Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial

Rahn, Anne Christin; Backhus, Imke; Fuest, Franz; Riemann-Lorenz, Karin; Köpke, Sascha; Roemer, Adrianus van de; Mühlhauser, Ingrid; Heesen, Christoph

doi:10.1186/s12911-016-0362-8

Cited by 9 publications

(6 citation statements)

References 34 publications

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“…The authors recommend for a two-armed pilot RCT a total sample size of 55, which would minimise the overall sample size for the main RCT for small to medium standardised effect sizes [52][53][54]. Additionally, pilot RCTs on decision support tools in MS showed comparable sample sizes [31,55].…”

Section: Sample Sizementioning

confidence: 99%

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

Riemann-Lorenz

Kofahl

et al. 2021

Pilot Feasibility Stud

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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

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Section: Sample Sizementioning

confidence: 99%

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

Riemann-Lorenz

Kofahl

et al. 2021

Pilot Feasibility Stud

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“…Five studies were on health literacy. [60][61][62][63][64] In an RCT, Kasper et al 60 evaluated newly developed bar graphs for persons with MS risk communication showing that they were understood as well as standard pictographs. Reen et al 61 showed improved understanding in persons with MS when treatment effects were communicated in absolute terms compared with relative terms and numbers needed to treat/harm.…”

Section: Health Literacymentioning

confidence: 99%

“…Adding baseline information on clinical trials significantly improved understanding. Rahn et al 63 developed and pilot tested different types of information materials exemplifying confidence intervals to persons with RRMS. Patient information materials were considered acceptable.…”

Section: Health Literacymentioning

confidence: 99%

“I Will Respect the Autonomy of My Patient”

Rahn

Solari

Beckerman

et al. 2020

International Journal of MS Care

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CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: 1) Identify the extent, range, and nature of the recent evidence on shared decision making and patient autonomy in MS. 2) Examine the limitations of the current available evidence and resulting research/knowledge gaps. Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by the Consortium of Multiple Sclerosis Centers (CMSC) and Delaware Media Group. The CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physician Credit: The CMSC designates this journal-based activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Credit: The CMSC designates this enduring material for 1.0 contact hour (none in the area of pharmacology). Disclosures: Francois Bethoux, MD, Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has disclosed relationships with Springer Publishing (royalty), Qr8 (receipt of intellectual property rights/patent holder), Biogen (receipt of intellectual property rights/patent holder, speakers’ bureau), GW Pharma (consulting fee), MedRhythms (consulting fee, contracted research), Genentech (consulting fee), Helius (consulting fee), and Adamas Pharmaceuticals (contracted research). Laurie Scudder, DNP, NP, has served as Reviewer for this activity. She has disclosed no relevant financial relationships. Anne Christin Rahn, PhD, has disclosed no relevant financial relationships. Alessandra Solari, MD, has disclosed relationships with Biogen, Merck Serono, Novartis, Almirall, and Excemed (personal fees for speaker honoraria). Heleen Beckerman, PhD, has disclosed no relevant financial relationships. Richard Nicholas, PhD, has disclosed relationships with Biogen, Roche, and Novartis (consulting fee) and Novartis, Biogen, Roche, and Sanofi (principal investigator on MS trials). David Wilkie, PhD, has disclosed no relevant financial relationships. Christoph Heesen, MD, has disclosed no relevant financial relationships. Andrea Giordano, MSc, has disclosed no relevant financial relationships. The peer reviewer for IJMSC has disclosed relationships with Biogen, Novartis, Roche, and Sanofi Genzyme (consulting fee, speakers’ bureau, contracted research); EMD Serono (consulting fee, speakers’ bureau); and Alexion and Teva Neuroscience (consulting fee). The staff at IJMSC, CMSC, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Financial relationships may have changed in the interval between listing these disclosures and publication of the article. Method of Participation: Release Date: December 1, 2020 Valid for Credit Through: December 1, 2021 In order to receive CME/CNE credit, participants must: 1) Review the continuing education information, including learning objectives and author disclosures.2) Study the educational content.3) Complete the post-test and evaluation, which are available at http://www.cmscscholar.org Statements of Credit are awarded upon successful completion of the evaluation and the post-test with a passing score of >70%. The post-test may be retaken if necessary. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. The CMSC and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the CMSC or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health care professionals without first evaluating their patients’ conditions, considering possible contraindications or risks, reviewing any applicable manufacturer’s product information, and comparing any therapeutic approach with the recommendations of other authorities.

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“…(54)(55)(56) Additionally, pilot RCTs on decision support tools in MS showed comparable sample sizes. (32,57) Recruitment Participants will be recruited by 2-3 neurological practices, clinics or rehabilitation centres in Germany.…”

Section: Sample Sizementioning

confidence: 99%

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

Riemann-Lorenz

Kofahl

et al. 2020

Preprint

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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 a four 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-members 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 (Identifier: NCT04236544).

show abstract

Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial

Cited by 9 publications

References 34 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

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

“I Will Respect the Autonomy of My Patient”

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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