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

BJA open Pub Date : 2025-07-24 DOI:10.1016/j.bjao.2025.100425

Joanna Kae Ling Wong , Caroline Thomas , Hannah Gravett , Kavi Thobhani , Ayah Mekhaimar , Jan Man Wong , Yize Isalina Wan

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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)

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重症监护和围手术期医学研究临床试验参与者的公平性：一项系统综述

背景：危重病护理和围手术期随机对照试验（RCTs）的代表性不足限制了普遍性，并导致健康不公平。本系统综述对大型、高质量的随机对照试验进行了分析，分析了10年来公平数据的代表性和报告趋势。方法我们在2013年1月1日至2023年5月11日期间检索MEDLINE、Embase和Clinicaltrials.gov，检索招募接受重症监护/围手术期干预的成人（年龄≥18岁）的随机对照试验。我们检查了研究特征、参与者特征报告的完整性、对参与者特征的考虑、差异缺失数据率、参与者代表性以及改善公平招募的考虑。使用PROGRESS框架定义参与者特征：居住地、种族/民族/文化/语言、职业、性别/性别、宗教、教育、社会经济地位和社会资本。我们使用Cochrane risk of bias 2工具评估偏倚风险。结果纳入60项试验（52项危重医学试验，8项围手术期医学试验），共纳入155036名受试者。平均（sd）年龄为62.9（4.1）岁。在试验中报告了性别/性别（n=59, 98.3%）、种族/民族（n=10, 16.7%）、居住地（n=1, 1.7%）和社会资本（n=1, 1.7%）。在9项（15.0%）试验中对性别/性别进行了统计考虑。两项试验缺少性别/性别数据，缺失率分别为5.0%和0.3%。7项试验缺少种族/族裔数据，缺失率为7.39%（四分位数间距为0.4-19.2%）。与基线人群相比，试验中女性和非白人参与者的代表性不足。没有一项试验明确说明了改善公平招聘的努力。结论：大型、高质量的危重病护理和围手术期随机对照试验收集和报告的公平数据不一致。女性和非白人参与者的人数不足。这些发现可能会限制研究结果的普遍性。需要进一步的工作来促进公平的研究设计。系统评价协议prospero （CRD42023401126）

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