Development and piloting of a blended learning training programme for physicians and medical students to enhance their competences in evidence-based decision-making.

INTRODUCTION: In 2016, the German Network for Evidence-based Medicine revised its basic curriculum for competences in evidence-based medicine. A curriculum-based training programme for physicians and medical students to enhance their competences in evidence-based decision-making was developed. The training programme was planned on the basis of problem-based learning. The aim of this qualitative pilot study was to explore the feasibility and acceptability of the training programme. Hypotheses concerning its influence on critical health literacy and the attitude toward evidence-based decision-making were to be generated. METHODS: Participating healthcare professionals received a structured training in a blended learning format. Data collection was conducted during the training sessions. The lessons were observed and protocolled and the working results were documented. Two focus group interviews were conducted after the training blocks with focus on acceptability and feasibility of the training programme. Interview transcripts and protocols were analysed using qualitative content analysis according to Mayring. Data saturation was intended by an iterative process of testing, analysing and revising the training programme. In addition, critical health literacy was assessed using the validated Critical Health Competence test. Levels of competence were calculated to measure the effect of the training on critical health competences. RESULTS: Two pilot courses with 29 physicians and other healthcare professionals were conducted between January and March 2019. Overall, the training programme proved to be feasible. The participants rated the comprehensibility of the learning modules as high. However, the practical exercises (e.g. role plays in shared decision-making) revealed that relevant subjects were insufficiently understood (e.g. the difference between the benefits and harms of a diagnostic test and its test accuracy). The interactive instructional design was appreciated. The participants appraised the work tasks as comprehensible but also challenging and requested a theoretical introduction to statistical terms in preparation for work tasks. The programme was revised iteratively according to the results. Critical health competences increased significantly after the training. Mean values (±SD) of levels of competence were 571.21 (±82.87) before training and 671.90 (±51.38) after training (p<0.0001) (levels of competence with a range from 0 to 1,000). CONCLUSION: The training programme is feasible and was well accepted by the participants. It should be established as a continuing medical education opportunity for practitioners. Evaluation in a randomised controlled trial is recommended. Furthermore, the training can easily be adapted for interprofessional training. A concept for long-term implementation is needed.

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.

Pictures in health information and their pitfalls: Focus group study and systematic review.

BACKGROUND: Health information often includes different categories of pictures. This study comprises: A) exploration of the perception of photos presented in a brochure on the prevention of osteoporosis and B) a systematic review on the effects of pictures in health information. METHODS: A) We conducted four focus groups. Participants with heterogeneous cultural and educational background were included. The interviews were subjected to qualitative content analysis. B) We searched PubMed, CENTRAL, PSYNDEX, PsycINFO, CINAHL, Campbell Collaboration and DIMDI. Randomized controlled trials (RCTs) on predefined cognitive and affective outcomes were included. Two reviewers independently extracted data and assessed the quality of evidence. Descriptive data synthesis was conducted. RESULTS: A) Within the focus groups comprising 37 participants, four generic categories were identified: comprehension, perception, congruence between photos and content, and alternatives. Identification with portrait photos and the connection between photos and text were important to participants. B) In total, 13 RCTs were included. Quality of evidence was moderate. Types of pictures and their intention varied between studies. Cartoons enhanced comprehension, satisfaction and readability. Photos did not improve cognitive or affective outcomes. Effects of anatomical pictures, pictographs, and drawings were ambiguous. CONCLUSION: The overall effect of using pictures in health information remains unclear. The type of pictures and readers' characteristics may influence both perception and interpretation. Type, amount, and intention of the pictures should be considered carefully.

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.

Effectiveness of training in evidence-based medicine skills for healthcare professionals: a systematic review.

BACKGROUND: Basic skills in evidence-based medicine (EbM) are indispensable for healthcare professionals to promote consumer-centred, evidence-based treatment. EbM training courses are complex interventions - a fact that has not been methodologically reflected by previous systematic reviews. This review evaluates the effects of EbM training for healthcare professionals as well as the quality of reporting of such training interventions. METHODS: We searched PubMed, EMBASE, CINAHL, Cochrane Library, ERIC, Campbell Library and PsycINFO up to 9/2014. Randomised controlled trials, controlled clinical trials as well as before-after trials were included. Authors were contacted in order to obtain missing data. Two independent reviewers extracted data and assessed risk of bias. RESULTS: We reviewed 14.507 articles; n = 61 appeared potentially eligible; n = 13 involving 1,120 participants were included. EbM training shows some impact on knowledge and skills, whereas the impact on practical EbM application remains unclear. Risk of bias of included trials raises uncertainty about the effects. Description of complex interventions was poor. CONCLUSIONS: EbM training has some positive effects on knowledge and skills of healthcare professionals. Appropriate methods for development, piloting, evaluation, reporting and implementation of the training should be applied.

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.

An informed shared decision making programme on the prevention of myocardial infarction for patients with type 2 diabetes in primary care: protocol of a cluster randomised, controlled trial.

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 .

[Development of a decision aid on post mortem organ donation - somewhere between evidence uncertainty, fears, and ethical and moral values]. / Entwicklung einer Entscheidungshilfe "Organspende nach dem Tod" - im Spannungsfeld zwischen Evidenz, Ungewissheit, Ängsten und ethisch-moralischen Wertvorstellungen.

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.

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

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.

Decision aids for patients.

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.