Evaluating student's ability to assess treatment claims: validating a German version of the Claim Evaluation Tools.

BACKGROUND: The Claim Evaluation Tools measure the ability to assess claims about treatment effects. The aim of this study was to adapt the German item sets to the target group of secondary school students (aged 11 to 16 years, grade 6 to 10) and to validate them accordingly. The scale's reliability and validity using Rasch's probabilistic test theory should be determined. METHODS: We conducted a sequential mixed-method study comprising three stages: contextualisation and adaption of the items (stage 1), piloting of the item sets using qualitative interviews (stage 2) and a construct validation by testing the unidimensional Rasch scalability for each item set after data collection in one secondary school in Germany and two secondary schools in Austria. We explored summary and individual fit statistics and performed a distractor analysis (stage 3). RESULTS: Secondary school students (n = 6) and their teachers (n = 5) participated in qualitative interviews in Germany. The qualitative interviews identified the need for minor modifications (e.g. reducing thematic repetitions, changing the order of the items). The data of 598 German and Austrian secondary school students were included to test for Rasch scalability. Rasch analyses showed acceptable overall model fit. Distractor analyses suggested that model fit could be improved by simplifying the text in the scenarios, removing and editing response options of some items. CONCLUSION: After the revision of some items, the questionnaires are suitable to evaluate secondary school students' ability to assess health claims. A future goal is to increase the pool of items being translated and tested.

Shared decision making and advance care planning: a systematic literature review and novel decision-making model.

BACKGROUND AND AIMS: Shared decision making (SDM) and advance care planning (ACP) are important evidence and ethics based concepts that can be translated in communication tools to aid the treatment decision-making process. Although both have been recommended in the care of patients with risks of complications, they have not yet been described as two components of one single process. In this paper we aim to (1) assess how SDM and ACP is being applied, choosing patients with aortic stenosis with high and moderate treatment complication risks such as bleeding or stroke as an example, and (2) propose a model to best combine the two concepts and integrate them in the care process. METHODS: In order to assess how SDM and ACP is applied in usual care, we have performed a systematic literature review. The included studies have been analysed by means of thematic analysis as well as abductive reasoning to determine which SDM and ACP steps are applied as well as to propose a model of combining the two concepts into one process. RESULTS: The search in Medline, Cinahl, Embase, Scopus, Web of science, Psychinfo and Cochrane revealed 15 studies. Eleven describe various steps of SDM while four studies discuss the documentation of goals of care. Based on the review results and existing evidence we propose a model that combines SDM and ACP in one process for a complete patient informed choice. CONCLUSION: To be able to make informed choices about immediate and future care, patients should be engaged in both SDM and ACP decision-making processes. This allows for an iterative process in which each important decision-maker can share their expertise and concerns regarding the care planning and advance care planning. This would help to better structure and prioritize information while creating a trustful and respectful relationship between the participants. PROSPERO 2019. CRD42019124575.

Decision coaching for people making healthcare decisions.

BACKGROUND: Decision coaching is non-directive support delivered by a healthcare provider to help patients prepare to actively participate in making a health decision. 'Healthcare providers' are considered to be all people who are engaged in actions whose primary intent is to protect and improve health (e.g. nurses, doctors, pharmacists, social workers, health support workers such as peer health workers). Little is known about the effectiveness of decision coaching. OBJECTIVES: To determine the effects of decision coaching (I) for people facing healthcare decisions for themselves or a family member (P) compared to (C) usual care or evidence-based intervention only, on outcomes (O) related to preparation for decision making, decisional needs and potential adverse effects. SEARCH METHODS: We searched the Cochrane Library (Wiley), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), CINAHL (Ebsco), Nursing and Allied Health Source (ProQuest), and Web of Science from database inception to June 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) where the intervention was provided to adults or children preparing to make a treatment or screening healthcare decision for themselves or a family member. Decision coaching was defined as: a) delivered individually by a healthcare provider who is trained or using a protocol; and b) providing non-directive support and preparing an adult or child to participate in a healthcare decision. Comparisons included usual care or an alternate intervention. There were no language restrictions. DATA COLLECTION AND ANALYSIS: Two authors independently screened citations, assessed risk of bias, and extracted data on characteristics of the intervention(s) and outcomes. Any disagreements were resolved by discussion to reach consensus. We used the standardised mean difference (SMD) with 95% confidence intervals (CI) as the measures of treatment effect and, where possible, synthesised results using a random-effects model. If more than one study measured the same outcome using different tools, we used a random-effects model to calculate the standardised mean difference (SMD) and 95% CI. We presented outcomes in summary of findings tables and applied GRADE methods to rate the certainty of the evidence. MAIN RESULTS: Out of 12,984 citations screened, we included 28 studies of decision coaching interventions alone or in combination with evidence-based information, involving 5509 adult participants (aged 18 to 85 years; 64% female, 52% white, 33% African-American/Black; 68% post-secondary education). The studies evaluated decision coaching used for a range of healthcare decisions (e.g. treatment decisions for cancer, menopause, mental illness, advancing kidney disease; screening decisions for cancer, genetic testing). Four of the 28 studies included three comparator arms.  For decision coaching compared with usual care (n = 4 studies), we are uncertain if decision coaching compared with usual care improves any outcomes (i.e. preparation for decision making, decision self-confidence, knowledge, decision regret, anxiety) as the certainty of the evidence was very low.  For decision coaching compared with evidence-based information only (n = 4 studies), there is low certainty-evidence that participants exposed to decision coaching may have little or no change in knowledge (SMD -0.23, 95% CI: -0.50 to 0.04; 3 studies, 406 participants). There is low certainty-evidence that participants exposed to decision coaching may have little or no change in anxiety, compared with evidence-based information. We are uncertain if decision coaching compared with evidence-based information improves other outcomes (i.e. decision self-confidence, feeling uninformed) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with usual care (n = 17 studies), there is low certainty-evidence that participants may have improved knowledge (SMD 9.3, 95% CI: 6.6 to 12.1; 5 studies, 1073 participants). We are uncertain if decision coaching plus evidence-based information compared with usual care improves other outcomes (i.e. preparation for decision making, decision self-confidence, feeling uninformed, unclear values, feeling unsupported, decision regret, anxiety) as the certainty of the evidence was very low. For decision coaching plus evidence-based information compared with evidence-based information only (n = 7 studies), we are uncertain if decision coaching plus evidence-based information compared with evidence-based information only improves any outcomes (i.e. feeling uninformed, unclear values, feeling unsupported, knowledge, anxiety) as the certainty of the evidence was very low. AUTHORS' CONCLUSIONS: Decision coaching may improve participants' knowledge when used with evidence-based information. Our findings do not indicate any significant adverse effects (e.g. decision regret, anxiety) with the use of decision coaching. It is not possible to establish strong conclusions for other outcomes. It is unclear if decision coaching always needs to be paired with evidence-informed information. Further research is needed to establish the effectiveness of decision coaching for a broader range of outcomes.

Ready for SDM: evaluating a train-the-trainer program to facilitate implementation of SDM training in Norway.

BACKGROUND: Healthcare providers need training to implement shared decision making (SDM). In Norway, we developed "Ready for SDM", a comprehensive SDM curriculum tailored to various healthcare providers, settings, and competence levels, including a course targeting interprofessional healthcare teams. The overall aim was to evaluate a train-the-trainer (TTT) program for healthcare providers wanting to offer this course within their hospital trust. METHODS: Our observational descriptive design was informed by Kirkpatrick´s Model of Educational Outcomes. The South-Eastern Regional Health Authority invited healthcare providers from all health trusts in its jurisdiction to attend. The TTT consisted of a one-day basic course with lectures on SDM, exercises and group reflections followed by a two-day advanced course including an SDM observer training. Immediately after each of the two courses, reaction and learning (Kirkpatrick levels 1 and 2) were assessed using a self-administered questionnaire. After the advanced course, observer skills were operationalized as accuracy of the participants' assessment of a consultation compared to an expert assessment. Within three months post-training, we measured number of trainings conducted and number of healthcare providers trained (Kirkpatrick level 3) using an online survey. Qualitative and quantitative descriptive analysis were performed. RESULTS: Twenty-one out of 24 (basic) and 19 out of 22 (advanced) healthcare providers in 9 health trusts consented to participate. The basic course was evaluated as highly acceptable, the advanced course as complex and challenging. Participants identified a need for more training in pedagogical skills and support for planning implementation of SDM-training. Participants achieved high knowledge scores and were positive about being an SDM trainer. Observer skills regarding patient involvement in decision-making were excellent (mean of weighted t = .80). After three months, 67% of TTT participants had conducted more than two trainings each and trained a total of 458 healthcare providers. CONCLUSION: Findings suggest that the TTT is a feasible approach for supporting large-scale training in SDM. Our study informed us about how to improve the advanced course. Further research shall investigate the efficacy of the training in the context of a comprehensive multifaceted strategy for implementing SDM in clinical practice. TRIAL REGISTRATION: Retrospectively registered at ISRCTN (99432465) March 25, 2020.

Patient autonomy in dentistry: demonstrating the role for shared decision making.

BACKGROUND: Evidence-based practice, decision aids, patient preferences and autonomy preferences (AP) play an important role in making decisions with the patient. They are crucial in the process of a shared decision making (SDM) and can be incorporated into quality criteria for patient involvement in health care. However, there are few studies on SDM and AP in the field of dentistry. This study explored patients' autonomy preferences in dentistry in comparison to other medical domains, comparing them with patient preferences in two other cohorts of patients with different conditions and in different health care settings. METHODS: A sample of 100 dental patients attending 16 dentists was consecutively recruited in a university-based prosthodontic clinic. Patients' and dentists' preferences regarding their roles in dental decision making for commonly performed diagnostic and treatment decisions were compared using the Control Preference Scale (CPS). This was followed by cross sectional surveys to study autonomy preferences in three additional cohorts recruited from general practices (n = 100), a multiple sclerosis clinic (n = 109), and a university-based prosthodontic clinic (n = 100). A questionnaire with combined items from the Autonomy Preference Index (API) to assess general and the CPS to assess specific preferences was used in the additional cohorts. RESULTS: Dentists were less willing to give patients control than patients were willing to enact autonomy. However, decisions about management of tooth loss were considered relevant for a shared decision making by both parties. When comparing cohorts from different samples, the highest AP was expressed by people with multiple sclerosis and the lowest by patients in dentistry (means: dentistry 2.5, multiple sclerosis 2.1, general practice 2.4, p = .035). There were considerable intra-individual differences in autonomy preferences referring to different decision types (p < .001). In general, more autonomy was desired for treatment decisions in comparison to diagnostic decisions, for trivial compared to severe conditions, and for dental care compared to general practice (all: p < .001). CONCLUSION: There is an important role of patient participation in decision making in dentistry. Furthermore, PA should be considered with respect to specific medical decisions instead of assessing autonomy preferences in general implying a need for communication skills training of health care professionals.

Training doctors briefly and in situ to involve their patients in making medical decisions-Preliminary testing of a newly developed module.

OBJECTIVE: To carry out preliminary evaluation of a training module for doctors to enhance their ability to involve their patients in medical decision making. The training refers to the shared decision-making (SDM) communication concept. METHODS: The training module includes a comprehensive manual, a corresponding video tutorial with communication examples and a 15-minute face-to-face feedback session based on an SDM analysis of a consultation recording provided by the trainee. Ten trainees (four neurologists, three dentists, and three general practitioners) participating in the pretest each recorded four clinical consultations (total sample: N=40) and received three training components. After the training, doctors provided feedback on the module's feasibility in a questionnaire. Communication performance of doctors, patients and doctor-patient dyads was assessed by trained observers and self-assessed by doctors and patients using the MAPPIN'SDM approach. Training effects were determined using Wilcoxon signed-rank tests comparing baseline values with post-intervention performance as assessed in the fourth consultations. RESULTS: The face-to-face training sessions were short and feasible with regard to clinical reality. Participants considered the training supportive for acquiring SDM skills and recommended more emphasis on the face-to-face feedback. Communication improved according to observers rating doctors (P=.05) and doctor-patient dyads (P=.07) and to doctors' own judgements (P=.02). No improvement was observed in patients' SDM behaviour (P=.11); accordingly, patients' judgements did not indicate improvement (P=.14). CONCLUSIONS: The training is designed to meet clinicians' needs. Improvement of risk communication after training encourages optimization according to doctors' feedback. Following this study, the efficacy of the training is now being examined in a randomized controlled trial.

A new graphical format to communicate treatment effects to patients-A web-based randomized controlled trial.

OBJECTIVE: Patients making treatment decisions require understandable evidence-based information. However, evidence on graphical presentation of benefits and side-effects of medical treatments is not conclusive. The study evaluated a new space-saving format, CLARIFIG (clarifying risk figures), aiming to facilitate accuracy of comprehension. METHODS: CLARIFIG displays groups of patients with and without treatment benefits as coloured sectors of a proportional bar graph representing in total 100 patients. Supplementary icons indicate the corresponding group's actual condition. The study used an application showing effects of immunotherapy intended to slow disease progression in multiple sclerosis (MS). In a four-arm web-based randomized controlled trial, CLARIFIG was compared to the reference standard, multifigure pictographs (MFP), regarding comprehension (primary outcome) and processing time. Both formats were presented as static and animated versions. People with MS were recruited through the website of the German MS society. RESULTS: Six hundred and eighty-two patients were randomized and analysed for the primary end point. There were no differences in comprehension rates (MFPstatic =46%, CLARIFIGstatic =44%; P=.59; MFPanimated =23%, CLARIFIGanimated =30%; P=.134). Processing time for CLARIFIG was shorter only in the animated version (MFPstatic =162 seconds, CLARIFIGstatic =155 seconds; P=.653; MFPanimated =286 seconds, CLARIFIGanimated =189 seconds; P≤.001). However, both animated versions caused more wrong answers and longer processing time than static presentation (MFPstatic vs animated : P≤.001/.001, CLARIFIGstatic vs animated : P=.027/.017). CONCLUSION: Comprehension of the new format is comparable to MFP. CLARIFIG has the potential to simplify presentation in more complex contexts such as comparison of several treatment options in patient decision aids, but further studies are needed.

Evidence-based patient information programme in early multiple sclerosis: a randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of an evidence-based patient information programme aiming to increase informed choice in patients with early multiple sclerosis (MS). BACKGROUND: Patients with early MS face a number of uncertainties concerning diagnosis, prognosis and effectiveness of immunotherapy. Prior studies suggest that evidence-based patient information combined with group education can promote informed choice in MS patients. METHODS: A 12-month, six-centre, double-blind randomised controlled clinical trial with 192 patients with a diagnosis of confirmed relapsing-remitting MS or clinical isolated syndrome in Germany. A 4-h interactive evidence-based educational programme was compared with a 4-h MS-specific stress management programme. The primary endpoint was informed choice after 6 months comprising risk knowledge and congruency between attitude towards immunotherapy and actual immunotherapy uptake. Secondary endpoints included autonomy preference, decision autonomy, decisional conflict and satisfaction, anxiety and depression, and number of immunotherapies. RESULTS: For the primary endpoint, a significant difference was shown with 50 of 85 (59%) participants in the intervention group achieving informed choice after 6 months compared with 18 of 89 (20%) in the control group (OR 0.2 (95% CI 0.1 to 0.4), p<0.001). Four weeks after the intervention, more participants in the intervention group showed good risk knowledge (difference between groups 39% (95% CI 26% to 53%), p<0.001). There were no significant differences between groups for attitude towards immunotherapy and for immunotherapy uptake. There were trends towards increased autonomy preference after the intervention and increased adherence to immunotherapies in the intervention group. CONCLUSIONS: The intervention significantly increased informed choice and relevant risk knowledge without negative side effects.

Evaluating Relapse Knowledge in People with Multiple Sclerosis: A Cross-Sectional Study on the Development and Validation of the Relapse Knowledge Questionnaire.

BACKGROUND: Multiple sclerosis (MS) knowledge is a prerequisite for active patient engagement in medical decision-making. Treatment of relapses in MS is a clinical field with many uncertainties and each acute relapse requires decisions regarding possible options for action, indicating the need for patient involvement. However, there is no validated instrument assessing relapse knowledge in people with MS. Our study aims to develop a valid MS relapse questionnaire for use as an outcome instrument for educational interventions. METHODS: A multidisciplinary panel developed the relapse knowledge questionnaire (RKQ) based on a previously developed questionnaire. We tested the RKQ on MS patients for comprehensibility, usability and acceptance in qualitative think-aloud interviews and conducted a cross-sectional quantitative online survey to validate the questionnaire. People with suspected or confirmed relapsing-remitting MS and a recent relapse experience were eligible for inclusion. We checked normal distribution of the RKQ score and determined the item difficulty. Construct validity was analysed using correlational analysis. RESULTS: The final RKQ consists of 10 items. After minor changes of the RKQ during pre-testing (n = 2), pilot testing (n = 10) confirmed the usability and acceptance of the instrument. The subsequent validation study (n = 203) resulted in a mean item difficulty of 0.44, ranging from 0.18 to 0.83. Seven items were particularly difficult and answered incorrectly by more than 50 % of participants. Construct validity of the RKQ was satisfactory. The RKQ score correlated only weakly with participants' degree of education (|rp|>0.1), years since diagnosis (|rp|>0.1), and the intention to receive corticosteroids (|rp|>0.1). CONCLUSION: This study indicates the validity of the RKQ and proposes that the RKQ is a suitable instrument to assess relapse knowledge in people with MS participating in educational interventions.

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.

MAPPinfo - mapping quality of health information: Validation study of an assessment instrument.

BACKGROUND: Health information is a prerequisite for informed choices-decisions, made by individuals about their own health based on knowledge and in congruence with own preferences. Criteria for development, content and design have been defined in a corresponding guideline. However, no instruments exist that provide reasonably operationalised measurement items. Therefore, we drafted the checklist, MAPPinfo, addressing the existing criteria with 19 items. OBJECTIVES: The current study aimed to validate MAPPinfo. METHODS: Five substudies were conducted subsequently at the Martin Luther University Halle-Wittenberg, Germany and the Medical University of Graz, Austria: (1) to determine content validity through expert reviews of the first draft, (2) to determine feasibility using 'think aloud' in piloting with untrained users, (3) to determine inter-rater reliability and criterion validity through a pretest on 50 health information materials, (4) to determine construct validity using 50 developers' self-declarations about development methods as a reference standard, (5) to determine divergent validity in comparison with the Ensuring Quality Information for Patients (EQIP) (expanded) Scale. The analyses used were qualitative methods and correlation-based methods for determining both inter-rater reliability and validity. RESULTS: The instrument was considered by experts to operationalise the existing guidelines convincingly. Health and nursing science students found it easy to understand and use. It also had good interrater reliability (mean of T coefficients = .79) and provided a very good estimate of the reference standard (Spearman's rho = .89), implying sound construct validity. Finally, comparison with the EQIP instrument revealed important and distinct areas of similarities and differences. CONCLUSIONS: The new instrument is ready for use as a screening instrument without the need for training. According to its underpinning concept the instrument exclusively comprises items which are justified by either ethics or research evidence, implying negligence of not yet evidence based, however, potentially important criteria. Further research is needed to complete the body of evidence-based criteria, aiming at an extension of the guideline and MAPPinfo. TRIAL REGISTRATION NUMBER: AsPredicted22546; date of registration: 24 July 2019.

Efficacy of Three Numerical Presentation Formats on Lay People's Comprehension and Risk Perception of Fact Boxes-A Randomized Controlled Pilot Study.

(1) Background: Fact boxes present the benefits and harms of medical interventions in the form of tables. Some studies suggest that people with a lower level of education could profit more from graphic presentations. The objective of the study was to compare three different formats in fact boxes with regard to verbatim and gist knowledge in general and according to the educational background. (2) Methods: In May 2020, recruitment started for this randomized controlled trial. Participants were given one out of three presentation formats: natural frequencies, percentages, and graphic. We used Limesurvey® to assess comprehension/risk perception as the primary outcome. The Kruskal-Wallis test and the Mann-Whitney U test were used in addition to descriptive analyses. (3) Results: A total of 227 people took part in the study. Results of the groups were nearly identical in relation to the primary outcome verbatim knowledge, likewise in gist knowledge. However, participants with lower educational qualifications differed from participants with higher educational qualifications in terms of verbatim knowledge in the group percentages. (4) Conclusions: The results indicate that all three forms of presentation are suitable for conveying the content. Further research should take the individual preferences regarding the format into account.

Turning signals into meaning--'shared decision making' meets communication theory.

Shared decision making (SDM) is being increasingly challenged for promoting an innovative role model while adhering to an archaic approach to patient-clinician communication, both in clinical practice and the research field. Too often, SDM has been studied at the individual level, which ignores the interpersonal system between patients and physicians. We aimed to encourage debate by reflecting on the essentials of SDM in terms of epistemology. We operationalized the SDM core concept of information exchange in terms of social systems theory. An epistemological analysis of the term information refers to its inherent process character. Exchange of information thereby becomes synonymous with social sense construction, indicating that, rather than just being a vehicle, the act of communication itself is the information. We plead for the adoption of existing dyadic analytical methods such as those offered by the interpersonal paradigm. Implications of an updated concept of information for the use of SDM-evaluation methods, for SDM-goal setting, and for clinical practice of SDM are described.

Applying the theory of planned behaviour to multiple sclerosis patients' decisions on disease modifying therapy--questionnaire concept and validation.

BACKGROUND: Patients making important medical decisions need to evaluate complex information in the light of their own beliefs, attitudes and priorities. The process can be considered in terms of the theory of planned behaviour. Decision support technologies aim at helping patients making informed treatment choices. Instruments assessing informed choices need to include risk knowledge, attitude (towards therapy) and actual uptake. However, mechanisms by which decision support achieves its goals are poorly understood.Our aim was therefore to develop and validate an instrument modeling the process of multiple sclerosis (MS) patients' decision making about whether to undergo disease modifying (immuno-)therapies (DMT). METHODS: We constructed a 30-item patient administered questionnaire to access the elaboration of decisions about DMT in MS according to the theory of planned behaviour. MS-patients' belief composites regarding immunotherapy were classified according to the domains "attitude", "subjective social norm" and "control beliefs" and within each domain to either "expectations" or "values" yielding 6 sub-domains. A randomized controlled trial (n = 192) evaluating an evidence based educational intervention tested the instrument's predictive power regarding intention to use immunotherapy and its sensitivity to the intervention. RESULTS: The psychometric properties of the questionnaire were satisfactory (mean item difficulty 62, mean SD 0.9, range 0-3). Responses explain up to 68% of the variability in the intention to use DMT was explained by up to 68% in the total sample. Four weeks after an educational intervention, predictive power was higher in the intervention (IG) compared to the control group (CG) (intention estimate: CG 56% / IG 69%, p = .179; three domains CG 56% / IG 74%, p = .047; six sub-domains CG 64% / IG 78%, p = .073). The IG held more critical beliefs towards immunotherapy (p = .002) and were less willing to comply with social norm (p = .012). CONCLUSIONS: The questionnaire seems to provide a valid way of explaining patients' inherent decision processes and to be sensitive towards varying levels of elaboration. Similar tools based on the theory of planned behaviour could be applied to other decision making scenarios.

Ready for SDM- evaluation of an interprofessional training module in shared decision making - A cluster randomized trial.

OBJECTIVE: Ready for SDM was developed in Norway as a comprehensive modularized curriculum for health care providers (HCP). The current study evaluated the efficacy of one of the modules, a 2-hour interprofessional SDM training designed to enhance SDM competencies. METHODS: A cluster randomized controlled trial was conducted with eight District Psychiatric Centres randomized to wait-list control (CG) or intervention group (IG). Participants and trainers were not blinded to their allocation. The IG received a 2-hour didactic and interactive training, using video examples. The primary outcome was the agreement between the participants' and an expert assessment of patient involvement in a video recorded consultation. The SDM-knowledge score was a secondary outcome. RESULTS: Compared to the CG (n = 65), the IG (n = 69) judged involvement behavior in a communication example more accurately (mean difference of weighted T, adjusted for age and gender:=-0.098, p = 0.028) and demonstrated better knowledge (mean difference=-0.58; p = 0.014). A sensitivity analysis entering a random effect for cluster turned out not significant. CONCLUSION: The interprofessional group training can improve HCPs' SDM-competencies. PRACTICE IMPLICATIONS: Addressing interprofessional teams using SDM communication training could supplement existing SDM training approaches. More research is needed to evaluate the training module's effects as a component of large-scale implementation of SDM.

New status report from Norway: Implementation of patient involvement in Norwegian health care.

In Norway, shared decision-making (SDM) is on the top of the priorities announced by the health authorities. Accountability for implementing this priority has been delegated to the four health regions, and from there into particular departments, hospital trusts, working groups or SDM coordinators. Using abundant public funding, different approaches to producing and implementing patient decision aids have been developed. However, none of these is implemented by any Norwegian services on a regular basis, while the accessible decision aids on the national health platform are not quality approved and in very little use. An ongoing new project is aimed to resolve this dilemma. Health professional training has been developed as a meta-curriculum with multiple modules, adaptive to setting and user group, and designed as an open-source learning platform, based upon the experience of "SDM Ambassadors" delivering the training. Most of the modules are already implemented on a regular basis in the South-Eastern Health Region, and 5000 health care professionals have already graduated from the training modules. However, in the standard patient pathways, and in most of the national medical guidelines, the patient is still considered to be a passive receiver of directives or recommendations, rather than an active participant in their own health decisions. Considerable structural implementation has been done in the education guidelines of all health professions on all levels to embed SDM principles. Teaching in SDM skills, quality of information and evidence-based nursing has become standard in most of the programs at Norwegian universities. Nevertheless, we currently still have no reliable estimate on the degree to which patients are actually involved in their own health decision-making. Further efforts in the process of implementing the patient's choice in the health system should involve the municipal services, follow a research-based strategy, include monitoring and consider the quality level of the informational environment of health-related decisions.

Population-based screening of children for specific speech and language impairment in Germany: a systematic review.

OBJECTIVE: The study was aimed at evaluating the effectiveness of a systematic population-based screening programme for specific language impairment (SLI) in preschool children in Germany. METHODS: The study question was divided into a review of (1) evidence from studies evaluating screening programmes, (2) diagnostic instruments in the German language, and (3) studies evaluating speech and language interventions. A systematic database search was conducted between June and October 2007 and was updated in January and again in May 2008. Relevant studies were identified by 2 independent reviewers based on screened titles/abstracts and full texts. RESULTS: 4,806 studies were screened. The only existing controlled screening study did not provide data for SLI. No diagnostic study met the inclusion criteria. Sixteen randomized intervention studies were included, 3 studies contributed to the appraisal of earlier against later initiation of treatment. Most studies were of limited quality. We found indications of short-term positive effects from language therapies in children with SLI. Long-term outcomes were not investigated. No evidence supporting the advantage of earlier treatment initiation was identified. CONCLUSIONS: The benefit of population-based language screening of preschool children with SLI is not proven. Controlled screening studies are therefore necessary. For Germany, the accuracy of existing diagnostic instruments has not yet been sufficiently examined.

Impact of a multimedia website with patient experiences of multiple sclerosis (PExMS) on immunotherapy decision-making: study protocol for a pilot randomised controlled trial in a mixed-methods design.

BACKGROUND: A variety of management options (e.g. immunotherapies, lifestyle interventions, and rehabilitation) are available for people with relapsing-remitting multiple sclerosis (RRMS). Besides coping with the diagnosis, people with MS (pwMS) have to make complex decisions such as deciding about immunotherapies. In addition to factual information, reports of patient experiences (PEx) may support patients in decision-making. The added value of PEx in decision-making is not clear, and controlled studies are rare. Therefore, systematic methods are necessary to develop and analyse PEx. As there are no evaluated PEx for MS in Germany, we are currently creating a website presenting PEx structured according to topics and illustrated by video, audio, and text files. We aim to determine the feasibility of an intervention using PEx and evaluate whether PEx may help pwMS in their immunotherapy decision-making processes as a supplement to evidence-based information. METHODS: This project will follow the Medical Research Council framework for development and evaluation of complex interventions. After the development of a website with PEx, a randomised controlled pilot trial (pilot RCT) will be conducted in 2-3 MS centres, clinics, or rehabilitation centres including 55 pwMS and accompanied by a process evaluation. Patients with a RRMS diagnosis considering immunotherapy are eligible. The primary outcome is decision self-efficacy. Secondary outcomes include preparation for decision-making, decisional conflict, risk knowledge, confidence in active participation, affective forecasting, social support, and self-reported impact of eHealth on its users. Participants will be randomly assigned either to (i) an intervention group with 4 weeks access to an evidence-based patient information resource and the PExMS-website as an adjunct or to (ii) the control group with access to evidence-based information alone. A 6-member advisory panel involving representatives of pwMS, researchers, and neurologists, who accompany the whole project, will mentor this pilot RCT. DISCUSSION: The intervention was developed with systematic methods, created with active patient involvement and in critical appraisal by an expert advisory panel. The study is innovative as it contributes to the controversial evidence on the use of PEx in the context of evidence-based patient information. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04236544.

Risk perception in natalizumab-treated multiple sclerosis patients and their neurologists.

BACKGROUND: Natalizumab is associated with the potentially life-threatening side-effect progressive multifocal leukoencephalopathy (PML). Little is known about patients' and physicians' risk estimates and attitudes towards natalizumab treatment. METHODS: Consecutive natalizumab-treated patients (n = 69) and neurologists (n = 66) in two centres and cooperating private practices received an evidence-based three-page information leaflet about natalizumab-associated PML and an evaluation sheet. RESULTS: After reading the information, patients were significantly more likely than physicians to intend continuation of natalizumab treatment and willing to accept higher risks of PML: 49% of physicians would stop treatment at a PML risk of 2:10,000 or lower, while only 17% of patients would do so (p < 0.001). This difference could not be explained by risk calculation abilities or lack of understanding. Both groups overestimated natalizumab treatment effects. CONCLUSION: Patients had a significantly worse perception of multiple sclerosis as a malignant disease. We conclude that patients were willing to accept a higher risk of PML than neurologists. Coherent with their perception of risks and benefits, patients were also more willing to continue treatment. Open information about treatment-related risks is appreciated and might support shared decision making.

Training of patient and consumer representatives in the basic competencies of evidence-based medicine: a feasibility study.

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.