Remote digital smart device follow-up in prospective clinical trials: early insights from ORBITA-2, ORBITA-COSMIC, and ORBITA-STAR.
Remote digital smart device follow-up in prospective clinical trials: early insights from ORBITA-2, ORBITA-COSMIC, and ORBITA-STAR.
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DOI：
10.1093/eurheartjsupp/suac058
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发表时间：
2022-11
影响因子：
1.6
通讯作者：
Al-Lamee, Rasha
中科院分区：
文献类型：
--
作者：
Ganesananthan, Sashiananthan;Rajkumar, Christopher A.;Foley, Michael;Francis, Darrel;Al-Lamee, Rasha
智能设备是采集、处理、存储和传输数字健康数据的基本介质。智能手机和健身监测器等智能设备的全球普及和高频率使用为我们提供了一个纳入临床试验的机会，以生成更具临床意义的数据。心绞痛的报告在患者之间以及在不同时间点的患者内可能存在显著差异。此外，心绞痛的性质可能导致患者适应日常生活活动的方式发生变化，因此报告症状和生活质量。目前研究干预对心绞痛影响的临床试验没有准确地纳入这些以患者为中心的结局和考虑因素。因此，以方便、以患者为中心和具有成本效益的方式同时评估每日心绞痛负荷的方法是当代临床试验要解决的优先事项。在这篇文章中，我们提供了我们对我们研究小组在稳定型冠状动脉疾病临床试验中使用远程数字智能设备的见解。我们讨论了我们以前的试验经验如何使其成为必要，并将为我们提供重要的数据，为临床实践提供信息。我们讨论了智能设备整合的好处、当前的挑战和局限性，同时提供了我们如何将智能设备整合到临床试验中的程序工作流程，供其他人考虑。我们希望这种方法将使我们能够理解心绞痛对患者生活的感知和影响，其粒度比以前探索的更大。
Smart devices are a fundamental media for acquisition, processing, storage, and transfer of digital health data. The global penetration and high frequency usage of smart devices such as smartphones and fitness monitors provide us an opportunity for incorporation into clinical trials to generate more clinically meaningful data. Reporting of angina can significantly vary between patients and also within patients at different timepoints. Furthermore, the nature of angina can lead to variation in ways patients adapt their activities of daily living and hence reporting of symptoms and quality of life. Current clinical trials investigating the effects of intervention on angina do not accurately incorporate these patient centred outcomes and considerations. Hence, methods to contemporaneously assess daily angina burden in a convenient, patient focused, and cost-effective manner are priorities for contemporary clinical trials to address. In this article, we provide our insights into the use of remote digital smart devices in clinical trials of stable coronary artery disease conducted by our research group. We discuss how our experiences from previous trials necessitated its incorporation and will provide us with important data that will inform clinical practice. We discuss the benefits and current challenges and limitations of smart device incorporation while providing our procedural workflow for how we incorporated smart devices into our clinical trials for others to consider. We hope that this approach will allow us to understand the perceptions and implications of angina on patient lives with greater granularity than previously explored.
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影响因子：
168.9
作者：
Al-Lamee, Rasha;Thompson, David;Francis, Darrel P.
通讯作者：
Francis, Darrel P.
影响因子：
158.5
作者：
Maron, David J.;Hochman, Judith S.;Rosenberg, Yves
通讯作者：
Rosenberg, Yves
影响因子：
46.9
作者：
Chan, Yu-Feng Yvonne;Wang, Pei;Schadt, Eric E.
通讯作者：
Schadt, Eric E.
影响因子：
37.8
作者：
Al-Lamee, Rasha;Howard, James P.;Francis, Darrel P.
通讯作者：
Francis, Darrel P.
DOI：
10.1056/nejmoa1901183
发表时间：
2019-11-14
期刊：
The New England journal of medicine
影响因子：
--
作者：
Perez MV;Mahaffey KW;Hedlin H;Rumsfeld JS;Garcia A;Ferris T;Balasubramanian V;Russo AM;Rajmane A;Cheung L;Hung G;Lee J;Kowey P;Talati N;Nag D;Gummidipundi SE;Beatty A;Hills MT;Desai S;Granger CB;Desai M;Turakhia MP;Apple Heart Study Investigators
通讯作者：
Apple Heart Study Investigators