The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.
Reproducibility and replicability of high‐frequency, in‐home digital biomarkers in reducing sample sizes for clinical trials
Open accessAbstract
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.
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Digital biomarkers used in clinical trials are capable of significantly reducing needed sample sizes.
“digital biomarkers used in clinical trials that are capable of significantly reducing needed sample sizes. 39 , 40”
From Developing digital health technologies for frontotemporal degeneration (2025) · cites this paper as [39]
The Introduction (page unavailable) reports markedly lower projected sample sizes for specific in-home digital biomarkers compared with cognitive tests. The estimates concern hypothetical preclinical Alzheimer’s trials; the paper does not establish that digital biomarkers have reduced sample sizes in clinical trials generally. (LLM, conf=0.84)
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Etz, A., & Vandekerckhove, J. (2016) · PLOS ONE · doi:10.1371/journal.pone.0149794 · Cited by 295 · cited 1×
“13,14 Thus, reproducing and replicating findings from previous studies has become important to increase the rigor of science and reduce study biases with a priori analytical plans.”
BackgroundUse of High-Frequency In-Home Monitoring Data May Reduce Sample Sizes Needed in Clinical Trials
Dodge, H. H., Zhu, J., Mattek, N. C., Austin, D., Kornfeld, J., & Kaye, J. A. (2015) · PLOS ONE · doi:10.1371/journal.pone.0138095 · Cited by 99
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Developing digital health technologies for frontotemporal degeneration
Nevler, N., Niehoff, D., Gleixner, A. M., Dodge, S., Vogel, A. P., Hill, D. L., Ducharme, S., Staffaroni, A. M., Yunusova, Y., Au, R., et al. (2025) · Alzheimer's & Dementia · doi:10.1002/alz.70082 · Cited by 7
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Metadata
- Authors
- Wu, C., Beattie, Z., Mattek, N., Sharma, N., Kaye, J., & Dodge, H. H.
- Affiliations
- Oregon Health & Science University (US)
- Corresponding author
- Wu, Chao‐Yi
- Venue
- Alzheimer's & Dementia: Translational Research & Clinical Interventions
- Publisher
- Wiley
- Published
- 2021-01
- Volume
- 7
- Issue
- 1
- Pages
- e12220-e12220
- ISSN
- 2352-8737 (ISSN-L)
- PMC
- PMC8719347
- OpenAlex
- W4205092819
- Cited by
- 18
- References
- 4
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 5 · 2023: 5 · 2022: 1 · 2021: 1
- FWCI
- 2.15
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Center for Advancing Translational Sciences (UL1 TR002369)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- digital biomarkers, reproducibility, replicability, sample size determination, clinical trial design, Alzheimer's disease, mild cognitive impairment, neuropsychological assessment, motion sensors, statistical power
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