Unveiling the Reporting and Representation of Race and Ethnicity in Acute Interventional Neurology Clinical Trials: Preliminary Results from the UNREAL Systematic Review
Hector David Meza Comparan1, Beulah Augustin2, Luciola Martins Frota1, Michael Mathelier1, Anum Khaliq1, Daniela Pomar-Forero1, Bakhtawar Ahmad1, Rodrigo F. Alcala Arana1, Mary Edwards3, Carolina B. Maciel1, Katharina M. Busl1
1Department of Neurology, Division of Neurocritical Care, 2Department of Emergency Medicine, 3Health Science Center Libraries, University of Florida
Objective:
To evaluate the extent and quality of race/ethnicity reporting in U.S. acute neurology trials.
Background:
Underreporting and underrepresentation of racial/ethnic minorities in clinical trials limits generalizability of results. This issue is known within stroke trials but unclear for other acute neurology trials.
Design/Methods:
A systematic review of MEDLINE (from inception-10/2023) was conducted. Phases II-IV adult acute neurology trials conducted in the U.S. and reporting race/ethnicity were included. Two reviewers screened and extracted data in a blinded fashion using Covidence®.
Results:
Of 349 fully reviewed articles, 26 (7.4%) otherwise eligible studies were excluded due to lacking race/ethnicity data (n=6756): 14 covered acute ischemic stroke (AIS), 6 subarachnoid hemorrhage (SAH), 4 intracerebral hemorrhage (ICH), 2 traumatic brain injury, 3 seizures/status epilepticus (SE), and 1 encephalitis. The final analysis included 23 studies (total n=10,554) from 1999-2023. Topics included AIS in 11 studies, ICH in 6, SAH in 4, and seizures/SE in 2. Race reporting included White in 22 (95.6%) studies, Black or African American in 17 (73.9%), Asian in 9 (39.1%), American Indian or Alaska Native in 3 (13%), and Native Hawaiian or Other Pacific Islander in 1 (4.3%). Ethnicity was reported in 14 studies, with 10 (71.4%) using it interchangeably with race. White individuals comprised >50% of patients in 18 (78.2%) studies. Incorrect/outdated race categories (e.g., Caucasian, European, African) were used in 6 (26%) studies (5 published after the 2001 NIH Policy on Reporting Race and Ethnicity Data). Only 17.4% of studies reported who classified race/ethnicity (75% of these being self-reported/family-reported).
Conclusions:
White individuals comprise the majority in most acute neurology trials. Underreporting and underrepresentation are both highly problematic since Black and Hispanic populations endure higher risks and worse outcomes for stroke, SAH, ICH, and SE. Improved reporting and recruitment are needed to guide adequate representation in trials, thus fulfilling the principle of justice in research.
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