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Murine Model of Controlled Cortical Impact for the Induction of Traumatic Brain Injury
Published on: August 16, 2019
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Sex Differences in Moderate-to-Severe Traumatic Brain Injury Randomized Controlled Trials
Cecilia Flores-Sandoval1, Heather M MacKenzie2,3, Emma A Bateman1,2,3
1Parkwood Institute Research, Lawson Research Institute, London, ON, Canada.
Summary
Females are underrepresented in traumatic brain injury (TBI) clinical trials, with only 23% of participants being female. This sex disparity is more pronounced in acute TBI research, hindering equitable treatment development.
Area of Science:
- Neuroscience
- Clinical Research
- Sex Differences in Medicine
Background:
- Understanding sex differences in moderate-to-severe traumatic brain injury (TBI) is crucial for tailored care.
- Epidemiological data indicates males constitute 70% of TBI cases, while females represent 30-33%.
Purpose of the Study:
- To determine the proportion of female and male participants in randomized controlled trials (RCTs) for moderate-to-severe TBI.
- To assess trends in sex representation within TBI RCTs over time.
Main Methods:
- A systematic review adhering to PRISMA guidelines was conducted.
- Searched multiple databases (MEDLINE, PubMed, Scopus, CINAHL, EMBASE, PsycINFO) up to December 2022.
- Included RCTs with adult participants (≥18 years) and at least 50% moderate-to-severe TBI cases.
Main Results:
- 595 RCTs (1978-2022) involving 86,662 participants were analyzed.
- The average proportion of female participants across all RCTs was 23.14%.
- Female underrepresentation was significantly greater in acute phase (≤1 month) RCTs compared to chronic phase (≥6 months) studies.
Conclusions:
- Females remain significantly underrepresented in moderate-to-severe TBI RCTs.
- Addressing this sex disparity is essential for developing effective TBI treatments for all individuals.
- Future research should prioritize equitable sex inclusion in TBI clinical trials.

