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April 22, 2021

Racial/Ethnic and Sex Representation in US-Based Clinical Trials of Hearing Loss Management in Adults: A Systematic Review

Author Affiliations
  • 1Cochlear Center for Hearing & Public Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland
  • 2Howard University College of Medicine, Washington, DC
  • 3University of Puerto Rico School of Medicine, San Juan, Puerto Rico
  • 4Albert S. Cook Library, Towson University, Towson, Maryland
  • 5Department of Otolaryngology–Head & Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 6Department of Speech, Language & Hearing Sciences, University of Arizona, Tucson
  • 7Center for Innovative Care in Aging, Johns Hopkins University School of Nursing, Baltimore, Maryland
JAMA Otolaryngol Head Neck Surg. 2021;147(7):656-662. doi:10.1001/jamaoto.2021.0550
Key Points

Question  What is the racial/ethnic and sex representation among clinical trials that evaluate the management of hearing loss in adults?

Findings  In this systematic review of 125 studies that evaluated hearing loss management among adults, 88 (70.4%) reported sex, but only 16 studies (12.8%) reported participant race/ethnicity. Among the 16 studies reporting race/ethnicity, only 5 included more than 30% from racial or ethnic minority groups.

Meaning  The inclusion of women and racial and ethnic minority groups in clinical trials is crucial to advancing the science and care of diverse populations with hearing loss, but is currently lacking.


Importance  Although the National Institutes of Health (NIH) mandated the inclusion and reporting of women and racial or ethnic minority groups in NIH-funded research in 1993, little is known regarding the representation of women and racial or ethnic minority groups in trials that investigate hearing loss management.

Objective  To assess sex and racial/ethnic representation in US-based clinical trials of hearing loss management in an adult population.

Data Sources  Pertinent studies were identified using search strategies in PubMed, Embase, and ClinicalTrials.gov.

Study Selection  Our search strategy yielded 6196 studies. We included prospective studies that were written in English, performed in the US, and evaluated hearing loss management in adults, including amplification devices, such as hearing aids or assistive listening devices, cochlear implants, aural rehabilitation, and therapeutics. Given its prevalence, only studies that addressed bilateral sensorineural hearing loss were included.

Data Extraction and Synthesis  Data from 125 studies were extracted. The Preferred Reporting Items for Systematic Reviews and Meta-analyses diagram for systematic reviews was used for abstracting data. The guidelines were applied using independent extraction by multiple observers.

Results  Among 125 clinical studies performed from January 1990 to July 2020 regarding hearing loss management, only 16 (12.8%) reported race/ethnicity, and 88 (70.4%) reported sex. Of the 16 studies that reported race/ethnicity, only 5 included more than 30% non-White representation. Among the 88 articles that reported sex, 44 (35.2%) reported more than 45% female representation. While the mean number of participants included in the observed trials was 80 (range, 7-644), the median number of participants from racial or ethnic minority groups in studies that reported race/ethnicity was 9 (range, 1-77), and a median of 12 female participants were included in studies with a numerical breakdown by sex. A mean of 41% (range, 1.55%-77.5%) of participants were female among studies that reported sex, and a mean of 30% (range, 1.96%-100%) of participants were from racial or ethnic minority groups among the 16 studies that reported race/ethnicity. Reporting of race/ethnicity varied substantially by funding source and journal type, while reporting by sex differed only by journal type.

Conclusions and Relevance  Studies investigating hearing loss management do not adequately reflect the US population. A closer examination of the inclusion of diverse adults in clinical research associated with hearing health may work to ameliorate disparities and contribute to the development of tailored interventions that address the needs of an increasingly diverse US population.

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