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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: Shared decision-making in oncology requires information on individual prognosis. This comprises cancer prognosis as well as competing risks of dying due to age and comorbidities. Decision aids usually do not provide such information on competing risks. We conducted an overview on clinical prediction tools for early breast cancer and developed and pilot-tested a decision aid (DA) addressing individual prognosis using additional chemotherapy in early, hormone receptor-positive breast cancer as an example., Methods: Systematic literature search on clinical prediction tools for the effects of drug treatment on survival of breast cancer. The DA was developed following criteria for evidence-based patient information and International Patient Decision Aids Standards. We included data on the influence of age and comorbidities on overall prognosis. The DA was pilot-tested in focus groups. Comprehension was additionally evaluated through an online survey with women in breast cancer self-help groups., Results: We identified three prediction tools: Adjuvant!Online, PREDICT and CancerMath. All tools consider age and tumor characteristics. Adjuvant!Online considers comorbidities, CancerMath displays age-dependent non-cancer mortality. Harm due to therapy is not reported. Twenty women participated in focus groups piloting the DA until data saturation was achieved. A total of 102 women consented to participate in the online survey, of which 86 completed the survey. The rate of correct responses was 90.5% and ranged between 84 and 95% for individual questions., Conclusions: None of the clinical prediction tools fulfilled the requirements to provide women with all the necessary information for informed decision-making. Information on individual prognosis was well understood and can be included in patient decision aids.

Objective: To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting., Design: Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data., Setting: 22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes., Participants: 279 of 363 eligible patients without myocardial infarction or stroke., Interventions: The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care., Primary and Secondary Outcome Measures: Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors., Results: ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%., Conclusions: The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable., Trial Registration Number: ISRCTN77300204; Results., Competing Interests: Competing interests: NK reports grant from the Diabetes Centre Thuringia during the conduct of the study., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Current German and EU package leaflets (PLs) do not distinguish to what extent listed side effects are indeed side effects caused by drug intake or instead symptoms that occur regardless of drug use. We recently showed that most health professionals misinterpret the frequencies of listed side effects as solely caused by the drug. The present study investigated whether (1) these misinterpretations also prevail among laypeople and (2) alternative PLs reduce these misinterpretations., Methods: In March 2017, 397 out of 400 laypeople approached completed an online survey. They were randomized to one of four PL formats: three alternative PLs (drug facts box with/without reading instruction, narrative format with numbers) and one standard PL. Each PL listed four side effects for a fictitious drug: two were presented as occurring more often, one as equally often, and one as less often with drug intake. The alternative formats (interventions) included information on frequencies with and without drug intake and included a statement on the causal relation. The standard PL (control) only included information on frequency ranges with drug intake. Questions were asked on general occurrence and causality of side effects., Results: Participants randomized to the standard PL were unable to answer questions on causality. For side effects occurring more often (equally; less often) with drug intake, only 1.9% to 2.8% (equally: 1.9%; less often: 1.9%) provided correct responses about the causal nature of side effects, compared to 55.0% to 81.9% (equally: 23.8% to 70.5%; less often: 21.0% to 43.2%) of participants who received alternative PLs. It remains unclear whether one alternative format is superior to the others., Conclusion: In conclusion, information on the frequency of side effects in current package leaflets is misleading. Comparative presentation of frequencies for side effects with and without drug intake including statements on the causal relation significantly improves understanding., Competing Interests: The authors have declared that no competing interests exist.

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.

Background: Media frequently draws inappropriate causal statements from observational studies. We analyzed the reporting of study results in the Medical News section of the German medical journal Deutsches Ärzteblatt (DÄ)., Methods: Study design: Retrospective quantitative content analysis of randomly selected news reports and related original journal articles and press releases. A medical news report was selected if headlines comprised at least two linked variables. Two raters independently categorized the headline and text of each news report, conclusions of the abstract and full text of the related journal article, and the press release. The assessment instrument comprised five categories from 'neutral' to 'unconditionally causal'. Outcome measures: degree of matching between 1) news headlines and conclusions of the journal article, 2) headlines and text of news reports, 3) text and conclusions, and 4) headlines and press releases. We analyzed whether news headlines rated as unconditionally causal based on randomized controlled trials (RCTs)., Results: One-thousand eighty-seven medical news reports were published between April 2015 and May 2016. The final random sample comprised 176 news reports and 100 related press releases. Degree of matching: 1) 45% (79/176) for news headlines and journal article conclusions, 2) 55% (97/176) for headlines and text, 3) 53% (93/176) for text and conclusions, and 4) 41% (41/100) for headlines and press releases. Exaggerations were found in 45% (80/176) of the headlines compared to the conclusions of the related journal article. Sixty-five of 137 unconditionally causal statements of the news headlines were phrased more weakly in the subsequent news text body. Only 52 of 137 headlines (38%) categorized as unconditionally causal reported RCTs., Conclusion: Reporting of medical news in the DÄ medical journal is misleading. Most headlines that imply causal associations were not based on RCTs. Medical journalists should follow standards of reporting scientific study results.

Background: Treatment decision-making is complex for people with multiple sclerosis. Profound information on available options is virtually not possible in regular neurologist encounters. The "nurse decision coach model" was developed to redistribute health professionals' tasks in supporting immunotreatment decision-making following the principles of informed shared decision-making., Objectives: To test the feasibility of a decision coaching programme and recruitment strategies to inform the main trial., Design: Feasibility testing and parallel pilot randomised controlled trial, accompanied by a mixed methods process evaluation., Setting: Two German multiple sclerosis university centres., Participants Pilot Trial: People with suspected or relapsing-remitting multiple sclerosis facing immunotreatment decisions on first line drugs were recruited. Randomisation to the intervention (n = 38) or control group (n = 35) was performed on a daily basis. Quantitative and qualitative process data were collected from people with multiple sclerosis, nurses and physicians., Methods: We report on the development and piloting of the decision coaching programme. It comprises a training course for multiple sclerosis nurses and the coaching intervention. The intervention consists of up to three structured nurse-led decision coaching sessions, access to an evidence-based online information platform (DECIMS-Wiki) and a final physician consultation. After feasibility testing, a pilot randomised controlled trial was performed. People with multiple sclerosis were randomised to the intervention or control group. The latter had also access to the DECIMS-Wiki, but received otherwise care as usual. Nurses were not blinded to group assignment, while people with multiple sclerosis and physicians were. The primary outcome was 'informed choice' after six months including the sub-dimensions' risk knowledge (after 14 days), attitude concerning immunotreatment (after physician consultation), and treatment uptake (after six months). Quantitative process evaluation data were collected via questionnaires. Qualitative interviews were performed with all nurses and a convenience sample of nine people with multiple sclerosis., Results: 116 people with multiple sclerosis fulfilled the inclusion criteria and 73 (63%) were included. Groups were comparable at baseline. Data of 51 people with multiple sclerosis (70%) were available for the primary endpoint. In the intervention group 15 of 31 (48%) people with multiple sclerosis achieved an informed choice after six months and 6 of 20 (30%) in the control group. Process evaluation data illustrated a positive response towards the coaching programme as well as good acceptance., Conclusions: The pilot-phase showed promising results concerning acceptability and feasibility of the intervention, which was well perceived by people with multiple sclerosis, most nurses and physicians. Delegating parts of the immunotreatment decision-making process to trained nurses has the potential to increase informed choice and participation as well as effectiveness of patient-physician consultations., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: To implement informed shared decision-making (ISDM) in breast care centres, we developed and piloted an inter-professional complex intervention., Methods: We developed an intervention consisting of three components: an evidence-based patient decision aid (DA) for women with ductal carcinoma in situ, a decision-coaching led by specialised nurses (breast care nurses and oncology nurses) and structured physician encounters. In order to enable professionals to gain ISDM competencies, we developed and tested a curriculum-based training programme for specialised nurses and a workshop for physicians. After successful testing of the components, we conducted a pilot study to test the feasibility of the entire revised intervention in two breast care centres. Here the acceptance of the intervention by women and professionals, the applicability to the breast care centres' procedures, women's knowledge, patient involvement in treatment decision-making assessed with the MAPPIN'SDM-observer instrument MAPPIN'O dyad, and barriers to and facilitators of the implementation were taken into consideration. We used questionnaires, structured verbal and written feedback and video recordings. Qualitative data were analysed descriptively, and mean values and ranges of quantitative data were calculated., Results: To test the DA, focus groups and individual interviews were conducted with 27 women. Six expert reviews were obtained. The components of the nurse training were tested with 18 specialised nurses and 19 health science students. The development and piloting of the components were successful. The pilot test of the entire intervention included seven patients. In general, the intervention is applicable. Patients attained adequate knowledge (range of correct answers: 9-11 of 11). On average, a basic level of patient involvement in treatment decision-making was observed for nurses and patient-nurse dyads (M(MAPPIN-O dyad ): 2.15 and M(MAPPIN-O nurse ): 1.90). Relevant barriers were identified; physicians barely tolerated women's preferences that were not in line with the medical recommendation. Classifying women as inappropriate for ISDM due to age or education led physicians to neglect eligible women during the recruitment phase., Conclusion: Decision-coaching is feasible. Nevertheless, there are some indications that structural changes are needed for long-term implementation. We are currently evaluating the intervention in a cluster randomised controlled trial in 16 breast care centres.

Background: In Germany, the guardianship system provides adults who are no longer able to handle their own affairs a court-appointed legal representative, for support without restriction of legal capacity. Although these representatives only rarely are qualified in healthcare, they nevertheless play decisive roles in the decision-making processes for people with dementia. Previously, we developed an education program (PRODECIDE) to address this shortcoming and tested it for feasibility. Typical, autonomy-restricting decisions in the care of people with dementia-namely, using percutaneous endoscopic gastrostomy (PEG) or physical restrains (PR), or the prescription of antipsychotic drugs (AP)-were the subject areas trained. The training course aims to enhance the competency of legal representatives in informed decision-making. In this study, we will evaluate the efficacy of the PRODECIDE education program., Methods: A randomized controlled trial with a six-month follow-up will be conducted to compare the PRODECIDE education program with standard care, enrolling legal representatives (N = 216). The education program lasts 10 h and comprises four modules: A, decision-making processes and methods; and B, C and D, evidence-based knowledge about PEG, PR and AP, respectively. The primary outcome measure is knowledge, which is operationalized as the understanding of decision-making processes in healthcare affairs and in setting realistic expectations about benefits and harms of PEG, PR and AP in people with dementia. Secondary outcomes are sufficient and sustainable knowledge and percentage of persons concerned affected by PEG, FEM or AP. A qualitative process evaluation will be performed. Additionally, to support implementation, a concept for translating the educational contents into e-learning modules will be developed., Discussion: The study results will show whether the efficacy of the education program could justify its implementation into the regular training curricula for legal representatives. Additionally, it will determine whether an e-learning course provides a valuable backup or even alternative learning strategy., Trial Registration: TRN: ISRCTN17960111 , Date: 01/06/2017.

Background: Associations between nursing home residents' oral health status and quality of life, respiratory tract infections, and nutritional status have been reported. Educational interventions for nurses or residents, or both, focusing on knowledge and skills related to oral health management may have the potential to improve residents' oral health., Objectives: To assess the effects of oral health educational interventions for nursing home staff or residents, or both, to maintain or improve the oral health of nursing home residents., Search Methods: We searched the Cochrane Oral Health Trials Register (to 18 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2015, Issue 12), MEDLINE Ovid (1946 to 18 January 2016), Embase Ovid (1980 to 18 January 2016), CINAHL EBSCO (1937 to 18 January 2016), and Web of Science Conference Proceedings (1990 to 18 January 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 18 January 2016. In addition, we searched reference lists of identified articles and contacted experts in the field. We placed no restrictions on language or date of publication when searching the electronic databases., Selection Criteria: Randomised controlled trials (RCTs) and cluster-RCTs comparing oral health educational programmes for nursing staff or residents, or both with usual care or any other oral healthcare intervention., Data Collection and Analysis: Two review authors independently screened articles retrieved from the searches for relevance, extracted data from included studies, assessed risk of bias for each included study, and evaluated the overall quality of the evidence. We retrieved data about the development and evaluation processes of complex interventions on the basis of the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). We contacted authors of relevant studies for additional information., Main Results: We included nine RCTs involving 3253 nursing home residents in this review; seven of these trials used cluster randomisation. The mean resident age ranged from 78 to 86 years across studies, and most participants were women (more than 66% in all studies). The proportion of residents with dental protheses ranged from 62% to 87%, and the proportion of edentulous residents ranged from 32% to 90% across studies.Eight studies compared educational interventions with information and practical components versus (optimised) usual care, while the ninth study compared educational interventions with information only versus usual care. All interventions included educational sessions on oral health for nursing staff (five trials) or for both staff and residents (four trials), and used more than one active component. Follow-up of included studies ranged from three months to five years.No study showed overall low risk of bias. Four studies had a high risk of bias, and the other five studies were at unclear risk of bias.None of the trials assessed our predefined primary outcomes 'oral health' and 'oral health-related quality of life'. All trials assessed our third primary outcome, 'dental or denture plaque'. Meta-analyses showed no evidence of a difference between interventions and usual care for dental plaque (mean difference -0.04, 95% confidence interval (CI) -0.26 to 0.17; six trials; 437 participants; low quality evidence) or denture plaque (standardised mean difference -0.60, 95% CI -1.25 to 0.05; five trials; 816 participants; low quality evidence). None of the studies assessed adverse events of the intervention., Authors' Conclusions: We found insufficient evidence to draw robust conclusions about the effects of oral health educational interventions for nursing home staff and residents. We did not find evidence of meaningful effects of educational interventions on any measure of residents' oral health; however, the quality of the available evidence is low. More adequately powered and high-quality studies using relevant outcome measures are needed.

Background: Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted., Methods: We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) "average weight" version and (3) "worm prophylaxis" version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge., Results: Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42-1.69), p = 0.002). The questionnaire's internal consistency was moderate (Cronbach's alpha = 0.56)., Conclusions: The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions., Trial Registration: German Clinical Trials Register: DRKS00008561 . Registered 8th of June 2015.

Background: Patients can only make well-informed decisions if the information they are given by health professionals is based on scientific evidence. In this study, we assessed the foundation in evidence of free, publicly available telephone consultations in Germany., Methods: From March 2013 to January 2014, four hidden clients seeking information asked standardized questions about three medical topics (screening for colorectal cancer, for glaucoma, and for trisomy 21) and three dental ones (the sealing of dental fissures, professional dental cleaning, and mercury detoxification). Depending on the topic, the questions addressed such issues as the risk of disease and the purpose, content, validity, benefits, and risks of potential diagnostic and therapeutic measures. All identifiable telephone consultation services that provided counselling on the above topics were included in the study (23 government-sponsored institutions, 31 institutions independently run by physicians, 521 institutions under religious auspices, 25 dental counselling services)., Results: Of the 599 telephone consultation services that were identified, 567 were contacted; 404 did not offer any relevant counselling. A total of 293 conversations were held with the remaining 163 consultation services. Six of these conversations fully met predefined criteria for evidence-based counselling. The percentage of appropriate answers to the key questions on each topic was 5% for colorectal cancer screening (7/140), 23.8% for glaucoma screening (25/105), 33.9% for trisomy 21 screening (121/357), 27.5% for the sealing of dental fissures (28/102), 16.2% for professional dental cleaning (19/117), and 12.9% for mercury detoxification (12/93). The percentage of appropriate answers also varied depending on the type of institution: 26.8% for government-sponsored institutions (67/250), 4.5% for institutions independently run by physicians (4/88), and 31.1% for institutions under religious auspices (82/264)., Conclusion: The medical and dental counselling now offered over the telephone by the types of institutions included in this study does not satisfy the criteria for evidence-based health information.

An array of oral agents is available for the treatment of hyperglycaemia in type 2 diabetes. This systematic inventory focuses on 'old' oral agents, including metformin, sulfonylureas (SUs), thiazolidinediones, alpha glucosidase inhibitors, and meglitinides. Twelve meta-analyses and six randomized controlled trials that used patient-relevant outcomes as primary endpoints were critically reviewed. Guidelines recommend the use of metformin or an SU as the first-line pharmacotherapeutic options. Beneficial effects of metformin have been demonstrated for 'any diabetes-related endpoint' and 'all-cause mortality' in small study groups of overweight and obese patients with newly manifested type 2 diabetes. Various SU agents are available, for which a class effect has clearly been disproven. Beneficial effects have only been demonstrated for glyburide in preventing microvascular complications. Thiazolidinediones have been withdrawn from the markets in some countries. Meta-analyses found an increased coronary risk for rosiglitazone. The benefit-to-risk ratios of alpha glucosidase inhibitors and meglitinides regarding hard endpoints remain uncertain. Diabetes treatment is complex and individualised. We identified several studies focusing on the efficacy of treatment policies rather than on single drug effects. However, as long as the efficacy of single agents regarding hard clinical endpoints is unclear, interpretation of study results on treatment policies remains speculative., (© 2016 S. Karger AG, Basel.)

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: Current German or UK package leaflets do not contain an explicit notice that the listing of side effects does not imply that they are caused by the drug. Causal interpretations by patients and lay people are frequently observed. The authors examined whether health professionals understand that there is not necessarily a causal relation between drug intake and the frequency of side effects and whether adding placebo comparison improves understanding., Methods: Exploratory survey consisting of eight assessments, each containing 2-6 survey items, and focus groups with one survey sample using questionnaires on adverse reactions in standard package leaflets and modified package leaflets supplemented with placebo comparison. Participants were convenience samples of 379 health professionals including 153 physicians (80 gynaecologists, 124 diabetes experts - physicians, nurses, and others, 39 medical students in their last year at university, 49 first year health science and education students with completed vocational training and professional experience in various health care professions and 87 pharmacists/pharmacy students). They were asked to rate how often the different adverse reactions listed were caused by drug intake. All surveys were carried out within university seminars and postgraduate lectures from April 2014 to June 2015 in Germany. Response rate was 86 % or higher., Results: Without placebo comparison, the majority of participants responded that the drug causes adverse reactions with the frequency given in the package leaflet or even more often (95 % of health science students, 100 % of medical students, 60 to 80 % of physicians and 66 % of pharmacists/pharmacy students). Simply adding placebo comparison in a table did not prevent misunderstanding. Analysis of focus groups with health science students supported the lack of understanding., Conclusions: In the present surveys, health professionals had major difficulties understanding frequency information on side effects in package leaflets. The great majority erroneously implied a causal relation between drug intake and the frequency of side effects, even though most side effects listed are symptoms commonly experienced in daily life.

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.

Evidence-based information is a prerequisite for informed choice. We compared the effect of evidence-based information on colorectal cancer screening with standard information in a randomised controlled trial. The primary endpoint was informed choice. We randomised 1,577 people insured by a large German statutory health insurance scheme, the Gmünder Ersatzkasse (GEK). The evidence-based information significantly increased informed choices: 44.0% vs. 12.8%; (difference 31.2%, 99% CI 25.7-36.7%; P<0.001)., (© Georg Thieme Verlag KG Stuttgart · New York.)

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: International and national societies claim a patient centred approach including shared decision making (SDM) in diabetes care. In a previous project, a SDM programme on the prevention of myocardial infarction has been developed. It is aimed at supporting patients with type 2 diabetes to make informed choices on preventive options, to share the decision making process with the health care team, and to improve adherence to the chosen treatment. In this study, the programme will be implemented and evaluated in primary care practices., Methods/design: A cluster randomised, controlled trial will be conducted to compare the SDM programme with standard care enrolling patients with type 2 diabetes (N = 306) from primary care practices (N = 24). The intervention programme comprises a six hours provider training, a patient decision aid including evidence-based information, a 90 minutes structured teaching session provided by medical assistants, a sheet to document the patients' individual treatment goals, and a structured consultation with the general practitioner for sharing information, setting treatment goals, and for adapting treatment regimens if necessary. Patients in the control group receive a brief extract of recommendations of the German National Disease Management Guideline on the treatment of patients with type 2 diabetes. Primary outcome measure is adherence to blood pressure treatment and statin treatment at 6 months follow-up. Secondary outcome measures comprise informed choice and the achievement of patients' treatment goals. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods will be used to explore the implementation processes., Discussion: At the end of this study, information on the efficacy of the SDM programme in the primary care context will be available. In addition, processes that might interfere with or that might promote a successful implementation will be identified., Trial Registration: ISRCTN77300204 .

Background: Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process. This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence., Methods/design: The decision coaching programme will be evaluated through an evaluator-blinded superiority cluster randomised controlled trial, including 300 patients with suspected or definite relapsing-remitting multiple sclerosis, facing an immunotherapy decision. The clusters are 12 multiple sclerosis outpatient clinics in Germany. Further, the trial will be accompanied by a mixed-methods process evaluation and a cost-effectiveness study. Nurses in the intervention group will be trained in shared decision-making, coaching, and evidence-based patient information principles. Patients who meet the inclusion criteria will receive decision coaching (intervention group) with up to three face-to-face coaching sessions with a trained nurse (decision coach) or counselling as usual (control group). Patients in both groups will be given access to an evidence-based online information tool. The primary outcome is 'informed choice' after six months, assessed with the multi-dimensional measure of informed choice including the sub-dimensions risk knowledge (questionnaire), attitude concerning immunotherapy (questionnaire), and immunotherapy uptake (telephone survey). Secondary outcomes include decisional conflict, adherence to immunotherapy decisions, autonomy preference, planned behaviour, coping self-efficacy, and perceived involvement in coaching and decisional encounters. Safety outcomes are comprised of anxiety and depression and disease-specific quality of life., Discussion: This trial will assess the effectiveness of a new model of patient decision support concerning MS-immunotherapy options. The delegation of treatment information provision from physicians to trained nurses bears the potential to change current doctor-focused practice in Germany., Trial Registration: Current Controlled Trials (identifier: ISRCTN37929939 ), May 27, 2014.

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.)

Background: Acknowledgment of all serious limitations to research evidence is important for patient care and scientific progress. Formal research on how biomedical authors acknowledge limitations is scarce., Objectives: To assess the extent to which limitations are acknowledged in biomedical publications explicitly, and implicitly by investigating the use of phrases that express uncertainty, so-called hedges; to assess the association between industry support and the extent of hedging., Design: We analyzed reporting of limitations and use of hedges in 300 biomedical publications published in 30 high and medium -ranked journals in 2007. Hedges were assessed using linguistic software that assigned weights between 1 and 5 to each expression of uncertainty., Results: Twenty-seven percent of publications (81/300) did not mention any limitations, while 73% acknowledged a median of 3 (range 1-8) limitations. Five percent mentioned a limitation in the abstract. After controlling for confounders, publications on industry-supported studies used significantly fewer hedges than publications not so supported (p = 0.028)., Limitations: Detection and classification of limitations was--to some extent--subjective. The weighting scheme used by the hedging detection software has subjective elements., Conclusions: Reporting of limitations in biomedical publications is probably very incomplete. Transparent reporting of limitations may protect clinicians and guideline committees against overly confident beliefs and decisions and support scientific progress through better design, conduct or analysis of new studies.

Background: Lack of patient involvement in decision making has been suggested as one reason for limited treatment success. Concepts such as shared decision making may contribute to high quality healthcare by supporting patients to make informed decisions together with their physicians.A multi-component shared decision making programme on the prevention of heart attack in type 2 diabetes has been developed. It aims at improving the quality of decision-making by providing evidence-based patient information, enhancing patients' knowledge, and supporting them to actively participate in decision-making. In this study the efficacy of the programme is evaluated in the setting of a diabetes clinic., Methods/design: A single blinded randomised-controlled trial is conducted to compare the shared decision making programme with a control-intervention. The intervention consists of an evidence-based patient decision aid on the prevention of myocardial infarction and a corresponding counselling module provided by diabetes educators. Similar in duration and structure, the control-intervention targets nutrition, sports, and stress coping. A total of 154 patients between 40 and 69 years of age with type 2 diabetes and no previous diagnosis of ischaemic heart disease or stroke are enrolled and allocated either to the intervention or the control-intervention. Primary outcome measure is the patients' knowledge on benefits and harms of heart attack prevention captured by a standardised knowledge test. Key secondary outcome measure is the achievement of treatment goals prioritised by the individual patient. Treatment goals refer to statin taking, HbA1c-, blood pressure levels and smoking status. Outcomes are assessed directly after the counselling and at 6 months follow-up. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods are used to explore intervention fidelity and to gain insight into implementation processes., Discussion: Interventions to facilitate evidence-based shared decision making represent an innovative approach in diabetes care. The results of this study will provide information on the efficacy of such a concept in the setting of a diabetes clinic in Germany., Trial Registration: ISRCTN84636255.

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.

During recent years much emphasis has been on the validity, reliability, reproducibility, clinical applicability, clarity, multidisciplinary process, scheduled review and documentation of clinical practice guidelines (CPGs). Still, CPGs show substantial variance in methodological quality. The present paper mainly focuses on two aspects that are particularly critical and contemporary from the perspective of evidence-based medicine: patient centredness and shared decision making, and conflict of interest. Sophisticated patient and consumer involvement at all stages of CPG development could be judged as being the gold standard. However, co-opting patients or consumer representatives and using other techniques of active patient involvement does not replace individual patient preferences in clinical decision-making processes. Current CPGs do not meet patient needs, since they do not provide concise, easy-to-read summaries of the benefits and risks of medicines together with more comprehensive scientific data as a prerequisite for informed or shared decision making. The vast majority of CPG panels have a financial conflict of interest (COI) and under-reporting is common. Not all organisations producing CPGs have set up COI policies, and existing policies vary widely. To solve the problem, CPG experts have recommended that methodologists without any important COI should lead the development process and have primary responsibility. There is a lot of room for other improvements through network transnational activities in the field of CPG development. Waste of time and resources should be avoided through sharing published and unpublished data identified, appraised and extracted for guideline development. The EASD could provide such a clearing house.

Background: Educational practice is characterised by fashion, myths und traditions. Studies examining the efficacy of educational interventions are rare., Objective: We studied which educational interventions in the field of education and training have been evaluated in randomised controlled trials (RCTs) during the past three years., Methods: Systematic searches were conducted in PubMed, Psyndex, Psychinfo, and Education Research Information Center (ERIC). The database searches were limited to the RCT study design and trials published in German or English language for the period from January 2009 to February 2012. Studies with the following target groups were included: children, pupils, students, and employed persons; settings: pre-school institutions, schools, universities and universities of applied sciences, and settings of vocational or occupational education and training; interventions: educational interventions in pre-school institutions, schools, universities, universities of applied sciences and institutions of vocational or occupational education and training, as well as prevention programmes in schools and pre-school institutions. We excluded studies on patient education. The data collection was carried out using a data extraction sheet. Only predefined categories were used for the interventions. Further categories were developed in a second step. The following data were surveyed: target group, setting, type of intervention, country, institutions conducting the studies, and funding. Sample size calculations were documented to survey the quality of studies. Frequencies were calculated for the categories., Results: 259 RCTs carried out in 36 countries were included. About half of the educational studies (n=154) were initiated in the medical field. The majority of the 95 studies, which addressed pre-schoolers and pupils, studied prevention programmes (n=75). Only 16 out of 259 studies were conducted in Germany. Sample size calculations were reported in 85 studies., Conclusion: As yet only very few RCTs of educational interventions have been conducted. In particular, this kind of study is lacking in Germany. The quality of the studies seems questionable. There is an urgent need for RCTs on educational interventions., (Copyright © 2012. Published by Elsevier GmbH.)

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: Informed and shared decision-making require competences for both partners - healthcare professionals and patients. There is a lack of training courses in evidence-based medicine for patients and counsellors., Objective: We investigated feasibility, acceptability and the potential effects of a 2 x 2.5 days training course on critical health competences in patients, patient counsellors, consumer representatives and healthcare professionals in Austria., Methods: We adapted a previously developed curriculum for patient and consumer representatives. The adaptation comprised the specific needs of our target group in Austria and was founded on Carl Rogers' theory of person-centred education. For the formative evaluation a questionnaire was applied to address the domains: 1) organisational conditions (time and duration of the course, location, and information given in advance, registration); 2) assistance outside the courses; 3) teaching methods (performance of lecturers, teaching materials, structure of modules and blocks) and 4) satisfaction; 5) subjective assessment of competences. Participants evaluated the course, using a 5-point Likert scale. Long-term implementation was assessed using semi-structured interviews three to six months after the course. To estimate the increase in critical health competences we used the validated Critical Health Competence Test (CHC test)., Results: Eleven training courses were conducted including 142 participants: patients (n=21); self-help group representatives (n=17); professional counsellors (n=29); healthcare professionals (n=10); psychologists (n=8); teachers (n=10) and others (n=29). 97 out of 142 (68 %) participants returned the questionnaire. On average, participants strongly agreed or agreed to 1) organisational conditions: 71 % / 23 %; 2) assistance outside the courses: 96 % / 10 %; 3) teaching methods: 60 % / 28 %; and 4) satisfaction: 78 % / 20 %, respectively. Interviews showed that the training course raised awareness, activated and empowered participants. Participants passed the CHC test with mean person parameters of 463±111 (pre-test, n=120) and 547±135 (post-test, n=91). For participants who returned both tests (n=71) person parameters were comparable: pre-test 466±121 versus post-test 574±100, p<0,001., Conclusion: Training in evidence-based medicine for patients, patient counsellors, consumer representatives and healthcare professionals is feasible. For a broad implementation, train-the trainer courses and further research are needed., (Copyright © 2012. 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.

Context: Despite unambiguous legal regulation and evidence for lack of effectiveness and safety, physical restraints are still frequently administered in nursing homes., Objective: To reduce physical restraint prevalence in nursing homes using a guideline- and theory-based multicomponent intervention., Design, Setting, and Participants: Cluster randomized controlled trial of 6 months' duration conducted in 2 German cities between February 2009 and April 2010. Nursing homes were eligible if they had 20% or more residents with physical restraints. Using external concealed randomization, 18 nursing home clusters were included in the intervention group (2283 residents) and 18 in the control group (2166 residents)., Intervention: The intervention was based on a specifically developed evidence-based guideline and applied the theory of planned behavior. Components were group sessions for all nursing staff; additional training for nominated key nurses; and supportive material for nurses, residents, relatives, and legal guardians. Control group clusters received standard information., Main Outcomes Measures: Primary outcome was percentage of residents with physical restraints (bilateral bed rails, belts, fixed tables, and other measures limiting free body movement) at 6 months, assessed through direct unannounced observation by blinded investigators on 3 occasions during 1 day. Secondary outcomes included restraint use at 3 months, falls, fall-related fractures, and psychotropic medication prescriptions., Results: All nursing homes completed the study and all residents were included in the analysis. At baseline, 30.6% of control group residents had physical restraints vs 31.5% of intervention group residents. At 6 months, rates were 29.1% vs 22.6%, respectively, a difference of 6.5% (95% CI, 0.6% to 12.4%; cluster-adjusted odds ratio, 0.71; 95% CI, 0.52 to 0.97; P = .03). All physical restraint measures were used less frequently in the intervention group. Rates were stable from 3 to 6 months. There were no statistically significant differences in falls, fall-related fractures, and psychotropic medication prescriptions., Conclusion: A guideline- and theory-based multicomponent intervention compared with standard information reduced physical restraint use in nursing homes., Trial Registration: isrctn.org Identifier: ISRCTN34974819.

Objective: To study the implementation of a patient education program on relapses and relapse therapy into routine care., Methods: 31 health care professionals took part in a one day train-the-trainer program (TTTP) and subsequently 261 persons with MS (pwMS) took part in the education program. Evaluation was carried out in trainers and pwMS., Results: Participants (health professionals) in the TTTP understood the program's main goals and reported that the TTTP enabled them to successfully perform the program. The majority of participants in the program (pwMS) understood the core messages. Also, they showed increased risk knowledge and increased decision autonomy preferences. Treatment decisions were reported as autonomous or as "informed choice" in 49%, and as "shared decisions" by 45%. Overall, effects were less marked compared to the results of the underlying randomized-controlled trial., Conclusion: PwMS! appreciate evidence-based information about relapse management and view the unbiased presentation of scientific uncertainty as a chance for decision autonomy., Practice Implications: The implementation study confirms the program's transferability into clinical practice., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Objective: To compare the effect of evidence based information on risk with that of standard information on informed choice in screening for colorectal cancer., Design: Randomised controlled trial with 6 months' follow-up., Setting: German statutory health insurance scheme., Participants: 1577 insured people who were members of the target group for colorectal cancer screening (age 50-75, no history of colorectal cancer)., Interventions: Brochure with evidence based risk information on colorectal cancer screening and two optional interactive internet modules on risk and diagnostic tests; official information leaflet of the German colorectal cancer screening programme (control)., Main Outcome Measure: The primary end point was "informed choice," comprising "knowledge," "attitude," and "combination of actual and planned uptake." Secondary outcomes were "knowledge" and "combination of actual and planned uptake." Knowledge and attitude were assessed after 6 weeks and combination of actual and planned uptake of screening after 6 months., Results: The response rate for return of both questionnaires was 92.4% (n = 1457). 345/785 (44.0%) participants in the intervention group made an informed choice, compared with 101/792 (12.8%) in the control group (difference 31.2%, 99% confidence interval 25.7% to 36.7%; P < 0.001). More intervention group participants had "good knowledge" (59.6% (n = 468) v 16.2% (128); difference 43.5%, 37.8% to 49.1%; P < 0.001). A "positive attitude" towards colorectal screening prevailed in both groups but was significantly lower in the intervention group (93.4% (733) v 96.5% (764); difference -3.1%, -5.9% to -0.3%; P<0.01). The intervention had no effect on the combination of actual and planned uptake (72.4% (568) v 72.9% (577); P = 0.87)., Conclusions: Evidence based risk information on colorectal cancer screening increased informed choices and improved knowledge, with little change in attitudes. The intervention did not affect the combination of actual and planned uptake of screening. Trial registration Current Controlled Trials ISRCTN47105521.

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.)

Objective: Statistical health risk information has been proven confusing and difficult to understand. While existing research indicates that presenting risk information in frequency formats is superior to relative risk and probability formats, the optimal design of frequency formats is still unclear. The aim of this study was to compare presentation of multi-figure pictographs in consecutive and random arrangements regarding accuracy in perception and vulnerability for cognitive bias., Methods: A total of 111 patients with multiple sclerosis were randomly assigned to two experimental conditions: patient information using 100 figure pictographs in 1) unsorted (UP group) or 2) consecutive arrangement (CP group).The study experiment was framed as patient information on how risks and benefit could be explained. The information comprised two scenarios of a treatment decision with varying levels of emotional relevance. Primary outcome measure was accuracy of information recall (errors made when recalling previously presented frequencies of benefits and side effects). Cognitive bias was measured as additional error appearing with higher emotional involvement. The uncertainty tolerance scale and a set of items to assess risk attribution were surveyed., Results: The study groups did not differ in their accuracy of recalling benefits, but recall of side effects was more accurate in the CP-group. Cognitive bias when recalling benefits was higher in the UP-group than in the CP-group and equal for side effects in both groups. RESULTS were similar in subgroup analyses of patients 1) with highly irrational risk attribution 2) with experience regarding the hypothetical contents or 3) with experience regarding pictograph presentation of frequencies. Overall, benefit was overestimated by more than 100% and variance of recall was extremely high., Conclusions: Consecutive arrangement as commonly used seems not clearly superior to unsorted arrangement which is more close to reality. General poor performance and the corresponding high variance of recall might have clouded existing effects of the arrangement types. More research is needed with varying proportions and other samples.

ADA/EASD recommendations and diabetes expert consensus statements are not evidence-based. Reform of guideline development is urgently needed. Overriding governance and composition of the guideline committee is a key problem. Methodologists without important conflicts of interest should lead the development process and have primary responsibility. The rating of the quality of evidence should be separated from making the recommendations, transparency has to be increased and conflicts of interest must be tackled. Patient needs are not yet met in guidelines. Patients increasingly demand concise, easy-to-read summaries of the benefits and risks of medicines together with more comprehensive scientific data. However, patient participation in individual decision making is not considered in guidelines. Guidelines do not provide the information necessary for informed or shared decision making. Study fact-sheets and drug facts boxes should be included in practice guidelines. It is timely to consider patient needs from the outset of the development of future guidelines.

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.)

Objective: To survey quality criteria for evidence-based patient information (EBPI) and to compile the evidence for the identified criteria., Methods: Databases PubMed, Cochrane Library, PsycINFO, PSYNDEX and Education Research Information Center (ERIC) were searched to update the pool of criteria for EBPI. A subsequent search aimed to identify evidence for each criterion. Only studies on health issues with cognitive outcome measures were included. Evidence for each criterion is presented using descriptive methods., Results: 3 systematic reviews, 24 randomized-controlled studies and 1 non-systematic review were included. Presentation of numerical data, verbal presentation of risks and diagrams, graphics and charts are based on good evidence. Content of information and meta-information, loss- and gain-framing and patient-oriented outcome measures are based on ethical guidelines. There is a lack of studies on quality of evidence, pictures and drawings, patient narratives, cultural aspects, layout, language and development process., Conclusion: The results of this review allow specification of EBPI and may help to advance the discourse among related disciplines. Research gaps are highlighted., Practice Implications: Findings outline the type and extent of content of EBPI, guide the presentation of information and describe the development process., (Copyright 2009 Elsevier Ireland Ltd. All rights reserved.)

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.

Aims: Development and testing of a decision aid about prevention of myocardial infarction for persons with type 2 diabetes., Methods: Development and testing were guided by the UK Medical Research Council's guidance for the development and evaluation of complex interventions. This comprised a systematic literature review, a focus group of 9 potential providers, modelling a prototype, interviews to qualitatively explore understanding and additional information needs, and revision of the decision aid., Results: The decision aid includes evidence-based information, a tool for individual risk-assessment, worksheets, and an action plan. Five diabetes educators and 15 patients underwent two 60-minutes face-to-face interviews, firstly browsing the decision aid for the first time and then after using it. Both groups differed in their ratings. Overall, the decision aid was rated to present essential information in a complex but understandable and unbiased manner. Difficulties involved understanding of terminology and risk interpretation. "Social status as a risk factor" was the most challenged content by educators but considered as highly important by patients. The risk assessment tool was used inadequately. 5 patients allocated themselves into false risk categories. After revision of the tool, all 12 patients who were recruited for reassessment used the tool correctly., Conclusion: The decision aid was evaluated with diabetes educators and patients. Qualitative data analysis revealed aspects for revision. The decision aid is planned to be part of a shared decision making programme, comprising a strategy for patient counselling and educational modules addressed to providers. Quantitative evaluation is required to assess its effectiveness.

Background: Overweight and obesity are generally thought to elevate morbidity and mortality. New data call this supposed association into question., Methods: The Cochrane, Pubmed, and other databases were systematically searched for a combination of relevant terms and subject headings. Meta-analyses and cohort studies based on the German population were evaluated for possible associations between overweight/ obesity and adult morbidity and mortality. Case-control and cross-sectional studies were excluded., Results: A total of 27 meta-analyses and 15 cohort studies were evaluated. The overall mortality of overweight persons (body mass index [BMI] 25-29.9 kg/m(2)) is no higher than that of persons of normal weight (BMI 18.5-24.9 kg/m(2)), but their mortality from individual diseases is elevated, diminished or unchanged, depending on the particular disease. The overall morbidity is unknown. Both obesity (BMI >30 kg/m(2)) and overweight are associated with increased disease-specific morbidity for some diseases, but decreased or unchanged for others. In general, obesity confers a higher risk than overweight. Morbidity and mortality are markedly influenced by the patient's age, sex, ethnic origin, and social status. The external validity of the comparative predictive performance (c-statistic) of BMI, waist circumference, and ratio of waist to hip circumference cannot be determined from the available analyses., Conclusion: The prevailing notion that overweight increases morbidity and mortality, as compared to so-called normal weight, is in need of further specification. Obesity, however, is indeed associated with an elevated risk for most of the diseases studied.

Background: Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations., Methods/design: Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures., Discussion: If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial., Trial Registration: ISRCTN34974819.

Background: Parallel to the establishment of early treatments in multiple sclerosis (MS), new diagnostic criteria have made an earlier diagnosis possible. While there is ongoing discussion about possible benign courses and only partial effective treatments, there have been no attempts today to facilitate shared decision making on diagnostic testing between patients with suspected MS and their physicians., Objective: This study describes the development and validation process of a leaflet to be presented to people with suspected MS to engage them in a diagnostic decision-making process., Methods: After a qualitative study showing acceptability among five patients, the leaflet was presented to a retrospective cohort (n = 87 of which 70 replied)) of patients being diagnosed within the last 2 years as well to a prospective cohort of n = 51 patients with symptoms suggestive of MS., Results: Approximately 70% of patients in the prospective as well as in the retrospective cohort wanted to be informed about a possible MS before testing, whereas 10% did not. The leaflet did not seem to elicit anxieties. The attitude to undergo diagnostic testing was not influenced by the leaflet, which can be explained by the nonexperimental design of the study., Conclusion: Taken together, our findings demonstrate that early information about possible MS is warranted by patients and does not show negative side effects. Further studies on evidence-based patient information in early MS seem necessary.