Sex and gender considerations in randomized controlled trials in critical care nephrology: a meta-epidemiologic study
Why this work is in the frame
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Bibliographic record
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Females/women are less frequently represented in critical care nephrology RCTs. Significant gaps exist in sex- and gender-specific eligibility criteria, reporting, and analysis.
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Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | MetaresearchMeta-epidemiology (broad)Meta-epidemiology (narrow) Domain: Methods · Genre: Review About the Canadian research system: no · About a Canadian topic: no | Systematic review | medium |
| gpt | Meta-epidemiology (broad)Meta-epidemiology (narrow) Domain: not available · Genre: Review About the Canadian research system: no · About a Canadian topic: no | Other design | medium |
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.059 | 0.364 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.057 | 0.002 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it