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Health services research examines the structures and processes of health care under everyday conditions. Routine data of the statutory health insurance (SHI) - the so-called routine practice data - represent real health care and are therefore an important data source for health services research. This paper presents 5 key questions that researchers and data-holding institutions can use to assess the suitability of this data source for answering their health services research question. The aim of these guiding questions is to generate a common understanding between researchers and data-holding institutions of the research project, the research objective, and the feasibility of implementation in health services research. The five guiding questions cover the formulation of the research question, the planned method, the target population, the relevant study periods, and the required information from SHI data. These methodologically oriented guiding questions are supplemented by the question of how the results of the research project could improve care. Thus, for researchers, the five guiding questions provide an initial structuring for data requests; for data-holding institutions, they provide a framework for considering possible involvement in or support of a research idea in health services research., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Changes in the employment market and improvements in the current prosthetic treatment have encouraged German Statutory Health Insurance e. V. (DGUV) to re-examine the standard values for reduced earning capacity after work related accidents. The new standard values for reduced earning capacity came into force on 01.11.2019. The present article summarises the consensus paper of the group of independent experts., Competing Interests: Erklärung zu finanziellen Interessen Forschungsförderung erhalten: nein; Honorar/geldwerten Vorteil für Referententätigkeit erhalten: ja, von einer anderen Institution (Pharma- oder Medizintechnikfirma usw.); Bezahlter Berater/interner Schulungsreferent/Gehaltsempfänger: ja, von einer anderen Institution (Pharma- oder Medizintechnikfirma usw.); Patent/Geschäftsanteile/Aktien (Autor/Partner, Ehepartner, Kinder) an im Bereich der Medizin aktiven Firma: nein; Patent/Geschäftsanteile/Aktien (Autor/Partner, Ehepartner, Kinder) an zu Sponsoren dieser Fortbildung bzw. durch die Fortbildung in ihren Geschäftsinteressen berührten Firma: nein.; Erklärung zu nichtfinanziellen Interessen Michael Wich, Paul Alfred Grützner und Reinhard Hoffmann sind Beschäftigte der BG Kliniken gGmbH und beratende Ärzte der DGUV. Dirk Scholtysik ist Beschäftigter der DGUV. M. Wich: stellv. Vorsitzender der Fachgesellschaft für interdisziplinäre medizinische Begutachtung (FGIMB)., (Thieme. All rights reserved.)

The German research data center for health will provide claims data of statutory health insurances. The data center was set up at the medical regulatory body BfArM pursuant to the German data transparency regulation (DaTraV). The data provided by the center will cover about 90% of the German population, supporting research on healthcare issues, including questions of care supply, demand and the (mis-)match of both. These data support the development of recommendations for evidence-based healthcare. The legal framework for the center (including §§ 303a-f of Book V of the Social Security Code and two subsequent ordinances) leaves a considerable degree of freedom when it comes to organisational and procedural aspects of the center's operation. The present paper addresses these degrees of freedom. From the point of view of researchers, ten statements show the potential of the data center and provide ideas for its further and sustainable development., Competing Interests: Stefanie March, Falk Hoffmann, Holger Gothe, Ingo Meier, Sebastian Claudius Semler, Christoph Stallmann, Enno Swart und Peter Ihle erklären, dass Sie innerhalb der vergangenen 3 Jahre Gutachtertätigkeit für das Bundesministerium für Gesundheit ausgeübt haben, und einzelne Autor*innen am begleitenden Arbeitskreis zum Forschungsdatenzentrum Gesundheit beim BfArM beteiligt sind., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Since fall of 2020, the first Digital Health Applications (DiGA) have been available as a service of the statutory health insurance. The National Association of Statutory Health Insurance Funds considers digital applications to have the potential to improve health care, e.g., for people with chronic diseases, and to consolidate the interconnectedness of the provided offers. DiGA can empower the insured persons to help shape their health care actively and to self-contribute to a successful treatment. At the same time, statutory health insurance identifies a number of basic and substantial critical issues regarding the legal requirements for the authorization of DiGA for reimbursement by insurance and the conceptional design of the fast-track process from the Federal Institute for Drugs and Medical Devices (BfArM).This article examines the DiGA, which have been listed in the BfArM directory up to this point, and takes stock after six months of the fast-track process being in place. According to this, the requirements and legal specifications for directory listings and reimbursement via the fast-track process are insufficient from the point of view of the statutory health insurance regarding proven medical effectiveness and economically efficient health care. At present, most of the authorized DiGA, which so far could not provide sufficient evidence about positive healthcare effects, are subsequently only listed provisionally. At the same time, the requirements for proof of medical benefit do not ensure the generation of valid results in studies or clinical trials with regards to routine everyday care. So far, there has been only a moderate qualitative reliability of results. Furthermore, in the context of free pricing by manufacturers, significant price increases can be observed in some cases compared to prices before the BfArM listing.This paper gives recommendations towards further development of the legal basis for the fast-track process, particularly in the subject areas of benefit and patient safety as well as cost effectiveness., (© 2021. Springer-Verlag GmbH Deutschland, ein Teil von Springer Nature.)

Introduction: After the Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) reformed digital health applications' (Digitale Gesundheitsanwendungen, DiGAs) access to German Statutory Health Insurance (SHI) reimbursement, the discussion concerning necessary evidence requirements has intensified. In the past, different "alternative study designs" have been proposed to replace randomized controlled trials (RCTs) in the DiGA efficacy and benefit assessments. The present paper examines the suitability of these alternative designs for informing SHI reimbursement decisions., Methods: The four alternative study designs primarily discussed in the context of DiGA - "Continuous Evaluation of Evolving Behavioral Intervention Technologies" (CEEBIT), "Multiphase Optimization Strategy" (MOST), "Sequential Multiple Assignment Randomized Trial" (SMART) and "Micro-Randomized Trial" (MRT) - are characterized and compared on the basis of relevant primary and secondary sources. Subsequently, their suitability for effectiveness and benefit evaluation in the context of SHI reimbursement decisions is discussed., Results: None of the study designs examined aims primarily at conclusively demonstrating efficacy and benefit. Three of the four designs (MOST, SMART, MRT) focus on the development and optimization of interventions. In order to reduce resource requirements, the approaches presented sometimes deviate considerably from the methodological approach in traditional RCTs. This is especially true for their applied statistical error tolerance and their underlying randomization logic. Three of the four concepts (MOST, SMART, MRT) therefore still require RCTs after the development phase in order to demonstrate the effectiveness and benefit of the optimized intervention., Discussion: The methodological differences of the alternative study designs compared to classical RCTs are accompanied by serious potentials for bias and uncertainties with regard to the identified intervention effects. These may be acceptable in the context of intervention development, but do not appear to be appropriate for use in collective SHI reimbursement decisions., Conclusion: The alternative study designs presented cannot be regarded as a suitable RCT alternative for efficacy and benefit assessments. A pragmatic study design, which continues to meet high methodological standards, and better utilization of real-world data could, in the future, contribute to a compromise between the justified claims to sufficient certainty of results on the one hand and appropriate procedural effort on the other., (Copyright © 2021. Published by Elsevier GmbH.)

Background: With the Act on Genetic Testing (GenDG), the German legislator has issued far-reaching regulations for human genetic services, including genetic counseling. This paper presents data on the use of human genetic counseling in the years before and after the entry into force of GenDG in order to provide an informed assessment of the possible effects of the law., Materials and Methods: Over a period of 13 years (2005 to 2017), the human genetic counseling services provided within the framework of the statutory health insurance and billable by EBM via the Kassenärztliche associations were recorded via a database query at the Central Institute of the National Association of Statutory Health Insurance Physicians (ZI-KBV) and via individual Kassenärztliche Vereinigungen Deutschlands. For the discussion of the observable development of using genetic counseling and possible future development, additional data on the referral behavior, the waiting times, processing time, and reasons for consultations were extracted from the GenBIn database., Results and Discussion: Demand for genetic counseling has steadily increased at an average rate of approximately 6% per year since 2009. This increase started well before the enactment of the GenDG and may be attributed to a multiplicity of factors. Change in demand for genetic counseling is characterized by increasing self-referrals and by increasing referrals by specialists other than obstetricians/gynecologists. Waiting times between 2011 and 2016/2017 have increased. While demand has been growing, the number of key service providers, the contracted medical specialists in human genetics, has remained almost constant. It is foreseeable that capacity limits will be reached if both trends continue.

Background: The paper analyzes the influence of population aging on the future number of medical rehabilitation cases. Implications for the most important providers of rehabilitation services (Deutsche Rentenversicherung (DRV) (German Pension Insurance) and Gesetzliche Krankenversicherung (GKV) (Statutory Health Insurance)) are discussed., Methods: Data provided by the DRV and the GKV were used. A third database is the Hospital Statistics of the Federal Statistical Office. Each database contains data of rehabilitation cases of certain subpopulations. Based on the 13 th coordinated population projection a forecast up to 2040 with each of these databases was undertaken., Results: Population aging will decrease case numbers for the DRV from 961 thousand (2015) to 911 thousand in 2040 (- 5.2%). Cases of GKV will rise from 742 thousand (2015) to 934 thousand in 2040 (+25.9%). Because of population aging, the case numbers of older people (65 years or older) in rehabilitation will increase by about a third until 2040., Conclusions: The expected increase in the number of elderly rehabilitants concerns especially the GKV. There are a number of problems arising from this, concerning financing of rehabilitation and the aspect of growing importance of multimorbidity and geriatric rehabilitation. Furthermore, there is a growing gap between the demographic development of rehabilitation in working age and the demographic component of the budgets for this rehabilitation in the DRV., Competing Interests: Der Autor gibt an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

The analysis of geographic variations has spurred arguments that area of residence determines access to and quality of healthcare. In this paper we argue that unwarranted geographic variations can be traced back to actions of individual patients and their healthcare providers (doctors, hospitals). These actors interact in a complicated web of shared responsibilities. Designing effective interventions to reduce unwarranted geographic variations may therefore depend on methods to identify these interactions and communities of providers with a shared accountability. In the US, Canada, and Germany, routine data have been used to identify self-organized informal or virtual networks of physicians and hospitals, so-called patient-sharing networks (PSNs). This is an emerging field of analysis. We attempt to provide a brief report on the state of work in progress. It can be shown that variation between PSNs in a given area is effectively greater than variation between regions. While this suggests that reducing unwarranted variation needs to start at the level of PSN, methods to identify PSNs still vary widely. We compare epidemiological approaches and approaches based on graph theory and social network analysis. We also present some preliminary findings of exploratory analyses based on comprehensive claims data of physician practices in Germany. Defining PSNs based on usual provider relationships helps to create distinctive patient populations while PSNs may not be mutually exclusive. Social network analysis, on the other hand, appears better equipped to differentiate between provider communities with stronger and weaker ties; it does not yield distinctive patient populations. To achieve accountability and to support change management, analytic methods to describe PSNs still need refinement. There are first projects in Germany which use PSNs as an intervention platform in order to achieve improved cooperation and reduce unwarranted variation in their care processes.

The Public Health White Paper draws up a vision of public health as a living, decentralized network that can help improve the health of the population in a sustained fashion. However, the central question remains open as to which prerequisites public health networks should fulfill in order to be effective in the long term. The aim of this paper is to provide a sociological view of the issue and offer some discussion ideas. Parsons' structural functionalism leads to the thesis that science networks in public health require structures that ensure that the 4 basic functions of viable social networks - (1) adaptation, (2) goal attainment, (3) integration and (4) latent pattern maintenance - are fulfilled. On this theoretical basis, suggestions are made to establish functional formal structures in public health networks., Competing Interests: Interessenkonflikt: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Purpose: Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided., Methods: A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS., Results: Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials., Conclusion: An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.

In general, cell-based medicinal products do not represent a uniform class of medicinal products, but instead comprise medicinal products with diverse regulatory classification as advanced-therapy medicinal products (ATMP), medicinal products (MP), tissue preparations, or blood products. Due to the legal and scientific consequences of the development and approval of MPs, classification should be clarified as early as possible. This paper describes the legal situation in Germany and highlights specific criteria and concepts for classification, with a focus on, but not limited to, ATMPs and non-ATMPs. Depending on the stage of product development and the specific application submitted to a competent authority, legally binding classification is done by the German Länder Authorities, Paul-Ehrlich-Institut, or European Medicines Agency. On request by the applicants, the Committee for Advanced Therapies may issue scientific recommendations for classification.

The goal of this paper is to present the research conducted for systemizing network elements and analyzing their interconnection that emerged during the establishment and functioning of health care innovation project of psychenet - the Hamburg Network for Mental Health.Semi-structured manual-based face-to-face interviews with project researchers and leaders were conducted. The gathered data was validated and updated several times during the project duration. The results include a systematic description of 186 network elements developed during the overall project and respective subprojects. The elements were consolidated in a web-based database and integrated into the psychenet.de public website. A clustering of elements was conducted and modules of elements were generated based on the interconnection between the related elements.The systematic description of network elements as well as determination of their interconnection and dependency can play an important role in understanding the emergence and functioning of integrated mental health networks. The innovative medical networks prove to be complex service systems and urge for a grounded application of integration techniques in order to be successfully transferred and adopted in other regions., (© Georg Thieme Verlag KG Stuttgart · New York.)

The German statutory health-care system is based on the principle of solidarity and thus it is committed to the objective of 'equal chances'. From an economic perspective it is also important to emphasise that scarcity of resources continuously pushes the services towards cost control and towards increasing cost-effect-iveness. There could be conflicts between the 2 objectives 'equal chances' and 'cost-effectiveness', of course, for example if measures for increasing cost-effectiveness lead to increased financial burdens of the insured. To date it has not been studied if and how this potential conflict is discussed in Germany.In a first step we searched for German publications discussing this potential conflict focusing on 3 major public health journals (Das Gesundheitswesen, Bundesgesundheitsblatt, Ethik in der Medizin) and on the internet portal "gerechte-gesundheit.de". For the main part of the paper, we looked for publications from 4 major health policy actors (Bundesärztekammer, Zentrale Ethikkommission bei der Bundesärztekammer, Deutscher Ethikrat, Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen). All papers published since the year 2000 were included in the system-atic qualitative analysis.The analyses show that the potential conflict between 'equal chances' and 'cost-effectiveness' is rarely discussed in any detail, at most in an implicit way. It would be important, though, to have an explicit discussion, supported by scientifically based analyses and recommendations. One step towards this objective could be, for example, a closer cooperation between social-epidemiologists and health--economists., (© Georg Thieme Verlag KG Stuttgart · New York.)

Since 2010, the German Agency for Quality in Medicine has developed so-called short information leaflets for patients that are specifically designed for use in doctor-patient encounters. Physicians, patient representatives and communication specialists were involved in the development of this format. Their implementation aims at enhancing awareness and dissemination of these leaflets amongst the members of the self-governing bodies and other multipliers (like medical specialty societies, patient organisations, other bodies and institutions of the healthcare system). This paper describes the first implementation experiences on the basis of internally collected data on the involvement of multipliers, availability and assessment of their relevance. A first analysis shows that the short information leaflets are broadly available amongst the self-governing bodies and that they are considered to be of high relevance. Due to the direct involvement of the members of specialty societies and patient organisations and other experts, short information leaflets are also gaining acceptance outside the self-governing system. This is emphasised by the rising number of requests to reprint or cite or use the leaflets. Consistency with evidence-based treatment recommendations promotes acceptance of these leaflets among physicians., (Copyright © 2015. Published by Elsevier GmbH.)

In 2008, the German Guidelines Program in Oncology (GGPO) was launched to promote the development and updating of evidence-based multidisciplinary practice guidelines. This paper describes the organizational structures and methods as well as the embeddedness of the program within a comprehensive strategy to enhance quality of cancer care. Using the example of the German Cancer Plan we argue that the GGPO guidelines are not only an instrument to transfer and exchange knowledge, but also provide an important basis for further initiatives in the field of quality improvement. It is illustrated what was achieved in the first seven years of the GGPO and which challenges will dominate the next years., (Copyright © 2015. Published by Elsevier GmbH.)

Objectives: "Stratifying medicine" is a topic of increasing importance in the public health system. There are several questions related to "stratifying medicine". This paper reconsiders definitions, opportunities and risks related to "stratifying medicine" as well as the main challenges of "stratifying medicine" from the perspective of a public health insurance., Definition: The application of the term and the definition are important points to discuss. Terms such as "stratified medicine", "personalised medicine" or "individualised medicine" are used. The Techniker Krankenkasse prefers "stratifying medicine", because it usually means a medicine that tailors therapy to specific groups of patients by biomarkers. OPPORTUNITIES AND RISKS: "Stratifying medicine" is associated with various hopes, e. g., the avoidance of ineffective therapies and early detection of diseases. But "stratifying medicine" also carries risks, such as an increase in the number of cases by treatment of disease risks, a duty for health and the weakening of the criteria of evidence-based medicine., Challenges: The complexity of "stratifying medicine" is a big challenge for all involved parties in the health system. A lot of interrelations are still not completely understood. So the statutory health insurance faces the challenge of making innovative therapy concepts accessible in a timely manner to all insured on the one hand but on the other hand also to protect the community from harmful therapies. Information and advice to patients related to "stratifying medicine" is of particular importance. The equitable distribution of fees for diagnosis and counselling presents a particular challenge. The solidarity principle of public health insurance may be challenged by social and ethical issues of "stratifying medicine"., Conclusion: "Stratifying medicine" offers great potential to improve medical care. However, false hopes must be avoided. Providers and payers should measure chances and risks of "stratifying medicine" together for the welfare of the patients., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Approximately 4 million patients with a rare disease live in Germany. The medical care of these patients is problematic because of the rarity and heterogeneity of different clinical pictures. The Federal Ministry of Health has therefore published a research report on "Measures to improve the health situation of people with rare diseases in Germany" in 2009., Objective: The aim of this paper is to present the main recommendations of this research report and relate it to current developments in the field of medical care for people with rare diseases., Methodology: The care situation of patients with rare diseases was determined using questionnaires, expert interviews and focus group discussions with representatives of patients, service providers and stakeholders from the health institutions., Results: The main range of actions that have been identified in the research report were centre and network formation, specialized forms of medical care, diagnosis and treatment, information and experience exchange, performance fees and reimbursement of the costs, guidelines and patient pathways, the research, the implementation of a National Action Alliance and the development of a National Action Plan., Discussion: In March 2010 a National Action League for People with Rare Diseases (NAMSE) was founded. The NAMSE created a national plan of action for people with rare diseases for improving medical care in the field of rare diseases which was approved by the Federal Government in August 2013. Thus, two important areas of the research report have already been implemented. In a comparison of the areas of activity of the research report with those of the National Action Plan it becomes clear that priorities will be in the context of health services research in rare diseases, for example the introduction of centres of reference for rare diseases, measures to accelerate the diagnostic process and the promotion of research and information management in the future.

Background: The topic of bedside rationing is increasingly discussed in Germany. Further need for clarification exists for the question how bedside rationing (e.g., in the area of overcare) can be justified despite coexistent inefficiencies., Discussion: This paper outlines and analyses the relationship of waste avoidance and rationing from an ethical perspective. Empirical findings regarding the status quo of bedside rationing and rationalization are presented. These normative and empirical explorations will then be further specified regarding opportunities for future physician-driven activities to tackle overuse., Conclusion: The self-government partners in Germany should communicate more explicitly within their communities and to the public how and with which benchmarks they aim to reduce inefficient health care (overuse) in an appropriate manner. Physician-driven activities such as the "Choosing Wisely®" initiative in the USA could provide a first step to raise the awareness for overuse among physicians as well as in the public.

Background: The purpose of periodic health examinations is to prevent disease through early intervention and through stratifying individual patients' health risk. The German health examination as defined in section 25 of the Social Code Book V (Sozialgesetzbuch V) seems to be outdated in many respects. In order to develop an alternative to the current German system an international comparison of periodic health examinations in other healthcare systems is useful., Objective: The study investigates the measures taken for primary prevention of cardiovascular disease in seven countries. Content, implementation and organisation of the various programmes are analysed in the present paper., Methods: The present study was designed as a qualitative multiple case study. The collection of data on cardiovascular screening programmes in the seven different healthcare systems in this study relies on information publicly available on the Internet. The data were entered into a matrix which had been created prior to the data collection and which covers the relevant points of screening. Finally, the data were triangulated using guided telephone interviews with key informants. One general practitioner (GP) was interviewed per country. The measures taken in the respective healthcare systems were then compared and analysed., Results: The measures taken in the countries studied for the primary prevention of cardiovascular disease are heterogeneous. The structures range from guideline recommendations (Castilla y León, Switzerland, Norway), and incentive payments for doctors (British Columbia), to opportunistic and population-based programmes (Germany and England, and Group Health in the US). The American health maintenance organisation Group Health offers an established, evidence-based programme whereas the German health examination dates back to a time when evidence-based medicine was not yet established and is therefore relatively outdated., Discussion: Despite scientific evidence of primary prevention of cardiovascular disease, evidence-based measures cannot be found in all the healthcare systems analysed. The paper discusses sociocultural and political aspects as influencing factors on prevention programmes., (Copyright © 2014. Published by Elsevier GmbH.)

The Act on the Reform of the Market for Medicinal Products (AMNOG) became effective in Germany on January 1, 2011. Since then, the assessment of the added benefit of new drugs versus a therapeutic standard on the basis of dossiers submitted by pharmaceutical companies has been required by law. The Federal Joint Committee (G-BA) generally commissions the Institute for Quality and Efficiency in Health Care (IQWiG) with this task. The added benefit is primarily to be demonstrated on the basis of patient-relevant outcomes. The aim of this paper is to describe the feasibility of the early benefit assessment on the basis of patient-relevant outcomes by systematically characterising the outcomes available in company dossiers and comparing the companies' and IQWiG's evaluations regarding patient relevance and surrogate validity. Dossier assessments published between October 2011 and June 2012 were used for this purpose. The outcomes available and the respective evaluations were extracted and compared. 12 out of 22 submitted dossiers contained sufficient data to assess outcomes; all 12 assessable dossiers provided data on patient-relevant outcomes. Data on mortality and adverse events were available in all dossiers, except that one dossier did not contain adverse event data on the relevant subpopulation. In contrast, data on morbidity and health-related quality of life were available in 8 and 7 dossiers, respectively. Of a total of 214 outcomes extracted by IQWiG, 124 patient-relevant and 3 surrogate outcomes were included in IQWiG's assessment (companies: a total of 183 outcomes included, of which 172 were patient-relevant and 11 were surrogates). The first experiences with AMNOG have shown that in principle an early benefit assessment of drugs based on patient-relevant outcomes is feasible. The companies' and IQWiG's evaluations regarding patient relevance and surrogate validity of outcomes partly deviated from each other. By increasingly considering patient-relevant outcomes in approval studies, pharmaceutical companies can create the necessary data basis for the early benefit assessment., (Copyright © 2014. Published by Elsevier GmbH.)

In 2013 Germany implemented a new payment system for the inpatient treatment of mental disorders. Besides perpetuating a per-diem payment, the payment system sets up a classification system that groups cases with comparable costs per diem. The first release of the system reveals the principal diagnosis to be the main grouping variable. Especially in psychosomatic and psychotherapy this approach seems to be at least questionable. Because of the insufficiently precise definition of the assignment of the principal diagnosis in the coding standards - and therefore the expected conflicts between clinics and health insurance funds - this paper discusses the difficulties involved in defining the principal diagnosis. It also formulates recommendations of how the principal diagnosis should be assigned.

In order to address the increasing complexity and continuously changing needs and demands in the German healthcare system, there is a need to strengthen knowledge translation, evidence-based practice and the conduct of clinical trials in the field of allied health professions. An interdisciplinary working group representing the fields of nursing, midwifery, physiotherapy, occupational therapy and speech therapy developed a guide and a concept for seminars to provide potential analyses for research and innovations in the allied health professions in Germany. These potential analyses compare the current state of health care delivery for specific health problems and the corpus of evidence for the effectiveness of related interventions. Thus innovations can be identified which might improve client-centred healthcare in Germany. The introductory paper briefly reports the activities and results of the working group, describes the international context of transferring research into practice and outlines possibilities for the future development of coordinated research strategies in Germany. The following papers consist of five potential analyses: (1) Advanced Practice Nursing (APN) in long-term care; (2) giving birth in an upright position; (3) treadmill training for patients with Parkinson's disease; (4) training of everyday activities after stroke; and (5) communication training for patients with aphasia., (Copyright © 2014. Published by Elsevier GmbH.)

Background: The topics of rationing and priority setting have been increasingly discussed over the past 5 years in Germany by physicians together with other health care stakeholders. The topic of overuse, however, has not been discussed with similar intensity and publicity., Objectives: This analysis paper outlines the relationships and differences between efficiency, priority setting, and rationing. Furthermore, it argues why and how German physicians should address the topic of overuse with more transparency and intensity., Discussion: Efforts of physicians to rationalize health care mainly comprise efforts to decrease overuse. The identification of important areas of overuse includes the prioritization of indications and medical interventions. Rationing health care can be unavoidable, for example, because other strategies such as rationalization, price regulation or disinvestments are not sufficient to avoid scarcity of financial resources. In such a case, rationing health care is unavoidable and, therefore, cannot be unethical per se. However, the debate on rationing becomes more legitimate if physicians demonstrate sufficient efforts to reduce overuse sufficiently. The Choosing Wisely initiative in the USA is outlined as one interesting option of how physicians could demonstrate and prove such efforts. Additional and more effective strategies to decrease overuse might be possible., Conclusion: German physicians demand a more explicit communication within their communities and together with other stakeholders on the appropriateness of existing and potential future activities to decrease overuse. Such initiatives to avoid and decrease overuse should primarily be motivated through the ethical principle of beneficence, while the effect of cost containment should be considered as a welcomed side effect.

For some years patient safety has been an important topic for the design of the healthcare systems in many countries. In Germany we are still in the starting phase of this development. Here, patient safety is not a main focus for research and there is only little funding for these topics. Thus most findings on patient safety have been derived in foreign studies. Slowly, some find their way into the clinical routine in Germany. This paper summarises the state of development of patient safety from a trans-sectoral point of view and outlines essential fields of action for the German healthcare system., (Copyright © 2014. Published by Elsevier GmbH.)

In 2013, the forum gesundheitsziele.de selected "reduction of alcohol consumption" and "patient safety" as new health targets. Besides the two selected targets, three other topics were considered: health at work, health during pregnancy and childbirth, and health and migration. This paper describes the selection process, which followed several criteria: mortality, morbidity, prevalence, burden of disease, economic impact, potential for improvement, equity in health, empowerment of and priorities of health problems in the population. The analysis particularly focused on the assessment of the feasibility and the readiness of stakeholders to participate in the development and implementation of health targets.

Background: The German National Surgical Trial Network (CHIR-Net) which has been funded since 2006 by the Federal Ministry of Education and Research (BMBF, funding code 01GH1001A-01GH1001F, 01GH0702) is made up of eight regional surgical centers. The aim of the CHIR-Net is the design, implementation and publication of prospective, randomized, multicenter trials to support evidence-based medicine in surgery. Two main pillars of the CHIR-Net are the surgeon on rotation program and the flying study nurse program. With these two programs the surgical hospitals are supported in their trial working by educating competent investigators and the infrastructural support of flexible and mobile study nurses., Methods: The surgeon on rotation program and the concept of the flying study nurse are presented descriptively. Furthermore, this paper provides reports of experiences of a surgeon on rotation and a flying study nurse of the CHIR-Net. Additionally, the results of an on-line evaluation of the regional surgical hospitals (belonging to the regional surgical center of the universities Witten/Herdecke and Cologne) regarding the needs and requirements of the regional surgical hospitals are presented., Results: The surgeon on rotation program of the CHIR-Net offers investigators the possibility to acquire the basics of designing, developing and implementation of high quality clinical trials. In addition, their own study projects could be intensively driven forward. The flying study nurse program enables in particular non-university surgical hospitals to be supported competitively in performing their own study projects and participating in muliticenter clinical trials. The success of these two programs has been confirmed by the conducted evaluations and the presented field reports., Conclusion: The CHIR-Net is able to develop a high quality study culture in Germany with its surgeon on rotation and flying study nurse program. In addition to the funding period by the BMBF, the continuance of the CHIR-Net should be a primary aim of further measures.

Voice prostheses are available in different types of architecture und from different producers. Especially the ones with antifungal properties are characterized by a high pricing. The aim of this paper is to check, whether these prices are reflected by the prosthesis life time.A Benchmarking with usage of mean lifetime and prosthesis costs. Comparing Provox 1, Provox 2, Provox Vega, Provox ActiValve, ESKA-Herrmann, Blom Singer Classic, Phonax, Blom Singer Advantage.The voice prosthesis Provox 1 offers the best price-lifetime-ratio (1.0). It's 6.7-times higher than the one of the Provox ActiValve (0.15). In addition, the classic prostheses Provox 2 (0.53), Blom Singer Classic (0.54) and ESKA-Herrmann (0.72) offer a good ratio compared to Provox 1, too.The mean lifetime of the voice prostheses do not reflect the pricing. The Provox 1 offers the best ratio and should be used as a reference in pricing the prostheses., (© Georg Thieme Verlag KG Stuttgart · New York.)

The present paper outlines two central challenges that should be taken into account when making a concerted effort to reduce excessive medical care (overdiagnosis and overtreatment): first, the inevitability of value judgements in the risk-benefit assessment of medical treatment measures in conjunction with the need to go beyond the individual doctor-patient relationship and make these value judgements while, at least in part, assuming the role of acting deputy; and second, the need for a sufficient level of competence and trust in evidence-based medicine on the part of both physicians and patients. The paper will explain how one can say in a methodologically reasonable and ethically acceptable manner that a certain medical measure - in the context of the regular care setting - will objectively cause a "net harm" to the patient. Relevant institutions in the German healthcare system will be described that are currently conducting risk-benefit assessments (by different means and with different purposes). Taking the known entity of clinical guidelines as an example, the paper will demonstrate that the subjects of overdiagnosis and overtreatment as well as shortage of medical care can be more explicitly communicated by employing certain additional methodological tools. Finally, some central implementation barriers to a successful application of "Less is more!" will be presented and critically discussed. (As supplied by publisher)., (Copyright © 2013. Published by Elsevier GmbH.)

The aim of the WINHO indicators project is to describe and enhance the quality of outpatient oncology care in Germany with indicators. This paper deals with the development of a set of evidence- and consensus-based meaningful indicators to assess the quality of outpatient oncology care in Germany. These indicators are intended to be applied in assessments of quality of patient care in oncology practices, in quality reports and in peer-to-peer benchmarking. A set of 272 already existing indicators was identified through internet and literature searches. After redundancy reduction and addition of newly developed indicators for areas of ambulatory oncology care that were not yet covered, a preliminary set of 67 indicators was established. The further development of the indicator set was based on a modified version of the two-step RAND/UCLA expert evaluation method, which has been internationally established for developing quality indicator sets. The indicators were modified after the first round of ratings. After completing and assessing the second round of ratings, a set of 46 homogeneously positively rated quality indicators is now available for outpatient oncology care in Germany., (Copyright © 2013. Published by Elsevier GmbH.)

The committee draft for the new patient rights act was approved by the Federal Cabinet on 23 May 2012. Both the demands of the patient representative of the Federal government and some of the demands from the cornerstone paper of the State commission were taken into consideration.The draft of the new act contains comprehensive amendments to the Civil Code with the subtitle"Treatment contract in accordance with §630" and encompasses §§630a-h. The valid legal situation is therefore to all intents and purposes now codified.

Objective: Using the categories of the German Inpatient Quality indicators (G-IQI) important characteristics of inpatient care were analyzed on the national level in Germany. The evaluation gives an overview of total national case numbers and number of hospitals involved in the treatment of important diseases., Method: The analysis was based on the national so called 'DRG database' for the year 2010, which covers all German inpatient DRG cases (all patient / all payer database). With the major exception of psychiatric and psychosomatic cases this database covers 17.43 of the 18.49 million German inpatient cases. The coded diagnoses and procedures as well as demographic information were used to group cases into G-IQI disease categories. The respective total case numbers, number of hospitals providing the services, interquartile range of case distribution, in-hospital mortality and interquartile range of standardized mortality ratios were investigated., Results: Especially for less frequent diseases and procedures it is shown, that many hospitals treat very low case numbers. For example for gastric resection the lower quartile is 4, for esophageal resection 1 and for cystectomy 5. Even for a more frequent disease like myocardial infarction the lower quartile is 36. Mortalities also show considerable variation. However, due to the low case numbers in many hospitals, the deviation of hospital mortality from the German average can only become significant for rather few hospitals., Conclusion: On the one hand this paper provides national reference values for the German Inpatient Quality Indicators, which cover 38.7 % of all inpatient cases and 50.8 % of in-hospital deaths. On the other hand it gives a first overview of the disease specific patterns of inpatient hospital care in Germany. Despite the high overall quality of the German health care system it suggests, that further improvement might be possible, if structural problems were addressed., (© Georg Thieme Verlag KG Stuttgart · New York.)

The paper discusses the question whether it could be ethically appropriate to "resolve" the problem of scarce resources in health care via priority lists. It is argued that such a schematical priority list could only be undisputed in ethical respects if it represented a broad consensus on the question what a good life would be. Priority lists are always implicit decisions about specific concepts of the good life. Using a priority list only in consideration of a mere cost-benefit ratio means to accept a mere utilitarian way of defining good life. Such a definition goes with neglect of the interests of people with chronic diseases, of patients with incurable diseases, of patients with a limited life expectancy. To neglect the interests of these patients means to abandon the core of medical identity, because medicine has the mission to help those above all who are most in need and those who cannot help themselves. And so we have to realize that for medicine there are some values which are more important than economic considerations. The physician is a person who gives a promise, the promise to be there for the patient. If the physician now is becoming a businessman, this promise is no longer valid. The businessman doesn't give any other promise than not to act against the contract. But the main need of the patient, his longing for a human person whom he can trust, cannot become part of a contract. Especially in our time medicine has to fight for the core of its identity., (© Georg Thieme Verlag KG Stuttgart · New York.)

In our society, taking personal responsibility is basically regarded as a key step to adopting a more active lifestyle. In health care, however, personal responsibility is primarily equated with higher levels of financial contribution from patients. Obviously, the individual's responsibility for his or her health and towards the mutually supportive community is a highly emotional and ideological issue, so the debate is usually rather heated. This is, however, at odds with the "empowered patient" concept. In the present paper "personal responsibility in practice" will be understood to include both physician and patient responsibility. Examples will be employed to demonstrate that, on an individual level, physicians are responsible for diagnosing and treating their patients as indicated and that, on a collective level, they are expected to make responsible use of the resources allocated. Here, patient responsibility will be defined as both taking care for one's own health and the individual's obligation to contribute to the maintenance of our solidarity-based health care system. The tensions between solidarity and subsidiarity and personal responsibility, respectively, will be outlined, and a readjustment of the relation between external support and individual strengths, between solidarity and personal responsibility in terms of Sect. 1 of the Social Book Code V will be advocated., (Copyright © 2012. Published by Elsevier GmbH.)

Fair rationing in publicly accessible health care has become a subject of current international debate. One suggestion is to cut reimbursement for any medical intervention below some threshold of small clinical benefit. One can further differentiate between thresholds of small expectable clinical benefit as such and thresholds of low chances for clinical success. Public acceptance of both types of thresholds has been tested in a population survey. Results are presented and discussed in this paper. (As supplied by publisher)., (Copyright © 2012. Published by Elsevier GmbH.)

Decisions on priority setting and rationing in health care have both informational and distributional aspects, which is why they require expert knowledge and specialised bodies on the one hand and democratic consent on the other hand. The paper presents normative criteria for the evaluation and empirical categories for the description and comparison of respective bodies. As procedural decisions always have implications for resulting distributional decisions, the bodies charged with priority setting and rationing decisions must be subject to democratic institutional design. (As supplied by publisher)., (Copyright © 2012. Published by Elsevier GmbH.)

Priority setting in medicine helps to achieve a fair and transparent distribution of health-care resources. The German discussion about priority setting is still in its infancy and may benefit from other countries' experiences. This paper aims to analyse the Danish priority setting debate in order to stimulate the German discussion. The methods used are a literature analysis and a document analysis as well as expert interviews. The Danish debate about priority setting in medicine began in the 1970s, when a government committee was constituted to evaluate health-care priorities at the national level. In the 1980s a broader debate arose in politics, ethics, medicine and health economy. The discussions reached a climax in the 1990s, when many local activities - always involving the public - were initiated. Some Danish counties tried to implement priority setting in the daily routine of health care. The Council of Ethics was a major player in the debate of the 1990s and published a detailed statement on priority setting in 1996. With the new century the debate about priority setting seemed to have come to an end, but in 2006 the Technology Council and the Danish Regions resumed the discussion. In 2009 the Medical Association called for a broad debate in order to achieve equity among all patients. The long lasting Danish debate on priority setting has entailed only very little practical consequences on health care. The main problems seem to have been the missing effort to bundle the various local initiatives on a national level and the lack of powerful players to put results of the discussion into practice. Nevertheless, today the attitude towards priority setting is predominantly positive and even politicians talk freely about it., (© Georg Thieme Verlag KG Stuttgart · New York.)

The dental curriculum in Germany is still based on a concept from 1955 with some revisions in certain aspects. All groups involved are interested in a new and more current version. In doing this, the compatibility with European concepts should be a main goal. The Association for Dental Education in Europe (ADEE), to which about 160 of the 200 European dental education associations are members, is in charge of coordinating projects to create a network of European universities, which intends to harmonize higher education in Europe and to create a core curriculum for the dentistry program. Based on a visitation and evaluation program at more than 50 oral and maxillofacial surgery centers, a paper for the profiles and competencies for future European dentists was formulated for the creation of a modular curriculum, for the integration of the ECT (European Credit Transfer) system, and for quality assurance of the dentistry curriculum. Especially for the situation in Germany, consequences must be drawn for further dentistry and postgraduate educational concepts, which are not completely identical with the ADEE concepts, but which can use elements of the basic Bologna concepts.

Background: The German DRG system forms the basis for billing inpatient hospital services. It includes not only the case groups (G-DRGs), but also copayments. This paper analyses and evaluates the relevant developments of the 2011 G-DRG system for orthopaedics and traumatology from the medical and classificatory perspective., Methods: An analysis was performed of relevant diagnoses, medical procedures and G-DRGs in the 2010 and 2011 versions based on the publications of the German DRG Institute (InEK) and the German Institute of Medical Documentation and Information (DIMDI)., Results: A number of codes for surgical measures have been newly established or modified - above all in foot surgery, arthroscopic surgery and wound surgery. Here, the identification and the correct and performance-based mapping of complex and elaborate scenarios was again the focus of the restructuring of the G-DRG system. The G-DRG structure in orthopaedics and traumatology is changed, especially for polytraumata., Conclusion: The allocation of common cases with a standardized treatment pattern appears to be appropriate and the reimbursement adequate. For the less common and more complex cases the 2011 G-DRG system still shows need for further modification (e.g. polytraumata, joint replacement, spine surgery). The proper integration of the modified OPS classification for foot surgery to the appropriate G-DRGs will be essential to maintain the high quality of the reimbursement structure for the future.

This paper is based on the Sixth National Social Report on the Situation of the Elderly, published in November 2010, that deals with the images of aging that exist in society. The aim of this paper is to describe how the commission that wrote the Sixth National Social Report on the Situation of the Elderly evaluates the role of images of aging in the field of health care and to specify the need for change that the commission identifies with respect to images of aging. The paper consists of four parts. A general introduction is followed by a discussion of some important aspects of images of aging, including a description of central assumptions and concepts of the expert commission. The main part is then the analysis of images of aging in the field of health care for the elderly. Finally, the recommendations of the expert commission in order to promote an adjustment of health care to an aging society are presented.

Novel therapies, e.g., cell and gene therapy or tissue engineering, are summarized in the European Union as advanced therapy medicinal products (ATMPs). In terms of composition and product properties, ATMPs are highly complex, and given their multiple potential actions they are subject to continuously developing regulatory requirements. Due to promising basic research findings, there are high expectations by the society toward the therapeutic potential of ATMPs. It is of utmost importance to develop a scientifically sound preclinical and clinical development plan before entering into the first clinical trial. Due to the complex features of ATMPs, this development plan should be discussed early with the regulatory authorities to define the specifics and challenges of each individual product. For planning as well as operational realization of the initial clinical trial involving ATMPs, specific requirements that need to be addressed are discussed in this paper.