Statistical Analysis Plan for L-oxiracetam Outcomes in Clinical Assessment of Traumatic Brain Injury Effects Trial (LOCATE trial): A Randomized Controlled Clinical Trial
Bibliographic record
Abstract
Background: The L-oxiracetam Outcomes in Clinical Assessment of Traumatic Brain Injury Effects (LOCATE) trial is a national, multicenter, randomized, parallel-group, phase III trial including 74 centers across 51 hospitals from 2019 to 2024. The objective is to evaluate the efficacy and safety of L-oxiracetam in improving memory and cognitive impairment in patients with acute traumatic brain injury (TBI). Methods: A total of 591 patients aged 18-75 years will be enrolled with mild acute TBI. The primary outcome is the change in scores on the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) at 90 days post-treatment compared to baseline. Secondary outcomes included change from baseline in LOTCA, Glasgow Coma Scale (GCS), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Glasgow Outcome Scale-Extended (GOS-E), and Barthel Index of Activities of Daily Living (ADL-BI) assessed at the end of treatment, 30 days, 60 days, and/or 90 days. A sample size of 591 allows 80% power (a=0.05) for the efficacy test in the primary outcome of LOTCA assessed at 90 days. Results: A detailed statistical analysis plan was developed for the LOCATE trial following international guidelines. The plan determined the statistical models for the primary and secondary outcomes and defined the covariates to be controlled and the content of the exploratory analyses. Conclusion: The application of this statistical analysis plan in the upcoming LOCATE trial will support an unbiased analysis of these important clinical data.
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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 | 0.050 | 0.073 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.007 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.005 | 0.009 |
| Insufficient payload (model declined to judge) | 0.042 | 0.006 |
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".