@article{8a24191ca8fa4977a9e3703b0cf9c6fe,
title = "Reproducibility and replicability of high-frequency, in-home digital biomarkers in reducing sample sizes for clinical trials",
abstract = "Introduction: 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. Methods: 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. Results: For the reproducibility, identical P-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 (r = 0.87, P <.001) than neuropsychological test outcomes (r = 0.75, P <.001). Discussion: Reproducibility and replicability of digital biomarker analyses are feasible and encouraged to establish the reliability of findings.",
author = "Wu, {Chao Yi} and Zachary Beattie and Nora Mattek and Nicole Sharma and Jeffrey Kaye and Dodge, {Hiroko H.}",
note = "Funding Information: We would like to thank participants in the ORCATECH Life Lab (OLL) study. This work was supported by several grants, including the National Institute on Aging: P30AG024978, R01AG024059, P30‐AG008017, P30AG066518 and U2C AG054397; Department of Veterans Affairs Health Services Research and Development: IIR 17‐144; National Center for Advancing Translational Sciences: UL1 TR002369. Funding Information: J. Kaye in the past 36 months has been directly compensated for serving on a Data Safety Monitoring Committee for Eli Lilly, the Scientific Advisory Board of Sage Bionetworks, the Roche/Genentech Scientific Advisory Committee for Digital Health Solutions in Alzheimer's Disease, and as an external Advisory Committee member for two Alzheimer's Disease Research Centers. He has received research support awarded to his institution (Oregon Health & Science University) from the NIH, NSF, the Department of Veterans Affairs, USC Alzheimer's Therapeutic Research Institute, Merck, AbbVie, Eisai, Green Valley Pharmaceuticals, and Alector. He holds stock in Life Analytics Inc., for which no payments have been made to him or his institution. He has received reimbursement through Medicare or commercial insurance plans for providing clinical assessment and care for patients. He has served on the editorial advisory board and as Associate Editor of the journal and as Associate Editor for . H. Dodge receives honorarium from the Alzheimer's Clinical Trials Consortium (ACTC) and is a consultant for Biogen, Inc. She serves as a Data Safety and Monitoring Board member for five clinical trials and an external Advisory Committee member for two Alzheimer's Disease Centers. She receives research funding from National Institute on Aging and serves as a senior editor for and the Statistical Editor for the journal . Z. Beattie holds stock in Life Analytics Inc. for which no payments have been made to him or his institution. CY Wu, N Sharma, N Mattek have no conflicts of interest to declare. Alzheimer's & Dementia Journal of Translational Engineering in Health and Medicine Alzheimer's & Dementia: Translational Research and Clinical Interventions Alzheimer's & Dementia Publisher Copyright: {\textcopyright} 2021 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, LLC on behalf of Alzheimer's Association.",
year = "2021",
doi = "10.1002/trc2.12220",
language = "English (US)",
volume = "7",
journal = "Alzheimer's and Dementia: Translational Research and Clinical Interventions",
issn = "2352-8737",
publisher = "Elsevier Inc.",
number = "1",
}