Altmann Patrick, Hinterberger Werner, Leutmezer Fritz, Ponleitner Markus, Monschein Tobias, Zrzavy Tobias, Zulehner Gudrun, Kornek Barbara, Lanzenberger Rupert, Berek Klaus, Rommer Paulus Stefan, Berger Thomas, Bsteh Gabriel
Department of Neurology, Medical University of Vienna, Vienna, Austria.
CAKE Communications, Vienna, Austria.
JMIR Res Protoc. 2021 May 7;10(5):e25011. doi: 10.2196/25011.
Treatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes. These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient-reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression, and sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS and their health-related quality of life. However, the assessment of PROs consumes resources, including time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed.
We aim to provide a rationale and pilot study protocol for a mobile health (mHealth) solution named "haMSter" that allows for remote monitoring of PROs in people with MS.
The core function of haMSter is to provide three scientifically validated PRO questionnaires relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit.
The pilot study is currently ongoing and will evaluate adherence to this mHealth solution in 50 patients over a period of 6 months. Results from the haMSter pilot study are expected in 2021.
haMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and ultimately saves time.
ClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25011.
多发性硬化症（MS）患者的治疗和监测决策通常基于临床医生报告的结果。这些结果反映了身体和影像学上的疾病活动情况，是临床试验中最相关的终点指标。在过去几年中，评估所谓患者报告结果（PROs）的研究数量一直在增加。PROs是患者关于自身健康认知的报告。它们通常通过问卷调查获得，旨在量化疲劳、抑郁和性功能障碍等症状。PROs的出现为理解MS患者疾病的个体影响及其健康相关生活质量做出了巨大贡献。然而，PROs的评估需要消耗资源，包括时间和人力。因此，需要有用的方法来方便地将PROs引入临床实践。
我们旨在为一种名为“haMSter”的移动健康（mHealth）解决方案提供理论依据和初步研究方案，该方案可对MS患者的PROs进行远程监测。
haMSter的核心功能是为患者提供三份经科学验证的与MS相关的PRO问卷，让患者每月在家填写一次。从而实现对PROs的纵向和远程记录。一种评分算法以图形方式绘制PRO分数随时间的变化，并在下一次就诊时提供这些分数。
初步研究目前正在进行，将在6个月内评估50名患者对这种mHealth解决方案的依从性。haMSter初步研究的结果预计在2021年得出。
haMSter是一种基于mHealth的新型PRO研究解决方案，可能是实现将PROs整合到临床实践能力的第一步。这使得在监测就诊时能够采用更以问题为导向的方法，满足患者需求并最终节省时间。
ClinicalTrials.gov NCT04555863；https://clinicaltrials.gov/ct2/show/NCT04555863。
国际注册报告识别码（IRRID）：DERR1-10.2196/25011。
