Treatment Outcomes in Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE) (P7.069)
Bibliographic record
Abstract
OBJECTIVE: To evaluate the effectiveness and safety of onabotulinumtoxinA treatment for cervical dystonia (CD). BACKGROUND: CD PROBE is a prospective, observational, multicenter registry designed to assess safety, effectiveness, and treatment utilization of onabotulinumtoxinA in clinical practice (ClinicalTrials.gov NCT00836017; Jankovic, et al. BMC Neurol 2011;11:140). METHODS: CD PROBE subjects were naïve to botulinum toxin, new to practice, or had 蠅16 weeks since last treatment if in a previous clinical trial. Effectiveness assessments included Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), Clinician Global Impression of Change (CGIC), Patient Global Impression of Change (PGIC), and Pain Numeric Rating Scale (PNRS). Dosages and inter-dose intervals varied due to the real-world nature of the design. Descriptive and inferential statistics were utilized to evaluate changes in outcomes over 3 treatments. RESULTS: In the 1046 enrolled subjects (74.4% female; 63.5% toxin naïve), mean age was 58.0±14.7y, mean time from onset to diagnosis was 5.0±8.1y, mean time from diagnosis to first treatment was 1.1±4.5y. Mean dose was 189.8±87.1U, with an average of 14.6 and 15.1 weeks between treatments. Mean TWSTRS total score in subjects who completed all TWSTRS assessments (n=479) decreased from 39.2 at baseline to 27.1 at final visit (P<0.0001). Furthermore, a significantly higher percentage of physicians reported improvement in CGIC from initial to final assessment (n=479, 91.2% vs 95.0%; P<0.0001), and significantly higher percentages of subjects reported improvement in PGIC (n=470; 83.0% vs 91.7%; P<0.0001). Mean PNRS scores significantly improved from 6.2±2.2 to 4.2±2.5 (n=286; P<0.0001). Regarding safety, 17.8% (n=185) subjects reported 蠅1 treatment-related adverse event (AE) and 3.2% (n=33) reported a serious AE. The most common AEs were muscular weakness (7.0%), dysphagia (6.4%), and neck pain (2.7%). CONCLUSIONS: Results from CD PROBE, the largest registry for CD, support the conclusion that onabotulinumtoxinA is an effective and safe treatment for patients with focal dystonia involving neck muscles. Study Supported by: Allergan, Inc.
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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 | 0.002 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".