An innovative protocol for the artificial speech-directed, contactless administration of laboratory-based comprehensive cognitive assessments: PAAD-2 trial management during the COVID-19 pandemic.
An innovative protocol for the artificial speech-directed, contactless administration of laboratory-based comprehensive cognitive assessments: PAAD-2 trial management during the COVID-19 pandemic.
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DOI：
10.1016/j.cct.2021.106500
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发表时间：
2021-08
影响因子：
2.2
通讯作者：
Etnier JL
中科院分区：
文献类型：
--
作者：
Park KS;Etnier JL
新冠肺炎大流行导致美国大多数机构暂停了人体实验研究。我们对第二阶段临床试验“身体活动和阿尔茨海默病-2”（PAAD-2）的广泛认知评估也于2020年3月暂停。在我们的测试过程中，重要的是要确定降低COVID-19传播风险的策略，最初需要大量的人类语言和密切的人与人之间的接触，以获得测试指示和纸/笔测试的即时反馈。鉴于目前对COVID-19传播的了解，我们大幅调整了测试方案，以尽量减少语音液滴的产生，并在保持测试完整性的同时允许社交距离。我们采用了最先进的语音合成和计算机化技术来创建一个代表实验者说话的化身，代表实验者进行所有口头指令/反馈，使用文档相机从要求的距离观察纸/笔测试，并自动执行测试顺序和时间。本文旨在1)描述一种创新的基于实验室的认知测试协议，用于完全无接触，计算机说话和半自动化的管理；2)比较修改后的方案（n = 37）与原始方案（n = 32）的完整性。自2020年7月以来，我们已经成功运行了修改后的协议，在测试期间没有发现COVID-19传播的证据，数据支持修改后的协议具有鲁棒性，并且捕获的数据与原始协议相同。这种数据收集方法的转变在大流行期间至关重要，并将有助于未来的研究，以减轻传染病传播的风险，并使基于实验室的心理测试标准化。试验注册：ClinicalTrials.gov NCT03876314。2019年3月15日注册
The COVID-19 pandemic resulted in suspending in-person human subject research across most institutions in the US. Our extensive cognitive assessment for a phase-2 clinical trial, Physical Activity and Alzheimer's Disease–2 (PAAD-2), was also paused in March 2020. It was important to identify strategies to mitigate the risk of COVID-19 transmission during our testing, which initially required substantial human speech and close person-to-person contact for test directions and instant feedback on paper/pencil tests. Given current understanding of the COVID-19 transmission, we dramatically adjusted the testing protocol to minimize the production of speech droplets and allow social distancing while maintaining the integrity of testing. We adopted state-of-the-art speech synthesis and computerization techniques to create an avatar to speak on behalf of the experimenter for all verbal instructions/feedback, used a document camera to observe the paper/pencil tests from the required distances, and automated the testing sequence and timing. This paper aims 1) to describe an innovative laboratory-based cognitive testing protocol for a completely contact-free, computer-speaking, and semi-automated administration; and 2) to evaluate the integrity of the modified protocol (n = 37) compared with the original protocol (n = 32). We have successfully operated the modified protocol since July 2020 with no evidence of COVID-19 transmission during testing, and data support that the modified protocol is robust and captures data identical to the original protocol. This transition of data collection methods has been critical during the pandemic and will be useful in future studies to mitigate the risk of contagious disease transmission and standardize laboratory-based psychological tests. Trial registration: ClinicalTrials.gov NCT03876314. Registered March 15, 2019
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