ABSTRACT: BACKGROUND: A variety of multimodal treatment options are available for colorectal cancer and many patients want to be involved in decisions about their therapies. However, their desire for autonomy is limited by lack of disease-specific knowledge. Visual aids may be helpful tools to present complex data in an easy-to-understand, graphic form to lay persons. The aim of the present study was to evaluate the treatment preferences of healthy persons and patients using visual aids depicting multimodal treatment options for colorectal cancer. METHODS: We designed visual aids for treatment scenarios based on four key studies concerning multimodal treatment of colorectal cancer. The visual aids were composed of diagrams depicting outcome parameters and side effects of two treatment options. They were presented to healthy persons (n = 265) and to patients with colorectal cancer (n = 102). RESULTS: Most patients and healthy persons could make immediate decisions after seeing the diagrams (range: 88%-- 100%). Patients (79%) chose the intensive-treatment option in the scenario with a clear survival benefit. In scenarios without survival benefit, all groups clearly preferred the milder treatment option (range: 78%- 90%). No preference was seen in the scenario depicting equally intense treatment options with different timing (neoadjuvant vs. adjuvant) but without survival benefit. CONCLUSIONS: Healthy persons' and patients' decisions using visual aids seem to be influenced by quality-of-life aspects rather than recurrence rates especially in situations without survival benefit. In the future visual aids may help to improve the management of patients with colorectal cancer.

RATIONALE, AIMS AND OBJECTIVES: Having a quick, practical, educational tool designed for busy child-care professionals to check whether systematic reviews (SRs) contain valid information would help them regularly update their evidence-based knowledge and apply it to their patients. Continuing our annual workshop courses encouraging paediatric hospital professionals to use evidence-based information, in a preliminary study, we compared the commonly used Critical Appraisal Skill Programme (CASP) questionnaire for appraising overall internal validity in SRs with a new, practical tool designed to check internal validity quickly. METHOD: During a course in 2010, two 'teacher-brokers' taught experienced paediatric hospital professionals to use and compare the CASP and the new practical tool to appraise a Cochrane SR on beclomethasone for asthma in children by assessing internal validity only from the two most weighted randomized controlled trials in the forest plot. At 15 days and 6 months, participants then answered questionnaires designed to assess qualitative data including feelings about working together, memorization and possibly provide feedback for Cochrane reviewers. RESULTS: Using the CASP, participants agreed that the Cochrane SR analysed contained overall valid results. Conversely, using the new quick tool, they found poor internal validity. Participants worked well together in a group, took less time to apply the new tool than the CASP (1 vs. 2.5 hours) and provided Cochrane feedback. CONCLUSIONS: Our quick practical tool for teaching critical appraisal encourages busy child-care hospital professionals to work together, carefully check validity in SRs, apply the findings in clinical practice and provide useful feedback for Cochrane reviewers.

BACKGROUND A variety of definitions of evidence-based practice (EBP) exist. However, definitions are in themselves insufficient to explain the underlying processes of EBP and to differentiate between an evidence-based process and evidence-based outcome. There is a need for a clear statement of what Evidence-Based Practice (EBP) means, a description of the skills required to practise in an evidence-based manner and a curriculum that outlines the minimum requirements for training health professionals in EBP. This consensus statement is based on current literature and incorporating the experience of delegates attending the 2003 Conference of Evidence-Based Health Care Teachers and Developers ("Signposting the future of EBHC"). DISCUSSION Evidence-Based Practice has evolved in both scope and definition. Evidence-Based Practice (EBP) requires that decisions about health care are based on the best available, current, valid and relevant evidence. These decisions should be made by those receiving care, informed by the tacit and explicit knowledge of those providing care, within the context of available resources. Health care professionals must be able to gain, assess, apply and integrate new knowledge and have the ability to adapt to changing circumstances throughout their professional life. Curricula to deliver these aptitudes need to be grounded in the five-step model of EBP, and informed by ongoing research. Core assessment tools for each of the steps should continue to be developed, validated, and made freely available. SUMMARY All health care professionals need to understand the principles of EBP, recognise EBP in action, implement evidence-based policies, and have a critical attitude to their own practice and to evidence. Without these skills, professionals and organisations will find it difficult to provide 'best practice'.

BACKGROUND The "real" effect size of a medical therapy is constant over time. In contrast, the effect size reported in randomised controlled trials (RCTs) may change over time because the sum of all kinds of bias influencing the reported effectiveness is not necessarily constant. As this would affect the validity of meta-analyses, we tested the hypothesis that the reported effect size decreases over time. Furthermore, we tested three hypotheses that would explain a possible change. METHODS Because of well established outcome measures, the lipid-lowering drugs Pravastatin and Atorvastatin (serum low-density lipoprotein cholesterol, LDL-C) and the anti-glaucoma drugs Timolol and Latanoprost (intraocular pressure, IOP) were chosen for this investigation. Studies were identified by a standardized MEDLINE search. RCTs investigating the above identified medications administered as monotherapy, and in defined dosages, were included. Publication year, baseline (= pre-treatment value in the treatment group of interest) and post intervention means, number of patients and the assignment to experimental or control group were extracted for each study. RESULTS A total of 625 citations were screened; 206 met the inclusion criteria. The reported effect size of Pravastatin (change of reported effect size in five years:-3.22% LDL-C, P <.0001), Timolol (-0.56 mmHg, P <.0001) and Latanoprost (-1.78 mmHg, P =.0074) decreased over time, while there was no significant change for Atorvastatin (+0.31% LDL-C, P =.8618). Multiple regression analysis showed that baseline values were the most important influencing factor; study size or treatment group did not play a significant role. CONCLUSION The effectiveness of medical therapies reported in RCTs decreases over time in three of the four investigated pharmaceuticals, caused mainly by baseline differences. We call this phenomenon "fading of reported effectiveness". Under this condition the validity of a meta-analysis may be impaired. Therefore we propose to observe this phenomenon in future meta-analyses in order to guarantee a maximum of transparency.

ABSTRACT: BACKGROUND: Interest in assessing the value of healthcare services in Germany has considerably increased since the foundation of the Institut fur Qualitat und Wirtschaftlichkeit im Gesundheitswesen, IQWiG (Institute for Quality and Efficiency in Health Care). The practical application of value assessment illustrates how problematic the process can be. In all decisions made for the provision of health care, data concerning the measurable dimensions (quantity and quality of efficacy and effectiveness, validity of the results and costs) flow into a complex and not yet standardized decision-making process concerning public financing. Some of these decisions are based on data of uncertain validity, unknown reproducibility and unclear appropriateness. DISCUSSION: In this paper we describe the theoretical aspects of value from psychological and economic viewpoints and discuss national and international approaches. Methodic details and difficulties in assessing the value of healthcare services are analysed. A definition of the intangible value of healthcare services will be proposed which contains only three factors: the absolute risk reduction (usually a measure of efficacy), the validity of the scientific papers examined and the type of the expected effectiveness (prevention of death and disability, restitution of well-being). The intangible value describes the additional benefit when comparing two possible actions, like treatment or observation only. CONCLUSION: The description of intangible value from the viewpoint of different stakeholders is a useful measure for subsequent steps (not discussed here)- the evaluation of costs and of patient benefit. A standardised, transparent, fair and democratic evaluation is essential for the definition of a basic benefit package.

BACKGROUND: In patients with very severe dementia self-rating of quality of life usually is not possible and appropriate instruments for proxy-ratings are not available. The aim of this project is to develop an instrument of clinical proxy-ratings for this population. METHODS: Using electronic instruments, physicians and nurses recorded patient behaviour and changes of behaviour over a period of one year. Based on these data a list of 65 items was generated and subsequently allocated to 14 categories. This list was tested in 217 patients (61-105 yrs) with dementia diagnosed according to ICD-10 by both physicians and nurses. The severity of dementia was assessed by means of the Global Deterioration Scale (GDS) and the Brief Cognitive Rating Scale (BCRS). The Spitzer-Index (proxy-rating) was used as a global quality of life measure. Activity of daily living was rated using the Barthel Index. RESULTS: A factor analysis of the original 65 items revealed 5 factors (communication, negative affect, bodily contact, aggression, and mobility). By stepwise removing items we obtained satisfactory internal consistencies of the factors both for nurses' and physicians' ratings. The factors were generally unrelated. The validity of the instrument was proven by correlations of the factors communication and mobility with the Brief Cognitive Rating Scale (BCRS) and the Barthel-Index. CONCLUSION: The results demonstrate the reliability and validity of the Vienna List as a proxy rating measurement of quality of life in patients with severe dementia. The psychometric properties of the scale have to be proved in further studies.

Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and "knowledge framing". While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing--which is only conceptually different from placebo--is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to investigate the effects of knowledge framing and its impact on ethical, medical, economical and legal decisions.

Finding the optimal use of health-care resources requires the reliable estimation of costs and consequences. Acquiring these estimates may not be difficult for some common treatments. More difficult is the optimization of resources in the area of diagnostics. Only a few attempts have been made to optimize the use of resources in the area of prevention. Several aspects have to be considered when optimizing the resources for prevention:(1) participation rates in structured prevention programs are low,(2), acquiring data on follow-up and outcomes is difficult,(3) there are concerns about the quality of information available to public, and (4), the public is often unaware of scientific assessments of prevention programs. As prevention programs are costly long-term projects, a strategy to select these programs according to possible predictors of success might be useful. The few analyses of cancer prevention in the literature have been directed towards the most common malignant diseases (as assessed by incidence) such as cancer of the breast, colon, lung and prostate. We argue that incidence is a poor marker for selecting secondary prevention programs. Incidence may be a misleading indicator for two reasons: incidence of disease does not predict efficiency of management or good health outcomes, and incidence does not separate clinically significant from non-significant disease. The traditional strategy is based on the assumption that more screening increases the chance of cure. We propose an alternative outcomes model that suggests better disease management justifies new prevention programs. Indicators for better disease management are effective and efficient treatments as well as high-quality screening (sensitivity and specificity) techniques and possibly "side-effects of prevention programs," which provide early signs of success to motivate the patient's participation, to keep up with the program and finally to succeed.

In assessing the benefits of health services it is presumed that the relationship of cause and effect can be determined by scientific methods. In general, the randomized controlled trial (RCT) is considered the gold standard for the generation of scientific evidence. Yet there is an increasing amount of data indicating that not in all situations RCTs seem to be the adequate tool for generating evidence. In many instances, RCTs are, in fact, barely useful to reflect the real-world situation of health-care services. Some of the well-known yet mostly ignored limitations of RCTs are summarized.The absence of definite a priori preferences for a specific kind of intervention (equipoise) is an essential prerequisite for both physicians' and patients' consent to participate in an RCT. Numerous examples of quantitative studies confirm that the willingness to accept randomization is limited in operative disciplines. If it is true that the invasiveness of a diagnostic or therapeutic intervention correlates with the preferences of doctors and patients, the small number of RCTs in operative fields should be expected. Further development of the important concept of RCTs should specify the conditions under which RCTs can generate significant results. Paying attention to this will open up new perspectives for the assessment of health-care services.