Efficacy and safety of bronchial thermoplasty in clinical practice: a prospective, longitudinal, cohort study using evidence from the UK Severe Asthma Registry
Bibliographic record
Abstract
Objectives Use data from the UK Severe Asthma Registry (UKSAR) to assess the efficacy and safety of bronchial thermoplasty (BT) in routine UK clinical practice and to identify characteristics of ‘responders’. Design Prospective, longitudinal, cohort, multicentre registry study. Setting All (11) UK centres performing BT. Participants and intervention Patients receiving BT in the UK between 01/06/2011 and 30/09/2016 who had consented to data entry into UKSAR (n=133). Efficacy data were available for 86 patients with a BT baseline and at least one follow-up record. Safety data were available for 131 patients with at least one BT procedure record. Primary and secondary outcome measures Efficacy: AQLQ, ACQ, EuroQol, HADS anxiety and HADS depression scores, FEV 1 (% predicted), rescue steroid courses, unscheduled healthcare visits (A&E/Asthma clinic/GP), hospital admissions and days lost from work/school. Safety: peri-procedural events, device problems and any other safety-related findings. Responder analysis: differences in baseline characteristics of ‘responders’ (≥0.5 increase in AQLQ at 12 months) and ‘non-responders’. Results Following Bonferroni correction for paired comparisons, mean improvement in AQLQ at 12 months follow-up compared with BT baseline was statistically and clinically significant (0.75, n=28, p=0.0003). Median reduction in hospital admissions/year after 24 months follow-up was also significant (−1.0, n=26, p<0.0001). No deterioration in FEV 1 was observed. From 28 patients with AQLQ data at BTBL and 12-month follow-up, there was some evidence that lower age may predict AQLQ improvement. 18.9% (70/370) of procedures and 44.5% (57/128) of patients were affected by an adverse event; only a minority were considered serious. Conclusions Improvement in AQLQ is consistent with similar findings from clinical trials. Other efficacy outcomes demonstrated improving trends without reaching statistical significance. Missing follow-up data impacted this study but multiple imputation confirmed observed AQLQ improvement. The safety review suggested BT is being performed safely in the UK.
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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 | 0.009 | 0.019 |
| Meta-epidemiology (narrow) | 0.000 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 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".