Lumlertgul Nuttha, Wannakittirat Anyarin, Kung Janice Y, Srisawat Nattachai, Collister David, See Emily J, Pannu Neesh, Mehta Ravindra L, Soranno Danielle E, Ostermann Marlies, Bagshaw Sean M
Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University; Excellence Centre for Critical Care Nephrology, King Chulalongkorn Memorial Hospital; Centre of Excellence in Critical Care Nephrology, Chulalongkorn University, Bangkok, Thailand.
Division of Nephrology, Department of Medicine, Faculty of Medicine, Naresuan University Hospital, Phitsanulok, Thailand.
BMC Med. 2025 Jul 1;23(1):386. doi: 10.1186/s12916-025-04202-y.
How sex and gender are considered in randomized controlled trials (RCTs) in critical care nephrology is unclear. We aimed to perform a meta-epidemiologic study to describe the representation, sex and gender reporting, and sex- and gender-based analyses (SGBA) in high-impact RCTs in critical care nephrology.
We searched the Web of Science Core Collection for critical care nephrology papers from 2000 to 2024. We included trials published in high-impact journals in general medicine, pediatrics, critical care, and nephrology. The main outcome was the proportion of female/woman participants enrolled and the association with trial characteristics, findings, and women authorship. We estimated the participation-to-prevalence ratio (PPR) to evaluate the representativeness of females within identified RCTs and selected case-mix and disease populations. Sex and gender reporting and SGBA were investigated.
A total of 117 RCTs, including 106,057 participants, were included. Sex (54.7%), gender (26.5%), both (2.6%), or none (16.2%) terminology were used for reporting. Male/female (82.1%), men/women (11.1%), both (4.3%), boys/girls (0.9%) and none (1.7%) were used as descriptors. Of the 115 RCTs with available sex/gender data, the median proportion of female/women participants was 35.4% (interquartile range (IQR) 31.2%-40.8%). Pediatric age group and process of care as an intervention were independently associated with the proportion of female/women participants. The median PPR was 0.89 (IQR 0.8-1.06), except in major surgery, for which PPR was 0.67 (IQR 0.29-0.73). Twelve (10.9%) and 49 (41.9%) studies used sex and/or gender as inclusion and exclusion criteria, respectively; 5 (4.3%) studies used sex/gender-stratified randomization; and 35 (29.9%) studies performed SGBA. RCTs with pregnancy, lactation, or women of childbearing age as exclusion criteria had a lower enrollment of female/women participants than RCTs that did not (33.6% vs. 36.8%, P = 0.04). Exclusion criteria of pregnancy, lactation, or childbearing age were considered strongly justified, potentially justified, and poorly justified in 36.1%, 14.9%, and 48.9%, respectively. There were no changes in the representation of females/women and SGBA across identified RCTs over the search range.
Females/women are less frequently represented in critical care nephrology RCTs. Significant gaps exist in sex- and gender-specific eligibility criteria, reporting, and analysis.
在重症监护肾脏病学的随机对照试验（RCT）中，如何考虑性别和性别的问题尚不清楚。我们旨在进行一项元流行病学研究，以描述重症监护肾脏病学领域高影响力RCT中的代表性、性别报告以及基于性别的分析（SGBA）。
我们在科学网核心合集（Web of Science Core Collection）中检索了2000年至2024年的重症监护肾脏病学论文。我们纳入了发表在普通医学、儿科学、重症监护和肾脏病学高影响力期刊上的试验。主要结果是纳入的女性参与者比例以及与试验特征、结果和女性作者身份的关联。我们估计参与率与患病率之比（PPR），以评估已识别的RCT以及选定的病例组合和疾病人群中女性的代表性。对性别报告和SGBA进行了调查。
共纳入117项RCT，包括106,057名参与者。报告中使用了性别（54.7%）、性（26.5%）、两者（2.6%）或都不使用（16.2%）术语。使用男性/女性（82.1%）、男性/女性（11.1%）、两者（4.3%）、男孩/女孩（0.9%）和都不使用（1.7%）作为描述词。在115项有可用性别/性数据的RCT中，女性参与者的中位数比例为35.4%（四分位间距（IQR）31.2%-40.8%）。儿科年龄组和作为干预措施的护理过程与女性参与者比例独立相关。中位数PPR为0.89（IQR 0.8-1.06），重大手术除外，其PPR为0.67（IQR 0.29-0.73）。分别有12项（10.9%）和49项（41.9%）研究将性别和/或性作为纳入和排除标准；5项（4.3%）研究使用了性别分层随机化；35项（29.9%）研究进行了SGBA。将怀孕、哺乳或育龄女性作为排除标准的RCT，其女性参与者的入组率低于未将这些作为排除标准的RCT（33.6%对36.8%，P = 0.04）。怀孕、哺乳或育龄的排除标准被认为有充分理由、可能有理由和理由不足的分别为36.1%、14.9%和48.9%。在搜索范围内，已识别的RCT中女性的代表性和SGBA没有变化。
在重症监护肾脏病学RCT中，女性的代表性较低。在性别特异性的纳入标准、报告和分析方面存在显著差距。
