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Purpose: The purpose of this meta-analysis was to assess the frequency of sex, race, and ethnicity reporting and proportional representation in funded, noncancerous voice clinical trials to determine the state of compliance with National Institutes of Health (NIH) guidelines for inclusivity in clinical research. Method: Clinical trials registered with the NIH/U.S. National Library of Medicine between January 1988 and September 2021 were analyzed. Primary reports of the trials were obtained from clinicaltrials.gov and PubMed. Outcomes included the proportion of trials reporting sex, race, and ethnicity and the proportion of participants by sex, race, and ethnicity in the trials. Descriptive statistics and chi-square tests were used to analyze the data with 95% confidence intervals (CIs) reported. Results: The search yielded 46 research studies. After inclusion and exclusion criteria were applied and attempts to locate studies were conducted, 11 total articles were ultimately evaluated. Descriptively, there were more female subjects, yet overall, no significant difference in sex distribution (χ 2 = 0.07, p = .75, 95% CI [−0.25, −0.19]). Race and ethnicity were only reported in two clinical trials. Black participants were underrepresented in one clinical trial (χ 2 = 4.93, p = .02, 95% CI [−0.11, −0.02]), whereas Hispanic participants were underrepresented in a second trial (χ 2 = 11.27, p < .00, 95% CI [−0.20, − 0.13]). Conclusions: This preliminary analysis highlights the disparities in race and ethnicity recruitment and reporting in noncancerous voice clinical trials. There is a need for strategic recruitment strategies and improved reporting practices to adhere to the NIH inclusivity directives.

To establish the validity of the OMNI Vocal Effort Scale (OMNI-VES) for resistance exercise, a single-question pictorial scale, in voice-related perceived exertion. Additionally, the study aimed to assess the role of the OMNI-VES as an outcome measurement in the treatment of adductor spasmodic dysphonia (ADSD).A prospective validation study was conducted on 226 participants. The case group was comprised of 178 patients receiving botulinum toxin (BTX) injections for ADSD and 48 controls without a voice disorder. Prior to a planned injection, the participants were asked to complete the OMNI-VES and the Voice-Related Quality-of-Life (V-RQOL) questionnaires, and the clinician completed the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). A subgroup of 17 patients were administered a repeat assessment 1 month after injection.There was a weak correlation between the OMNI-VES and the V-RQOL score (Tau-b = -0.252, P 0.001), and no significant correlation with the CAPE-V. Participants with ADSD had significantly higher OMNI-VES scores compared with normal controls, 5.07 ± 2.18 and 1.47 ± 2.28, respectively (P value 0.0001). The average OMNI-VES score significantly improved 1 month following a BTX injection, from 6 ± 2.4 to 3.4 ± 2.8 (P value = 0.0003). Eighty-eight percent of the patients demonstrated a decrease in the OMNI-VES score following injection, whereas only 47% demonstrated an improvement in the V-RQOL score.The OMNI-VES is a validated tool for rating perceived voice-related exertion in people with ADSD and can be used for evaluating response to BTX injection treatment.2b Laryngoscope, 129:448-453, 2019.