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.

中文翻译：

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基于语音的数字生物标志物的评估：回顾和建议

言语代表了一种有前途的新型生物标志物，它提供了一个了解大脑健康的窗口，正如它对各种神经和精神疾病的破坏所表明的那样。然而，与许多新型数字生物标志物一样，目前缺乏严格的评估，并且需要有效和安全地使用这些措施。本文基于最近的 V3 框架（Goldsack 等人，2020）概述并提供了基于语音的数字生物标志物评估步骤的文献示例。V3 框架描述了数字生物标志物评估的 3 个组成部分：验证、分析验证和临床验证。验证包括评估语音录音的质量并比较硬件和录音条件对录音完整性的影响。分析验证包括检查数据处理和计算测量的准确性和可靠性，包括了解重测可靠性、人口统计学差异以及将测量与参考标准进行比较。临床有效性涉及验证测量与临床结果的对应关系，临床结果可以包括诊断、疾病进展或对治疗的反应。对于这些部分中的每一个，我们都为基于语音的生物标志物所需的评估类型提供了建议，并审查了已发表的示例。本文中的示例侧重于基于语音的生物标志物，但它们可以更广泛地用作数字生物标志物开发的模板。并将措施与参考标准进行比较。临床有效性涉及验证测量与临床结果的对应关系，临床结果可以包括诊断、疾病进展或对治疗的反应。对于这些部分中的每一个，我们都为基于语音的生物标志物所需的评估类型提供了建议，并审查了已发表的示例。本文中的示例侧重于基于语音的生物标志物，但它们可以更广泛地用作数字生物标志物开发的模板。并将措施与参考标准进行比较。临床有效性涉及验证测量与临床结果的对应关系，临床结果可以包括诊断、疾病进展或对治疗的反应。对于这些部分中的每一个，我们都为基于语音的生物标志物所需的评估类型提供了建议，并审查了已发表的示例。本文中的示例侧重于基于语音的生物标志物，但它们可以更广泛地用作数字生物标志物开发的模板。