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Evidence-based and comprehensible health information is a key element of evidence-based medicine and public health. The goal is informed decision-making based on realistic estimations of health risks and accurate expectations about benefits and harms of interventions. In Germany, standards of evidence-based risk information were poorly followed during the COVID-19 pandemic. Frequently, public information was biased, fragmentary and misleading. Pandemic-related threat scenarios induced emotional distress and unnecessary anxiety. A systematic and comprehensive evaluation of the pandemic measures is crucial, but still pending in Germany. A critical analysis of risk communication by experts, politicians and the media during the pandemic should be a key element of the evaluation process. Evaluation of decision making and media reporting during the pandemic should improve preparedness for future crises., (Copyright © 2024. Published by Elsevier GmbH.)

Background: Women with breast cancer demand informed shared decision-making. Guidelines support these claims., Objectives: To investigate whether an informed shared decision-making intervention for women with 'ductal carcinoma in situ' comprising an evidence-based decision aid with nurse-led decision coaching enhances the extent of the mutual shared decision-making behavior of patients and professionals regarding treatment options, and to analyze implementation barriers., Design: Cluster randomized controlled trial with accompanying process evaluation., Setting: Certified breast care centers in Germany., Participants: Women with ductal carcinoma in situ and no previous history of breast cancer facing a primary treatment decision., Methods: Sixteen breast centers were randomized to intervention or standard care to recruit 192 patients (partially-blinded). All coaching sessions and physician consultations were videotaped to assess the primary outcome 'extent of patient involvement in shared decision-making' using the MAPPIN-O dyad observer instrument (scores 0 to 4). Secondary endpoints included the sub-measures of the MAPPIN-inventory (MAPPIN-O nurse , MAPPIN-O physician , MAPPIN-O patient , MAPPIN-Q nurse , MAPPIN-Q patient and MAPPIN-Q physician ), 'informed choice', 'decisional conflict' and 'duration of consultations'. Primary intention-to-treat analyses were on cluster level comparing means of cluster values using t-tests. An accompanying process evaluation was conducted comprising 1) analysis of all video recordings with focus on procedures and intervention fidelity and 2) field notes of researchers and feedback from professionals and patients assessed by questionnaires and interviews with focus on barriers and facilitators for implementation at different time points., Results: Due to protracted recruitment, the study was terminated after 14 centers had included 64 patients (intervention group 36, control group 28). Patient participation in informed shared decision-making was significantly higher in the intervention group (mean (SD) score 2.29 (0.56) vs. 0.42 (0.51) in the control group; difference 1.88 (95% CI 1.26-2.50, p < 0.0001). 47.7% women in the intervention group made informed choices, but none in the control group, difference 47.7% (95% CI 12.6-82.7%, p = 0.016). In the intervention group physician consultations lasted 12.8 (6.6) min. vs. 24.3 (6.3) min. in the control group. Physicians' attitudes, false incentives and structural barriers hindered implementation of informed shared decision-making. Nurses appreciated their new roles., Conclusions: Informed shared decision-making is not yet implemented in German breast care centers. Nurse-led decision coaching grounded on evidence-based patient information enhances informed shared decision-making. Trial registration No. ISRCTN46305518., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The patient's consent to a medical procedure must be preceded by a pre-procedure discussion with the physician that is documented on a standardized form. Evidence suggests that these forms lack information that would be relevant for an informed decision., Methods: We carried out a systematic literature search up to February 2017 for evidence on the quality and efficacy of informed consent forms. The definition of criteria for the evaluation of meta-information, content, and presentation were derived from current guidelines for evidence-based health information. As an example, we analyzed consent forms currently in use in Germany for 10 medical interventions with regard to decisionally relevant content and intelligibility of format., Results: Our literature search yielded 14 content analyses, which revealed that even some of the more important evaluative criteria were not always met, including information on benefits (9/14), risks (14/14), alternatives (11/14), the option of doing nothing (6/14), and numerical frequencies (2/14). All analyses indicated deficiencies in the content of the consent forms. We then analyzed 37 consent forms obtained from publishing companies (across Germany) and physician's practices in Hamburg. These forms were found to contain information on: the intervention (37/37), benefits (30/37), risks (37/37), alternatives (26/37), the option of doing nothing (4/37), numerical frequencies (10/37), the names of the authors (17/37), sources of information (0/37), and date of issue (21/37)., Conclusion: Both the evidence from foreign countries and our own analysis of the consent forms now in use in Germany revealed deficiencies, particularly in the communication of risks. New standards are needed to promote well-informed decision-making. Structural changes in the process of patient information and decision-making should be discussed.

Objective: To evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions., Design: Randomised, single-blinded trial with sham control intervention and follow-up of 6 months., Setting: Single-centre diabetes clinic providing care according to the national disease management programme in Germany., Participants: 154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke., Interventions: The ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues., Main Outcome Measures: Primary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity., Results: 72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0-12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0-6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups., Conclusions: The ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity conditions. Involvement of diabetes educators may facilitate implementation of the informed shared decision-making., Trial Registration Number: ISRCTN84636255., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Women with breast cancer want to participate in treatment decision-making. Guidelines have confirmed the right of informed shared decision-making. However, previous research has shown that the implementation of informed shared decision-making is suboptimal for reasons of limited resources of physicians, power imbalances between patients and physicians and missing evidence-based patient information. We developed an informed shared decision-making program for women with primary ductal carcinoma in situ (DCIS). The program provides decision coaching for women by specialized nurses and aims at supporting involvement in decision-making and informed choices. In this trial, the informed shared decision-making program will be evaluated in breast care centers., Methods/design: A cluster randomized controlled trial will be conducted to compare the informed shared decision-making program with standard care. The program comprises an evidence-based patient decision aid and training of physicians (2 hours) and specialized breast care and oncology nurses (4 days) in informed shared decision-making. Sixteen certified breast care centers will be included, with 192 women with primary DCIS being recruited. Primary outcome is the extent of patients' involvement in shared decision-making as assessed by the MAPPIN-Odyad (Multifocal approach to the 'sharing' in shared decision-making: observer instrument dyad). Secondary endpoints include the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), informed choice, decisional conflict and the duration of encounters. It is expected that decision coaching and the provision of evidence-based patient decision aids will increase patients' involvement in decision-making with informed choices and reduce decisional conflicts and duration of physician encounters. Furthermore, an accompanying process evaluation will be conducted., Discussion: To our knowledge, this is the first study investigating the implementation of decision coaches in German breast care centers., Trial Registration: Current Controlled Trials ISRCTN46305518 , date of registration: 5 June 2015.

Consumers and patients want to be included in decisions regarding their own health and have an ethically justified claim on informed decisions. Therefore, sound information is required, but health information is often misleading and based on different interests. The risks of disease and the benefits of medical interventions tend to be overestimated, whereas harm is often underestimated. Evidence-based health information has to fulfil certain criteria, for instance, it should be evidence-based, independent, complete, true as well as understandable. The aim of a medical intervention has to be explained. The different therapeutic options including the option not to intervene have to be delineated. The probabilities for success, lack of success and unwanted side effects have to be communicated in a numerical and understandable manner. Patients have the right to reject medical interventions without any sanctions.

Background: Both pharmacological and non-pharmacological preventive interventions can do more harm than good. Health checks target a healthy or symptomless population. This is why randomised controlled trials (RCTs) must be conducted to provide high-quality evidence for the benefit of an intervention. The present article presents examples to demonstrate that the benefit of preventive interventions is usually overestimated., Methods: Standard screening criteria are used to critically appraise selected preventive interventions. Screening criteria cover the disease, the test, the treatment and the whole programme including evaluation and quality assurance. Type-2 diabetes mellitus is used as an example to discuss specific criteria for preventive interventions. The current state of the evidence is outlined. The article is based primarily on systematic / Cochrane reviews of RCTs., Results: A recent Cochrane review including 16 RCTs concluded that there is no benefit of general health checks. High-quality evidence on individual components of health checks is frequently missing or inconclusive. Over the last 30 years reference values for normal blood glucose and normal blood pressure as well as treatment targets for patients with type-2 diabetes mellitus and hypertension have been repeatedly decreased though this is not supported by evidence. Recent high-quality RCTs have shown that these "hit hard and early" interventions are detrimental, particularly to those who were the primary target group. Consequently, treatment targets have again been raised and recent guidelines recommend individualisation of treatment goals taking age and comorbidities into account. Important criteria for the implementation of preventive interventions are not currently met. With regard to type-2 diabetes uncertainties remain as to the clinical significance of pre-diabetes, the treatment of pre-diabetes and early treatment of diabetes, the screening tests, and target groups. The ADDITION study was unable to prove the benefit of a diabetes screening. Intensive lifestyle interventions may result in modest reductions of body weight and fewer diabetes diagnoses. However, the clinical relevance of the underlying metabolic changes is doubtful or even negligible. After almost 10 years, the Look AHEAD study has been terminated early due to the ineffectiveness of its intensive lifestyle interventions and the lack of hope that the study will succeed in demonstrating any benefit on the primary cardiovascular endpoints during the originally planned study period of another 3 years., Conclusion: The benefit of prevention is overestimated whereas harm is underestimated. It is most unlikely that medical preventive interventions targeting individual behaviour changes will result in better health for our population., (Copyright © 2013. Published by Elsevier GmbH.)

Introduction: In Germany the implementation of human papillomavirus (HPV) vaccination for women aged 12-17 years was accompanied by various campaigns. Evidence-based information including numerical data was not provided. However, standard information leads to overestimation of cancer risk and effects of HPV vaccination. Confidence in children's ability to deal with numerical data is low, especially in disadvantaged pupils. The aim of the present study was to compare the effects of a standard leaflet with an information leaflet supplemented with numerical data on 'risk knowledge' regarding HPV vaccination among schoolgirls., Methods: Randomised-controlled short-term trial. All 108 schoolgirls of seven school classes were asked to participate and 105 agreed. Participants were vocational schoolgirls who were preparing for grade 10 graduation and who were members of the target group for HPV vaccination. The control group was asked to read a standard leaflet on HPV vaccination of the German Women's Health Network. The intervention group received the same leaflet, but it was supplemented with numerical information on cancer risk and assumed effects of the HPV vaccination on cancer prevention. As baseline characteristics we surveyed: age, vaccination status, attitude towards HPV vaccination and aspects regarding migration background. The primary end point was 'risk knowledge'. Questionnaire surveys were performed under experimental conditions. Individual randomisation, participants, and intention-to-treat data analyses were blinded. The study was approved by the Ministry of Education and Culture of Schleswig-Holstein and the ethics committee of the Hamburg Chamber of Physicians., Results: We analysed 'risk knowledge' for all 105 randomised participants. Baseline characteristics of the two groups were comparable. Numerical risk information recipients were more likely to give correct answers compared to standard information recipients: Mean value of risk knowledge score (0-5 points): 4.6±1.0 vs. 2.6±1.2 (mean difference 2.0 (95% CI 1.6-2.4)); (P<0.001). Post hoc distractor analysis of single items was performed. Incorrect answers of control participants indicated that cervical cancer risk was highly overestimated whereas total cancer risk was mostly underestimated, and possible impact of HPV vaccination on cancer prevention was overestimated., Conclusion: Supplementing health information on HPV vaccination with numerical data improves 'risk knowledge' among schoolgirls.

The recently revised German transplantation law provides that people are to be supported to make informed decisions on post-mortem organ donation by implementing broad education campaigns. A comprehensive web-based decision aid "organ donation after death" was developed, evaluated and optimised utilising multiple methodological phases. The decision aid comprises 1) factual information in a question-answer format, 2) tools for the individual assessment of this information, and 3) narratives addressing attitudes and emotional aspects. The website content was compiled by participating experts and potential users of the decision aid. Potential users also participated in the usability evaluation. Version 1.0 was made publicly available on the Internet in April 2012. Currently, version 2.0 of the decision aid is being updated step-by-step, based on the results of the evaluation., (Copyright © 2013. Published by Elsevier GmbH.)

Background: Patients want to be more involved in medical decision-making. To this end, some decision aids are now available., Methods: We present an overview of this subject, in which we explain the terms "shared decision-making", "decision aid", and "evidence-based patient information" and survey information on the available decision aids in German and other languages on the basis of a literature search in MEDLINE, EMBASE and PsycInfo and a current Cochrane Review. We also searched the Internet for providers of decision aids in Germany., Results: Decision aids exist in the form of brochures, decision tables, videos, and computer programs; they address various topics in the prevention, diagnosis, and treatment of disease. They typically contain information on the advantages and disadvantages of the available options, as well as guidance for personal decision-making. They can be used alone or as a part of structured counseling or patient education. Minimal quality standards include an adequate evidence base, completeness, absence of bias, and intelligibility. Our search revealed 12 randomized controlled trials (RCTs) of decision aids in German and 106 RCTs of decision aids in other languages. These trials studied the outcome of the use of decision aids not just with respect to clinical developments, but also with respect to patient knowledge, adherence to treatment regimens, satisfaction, involvement in decision-making, autonomy preference, and decisional conflicts., Conclusion: Only a small fraction of the available decision aids were systematically developed and have been subjected to systematic evaluation. Patients are still not receiving the help in decision-making to which medical ethics entitles them. Structures need to be put in place for the sustainable development, evaluation and implementation of high-quality decision aids.

Background: Many medical interventions are of a complex nature. They comprise interdependent components differently interacting within various complex settings, e.g., stroke units. Appraising the efficacy, benefit and harm of complex interventions is far more difficult than appraising single interventions like specific drug treatments. Detailed methodological procedures for the development, appraisal and synthesis of complex interventions are increasingly discussed internationally., Methods: Systematic inventory of methodological guidance for the development and evaluation of complex interventions through searching scientific literature databases and web resources of international institutes. Review of the current state of discussion and suggestions for the development, appraisal and synthesis of complex interventions., Results: Five methodological guidance papers have been identified. In particular, the UK Medical Research Council's guidance offers a structured introduction to the development and evaluation of complex interventions in health care and medicine. Synthesis of complex interventions using customary methods of systematic reviews is not satisfying. Other approaches to synthesis like realist evaluation as well as statistical procedures exploring the active components of complex interventions have been discussed. However, post hoc analytical procedures could never adequately replace careful prospective development and exploration of complex interventions and interdependencies with contextual factors., Conclusion: Complex interventions require multi-stage development, use of different methods, reporting on all developing phases and new approaches for synthesis. Presentation of the complete evidence on a specific complex intervention might be more useful than synthesis of a variety of different complex interventions by customarily applied methods of (meta-analytical) systematic review., (Copyright © 2011. Published by Elsevier GmbH.)

So far there has been no consensus on the criteria which confirm the validity of scientific contributions in conventional medicine (CM) and complementary/ alternative medicine (CAM). An interdisciplinary group of experts from various disciplines within each of the areas of medicine held six well-documented sessions in an effort to reach a consensus. The group agreed that the methods to confirm the validity of clinical trials are identical in CM and CAM. There are differences in research strategies and there may also be differences in interpreting the results, depending on the concept of medicine., (Georg Thieme Verlag KG Stuttgart, New York.)

Background: Evidence-based medicine (EBM) has become standard approach in medicine. Patients and health authorities increasingly claim active patient roles in decision making. Education to cope with these roles might be useful. We investigated the feasibility, acceptability and possible impact of EBM training courses for patient and consumer representatives., Methods: We designed a generic one-week EBM course based on previous experience with EBM courses for non-medical health professionals. A course specific competence test has been developed and validated to measure EBM skills. Formative and summative evaluation of the course comprised: 1) EBM skills; 2) individual learning goals; 3) self-reported implementation after six months using semi-structured interviews; 4) group-based feedback by content analysis. EBM skills' achievement was compared to results gathered by a group of undergraduate University students of Health Sciences and Education who had attended a comparable EBM seminar., Results: Fourteen EBM courses were conducted including 161 participants without previous EBM training (n = 54 self-help group representatives, n = 64 professional counsellors, n = 36 patient advocates, n = 7 others); 71% had a higher education degree; all but five finished the course. Most participants stated personal learning goals explicitly related to practicing EBM such as acquisition of critical appraisal skills (n = 130) or research competencies (n = 67). They rated the respective relevance of the course on average with 80% (SD 4) on a visual analogue scale ranging from 0 to 100%.Participants passed the competence test with a mean score of 14.7 (SD 3.0, n = 123) out of 19.5 points. The comparison group of students achieved a mean score of 14.4 (SD 3.3, n = 43). Group-based feedback revealed increases of self confidence, empowerment through EBM methodology and statistical literacy, and acquisition of new concepts of patient information and counselling. Implementation of EBM skills was reported by 84 of the 129 (65%) participants available for follow-up interviews. Barriers included lack of further support, limited possibilities to exchange experiences, and feeling discouraged by negative reactions of health professionals., Conclusions: Training in basic EBM competencies for selected patient and consumer representatives is feasible and accepted and may affect counselling and advocacy activities. Implementation of EBM skills needs support beyond the training course.

Background: the impact of fall risk assessment tools on clinical endpoints is unknown., Objective: we compared a standardised fall risk assessment tool alongside nurses' clinical judgement with nurses' judgement alone., Design: a 12-month cluster-randomised controlled trial., Setting: nursing homes in Hamburg (29 per study group)., Subjects: 1,125 residents (n = 574 intervention group, IG; n = 551 control group, CG)., Interventions: all homes received structured information on fall prevention before randomisation. The IG monthly administered the Downton Index, and the CG did not use a tool. Measurements were number of participants with at least one fall, falls, fall-related injuries and medical attention, fall preventive measures, physical restraints., Results: the mean follow-up was 10.8 +/- 2.9 months in both groups: 105 (IG) and 114 (CG) residents died or moved away. There was no difference between the groups concerning the number of residents with at least one fall (IG: 52%, CG: 53%, mean difference -0.7, 95% confidence interval -10.3 to 8.9, P = 0.88) and the number of falls (n = 1,016 and n = 1,014). All other outcomes were also comparable between the IG and CG., Conclusions: application of a fall risk assessment tool in nursing homes does not result in the better clinical outcome than reliance on nurses' clinical judgement alone.

The article elucidates consideration of scientific criteria for the development and design of evidence-based patient information (EBPI). Immunotherapy of multiple sclerosis serves as an example. Since in EBPI lack of evidence or ambiguities in available evidence are explicitly communicated, processing of EBPI does not necessarily lead to certainty about benefit and harms of medical interventions. However, only if the information is comprehensive in this respect can the EBPI be regarded as a robust basis for an informed choice. EBPI requires substantial developmental efforts. Regarding the growing number of medical interventions and the half-life of information, the question of responsibility for provision of EBPI is crucial. A vision is drafted in which EBPI is driven by demand of the patients and the public and is provided according to a costs-by-cause principle by those who distribute usual information hitherto. Trained patient advocates can appraise quality of information by use of instruments that consider criteria of EBPI. Critical health literacy should evolve early in school and can later on enhance usefulness of EBPI for people concerned with health issues.

Objectives: Increasingly, patients and consumers are taking responsibility for their diagnostic and therapeutic decisions. This requires a certain amount of health literacy in order to critically assess the various procedures and products. The aim of this study was to develop and pilot test a curriculum of critical health literacy for secondary school students., Methods: The curriculum is based on the concept of evidence-based medicine and consists of six modules. Development and pilot testing was performed with two classes of secondary school students (n = 45) in Grade 11. The Metaplan method was used to document feedback regarding teaching methods, worksheets, satisfaction and individually perceived benefits. Additionally, systematic observations by researchers were documented and students' presentations assessed. A sample of untrained students (n = 218) served as a control group. The Critical Health Competency Test was employed for evaluating competencies in critical health literacy. Data were analyzed qualitatively and person parameters were calculated., Results: Overall, the pilot courses were well-accepted and have been proven to be feasible. Students' feedback guided revision of the curriculum. Trained students achieved significantly higher person parameters (+/- SD) than the control group: 597 (+/- 79) versus 483 (+/- 94), p < 0.01, indicating enhancement of critical health competencies., Conclusion: Teaching critical health literacy to secondary school students is feasible and is likely to enhance the competence of critical health literacy. Further studies are needed to show the effectiveness of the intervention.

Background and Purpose: To evaluate the effects of an evidence-based patient decision aid (DA) on multiple sclerosis (MS) immunotherapy., Methods: Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a randomized community-based controlled trial in Germany. An intervention group (IG) received the DA and a control group (CG) received standard information. Primary outcome measure was the match between the patient's preferred and actual roles during consultation with the physician. Secondary end-point was treatment choice. The course of the decision-making process and patients; evaluation of the decision were also evaluated. Data were collected at baseline, after receiving the information, after consultation with the physician and 6 months after baseline., Results: The percentage of preference matches did not differ between groups (IG 49%, CG 51%, P = 0.71). There were no differences in immunotherapy choices between groups. IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful., Conclusions: Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician-patient encounters nor the immunotherapy choices made. Providing patients with balanced information may not be sufficient to alter the decision-making process.

Background: "How can I find a good doctor?" is one of the most frequent requests patients' help desks receive. The aim of the present study is to appraise whether current available patient satisfaction surveys reflect the quality of ambulatory care from the patients' perspective, and whether this information can be used to choose an adequate care facility., Method: Systematic literature searches and critical appraisal of validated German instruments for the evaluation of patient satisfaction in ambulatory care were conducted., Results: Four instruments were evaluated (ZAP; EUROPEP, Qualiskope-A, GEB/QP-Qualitätspraxen). For each instrument, multistage development processes are reported. The instruments are intended to survey patient satisfaction in terms of subjective process-related aspects of ambulatory care. Constructs of satisfaction and items used in the instruments differ substantially. External criteria that are necessary to evaluate the quality of care have not been considered. Data about the availability and quality of patient information have not been retrieved. Patient participation in decision-making has been assessed in a subjective manner. Individual expectations and patient preferences are only accounted for by GEB/QP-Qualitätspraxen. Controlled trials proving the efficacy of the instruments were not identified. It remains unclear whether the use of these instruments has beneficial or adverse effects., Conclusion: Patient satisfaction is an aspect of ambulatory care. However, quality of ambulatory care is not reflected by patient satisfaction alone. Evidence-based information is decisive for the patient's judgement of the quality of medical care. The instruments analysed cannot be used to answer the question: "Is this a good doctor?", unless they consider the availability of adequate patient information.

Aims: Health-care professionals are increasingly asked to communicate research results to patients and consumers. Diabetes educators play a decisive role in the information process of patients with diabetes. Evidence-based medicine (EBM) is not a regular part of their training in Germany. We performed a pilot study to test whether the inclusion of a short EBM module into the standard graduate programme is feasible and leads to a meaningful increase in knowledge and skills., Methods: The study group consisted of 121 diabetes educator trainees. The EBM modules were delivered in 1- to 3-day courses. Increase in knowledge and skills were assessed using a questionnaire covering three main elements: (i) general aspects of an intervention study, (ii) effect size calculation, (iii) general aspects of evidence-based patient information and communicating numbers as patient orientated statements. Two researchers independently rated the assessment sheets., Results: The majority of participants rated the course as important and useful but too short. Knowledge and skills in EBM increased after the course by 2 points out of 13.5 (mean score before course 5 +/- 2 vs. 7 +/- 2; P < 0.001). Inter-rater reliability analysis using Cohen's Kappa coefficients demonstrated substantial to almost perfect agreement for 10 of the 13 items., Conclusions: Our pilot study demonstrates that EBM education for diabetes educator trainees is feasible. However, the increase in knowledge and skills appears not to be clinically relevant. Short EBM courses are unlikely to yield important effects. More intensified course formats are necessary to meet the needs of diabetes educators.

There is much enthusiasm for cancer screening in the United States. In Germany, promotion of cancer screening is growing, often including biased and misleading information. Consequently, the risks of cancer and death from cancer are overestimated, while the harms of screening such as false positive results and over-treatment are underestimated. However, high-quality evidence-based information on breast cancer screening and colorectal cancer screening is available in Germany.

A quality of life scale was developed to measure the subjective fear of falling in nursing home residents. We assessed the dimensions fear of falling, daily living and social life within a randomized controlled trial of hip protector use. The Nottingham Health Profile (NHP) was used for validation. Statistical analysis covered factor analysis, internal consistency of subscales, construct and discriminant validity. Factor analysis revealed three reliable components (Cronbach's Alpha): fear of falling (0.92), social restriction due to limited mobility (0.74) and restriction by clothes due to the hip protector (0.72). The subscales fear of falling and social restriction were significantly intercorrelated with all subscales of the NHP. The new tool is a reliable and valid measure of fear of falling in nursing home residents. However, generalizability and applicability are limited by the small proportion of subjects able to complete the tests.

Background: Involving patients in decision making on diagnostic procedures requires a basic level of statistical thinking. However, innumeracy is prevalent even among physicians. In medical teaching the 2 x 2 table is widely used as a visual help for computations whereas in psychology the frequency tree is favoured. We assumed that the 2 x 2 table is more suitable to support computations of predictive values., Methods: 184 students without prior statistical training were randomised either to a step-by-step self-learning tutorial using the 2 x 2 table (n = 94) or the frequency tree (n = 90). During the training session students were instructed by two sample tasks and a total of five positive predictive values had to be computed. During a follow-up session 4 weeks later participants had to compute 5 different tasks of comparable degree of difficulty without having the tutorial instructions at their disposal. The primary outcome was the correct solution of the tasks., Results: There were no statistically significant differences between the two groups. About 58% achieved correct solutions in 4-5 tasks following the training session and 26% in the follow-up examination., Conclusions: These findings do not support the hypothesis that the 2 x 2 table is more valuable to facilitate the calculation of positive predictive values than the frequency tree.

Diabetes education or self-management programmes are complex interventions. Their evaluation is difficult because of problems in identifying and separately assessing the effect of the various components of the intervention. A phased approach defining sequential stages of a continuum of increasing evidence has been proposed as a framework for the design and evaluation of such complex interventions. As an example we present the available evidence for diabetes treatment and teaching programmes implemented in Germany. Evidence is compiled for structured group treatment and teaching programmes for Type I diabetes, non-insulin dependent Type II diabetes, and hypertension according to the following sequential stages of increasing evidence: (i) preclinical or theoretical phase; (ii) modelling the components of the intervention; (iii) exploratory trials; (iv) randomized controlled trials; (v) phase of implementation including replication and transfer to different settings. Evidence for most of these phases has been generated for the three programmes, although individual studies do not fulfill all important quality criteria by today's standards. The time span for gathering the evidence from the theoretical phase to surveillance after implementation was about 20 years. It can only be speculated which parts of the programmes are the most active ones. The presentation of a continuum of increasing evidence for diabetes education or self-management programmes could provide useful information for the appraisal of such complex interventions. Since this evidence cannot be readily extracted from databases we suggest that other research groups present their data in a similar way.

A total of 17 consumer brochures that deal with the screening for colorectal cancer were analysed by two independently working researchers. The aim was to assess the quality of the information as a basis for evidence-based informed decision making using pre-defined evaluation criteria. No brochures fulfilled the necessary criteria. In most brochures there was a lack of transparency of the information process. No data was provided for estimating individual risks of colorectal cancer morbidity or mortality. With respect to the efficacy of screening no data was provided about relative or absolute risk reductions, number needed to screen, number needed to harm, predictive rates and false positive rates. In conclusion, presently available information brochures in Germany do not allow informed decision-making by consumers.

This article presents the evidence of mammography-screening for communication between the physician and the consumer. Scientific data on the quality of mammography as a screening test (sensitivity, specificity, positive and negative predictive values), effectiveness of screening programs (breast cancer mortality, total mortality), and possible harm (consequences of false positive and false negative results, overdiagnosis of breast cancer, radiation) are presented. Outcome data are communicated as absolute numbers rather than relative differences. In order to avoid framing of data equal emphasis is put on the proportion of persons who are likely to benefit and those who are unlikely to benefit or likely to be harmed.

Before any treatment of type 2 diabetes in accordance with the principles of evidence-based medicine can be generally recommended, the considerable disease heterogeneity must be taken into account, and randomized controlled intervention trials directed to cardiovascular and microangiopathic organ damage end points must be performed for the various subgroups of patients. Until then, it appears prudent to treat the typical Caucasian type 2 diabetic patient primarily by nondrug therapies, and if they fail to achieve the patient's individual treatment goals, then insulin treatment should be initiated. Treatment of type 2 diabetic patients with insulin alone, aimed at the patient's individual therapeutic goals, is effective and safe when conducted as an integral part of specific and structured treatment and teaching programs. Insulin treatment can be safely used to achieve near-normal HbA1c levels (< 7.0-7.5%) if prevention of diabetic microangiopathy is indicated, or to maintain HbA1c levels < 8.5-9.0% if catabolic symptoms due to insulin deficiency are to be prevented.

This contribution describes the nationwide implementation of an intensive treatment and education program for type 1 diabetic patients in the clinical routine of the German health care system. Based on the formation of a working group (Arbeitsgemeinschaft Strukturierte Diabetestherapie [ASD]) of presently 57 general internal medicine departments, mainly from secondary and tertiary care levels in city and country hospitals throughout the country, a peer-review quality circle was formed as an official working group of the German Diabetes Association. The participating institutions performed a structured program of intensive treatment and education in all type 1 diabetic patients referred to them on a routine basis. The program includes multiple daily insulin injections or continuous subcutaneous insulin infusion, several times daily blood glucose self-monitoring and self-adaptation of insulin dosages and other aspects of treatment by the patients, and a far-reaching liberalization of the nutrition regimen. The group has attempted to document and to improve the quality of the structure and process of type 1 diabetes care in its participating institutions by a system of peer supervision. Furthermore, all member institutions volunteered to collect outcome data based on systematic 1-1.3 years' follow-up examinations of consecutive type 1 diabetic patients. For the 1997 evaluation of 1,103 type 1 diabetic patients, significant decreases of GHb levels and of incidence rates of severe hypoglycemia (from 0.35 to 0.16 cases per patient-year) and ketoacidosis (from 0.08 to 0.02 cases per patient-year) are presented. The ASD quality circle represents a model to improve principal aspects of type 1 diabetes care on a nationwide basis.

The objective of this study was to identify possible risk factors of severe hypoglycaemia (SH) in a prospective population based study of adult Type I (insulin-dependent) diabetic patients. A representative sample of 684 patients (41% women, mean +/- SD age 36 +/- 11, diabetes duration 18 +/- 11 years), living in the district of Northrhine (9.5 million inhabitants), Germany, were examined in their homes using a mobile ambulance. A comprehensive baseline assessment of possible predictors of SH included sociodemographic and disease related variables, hypoglycaemia awareness, diabetes management, and attitudes and behavioural aspects as expressed by the patients. After a mean of 19 +/- 6 months 669 (98%) patients were interviewed about events of SH since the baseline examination. Using the multiple Cox proportional hazards model, five risk factors of SH were identified: SH during the preceding year [hazard ratio (HR) 2.7, 95% confidence intervals (CI) 1.8-4.2], any history of SH (HR 1.9, CI 1.1-3.4), C-peptide negativity (HR 4.0, CI 1.2-12.7), social status (HR 0.8 for a difference of 5 units for a value range of 0-24, CI 0.6-0.9), and patients' determination to reach normoglycaemia (HR 0.7 for a difference of 1 unit for a value range of 1-6, CI 0.5-0.9), indicating that the lower the social status and the higher the patients' determination to reach normoglycaemia, the higher the risk of SH. After eliminating the history of hypoglycaemia from the model, impaired hypoglycaemia awareness and patients' inappropriate denial of SH as their particular problem became additional significant risk factors of SH. In conclusion, in this population based study of adult Type I diabetic patients, C-peptide negativity, a previous event of SH, patients' determination to reach normoglycaemia and social class were risk factors of SH.

Objective: To validate a diabetes-specific quality-of-life scale and to assess its psychometric properties in a large sample of patients with type 1 diabetes., Research Design and Methods: To assess the quality of diabetes care in a population-based study, a representative sample of 684 patients with type 1 diabetes was examined. A total of 657 patients (42% female; mean age 36 years; mean diabetes duration 18 years) completed the diabetes-specific quality-of-life scale (DSQOLS), which comprised 64 items on individual treatment goals (10 items), satisfaction with treatment success (10 items), and diabetes-related distress (44 items). Statistical examinations covered factor analysis, internal consistency of subscales, and construct and discriminant validity., Results: Factor analysis of the 44 items on diabetes-specific burdens revealed six reliable components (Cronbach's alpha): social relations (0.88), physical complaints (0.84), worries about future (0.84), leisure time flexibility (0.85), diet restrictions (0.71), and daily hassles (0.70). All six subscales were significantly correlated with a validated well-being scale (r = -0.35 to -0.53, P < 0.001) and treatment satisfaction (r = 0.28 to 0.43, P < 0.001). Physical complaints (r = 0.24) and worries about future (r = 0.17) showed the highest correlations with HbA1c (P < 0.001). A flexible insulin therapy, a liberalized diet, the absence of late complications, and a higher social status were significantly associated with more favorable scores in different domains., Conclusions: The DSQOLS is a reliable and valid measure of diabetes-specific quality of life. The scale is able to distinguish between patients with different treatment and dietary regimens and to detect social inequities. Use of the DSQOLS for assessment of individual treatment goals as defined by the patients may be helpful to identify motivational deficits and to tailor individual treatment strategies.

Up to now all published experience with intensified insulin therapy has originated from specialized diabetes centres. However, even in diabetes centres and under research conditions intensification of insulin therapy may substantially increase the risk of severe hypoglycaemia. The aim of the present study was to demonstrate the feasibility of effectively and safely transferring intensified insulin therapy based upon a 5-day in-patient treatment and teaching programme from a University diabetes centre to non-specialized general hospitals. A total of nine general hospitals were recruited; the University diabetes centre served as a reference centre. From each general hospital a nurse and a dietitian were trained as diabetes educators, and a diabetes unit with about 10 beds was organized within each department of internal medicine. A total of 697 consecutively admitted Type 1 (insulin-dependent) diabetic patients (age 26 +/- 7 years, duration of diabetes 8 +/- 7 years) who participated in the programme either in one of the general hospitals (n = 579) or in the reference centre (n = 118) were re-examined after 1, 2 and 3 years. Insulin therapy was intensified to a similar extent in the reference centre and the general hospitals; at the 3-year follow-up about 80% of the patients injected insulin at least three times daily or used continuous subcutaneous insulin infusion (10%), and about 70% reported measuring blood glucose levels more than twice per day. HbA1 levels were lowered (p < 0.0001) to comparable levels, i.e. from 10.6% (reference centre) and 9.9% (general hospital), respectively, at baseline to 9.4% and 9.3%, respectively, at the 3-year follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)