Bensoussan, Yael

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.

AbstractObjectiveBilateral vocal fold paralysis (BVFP) and posterior glottic stenosis (PGS) are causes of bilateral vocal fold immobility (BVFI) and may cause shortness of breath, stridor, and need for surgical intervention. Although increased body mass index (BMI) is associated with restrictive breathing patterns in patients with normal upper airways, it is unclear how BMI impacts dyspnea and need for surgical intervention in BVFI patients.Study DesignRetrospective cohort study.SettingThree tertiary academic centers in the United States.MethodsDemographics, BMI, Dyspnea Index (DI), etiology, presence of tracheostomy and surgical intervention (dilation, tracheostomy, cordotomy, arytenoidectomy, open reconstruction) were collected. Primary outcomes included dyspnea measured by DI and need for surgery to improve airway. Linear regressions were performed to assess continuous outcomes. Mann‐Whitney U‐test was utilized to assess categorical outcomes.ResultsAmong 121 patients, 52 presented with BVFP and 69 with PGS. Previous neck surgery was the most common cause of BVFI (40.2%). 44.3% of patients received a tracheostomy. Through multivariate linear regression, increased BMI was significantly associated with increased DI in the entire cohort (β = .43, P = .016). Increased BMI was also associated with need for any surgical intervention (odds ratio [OR] = 1.07, 95% confidence interval [CI] = [1.01‐1.13]) in the overall cohort. When stratifying our data, BMI was only significantly associated with DI in BVFP (β = .496) and need for surgical intervention in PGS (OR = 1.11, 95% CI = [1.01‐1.21]), although a positive trend was seen in all analyses.ConclusionIncreased BMI may correlate with worsening dyspnea symptoms and need for surgical intervention in patients with BVFI. Weight‐loss‐related counseling may benefit symptom management.