Trends in day-case bladder outflow obstruction surgery: a study using Hospital Episode Statistics.

OBJECTIVES: To describe the contemporary evolution of day-case bladder outflow obstruction (BOO) surgery in England and to profile day-case BOO surgery practices across England in terms of the types of operation performed and their safety profiles. MATERIALS AND METHODS: This was a retrospective observational analysis of Hospital Episode Statistics and UK Office for National Statistics data. All 111 043 recorded operations across 117 hospital trusts over 66 months, from 1 January 2017 to 30 June 2022, were obtained. Operations were identified as one of: transurethral resection of prostate (TURP); laser ablation or enucleation; vapour therapy; prostatic urethral lift (PUL); or bladder neck incision. Monthly day-case rate trends were plotted across the study period. Descriptive data, day-case rates and 30-day hospital readmissions were analysed for each operation type. Multilevel regression modelling with mixed effects was performed to determine whether day-case surgery was associated with higher 30-day hospital readmissions. RESULTS: Day-case patients were younger, with fewer comorbidities. Time series analysis showed a linear day-case rate increase from 8.3% (January 2017) to 21.0% (June 2022). Day-case rates improved for 92/117 trusts in 2021/2022 compared with 2017. Three of the six trusts with the highest day-case rates performed predominantly day-case TURP, and the other three laser surgery. Nationally, PUL and vapour surgery had the highest day-case rates (80.9% and 38.1%). Most inpatient operations were TURP. Multilevel regression modelling found reduced odds of 30-day readmission after day-case BOO surgery (all operations pooled), no difference for day-case vs inpatient TURP, and reduced odds following day-case LASER operations. CONCLUSIONS: The day-case rates for BOO surgery have linearly increased. Minimally invasive surgical technologies are commonly performed as day cases, whereas high day-case rates for TURP and for laser ablation operations are seen in a minority of hospitals. Day-case pathways to treat BOO can be safely developed irrespective of operative modality.

The Getting It right First Time (GIRFT) programme in urology; rationale and methodology.

The Getting It Right First Time (GIRFT) programme is a quality improvement initiative covering the National Health Service in England. The programme aims to standardise clinical practices and improve patient and system level outcomes by utilising data-driven insights and clinically-led recommendations. There are GIRFT workstreams for every medical and surgical specialty, including urology. Defining features of the GIRFT methodology are that it is clinically led by experienced clinicians, data-driven, and specialty specific. Each specialty workstream conducts deep-dive visits to every hospital, analysing performance data and engaging with clinicians and management to identify and share improvement priorities. For urology, GIRFT has completed deep-dive visits and published reports outlining priority areas for development. Reports include recommendations pertaining to streamlining care pathways, reducing the acuity of care environments, enhancing emergency services, optimising utilisation of outpatient services, and workforce training and utilisation. The GIRFT academy provides guides for implementing best practices specific to priority areas of care. These include important disease pathways, and GIRFT-advocated innovations such as urology investigation units and urology area networks. GIRFT offers clinical transformation, cost reduction, equity in access to care, and leaner models of care that are often more environmentally sustainable. Evaluation efforts of the programme have focussed on assessing the adoption of GIRFT recommendations, understanding barriers to change, and modelling the climate impact of advocated practices.

Factors associated with poorer outcomes for posterior lumbar decompression and or/or discectomy: an exploratory analysis of administrative data.

PURPOSE: This study aimed to identify factors associated with poorer patient outcomes for lumbar decompression and/or discectomy (PLDD). METHODS: We extracted data from the Hospital Episodes Statistics database for the 5 years from 1st April 2014 to 31st March 2019. Patients undergoing an elective one- or two-level PLDD aged ≥ 17 years and without evidence of revision surgery during the index stay were included. The primary patient outcome measure was readmission within 90 days post-discharge. RESULTS: Data for 93,813 PLDDs across 111 hospital trusts were analysed. For the primary outcome, greater age [< 40 years vs 70-79 years odds ratio (OR) 1.28 (95% confidence interval (CI) 1.14 to 1.42), < 40 years vs ≥ 80 years OR 2.01 (95% CI 1.76-2.30)], female sex [OR 1.09 (95% CI 1.02-1.16)], surgery over two spinal levels [OR 1.16 (95% CI 1.06-1.26)] and the comorbidities chronic pulmonary disease, connective tissue disease, liver disease, diabetes, hemi/paraplegia, renal disease and cancer were all associated with emergency readmission within 90 days. Other outcomes studied had a similar pattern of associations. CONCLUSIONS: A high-throughput PLDD pathway will not be suitable for all patients. Extra care should be taken for patients aged ≥ 70 years, females, patients undergoing surgery over two spinal levels and those with specific comorbidities or generalised frailty.

Prevention of hospital-associated venous thromboembolism - Insight from the Getting It Right First Time thrombosis survey in England.

A national Venous Thromboembolism (VTE) Prevention Programme was introduced in England in 2010, with limited subsequent study of its impact. Whilst the National Outcomes Framework reports VTE deaths related to hospitalisation annually, there are little data regarding VTE prevention practice or non-fatal VTE associated with hospitalisation. We report the first national thrombosis survey undertaken in collaboration with Getting It Right First Time. 98 Trusts (103 sites, 67% of 144 invited) participated in at least one survey, contributing data regarding VTE prevention in 9553 patients. Anti-coagulant thromboprophylaxis was prescribed to 88% (when indicated), with 8.1% of patients missing doses. Written patient information was provided to 31%. Of 4595 episodes of hospital-associated VTE, 13% were considered potentially preventable. The survey highlights the success of the national programme and areas for improvement in delivery of thromboprophylaxis and patient information.

The volume-outcome relationship for endoscopic transsphenoidal pituitary surgery for benign neoplasm: analysis of an administrative dataset for England.

BACKGROUND: Setting minimum annual volume thresholds for pituitary surgery in England is seen as one way of improving outcomes for patients and service efficiency. However, there are few recent studies from the UK on whether a volume-outcome effect exists, particularly in the era of endoscopic surgery. Such data are needed to allow evidence-based decision making. The aim of this study was to use administrative data to investigate volume-outcome effects for endoscopic transsphenoidal pituitary surgery in England. METHODS: Data from the Hospital Episodes Statistics database for adult endoscopic transsphenoidal pituitary surgery for benign neoplasm conducted in England from April 2013 to March 2019 (inclusive) were extracted. Annual surgeon and trust volume was defined as the number of procedures conducted in the 12 months prior to the index procedure. Volume was categorised as < 10, 10-19, 20-29, 30-39 and ≥40 procedures for surgeon volume and < 20, 20-39, 40-59, 60-79 and ≥80 procedures for trust volume. The primary outcome was repeat ETSPS during the index procedure or during a hospital admission within one-year of discharge from the index procedure. RESULTS: Data were available for 4590 endoscopic transsphenoidal pituitary procedures. After adjustment for covariates, higher surgeon volume was significantly associated with reduced risk of repeat surgery within one year (odds ratio (OR) 0.991 (95% confidence interval (CI) 0.982-1.000)), post-procedural haemorrhage (OR 0.977 (95% CI 0.967-0.987)) and length of stay greater than the median (0.716 (0.597-0.859)). A higher trust volume was associated with reduced risk of post-procedural haemorrhage (OR 0.992 (95% CI 0.985-0.999)), but with none of the other patient outcomes studied. CONCLUSIONS: A surgeon volume-outcome relationship exists for endoscopic transsphenoidal pituitary surgery in England.

Role of hospital strain in determining outcomes for people hospitalised with COVID-19 in England.

BACKGROUND: In England, reported COVID-19 mortality rates increased during winter 2020/21 relative to earlier summer and autumn months. This study aimed to examine the association between COVID-19-related hospital bed-strain during this time and patient outcomes. METHODS: This was a retrospective observational study using Hospital Episode Statistics data for England. All unique patients aged ≥18 years in England with a diagnosis of COVID-19 who had a completed (discharged alive or died in hospital) hospital stay with an admission date between 1 July 2020 and 28 February 2021 were included. Bed-strain was calculated as the number of beds occupied by patients with COVID-19 divided by the maximum COVID-19 bed occupancy during the study period. Bed-strain was categorised into quartiles for modelling. In-hospital mortality was the primary outcome of interest and length of stay a secondary outcome. RESULTS: There were 253 768 unique hospitalised patients with a diagnosis of COVID-19 during a hospital stay. Patient admissions peaked in January 2021 (n=89 047), although the crude mortality rate peaked slightly earlier in December 2020 (26.4%). After adjustment for covariates, the mortality rate in the lowest and highest quartile of bed-strain was 23.6% and 25.3%, respectively (OR 1.13, 95% CI 1.09 to 1.17). For the lowest and the highest quartile of bed-strain, adjusted mean length of stay was 13.2 days and 11.6 days, respectively in survivors and was 16.5 days and 12.6 days, respectively in patients who died in hospital. CONCLUSIONS: High levels of bed-strain were associated with higher in-hospital mortality rates, although the effect was relatively modest and may not fully explain increased mortality rates during winter 2020/21 compared with earlier months. Shorter hospital stay during periods of greater strain may partly reflect changes in patient management over time.

Safety of day-case endoscopic sinus surgery in England: An observational study using an administrative dataset.

INTRODUCTION: As elective surgical services recover from the COVID-19 pandemic a movement towards day-case surgery may reduce waiting lists. However, evidence is needed to show that day-case surgery is safe for endoscopic sinus surgery (ESS). The aim of this study was to investigate the safety of day-case ESS in England. DESIGN: Secondary analysis of administrative data. METHODS: We extracted data from the Hospital Episodes Statistics database for the 5 years from 1 April 2014 to 31 March 2019. Patients undergoing elective ESS procedures aged ≥17 years were included. Exclusion criteria included malignant neoplasm, complex systemic disease and trans-sphenoidal pituitary surgery. The primary outcome was readmission within 30 days post-discharge. Multilevel, multivariable logistic regression modelling was used to compare outcomes for those operated on as day-cases and those with an overnight stay after adjusting for demographic, frailty, comorbidity and procedural covariates. RESULTS: Data were available for 49 223 patients operated on across 129 NHS hospital trusts. In trusts operating on more than 50 patients in the study period, rates of day-case surgery varied from 20.6% to 100%. Nationally, rates of day-case surgery increased from 64.0% in the financial year 2014/2015 to 78.7% in 2018/2019. Day-case patients had lower rates of 30-day emergency readmission (odds ratio 0.71, 95% confidence interval 0.62 to 0.81). Outcomes for patients operated on in trusts with ≥80% day-case rates compared with patients operated on in trusts with <50% rates of day-case surgery were similar. CONCLUSIONS: Our data support the view that ESS can safely be performed as day-case surgery in most cases, although it will not be suitable for all patients. There appears to be scope to increase rates of day-case ESS in some hospital trusts in England.

COVID-19 hospital activity and in-hospital mortality during the first and second waves of the pandemic in England: an observational study.

INTRODUCTION: We aimed to examine the profile of, and outcomes for, all people hospitalised with COVID-19 across the first and second waves of the pandemic in England. METHODS: This was an exploratory retrospective analysis of observational data from the Hospital Episode Statistics data set for England. All patients aged ≥18 years in England with a diagnosis of COVID-19 who had a hospital stay that was completed between 1 March 2020 and 31 March 2021 were included. In-hospital mortality was the primary outcome of interest. The second wave was identified as starting on 1 September 2020. Multilevel logistic regression modelling was used to investigate the relationship between mortality and demographic, comorbidity and temporal covariates. RESULTS: Over the 13 months, 374 244 unique patients had a diagnosis of COVID-19 during a hospital stay, of whom 93 701 (25%) died in hospital. Adjusted mortality rates fell from 40%-50% in March 2020 to 11% in August 2020 before rising to 21% in January 2021 and declining steadily to March 2021. Improvements in mortality rates were less apparent in older and comorbid patients. Although mortality rates fell for all ethnic groups from the first to the second wave, declines were less pronounced for Bangladeshi, Indian, Pakistani, other Asian and black African ethnic groups. CONCLUSIONS: There was a substantial decline in adjusted mortality rates during the early part of the first wave which was largely maintained during the second wave. The underlying reasons for consistently higher mortality risk in some ethnic groups merits further study.

An observational study of volume-outcome effects for robot-assisted radical prostatectomy in England.

OBJECTIVES: To investigate volume-outcome relationships in robot-assisted radical prostatectomy (RARP) for cancer using data from the Hospital Episodes Statistics (HES) database for England. MATERIALS AND METHODS: Data for all adult, elective RPs for cancer during the period January 2013-December 2018 (inclusive) were extracted from the HES database. The HES database records data on all National Health Service (NHS) hospital admissions in England. Data were extracted for the NHS trust and surgeon undertaking the procedure, the surgical technique used (laparoscopic, open or robot-assisted), hospital length of stay (LOS), emergency readmissions, and deaths. Multilevel modelling was used to adjust for hierarchy and covariates. RESULTS: Data were available for 35 629 RPs (27 945 RARPs). The proportion of procedures conducted as RARPs increased from 53.2% in 2013 to 92.6% in 2018. For RARP, there was a significant relationship between 90-day emergency hospital readmission (primary outcome) and trust volume (odds ratio [OR] for volume decrease of 10 procedures: 0.99, 95% confidence interval [CI] 0.99-1.00; P = 0.037) and surgeon volume (OR for volume decrease of 10 procedures: 0.99, 95% CI 0.99-1.00; P = 0.013) in the previous year. From lowest to highest volume category there was a decline in the adjusted proportion of patients readmitted as an emergency at 90 days from 10.6% (0-49 procedures) to 7.0% (≥300 procedures) for trusts and from 9.4% (0-9 procedures) to 8.3% (≥100 procedures) for surgeons. LOS was also significantly associated with surgeon and trust volume, although 1-year mortality was associated with neither. CONCLUSIONS: There is evidence of a volume-outcome relationship for RARP in England and minimising low-volume RARP will improve patient outcomes. Nevertheless, the observed effect size was relatively modest, and stakeholders should be realistic when evaluating the likely impact of further centralisation at a population level.

Recovery of health-related quality of life in patients undergoing robot-assisted radical cystectomy with intracorporeal diversion.

OBJECTIVE: To report the health-related quality of life (HRQoL) after robot-assisted radical cystectomy and intracorporeal urinary diversion (iRARC), and to identify factors impacting on return to baseline. PATIENTS AND METHODS: Consecutive patients undergoing iRARC between January 2016 and December 2017 completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item core (EORTC-QLQ-C30) and EORTC-QLQ-Muscle-Invasive Bladder Cancer Module (EORTC-QLQ-BLM30) questionnaires before surgery and had a minimum of 12 months follow-up postoperatively. RESULTS: A total of 76 patients met the inclusion criteria at 12 months. Neobladder (NB) cases (n = 24) were younger (57.0 vs 71.0 years, P < 0.001) and fitter than ileal conduit (IC) cases (n = 52), and had higher physical (100.0 vs 93.3, P = 0.039) and sexual functioning (66.7 vs 50.0, P = 0.013) scores at baseline. Longitudinal analysis of the EORTC-QLQ-C30 showed that physical (NB: 93.3 vs 100.0, P = 0.020; IC: 80.0 vs 93.3, P < 0.001) and role functioning scores (NB: 83.3 vs 100.0, P = 0.010; IC: 83.3 vs 100.0, P = 0.017) decreased and fatigue score (NB: 22.2 vs 11.1, P = 0.026; IC: 33.3 vs 22.2, P = 0.008) increased at 3 months in both diversion groups. Scores returned to baseline at 6 months except physical functioning score in IC patients that remained below baseline until 12 months (86.7 vs 93.3, P = 0.012). The global HRQoL score did not show significant change postoperatively in both groups. A major 90-day Clavien-Dindo complication was a significant predictor (odds ratio [OR] 0.11, 95% confidence interval [CI] 0.02-0.62; P = 0.012) of deteriorated global HRQoL score at 3 months, while occurrence of a late complication (OR 0.14, 95% CI 0.03-0.65; P = 0.013) was a predictor of deteriorated global HRQoL score at 12 months. Longitudinal analysis of the EORTC-QLQ-BLM30 showed that urinary problems (NB: 14.3 vs 38.3, P < 0.001; IC: 5.6 vs 19.1, P < 0.001) and future perspective (NB: 33.3 vs 44.4, P = 0.004; IC: 22.2 vs 44.4, P < 0.001) scores were better than baseline at 3 months. Sexual function deteriorated significantly at 3 months (NB: 8.3 vs 66.7, P < 0.001; IC: 4.2 vs 50.0, P < 0.001) and then showed improvement at 12 months but was still below baseline (NB: 33.3 vs 66.7, P = 0.001; IC: 25.0 vs 50.0, P < 0.001). Involvement in penile rehabilitation was shown to be a significant predictor (ß 18.62, 95% CI 6.06-30.45; P = 0.005) of higher sexual function score at 12 months. CONCLUSION: While most functional domains and symptoms scales recover to or exceed baseline within 6 months of iRARC, physical function remains below baseline in IC patients up to 12 months. Global HRQoL is preserved for both types of urinary diversion; however, postoperative complications seem to be the main driving factor for global HRQoL. Sexual function is adversely affected after iRARC suggesting that structured rehabilitation of sexual function should be an integral part of the RC pathway.

Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial.

Importance: Robot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer. Objectives: To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy. Design, Setting, and Participants: Randomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021. Interventions: Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169). Main Outcomes and Measures: The primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center. Results: Among 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received neoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P = .01). Thromboembolic complications (1.9% vs 8.3%; difference, -6.5% [95% CI, -11.4% to -1.4%]) and wound complications (5.6% vs 16.0%; difference, -11.7% [95% CI, -18.6% to -4.6%]) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 [18%] vs 25/156 [16%] after robotic and open surgery, respectively) and overall mortality (23/161 [14.3%] vs 23/156 [14.7%]), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1). Conclusions and Relevance: Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain. Trial Registration: ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.

Utilisation of tracheostomy in patients with COVID-19 in England: Patient characteristics, timing and outcomes.

OBJECTIVES: We aimed to characterise the use of tracheostomy procedures for all COVID-19 critical care patients in England and to understand how patient factors and timing of tracheostomy affected outcomes. DESIGN: A retrospective observational study using exploratory analysis of hospital administrative data. SETTING: All 500 National Health Service hospitals in England. PARTICIPANTS: All hospitalised COVID-19 patients aged ≥18 years in England between 1 March and 31 October 2020 were included. MAIN OUTCOMES AND MEASURES: This was a retrospective exploratory analysis using the Hospital Episode Statistics administrative data set. Multilevel modelling was used to explore the relationship between demographic factors, comorbidity and use of tracheostomy and the association between tracheostomy use, tracheostomy timing and the outcomes. RESULTS: In total, 2200 hospitalised COVID-19 patients had a tracheostomy. Tracheostomy utilisation varied across the study period, peaking in April-June 2020. In multivariable modelling, for those admitted to critical care, tracheostomy was most common in those aged 40-79 years, in males and in people of Black and Asian ethnic groups and those with a history of cerebrovascular disease. In critical care patients, tracheostomy was associated with lower odds of mortality (OR: 0.514 [95% CI 0.443 to 0.596], but greater length of stay OR: 41.143 [95% CI 30.979 to 54.642]). In patients that survived, earlier timing of tracheostomy (≤14 days post admission to critical care) was significantly associated with shorter length of stay. CONCLUSIONS: Tracheostomy is safe and advantageous for critical care COVID-19 patients. Early tracheostomy may be associated with better outcomes, such as shorter length of stay, compared to late tracheostomy.

NeuroSAFE frozen section during robot-assisted radical prostatectomy: peri-operative and histopathological outcomes from the NeuroSAFE PROOF feasibility randomized controlled trial.

OBJECTIVES: To report on the methods, peri-operative outcomes and histopathological concordance between frozen and final section from the NeuroSAFE PROOF feasibility study (NCT03317990). PATIENTS AND METHODS: Between May 2018 and March 2019, 49 patients at two UK centres underwent robot-assisted radical prostatectomy (RARP). Twenty-five patient were randomized to NeuroSAFE RARP (intervention arm) and 24 to standard RARP (control arm). Frozen section was compared to final paraffin section margin assessment in the 25 patients in the NeuroSAFE arm. Operation timings and complications were collected prospectively in both arms. RESULTS: Fifty neurovascular bundles (NVBs) from 25 patients in the NeuroSAFE arm were analysed. When analysed by each pathological section (n = 250, average five per side), we noted a sensitivity of 100%, a specificity of 99.2%, and an area under the curve (AUC) of 0.994 (95% confidence interval [CI] 0.985 to 1; P ≤0.001). On an NVB basis (n = 50), sensitivity was 100%, specificity was 92.7%, and the AUC was 0.963 (95% CI 0.914 to 1; P ≤0.001). NeuroSAFE RARP lasted a mean of 3 h 16 min (knife to skin to off table, 95% CI 3 h 2 min-3 h 30 min) compared to 2 h 4 min (95% CI 2 h 2 min-2 h 25 min; P ≤0.001) for standard RARP. There was no morbidity associated with the additional length of operating time on in the NeuroSAFE arm. CONCLUSION: This feasibility study demonstrates the safety, reproducibility and excellent histopathological concordance of the NeuroSAFE technique in the NeuroSAFE PROOF trial. Although the technique increases the duration of RARP, this does not cause short-term harm. Confirmation of feasibility has led to the opening of the fully powered NeuroSAFE PROOF randomized controlled trial, which is currently under way at four sites in the UK.

Otorhinolaryngology litigation in England: 727 clinical negligence cases against the National Health Service.

INTRODUCTION: Litigation against the National Health Service (NHS) in England is rising. The aim of this study was to determine the incidence and characteristics of otorhinolaryngology clinical negligence claims in England. METHODS: A retrospective review was undertaken of all clinical negligence claims in England held by NHS Resolution relating to otorhinolaryngology between April 2013 and April 2018. Analysis was performed using information for cause, patient injury and claim cost. Where claim information was adequately detailed, the authors categorised claims by subspecialty, diagnosis and surgery. RESULTS: A total number of 727 claims were identified with an estimated potential cost of £108 million. Out of these, 463 were closed claims. Including open claim reserves, the mean cost of a claim was £148 923. Head and neck surgery was the subspecialty with the highest number of claims (n = 313, 43%) and highest cost (£51.5 million) followed by otology (n = 171, £24.5 million) and rhinology (n = 171, £13.6 million). Over half of claims were associated with an operation (n = 429, 59%) where mastoid surgery (n = 46) and endoscopic sinus surgery (n = 46) were equally associated with the greatest number of claims. The most frequent causes for clinical negligence claims included failure or delay to diagnose (n = 178, 25%), failure or delay to treat (n = 136, 19%), intra-operative complications (n = 130, 18%) and failure of the consent process (n = 107, 15%). DISCUSSION: Clinical negligence claims in otorhinolaryngology are related to several different components of patient management and are not limited to postoperative complications. This study highlights the importance of robust pathways in out-patient diagnostics and the consenting process in order to deliver better patient care and reduce the impact of litigation. Keywords informed consent, malpractice, clinical negligence claims, litigation, otolaryngology.

Understanding volume-outcome relationships in nephrectomy and cystectomy for cancer: evidence from the UK Getting it Right First Time programme.

OBJECTIVES: To investigate volume-outcome relationships in nephrectomy and cystectomy for cancer. MATERIALS AND METHODS: Data were extracted from the UK Hospital Episodes Statistics database, which records data on all National Health Service (NHS) hospital admissions in the England. Data were included for a 5-year period (April 2013-March 2018 inclusive) and data on emergency and paediatric admissions were excluded. Data were extracted on the NHS trust and surgeon undertaking the procedure, the surgical technique used (open, laparoscopic or robot-assisted) and length of hospital stay during the procedure. This dataset was supplemented by data on mortality from the UK Office for National Statistics. A number of volume thresholds and volume measures were investigated. Multilevel modelling was used to adjust for hierarchy and confounding factors. RESULTS: Data were available for 18 107 nephrectomy and 6762 cystectomy procedures for cancer. There was little evidence of trust or surgeon volume influencing readmission rates or mortality. There was some evidence of shorter length of hospital stay for high-volume surgeons, although the volume measure and threshold used were important. CONCLUSIONS: We found little evidence that further centralization of nephrectomy or cystectomy for cancer surgery will improve the patient outcomes investigated. It may be that length of stay can be optimized though training and support for lower-volume centres, rather than further centralization.

The sensitivity, specificity, and diagnostic accuracy of whole-bone MRI for identifying skip metastases in appendicular osteosarcoma and Ewing sarcoma.

OBJECTIVE: Pre-operative whole-bone MRI is required to assess intra-osseous tumour extent and to identify skip metastases in cases of bone sarcoma. The current study aims to determine the sensitivity, specificity, and diagnostic accuracy of whole-bone MRI for the identification of skip metastases. MATERIALS AND METHOD: Review of 162 patients with long bone osteosarcoma or Ewing sarcoma who had undergone whole-bone MRI to assess intra-osseous tumour length and identify skip metastases. Comparison was made with post-chemotherapy MRI to look for a change in the appearance of suspected skip metastases, and resection specimens were assessed for the presence of skip metastases. The presence of local osseous recurrence was determined at final follow-up. RESULTS: There were 112 males and 50 females (mean age 18.8 years), with 119 osteosarcomas and 43 Ewing sarcomas. Skip metastases were diagnosed on whole-bone MRI in 23 cases (14.2%). In 2 cases, pre-operative needle biopsy diagnosed enchondromata, resulting in false positive diagnoses. Skip metastases were diagnosed in the resection specimens in 3 cases, and based on comparison with post-chemotherapy MRI in 12. There was no evidence of local osseous recurrence in 160 patients, while late recurrence occurred in 2 patients. Sensitivity was calculated as 88.2%, specificity as 97.6%, and diagnostic accuracy as 96.7%. CONCLUSION: Whole-bone MRI has a high sensitivity, specificity, and diagnostic accuracy for the identification of skip metastases in osteosarcoma and Ewing sarcoma. The possibility of false positive skip lesions and late local osseous recurrence is also highlighted.

Fixation Method and Subsequent Revision Rates for Elective Primary Hip Arthroplasty in People Aged 70 Years and Older: Analysis of National Administrative Data Sets by the UK Getting It Right First Time Program.

BACKGROUND: We aimed to understand the role of fixation method in predicting subsequent revision rates in people aged 70 years and older undergoing elective primary total hip arthroplasty (THA) within the UK National Health Service (NHS). METHODS: Data on elective primary THAs conducted in people aged 70 years and older between April 1, 2012, and March 31, 2018, and subsequent revisions conducted up to March 31, 2019, were extracted from the Hospital Episodes Statistics database for all NHS procedures in England. A flexible parametric competing risks model was used to identify the role of fixation method in predicting revision and adjust for age, sex, frailty, year of surgery, and all-cause mortality. RESULTS: Data were available for 190,656 procedures. Crude revision rates at 1-7 years follow-up in those who had cemented, hybrid/reverse hybrid, and uncemented fixation were 1.8%, 1.8%, and 2.3%, respectively. There was a high level of variation between NHS trusts in the proportionate use of fixation method. The differences in the hazard of revision between uncemented and cemented fixation (hazard ratio, 1.238 [95% confidence interval, 1.148-1.336]) and hybrid/reverse hybrid fixation (hazard ratio, 1.184 [95% confidence interval, 1.082-1.297]) were both significant. In secondary analysis, there was evidence that revision rates in trusts where uncemented fixation predominated were not significantly lower for uncemented fixation compared to all other fixation methods. CONCLUSIONS: Revision rates were significantly higher for elective primary THA in people aged 70 years and older who have uncemented fixation, compared to those who had cemented and hybrid/reverse hybrid fixation.

Stanmore noninvasive extendible endoprosthesis in the treatment of bone sarcoma in the preadolescent.

AIMS: The aim of this study is to assess outcomes of patients ≤12 years who undergo Stanmore noninvasive extendible endoprosthetic replacement of the distal femur (DF NIEPR). PATIENTS AND METHODS: A total of 101 children (mean age 9.6 years) were included. All complications which required further surgery were recorded. Clinical and functional outcomes were evaluated with Musculoskeletal Tumor Society (MSTS) scores at a mean follow-up of 64 months (range 6-174). RESULTS: Thirty-one (30.7%) patients died at a mean of 33 months. Forty had prosthesis removed after a mean of 43 months (range, 7-103). Attaining of the full lengthening potential before skeletal maturity was the most frequent reason for revision surgery, particularly in those with smaller lengthening potential (P = 0.039). Implant survival rate for other causes was 61.7% at 5 years and 45.0% at 10 years. At final follow-up mean MSTS score was 26 (range, 13-29). Twenty-two (21.5%) patients had a final limb-length discrepancy (LLD) > 2 cm. CONCLUSIONS: DF NIEPR produces a good functional outcome, with the prevention of major LLD at skeletal maturity in the majority of the cases. We suggest patient selection criteria to account for the stage of the disease due to the high cost of the NIEPR, and high percentage requiring revision, and a 60% mortality rate in those patients presenting with distant disease burden.

Immunohistochemical biomarker validation in highly selective needle biopsy microarrays derived from mpMRI-characterized prostates.

INTRODUCTION: Diagnosing prostate cancer routinely involves tissue biopsy and increasingly image guided biopsy using multiparametric MRI (mpMRI). Excess tissue after diagnosis can be used for research to improve the diagnostic pathway and the vertical assembly of prostate needle biopsy cores into tissue microarrays (TMAs) allows the parallel immunohistochemical (IHC) validation of cancer biomarkers in routine diagnostic specimens. However, tissue within a biopsy core is often heterogeneous and cancer is not uniformly present, resulting in needle biopsy TMAs that suffer from highly variable cancer detection rates that complicate parallel biomarker validation. MATERIALS AND METHODS: The prostate cores with the highest tumor burden (in terms of Gleason score and/or maximum cancer core length) were obtained from 249 patients in the PICTURE trial who underwent transperineal template prostate mapping (TPM) biopsy at 5 mm intervals preceded by mpMRI. From each core, 2 mm segments containing tumor or benign tissue (as assessed on H&E pathology) were selected, excised and embedded vertically into a new TMA block. TMA sections were then IHC-stained for the routinely used prostate cancer biomarkers PSA, PSMA, AMACR, p63, and MSMB and assessed using the h-score method. H-scores in patient matched malignant and benign tissue were correlated with the Gleason grade of the original core and the MRI Likert score for the sampled prostate area. RESULTS: A total of 2240 TMA cores were stained and IHC h-scores were assigned to 1790. There was a statistically significant difference in h-scores between patient matched malignant and adjacent benign tissue that is independent of Likert score. There was no association between the h-scores and Gleason grade or Likert score within each of the benign or malignant groups. CONCLUSION: The construction of highly selective TMAs from prostate needle biopsy cores is possible. IHC data obtained through this method are highly reliable and can be correlated with imaging. IHC expression patterns for PSA, PSMA, AMACR, p63, and MSMB are distinct in malignant and adjacent benign tissue but did not correlate with mpMRI Likert score.

Accuracy of Transperineal Targeted Prostate Biopsies, Visual Estimation and Image Fusion in Men Needing Repeat Biopsy in the PICTURE Trial.

PURPOSE: We evaluated the detection of clinically significant prostate cancer using magnetic resonance imaging targeted biopsies and compared visual estimation to image fusion targeting in patients requiring repeat prostate biopsies. MATERIALS AND METHODS: The prospective, ethics committee approved PICTURE trial (ClinicalTrials.gov NCT01492270) enrolled 249 consecutive patients from January 11, 2012 to January 29, 2014. Men underwent multiparametric magnetic resonance imaging and were blinded to the results. All underwent transperineal template prostate mapping biopsies. In 200 men with a lesion this was preceded by visual estimation and image fusion targeted biopsies. As the primary study end point clinically significant prostate cancer was defined as Gleason 4 + 3 or greater and/or any grade of cancer with a length of 6 mm or greater. Other definitions of clinically significant prostate cancer were also evaluated. RESULTS: Mean ± SD patient age was 62.6 ± 7 years, median prostate specific antigen was 7.17 ng/ml (IQR 5.25-10.09), mean primary lesion size was 0.37 ± 1.52 cc with a mean of 4.3 ± 2.3 targeted cores per lesion on visual estimation and image fusion combined, and a mean of 48.7 ± 12.3 transperineal template prostate mapping biopsy cores. Transperineal template prostate mapping biopsies detected 97 clinically significant prostate cancers (48.5%) and 85 insignificant cancers (42.5%). Overall multiparametric magnetic resonance imaging targeted biopsies detected 81 clinically significant prostate cancers (40.5%) and 63 insignificant cancers (31.5%). In the 18 cases (9%) of clinically significant prostate cancer on magnetic resonance imaging targeted biopsies were benign or clinically insignificant on transperineal template prostate mapping biopsy. Clinically significant prostate cancer was detected in 34 cases (17%) on transperineal template prostate mapping biopsy but not on magnetic resonance imaging targeted biopsies and approximately half was present in nontargeted areas. Clinically significant prostate cancer was found on visual estimation and image fusion in 53 (31.3%) and 48 (28.4%) of the 169 patients (McNemar test p = 0.5322). Visual estimation missed 23 clinically significant prostate cancers (13.6%) detected by image fusion. Image fusion missed 18 clinically significant prostate cancers (10.8%) detected by visual estimation. CONCLUSIONS: Magnetic resonance imaging targeted biopsies are accurate for detecting clinically significant prostate cancer and reducing the over diagnosis of insignificant cancers. To maximize detection visual estimation as well as image fusion targeted biopsies are required.