1 Faculty of Medicine, University of British Columbia, Vancouver, Canada.
2 Vancouver Stroke Program, Vancouver, Canada.
Telemed J E Health. 2019 Mar;25(3):237-242. doi: 10.1089/tmj.2018.0023. Epub 2018 Jun 21.
Cognition is an important outcome in many clinical trials. The NIH Toolbox-Cognition Battery (NIHTB-CB) is a computerized cognitive assessment designed for clinical research that is administered in-person. Here, we evaluated the equivalency of a novel videoconference protocol for administering the NIHTB-CB. Since our protocol required repeated assessments, we further explored the NIHTB-CB's practice effect.
Twenty-five healthy participants completed the NIHTB-CB under two separate conditions 4 weeks apart. The standard condition followed the recommended administration protocol, whereas the videoconference condition had the examiner and participant in separate rooms but able to communicate over videoconference. A linear mixed-model analysis was performed to explore the fixed effect of testing condition and time on NIHTB-CB performance.
Across all three NIHTB-CB composite scores (total, fluid, and crystallized cognition), no significant fixed effect of administration condition was found. A significant practice effect was observed for the fluid and total cognition composite scores over a 29.0 (±2.1) day test-retest interval.
Our novel videoconference protocol for the NIHTB-CB is equivalent to the standard protocol in healthy participants, and may provide a solution for researchers seeking to engage study participants at remote sites. If the NIHTB-CB is used longitudinally to monitor patients, corrections for repeated measures may be required.
认知是许多临床试验中的一个重要结果。NIH 工具包认知电池(NIHTB-CB)是一种专为临床研究设计的计算机化认知评估工具,以面授形式进行。在这里,我们评估了一种新的视频会议协议用于管理 NIHTB-CB 的等效性。由于我们的方案需要重复评估,我们进一步探讨了 NIHTB-CB 的练习效应。
25 名健康参与者在相隔 4 周的两个不同条件下完成了 NIHTB-CB。标准条件遵循推荐的管理方案,而视频会议条件则使检查者和参与者在不同的房间,但能够通过视频会议进行交流。进行线性混合模型分析,以探索测试条件和时间对 NIHTB-CB 表现的固定效应。
在所有三个 NIHTB-CB 综合得分(总体、流体和晶体认知)中,均未发现管理条件的固定效应显著。在 29.0(±2.1)天的测试-重测间隔内,观察到流体和总体认知综合得分的显著练习效应。
我们的 NIHTB-CB 新视频会议协议在健康参与者中与标准方案等效,并且可能为寻求在远程站点参与研究的研究人员提供解决方案。如果使用 NIHTB-CB 对患者进行纵向监测,则可能需要进行重复测量的校正。