Wong Joanna Kae Ling, Thomas Caroline, Gravett Hannah, Thobhani Kavi, Mekhaimar Ayah, Wong Jan Man, Wan Yize Isalina
Department of Anaesthesia, Royal London Hospital, Barts Health NHS Trust, London, UK.
Department of Anaesthesia, St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
BJA Open. 2025 Jul 24;15:100425. doi: 10.1016/j.bjao.2025.100425. eCollection 2025 Sep.
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 (=59, 98.3%), race/ethnicity (=10, 16.7%), place of residence (=1, 1.7%), and social capital (=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).
背景：重症监护和围手术期随机对照试验（RCT）中代表性不足限制了研究结果的普遍性，并加剧了健康不平等。这项对大型高质量RCT的系统评价分析了10年来公平性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日期间检索了MEDLINE、Embase和Clinicaltrials.gov，以查找招募接受重症监护/围手术期干预的成年人（年龄≥18岁）的RCT。我们检查了研究特征、参与者特征报告的完整性、考虑参与者特征的因素、不同的数据缺失率、参与者代表性以及改善公平招募的考虑因素。参与者特征使用PROGRESS框架定义：居住地、种族/民族/文化/语言、职业、性别、宗教、教育、社会经济地位和社会资本。我们使用Cochrane偏倚风险2工具评估偏倚风险。 结果：我们纳入了60项试验（52项重症监护试验，8项围手术期医学试验），涉及155036名参与者。平均（标准差）年龄为62.9（4.1）岁。试验报告了性别（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%）。9项（15.0%）试验对性别进行了统计学考量。两项试验存在性别数据缺失，缺失率分别为5.0%和0.3%。7项试验存在种族/民族数据缺失，缺失率为7.39%（四分位间距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。没有试验明确说明为改善公平招募所做的努力。 结论：大型高质量的重症监护和围手术期RCT在公平性数据的收集和报告方面不一致。女性和非白人参与者的代表性不足。这些发现可能会限制研究结果的普遍性。需要进一步开展工作以促进公平的研究设计。 系统评价方案：PROSPERO（CRD42023401126）
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