Prostatic urethral lift (UroLift): a real-world analysis of outcomes using hospital episodes statistics.

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.

Balloon dilatation for paediatric airway stenosis: Evidence from the UK Airway Intervention Registry.

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, in-hospital 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 and is 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.

Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics.

OBJECTIVE: Bronchial thermoplasty (BT) is a novel treatment for severe asthma. Its mode of action and ideal target patient group remain poorly defined, though clinical trials provided some evidence on efficacy and safety. This study presents procedural and short-term safety evidence from routine UK clinical practice. METHODS: Patient characteristics and safety outcomes (procedural complications, 30-day readmission and accident and emergency (A&E) attendance, length of stay) were assessed using two independent data sources, the British Thoracic Society UK Difficult Asthma Registry (DAR) and Hospital Episodes Statistics (HES) database. A matched cohort (with records in both) was used to estimate safety outcome event rates and compare them with clinical trials. RESULTS: Between June 2011 and January 2015, 215 procedure records (83 patients; 68 treated in England) were available from DAR and 203 (85 patients) from HES. 152 procedures matched (59 patients; 6 centres), and of these, 11.2% reported a procedural complication, 11.8% resulted in emergency respiratory readmission, 0.7% in respiratory A&E attendance within 30 days (20.4% had at least one event) and 46.1% involved a post-procedure stay. Compared with published clinical trials which found lower hospitalisation rates, BT patients in routine clinical practice were, on average, older, had worse baseline lung function and asthma quality of life. CONCLUSIONS: 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.

Monitoring the use and outcomes of new devices and procedures: how does coding affect what Hospital Episode Statistics contribute? Lessons from 12 emerging procedures 2006-10.

BACKGROUND: New devices and procedures are often introduced into health services when the evidence base for their efficacy and safety is limited. The authors sought to assess the availability and accuracy of routinely collected Hospital Episodes Statistics (HES) data in the UK and their potential contribution to the monitoring of new procedures. METHODS: Four years of HES data (April 2006-March 2010) were analysed to identify episodes of hospital care involving a sample of 12 new interventional procedures. HES data were cross checked against other relevant sources including national or local registers and manufacturers' information. RESULTS: HES records were available for all 12 procedures during the entire study period. Comparative data sources were available from national (5), local (2) and manufacturer (2) registers. Factors found to affect comparisons were miscoding, alternative coding and inconsistent use of subsidiary codes. The analysis of provider coverage showed that HES is sensitive at detecting centres which carry out procedures, but specificity is poor in some cases. CONCLUSIONS: 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.

Assessment of competency in clinical measurement: comparison of two forms of sequential test and sensitivity of test error rates to parameter choice.

OBJECTIVE: To assess clinical measurement competency by two sequential test formulations [resetting sequential probability ratio test (R-SPRT) and learning curve cumulative summation (LC-CUSUM)]. DESIGN: Numerical simulation and retrospective observational study. SETTING: Obstetric ultrasound department. PARTICIPANTS: Cohorts of 10,000 simulated trainees and 62 obstetric sonographers training in nuchal translucency (NT) measurement at the 11-14-week pregnancy scan with limited case availability. INTERVENTION: Application of LC-CUSUM and R-SPRT to clinical measurement training. MAIN OUTCOME MEASURES: Proportions of real trainees achieving competency by LC-CUSUM and R-SPRT, proportions of simulated competent trainees not achieving competency (Type I error), proportions of simulated incompetent trainees achieving competency (Type II error), distribution of case number required to achieve competency (run length) and frequency of resets. RESULTS: For simulated cohorts, significant differences in run-length distribution and true test error rates were found between the R-SPRT and LC-CUSUM tests with equivalent parameters. Increasing the cases available to each trainee reduced the Type I error rate but increased the Type II error rate for both sequential tests for all choices of unacceptable failure rate. Discontinuities in the proportion of trainees expected to be test competent were found at critical values of unacceptable failure rate. CONCLUSIONS: 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.

Impact on stable chest pain pathways of CT fractional flow reserve.

OBJECTIVES: To evaluate the impact of introducing CT fractional flow reserve (FFRCT) on stable chest pain pathways, concordance with National Institute for Health and Care Excellence (NICE) chest pain guidelines, resource usage and revascularisation of patients from a tertiary UK cardiac centre rapid access chest pain clinic (RACPC). METHODS: Single-centre before and after study comparing data from electronic records and Strategic Tracing Service of all RACPC patients attending between 1 July 2017 and 31 December 2017, and 1 August 2018 and 31 January 2019. RESULTS: Two hundred and sixty-eight and 287 patients (overall mean age 62 years, range 26-89 years, 48.3% male), were eligible for first-line CT coronary angiography (CTCA) pre-FFRCT and post-FFRCT, respectively. First-line CTCA use per NICE Guideline CG95 increased (50.6% pre-FFRCT vs 75.7% post-FFRCT, p<0.001). More patients reached pathway endpoint (revascularisation or assumed medical management) after one investigation (74.9% pre-FFRCT vs 84.9% post-FFRCT, p=0.005). There were fewer stress (22.8% pre-FFRCT vs 7.7% post-FFRCT, p<0.001) and rest (10.4% pre-FFRCT vs 4.2% post-FFRCT, p=0.007) myocardial perfusion scans and diagnostic-only angiograms (25.5% vs 13.7%, p<0.001). Despite fewer invasive procedures (29.3% pre-FFRCT vs 17.6% post-FFRCT, p=0.002), revascularisation rates remained similar (10.4% pre-FFRCT vs 8.8% post-FFRCT, p=0.561). Avoiding invasive investigations reduced inpatient admissions (39.0% pre-FFRCT vs 24.3% post-FFRCT, p<0.001). Time to revascularisation was unchanged (153.5 days pre-FFRCT vs 142.0 post-FFRCT, p=0.925). Unplanned hospital attendances, emergency admissions and adverse events were similar. CONCLUSIONS: FFRCT adoption was associated with greater compliance with NICE guidelines, reduced invasive diagnostic angiography, planned admissions and needing more than one test to reach a pathway endpoint.

Our experience in developing and operating the Airway Intervention Registry for Recurrent Respiratory Papillomatosis (AIR-RRP): national data collection [version 2; peer review: 2 approved].

Recurrent respiratory papillomatosis (RRP) is characterised by benign wart-like growths in the respiratory tract caused by the human papillomavirus (HPV). These warts vary in size and grow quickly, causing voice changes and airway obstruction. Whilst the condition is rare, RRP is more common and aggressive in children. There is currently no curative treatment for HPV, therefore RRP is managed by maintaining a safe airway and a serviceable voice by repeated surgery to remove the growths. A lack of specific diagnostic codes prevents reliable case ascertainment of RRP from routine administrative databases such as Hospital Episode Statistics. In 2017 a cross-sectional survey identified 918 RRP patients in the UK, half of whom had received surgical intervention for RRP in the previous 12 months with 16 different interventions. Randomised controlled trials for RRP interventions are difficult due to the rarity of the disease, variation in severity and progression and non-standard care across the NHS. Consequently, there is a lack of definitive efficacy and safety evidence. The only national guidance for RRP interventions is "Radiofrequency cold ablation for respiratory papillomatosis" (NICE IPG434, 2017) which recommended further data collection due to lack of evidence. However, due to the wide variation in RRP management across the NHS, clinical opinion favoured that any data collection should include a comparison of safety and efficacy of all RRP interventions in order to advise which improved patient outcomes and quality of life. To address lack of evidence, and inform the future care of RRP patients, we developed a registry and used it to collect real-world data from patients receiving treatment for RRP in NHS hospitals across the UK. The purpose of this paper is to share lessons learned from this national data collection exercise to inform future clinical registry development.

Comparison of identifiable and non-identifiable data linkage: health technology assessment of MitraClip using registry, administrative and mortality datasets.

OBJECTIVES: The UK MitraClip registry was commissioned by National Health Service (NHS) England to assess real-world outcomes from percutaneous mitral valve repair for mitral regurgitation using a new technology, MitraClip. This study aimed to determine longitudinal patient outcomes by linking to routine datasets: Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Office of National Statistics. METHODS: Two methods of linkage were compared, using identifiable (NHS number, date of birth, postcode, gender) and non-identifiable data (hospital trust, age in years, admission, discharge and operation dates, operation and diagnosis codes). Outcome measures included: matching success, patient demographics, all-cause mortality and subsequent cardiac intervention. RESULTS: A total of 197 registry patients were eligible for matching with routine administrative data. Using identifiable linkage, a total of 187 patients (94.9%) were matched with the HES APC dataset. However, 21 matched individuals (11.2%) had inconsistencies across the datasets (eg, different gender) and were subsequently removed, leaving 166 (84.3%) for analysis. Using non-identifiable data linkage, a total of 170 patients (86.3%) were uniquely matched with the HES APC dataset.Baseline patient characteristics were not significantly different between the two methods of data linkage. The total number of deaths (all causes) identified from identifiable and non-identifiable linkage methods was 37 and 40, respectively, and the difference in subsequent cardiac interventions identified between the two methods was negligible. CONCLUSIONS: Patients from a bespoke clinical procedural registry were matched to routine administrative data using identifiable and non-identifiable methods with equivalent matching success rates, similar baseline characteristics and similar 2-year outcomes.

Prevalence of the EGFR T790M and other resistance mutations in the Australian population and histopathological correlation in a small subset of cases.

We sought to review the prevalence of EGFR T790M and other EGFR mutations associated with either proven or probable tyrosine kinase inhibitor (TKI) resistance in the Australasian lung cancer population and to perform histopathological correlation in a subset of cases. Retrospective statistical analysis was performed on a set of targeted lung cancer gene mutation tests (FIND IT gene panel) performed at Sonic Healthcare during 2018 and early 2019. A total of 1833 lung adenocarcinoma tumour samples underwent somatic mutation testing. EGFR mutations were found in 28% (n=514) of patients, in whom 9.3% (n=48) T790M mutations were present (always combined with other EGFR mutations) and 4.8% (n=25) exon 20 insertions were found. We also compared the prevalence of EGFR mutations identified in our population with that of the four largest publicly available lung cancer cohorts (total n=576 samples). Finally, a subset of 38 samples of primary/and or metastatic lung adenocarcinomas from 23 patients, including five with serial biopsies, underwent detailed morphological analysis. No reproducible morphological correlates were found to be associated with T790M, exon 20 resistance mutations or rarer co-occurring EGFR mutations. Although this may be subject to referral bias towards patients with resistant disease, the incidence of EGFR and T790M mutations is higher in this series from an Australasian population than in other similar publicly available lung adenocarcinoma cohorts. We conclude that histopathological features cannot be used to predict the acquisition of EGFR resistance.

Efficacy and safety of bronchial thermoplasty in clinical practice: a prospective, longitudinal, cohort study using evidence from the UK Severe Asthma Registry.

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, 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'. 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 FEV1 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.

What proportions of focal liver lesions detected by unenhanced ultrasound are inconclusive?

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.