Equity of participants in clinical trials in critical care and perioperative medicine research: a systematic review

Joanna Kae Ling Wong¹, Caroline Thomas², Hannah Gravett³, Kavi Thobhani⁴, Ayah Mekhaimar⁵, Jan Man Wong⁶, Yize Isalina Wan^{7

8}

Affiliations

¹ Department of Anaesthesia, Royal London Hospital, Barts Health NHS Trust, London, UK.
² Department of Anaesthesia, St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
³ Department of Anaesthesia, Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Trust, Doncaster, UK.
⁴ Barts and The London School of Medicine, Queen Mary University of London, London, UK.
⁵ Critical Care and Peri-operative Medicine Research group, William Harvey Research Institute, Faculty of Medicine, Queen Mary University of London, London, UK.
⁶ Department of Anaesthesia, Homerton University Hospital, Homerton Healthcare NHS Foundation Trust, London, UK.
⁷ William Harvey Research Institute, Queen Mary University of London, London, UK.
⁸ Acute Critical Care Research Unit, Royal London Hospital, Barts Health NHS Trust, London, UK.

PMID: 40746650
PMCID: PMC12311584
DOI: 10.1016/j.bjao.2025.100425

Review

Equity of participants in clinical trials in critical care and perioperative medicine research: a systematic review

Joanna Kae Ling Wong et al. BJA Open. 2025.

. 2025 Jul 24:15:100425.

doi: 10.1016/j.bjao.2025.100425. eCollection 2025 Sep.

Authors

Joanna Kae Ling Wong¹, Caroline Thomas², Hannah Gravett³, Kavi Thobhani⁴, Ayah Mekhaimar⁵, Jan Man Wong⁶, Yize Isalina Wan^{7

8}

Affiliations

¹ Department of Anaesthesia, Royal London Hospital, Barts Health NHS Trust, London, UK.
² Department of Anaesthesia, St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
³ Department of Anaesthesia, Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Trust, Doncaster, UK.
⁴ Barts and The London School of Medicine, Queen Mary University of London, London, UK.
⁵ Critical Care and Peri-operative Medicine Research group, William Harvey Research Institute, Faculty of Medicine, Queen Mary University of London, London, UK.
⁶ Department of Anaesthesia, Homerton University Hospital, Homerton Healthcare NHS Foundation Trust, London, UK.
⁷ William Harvey Research Institute, Queen Mary University of London, London, UK.
⁸ Acute Critical Care Research Unit, Royal London Hospital, Barts Health NHS Trust, London, UK.

PMID: 40746650
PMCID: PMC12311584
DOI: 10.1016/j.bjao.2025.100425

Abstract

Background: Underrepresentation in critical care and perioperative randomised controlled trials (RCTs) limit generalisability and drive health inequity. This systematic review of large, high-quality RCTs analysed representation and reporting trends of equity data over 10 yr.

Methods: We searched MEDLINE, Embase, and Clinicaltrials.gov between 01 January 2013 and 11 May 2023 for RCTs recruiting adults (age ≥18 yr) receiving a critical care/perioperative intervention. We examined study characteristics, completeness of participant characteristic reporting, considerations accounting for participant characteristics, differential missing data rates, participant representativeness, and considerations to improve equitable recruitment. Participant characteristics were defined using the PROGRESS framework: Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social capital. We assessed risk of bias using the Cochrane Risk of Bias 2 tool.

Results: We included 60 trials (52 critical care, eight perioperative medicine) involving 155 036 participants. Mean (sd) age was 62.9 (4.1) yr. Gender/sex (n=59, 98.3%), race/ethnicity (n=10, 16.7%), place of residence (n=1, 1.7%), and social capital (n=1, 1.7%) were reported in trials. Statistical considerations were made for gender/sex in nine (15.0%) trials. Gender/sex data were missing in two trials with 5.0% and 0.3% missingness. Race/ethnicity data were missing in seven trials, with 7.39% (inter-quartile range 0.4-19.2%) missingness. Trials underrepresented female and non-White participants compared with baseline populations. No trial explicitly stated efforts to improve equitable recruitment.

Conclusions: Large, high-quality critical care and perioperative RCTs inconsistently collect and report equity data. Female and non-White participants are underrepresented. These findings potentially limit generalisability of research findings. Further work is required to promote equitable study designs.

Systematic review protocol: PROSPERO (CRD42023401126).

Keywords: critical care; equity; perioperative medicine; randomised clinical trials; recruitment.

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Conflict of interest statement

YIW is a member of the associate editorial board of the British Journal of Anaesthesia.

Figures

**Fig 1**
PRISMA flowchart for the study selection process. RoB, risk of bias.

See this image and copyright information in PMC

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Equity of participants in clinical trials in critical care and perioperative medicine research: a systematic review

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Equity of participants in clinical trials in critical care and perioperative medicine research: a systematic review

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Conflict of interest statement

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