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一款智能手机应用程序用于监测多发性硬化症患者报告结局的可行性:haMSter干预试验。

Feasibility of a smartphone app to monitor patient reported outcomes in multiple sclerosis: The haMSter interventional trial.

作者信息

Altmann Patrick, Ponleitner Markus, Monschein Tobias, Krajnc Nik, Zulehner Gudrun, Zrzavy Tobias, Leutmezer Fritz, Rommer Paulus Stefan, Kornek Barbara, Berger Thomas, Bsteh Gabriel

机构信息

Department of Neurology, Medical University of Vienna, Vienna, Austria.

出版信息

Digit Health. 2022 Nov 4;8:20552076221135387. doi: 10.1177/20552076221135387. eCollection 2022 Jan-Dec.

Abstract

BACKGROUND

Monitoring of patient outcomes in multiple sclerosis (MS) is fundamental for individualized treatment decisions. So far, these decisions have been motivated by conventional outcomes, i.e., relapses or clinical disability supported by radiological disease activity. Complementing this concept, patient reported outcomes (PROs) assess individual health-related quality of life, among other constructs. Their inclusion in clinical routine, however, has been challenging as assessing them requires resources of time and personnel.

OBJECTIVE

This interventional feasibility study investigated the haMSter app, a mobile health solution for remote and longitudinal monitoring of PROs in a sample of people with MS (pwMS).

METHODS

The core feature of haMSter is the provision of three PRO questionnaires relevant to MS (anxiety/depression, MS-related quality of life, and fatigue) that patients can fill out once a month. For this feasibility trial, we offered 50 volunteers to use the haMSter app over six months and to take part in a haMSter study visit. This consultation concluded the study and participants had the opportunity to discuss their graphically plotted PRO results with their treating physician.

RESULTS

The main outcome was overall patient adherence to monthly completion of the PRO questionnaires, which remained high up to 4 months (98%) and dropped over time (months 5: 83% and 6: 66%). Exploratory outcomes included patient satisfaction as estimated on the Telemedicine Perception Questionnaire (TMPQ, 17-85 points). The mean TMPQ score was 64 (95%CI: 62-66) points, indicating a high degree of approval. Ancillary tests included subgroup analyses of participants with particularly high or low satisfaction and upper extremity disability as a potential obstacle to utility or acceptance. We found no distinct characteristics separating participants with high or low satisfaction.

CONCLUSIONS

In this first feasibility trial, the haMSter app for longitudinal PRO monitoring was well received in terms of adherence and satisfaction. NCT04555863.

摘要

背景

监测多发性硬化症(MS)患者的预后对于个体化治疗决策至关重要。到目前为止,这些决策一直受传统预后指标的驱动,即由放射学疾病活动支持的复发或临床残疾。作为这一概念的补充,患者报告结局(PROs)评估个体与健康相关的生活质量等内容。然而,将其纳入临床常规操作具有挑战性,因为评估这些结局需要时间和人力。

目的

这项干预性可行性研究调查了haMSter应用程序,这是一种用于对多发性硬化症患者样本进行远程和长期PROs监测的移动健康解决方案。

方法

haMSter的核心功能是提供三份与MS相关的PRO问卷(焦虑/抑郁、与MS相关的生活质量和疲劳),患者每月可填写一次。在这项可行性试验中,我们招募了50名志愿者使用haMSter应用程序六个月,并参加一次haMSter研究访视。这次咨询结束了研究,参与者有机会与他们的主治医生讨论以图表形式呈现的PRO结果。

结果

主要结局是患者总体上每月完成PRO问卷的依从性,在长达4个月的时间里保持在较高水平(98%),但随着时间推移有所下降(第5个月:83%,第6个月:66%)。探索性结局包括根据远程医疗感知问卷(TMPQ,17 - 85分)评估的患者满意度。TMPQ的平均得分是64分(95%CI:62 - 66),表明认可度较高。辅助测试包括对满意度特别高或低的参与者进行亚组分析,以及将上肢残疾作为实用性或可接受性的潜在障碍进行分析。我们没有发现区分高满意度和低满意度参与者的明显特征。

结论

在这项首次可行性试验中,用于长期PRO监测的haMSter应用程序在依从性和满意度方面受到好评。NCT04555863。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/041e/9638697/2510ba560df6/10.1177_20552076221135387-fig5.jpg

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