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Abstract
Background Female participants are underrepresented in randomised control trials conducted in urgent care settings. Although sex and gender are frequently reported within demographic data, it is less common for primary outcomes to be disaggregated by sex or gender. The aim of this review is to report sex and gender of participants in the primary papers published on research listed on the National Institute of Health and Care Research (NIHR) Trauma and Emergency Care (TEC) portfolio and how these data are presented.
Methods This is a systematic review of the published outputs of interventional trials conducted in UK EDs. Interventional trials were eligible to be included in the review if they were registered on the NIHR TEC research portfolio from January 2010, if the primary paper was published before 31 December 2023 and if the research was delivered primarily in the ED. Trials were identified through the NIHR open data platform and the primary papers were identified through specific searches using MedLine, EMBASE and PubMed. The primary objective of the review is to quantify the proportion of sex-disaggregated or gender-disaggregated primary outcomes in clinical trials within UK emergency medicine.
Results The initial search revealed 169 registered research projects on the NIHR TEC portfolio during the study period, of which 24 met the inclusion criteria. Overall, 76 719 participants were included, of which 31 374 (40%) were female. Only one trial (CRYOSTAT-2) reported a sex-disaggregated analysis of the effect of the intervention on either primary or secondary outcomes, and no sex-based difference in treatment effect was detected.
Conclusions Fewer females than males were included in TEC trials from 2010 to 2023. One trial reported the primary outcome stratified by sex. There is significant scope to increase the scientific value of TEC trials to females by funders.
- Clinical Trial
- methods
- research design
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
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Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information.
Footnotes
Handling editor Richard Body
Contributors RA-C conceived the study, with support from JP. RA-C and JP conducted the search screening and full text identification. RA-C extracted data for the primary outcome and study characteristics. RA-C drafted the paper with JP, EC and BMB. All authors provided comments on the paper. RA-C acts as guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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