Rationale and design of a multicentre, double-blind, prospective, randomized, European and Canadian study: Evaluating patient outcomes and costs of managing adults with post-stroke focal spasticity
Bibliographic record
Abstract
OBJECTIVE: This report describes the design of a study aiming to provide evidence for the extended use of botulinum toxin A in focal post-stroke upper and lower limb spasticity and to evaluate the impact of incorporating botulinum toxin treatment into the rehabilitation of patients with spasticity. DESIGN: International, prospective, randomized, double-blind, placebo-controlled study with an open-label extension. METHODS: Approximately 300 adults with a stroke occurring ≥ 3 months before screening, presenting with symptoms and signs of an upper motor neuron syndrome and focal spasticity-related functional impairment, were randomized to botulinum toxin (BOTOX®, Allergan Inc.) + standard care or placebo + standard care. Study medication was administered at baseline and again at Week 12 if required, with follow-up to 52 weeks. The primary endpoint was the number of patients who achieved their investigator-rated principal active functional goal (as measured by Goal Attainment Scaling), at 10 weeks after the second injection (Weeks 22-34) or at the 24-week visit if no second injection was administered. Secondary endpoints included changes from baseline in level of goal achievement, health-related quality of life and resource utilization. CONCLUSION: Botulinum toxin A Economic Spasticity Trial (BEST) will provide information regarding clinical and cost-effectiveness of botulinum toxin + standard care vs standard care alone in patients with upper and/or lower limb post-stroke spasticity typically seen in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov number NCT-00549783.
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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 | 0.106 | 0.058 |
| Meta-epidemiology (narrow) | 0.006 | 0.004 |
| Meta-epidemiology (broad) | 0.007 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.006 | 0.010 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.005 | 0.002 |
| Research integrity | 0.008 | 0.005 |
| Insufficient payload (model declined to judge) | 0.013 | 0.003 |
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".