[From Science to Law: Findings of Reha XI Project on Ascertaining the Need for Rehabilitation in Medical Service Assessments]. / Aus der Forschung ins Pflegestärkungsgesetz II: Das Projekt Reha XI zur Feststellung des Rehabilitationsbedarfs in der MDK-Pflegebegutachtung.

Introduction: In the broad-based consortium project "Reha XI - Identifying rehabilitative requirements in medical service assessments: evaluation and implementation", a comprehensive analysis of the corresponding procedures was carried out by the medical services of the German Health Insurance Funds (MDK). On the basis of this analysis, a Good Practice Standard (GPS) for assessments was drawn up and scientifically evaluated. This article discusses the findings and applicability of the GPS as the basis for a nationwide standardized procedure in Germany as required by the Second Act to Strengthen Long-Term Care (PSG II) under Vol. XI Para. 18 (6) of the German Social Welfare Code. Method: The consortium project comprised four project phases: 1. Qualitative and quantitative situation analysis of the procedures for ascertaining rehabilitative needs in care assessments carried out by the MDK; 2. Development of a Good Practice Standard (GPS) in a structured, consensus-based procedure; 3. Scientific evaluation of the validity, reliability and practicability of the assessment procedure according to the GPS in the MDK's operational practice; 4. Survey of long-term care insurance funds with respect to the appropriateness of the rehabilitation recommendations drawn up by care assessors in line with the GPS for providing a qualified recommendation for the applicant. The evaluation carried out in the third project phase was subject to methodological limitations that may have given rise to distortions in the findings. Findings: On the basis of the situation analysis, 7 major thematic areas were identified in which improvements were implemented by applying the GPS. For the evaluation of the GPS, a total of 3 247 applicants were assessed in line with the GPS; in 6.3% of the applicants, an indication for medical rehabilitation was determined. The GPS procedure showed a high degree of reliability and practicability, but the values for the validity of the assessment procedure were highly unsatisfactory. The degree of acceptance by the long-term care insurance funds with respect to the recommendations for rehabilitation following the GPS procedure was high. Conclusion: The application of a general standard across all MDKs shows marked improvements in the quality of the assessment procedure and leads more frequently to the ascertainment of an indication for medical rehabilitation. The methodological problems and the unsatisfactory findings with respect to the validity of the assessors' decisions require further scientific scrutiny.

[Linkage of statutory health insurance data with those of a hospital information system: feasible, but also "useful"?]. / Verknüpfung von Routinedaten der Gesetzlichen Krankenversicherung mit Daten eines Krankenhausinformationssystems: Machbar, aber auch "nützlich"?

AIM: Administrative data are increasingly being linked with other data sources for research purposes in the field of epidemiology and health services research abroad. In Germany, the direct linkage of routine data of statutory health insurance (SHI) providers with other data sources is complicated due to strict data protection requirements. The aim of this analysis was to evaluate an indirect linkage of SHI routine data with data of a hospital information system (HIS). METHODS: The dataset comprised data from 2004 to 2010 from 2 sickness funds and one HIS. In both data sources, hospitalisations were restricted to admissions into one hospital with at least one diagnosis of heart failure. The 2 data sources were linked, in cases of the agreement of the admission and discharge dates, as well as the agreement of at least a certain percentage of diagnoses in HIS data when compared to SHI data (full coding depth). Based on the direct linkage using the pseudonymised insurance number as gold standard, the proposed linkage approach was evaluated by means of test statistics. Furthermore, the completeness of relevant information of the HIS was described. RESULTS: The dataset contained 3 731 hospitalisations from the HIS and 8 172 hospitalisations from the SHI routine data. The sensitivity of the linkage approach was 86.7% in the case of an agreement of at least 30% of the diagnoses and decreased to 41.7% in the case of 100% agreement in the diagnoses. The specificity was almost 100% at all studied cut-offs of agreement. Anthropometric measures and diagnostic information were available only for a small fraction of cases in the data of the HIS, whereas information on the health status and on laboratory information was comparatively complete. CONCLUSION: For the linkage of SHI routine data with complementary data sources, indirect linkage methods can be a valuable alternative in comparison to direct linkage, which is time-consuming with regard to planning and application. Since the proposed approach was used in a relatively small sample and a restricted patient population, a replication using nation-wide data without respective restrictions would require an extension of the algorithm. Furthermore, the large administrative effort seems questionable considering the comparatively high amount of missing values in interesting information in the HIS.

[Economic Evaluation of Integrated Care Systems - Scientific Standard Specifications, Challenges, Best Practice Model]. / Ökonomische Erfolgsmessung von integrierten Versorgungsnetzen - Gütekriterien, Herausforderungen, Best-Practice-Modell.

PURPOSE: Transparency of economic performance of integrated care systems (IV) is a basic requirement for the acceptance and further development of integrated care. Diverse evaluation methods are used but are seldom openly discussed because of the proprietary nature of the different business models. The aim of this article is to develop a generic model for measuring economic performance of IV interventions. METHODS: A catalogue of five quality criteria is used to discuss different evaluation methods -(uncontrolled before-after-studies, control group-based approaches, regression models). On this -basis a best practice model is proposed. RESULTS: A regression model based on the German morbidity-based risk structure equalisation scheme (MorbiRSA) has some benefits in comparison to the other methods mentioned. In particular it requires less resources to be implemented and offers advantages concerning the relia-bility and the transparency of the method (=important for acceptance). Also validity is sound. Although RCTs and - also to a lesser -extent - complex difference-in-difference matching approaches can lead to a higher validity of the results, their feasibility in real life settings is limited due to economic and practical reasons. That is why central criticisms of a MorbiRSA-based model were addressed, adaptions proposed and incorporated in a best practice model: Population-oriented morbidity adjusted margin improvement model (P-DBV(MRSA)). CONCLUSION: The P-DBV(MRSA) approach may be used as a standardised best practice model for the economic evaluation of IV. Parallel to the proposed approach for measuring economic performance a balanced, quality-oriented performance measurement system should be introduced. This should prevent incentivising IV-players to undertake short-term cost cutting at the expense of quality.

[Institutionalised dying in Germany. Trends in place of death distribution: home, hospitals and nursing homes]. / Institutionalisiertes Sterben in Deutschland. Trends in der Sterbeortverteilung: zu Hause, Krankenhaus und Pflegeheim.

BACKGROUND: The aim of this study is to identify the degree of institutionalised dying and to assess the differentiation between place of death, be it at a hospital, in a nursing home or at home (with/or without home care), as well as to illustrate trends in the place of death distribution. DATA AND METHODS: Process-produced routine data of the deaths of patients insured with the statutory health insurance "Gmünder Ersatzkasse" (GEK, n = 59,922) are used to calculate distributions of the deceased population (≥ 30 years old) from 2000-2009. RESULTS: In 2009, about 248,000 (29 %) and 598,000 (71 %) people in Germany died at home and in an institution, respectively. During the last 10 years the degree of institutionalised dying has increased by 6 percentage points. Women die more frequently in institutions than men (74 % compared to 67 %). For older age groups, dying in nursing homes becomes more prominent than dying in hospitals. CONCLUSION: The discrepancy between the preferred (at home) and empirically ascertained (institutions) place of death could increase even further as a result of the demographic as well as disease-specific developments in Germany.

[Does the resident care assessment instrument improve long-term home care? - results of a nation-wide study in Germany]. / Verbessert das Resident Assessment Instrument die ambulante Pflege? - Ergebnisse einer bundesweiten Studie.

BACKGROUND: Effective and efficient instruments for care planning and controlling are required to optimise the nursing process and improve outcome quality despite of various lacks of quality and precarious circumstances. METHODS: A cluster randomised controlled trial was conducted to assess whether the implementation of the Resident Assessment Instrument (RAI) into home care service providers can help to improve or stabilise functional abilities (ADL, IADL) and cognitive skills (MMST), improve quality of life (EQ-5D), reduce institutionalisation and thereby increase outcome quality. RESULTS: A comparison of mean differences between the treatment and control group showed no significant effects. Although the multilevel regression results show that clients in the treatment group fared better in terms of ADL and IADL (smaller decline) and were less likely to move to nursing homes and be hospitalised, none of these effects are significant. CONCLUSIONS: The lack of significance might be due to the fact that RAI was not fully implemented and even the partial implementation lasted much longer than expected. Moreover, the number of clients included in the study was smaller than originally planned.

Effects of the Resident Assessment Instrument in home care settings: results of a cluster randomized controlled trial.

Deficits in quality, a lack of professional process management and, most importantly, neglect of outcome quality are criticized in long-term care. A cluster randomized, controlled trial was conducted to assess whether the Resident Assessment Instrument (RAI) can help to improve or stabilize functional abilities (ADL, IADL) and cognitive skills (MMST), improve quality of life (EQ-5D), and reduce institutionalization, thereby, increasing outcome quality. A total of 69 home care services throughout Germany were included and randomized. The treatment group (n = 36) received training in RAI and was supported by the research team during the study (13 months). Comparison of mean differences between the treatment and control groups (n = 33) showed no significant effect. Although the multilevel regression results show that clients in the treatment group fared better in terms of ADLs and IADLs (smaller decline) and were less likely to move to nursing homes and be hospitalized, none of these effects is significant. The lack of significance might result from the small number of clients included in the study. Moreover, RAI was not fully implemented and even partial implementation required more time than expected.

[Life expectancy with and without need for care. Extent and development trends in Germany]. / Lebenserwartung in und ohne Pflegebedürftigkeit. Ausmaß und Entwicklungstendenzen in Deutschland.

This article addresses the question if the number of life years men and women can expect to live in good health is increasing and secondly if the life years in long-term care decline to a shorter period before death (compression of morbidity) during the periods 1999-2003 to 2004-2008. The analyses is based on data of a health insurance company (Gmünder Ersatzkasse, GEK), which are calculated, using the prevalence-rate method of Sullivan. The results show that men and women at age 60 can expect to live longer (21.21 years instead of 20.04 years for men and 25.1 years instead of 23.96 years for women) and also live longer free of long-term care (19.89 instead of 18.89 years for men and 22.37 instead of 21.55 years for women). In addition to the prolonged life years, also the number of years a person can expect to live in long-term-care has increased (from 1.15 years to 1.32 years for men and from 2.41 years to 2.73 years for women). Therefore the data suggest that there is no compression of morbidity.

[Fairness in Germany's long-term care insurance: the relationship between social insurance and private mandatory insurance]. / Gerechtigkeit im Verhältnis von Sozialer Pflegeversicherung und Privater Pflegepflichtversicherung.

The long-term care insurance act of 1994 introduced two branches of long-term care insurance (LTCI), namely the social LTCI and a mandatory private LTCI. Both branches together cover almost the whole population. Insurees of the social LTCI, however, have a higher age-specific dependency ratio. Furthermore, social LTCI covers a higher share of elderly people. Therefore, per capita expenses are twice as high as in private LTCI - even if benefits for civil servants directly financed out of the public purse are taken into consideration. Moreover, on average members of private LTCI have higher incomes. If organised according to the principles of social LTCI, private LTCI could therefore operate with a contribution rate that is only one third of the rate necessary in social LTCI. Being assigned to social LTC thus creates a considerable disadvantage for the insurees that cannot be justified. Fairness considerations therefore demand reform. The most simple, but politically most difficult, reform option is to abolish the dualism of social and private LTCI and create an integrated system for the whole population instead. If this is not possible at least a risk equalization scheme should be introduced that equalizes the risk structure concerning the expenses and - if possible - also the income side.

[Ethics versus economics in public health? On the integration of economic rationality in a discourse of public health ethics]. / Ethik versus Okonomie in Public Health? Zur Integration ökonomischer Rationalität in einen Public-Health-Ethik-Diskurs.

In the course of establishing the discourse of public health ethics in Germany, we discuss whether economic efficiency should be part of public health ethics and, if necessary, how efficiency should be conceptualized. Based on the welfare economics theory, we build a theoretical framework that demands an integration of economic rationality in public health ethics. Furthermore, we consider the possible implementation of welfare efficiency against the background of current practice in an economic evaluation of health care in Germany. The indifference of the welfare efficiency criterion with respect to distribution leads to the conclusion that efficiency must not be the only criteria of public health ethics. Therefore, an ethical approach of principles should be chosen for public health ethics. Possible conflicts between principles of such an approach are outlined.

[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.

[Optimizing the nursing process by new management instruments. The Northern Germany Nursing Research Network]. / Optimierung des Pflegeprozesses durch neue Steuerungsinstrumente: Der Pflegeforschungsverbund Nord.

The Northern Germany Nursing Research Network (Pflegeforschungsverbund Nord) has dedicated itself to developing management instruments intended to optimize the nursing process. It is coordinated by the administrative office of the Institute of Public Health and Nursing Research (Institut für Public Health und Pflegeforschung IPP, director: Prof. Dr. Stefan Görres), Department of "Interdisziplinäre Alterns- und Pflegeforschung", University of Bremen. Four partial projects are currently being worked on in two groups: Group A--"Deficient areas of nursing action": The projects belonging to this group are "Individual care-patterns of elderly people and their determinants" (University of Bremen) and "Mobility Restrictions in Nursing Homes-Multicentre Observational Study (MORIN)" (University of Hamburg). The purpose of these studies is to examine the relevance of quantitatively significant risk combinations from a nursing science perspective. Group B--"The generation and testing of nursing action management instruments": The projects in this area are "Nursing rounds as instruments of quality assurance in home-based care" (University of Applied Sciences, Bremen) and "Predicting the risk of falls, efficiency of standard scales in opposition to nursing assessment-Cluster-Randomised Controlled Trial (PROFESSION)" (University of Hamburg). These studies concentrate in a unique manner on the generation and testing of management/control instruments suitable for application to nursing action.

[Need for care. The role of family care in long-term care]. / Pflegebedürftigkeit. Zur Bedeutung der familialen Pflege für die Sicherung der Langzeitpflege.

In Germany, more than 2 million people are currently in need of care, and another 3 million need help below the threshold that entitles them to benefits by social legislation. Thus, the need of care, in contrast to the need of help, is a general risk recognised by legislation. Accordingly, the German long-term care insurance was introduced in 1994, where entitlement to benefits depends on the ability to perform activities of daily living; it neglects the requirements of care arising from gerontopsychiatric impairments. In this article, the concept of "need of care" will be critically discussed and the influence of demographic changes on the state of needing care will be explored. Against this background, future challenges of caregiving will be analysed. This analysis leads to a call for "mixed care arrangements", where family care can only be maintained by relying on professional relief and support of voluntary helpers, and where care institutions would have to define themselves as partners of families. This demand will have to be reflected in changed training concepts. Structurally, it is necessary to develop arrangements, which promote self-determined individual solutions, e.g. by implementing (personal) care budgets. Moreover, target group-orientated counselling offers and network structures will have to be established; in this respect, co-operative efforts between professional case management and voluntary work are exemplary approaches.

[The changing role of the state in health care systems in OECD countries--research questions, research design and first results]. / Der Wandel der Staatlichkeit im Gesundheitswesen von OECD-Ländern -- Fragestellungen, Untersuchungsdesign und erste Ergebnisse.

In the framework of the DFG-Research-Unit 597 "Transformation of the State" is Project C3 investigating the change of the role of the state in health care systems in OECD-countries between 1970 and 2000. The primary research hypothesis is, that a tendency of convergence exists regarding the role of the state for the three main dimensions of health care systems, namely service provision, financing and regulation. This is carried out firstly based on a quantitative oriented analysis for 23 OECD-countries, utilising the data set "OECD Health Data 2002", and secondly with qualitative oriented country-studies for England, Germany and the U.S. Findings for the qualitative country-studies give some hints of convergence regarding the "private-public-mix" between the health system types "social insurance" (Germany), "national health system" (England), and "market oriented health system" (USA). First quantitative results concerning the changing role of the state in relation to the health care systems in OECD-countries provide evidence for a convergence process between these states in the financing dimension. For the dependent variable "total health care costs in % of gross domestic product" a trend of convergence is observed for the members states of the European Union (n = 12), while in the remaining Non-EU countries (n = 11) a trend of divergence is identified. For the same parameter we found a convergence for OECD-countries of the type "national health system" (n = 14). For OECD-countries of the type "social insurance" (n = 8) this convergence process is observed only for the time period 1970 - 1980. Some results confirm the hypothesis of the "growth to limits" (Flora). But it appears to us that in future other significant factors like globalisation processes, the increasing potentials of the medical technology and demographic changes may play an important role for the overall health budget and specific needs of the population in the OECD-states.

[The National Institute for Clinical Excellence (NICE)]. / Das National Institute for Clinical Excellence (NICE) - Staatsmedizinisches Rationierungsinstrument oder Vorbild für die evidenzbasierte Bewertung medizinischer Leistungen?

In discussions on the development of the institutional framework for decisions on the benefit package of social health insurance in Germany, the English National Institute for Clinical Excellence (NICE) is considered as either a good or a bad example for reform. According to this study, the procedures and criteria applied by NICE for making health care coverage decisions are legitimate. Procedures are transparent and interest groups are broadly represented. Decision criteria include cost effectiveness of services - albeit only if information on cost effectiveness is available and highly evident. Furthermore, cost effectiveness is not the only criteria for coverage decisions. NICE very rarely induces strong direct rationing, but rather leaves room for discretion. However, the trade-off between maximising allocative efficiency and avoiding distributional consequences becomes apparent.