Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Barabasch A

PROVIDER: S-EPMC7788927 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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.

Barabasch Anna A Riemann-Lorenz Karin K Kofahl Christopher C Scheiderbauer Jutta J Eklund Desiree D Kleiter Ingo I Kasper Jürgen J Köpke Sascha S Lezius Susanne S Zapf Antonia A Rahn Anne Christin AC Heesen Christoph C

Pilot and feasibility studies 20210107 1

<h4>Background</h4>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 co ...[more]

PMID: 33413658

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Project description:(1) Objective: Atopic dermatitis (AD) is a recurring skin disease that affects children's daily activities and sleep quality. Due to the limitations of children's understanding and ability to express themselves, shared decision making (SDM) is often made by guardians, which thus affects the acceptance and effectiveness of children's treatments. Previous studies have demonstrated that involving both children and parents in decision making may help improve treatment outcomes; thus, we designed a multimedia mixed reality (MR) interactive game of SDM for children with moderate to severe AD. (2) Methods: Research participants included 6-18-year-old patients with moderate to severe AD. This research consisted of the following steps: designing SDM; character setting and visual design; performing games; system modification and optimization; screen editing and dubbing; and user testing and questionnaires by the System Usability Scale (SUS). (3) Results: We completed the SDM design for children with moderate to severe AD. Four different treatments were biologics, oral immune-modulating drugs, phototherapy, and wet wrap. An animated PowerPoint slide showed the AD apple rolling around before treatments and the AD apple sleeping soundly after treatments. Instructions with video teaching for the four different treatments were played, and then, the MR was turned on so that the patients could help the AD apple in the metaverse to undergo these four treatments. A total of 12 moderate to severe AD patients and six control patients used the game, all aged between six and eighteen years old, with an average SUS score of 81.0 and a standard error of 2.1 points. Adjective ratings yielded a rating between good and excellent. The game showed acceptable usability. We found no statistically significant differences in SUS scores between patients with and without moderate to severe AD or between boys and girls nor significant associations between SUS and age or severity. The analysis identified that the two items with the lowest SUS scores were "I think that I would need the support of a technical person to be able to use this product" and "I needed to learn a lot of things before I could get going with this product". Both of these comments show the limitations of this game. (4) Conclusions: Overall, this study provides the first MR SDM game that has passed the SUS and can be used as an aid in clinical SDM.

Project description:BackgroundA variety of management options (e.g., disease-modifying therapy, lifestyle interventions, rehabilitation) are available for persons with relapsing-remitting multiple sclerosis (MS). Besides coping with the diagnosis, persons with MS have to make complex decisions, e.g., regarding disease-modifying therapies. In addition to factual information, reports of patient experiences may support other patients in their decision-making. Therefore, we developed a website presenting patient experiences illustrated by video, audio and text files. This study aimed to test the acceptability and usability of a website with patient experiences with MS.MethodsA mixed-methods approach was applied. A total of 69 participants visited the German "Patient Experiences with MS (PExMS)" website and among them, 50 persons with MS and 6 experts completed an online survey. In total, 18 participants took part in telephone interviews or focus groups. Data from the survey were analysed using descriptive statistics. Qualitative data were analysed using thematic analysis.ResultsBoth quantitative and qualitative responses suggest that the PExMS website was viewed positively by patients and experts. 94% of persons with MS agreed that the information was comprehensible and reliable. 54% felt encouraged to share their health problems with others after having studied the website. 74% claimed to use the website if they had to make a decision regarding their health. Qualitative responses deduced from the website fell into 5 key themes: (1) web design, appearance, and functionality, (2) content, (3) usability, (4) satisfaction, and (5) loyalty. The search for persons of similar age and with comparable experiences was a major driving force to navigate the website. The material on the website was perceived as diverse, covering both positive and negative experiences in daily living with MS. All participants greatly appreciated having access to other people's experiences online and judged the material on the website as particularly helpful in decision-making for disease-modifying therapies.ConclusionsThe findings suggest that the PExMS website might have the potential to be a useful source of audio-visual information for persons with MS. Given the lack of websites available to patients with experiential information, health care professionals may be encouraged to routinely inform patients about this website at regular appointments.

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Project description:IntroductionDecision analysis is a quantitative approach to decision making that could bridge the gap between decisions based solely on evidence and the unique values and preferences of individual patients, a feature especially important when existing evidence cannot support clear recommendations and there is a close balance between harms and benefits for the treatments options under consideration. Low molecular weight heparin (LMWH) for the prevention of venous thromboembolism (VTE) during pregnancy represents one such situation. The objective of this paper is to describe the rationale and methodology of a pilot study that will explore the application of decision analysis to a shared decision-making process involving prophylactic LMWH for pregnant women or those considering pregnancy who have experienced a VTE.Methods and analysisWe will conduct an international, mixed methods, explanatory, sequential study, including quantitative data collection and analysis followed by qualitative data collection and analysis. In step I, we will ask women who are pregnant or considering pregnancy and have experienced VTE to participate in a shared decision-making intervention for prophylactic LMWH. The intervention consists of three components: a direct choice exercise, a values elicitation exercise and a personalised decision analysis. After administration of the intervention, we will ask women to make a treatment decision and measure decisional conflict, self-efficacy and satisfaction. In step II, which follows the analysis of quantitative data, we will use the results to inform the qualitative interview. Step III will be a qualitative descriptive study that explores participants' experiences and perceptions of the intervention. In step IV, we will integrate findings from the qualitative and quantitative analyses to obtain meta-inferences.Ethics and disseminationSite-specific ethics boards have approved the study. All participants will provide informed consent. The research team will take an integrated approach to knowledge translation.

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Dataset Information

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

Methods

Discussion

Trial registration

Publications

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.

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