Safety of bronchial thermoplasty out to 5 years in patients with severe refractory asthma: Research in severe asthma (RISA) trial
Bibliographic record
Abstract
Introduction: Bronchial thermoplasty (BT) is a bronchoscopic procedure designed to control asthma by reducing airway smooth muscle mass. BT-treated patients from the RISA Trial have been followed to evaluate long-term safety. Methods: The RISA Trial enrolled 15 patients on ICS ≥1500μg BDP or equiv. + LABA ± ≤ 30mg OCS; pre-BD FEV 1 ≥50% predicted; and remained symptomatic (daytime symptoms on ≥10 of 14 days or rescue medication use on ≥8 of 14 days prior to enrollment). Long-term safety of BT was assessed over a 5 y period following BT. Results: 14 patients entered the long-term follow up phase. Safety measures are summarized below: Parameter Baseline Y1 Y2 Y 3 Y 4 Y 5 (n=14) (n=14) (n=14) (n=14) (n=12) (n=12) Respiratory Adverse Events/Subject* 8.4 1.4 2.4 1.7 2.4 Hospitalizations for resp. symptoms Events (no. of subjects)* 10(6) § 6(3) 5(4) 3(2) 1(1) 1(1) ER visits for resp. symptoms Events (no. of subjects)* 3(2) § 3(3) 4(2) 0(0) 0(0) 1(1) Pre-BD FEV1 (% pred.) † 63.5 69.5 70.2 69.4 68.2 70.6 Post-BD FEV1 (% pred.) † 75.2 78.4 79.5 78.7 80.0 79.4 § Patient reported for the 12 mo prior to study entry. *Not significant (Repeated measures logistic regression (% of subjects reporting the event, Year 1 to 5). † Not significant (Repeated measures analysis (Year 1 to 5). There were no incidences of pneumothorax, intubation, mechanical ventilation, cardiac arrhythmias, or death as a result of BT treatment over the 5 y. Conclusions: The absence of clinical complications and the maintenance of stable lung function over a 5-y period post-BT in patients with severe refractory asthma suggest long-term safety of the procedure out to 5 y.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 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; 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".