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使用ResearchKit智能手机应用程序从真实世界参与者中收集类风湿性关节炎症状:可行性研究。

Using a ResearchKit Smartphone App to Collect Rheumatoid Arthritis Symptoms From Real-World Participants: Feasibility Study.

作者信息

Crouthamel Michelle, Quattrocchi Emilia, Watts Sarah, Wang Sherry, Berry Pamela, Garcia-Gancedo Luis, Hamy Valentin, Williams Rachel E

机构信息

GlaxoSmithKline, Collegeville, PA, United States.

GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom.

出版信息

JMIR Mhealth Uhealth. 2018 Sep 13;6(9):e177. doi: 10.2196/mhealth.9656.

Abstract

BACKGROUND

Using smartphones to enroll, obtain consent, and gather self-reported data from patients has the potential to enhance our understanding of disease burden and quantify physiological impact in the real world. It may also be possible to harness integral smartphone sensors to facilitate remote collection of clinically relevant data.

OBJECTIVE

We conducted the Patient Rheumatoid Arthritis Data From the Real World (PARADE) observational study using a customized ResearchKit app with a bring-your-own-device approach. Our objective was to assess the feasibility of using an entirely digital approach (social media and smartphone app) to conduct a real-world observational study of patients with rheumatoid arthritis.

METHODS

We conducted this observational study using a customized ResearchKit app with a bring-your-own-device approach. To recruit patients, the PARADE app, designed to guide patients through a series of tasks, was publicized via social media platforms and made available for patients in the United States to download from the Apple App Store. We collected patient-reported data, such as medical history, rheumatoid arthritis-related medications (past and present), and a range of patient-reported outcome measures. We included in the assessment a joint-pain map and a novel objective assessment of wrist range of movement, measured by the smartphone-embedded gyroscope and accelerometer.

RESULTS

Within 1 month of recruitment via social media campaigns, 399 participants self-enrolled, self-consented, and provided complete demographic data. Joint pain was the most frequently reported rheumatoid arthritis symptom to bother study participants (344/393, 87.5%). Severe patient-reported wrist pain appeared to be inversely linked with the range of wrist movement measured objectively by the app. At study entry, 292 of 399 participants (73.2%) indicated a preference for participating in a mobile app-based study. The number of participants in the study declined to 45 of 399 (11.3%) at week 12.

CONCLUSIONS

Despite the declining number of participants over time, the combination of social media and smartphone app with sensor integration was a feasible and cost-effective approach for the collection of patient-reported data in rheumatoid arthritis. Integral sensors within smartphones can be harnessed to provide novel end points, and the novel wrist range of movement test warrants further clinical validation.

摘要

背景

使用智能手机招募患者、获取同意并收集患者自我报告的数据,有可能增进我们对疾病负担的理解,并量化现实世界中的生理影响。利用智能手机的内置传感器来促进临床相关数据的远程收集也具有可行性。

目的

我们采用自带设备的方式,使用定制的ResearchKit应用程序开展了“来自现实世界的患者类风湿关节炎数据(PARADE)”观察性研究。我们的目的是评估采用完全数字化方法(社交媒体和智能手机应用程序)对类风湿关节炎患者进行现实世界观察性研究的可行性。

方法

我们采用自带设备的方式,使用定制的ResearchKit应用程序开展了这项观察性研究。为招募患者,旨在引导患者完成一系列任务的PARADE应用程序通过社交媒体平台进行了宣传,并可供美国患者从苹果应用商店下载。我们收集了患者自我报告的数据,如病史、类风湿关节炎相关药物(过去和现在使用的)以及一系列患者报告的结局指标。我们在评估中纳入了关节疼痛地图以及通过智能手机内置的陀螺仪和加速度计对腕关节活动范围进行的一项新型客观评估。

结果

通过社交媒体活动招募的1个月内,399名参与者自行报名、自行同意并提供了完整的人口统计学数据。关节疼痛是困扰研究参与者的最常见类风湿关节炎症状(344/393,87.5%)。患者报告的严重腕部疼痛似乎与应用程序客观测量的腕关节活动范围呈负相关。在研究开始时,399名参与者中有292名(73.2%)表示倾向于参与基于移动应用程序的研究。在第12周时,研究参与者人数降至399名中的45名(11.3%)。

结论

尽管随着时间推移参与者数量有所下降,但社交媒体和智能手机应用程序与传感器集成相结合,是收集类风湿关节炎患者自我报告数据的一种可行且具有成本效益的方法。可以利用智能手机中的内置传感器提供新的终点指标,新型腕关节活动范围测试值得进一步进行临床验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f97d/6231853/b883dd29a2ff/mhealth_v6i9e177_fig1.jpg

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