Abstract Details

Title Unveiling the Reporting and Representation of Race and Ethnicity in Acute Interventional Neurology Clinical Trials: Preliminary Results from the UNREAL Systematic Review

Topic General Neurology

Presentation(s) P1 - Poster Session 1 (11:45 AM-12:45 PM)

Poster/Presentation
Number 2-002

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 Incorrect/outdated race categories (e.g., Caucasian, European, African) were used in 6 (26%) studies (5 published after the 2001 NIH Policy on Reporting Race and Ethnicity Data).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.

Authors/Disclosures
Luciola Martins Frota, MD PRESENTER	Dr. Martins Frota has nothing to disclose.
Hector David Meza Comparan, MD (University of Florida)	Dr. Meza Comparan has nothing to disclose.
Beulah Augustin, MD	Dr. Augustin has nothing to disclose.
Michael Mathelier, BS	Mr. Mathelier has nothing to disclose.
Anum Khaliq, MD	Dr. Khaliq has nothing to disclose.
Daniela Pomar Forero, MD (University of Florida)	Ms. Pomar Forero has nothing to disclose.
Bakhtawar Ahmad, MBBS	Dr. Ahmad has nothing to disclose.
Rodrigo F. Alcala Arana, Medical Student	Dr. Alcala Arana has nothing to disclose.
Mary E. Edwards, EdD	Dr. Edwards has received publishing royalties from a publication relating to health care.
Carolina B. Maciel, MD, MSCR, FAAN	Dr. Maciel has received research support from American Heart Association. Dr. Maciel has received research support from National Institute of Health.
Katharina M. Busl, MD, MS, FAAN (University of Florida)	Dr. Busl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Rissman Law. Dr. Busl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Huffman Powell Baley. Dr. Busl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for University Science. Dr. Busl has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SCCM. Dr. Busl has a non-compensated relationship as a Board Member with Art in Medicine that is relevant to AAN interests or activities. Dr. Busl has a non-compensated relationship as a Associate Editor with Critical Care Explorations that is relevant to AAN interests or activities. Dr. Busl has a non-compensated relationship as a Assistant Editor with Neurocritical Care that is relevant to AAN interests or activities.

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