Feasibility, Reliability, and Value of Remote Video-Based Trial Visits in Parkinson's Disease
Feasibility, Reliability, and Value of Remote Video-Based Trial Visits in Parkinson's Disease
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DOI：
10.3233/jpd-202163
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发表时间：
2020-01-01
影响因子：
5.2
通讯作者：
Simuni, Tanya
中科院分区：
文献类型：
--
作者：
Tarolli, Christopher G.;Andrzejewski, Kelly;Simuni, Tanya
背景资料：远程临床试验评估越来越受到人们的关注，尤其是在COVID-19大流行的背景下。Objective：To demonstrate the reliability，reliability，and value of remote visits in a phase III clinical trial of individuals with Parkinson's disease.Methods：我们邀请参加III期临床试验（STEADY-PD III）的帕金森病患者参加远程视频访视的子研究。参与者在一年内完成了三次远程访问，并在一次亲自访问后的四周内完成了远程访问期间进行的评估。我们评估了远程完成预定评估的能力;远程和面对面结果测量之间的协议;和远程visits.Results的意见：我们招募了40名参与者（平均（SD）年龄64.3（10.4），29%的妇女），38（95%）完成了所有远程访问。远程和现场患者报告的结果之间存在良好的相关性（ICC 0.81-0.87），远程和现场运动评估之间存在中度相关性（ICC 0.43-0.51）。平均而言，远程访问所需时间约为亲自访问时间的四分之一（54 vs 190分钟）。几乎所有的参与者都喜欢远程访问，四分之三的人说，他们将更有可能参加未来的试验，如果一些访问可以进行远程.Conclusion：远程访问是可行的，可靠的第三阶段临床试验的个人早期，未经治疗的帕金森病。这些访问时间更短，减轻了参与者的负担，并使研究访问能够安全进行，这在COVID-19大流行中尤为重要。
Background: There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic.Objective: To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson's disease.Methods: We invited individuals with Parkinson's disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits.Results: We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81-0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43-0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely.Conclusion: Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson's disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic.