Resource allocation in health care and the role of personal autonomy.

Resource allocation decisions in health care require the consideration of ethical values. Major ethical theories include Amartya Sen's capability approach, Norman Daniels's theory of justice for health, and preference utilitarian theory. This paper argues that while only preference utilitarian theory explicitly considers the impact of an individual's actions on others, all 3 theories agree in terms of providing individual autonomy. Furthermore, it shows that all 3 theories emphasise the role of informed preferences in securing individual autonomy. Still, stressing personal autonomy has limited direct implications for priority setting. 2 priority rules for resource allocation could be identified: 1) to give priority to patients with mental disability (over those with pure physical disability); and 2) to give priority to patients with a large expected loss of autonomy without treatment.

Cost-effectiveness analysis in health care based on the capability approach.

It is well known that Sen's capability approach and preference utilitarianism have different distributional values. The purpose of this paper is to discuss how Sen's capability approach might be operationalised for allocation decisions and cost-effectiveness analysis in health care. The paper identifies several requirements for measuring health or well-being in line with the capability approach. Among them is the need for objective assessments of capabilities. This paper also shows that from the perspective of the capability approach a portion of productivity changes are irrelevant for allocation decisions.

[Methods of health economic evaluation for health services research]. / Methoden der gesundheitsökonomischen Evaluation in der Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. The present paper focuses on methodological issues of economic evaluation of health care technologies. It complements the Memorandum III "Methods for Health Services Research", part 2. First, general methodological principles of the economic evaluations of health care technologies are outlined. In order to adequately reflect costs and outcomes of health care interventions in the routine health care, data from different sources are required (e. g., comparative efficacy or effectiveness studies, registers, administrative data, etc.). Therefore, various data sources, which might be used for economic evaluations, are presented, and their strengths and limitations are stated. Finally, the need for methodological advancement with regard to data collection and analysis and issues pertaining to communication and dissemination of results of health economic evaluations are discussed.

[Impact of demographic changes on health care expenditure in Germany: an analysis considering the expenditures of decedents]. / Einfluss der demographischen Entwicklung auf Gesundheitsausgaben in Deutschland: Eine Analyse unter Berücksichtigung der Ausgaben Versterbender.

The purpose of this study was to evaluate the impact of demographic changes on future health care expenditure of the German social health insurances considering the expenditures of survivors and decedents by age. The study analysed data from 269,646 members up to the age of 99 years of the AOK - one of Germany's largest social health insurers - in the State of Hesse in 2000/2001. In order to determine future health care expenditures, per-capita expenditures by age for outpatient, inpatient, rehabilitation, and nursing services of survivors and decedents (death within the next 12 months) were multiplied by the estimated number of survivors and decedents by age in Germany in 2020, 2035 und 2050. Expenditures for all ages were summed together. The paper shows that demographic changes until 2050 will lead to an increase of health care expenditures by 20% in total or less than 1% annually. Considering the future re-duction in workforce, demographic changes until 2050 will result in an estimated increase in health care expenditures per employee by about 57% (undifferentiated model). Considering the cost of survivors and decedents separately, this increase will amount to 50%. Hence, undifferentiated models overestimate the impact of demographic changes by about 10%.

[Socioeconomic burden of hip fractures in Germany]. / Sozioökonomische Bedeutung von Hüftfrakturen in Deutschland.

BACKGROUND AND OBJECTIVE: Treatment of hip fractures is a major challenge for the German health-care system due to the increasing incidence, high mortality rate, and need for long-term care. The purpose of this study was to determine the present and future economic burden of hip fractures in Germany. METHODS: Annual costs of hip fractures were determined from a societal perspective, by multiplying individual lifetime costs at different ages by the incidence of hip fractures (incidence-based cost-of-illness study). To calculate individual lifetime costs, a Markov decision model was developed. Secondary data were used. RESULTS: Total annual costs related to hip fractures were euro 2.77 billion. Due to population aging, costs of hip fractures may increase to euro 3.85 billion in 2030. CONCLUSION: The result implies the need to identify effective prevention strategies for hip fractures and evaluate their cost-effectiveness.

Clinical and cost-effectiveness of primary prevention of Type 2 diabetes in a 'real world' routine healthcare setting: model based on the KORA Survey 2000.

AIMS: To analyse the clinical and cost-effectiveness of the primary prevention of Type 2 diabetes in a 'real world' routine healthcare setting using population-based data (KORA Survey in Augsburg, Germany, total population approximately 600,000). METHODS: Decision analytic model, time horizon 3 years. INTERVENTIONS: Staff education, targeted screening and lifestyle modification or metformin in people aged 60-74 years with a body mass index of > or = 24 kg/m(2) and prediabetic status (fasting glucose 5.3-6.9 mmol/l and 2-h post load glucose 7.8-11.0 mmol/l) (target population approximately 72,500), according to the Diabetes Prevention Program trial. MAIN OUTCOME MEASURES: Cases of Type 2 diabetes prevented, cost (Euro), incremental cost-effectiveness ratios (ICERs). RESULTS: Under model assumptions, 14 908 people in the target population would develop diabetes if there was no intervention, 184 cases would be avoided with lifestyle intervention and 42 cases with metformin intervention. From the perspective of statutory health insurance and society, costs for lifestyle modification were 856,507 euro (574,241 pounds) and 4,961,340 euro (3,326,307 pounds), respectively, and for metformin 797,539 euro (534,706 pounds) and 1,335,204 euro(895,181 pounds). Up to 5% of the costs were due to staff education and up to 36% to screening. Lifestyle was more cost effective than metformin. ICERs for lifestyle vs. 'no intervention' were 4664 euro (3127 pounds) and 27,015 euro (18,112 pounds) per case prevented from the statutory health insurance and societal perspective. CONCLUSIONS: Total cost and cost per case of diabetes avoided was high. Staff education and screening had a considerable impact. In view of the low participation in a routine healthcare setting, with both strategies only a small number of cases of diabetes would be prevented. Before implementing the programme, efforts should be made to improve patient participation in order to achieve better clinical and cost-effectiveness of the prevention of Type 2 diabetes in 'real world' clinical practice.

Appropriateness of invasive cardiovascular interventions in German hospitals (2000-2001): an evaluation using the RAND appropriateness criteria.

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.

Direct costs of pediatric diabetes care in Germany and their predictors.

INTRODUCTION: Cost-of-illness study to evaluate diabetes-related direct costs for the care of diabetic children and adolescents in Germany from the perspective of the statutory health insurance. MATERIAL AND METHODS: For all continuously treated patients < 20 years of age from 89 pediatric departments (n = 6437, 52 % male, mean age 12.5 [SD 3.8], diabetes duration 5.2 [3.3] years), diabetes-related hospitalization, ambulatory care, insulin management, glucose self measurement, and treatment with antihypertensive drugs in 2000 were ascertained, as well as metabolic control (HbA1c). Costs per patient-year were calculated in Euros (EUR) based on year 2000 prices. Using multivariate regression, the associations between costs and age, sex, diabetes duration, and metabolic control were evaluated. RESULTS: Mean total costs per patient-year were EUR 2611 (interquartile range 1665 - 2807). Blood glucose self measurement, hospitalization, and insulin accounted for 37 %, 26 %, and 21 % of the costs, respectively, followed by ambulatory care (9 %), injection equipment and glucagon sets (7 %), and treatment with antihypertensive drugs (0.1 %). The total costs were significantly increased for higher age, longer diabetes duration, and higher HbA1c (p < 0.01). The costs for hospitalization were significantly associated with pubertal age (10 - 14 years) and poor metabolic control (HbA1c SDS > 5) (p < 0.001). Based on the present estimations, the total direct costs for the care of all diabetic subjects in Germany < 20 years would be EUR 66.8 (95 % CI 65.4 - 68.1) million in 2000. DISCUSSION: Among the direct medical costs of childhood diabetes, the highest economic burden was due to glucose self measurement, hospitalization, and insulin. The costs were considerably higher in adolescents with poor metabolic control, especially the costs for hospitalization. Outpatient education programs in pediatric diabetes care, in particular targeting children with poor metabolic control, should be encouraged, including their evaluation with respect to cost and effectiveness.

[Prospective observation of abdominal ultrasound in radiological emergency services: approaches to cost saving]. / Prospektive Observationsstudie zur Abdomen-Sonographie im radiologischen Bereitschaftsdienst einer Universitätsklinik: Ansätze zur Rationalisierung.

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.

Effectiveness of the glycoprotein IIb/IIIa antagonist abciximab during percutaneous coronary interventions (PCI) in clinical practice at a single high-volume center.

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.

European comparison of costs and quality in the prevention of secondary complications in Type 2 diabetes mellitus (2000-2001).

AIMS: To compare the out-patient costs and process quality of preventing secondary complications in patients with Type 2 diabetes mellitus in France, Germany, Italy, The Netherlands, Sweden, Switzerland, and the UK. METHODS: A total of 188 European physician practices assessed annual services for one hypothetical average patient (cost evaluation) and 178 practices reported retrospective data on one or two real patients (quality evaluation) in 2000/2001. In countries with a detailed fee-for-service schedule (Germany, Italy, and Switzerland) reimbursement fees were used to approximate costs. These fee-for-service schedules were also used to develop index (average) fees for all countries, in order to measure resource utilization. The following process quality indicators were evaluated: control of HbA1c; control of lipids; urine test for (micro)albuminuria; control of blood pressure; foot examination; neurological examination; eye examination; and patient education. For each country an average quality rating was calculated by weighting the response to each quality indicator with the level of scientific evidence. RESULTS: Average quality ratings ranged from 0.40 in The Netherlands to 0.62 in the UK (0 = lowest rating; 1 = highest rating). Total annual costs for secondary prevention were higher in Switzerland than in Germany and Italy (EUR475, EUR381, and EUR283, respectively). Resource utilization was highest in Germany and lowest in the UK. CONCLUSIONS: The overall quality of preventive services documented was found to be poor in the seven European countries studied. The UK rated as both the most effective and the most efficient country in providing secondary prevention in Type 2 diabetes.

European comparison of costs and quality in the treatment of acute myocardial infarction (2000-2001).

AIMS: To compare the inpatient costs and process quality in the treatment of acute myocardial infarction in France, Germany, Italy, The Netherlands, Sweden, Switzerland, and the U.K. METHODS: A total of 208 European hospitals assessed services for one hypothetical average patient with acute myocardial infarction (cost evaluation) and prospectively followed up one or two real acute myocardial infarction patients (quality evaluation) in 2000/2001. The following cost modules were evaluated: general medicine ward, critical care unit (both personnel costs only), and reperfusion therapy. The following process quality indicators were evaluated: reperfusion therapy; and prescription of aspirin, lidocaine, beta-blockers, and ACE inhibitors. RESULTS: Switzerland, Germany, and France had the highest reperfusion costs due to a relatively high percentage of patients receiving percutaneous transluminal coronary angioplasties, stents, and glycoprotein IIb/IIIa blockers. Personnel costs for general medicine wards and critical care units were highest in Italy and Germany due to relatively long hospital stays. Average quality ratings ranged from 89% in the U.K. and France to 96% in Germany. CONCLUSION: There was little variation in the process quality of care for treating acute myocardial infarction. Differences in resource use may result from differences in the types of reimbursement and in the rates of diffusion of new technology.

[The relationship between provider volume and mortality rate: volume data of German centres of excellence]. / Zusammenhang zwischen Leistungsmenge und Letalitätsrate: Leistungszahlen deutscher "Centres of excellence".

The purpose of this study was to determine the percentage of centres of excellence (COEs) in Germany that achieved, for selected diagnoses and interventions, annual hospital or surgeon threshold volumes associated with a lower mortality rate. A systematic review and evaluation of the literature identified the most relevant study for each diagnosis and intervention selected. Each diagnosis and intervention was only considered if the most relevant source yielded a threshold volume associated with a reduced mortality rate. COEs received questionnaires on the annual volume of such diagnoses and interventions for each department, providing physician (median), and senior consultant in 1999. For most of the diagnoses and interventions considered, the percentage of COEs meeting their respective threshold volumes exceeded 50%. Exceptions were carotid endarterectomy (performed in departments of general cardiac surgery) and liver transplantation. The percentage of providing physicians and senior consultants performing to the desired standard remained above 75% for most of the diagnoses and interventions. Exceptions were surgeons dealing with carotid endarterectomy, correcting congenital heart disease (both performed in departments of general cardiac surgery), and correcting primary hyperparathyroidism. That a smaller percentage of centres for general cardiac surgery, liver transplantation, and primary hyperparathyroidism operates at their threshold volumes may be due to a relative oversupply of centres specialising in these treatments as well as a the lack of regional centres with a high referral rate. Due to the country-specificity of studies performed on the relationship between volume and mortality rate, it is highly recommended that Germany-specific volume-outcome studies be performed particularly in specialties with relatively low case volumes.

Development process of an evidence-based guideline for the treatment of obesity.

OBJECTIVES: To present the development process, summarize the content and discuss the implications of the German evidence-based guideline for the treatment of obesity. DESIGN: The target audience and the development process were defined by a multidisciplinary team of experts. A systematic search of the literature was performed to identify relevant clinical articles. The validity of published studies was systematically evaluated. After developing the draft, an external peer review process was initiated. RESULTS: Three versions of the guideline were published; an expert version, a short version tailored to primary care physicians and a patient version supporting patient participation in the decision-making process. Total development, printing and distribution costs xvere estimated to be 300,000 Euro. CONCLUSIONS: The guideline raises the awareness of obesity and related comorbidities in Germany and may improve the quality of care for obese patients. The development process could serve as an efficient model for other guideline developers.

[Development of an evidence-based questionnaire for evaluating the structural quality of providers]. / Beurteilung der Strukturqualität von Leistungserbringern. Entwicklung eines evidenzbasierten Fragebogens.

The goal of this paper is to present the method used to develop an evidence-based questionnaire for the evaluation of the structural quality of provider institutions. Structural features addressed in the questionnaire are validated by study-based evidence for a relationship with improved outcome quality. For the purpose of identifying relevant studies, a systematic review and evaluation of the literature was performed. The questionnaire contains the following items: continuous medical education with interactive elements (yes/no); use of evidence-based clinical practice guidelines (yes/no); implementation of a computer alert system to prevent injury from adverse drug events (yes/no); and annual diagnosis- or procedure-specific volumes for each department, providing physician, and senior consultant (threshold volume met or not).

A method for assessing the cost-effectiveness and the break-even point of clinical practice guidelines.

Assessing the costs and benefits of developing a clinical practice guideline is important because investments in guidelines compete with investments in other clinical programs. Despite the considerable number of guidelines in many industrialized countries, little is known about their costs and cost-effectiveness. The authors have developed specific measures to determine the cost-effectiveness of guidelines, using a German evidence-based guideline on obesity for the diagnosis and treatment of obese patients as a model. The measures are: the number of people needed to cure, the number of people needed to prevent from developing the disease in question, and the number of people to treat in order to break even.