The Diversity of Research Participants in Randomized Controlled Trials and Observational Studies Conducted by the Canadian Critical Care Trials Group
Bibliographic record
Abstract
Abstract Rationale Women, older individuals, and racial and ethnic minority groups are often underrepresented in research studies. Objectives We evaluated the demographics and diversity of participants enrolled in randomized controlled trials (RCTs) and observational studies published by investigators in association with the Canadian Critical Care Trials Group. Methods We performed quantitative content analysis of peer-reviewed RCTs and observational studies from December 1994 to December 2022. For each publication, we extracted participant demographic variables, including sex, gender, age, race or ethnicity, sexual orientation, pregnancy status, language proficiency, income/financial status, housing, education, disability, and geography. Results A total of 120 publications (28 RCTs, 92 observational studies) included 211,144 enrolled participants. Most (107 of 120; 89.2%) were multicenter studies, and 70% (84 of 120) were conducted exclusively in Canadian centers; 77.5% (93 of 120) studies enrolled adult participants, and 19.2% (23 of 120) enrolled pediatric participants. All studies reported participant mean or median age, 118 (98.3%) reported binary sex or gender, and 9 (7.5%) reported race or ethnicity. No justification was provided in 35 studies that listed pregnancy as an exclusion. There was infrequent reporting of housing (n = 4), employment (n = 2), income (n = 2), and education (n = 1). No studies reported the language proficiency, sexual orientation, disability, or geography of participants. Of the studies reporting gender, women and/or girls comprised 42.3% participants (range, 8.9–67.7%). Within nine studies reporting race or ethnicity of 2,950 participants, 59.7% were White, 8% South Asian, 7% Indigenous, 3% Asian, 1% Black, 14% unknown, and 6% “other.” Conclusions Research publications from the Canadian Critical Care Trials Group infrequently report important participant demographics, and diversity of research participants is disproportionate compared with Canadian societal demographics.
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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 | 0.600 | 0.819 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.036 | 0.040 |
| Science and technology studies | 0.006 | 0.009 |
| Scholarly communication | 0.013 | 0.007 |
| Open science | 0.006 | 0.007 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".