Barabasch Anna, Riemann-Lorenz Karin, Kofahl Christopher, Scheiderbauer Jutta, Eklund Desiree, Kleiter Ingo, Kasper Jürgen, Köpke Sascha, Lezius Susanne, Zapf Antonia, Rahn Anne Christin, Heesen Christoph
Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Institute of Medical Sociology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Pilot Feasibility Stud. 2021 Jan 7;7(1):16. doi: 10.1186/s40814-020-00749-0.
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.
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.
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.
ClinicalTrials.gov, NCT04236544.
对于复发缓解型多发性硬化症（RRMS）患者，有多种管理方案可供选择（如免疫疗法、生活方式干预和康复治疗）。除了应对疾病诊断外，MS患者（pwMS）还必须做出复杂的决策，比如决定是否采用免疫疗法。除了事实信息外，患者经历报告（PEx）可能有助于患者进行决策。PEx在决策中的附加价值尚不清楚，且对照研究很少。因此，需要系统的方法来开发和分析PEx。由于德国尚无经过评估的MS患者经历报告，我们目前正在创建一个网站，该网站将按主题展示PEx，并配有视频、音频和文本文件进行说明。我们旨在确定使用PEx进行干预的可行性，并评估PEx作为循证信息的补充，是否有助于pwMS在免疫治疗决策过程中做出决策。
本项目将遵循医学研究理事会关于复杂干预措施开发和评估的框架。在开发一个包含PEx的网站后，将在2 - 3个MS中心、诊所或康复中心进行一项随机对照试验（pilot RCT），纳入55名pwMS患者，并进行过程评估。考虑采用免疫疗法的RRMS诊断患者符合入选条件。主要结局是决策自我效能感。次要结局包括决策准备情况、决策冲突情况、风险知识、积极参与的信心、情感预测、社会支持以及自我报告的电子健康对其用户的影响。参与者将被随机分配到以下两组之一：（i）干预组，可在4周内访问循证患者信息资源以及作为辅助的PExMS网站；（ii）对照组，仅可访问循证信息。一个由6名成员组成的咨询小组，包括pwMS代表、研究人员和神经科医生，将全程参与该项目并指导这项pilot RCT。
该干预措施采用系统方法开发，在患者积极参与下创建，并经过专家咨询小组的严格评估。该研究具有创新性，因为它为在循证患者信息背景下使用PEx这一有争议的证据做出了贡献。
ClinicalTrials.gov，NCT04236544。
