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
Comparative Study
. 2021 Aug;131(8):1722-1728.
doi: 10.1002/lary.29371. Epub 2021 Jan 25.

Race in Rhinology Clinical Trials: A Decade of Disparity

Daniel B Spielman  1 , Andi Liebowitz  1 , Saveliy Kelebeyev  1 , Timothy L Smith  2 , Kibwei McKinney  3 , Troy Woodard  4 , Chetan Safi  1 , Jonathan B Overdevest  1 , David A Gudis  1
Affiliations
Comparative Study

Race in Rhinology Clinical Trials: A Decade of Disparity

Daniel B Spielman et al. Laryngoscope. 2021 Aug.

Abstract

Objective/hypothesis: The aim of this study is to assess the ethnic and racial demographics of patients enrolled in prospective chronic rhinosinusitis (CRS) studies relative to the corresponding geographic demographics of the United States (U.S.) census data.

Study design: Systematic Review and Population analysis.

Methods: A systematic review was performed to identify CRS clinical trials, conducted in the U.S. and published between 2010 and 2020 in which patients were prospectively enrolled. Pooled racial and ethnicity data were compared to national and corresponding regional census data.

Results: Eighty-three studies were included, comprising 12,027 patients. 50.4% were male and the average age was 49.2 years. 8,810 patients underwent a surgical procedure. Of the 12,027 patients, 81.67% were identified as White, 5.35% as Black, 1.27% as Asian, 0.02% as Pacific Islander, 0.12% as American Indian, and 11.57% were classified as Other. The racial and ethnic composition of the pooled study population differs significantly from the national U.S. census data with the underrepresentation of each minority population (P ≤ .0002). Regional sub-analyses yield variable results. In the Northeast and West, there was an underrepresentation of all minority populations. In the South and Midwest, Black enrollment was similar to the U.S. census data, while all other minorities were underrepresented.

Conclusions: The racial and ethnic composition of patients enrolled in prospective CRS clinical trials differs significantly from the demographics of the U.S.

Population: The generalizability and external validity of findings derived from studies comprised of demographically mismatched populations has not been established. Future efforts to enroll more representative populations should be emphasized by the research community, funding bodies, and editorial boards.

Level of evidence: NA Laryngoscope, 131:1722-1728, 2021.

Keywords: Chronic rhinosinusitis; clinical trial enrollment; healthcare disparities; socioeconomic disparities.

PubMed Disclaimer

References

BIBLIOGRAPHY

    1. Chen J, Rathore SS, Radford MJ, Wang Y, Krumholz HM. Racial differences in the use of cardiac catheterization after acute myocardial infarction. N Engl J Med 2001;344:1443-1449. https://doi.org/10.1056/NEJM200105103441906.
    1. Sonel AF, Good CB, Mulgund J, et al. Racial variations in treatment and outcomes of black and white patients with high-risk non-ST-elevation acute coronary syndromes. Circulation 2005;111:1225-1232. https://doi.org/10.1161/01.CIR.0000157732.03358.64.
    1. Immunizations and Hispanic Americans - The Office of Minority Health. Available at: https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=67. Accessed August 4, 2020.
    1. Chen A, Wright H, Itana H, et al. Representation of women and minorities in clinical trials for new molecular entities and original therapeutic biologics approved by FDA CDER from 2013 to 2015. J Womens Health 2018;27:418-429. https://doi.org/10.1089/jwh.2016.6272.
    1. Russo DP, Tham T, Bardash Y, Kraus D. The effect of race in head and neck cancer: a meta-analysis controlling for socioeconomic status. Am J Otolaryngol 2020;41:102624. https://doi.org/10.1016/j.amjoto.2020.102624.

LinkOut - more resources