Wu Chao-Yi, Beattie Zachary, Mattek Nora, Sharma Nicole, Kaye Jeffrey, Dodge Hiroko H
Department of Neurology Oregon Health & Science University (OHSU) Portland Oregon USA.
Oregon Center for Aging & Technology (ORCATECH) OHSU Portland Oregon USA.
Alzheimers Dement (N Y). 2021 Dec 31;7(1):e12220. doi: 10.1002/trc2.12220. eCollection 2021.
Reproducibility and replicability of results are rarely achieved for digital biomarkers analyses. We reproduced and replicated previously reported sample size estimates based on digital biomarker and neuropsychological test outcomes in a hypothetical 4-year early-phase Alzheimer's disease trial.
Original data and newly collected data (using a different motion sensor) came from the Oregon Center for Aging & Technology (ORCATECH). Given trajectories of those with incident mild cognitive impairment and normal cognition would represent trajectories of the control and experimental groups in a hypothetical trial, sample sizes to provide 80% power to detect effect sizes ranging from 20% to 50% were calculated.
For the reproducibility, identical -values and slope estimates were found with both digital biomarkers and neuropsychological test measures between the previous and current studies. As for the replicability, a greater correlation was found between original and replicated sample size estimates for digital biomarkers ( = 0.87, < .001) than neuropsychological test outcomes ( = 0.75, < .001).
Reproducibility and replicability of digital biomarker analyses are feasible and encouraged to establish the reliability of findings.
数字生物标志物分析很少能实现结果的可重复性和可再现性。我们在一项假设的为期4年的早期阿尔茨海默病试验中，基于数字生物标志物和神经心理学测试结果，对先前报告的样本量估计进行了重复和再现。
原始数据和新收集的数据（使用不同的运动传感器）来自俄勒冈衰老与技术中心（ORCATECH）。鉴于轻度认知障碍和正常认知患者的轨迹将代表假设试验中对照组和实验组的轨迹，计算了为检测20%至50%效应量提供80%检验效能所需的样本量。
在可重复性方面，在前一项研究和当前研究之间，数字生物标志物和神经心理学测试指标的p值和斜率估计值相同。在可再现性方面，数字生物标志物的原始样本量估计值与再现样本量估计值之间的相关性（r = 0.87，p <.001）高于神经心理学测试结果（r = 0.75，p <.001）。
数字生物标志物分析的可重复性和可再现性是可行的，并且对于确定研究结果的可靠性很有必要。
