[Health status of adults in Germany: results from a representative survey using the EuroQol 5D (EQ-5D)]. / Gesundheitszustand bei Erwachsenen in Deutschland: Ergebnisse einer repräsentativen Befragung mit dem EuroQol 5D (EQ-5D).

OBJECTIVE OF THE STUDY: Over the past few years, the discussion on health-related quality of life (HRQL) has increased considerably in Germany as well. HRQL can be assessed by different dimensions of health, and it can be summarised by a single numerical value. This study intends to describe the HRQL of German adults based on individual valuations, to compare the results with those of an earlier study, to investigate the impact of using valuations based on given health states, and as an example of use to analyse socioeconomic differences using the EQ-5D. METHODS: The analyses are based on a representative survey in Germany, conducted by the Wort und Bild Verlag in 2006. HRQL has been assessed by the EuroQol 5D (EQ-5D). In the descriptive part, health was assessed by five descriptive questions. Next, valuations of overall health were elicitated from survey participants using a visual analogue scale (VAS) and, alternatively, taken from a different sample based on the time trade off (TTO) method. Five independent variables were included in the analysis: age, sex, educational level, per capita income, employment status. The results are compared with previous German evidence from the ESEMeD study. RESULTS: Data were retrieved from 1 966 persons (aged 20 years or above); the response rate was 73%. In the descriptive part of the EQ-5D, the prevalence of some problems was especially high in the dimension pain/discomfort (31.9%). In contrast, the prevalence of extreme problems was very low in all five dimensions. The mean VAS value was 79.2. Considering the five dimensions, the VAS values and the TTO score, HRQL was mostly higher for men than for women, and mostly higher for the upper educational groups (as compared with the lower educational groups). Very similar associations were found when the independent variables are mutually controlled for, in logistic regressions (dependent variables: five dimensions) as well as in linear regressions (dependent variables: VAS value or TTO score). The linear regressions also showed that HRQL increases with increasing per capita income. DISCUSSION: The EQ-5D provides a simple instrument for assessing HRQL. It can well detect health inequalities, and the results can be replicated in different studies. More research is needed on the techniques to valuate HRQL in population studies. The EQ-5D provides a tool to assess the HRQL of the German population. New reference figures have been presented for this, and it has been shown how health economic tools and research on health inequalities can be integrated.

Time trends in type 2 diabetes patients' disease management and outcomes: evidence from two KORA surveys in Germany.

To explore time trends in diabetes management and intermediate health outcomes of people with type 2 diabetes, data from two population-based survey studies were compared. The surveys were conducted in the Augsburg region of Southern Germany in 1997/98 and in 2004/05, and included physical examinations, interviews, self-administered questionnaires and laboratory tests. Data from 334 participants aged 40-84 were analysed, including a longitudinal sub-sample of 50 persons. Results show significant time trends towards improvements over the seven year period. Controlling for age, sex, education and duration of diabetes, people felt better informed about diabetes (Odds Ratio (OR) 1.87; 95% CI: 1.12, 3.14) and stated greater adherence to the treatment plan (OR 4.42; CI: 2.62, 7.45) as well as higher participation in diabetes education programmes (OR 2.20; CI: 1.44, 3.38). Mean haemoglobin A1c levels decreased by -0.97% from 7.3% to 6.3% (CI:-0.66%, -1.28%). Physical activity (> or =1 h/week) was more frequent (OR 2.75; CI: 1.65, 4.59), although Body Mass Index increased by 1.43 kg/m (2) (CI: 0.86, 2.00). The positive changes in disease management and metabolic outcomes for type 2 diabetic patients between 1997/98 and 2004/05 indicate a shift towards greater patient involvement in diabetes care and possibly more efficient medical management practices.

[Comments by the Working Group for Methods of Economic Evaluation in Health Care (AG MEG) to IQWiG's Draft Guidelines "Methods for Assessment of the Relation of Benefits to Costs in the German Statutory Health Care System"]. / Stellungnahme der AG Methoden der gesundheitsökonomischen Evaluation (AG MEG) zu dem Methodenpapier "Methodik für die Bewertung von Verhältnissen zwischen Nutzen und Kosten im System der deutschen gesetzlichen Krankenversicherung" des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG).

Since the coming into force of the GKV-Wettbewerbsstärkungsgesetz ("Act to strengthen competition in the statutory health insurance system") in April 2007, the Gemeinsame Bundesausschuss (G-BA "Federal Joint Committee") can commission the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG--Institute for Quality and Efficiency in Health Care") with the assessment of costs and benefits of drugs. In January 2008, IQWiG published a working document for consultation describing the proposed methods for carrying out those evaluations. This commentary by the AG Methoden der Gesundheitsökonomischen Evaluation (AG MEG--"Working Group for methods of economic evaluation in health care") provides a critical appraisal and recommendations for the further development of IQWIG's draft guidelines. The core statements of the commentary are as follows: (1) The draft guidelines are unbalanced. Instead of providing comprehensive methodological guidance for health technology assessment, which is the actual task of IQWiG, they deal predominantly with the methods of technology appraisal which is in the responsibility of the decision-making bodies, i.e. of the G-BA and the Spitzenverband Bund der Krankenkassen ("Central Federal Association of Health Insurance Funds"). (2) IQWiG intends to compare the cost-effectiveness of alternative treatment options only within a given therapeutic area. The rationale for this restriction is not clear, as the decision-makers have to determine ceiling prices across therapeutic areas and diseases and effectively the overall volume of health care expenditure, as well. (3) IQWiG aims at carrying out an economic evaluation only if in a preceding benefit assessment a drug has been judged to be superior. Therefore, it has to be assured that the benefit assessment is performed in such a way that its results may be used for the economic assessment. This requires the application of summary scores for the joint measurement of multidimensional endpoints (as, e.g., QALYs), to evaluate community effectiveness instead of efficacy, and to choose a time horizon that is sufficiently long to reflect any differences in the health benefits between the technologies being compared. Furthermore, the comment hints at some additional problems embodied in the draft guidelines and a number of key methodological issues which are not discussed at all in the working document. In summary, the methods currently proposed by IQWiG are not up to the task of conducting economic evaluations. It is strongly recommended to perform a public consultation process for the revised draft guidelines anew.

[Decisions in case of "problematic" cost-effectiveness ratios based on the example of a clinical trial in rehabilitation care]. / Entscheidungen bei "schwierigen" Kosteneffektivitätsrelationen am Beispiel eines klinischen Versuchs aus der Rehabilitation.

PURPOSE: Economic assessment of an additional psychological intervention in the rehabilitation of patients with chronic low-back pain and evaluation of results by decision makers. METHODS: Piggy-back cost-utility analysis of a randomised clinical trial, including a bootstrap analysis. Costs were measured by using the cost accounting systems of the rehabilitation clinics and by surveying patients. Health-related quality of life was measured using the EQ-5D. Implications of different representations of the decision problem and corresponding decision rules concerning the cost-effectiveness plane are discussed. RESULTS: As compared with the 126 patients of the control arm, the 98 patients in the intervention arm gained 3.5 days in perfect health on average as well as 1219 euro cost saving. However, because of the uncertainty involved, the results of a bootstrap analysis cover all quadrants of the cost-effectiveness plane. Using maximum willingness-to-pay per effect unit gained, decision rules can be defined for parts of the cost-effectiveness plane. These have to be aggregated in a further valuation step. CONCLUSIONS: Study results show that decisions on stochastic economic evaluation results may require an additional valuation step aggregating the various parts of the cost-effectiveness plane.

Validation of the EuroQol questionnaire in cardiac rehabilitation.

OBJECTIVE: To analyse the psychometric properties of the EuroQol questionnaire (EQ-5D) applied to patients with acute coronary syndromes (ACS). SETTING: Rehabilitation hospital. PATIENTS AND DESIGN: 106 consecutive patients with ACS (51% myocardial infarction, 42% coronary artery bypass grafting, 7% angina) completed the EQ-5D, the 36 item short form health survey (SF-36), and the MacNew questionnaire at admission, at discharge, and three months after inpatient cardiac rehabilitation. Acceptance, validity, reliability, and responsiveness of the EQ-5D were tested. RESULTS: The EQ-5D was highly accepted. The EQ-5D index showed substantial ceiling effects after rehabilitation. As expected the EQ-5D visual analogue scale (VAS) score (70.3 v 57.1) and EQ-5D index (77.8 v 64.5) were significantly better for patients with myocardial infarction than for patients who underwent surgery (both p < or = 0.001). Significant correlations were found between the EQ-5D VAS score, EQ-5D index, and domains of the SF-36 (r = 0.21 to r = 0.74). The correlation with the MacNew subscores and with the global score ranged between 0.55 and 0.78. With repeated measurement the EQ-5D showed reasonable reliability in stable patients with intraclass correlation ranging between 0.91 and 0.54. EQ-5D was responsive in patients who indicated improvement in health states between admission and discharge (effect size 0.74-0.82). CONCLUSION: The psychometric properties of the EQ-5D were satisfying. It is a reasonably valid, reliable, and responsive instrument for patients with ACS. It may be useful in clinical research and epidemiological studies to generate preference based valuations of health related quality life.

[Health economic evaluation of rehabilitation programmes in the "rehabilitation sciences" research funding programme in Germany]. / Gesundheitsökonomische Evaluation von Rehabilitationsprogrammen im Förderschwerpunkt Rehabilitationswissenschaften.

A main problem of the German rehabilitation sector is to meet the increasing demand for rehabilitation treatment while available resources are scarce. Thus, health economic evaluation is gaining more importance for decision making in the rehab system. In the "Rehabilitation Sciences" research funding programme the relevance of health economic analyses was recognised from the outset. In nearly all regional networks health economic analyses were conducted - though with different scope. In the first funding period the main focus of health economic evaluation was on (1) patient education programmes and (2) the comparison of inpatient versus outpatient rehabilitation. The projects of the research funding programme have initialised health economic evaluation of rehabilitation in Germany. It was shown that health economics can contribute relevant results for designing rehabilitation concepts. The article concludes with an outlook on the main future questions of rehab economic evaluation.

[Empirical standard costs for health economic evaluation in Germany -- a proposal by the working group methods in health economic evaluation]. / Empirische Bewertungssätze in der gesundheitsökonomischen Evaluation -- ein Vorschlag der AG Methoden der gesundheitsökonomischen Evaluation (AG MEG).

Measurement of health care costs is a crucial task in health economic evaluation. Various guidelines with different amount of details have been set up for costing methods in economic evaluation which, however, do not precisely stipulate how to value resource consumption. In this article we present a proposal for the standardisation of the monetary valuation of health care utilisation occurring in the follow up period after the actual intervention to be evaluated. From a societal perspective the primary direct and indirect cost components are considered, such as outpatient medical care, pharmaceuticals, non-physician health services, inpatient care, days of sick leave and early retirement due to sickness. The standard costs are based on administrative charges and rates or on official statistics. They are based on the most current data sources which are mainly from 2002 and 2003. This system of standard costs aims at an average valuation of resource consumption. This makes for the comparability of different health economic studies. Most standard costs are not based on market prices but on administratively specified charges and rates. This implies that institutional changes which are quite common in the health care system, may also affect the valuation rates, for example the introduction of DRGs. This should be taken into account when updating the system of standard costs.

[Economic rehabilitation management among patients with chronic low back pain]. / Okonomisches Rehabilitationsmanagement bei chronischen Rückenschmerzen.

BACKGROUND AND STUDY PURPOSE: Back pain causes high costs to society. In Germany, these amount to an estimated total of 5 billion euro of direct costs per year and 13 billion euro of indirect costs, the latter being caused by incapacity to work. The purpose of this study is to develop a concept for economic rehabilitation management. This concept is based on the managed care approach and aims at improving efficiency of care. METHODS: The concept development consists of a theoretical and an empirical part. The method of the theoretical part is based on a systematic literature review on managed care (not included in this article), health systems research and the analysis of economic incentives. For the empirical investigation, long term effects and costs were calculated. For the evaluation of effects, we psychometrically tested and used the EuroQol (EQ-5D) as a measure of health-related quality of life (HRQL). The calculation of costs (both direct and indirect) is based on routine data of payers, a cost diary and the internal cost accounting systems of rehabilitation clinics. We statistically analysed the cost distribution and identified predictors of the management targets (e.g., costs of care) by means of regression analyses. RESULTS: The market-driven managed care approach is based on three tools: (1) a primary care system with case management and gatekeeping, (2) direct influence on providers by utilisation review and setting guidelines, and (3) indirect influence by setting supply-side economic incentives via the remuneration mode. The third managed care tool is most important when managing the rehabilitation of working age patients with chronic low back pain from an economic point of view. This concept consists of three components: (1) a case-based budget for direct costs; this is a prospective remuneration mode for an integrated primary care network including a rehabilitation facility, (2) retrospective bonus payments which are related to savings of indirect costs, and (3) retrospective bonus payments which are related to the effectiveness of rehabilitation, i.e. gains in HRQL. Common features of the three management components are a long-term perspective (e.g., from admission to a rehabilitation clinic until six months after discharge) and risk-adjustment of the three management targets (i.e., direct and indirect costs and gains in HRQL) in order to avoid selection and to limit the financial risk for providers. The EuroQol instrument shows acceptable psychometric properties in the rehabilitation setting for back pain patients. This instrument may yield two kinds of preference-based index values, one reflecting the preferences of the general population and one those of the patient. The Pearson correlation of these two approaches is fair, but there is a systematic difference. Empirical investigation shows that the distribution of both direct and indirect costs is skewed to the right. Statistically relevant predictors of the management targets are incapacity to work and HRQL at admission. CONCLUSIONS: Economic rehabilitation management might help to save money and to improve health outcomes, thus increasing the efficiency of care. The results of our empirical studies show the feasibility of tools for the economic management of rehabilitation. Risk adjustment of the management components is of paramount importance.

Ciclosporin and prednisone v. prednisone in treatment of Graves' ophthalmopathy: a controlled, randomized and prospective study.

Forty patients with Graves' ophthalmopathy stages III-V were divided into two groups in a random manner according to their year of birth. Group I received prednisone in decreasing dosage. Group II received prednisone at a comparable dosage and ciclosporin. Steroids were discontinued after 10 weeks in the two groups. In the patients of group II, ciclosporin was continued over 12 months. The therapeutic effect was assessed by an activity score based on subjective and objective symptoms (computerized tomography and sonography of the orbit, Hertel values, clinical findings). All signs of endocrine ophthalmopathy improved significantly in both groups (P less than 0.01 in group I; P less than 0.001 in group II). The improvement was significantly greater in group II (P less than 0.05) according to the predefined score. After corticosteroids were discontinued, inflammatory signs recurred in nine patients in group I and in one of group II. During the observation period of 12 months, relapses occurred in eight out of twenty patients in group I and in only one out of twenty in group II. Muscle thickness decreased in nine patients in group II, 6 months after beginning therapy. At this time, the results were not influenced in any of the twenty patients in group I. Microsomal antibodies decreased significantly (P less than 0.001) in the ciclosporin group, whereas no change was seen in the other group. Renal values rose within the normal range in group II. In this group, an infection with Klebsiella pneumoniae occurred in one patient after 4 months of therapy.(ABSTRACT TRUNCATED AT 250 WORDS)