommend lowering the legislative hurdle hindering hospitals and physicians from entering the area of ambulatory surgery for specific diagnoses. Same-day treatment should also be encouraged.

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Disease management programmes will increasingly be introduced in Germany due to the new risk adjustment scheme. The first disease management programmes started in 2003 for breast cancer and diabetes mellitus type II. German rehabilitation will have to face several challenges. Disease management programmes are strongly based on the notion of Evidence so that proof of the efficacy of a care giving task should be present. Verification of the evidence of the specifically German rehabilitation treatments must therefore be given. However, integration of rehabilitation in disease management programmes could lead to changes in the alignment of German rehabilitation. The essence of German rehabilitation, notably its holistic approach, could get lost with integration in disease management programmes.

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PURPOSE: To analyze prospectively abdominal ultrasound in an emergency department (ED) with special emphasis on different routes of obtaining radiology service, reasons for consultation and ordering diagnosis, and to identify strategies for realizing cost savings. MATERIALS AND METHODS: Over a three-month period, the course of events of 295 patients, who entered the ED and underwent on-call sonography, was recorded from the initial presentation to the commencement of treatment, and the results were subsequently evaluated. RESULTS: Of all patients sonographically examined in the ED, 60 % had no prior contact to ambulatory medical services (self-referred, S), 15 % had been sent by a physician (physician-referred, P), and 25 % were inpatients. The most frequent reason for consultation was acute abdominal pain in self-referred patients (70 %) and blunt abdominal trauma in physician-referred patients (70 %). Sonography for acute abdominal pain was considered indicated by the examining radiologist prior to the examination in 90 % (P) and 70 % (S). Sonography contributed to the diagnosis in 44 % (P) and 22 % (S). Patients had to be hospitalized in 80 % (P) and 40 % (S), and needed immediate treatment in 78 % (P) and 43 % (S). Sonography after blunt abdominal trauma was considered appropriate in 90 % (P) and 65 % (S). Diagnostic information was obtained in 90 % (P) and 88 % (S), and therapeutic interventions were required in 10 % (P) and 0 % (S). The admission rate was 97 % (P) and 29 % (S), respectively. CONCLUSIONS: In the ED, sonography was performed with significantly lower clinical effectiveness on self-referred than on physician-referred patients. Substantial cost-savings could be achieved by more selective use of abdominal sonography for self-referred patients.

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OBJECTIVE: Randomized controlled trials (RCTs) showed that the glycoprotein (GP) IIb/IIIa antagonist abciximab is able to reduce ischemic complications during percutaneous transluminal coronary interventions (PCIs). Its effectiveness in daily clinical practice in unselected patients remains to be determined. DESIGN, SETTING AND PATIENTS: From 7/1997 until 12/2000, 3310 PCIs were performed at the Heart Center Ludwigshafen. Out of them, 1076 (32.5%) patients were nonrandomly treated with a GP IIb/ IIa antagonist. Patients who were treated with abciximab were matched with patients not treated with abciximab. The matching procedure resulted in 590 pairs of patients. RESULTS: Patients treated with abciximab were more likely to have a history of former PCI (13.7% versus 8.8%, p=0.008) or coronary artery bypass surgery (19.2% versus 12.8%, p=0.003). There were no differences in concomitant diseases, left ventricular function, number of vessels diseased or target vessel. However, patients treated with abciximab had a higher rate of more complex stenosis (> or =B2; 94.4% versus 80.7%, p<0.001) and a longer x-ray exposition (median 486 s versus 422 s, p<0.001). Treatment with abciximab was associated with a significantly lower incidence of the combined endpoint of death, reinfarction or stroke during the hospital stay (2.4% versus 4.4%, p=0.039). This was confirmed after adjustment for confounding parameters (p=0.034). There was no increase in the rate of severe bleeding in the abciximab group (p=0.347). After one year the rates for the combined endpoint were 8.5% in the control group and 6.2% in the abciximab group (univariate analysis, p=0.134; multivariate analysis, p=0.143). CONCLUSION: Treatment with abciximab during PCI in daily clinical practice at a high volume center in patients with a high rate of acute coronary syndromes seems to be as effective as shown in RCTs.

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After introducing DRGs (Diagnosis-Related Groups) in the prospective payment system for German hospitals, the use of per-case reimbursement for medical rehabilitation as well is being discussed. In particular two systems have already been tested internationally. FIM-FRG were especially developed for a prospective payment system for inpatient rehabilitation facilities. RUG-III are used for reimbursing long-term care in nursing homes and are based on a per-day payment. It is recommended to test the FIM-FRG or one of the refined systems in Germany in a pilot project.

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PURPOSE: In the state of North Rhine-Westphalia (NRW), Germany, a survey was conducted on radiologic examinations ordered by general practitioners (GPs). Part II of this study aims to determine the quality of the process and outcome. The reference standard is the assessment of both radiologists and physicians without board certification in radiology working at a university hospital and in outpatient facilities. MATERIALS AND METHODS: AllGPs in NRW were asked to cooperate. Participating GPs filled out a questionnaire for each patient. The patients recorded the symptoms prompting the imaging examinations. The radiologists or other physicians performing the examinations were asked to provide the images and written reports and to complete a questionnaire. A file was created for each of the 394 patients with image documentation of at least one examination. Each file, which included medical history, physical findings, imaging documentation and written report, was sequentially forwarded to a board-certified radiologist and to a physician without board certification in radiology working in a university hospital and in an outpatient facility. All physicians were requested to complete a structured questionnaire for each file. RESULTS: The referral diagnoses were rated as medically plausible in 81%, the indications for imaging found correct in 76%, the examination techniques considered appropriate in 69%, the clinical question answered in 63%, the interpretation judged medically correct in 50% and all incidental findings documented in 49%. In retrospect, 32 % of the examinations were judged superfluous. The sequence of multiple examinations performed on a particular patient was rated as appropriate in 51%. The interpretation revealed specialty-related differences. The plausibility of the referral diagnoses had a significant impact on the appropriateness of subsequent diagnostic investigations. Marked deficits showed sonography, performance by non-radiologists, self-referrals by GPs, gastroenterologic radiology and the ICD-10 coding (suspicion of cardiovascular disease). CONCLUSION: In the "best-case" scenario, the process quality proved to have moderate deficiencies and the outcome quality severe deficiencies. In consequence, GPs and radiologists should be more communicative by sharing information and exchanging opinions. GP self-referrals should be restricted. Sonography and examinations performed by physicians without board certification in radiology should undergo stricter quality controls. A more intensive interdisciplinary collaboration is needed to determine the optimum implementation of diagnostic imaging of gastroenterologic and cardiovascular diseases.

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