[Where does Germany's aversion to cost-benefit assessments in health care come from?] / Woher kommt Deutschlands Scheu vor Kosten-Nutzen-Bewertungen im Gesundheitswesen?

It is widely assumed that in Germany it is particularly difficult to address the issue of the relationship between costs and benefits in medicine. It is argued that the reception of recent medical historiography makes it possible to more clearly identify a specifically German tradition of questioning theory-based controlled comparisons of clinical efficacy. Of central importance here is the Comparative Therapy (Vergleichende Therapie - V.T.) project carried out during the Second World War, whose guiding spirit was Paul Martini (1889-1964). The failure of this large-scale project influenced the further development of the methodology of clinical research and contributed to the "lateness" of the acceptance in Germany of prospective controlled clinical trials compared to the Anglo-American world. This also needs to be viewed in combination with the deep scepticism towards the cost-benefit debate whose rationale is still frequently questioned in Germany in relation to the need for individualised medicine. It seems important to give medical historiography greater space in order to reach a better understanding of the culture of the "late EbM nation Germany".

[Homeopathy: insubstantial doctrine of salvation]. / Homöopathie: Heilslehre "ohne Substanz".

Homeopathy is one of the frequently used alternative healing methods in Germany. This article is intended to discuss and analyze why homeopathy should not be part of medicine and should rather be understood as a concept of belief that lies outside of scientific methods. The clinical, legal, and political dimensions of the homeopathy debate are explained. Finally, the question of the legitimacy of placebo applications is discussed in light of the demand for patient-centered medicine.

[Patient involvement: challenges for organized self-help and joint self-government]. / Patientenbeteiligung: Herausforderungen für die verbandliche Selbsthilfe und die Gemeinsame Selbstverwaltung.

The involvement of the patient perspective in decision-making processes in the healthcare system is commonly welcome, especially in Germany, with self-help organizations currently providing the vast majority of patient representatives in the various committees. The central plank of organized self-help is the mutual support of chronically diseased and disabled people as well as their relatives in self-help groups.Patient involvement, however, seems to lead organized self-help to an insoluble dilemma. Either organized self-help must give up their traditional working principles in order to be capable of acting as a professional player in the discourse of the joint self-government of doctors and healthcare funds, or they will simply be unable to cope with patient involvement if they remain true to their original way of mutual exchange and communication. But if organized self-help and joint self-government are considered as social systems, it becomes clear that though patient involvement relates these systems to each other, it does not give rise to a relation of dominance and subordination. Organized self-help may have to handle the requirements and inputs of self-government as well as of the systems of science and law, but also has to be considered a challenge to and an opportunity for the self-government to help them achieve their system-related goals.

The Role of End-of-Life Issues in the Design and Reporting of Cancer Clinical Trials: A Structured Literature Review.

BACKGROUND: Randomized controlled trials (RCTs) are important sources of information on the benefits and harms patients may expect from treatment options. The aim of this structured literature review by the German Institute for Quality and Efficiency in Health Care was to explore whether and how the end-of-life (EoL) situation of patients with advanced cancer is considered in RCTs investigating anti-cancer treatments. METHODS: Our journal pool comprised 19 medical journals, namely five preselected key general medical journals as well as 14 specialist journals (mainly cancer) identified via a scoping search. We systematically searched these journals in MEDLINE to identify RCTs investigating anti-cancer treatments for the following four cancer types: glioblastoma, lung cancer (stage IIIb-IV), malignant melanoma (stage IV), and pancreatic cancer (search via OVID; November 2012). We selected a representative sample of 100 publications, that is, the 25 most recent publications for each cancer type. EoL was defined as a life expectancy of ≤ two years. We assessed the information provided on (1) the descriptions of the terminal stage of the disease, (2) the therapeutic goal (i.e. the intended therapeutic benefit of the intervention studied), (3) the study endpoints assessed, (4) the authors' concluding appraisal of the intervention's effects, and (5) the terminology referring to the patients' EoL situation. RESULTS: Median survival was ≤ one year for each of the four cancer types. Descriptions of the terminal stage of the disease were ambiguous or lacking in 29/100 publications. One or more therapeutic goals were mentioned in 51/100 publications; these goals were patient-relevant in 38 publications (survival alone: 30/38; health-related quality of life (HRQoL) or HRQoL and survival: 6/38; symptom control or symptom control and survival: 2/38). Primary endpoints included survival (50%), surrogates (44%), and safety (3%). Patient-reported outcomes (PROs) were assessed in 36/100 RCTs. The implications of treatment-related harms for the patients were discussed in 22/100 appraisals. Terminology referring to the patients' EoL situation (e.g. "terminal") was scarce, whereas terms suggesting control of the disease (e.g. "cancer control") were common. CONCLUSIONS: The EoL situation of patients with advanced cancer should be more carefully considered in clinical trials. Although the investigation and robust reporting of PROs is a prerequisite for informed decision-making in healthcare, they are rarely defined as endpoints and HRQoL is rarely mentioned as a therapeutic goal. Suggestions for improving standards for study design and reporting are presented.

The Long Way Toward Cooperation: Nurses and Family Physicians in Northern Germany.

To better understand why cooperation between health care professionals is still often problematic, we carried out 25 semistructured face-to-face expert interviews with physicians and nurses in different rural and urban areas in northern Germany. Using Mayring's qualitative content analysis method to analyze the data collected, we found that doctors and nurses interpreted interprofessional conflicts differently. Nursing seems to be caught in a paradoxical situation: An increasing emphasis is placed on achieving interprofessional cooperation but the core areas of nursing practice are subject to increasing rationalization in the current climate of health care marketization. The subsequent and systematic devaluation of nursing work makes it difficult for physicians to acknowledge nurses' expertise. We suggest that to ameliorate interprofessional cooperation, nursing must insist on its own logic of action thereby promoting its professionalization; interprofessional cooperation cannot take place until nursing work is valued by all members of the health care system.

What is it about homeopathy that patients value? and what can family medicine learn from this?

BACKGROUND: Homeopathy is one of the most frequently used areas of complementary and alternative medicine (CAM). Previous research has focused in particular on the pharmacological effectiveness of homeopathy. There is intense discussion among German family medical practitioners as to whether family medicine should adopt elements of homeopathy because of the popularity of this treatment method. AIM: For the first time in Germany, patients with chronic conditions were asked about their views on the medical care provided by homeopathic medical practitioners. METHODS: The survey used questionnaire-based, semi-structured expert interviews, the contents of which were then analysed and summarised. RESULTS: A total of 21 women and five men aged from 29 to 75 years were surveyed. The 'fit' between therapist and patient proved to be particularly important. Both the initial homeopathic consultation and the process of searching for the appropriate medication were seen by patients as confidence-inspiring confirmations of the validity of homeopathic therapy which they considered desirable in this personalised form. CONCLUSION: The possible adoption by family medicine of elements of homeopathy may be seen as controversial, but this study again indicates the vital importance of successful communication to ensure a sustainable doctor-patient relationship. Advances in this sector not only require continuous efforts in the areas of medical training and professional development, but also touch on basic questions relating to the development of effective medical care, such as those currently being discussed in the context of the 'patient-centred medical home'.

[Palliative care: an example of Comparative Effectiveness Research?]. / Palliativmedizin: Ein Modell für Comparative Effectiveness Research?

Comparative Effectiveness Research (CER) seeks to establish treatment objectives and concepts striving to achieve patient relevant progress in therapy on the basis of published evidence. Using the example of palliative medicine and palliative care, respectively, it will be demonstrated that these two are under-researched areas of care. In addition, it will become clear that the success of this interdisciplinary treatment concept for the seriously ill must be weighed in the light of traditional clinical research - far beyond the cancer diagnosis. The current distinction between curative and palliative research and care urgently needs to be reconsidered.

[Desirable, unfamiliar and in need of communication - the evidence-based decision aid of the Institute for Quality and Efficiency in Health Care (IQWiG)]. / Erwünscht, ungewohnt und kommunikationsbedürftig - Die evidenzbasierte Entscheidungshilfe des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG).

In 2004 the German Institute for Quality and Efficiency in Health Care (IQWiG) was given a statutory mandate to prepare and publish evidence-based information for consumers and patients. The current study investigated the extent to which the IQWiG's "Change of Life" information pack was found to be both comprehensible and useful by users. A total of 41 qualitative, semi-structured interviews were conducted with menopausal women. The partial analysis presented here is based solely on the "Decision Aid" part of the information pack. For many women the information contained in the Decision Aid was new and the manner of presentation unusual. In the sample investigated here the Decision Aid was used rather as a confirmation of decisions that had already been made than as an aid in the decision-making process. Where it was not possible to harmonise the scientific evidence presented with the individual's own opinion, the decision-making conflict was intensified. Balancing of individual preferences against study results proved to be difficult for two reasons: first, the unusual manner of presentation and second, the two contrasting poles of "science-based information" and "own preferences", which were not regarded as being of equal significance. This conflict represents a fundamental problem in evidence-based decision aids.

[Balancing benefit and harm in palliative care: the difficult position of palliative medicine in view of the promises of curative medicine]. / Nutzen-Schaden-Abwägung in der PalliativmedizinÜber den schwierigen Stand der Palliation angesichts der Versprechungen der kurativen Medizin.

The significance of palliative care as an interdisciplinary and multi-professional approach to treating patients with extremely severe medical conditions should be investigated using the same methodological standards as for clinical medicine in general. Clinical studies in palliative medicine show that certain standards, e.g. in pain therapy, have still not been sufficiently implemented. There is also a lack of methodologically appropriate studies to investigate palliative medicine as a complex intervention. This research deficit is all the more regrettable as - specifically in the field of oncology - it can be demonstrated that the benefit provided by the services of palliative care teams is very large, especially for patients with a particularly unfavorable course of the disease.

EVITA: a tool for the early evaluation of pharmaceutical innovations with regard to therapeutic advantage.

BACKGROUND: New drugs are generally claimed to represent a therapeutic innovation. However, scientific evidence of a substantial clinical advantage is often lacking. This may be the result of using inadequate control groups or surrogate outcomes only in the clinical trials. In view of this, EVITA was developed as a user-friendly transparent tool for the early evaluation of the additional therapeutic value of a new drug. METHODS: EVITA does not evaluate a new compound per se but in an approved indication in comparison with existing therapeutic strategies. Placebo as a comparator is accepted only in the absence of an established therapy or if employed in an add-on strategy on top. The evaluation attributes rating points to the drug in question, taking into consideration both therapeutic benefit and risk profile. The compound scores positive points for superiority in efficiency and/or adverse effects as demonstrated in randomized controlled trials (RCTs), whilst negative points are awarded for inferiority and/or an unfavorable risk profile. The evaluation follows an algorithm considering the clinical relevance of the outcomes, the strength of the therapeutic effect and the number of RCTs performed. Categories for therapeutic aim and disease severity, although essential parts of the EVITA assessment, are attributed but do not influence the EVITA score which is presented as a color-coded bar graph. In case the available data were unsuitable for an EVITA calculation, a traffic-type yield sign is assigned instead to criticize such practice. The results are presented online http://www.evita-report.de together with all RCTs considered as well as the reasons for excluding a given RCT from the evaluation. This allows for immediate revision in response to justified criticism and simplifies the inclusion of new data. RESULTS: As examples, four compounds which received approval within the last years were evaluated for one of their clinical indications: lenalidomide, pioglitazone, bupropion and zoledronic acid. Only the first achieved an EVITA score above zero indicating therapeutic advantage. CONCLUSIONS: The strength of EVITA appears to lie in its speedy assessment of the potential therapeutic advantage of a new drug for a given indication. At the same time, this approach draws attention to the typical deficits of data used for drug approval. EVITA is not intended to replace classical health technology assessment reports but rather serves as a screening tool in the sense of horizon scanning.

Co-ordination and management of chronic conditions in Europe: the role of primary care--position paper of the European Forum for Primary Care.

Healthcare systems in Europe struggle with inadequate co-ordination of care for people with chronic conditions. Moreover, there is a considerable evidence gap in the treatment of chronic conditions, lack of self-management, variation in quality of care, lack of preventive care, increasing costs for chronic care, and inefficient use of resources. In order to overcome these problems, several approaches to improve the management and co-ordination of chronic conditions have been developed in European healthcare systems. These approaches endeavour to improve self-management support for patients, develop clinical information systems and change the organisation of health care. Changes in the delivery system design and the development of decision support systems are less common. Almost as a rule, the link between healthcare services and community resources and policies is missing. Most importantly, the integration between the six components of the chronic care model remains an important challenge for the future. We find that the position of primary care in healthcare systems is an important factor for the development and implementation of new approaches to manage and coordinate chronic conditions. Our analysis supports the notion that countries with a strong primary care system tend to develop more comprehensive models to manage and co-ordinate chronic conditions.

Attitudes toward postmenopausal long-term hormone therapy.

In this article we address the question of why postmenopausal women undergo hormone therapy. Thirty-five women aged 46 to 75 years living in Bremen (Germany) and taking postmenopausal hormones for at least 12 months were interviewed. Following Fritz Schütze, the interviews were analyzed according to a reconstructive analytical procedure. Five different types of users were identified. They differed from each other in terms of their reasons for using hormones, their expectations of this type of therapy, and their personal habits and circumstances, including an integrity-preserving attitude, a performance-oriented attitude, a searching attitude, a faith-in-medicine attitude, and a benefit-generalizing attitude. The interviews show that there is a need for target-oriented counseling, taking into account the individual attitudes toward menopause and postmenopausal hormone therapy.

CRISTOPH - a cluster-randomised intervention study to optimise the treatment of patients with hypertension in General Practice.

BACKGROUND: Recent guidelines for the management of hypertension focus on treating patients according to their global cardiovascular risk (CVR), rather than strictly keeping blood pressure, or other risk factors, below set limit values. The objective of this study is to compare the effect of a simple versus a complex educational intervention implementing this new concept among General Practitioners (GPs). METHODS/DESIGN: A prospective longitudinal cluster-randomised intervention trial with 94 German GPs consecutively enroling 40 patients each with known hypertension. All GPs then received a written manual specifically developed to transfer the global concept of CVR into daily General Practice. After cluster-randomisation, half of the GPs additionally received a clinical outreach visit, with a trained peer discussing with them the concept of global CVR referring to example study patients from the respective GP. Main outcome measure is the improvement of calculated CVR six months after intervention in the subgroup of patients with high CVR (but no history of cardiovascular disease), defined as 10-year-mortality > or = 5% employing the European SCORE formula. Secondary outcome measures include the intervention's effect on single risk factors, and on prescription rates of drugs targeting CVR. All outcome measures are separately studied in the three subgroups of patients with 1. high CVR (defined as above), 2. low CVR (SCORE < 5%), and 3. a history of cardiovascular disease. The influence of age, sex, social status, and the perceived quality of the respective doctor-patient-relation on the effects will be examined. DISCUSSION: To our knowledge, no other published intervention study has yet evaluated the impact of educating GPs with the goal to treat patients with hypertension according to their global cardiovascular risk. TRIAL REGISTRATION: ISRCTN44478543.