Abstract WMP106: Why Are Women Less Represented in ICH Trials?
Bibliographic record
Abstract
Background: Fewer women than men tend to be enrolled in clinical trials of intracerebral hemorrhage (ICH). It is unclear whether this reflects lower prevalence of ICH in women, selection bias, poor recruitment efforts, or other factors. We undertook this study to examine differences between women and men in the reasons for exclusion from the iDEF (Intracerebral hemorrhage Deferoxamine) trial. Methods: The screen failure log included 29 different reasons for exclusion. Chi square statistics and p-values were used to evaluate whether women and men differed with regard to reason for screen failure. Findings: The iDEF trial enrolled 294 subjects; 38.5% were women. A total of 8776 subjects were screen failures. Sex was missing in 58. The remaining 8718 were included in this analysis; 3982 women (45.7%) and 4736 men (54.3%) (p<0.0001). The enrollment rates were 2.8% in women vs. 3.7% in men (p=0.01). We were unable to obtain consent in 1.3% of women vs 1.7% of men (p=0.1), and patients/families declined participation in 1.3% of women vs. 1.3% of men (p=0.9). More women than men failed screening because of age >80 (22.4% vs 12.6%) and pre-existing DNR/DNI (3.7% vs. 2.8%). Conversely, fewer women than men failed screening because inability to administer study drug within 24 hour due to late presentation (6.6% vs 7.8%), admission NIHSS score <6 (10.2% vs 13.2%), coagulopathy (5.3% vs 7.5%), inability to comply with the protocol (0.7% vs 1.3%), abnormal renal function (1.9% vs 2.9%), drug/alcohol abuse (1.7% vs 3.7%), and presentation with confirmed aspiration or pneumonia (1.1% vs 1.8%).These differences were statistically significant. Interpretation: Results from this multi-center, prospective, ICH trial indicate that lower rates of women enrollment may be attributed to older age and higher rates of pre-existing DNR/DNI orders. Inability to obtain consent or declining participation was similar between women and men, arguing against selection bias. Our findings should be confirmed in other ICH trials to determine if additional efforts are needed to improve women’s participation in future studies. Funding: US National Institutes of Health and US National Institute of Neurological Disorders and Stroke (U01NS074425)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.058 | 0.172 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.013 | 0.002 |
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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".