[Evaluation of the public health measures introduced during the coronavirus pandemic: Evidence-based risk communication must be a central topic]. / Aufarbeitung der Corona-Pandemiemaßnahmen - Evidenzbasierte Risikokommunikation muss ein zentrales Thema sein.

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.

Nurse-led coaching of shared decision-making for women with ductal carcinoma in situ in breast care centers: A cluster randomized controlled trial.

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-Odyad observer instrument (scores 0 to 4). Secondary endpoints included 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 '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.

Communicating prognosis to women with early breast cancer - overview of prediction tools and the development and pilot testing of a decision aid.

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.

Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial.

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.

Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.

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.

The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis.

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.

Causal interpretation of correlational studies - Analysis of medical news on the website of the official journal for German physicians.

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.

Implementation of shared decision-making in oncology: development and pilot study of a nurse-led decision-coaching programme for women with ductal carcinoma in situ.

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'Odyad, 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-Odyad): 2.15 and M(MAPPIN-Onurse): 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.

Informed decision-making with and for people with dementia - efficacy of the PRODECIDE education program for legal representatives: protocol of a randomized controlled trial (PRODECIDE-RCT).

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.

Oral health educational interventions for nursing home staff and residents.

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.

Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial.

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.

The Foundation in Evidence of Medical and Dental Telephone Consultations.

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.

The 'Old' Anti-Diabetic Agents: A Systematic Inventory.

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.

Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial.

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.

Understanding adverse drug reactions in package leaflets - an exploratory survey among health care professionals.

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.

Informed shared decision-making supported by decision coaches for women with ductal carcinoma in situ: study protocol for a cluster randomized controlled trial.

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.