Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Oct 19;4(3):99-108.
doi: 10.1159/000510820. eCollection 2020 Sep-Dec.

Evaluation of Speech-Based Digital Biomarkers: Review and Recommendations

Affiliations
Review

Evaluation of Speech-Based Digital Biomarkers: Review and Recommendations

Jessica Robin et al. Digit Biomark. .

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.

PubMed Disclaimer

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.

Figures

Fig. 1
Fig. 1
Example of speech tasks ranging from short, structured speech, to unstructured, naturalistic conversation.
Fig. 2
Fig. 2
Recommended steps of evaluation of a speech biomarker, based on the V3 framework (Goldsack et al. [9]).

References

    1. Babrak LM, Menetski J, Rebhan M, Nisato G, Zinggeler M, Brasier N, et al. Traditional and Digital Biomarkers: Two Worlds Apart? Digit Biomark. 2019 Aug;3((2)):92–102. - PMC - PubMed
    1. Coravos A, Khozin S, Mandl KD. Developing and adopting safe and effective digital biomarkers to improve patient outcomes. NPJ Digit Med. 2019;2((1)):14. - PMC - PubMed
    1. Sabbagh MN, Boada M, Borson S, Chilukuri M, Doraiswamy PM, Dubois B, et al. Rationale for Early Diagnosis of Mild Cognitive Impairment (MCI) supported by Emerging Digital Technologies. J Prev Alzheimers Dis. 2020;7((3)):158–64. - PubMed
    1. Kourtis LC, Regele OB, Wright JM, Jones GB. Digital biomarkers for Alzheimer's disease: the mobile/ wearable devices opportunity. NPJ Digit Med. 2019;2((1)):9. - PMC - PubMed
    1. Piau A, Wild K, Mattek N, Kaye J. Current State of Digital Biomarker Technologies for Real-Life, Home-Based Monitoring of Cognitive Function for Mild Cognitive Impairment to Mild Alzheimer Disease and Implications for Clinical Care: systematic Review. J Med Internet Res. 2019 Aug;21((8)):e12785. - PMC - PubMed