Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD).
Design of a virtual longitudinal observational study in Parkinson's disease (AT-HOME PD).
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帕金森病虚拟纵向观察研究（home - PD）的设计
DOI：
10.1002/acn3.51236
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发表时间：
2021-03
影响因子：
5.3
通讯作者：
Parkinson Study Group AT-HOME PD Investigators
中科院分区：
文献类型：
--
作者：
Schneider RB;Omberg L;Macklin EA;Daeschler M;Bataille L;Anthwal S;Myers TL;Baloga E;Duquette S;Snyder P;Amodeo K;Tarolli CG;Adams JL;Callahan KF;Gottesman J;Kopil CM;Lungu C;Ascherio A;Beck JC;Biglan K;Espay AJ;Tanner C;Oakes D;Shoulson I;Novak D;Kayson E;Ray Dorsey E;Mangravite L;Schwarzschild MA;Simuni T;Parkinson Study Group AT-HOME PD Investigators
个人技术不断扩大的力量和可及性为减少帕金森病传统临床中心治疗试验的负担和成本提供了机会，并产生了新的见解。在当前的COVID-19疫情期间，这种方法的价值从未如此明显。我们试图（1）建立和实施临床试验参与者纵向虚拟随访的基础设施，（2）比较基于智能手机的评估，在线患者报告结果和远程专家评估的变化，（3）探索帕金森病残疾和进展的新数字标记。来自两个最近完成的肌苷和伊拉地平III期临床试验的参与者参加了评估帕金森病多年扩展试验（AT‐HOME PD）的远程健康结局，这是一项为期两年的虚拟队列研究。在提供电子知情同意书后，个人完成与运动障碍专家的年度视频访问，基于智能手机的运动功能和社会化评估，以及患者在线报告的结果。来自美国和加拿大42个州的226名患者参加了这两项临床试验。其中，181人（80%）成功下载了研究的智能手机应用程序，161人（71%）在在线平台上完成了患者报告的结局。在完成参与帕金森病的实体临床试验后，进行大规模的国际虚拟观察性研究是可行的。这项研究为参与者带来了研究，将比较已建立的临床终点与新型数字生物标志物，从而为临床试验参与者的纵向随访和未来临床试验的设计提供信息。
The expanding power and accessibility of personal technology provide an opportunity to reduce burdens and costs of traditional clinical site‐centric therapeutic trials in Parkinson’s disease and generate novel insights. The value of this approach has never been more evident than during the current COVID‐19 pandemic. We sought to (1) establish and implement the infrastructure for longitudinal, virtual follow‐up of clinical trial participants, (2) compare changes in smartphone‐based assessments, online patient‐reported outcomes, and remote expert assessments, and (3) explore novel digital markers of Parkinson’s disease disability and progression. Participants from two recently completed phase III clinical trials of inosine and isradipine enrolled in Assessing Tele‐Health Outcomes in Multiyear Extensions of Parkinson’s Disease trials (AT‐HOME PD), a two‐year virtual cohort study. After providing electronic informed consent, individuals complete annual video visits with a movement disorder specialist, smartphone‐based assessments of motor function and socialization, and patient‐reported outcomes online. From the two clinical trials, 226 individuals from 42 states in the United States and Canada enrolled. Of these, 181 (80%) have successfully downloaded the study’s smartphone application and 161 (71%) have completed patient‐reported outcomes on the online platform. It is feasible to conduct a large‐scale, international virtual observational study following the completion of participation in brick‐and‐mortar clinical trials in Parkinson’s disease. This study, which brings research to participants, will compare established clinical endpoints with novel digital biomarkers and thereby inform the longitudinal follow‐up of clinical trial participants and design of future clinical trials.
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影响因子：
29
作者：
Beal, M. Flint;Oakes, David;Boyar, Karyn
通讯作者：
Boyar, Karyn
影响因子：
8.6
作者：
Espay, Alberto J;Bonato, Paolo;Nahab, Fatta B;Maetzler, Walter;Dean, John M;Klucken, Jochen;Eskofier, Bjoern M;Merola, Aristide;Horak, Fay;Lang, Anthony E;Reilmann, Ralf;Giuffrida, Joe;Nieuwboer, Alice;Horne, Malcolm;Little, Max A;Litvan, Irene;Simuni, Tanya;Dorsey, E Ray;Burack, Michelle A;Kubota, Ken;Kamondi, Anita;Godinho, Catarina;Daneault, Jean-Francois;Mitsi, Georgia;Krinke, Lothar;Hausdorff, Jeffery M;Bloem, Bastiaan R;Papapetropoulos, Spyros
通讯作者：
Papapetropoulos, Spyros
影响因子：
9.9
作者：
Beck, Christopher A.;Beran, Denise B.;Zhu, William
通讯作者：
Zhu, William
影响因子：
5.2
作者：
Dorsey, E. Ray;Wagner, Joseph D.;Biglan, Kevin M.
通讯作者：
Biglan, Kevin M.
DOI：
10.1002/mds.27376
发表时间：
2018-08
期刊：
Movement disorders : official journal of the Movement Disorder Society
影响因子：
--
作者：
Lipsmeier F;Taylor KI;Kilchenmann T;Wolf D;Scotland A;Schjodt-Eriksen J;Cheng WY;Fernandez-Garcia I;Siebourg-Polster J;Jin L;Soto J;Verselis L;Boess F;Koller M;Grundman M;Monsch AU;Postuma RB;Ghosh A;Kremer T;Czech C;Gossens C;Lindemann M
通讯作者：
Lindemann M