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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

MAPPinfo, mapping quality of health information: study protocol for a validation study of an assessment instrument.

INTRODUCTION: Health information is a prerequisite of informed decision-making. Criteria for development, content and presentation have recently been published in a corresponding guideline. Within a systematic search, 27 relevant checklists were identified, none of them, however, complying with the guideline or providing reasonably operationalised measurement items. Therefore, a draft of a checklist with 19 criteria was drafted. The current study aims at developing and validating this measure of quality. METHODS AND ANALYSIS: The validation design consists of five single studies to be conducted at the University of Halle-Wittenberg/Germany and Graz/Austria. (1) Achieving content validity through expert reviews of the first draft, (2) achieving feasibility using 'think aloud' in piloting with untrained users, (3) pretesting the instrument applied to health information materials without use of secondary sources: determining inter-rater reliability and criterion validity, (4) determining construct validity using information on proceedings and methods in the development process provided by the developers and (5) determining divergent validity in comparison with the Ensuring Quality Information for Patients (EQUIP) (expanded) Scale. The substudies will use varying samples of experts, students and developers and will apply the instrument to materials of various domains. Sample sizes will be adjusted to the particular research designs and questions. Analyses will employ qualitative methods, such as content analyses and discourse within the expert panel, and correlation-based methods both for determining inter-rater reliability and validity. ETHICS AND DISSEMINATION: The project is approved by the ethics committee of the Martin Luther University Halle-Wittenberg (approval number: 2019 115). Results will be published, and the instrument made accessible on public health platforms. It is meant to become a certification standard. MAPPinfo can be used as a screening instrument without training or secondary sources. Although developed in the German language, the instrument will be applicable also in other languages. TRIAL REGISTRATION NUMBER: AsPredected22546; date of registration: 24 July 2019. PROTOCOL VERSION: July 2020.

Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial.

BACKGROUND: The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline addresses providers of health information and its goal is to improve the quality of health information. In addition, we explored the competences of providers of health information and developed a training programme. The aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expected the intervention to improve the quality of health information in comparison to the provision of the guideline on its own. METHODS/DESIGN: The trial uses a superiority randomised control group design with 10 months' follow-up. Twenty-six providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline and training programme) with usual care (a publicly available guideline). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline's recommendations. Each provider will prepare a single health information item informing a health-related decision on a topic freely chosen before randomisation. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) Checklist. An accompanying process evaluation will then be conducted. DISCUSSION: The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN96941060. Registered on 7 March 2019.

Ready for shared decision making: Pretesting a training module for health professionals on sharing decisions with their patients.

INTRODUCTION: While shared decision-making (SDM) training programmes for health professionals have been developed in several countries, few have been evaluated. In Norway, a comprehensive curriculum, "klar for samvalg" (ready for SDM), for interprofessional health-care teams was created using generic didactic methods and guidance to tailor training to various contexts. The programmes adapted didactic methods from an evidence-based German training programmes (doktormitSDM). The overall aim was to evaluate two particular SDM modules on facilitating SDM implementation into clinical practice. METHOD: A descriptive mixed methods study using questionnaires and a focus group guided by the Medical Research Council Complex Interventions Framework. The training was provided as two different applications (module AB [introduction and SDM-basics] and module ABC [introduction, SDM-basics and interactive training]) with differing learning objectives, extent of interactivity, and duration (1 vs 2 hours). Groups of participants were recruited consecutively based on requests for health professional SDM training in university/college- and hospital-settings. By a focus group and a self-administered questionnaire comprehensibility, relevance and acceptance were assessed and qualitative feedback collected after the training. Data passed descriptive and content analysis, respectively. Knowledge was assessed twice using five multiple-choice items and analysed using paired t-tests. RESULTS: In 11 (six AB and five ABC) training sessions, 357/429 (296 AB and 133 ABC) eligible nurses, physicians and health professional students with varying clinical backgrounds and previous levels of SDM-knowledge participated. SDM-knowledge increased from 25-78% (range pretest) to 85-95% (range post-test) (P ≤ .001). The training was rated easy to understand, acceptable and relevant for practice. Findings to improve the education suggest higher emphasis on interprofessional teaching methods. CONCLUSIONS: The two SDM training modules met the basic requirements for use in a broader SDM implementation strategy and can even improve knowledge.

Building ground for didactics in a patient decision aid for hip osteoarthritis. Exploring patient-related barriers and facilitators towards shared decision-making.

OBJECTIVE: The aim of the present study was to explore patient-related barriers and facilitators towards shared decision-making (SDM) during routine orthopedic outpatient consultations as part of the process of developing a patient decision aid (PDA) for patients with hip osteoarthritis (OA). METHODS: Consultations comprising nineteen hip OA patients referred to an orthopedic surgeon for treatment decision-making were observed, audio recorded and transcribed. Iterative thematic analysis proceeded, based on a taxonomy of generic patient-related barriers towards SDM grounded in the Theory of Planned Behavior (TPB). RESULTS: A targeted taxonomy provided a structured overview of 26 factors influencing hip OA patients' intention to engage in SDM. Patients' perceived ability to change the agenda of the visit emerged as seminal factor and was added to the generic taxonomy. CONCLUSION: Using a TPB-based taxonomy, we were able to identify and structure generic and context specific SDM barriers. Addressing patients' communication self-efficacy should be included as didactic feature in PDAs. PRACTICE IMPLICATIONS: PDAs for hip OA should be designed for the broad spectrum of decision-making support needs occurring throughout the continuum of the disease. The provided taxonomy may contribute as guidance within implementation strategies that aim to support patients' intentions to engage in SDM.

Shared decision-making in older patients with colorectal or pancreatic cancer: Determinants of patients' and observers' perceptions.

OBJECTIVE: To identify determinants of older patients' perceptions of involvement in decision-making on colorectal (CRC) or pancreatic cancer (PC) treatment, and to compare these with determinants of observers' perceptions. METHODS: Patients' perceptions of involvement were constructed by the 9-item SDM questionnaire (SDM-Q-9) and a Visual Analogue Scale for Involvement (VAS-I). Observers' perceptions were constructed by the OPTION5, OPTION12, and MAPPIN'SDM. Convergent validities were calculated between the patient-sided and observer instruments using Spearman's correlation coefficient. Linear regression was used to identify determinants per criterion. RESULTS: 58 CRC and 22 PC patients were included (mean age: 71.8 ±â€¯5.2 years, 45.0% female). No significant correlations were found between the patient-sided and observer instruments. Patients' impression of involvement was influenced by patient characteristics such as quality of life and satisfaction, while observers' perceptions mainly referred to encounter characteristics such as the mean duration of consultations and general communication skills. CONCLUSION: Due to evident differences in determinants, older CRC/PC patients' and observers' perceptions of involvement should both be collected in evaluating the quality of medical decision-making. PRACTICE IMPLICATIONS: General communication skills should be integrated in SDM training interventions. New SDM measurement tools for patients are needed to sufficiently discriminate between the constructs of involvement and satisfaction.

Efficacy of the doktormitSDM training module in supporting shared decision making - Results from a multicenter double-blind randomized controlled trial.

OBJECTIVE: Training to improve physicians' shared decision making (SDM) competencies with proven effectiveness and efficiency is rare. This study evaluated the brief in situ training module 'doktormitSDM'. METHODS: In a multicenter RCT, each physician recorded four consultations, each of which included a diagnostic or treatment decision (N=152 consultations from seven medical specialties). The doktormitSDM training module included two video-based individual coaching sessions (15min) at the physicians' workplaces, supplemented by a manual and a video tutorial. Primary endpoint was the compound measure SDMmass (based on the MAPPIN'SDM system) which incorporates patient and observer perceptions of involvement and doctor-patient concordance on perceived involvement. RESULTS: SDMmass increased significantly in the intervention group compared to the controls (effect size 0.58; p=0.05; t-test). This effect tended to persist at follow-up (effect size 0.63; p=0.06). Patients' perceived involvement increased accordingly (effect sizes 0.9/.58; p=0.01/.07). CONCLUSION: The doktormitSDM training module is effective and efficient at improving SDM competencies. This is the first SDM training to be evaluated with a compound measure simultaneously considering doctor, patient and observer ratings. PRACTICE IMPLICATIONS: Owing to its very brief form and its reference to the doctors' own consultation videos, the doktormitSDM training module meets clinicians' needs and time constraints.

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.

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

Norway has traditionally high standards regarding civil rights particularly emphasizing equal access to societal resources including health care. This background and the health care system's centralized national organization make it perfectly suited for implementation of shared decision making (SDM). In recent years, great efforts have been made by policy- makers, regional health authorities and not least the patients to facilitate a process of change in health communication culture. SDM is currently even given highest priority in health care strategies on all system levels. SDM has been structurally implemented, e.g. by including corresponding guidance in the standard patient pathways. Moreover, SDM is established as an element of service on the national health portal hosting a constantly increasing number of decision aids. Essentially the Norwegian Knowledge Center for Health Services contributes by searching and providing information for use in decision aids. Implementation is now being rolled out unit by unit for a list of medical problems as a series production of SDM using decision aids and health professional training. Importantly, production of SDM begins and succeeds as a soundly structured communication with both clinical environments and patients. However, as communication training has not been implemented before now, there are no data demonstrating sufficient realization of SDM in current health care. Beyond making reasonable use of scientific achievements, the Norwegian movement's secret of success is the simultaneous commitment of all actors of the health system to a common idea.

Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients.

BACKGROUND: Natalizumab (NAT) is associated with the risk of progressive multifocal leukoencephalopathy (PML). Risk stratification algorithms have been developed, however, without detectable reduction of PML incidence. OBJECTIVE: To evaluate to which extent patients and physicians understand and accept risks associated with NAT treatment. METHODS: Prospective observational cohort study in German MS centers (n=73) among NAT-treated MS patients (n=801) and their neurologists (n=99). Patients included in this study had mean disease duration of 10.2years and a mean NAT treatment duration of 24months. RESULTS: More than 90% of patients and physicians voted for shared decision making or an informed choice decision making approach. Patients and physicians perceived a similar threat from MS as serious disease and both overestimated treatment benefits from NAT based on trial data. Men perceived MS more severe than women and perception of seriousness increased with age in both groups and in patients as well with increasing disability. Although patients evaluated their PML risk higher, their risk acceptance was significantly higher than of their neurologists. Risk stratification knowledge was good among neurologists and significantly lower among patients. CONCLUSION: While patients and physicians seem to have realistic risk perception of PML and knowledge of risk stratification concepts, the threat of MS and the perception of treatment benefits may explain the ongoing high acceptance of PML risk.