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多发性硬化症行为测试:技术研发与可用性评估。

Multiple Sclerosis Performance Test: Technical Development and Usability.

机构信息

FORMA Therapeutics, Watertown, MA, USA.

Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.

出版信息

Adv Ther. 2019 Jul;36(7):1741-1755. doi: 10.1007/s12325-019-00958-x. Epub 2019 May 3.

Abstract

INTRODUCTION

In the clinic, the assessment of patients with multiple sclerosis (MS) is typically qualitative and non-standardized.

OBJECTIVES

To describe the MS Performance Test (MSPT), an iPad Air 2 (Apple, Cupertino, CA, USA)-based neurological assessment platform allowing patients to input relevant information without the aid of a medical technician, creating a longitudinal, clinically meaningful, digital medical record. To report results from human factor (HF) and usability studies, and the initial large-scale implementation in a practice setting.

METHODS

The HF study examined use-error patterns in small groups of MS patients and healthy controls (n = 14), the usability study assessed the effectiveness of patient interaction with the tool by patients with a range of MS disability (n = 60) in a clinical setting, and the implementation study deployed the MSPT across a diverse population of patients (n = 1000) in a large MS center for routine clinical care.

RESULTS

MSPT assessments were completed by all users in the HF study; minor changes to design were recommended. In the usability study, 73% of patients with MS completed the MSPT, with an average administration time of 32 min; 85% described their experience with the tool as satisfactory. In the initial implementation for routine care, 84% of patients with MS completed the MSPT, with an average administration time of 28 min.

CONCLUSION

Patients with MS with varying disability levels completed the MSPT with minimal or no supervision, resulting in comprehensive, efficient, standardized, quantitative, clinically meaningful data collection as part of routine medical care, thus allowing for large-scale, real-world evidence generation.

FUNDING

Biogen.

TRIAL REGISTRATION

NCT02664324.

摘要

简介

在临床中,多发性硬化症(MS)患者的评估通常是定性的、非标准化的。

目的

描述基于 iPad Air 2(Apple,Cupertino,CA,USA)的 MS 性能测试(MSPT),该平台允许患者在无需医疗技术人员协助的情况下输入相关信息,创建一个纵向的、具有临床意义的数字化医疗记录。报告人体因素(HF)和可用性研究的结果,并在实践环境中首次进行大规模实施。

方法

HF 研究在小样本的 MS 患者和健康对照组(n=14)中研究了使用错误模式;可用性研究在临床环境中评估了具有不同 MS 残疾程度的患者(n=60)与该工具的交互效果;实施研究则在大型 MS 中心的多样化患者群体(n=1000)中部署了 MSPT,以用于常规临床护理。

结果

HF 研究中的所有用户都完成了 MSPT 评估;建议对设计进行一些小的更改。在可用性研究中,73%的 MS 患者完成了 MSPT,平均管理时间为 32 分钟;85%的患者对该工具的体验表示满意。在最初用于常规护理的实施中,84%的 MS 患者完成了 MSPT,平均管理时间为 28 分钟。

结论

具有不同残疾程度的 MS 患者在最小或无需监督的情况下完成了 MSPT,从而在常规医疗护理中实现了全面、高效、标准化、定量的、具有临床意义的数据收集,从而能够进行大规模的真实世界证据生成。

资金来源

Biogen。

临床试验注册号

NCT02664324。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c34e/6824297/5ee57879e1bf/12325_2019_958_Fig1_HTML.jpg

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