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Objective: To evaluate a nurse-led decision coaching programme aiming to redistribute health professionals' tasks to support immunotherapy decision-making in people with multiple sclerosis (MS)., Methods: Cluster-randomised controlled trial with an accompanying mixed methods process evaluation (2014 - 2018). We planned to recruit 300 people with clinically isolated syndrome or relapsing-remitting MS facing immunotherapy decisions in 15 clusters across Germany. Participants in the intervention clusters received up to three decision coaching sessions by a trained nurse and access to an evidence-based online information platform. In the control clusters, participants also had access to the information platform. The primary outcome was informed choice after six months, defined as good risk knowledge and congruent attitude and uptake., Results: Twelve nurses from eight clusters participated in the decision coaching training. Due to insufficient recruitment, the randomised controlled trial was terminated prematurely with 125 participants (n = 42 intervention clusters, n = 83 control clusters). We found a non-significant difference between groups for informed choice favouring decision coaching: odds ratio 1.64 (95% CI 0.49-5.53)., Conclusions: Results indicate that decision coaching might facilitate informed decision-making in MS compared to providing patient information alone., Practice Implications: Barriers have to be overcome to achieve structural change and successful implementation., Competing Interests: Declaration of Competing Interest AR, EV, SK, GA, KL and JP declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. CH declares the following financial interests/personal relationships which may be considered as potential competing interests: CH has received research grants from Merck, Novartis and Roche., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: To evaluate patient information materials on confidence intervals (CIs) in multiple sclerosis to be used with patient decision aids., Methods: Web-based randomised controlled parallel group trial with four study arms. Participants were equally allocated to one of three versions of audio-visual patient information or to a standard written information (arm IV). In the short version (arm III), CIs were explained without using an example, in the other two versions examples were used (arm I and arm II). The examples are based on an apple farmer who wants to estimate the average weight of his apples (arm I) and to test a treatment against worms (arm II). Primary endpoint was comprehension of CIs, assessed with a six-item multiple-choice questionnaire., Results: 855 of 1068 (80 %) randomised participants completed the survey (71 % arm I, 73 % arm II, 87 % arm III, 90 % arm IV). The median of correctly answered questions on CIs was 4 out of 6 questions in arms I and II and 5 out of 6 questions in arm III. Compared to the standard information (arm IV), all the other arms scored better on the comprehension questionnaire (ANOVA, p ≤ 0.003)., Conclusions: Information about CIs can be presented comprehensibly. High scores and a high rate of completers indicate that the short version is the favourable one., Practice Implications: Information materials on CIs should be used alongside absolute risk reductions in patient decision aids to enhance the interpretation of study results., Competing Interests: Declaration of Competing Interest The authors report no declarations of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: To critically appraise the recognition of methodological challenges in evaluation studies on assessment tools and nurses' clinical judgment on fall risk in older people and suggest how to reduce respective research waste., Study Design and Setting: Opinion article and narrative review covering systematic reviews on studies assessing diagnostic accuracy and impact of assessment tools and/or nurses' clinical judgment., Results: Eighteen reviews published in the last 15 years were analyzed. Only one reflects potentially important factors threatening the accuracy of assessments using delayed verification with fall events as reference after a certain period of time, that is, natural course, preventive measures, and treatment paradox where accurate assessment leads to prevention of falls, that is, influencing the reference standard and falsely indicating low diagnostic accuracy. In addition, only one review mentions randomized controlled trials as appropriate study design for the investigation of the impact of fall risk assessment tools on patient-important outcomes. Until now, only one randomized controlled trial dealing with this question has been performed showing no effect on falls and injuries. Instead of investigating the diagnostic accuracy of fall assessment tools, the focus of future research should be on the effectiveness of the implementation of fall assessment tools at reducing falls and injuries., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: A shared decision-making approach is suggested for multiple sclerosis (MS) patients. To properly evaluate benefits and risks of different treatment options accordingly, MS patients require sufficient numeracy - the ability to understand quantitative information. It is unknown whether MS affects numeracy. Therefore, we investigated whether patients' numeracy was impaired compared to a probabilistic national sample., Methods: As part of the larger prospective, observational, multicenter study PERCEPT, we assessed numeracy for a clinical study sample of German MS patients (N=725) with a standard test and compared them to a German probabilistic sample (N=1001), controlling for age, sex, and education. Within patients, we assessed whether disease variables (disease duration, disability, annual relapse rate, cognitive impairment) predicted numeracy beyond these demographics., Results: MS patients showed a comparable level of numeracy as the probabilistic national sample (68.9% vs. 68.5% correct answers, P=0.831). In both samples, numeracy was higher for men and the highly educated. Disease variables did not predict numeracy beyond demographics within patients, and predictability was generally low., Conclusion: This sample of MS patients understood quantitative information on the same level as the general population., Practice Implications: There is no reason to withhold quantitative information from MS patients., (Copyright © 2017 Elsevier B.V. All rights reserved.)

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., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Patient autonomy has been increasingly acknowledged as prerequisite for successful medical decision making in Western countries. In medical decisions with a need to involve a health professional, patient autonomy becomes apparent in the extent of patients' participation in the communication as described in the concept of shared decision making. Patient autonomy can be derived from different perspectives or goals and the focus of evaluation approaches may vary accordingly. Multiple sclerosis (MS) is a paradigmatic disease to study patient autonomy mainly because MS patients are highly disease competent and due to ambiguous evidence on many aspects of disease-related medical decision making. This review gives an overview on measurement issues in studying decision making in MS, categorized according to prerequisites, process measures and outcomes of patient autonomy. As relevant prerequisites role preferences, risk attribution, risk tolerance, and risk knowledge are discussed. Regarding processes, we distinguish intra-psychic and interpersonal aspects. Intra-psychic processes are elucidated using the theory of planned behavior, which guided development of a 30-item scale to capture decisions about immunotherapy. Moreover, a theory of uncertainty management has been created resulting in the development of a corresponding measurement concept. Interpersonal processes evolving between physician and patient can be thoroughly analyzed from different perspectives by use of the newly developed comprehensive MAPPIN'SDM inventory. Concerning outcomes, besides health related outcomes, we discuss match of preferred roles during the decision encounters (preference match), decisional conflict as well as an application of the multidimensional measure of informed choice to decisions of MS patients. These approaches provide an overview on patient-inherent and interpersonal factors and processes modulating medical decision making and health behavior in MS and beyond., (Copyright © 2013. Published by Elsevier B.V.)

Background: Despite increasing knowledge about the limited effectiveness and severe adverse effects, the prescription rate of psychotropic medications in frail elderly persons remains high. Prescriptions are mainly made to control behavioral and psychological symptoms of dementia, although factors associated with prescriptions are rarely reported. However, such information is a prerequisite to develop intervention programs aiming to safely reduce psychotropic medication in nursing home residents., Methods: We report the comparison of cross-sectional data of psychotropic medication prescription rates from 3 large studies including nursing home residents in Germany and Austria. We aimed to compare the prevalence of (1) psychotropic medication, (2) different classes of psychotropic medication, (3) psychotropic medication administered for bedtime use, and (4) associations between prescription of psychotropics and institutional and residents' characteristics. Confidence intervals of prevalences and multiple logistic regression analyses were adjusted for cluster correlation., Results: Data from 5336 residents in 136 long term care facilities were included. In Austria, 74.6% (95% CI 72.0-77.2%) of all residents had a prescription of at least one psychotropic medication compared to Germany with about 51.8% (95% CI 48.3-55.2%) and 52.4% (95% CI 48.7-56.1%). Of all antipsychotics, 66% (Austria) and 47% (Germany) were prescribed for bedtime use. Most prescriptions were conventional, low-potency antipsychotics. In all 3 studies, there was no statistically significant association between psychotropic medication prescription and nursing home characteristics. On the level of residents, consistent positive associations were found for higher level of care dependency and permanent restlessness. Consistent negative associations were found for older age and male gender., Conclusion: Frequency of psychotropic and especially antipsychotic medication is substantial in nursing home residents in Germany and Austria. The high number of prescriptions is likely to be an indicator for a perceived or actual lack of strategies to handle behavioral and psychological symptoms of dementia., (Copyright © 2012 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.)

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

For patients with multiple sclerosis (MS) involvement in treatment decisions becomes ever more imperative. Recently new therapeutic options have become available for the treatment of MS and more will be licensed in the near future. Although more efficacious and easier to administer, the new drugs pose increased risks of severe side effects. Also, new diagnostic criteria lead to more and earlier MS diagnoses. Facing increasingly complex decisions, patients need up-to-date evidence-based information and decision support systems in order to make informed decision together with physicians based on their autonomy preferences. This article summarizes recently terminated and ongoing trials on MS patient education and decision aids conducted by the authors' study groups. Programs on relapse management, immunotherapy, and for patients with suspected and early MS have been developed and evaluated in randomized controlled clinical trials. It could be shown that the programs successfully increase knowledge and allow patients to make informed decisions based on their preferences. For the near future, we aim to develop a modular program for all relevant decisions in MS to increase patients' self-management and empower patients to develop their individual approach with the disease. Faced by a disease with many uncertainties, this should enhance patients' sense of control. Still, it remains a challenge to adequately assess decision quality. Therefore, a study in six European and one Australian centers will start soon aiming to establish adequate tools to assess decision-making quality., (Copyright © 2010 Elsevier B.V. All rights reserved.)

Patients and health authorities increasingly claim active roles in health care decision making processes. As immune therapies in MS are partially effective MS is a prototypic condition for a shared decision making process. The treatment of acute relapses and the initiation, change or withdrawal of so called disease-modifying treatments are key decisions in MS management. We developed two decision aids following the phased approach of the framework of increasing evidence for complex interventions for these key decisions. In prestudies we found that 80% of MS patients demand autonomous roles in treatment decisions which contrasts with a poor knowledge of risks. On the other hand MS patients are not disturbed by evidence-based, balanced complex information. MS patients do understand this kind of information and are able to transfer new abilities to other situations. Currently we study the effects of a 4-hour education programme on relapse management versus an information leaflet in controls in 150 MS patients. In a second trial with n=298 MS patients we study the effects of an evidence-based patient information on immunotherapy on decisional role preference and performance in the patient physician encounter. Results in early 2007 will show to which extent patient education with a focus on evidence-based patient information influences participation in the decision making process.

Objective: This study analysis the comprehension and emotional responses of people suffering from multiple sclerosis when provided with an evidence-based information module. It is a core module of a comprehensive decision aid about immunotherapy. The core module is designed to enable patients to process scientific uncertainty without adverse effects. It considers existing standards for risk communication and presentation of data., Methods: Using a mailing approach we investigated 169 patients with differing courses of disease in a before-after design. Items addressed the competence in processing relative and absolute risk information and patients' emotional response to the tool, comprising grade of familiarity with the information, understanding, relevance, emotional arousal, and certainty., Results: Overall, numeracy improved (p < 0.001), although 99 of 169 patients did not complete the numeracy task correctly. Understanding depended on the relevance related to the course of disease. A moderate level of uncertainty was induced. No adverse emotional responses could be shown, neither in those who did comprehend the information, nor in those who did not develop numeracy skills., Conclusion: In conclusion, the tool supports people suffering from multiple sclerosis to process evidence-based medical information and scientific uncertainty without burdening them emotionally., Practice Implications: This study is an example for the documentation of an important step in the development process of a complex intervention.