Evaluation of Speech-Based Digital Biomarkers: Review and Recommendations
- PMID: 33251474
- PMCID: PMC7670321
- DOI: 10.1159/000510820
Evaluation of Speech-Based Digital Biomarkers: Review and Recommendations
Abstract
Speech represents a promising novel biomarker by providing a window into brain health, as shown by its disruption in various neurological and psychiatric diseases. As with many novel digital biomarkers, however, rigorous evaluation is currently lacking and is required for these measures to be used effectively and safely. This paper outlines and provides examples from the literature of evaluation steps for speech-based digital biomarkers, based on the recent V3 framework (Goldsack et al., 2020). The V3 framework describes 3 components of evaluation for digital biomarkers: verification, analytical validation, and clinical validation. Verification includes assessing the quality of speech recordings and comparing the effects of hardware and recording conditions on the integrity of the recordings. Analytical validation includes checking the accuracy and reliability of data processing and computed measures, including understanding test-retest reliability, demographic variability, and comparing measures to reference standards. Clinical validity involves verifying the correspondence of a measure to clinical outcomes which can include diagnosis, disease progression, or response to treatment. For each of these sections, we provide recommendations for the types of evaluation necessary for speech-based biomarkers and review published examples. The examples in this paper focus on speech-based biomarkers, but they can be used as a template for digital biomarker development more generally.
Keywords: Dementia; Digital biomarkers; Digital health; Language; Speech; Validation.
Copyright © 2020 by S. Karger AG, Basel.
Conflict of interest statement
J.R., L.D.K., W.S., and M.Y. are employees of Winterlight Labs. J.E.H. reports receipt of personal fees in the past 3 years from AlzeCure, Aptinyx, Astra Zeneca, Athira Therapeutics, Axon Neuroscience, Axovant, Biogen Idec, BlackThornRx, Boehringer Ingelheim, Cerecin, Cognition Therapeutics, Compass Pathways, CRF Health, Curasen, EIP Pharma, Eisai, FSV7, G4X Discovery, GfHEU, Heptares, Lundbeck, Lysosome Therapeutics, MyCognition, Neurocentria, Neurocog, Neurodyn Inc, Neurotrack, Novartis, Nutricia, Probiodrug, Regeneron, Rodin Therapeutics, Samumed, Sanofi, Servier, Signant, Syndesi Therapeutics, Takeda, Vivoryon Therapeutics, vTv Therapeutics, and Winterlight Labs. Additionally, he holds stock options in Neurotrack Inc. and is a joint holder of patents with My Cognition Ltd. F.R. is an employee of Surgical Safety Technologies.
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