Sex and Race Reporting and Representation in Noncancerous Voice Clinical Trials: A Meta-Analysis of National Institutes of Health–Registered Research Between 1988 and 2021

Abstract

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.

Diversity of Research Participant Gender, Race, and Ethnicity in Communication Sciences and Disorders: A Systematic Review and Quantitative Synthesis of ASHA Publications in 2020

“…A finding from our first research question, and perhaps the most striking result of the current study, was that nearly two thirds of the publications that we reviewed omitted information about participants' race or ethnicity. These findings are consistent with prior studies in CSD sub-disciplines (Ellis, 2009;Morton & Sandage, 2022;Nelson, 2022;Nguy et al, 2022;Pierce et al, 2014;Steinbrenner et al, 2022;West et al, 2016) and with broader biomedical science research (see National Academies of Sciences, Engineering, and Medicine, 2022). Such low rates of reporting for race and ethnicity in the year 2020 perhaps reveals the ongoing limitations of past and current practices, underscoring a need for new policies and strategies to address gaps in obtaining even a baseline understanding of broad representation of different racial and ethnic groups in CSD research.…”

“…Despite an ever-growing body of literature underscoring the differential impact of sex, gender, race, and ethnicity in persons impacted by communication disorders in the United States, there is also some evidence suggesting that such demographic variables are underreported or not representative of the broader populations that we serve and study, particularly with regard to racial and ethnic diversity (Cascio et al, 2020;Ellis, 2009;Morton & Sandage, 2022;Nelson, 2022;Pierce et al, 2014;Sinclair et al, 2018;Steinbrenner et al, 2022;West et al, 2016). For example, Ellis (2009) reviewed 116 articles published from 1997 through 2007 in the American Journal of Speech-Language Pathology and the Journal of Speech, Language, and Hearing Research in the area of adult neurogenic communication disorders and found that fewer than 15% of the articles reported race or ethnicity of their participants.…”

Adult Normative Data for the OMNI‐Vocal Effort Scale (VES)

“…Furthermore, the lack of reported racial and ethnic demographic data and unequal distribution between ages and sex groups is a limitation. These normative data are preliminary until further investigations report more detailed demographic data to ensure the translatability and equitability of such data to clinical practice 42 . Also, due to the greater consideration of presbyphonia in the 70+ population, participants in this age range were excluded.…”

“…These normative data are preliminary until further investigations report more detailed demographic data to ensure the translatability and equitability of such data to clinical practice. 42 Also, due to the greater consideration of presbyphonia in the 70+ population, participants in this age range were excluded. Further research is needed to determine the normative values of perceived vocal effort for vocally healthy elderly patients as well.…”