A higher proportion of patients experienced adverse events compared with clinical trials. The greater severity of disease amongst patients treated in clinical practice may explain the observed rate of post-procedural stay and readmission. Study of long-term safety and efficacy requires continuing data collection.

ObjectivesUse 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’.DesignProspective, longitudinal, cohort, multicentre registry study.SettingAll (11) UK centres performing BT.Participants and interventionPatients 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 measuresEfficacy: AQLQ, ACQ, EuroQol, HADS anxiety and HADS depression scores, FEV1(% 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’.ResultsFollowing 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 FEV1was 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.ConclusionsImprovement 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.

Routinely collected HES data have the potential to support quality improvements and evidence-based commissioning of devices and procedures in health services but achievement of this potential depends upon the accurate coding of procedures.

Background To determine real-world outcomes of prostatic urethral lift (UroLift) procedures conducted in hospitals across England. Methods A retrospective observational cohort was identified from Hospital Episode Statistics data including men undergoing UroLift in hospitals in England between 2017 and 2020. Procedure uptake, patient demographics, inpatient complications, 30-day accident and emergency re-attendance rate, requirement for further treatment and catheterization were captured. Kaplan–Meier and hazard analysis were used to analyse time to re-treatment. Results 2942 index UroLift procedures from 80 hospital trusts were analysed; 85.3% conducted as day-case surgery (admitted to hospital for a planned surgical procedure and returning home on the same day). In-hospital complication rate was 3.4%. 93% of men were catheter-free at 30 days. The acute accident and emergency attendance rate within 30 days was 12.0%. Results of Kaplan Meier analysis for subsequent re-treatment (including additional UroLift and endoscopic intervention) at 1 and 2 years were 5.2% [95% CI 4.2 to 6.1] and 11.9% [10.1 to 13.6] respectively. Conclusions This real-world analysis of UroLift shows that it can be delivered safely in a day-case setting with minimal morbidity. However, hospital resource usage for catheterization and emergency hospital attendance in the first 30 days was substantial, and 12% required re-treatment at 2 years.

In August 2012, the National Institute for Health and Care Excellence produced positive diagnostics guidance on the ultrasound contrast agent SonoVue®, but recommended further research involving an estimation of the proportion of unenhanced ultrasound scans reporting, but not characterising, focal liver lesions, particularly in cirrhotic livers. Patient records from the Radiology Information System of an acute hospital trust were progressively filtered based on categorical fields and keywords in the free text reports, to obtain ultrasound records including the liver that were appropriate for manual analysis. In total, 21,731 records referred from general practice or out-patient clinics were analysed. Patients described as having cirrhosis were analysed as a subgroup. After automatic exclusion of records considered likely to be negative, 5812 records were manually read and categorised as focal liver lesion inconclusive, benign or malignant. In the general practice cohort of 9175 records, 746 reported the presence of one or more focal liver lesions, with 18.4% (95% CI 15.7% to 21.3%) of these records mentioning an inconclusive focal liver lesion. In the out-patient cohort of 12,556 records, 1437 reported one or more focal liver lesions, and 29.4% (95% CI 26.9% to 32.0%) of these were inconclusive. Cirrhosis was reported in 10.8% of the out-patient scans that also reported a focal liver lesion, and 47.4% (95% CI 39.3% to 55.6%) of these scans had an inconclusive focal liver lesion, compared with 27.3% (95% CI 24.9% to 29.8%) that were inconclusive in non-cirrhotic livers (odds ratio 2.4; 95% CI 1.7 to 3.4). This retrospective study indicates that unenhanced ultrasound scans, in which a focal liver lesion is detected, are frequently inconclusive, with the probability of an inconclusive scan being greater in out-patient than general practice referrals. Inconclusive focal liver lesions were also reported in greater proportions of cirrhotic than non-cirrhotic livers. The results of this research will inform future updates of National Institute for Health and Care Excellence diagnostics guidance.

There was no association between the outcomes of endovascular iliac artery intervention and centre volume, but outcomes were significantly worse with increasing age and female sex.

With equivalent parameters, the R-SPRT and LC-CUSUM formulations of sequential tests produced different outcomes, demonstrating that the choice of test method, as well as the choice of parameters, is important in designing a training scheme. The R-SPRT detects incompetence as well as competence and may indicate need for further training. Simulations are valuable in estimating the proportions of trainees expected to be assessed as competent.

Objectives:To assess the safety and efficacy in routine clinical practice of balloon dilatation procedures in the treatment of paediatric airway stenosis.Design: Observational data collection in prospective online research database.Setting: Acute NHS Trusts with ENT department undertaking complex paediatric airway work.Participants: Children (<18) undergoing balloon dilatation treatment for airway stenosis. Main outcome measures: Airway diameter, complications, hospital resource usage.Results: Fifty-nine patients had 133 balloon procedures during 128 visits to 10 hospitals. Sixty-nine (52%) of balloon procedures were conducted with a tracheostomy.Intra-operative Cotton-Myer grade decreased in 43 (57%). The mean pre-balloon subglottic diameter was 4.2 [95% CI: 3.8 to 4.5] mm, and its rate of increase was 0.8 [0.5 to 1.2] mm per year modelled on 30 patients' long-term data. As the primary treatment of stenosis, the procedural success rate of balloon dilatation (n = 52) was 65% (22% with tracheostomy, 88% without tracheostomy), and 71% as an adjunct to open reconstructive surgery (n = 7). In the 64 hospital visits where a balloon procedure was conducted with a tracheostomy in place, only one in-hospital complication (lower respiratory tract infection) occurred. For those without a tracheostomy in place, inhospital complications occurred in seven of 64 balloon hospital visits, all related to ongoing or worsening stenosis. Six out-of-hospital complications were deemed related to ongoing or worsening stenosis following the procedure, and two complications were a combination of lower respiratory infection and ongoing or worsening stenosis. Conclusions: Balloon dilation increases the size of the airway intraoperatively andis associated with long-term increase in airway diameter. Safety outcomes mostly relate to ongoing or worsening stenosis and are more common in patients without a tracheostomy.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.