[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.

[SIMBO: a Screening Instrument for Identification of Work-Related Disabilities--analyses of construct and prognostic validity]. / SIMBO: Ein Screening-Instrument zur Feststellung des Bedarfs an Medizinisch-Beruflich Orientierten Massnahmen in der medizinischen Rehabilitation--Analysen zur Konstruktvalidität und Prognosegüte.

BACKGROUND: For a number of years, work-related interventions in medical rehabilitation (MBO) have been developed. Basically, these interventions concentrate on vocational problems of rehabilitees whose health disorders are strongly associated with contextual factors of the environment as well as personal factors. Previous studies showed a close relationship between the success of an intervention and identification of a specific demand. In fact there are several clinical concepts regarding specific demand. But there still is a lack of appropriate instruments for use in identification of occupational challenges. Therefore SIMBO (Screening Instrument for Identification of a Demand for Medical-Vocational Oriented Rehabilitation) has been developed recently. By using a scale for the intensity of work-related problems as well as a cut-off point, SIMBO is able to identify patients with and without a demand for work-related interventions. METHOD: Analyses relative to construct validity and predictive validity were carried out on two different samples--a multi-clinic sample (patients with musculoskeletal disorders) and a sample from the German statutory pension insurance agency DRV Westfalen (successful applications for medical rehabilitation). In this context the cut-off level discussion is very important. RESULTS: By means of the multi-clinic sample--irrespective of cut-off definition--the SIMBO-decision and the clinical identification of MBO-demand were found to agree in 74-78% of the cases. This corresponds to a maximum adjusted correlation of r=0.59 (phi coefficient). Compared to the external ratings of vocational problems given by DRV staff in handling the applications, however, only little agreement is found (64%, r=0.25). In fact, SIMBO had in 77% (r=0.50) of the cases been able to correctly predict work-related problems to be expected. So the result obtained using this instrument is far better than prediction of these problems in the external ratings by DRV staff (54%, r=0,21). Also, return to work (RTW) in good health after six months can be predicted correctly by SIMBO in 77% of the cases. This means that the probability of RTW in good health is reduced by 90% (Odds Ratio=0.1) if work-related problems had been identified by SIMBO. DISCUSSION AND CONCLUSION: Concerning its clinical as well as predictive quality, the validity of SIMBO-based ratings of work-related problems has been proven. Further, it has become obvious that SIMBO is suitable as an easy-to-handle tool for identification of a need for vocationally-focused interventions for use by the social insurance agencies which finance rehabilitation. Further interesting questions arise relative to application in different indications as well as potential uses as an outcome instrument.

[Effects of work-related medical rehabilitation in patients with musculoskeletal disorders]. / Effekte berufsbezogener Behandlungselemente in der orthopädischen Rehabilitation der Rentenversicherung. Ergebnisse einer randomisierten Verlaufsstudie.

A work-related orientation within medical rehabilitation represents concepts with a stronger focus on the patient's individual vocational requirements and is based on different vocationally-orientated strategies of treatment. "Medical Occupational Orientation" ("Medizinisch-berufliche Orientierung", MBO), the model of Klinik Niedersachsen in Bad Nenndorf, places Functional Capacity Evaluation according to Susan Isernhagen (EFL) at the centre of rehabilitation diagnostics and therapy. This study investigates the effects of the MBO model relative to activities and vocational participation of patients with musculoskeletal disorders faced with vocational problems and on management at the interface between medical and vocational rehabilitation. Presented are findings of a randomized follow-up study aimed at evaluating the MBO model. A total of 494 patients of LVA Westfalen, a regional insurance agency, took part. A need for MBO was diagnosed for 222 patients. These patients were randomly assigned either to the MBO model of treatment (experimental group --> U[+]) or to the conventional medical treatment (control group --> K[+]). Patients without a need for MBO (U[-], K[-]) were treated likewise. The written questionings took place at the beginning (t (1)) and end of rehabilitation (t (2)), as well as six (t (3)) and twelve months (t (4)) after the patients' discharge. Currently, the results are based on the 6-month follow-up. Concerning the activities, an MBO-related effect in the experimental group (U[+]) has been found for the Pain Disability Index (PDI), effect sizes being d (u+) = 0.82; d (k+) = 0.17. The risk of unemployment six months after rehabilitation is decreased for MBO(+) patients who participated in the MBO model. In addition, the clinic can make effective prognosis concerning subsequent participation in vocational rehabilitation for both experimental groups (U[+], U[-]). Established for the first time in a randomized controlled trial, the findings presented show that patients with musculoskeletal disorders who are faced with particular vocational problems will achieve significantly better results concerning activities and vocational reintegration if their medical rehabilitation had been based upon an EFL-centred MBO approach.

[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.

[Occupational orientation in medical rehabilitation and measures for participation in the professional life]. / Berufliche Orientierung in der medizinischen Rehabilitation und Leistungen zur Teilhabe am Arbeitsleben.

Return-to-work and protection of work-related participation is stated as a primary objective of rehabilitation by the statutory pension insurance institutes. A general continuous management of work-related participation in rehabilitation is a prerequisite for optimal results in view of stay in work and return to work. This means an extended vocational orientation in medical rehabilitation, individualized occupational rehabilitation according to need and capacity in connection with closer linkages between medical and occupational rehabilitation. In the course of the "Rehabilitation Sciences" research funding programme and beyond it, quite a few research projects and scientific activities aimed at development, testing and evaluation of -new screenings and diagnostic instruments with better findings of vocational related needs in medical and occupational rehabilitation, -specific methods of therapy and models for treatment settings with immediate reference to the work related restriction and capacity, as well as -models of the organization and forms of cooperation between medical and occupational rehabilitation. This paper reviews the projects and findings in these research fields in relation to the requirements for an increase of general continuous vocational orientation in rehabilitation.

[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.

[Demographic and curative factors of need for rehabilitation--possibilities and limits of simple time series models]. / Demographische und kurative Bedingungsfaktoren des Reha-Bedarfs--Möglichkeiten und Grenzen von einfachen Zeitreihenmodellen.

Regarding rehabilitation demands, macro-analytical time-series models outline a method for the estimation of effective rehabilitation needs and for explaining the magnitude of the requirements. Their range is limited, in so far as they are unable to clarify the rehabilitation requirement regarding individual micro-level behavioural aspects. For the moment the rehabilitation requirements are hidden units in the models. Differing macro-dimensions have been gradually included in the analysis. The demographic parameters of the potential patients in need of rehabilitation are the fundamental starting point. Rehabilitation requirements are increasingly modelled by the magnitude of the curative requirements. These are characterised in the rehabilitation as "preliminary or follow up". Two examples of simple time-series models in rehabilitation--for the development of rehabilitation demand--illustrate empirically, which possibilities and boundaries are set in view of demographic and curative requirements by the interpretative range of the macro-concepts. What is methodically interesting with it, is how the analytical borders of such time-series models can experience a recognisable theoretical broadening, through a projection in real logistical facts--here in the interaction between prognosis and retrospection.

[Concept and measurement of need for rehabilitation--framework for a multidimensional investigational approach]. / Zum Begriff und zur Messbarkeit der Rehabilitationsbedürftigkeit--Ein Rahmenkonzept für einen mehrdimensionalen Untersuchungsansatz.

As before the concept and content regarding the need for rehabilitation have still not been sufficiently clarified. In particular, an operationalization of the underlying parameters, as the basis for their measurement is absent. Some exemplary research concepts have been introduced and their methodological implications have been put out. Resulting from this, up till now, in the most developed model, determining the need for rehabilitation has been developed as a latent multi-dimensional variable. A framework, as a starting point for a multi-dimensional investigation regarding the need for rehabilitation has been introduced. According to this, the need for rehabilitation is a multidimensional, qualitative construct, that can not be directly observed and measured. The empirical investigation, which is based on this, limits the description of the need for rehabilitation to the various patterns of determinants, (description by a set of requirement factors and arranged factors) which result in different effects. Therefore different samples regarding the qualitative aspect do not mean the lesser or greater need for rehabilitation based on a continuum of measurement, but different qualitative forms which are visible in different effects.

[Assessment of long-term needs and expenditures development for rehabilitation services of the BfA with reference to the growth and occupational rehabilitation regulation (WFG)]. / Abschätzung der langfristigen Bedarfs- und Ausgabenentwicklung für die Rehabilitationsleistungen der BfA unter Berücksichtigung des Wachstums- und Beschäftigungsförderungsgesetzes (WFG).

Based on a Prognos Model projection (1998 to 2040), the number of medical and occupational rehabilitation service treatments required will increase by about 70,000 between 1998 and 2015, reaching 500,000. Thereafter, the situation improves and the number drops to between 370,000 and 430,000. The WFG law provides a 2.7 billion DM budget for the entire time period which results in a growing deficit, reaching 1.7 billion DM by 2015, and enabling the provision of only 50% of the treatments required in the western states, if it is assumed that a reduction of treatment in the eastern states is precluded. This service deficit makes an increase in early retirements probable, thereby, generating costs on balance which exceed any potential savings in the areas of rehabilitation. It is, therefore, necessary to adapt the WFG law to the demands of real needs so that the BfA may continue to fulfill its legal obligation, "rehabilitation before retirement" to the accustomed and necessary extent.

[Cost-benefit evaluation of medical rehabilitation by social security pensions and effects of the growth and occupational rehabilitation regulation (WFG)]. / Kosten-Nutzen-Bewertung der medizinischen Rehabilitation der Rentenversicherung (RV) und die Auswirkungen des Wachstums- und Beschäftigungsförderungsgesetzes (WFG).

The retirement insurers, within the scope of their responsibility for health care, have already adopted the standard that calls for quality control, cost-efficiency, and outcome-focusing. For a start, the BfA (Federal Insurance Agency for Salaried Employees) has compiled a pilot evaluation presented here, based solely on its own costs and returns on costs. This evaluation demonstrates that rehabilitation "pays off". With regard to the WFG, this means that cost-saving in rehabilitation generates significant cost increases through loss of premium payments and necessary early-retirement outlays. The analysis presented shows that future investment in rehabilitation is required to ensure positive returns for the RV.

[A disease substitution index: construction and validation]. / Ein Krankheitsersatzindex: Konstruktion und Validierung.

Empirical research dealing with health and illness often has the problem that the data sets contain a variety of health related variables but no variables abou the appearance of diseases and complaints. In order to solve this problem a disease substitution index (DSI) based on data of the German Socio-Economic Panel (GSOEP, 1985) and the national health survey conducted in the framework of the German Cardiovascular Prevention Study (GCP, 1984-1986) was constructed. Consisting of the variables "medical attendance", "hospital attendance" "existence of chronical diseases" the DSI shows statistically significant association with a series of diseases and complaints. These findings indicate that the DSI can be used to substitute diseases and/or complaints in datasets with the mentioned variables but no informations about diseases or complaints.