Clinical Trials in Acute Stroke: Is it ethical to randomise patients to the placebo group?.
Bibliographic record
Abstract
P178 The ethics of randomising a patient to the placebo group in acute stroke clinical trials has been called into question in one study as these patients may be deprived of routinely applied therapies. No other study has previously analysed this hypothesis. Objective: To compare the prognosis at day 90 of patients included in clinical trials of acute stroke and randomised to the placebo group with patients not included in any clinical trial. Material and Methods: 50 patients consecutively included in the placebo group (CLASS, ECASS-II, Trafermin, GAIN), and 50 patients not included in any clinical trial randomly selected from those sharing similar characteristics (age, sex, stroke severity and stroke subtype using the TOAST criteria) and hospitalised during the same period. Results: No differences were found in neurological attention delay, Canadian scale at admission, final infarct volume and length of hospital stay. The placebo group had a lower proportion of progressing stroke than the control group (14% vs. 25%). Infectious and cardiovascular complications were more frequent in the placebo group (12% vs. 6% and 15% vs. 8%, respectively). However, the placebo group displayed a more favourable outcome at day 90 (Figure). Conclusions: Inclusion in a placebo group in acute stroke clinical trials results in a significant benefit. This advantage may be explained by a more active intervention over progressing stroke, resulting from a higher rate of detection and control of the related factors.
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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 | 0.231 | 0.435 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.002 | 0.013 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.018 | 0.013 |
| Insufficient payload (model declined to judge) | 0.005 | 0.005 |
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".