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Eligibility Criteria and Consent Practices of Randomized Controlled Trials in Trauma Care: A Systematic Review
Angela Li1, Kevin Durr2, Bram Rochwerg3
1Faculty of Medicine, University of Ottawa, Ottawa, Canada.
Introduction:
High quality randomized controlled trials (RCTs) are essential for evaluating the efficacy and safety of interventions in trauma care, but their external validity is often limited by restrictive eligibility criteria and challenges with obtaining timely informed consent. To assess the eligibility criteria and consent practices of RCTs involving trauma patients, with a focus on the justification of exclusion criteria and the consideration of sociodemographic characteristics.
Methods:
We conducted a systematic review of RCTs involving adult trauma patients, searching Medline and Embase from January 1, 2000 through April 11, 2025. We assessed eligibility criteria independently and in duplicate as strongly, potentially, or poorly justified based on prespecified criteria. We also evaluated the inclusion of PROGRESS-Plus sociodemographic characteristics and various consent approaches that were used.
Results:
Of 1839 citations, we included 55 eligible RCTs. Among these studies, we identified 302 unique exclusion criteria, of which 247 (82%) were strongly or potentially justified. Age restrictions and pregnancy or lactation exclusions were common; poorly justified criteria most often involved unexplained age thresholds or pregnancy/lactation exclusions without a trial-specific safety rationale. Approximately two thirds of patients screened were ineligible for inclusion. Among PROGRESS-Plus factors, only age and sex were consistently reported as part of baseline characteristics. Consent approaches differed across studies, with the majority (62%) of trials obtaining consent from patients or their substitute decision-makers. Besides studies using waivers of consent (16%), consent was most frequently obtained a priori (67%), with a further 11% not reporting their method of consent and 6% using deferred consent.
Conclusions:
Trauma RCTs can exclude patients based on poorly justified criteria, thereby limiting external generalizability. Greater transparency and inclusivity with regards to eligibility criteria, as well as systematic approaches to consent are necessary to improve the applicability of trauma research.
