Watts, Stephanie

Abstract Importance Voice-based health technologies are growing rapidly, but they lack standardized terminology, which hinders interdisciplinary collaboration, research quality, and clinical translation. Objective The objective of this work is to develop universally accepted definitions in the rapidly evolving field of vocal biomarkers, as part of the VOCAL ( V ocal Biomarker Guidelines for O ntology, C lassification, A pplication, and L ogistics) initiative, a structured, international consensus-based framework that aims to provide standards, and guidelines. Design VOCAL is a rigorous, international, multi-stage consensus-building study conducted in 2024-2025. Setting Multi-institutional collaboration between representatives from the Bridge2AI-Voice Consortium (North America) and the eVoiceNet Network (European Union), culminating in an in-person workshop at the 2025 Bridge2AI Voice Symposium. Participants A group of 24 international experts in medicine, clinical research, speech and language, audio signal processing, statistics, methodology, regulation, ethics. Methods VOCAL’s iterative process involved five rounds of review, feedback, and an in-person workshop at the international 2025 Bridge2AI Voice Symposium, ensuring the incorporation of diverse perspectives and achieving a robust agreement on the proposed definitions. Main outcomes and measures Consensus-based definitions for vocal biomarkers, spanning from broad concepts (biomarker, digital biomarker, vocal biomarker) to domain-specific measures (cardio-respiratory acoustic, voice, speech/articulatory, cognitive/language). Results A hierarchical continuum model of vocal biomarkers was established. We first distinguished between the concepts of vocal measures and vocal biomarkers. We then defined terms from broad, overarching concepts (Level 0: Biomarker, Digital Biomarker, Vocal Biomarker) to more specific physiological and cognitive domains (Level 1: Cardio-Respiratory Acoustic; Level 2: Voice; Level 3: Speech/Articulatory; Level 4: Cognitive/Language, including linguistic and paralinguistic subtypes). Conclusions and Relevance This work provides a shared vocabulary that is essential for fostering communication through interdisciplinary collaboration, improving the quality and efficiency of research and development, and ensuring the ethical, reliable, and scalable deployment of future voice-based health technologies. It lays foundational groundwork for upcoming guidelines and standards, which are crucial for advancing the field of vocal biomarkers into widespread clinical utility. Key points Question Can we establish an international consensus on the definitions related to vocal biomarkers? Findings Through a multi-stage international consensus process involving expert representatives from the Bridge2AI-Voice Consortium and eVoiceNet Network, a hierarchical model of vocal biomarkers was developed, defining terms from broad concepts (biomarker, digital biomarker, vocal biomarker) to specific physiological and cognitive domains (cardio-respiratory acoustic, voice, speech/articulatory, cognitive/language). Meaning Standardized definitions for vocal biomarkers provide an essential shared vocabulary for interdisciplinary collaboration and lay the foundational groundwork for future guidelines needed to advance the implementation of voice-based health technologies into clinical practice and clinical research.

Purpose: Despite evidence supporting interconnectivity of oropharyngeal and esophageal swallowing, evaluation and treatment are dichotomized. When the videofluoroscopic swallowing study (VFSS) only considers oropharyngeal swallowing, the full scope of swallowing impairment may be missed. A lower rate of esophageal screening in an outpatient hospital setting may result from lack of speech-language pathologist (SLP) training and understanding of screening feasibility. This project was an internal quality improvement project (QIP) at Mayo Clinic in Arizona to (a) educate and train SLPs on conducting the Robust Esophageal Screening Test (REST) and (b) determine the feasibility of REST protocol implementation in a multidisciplinary swallow clinic. Method: Fishbone analysis was used to identify potential causes of the gap in quality. Six Sigma methodology was used to outline the QIP. SLPs were trained in the REST protocol. To ensure adequate training, reliability ratings were assessed with the Cohen's kappa statistic. Esophageal screening via REST was implemented as an adjunct to the standard protocol during VFSS over a 3-month period for referred patients with dysphagia. Clinical findings were recorded. Results: All clinical rater SLPs reached the threshold of κ = .8 to ensure adequate rater reliability. Among 136 outpatients who underwent esophageal screening via REST, 100 patients completed the full REST screening and 36 completed a partial REST screening. Of the 100 full screenings, 80 patients had a failed screening, which indicated a potential esophageal swallowing impairment. Findings were discussed by members of the multidisciplinary dysphagia care team. Conclusions: The results of this QIP show that focusing on assessment of dysfunction and interplay across the swallowing continuum can substantially improve patient care by expediting and specifying next steps of the multidisciplinary dysphagia care team.