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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.

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.

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.

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.

D Debatte um die Evidenz fur das Verschreiben von Ostrogenen oder Ostrogen-Gestagen-Kombinationen in und nach den Wechseljahren konzentriert sich nach wie vor auf die Frage, ob es jenseits der Moglich keit der Beeinflussung von starken Wechseljahresbeschwerden nicht doch Chancen der Pravention durch Hormon„substitution“ gibt. Der Abbruch des ersten Untersuchungsarms der WHI-Studie [12] im Jahre 2002 fuhrte allerdings aus wissenschaftlicher Sicht definitiv zu einer Zasur in der Debatte um die Hormoneinnahme in den weiblichen Wechsel jahren [7]. Angesichts dieser randomisierten, kontrollierten Studie wurde eine negative Nutzen-Risiko-Bilanz deutlich, vor allem hinsichtlich eines erhohten Risikos fur Brustkrebs, Herzinfarkt, Schlaganfalle und Thromboembolien. In Deutschland nahmen – bei einem beachtlichen Ruckgang der Verschreibungsmengen – 2007 noch immer „1,5 Mio. Frauen in der Gesamtbevolkerung“ [11] taglich Hormone in den Wechseljahren ein. Grund fur diese noch immer verhaltnismasig hohe Zahl von Anwenderinnen sind die in diesem Spektrum fortbestehenden „Lagerkampfe“ von Befurwortern und Gegnern. Auf der einen Seite sind nach wie vor Stimmen aus gynakologischen Fachkreisen zu vernehmen, die geradezu unerschutterlich den angeblich noch immer bestehenden Nutzen einer Hormontherapie (HT) fur einen grosen Anteil von Frauen mit Beschwerden in den Wechseljahren uberbetonen [6, 8]. Eine Schlusselrolle kommt dabei der internationalen Menopausegesellschaft zu, die erst jungst noch einmal den Versuch unternommen hat, die Studienlage im Sinne einer positiven Nutzen-Risiko-Bilanz fur die Pravention kardiovaskularer Erkrankungen umzudeuten [5]; dabei beharrt sie auf dem Konstrukt der Hormon„ersatz“therapie, die Frauen in und nach den Wechseljahren de facto als Hormonmangelwesen versteht. Auf der anderen Seite sind die Stimmen der deutschen Arzteschaft deutlich zu vernehmen, die sich der Position der Arzneimittelkommission der Deutschen Arzteschaft [1] anschliesen, welche zur Zuruckhaltung in der Verordnung mahnt. So finden sich etwa im Deutschen Arzteblatt jungst noch einmal Stimmen, die deutlich machen, dass von einer „Entwarnung“ fur ein auf Pravention abzielendes Verschreiben von Hormonen nicht die Rede sein kann [2, 9].

Troger and co-authors assume to have presented evidence proving that mistletoe treatment in patients with locally advanced or metastatic pancreatic carcinoma significantly improves quality of life compared with best supportive care (BSC). In the original publication (1) the authors claim that survival was significantly extended by this therapy. To publish the primary endpoint, survival, and the secondary endpoint, quality of life, separately (2), follows in the tradition of unnecessary multiple publications. Both statements are unsustainable because of the study’s serious methodological shortcomings. Without blinding, it is not possible to make a valid statement with regard to quality of life and the chosen method of randomization using sealed envelopes does not meet the requirements of good study practice. The study was terminated early after enrolment of approximately half of the intended number of patients. The authors do not mention that early termination may lead to significant overestimation of treatment effects, especially in small studies (3). The therapy standard at the time of the study was not adequately reported. Best supportive care is here a commonly used “euphemism” for doing without sensible disease-modifying therapies. The authors declare financial support from the Swiss Cancer Research Association (Verein fur Krebsforschung e. V. (VfK), Schweiz) which generates revenues from license fees received from Weleda AG for the preparation of the active substance and, at the same time, state that no conflict of interest exists.

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.

Evidence-based Medicine (EbM) was accepted during the last decade both as a method for systematically evaluating risks and benefits and a decision aid for therapists in practice. Randomized controlled trials (RCT) have become the gold standard for medical research. The medical community is sceptical about RCTs because many therapists are not convinced that care can be mirrored adequately enough, though. The doubts are especially strong among psychiatrists and psychotherapists. The paper argues in favour of EbM in two ways. Firstly, from a scientific point of view there are no reasons why RCTs could not contribute to improve the standards of care. Secondly, health services research doesn't amount to much more than RCTs. The importance of qualitative methods is a black box as large within health services research as the meaningful use of RCTs.

In the immigrant-absorbing countries migrants are regularly confronted with manifold forms of segregation and exclusion. This is also true of the health care system, thus impeding it in its humanitarian goals. One must try to understand why there should be a traditional tendency to encourage segregation. Among the reasons are explicit rejection of migration as such, poor understanding of other peoples, fear of infectious diseases and rising health care costs. In addition a misunderstanding of the integration process plays an important role. What is necessary is, firstly, a realistic view of the world-wide process of migration which inevitably affects the rich industrial nations and, secondly, respect for ethnic identity instead of an out-dated concept of assimilation.

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.

SUMMARY George Rosen was not only one of the most noted medical historians in the United States, but also a pioneer in the scientific and practical establishment of public health. He promoted the socio-historical foundation of public health and emphasized the ambivalent role of the government between the creation of healthy living conditions and the control of individuals. Rosen was one of the first to point out the consequences of approaching social medicine exclusively from the perspective of modern bacteriology. The article shows that Rosen located elements of a democratic and holistic health system in his analysis of the Neighborhood Health Centers of the early 20th century. At the same time, he assessed the reasons for the demise of these efforts with the expansion of the medical‐industrial complex after Word War II. According to Rosen this development was mainly due to the lack of a solid financial plan that was feasible for the entire country. Until today the integration of medical care, social security and psychosocial counseling has not been re-established in this kind of community-oriented form. The Neighborhood Health Centers were mainly characterized by a democratic integration of the population to be served, by their intercultural approach and by the cooperation of people from a variety of professional backgrounds. They were thus an example of a cooperative, community-based health promotion in residential areas with a high degree of social problems. The aspects of integrative programs, proximity to residential areas and the participation of the population present key elements that could also prove significant for the future development of health promotion in today’s health system. Reading George Rosen’s work creates an awareness for the central questions concerning the definition of the ‘New Public Health’.

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.

BackgroundRecent 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/designA 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 ≥ 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.DiscussionTo 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 registrationISRCTN44478543

EDITOR—Tuffs' news item on the new chronic disease management programmes in Germany is misleading.1 The new programmes have arisen from economic analysis showing the importance of ensuring that health insurance funds should not continue to be penalised financially when they have large numbers of patients with chronic diseases. The economic rationale for these programmes is not simply to fund deficits. There will be no extra money put into the system. Instead the existing risk adjustment strategy will take the higher costs for patients with chronic …