Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Sep;134(9):4101-4110.
doi: 10.1002/lary.31467. Epub 2024 Apr 24.

Demographic Representation in Clinical Research Relative to a Cochlear Implant Patient Population

Evan P Nix  1 , Amanda G Davis  1 , Kevin D Brown  1 , Stephanie G Panoncillo  1 , Nicholas J Thompson  1 , Andrea B Overton  2 , Matthew M Dedmon  1 , Margaret T Dillon  1
Affiliations

Demographic Representation in Clinical Research Relative to a Cochlear Implant Patient Population

Evan P Nix et al. Laryngoscope. 2024 Sep.

Abstract

Objectives: Research samples that are representative of patient populations are needed to ensure the generalizability of study findings. The primary aim was to assess the efficacy of a study design and recruitment strategy in obtaining a participant sample that was representative of the broader cochlear implant (CI) patient population at the CI center. A secondary aim was to review whether the CI recipient population was representative of the state population.

Methods: Demographic variables were compared for a research participant sample (n = 79) and the CI patient population (n = 338). The participant sample was recruited from the CI patient population. The study design included visits that were at the same location and frequency as the recommended clinical follow-up intervals. The demographics for the combined group (participant sample and patient population) were then compared to the reported demographics for the population in North Carolina.

Results: There were no significant differences between the participant sample and patient population for biological sex, age at implantation, racial distribution, socioeconomic position, degree of urbanization, or drive time to the CI center (p ≥ 0.086). The combined CI recipient population was significantly different from the North Carolina population for the distributions of race, ethnicity, and degree of urbanization (p < 0.001).

Conclusion: The study design and recruitment strategy allowed for recruitment of a participant sample that was representative of the CI patient population. Disparities in access to cochlear implantation persist, as supported by the significant differences in the combined CI recipient population and the population for our state.

Level of evidence: 3 Laryngoscope, 134:4101-4110, 2024.

Keywords: health care disparity; hearing health care.

PubMed Disclaimer

References

BIBLIOGRAPHY

    1. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290(12):1624‐1632. https://doi.org/10.1001/jama.290.12.1624.
    1. Nieman CL, Suen JJ, Dean LT, Chandran A. Foundational approaches to advancing hearing health equity: a primer in social epidemiology. Ear Hear. 2022;43(suppl 1):5S‐14S. https://doi.org/10.1097/AUD.0000000000001149.
    1. Bibbins‐Domingo K, Helman A, eds. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington (DC): National Academies Press (US); 2022.
    1. Meinhardt G, Sharrer C, Perez N, et al. Reporting of sociodemographic data in cochlear implant clinical trials: a systematic review. Otol Neurotol. 2023;44(2):99‐106. https://doi.org/10.1097/MAO.0000000000003766.
    1. Pittman CA, Roura R, Price C, Lin FR, Marrone N, Nieman CL. Racial/ethnic and sex representation in US‐based clinical trials of hearing loss management in adults: a systematic review. JAMA Otolaryngol Head Neck Surg. 2021;147(7):656‐662. https://doi.org/10.1001/jamaoto.2021.0550.

Grants and funding

LinkOut - more resources