Cost-effectiveness and quality of life after treatment of Lumbar Spinal Stenosis with the interspinous distractor device (X-Stop) or laminectomy: a randomised control trial

Lumbar Spinal Stenosis (LSS) is becoming increasingly prevalent in the ageing population and surgery is regarded as the gold standard treatment after conservative measures have failed. Many patients do not improve however, and the complication rates are high. Interspinous distraction devices (IDDs) have been proposed as a safe alternative however their cost and their failure rate has made their use controversial. No UK data exists to date with regards to the cost-effectiveness of the surgical management of IDDs in LSS and there is a lack of long term follow up. Objective – To determine the cost-effectiveness and quality of life after the treatment of LSS with the X-Stop device and laminectomy. Method – A randomised control trial of 47 patients with LSS (26 laminectomy and 21 X-Stop). The primary outcome was cost and quality of life measured using EQ5D. Other clinical outcomes were measured using SF36, ZCQ, ODI and QBPDS. Secondary measures included, operating time, length of stay and complication rates. Patients were followed up at 6 months, 12 months and 24 months. Results – The mean cost of the Laminectomy group was £2,711.8 and the mean cost of the X-Stop group was £5,148 (£1,799 plus the cost of the device £2,605 per device). Using intention to treat analysis, the mean QALY gain for the laminectomy group was 0.92 and for the X-Stop group was 0.81. The incremental cost effectiveness ratio was £-22,247.27. The complication rate for the laminectomy group was 19.2% vs 9.5% for the X-Stop group. Conclusion – Laminectomy is more cost-effective than X-Stop insertion for the treatment of LSS, mainly due to the high cost of the device. The X-Stop device does not replace a laminectomy as gold standard treatment however it should be considered when a less invasive procedure is required

High fidelity simulation of the endoscopic transsphenoidal approach: Validation of the UpSurgeOn TNS Box

Objective: Endoscopic endonasal transsphenoidal surgery is an established technique for the resection of sellar and suprasellar lesions. The approach is technically challenging and has a steep learning curve. Simulation is a growing training tool, allowing the acquisition of technical skills pre-clinically and potentially resulting in a shorter clinical learning curve. We sought validation of the UpSurgeOn Transsphenoidal (TNS) Box for the endoscopic endonasal transsphenoidal approach to the pituitary fossa./ Methods: Novice, intermediate and expert neurosurgeons were recruited from multiple centres. Participants were asked to perform a sphenoidotomy using the TNS model. Face and content validity were evaluated using a post-task questionnaire. Construct validity was assessed through post-hoc blinded scoring of operative videos using a Modified Objective Structured Assessment of Technical Skills (mOSAT) and a Task-Specific Technical Skill scoring system./ Results: Fifteen participants were recruited of which n = 10 (66.6%) were novices and n = 5 (33.3%) were intermediate and expert neurosurgeons. Three intermediate and experts (60%) agreed that the model was realistic. All intermediate and experts (n = 5) strongly agreed or agreed that the TNS model was useful for teaching the endonasal transsphenoidal approach to the pituitary fossa. The consensus-derived mOSAT score was 16/30 (IQR 14–16.75) for novices and 29/30 (IQR 27–29) for intermediate and experts (p < 0.001, Mann–Whitney U). The median Task-Specific Technical Skill score was 10/20 (IQR 8.25–13) for novices and 18/20 (IQR 17.75–19) for intermediate and experts (p < 0.001, Mann-Whitney U). Interrater reliability was 0.949 (CI 0.983–0.853) for OSATS and 0.945 (CI 0.981–0.842) for Task-Specific Technical Skills. Suggested improvements for the model included the addition of neuro-vascular anatomy and arachnoid mater to simulate bleeding vessels and CSF leak, respectively, as well as improvement in materials to reproduce the consistency closer to that of human tissue and bone./ Conclusion: The TNS Box simulation model has demonstrated face, content, and construct validity as a simulator for the endoscopic endonasal transsphenoidal approach. With the steep learning curve associated with endoscopic approaches, this simulation model has the potential as a valuable training tool in neurosurgery with further improvements including advancing simulation materials, dynamic models (e.g., with blood flow) and synergy with complementary technologies (e.g., artificial intelligence and augmented reality)

Pituitary society expert Delphi consensus: operative workflow in endoscopic transsphenoidal pituitary adenoma resection

Abstract: Purpose: Surgical workflow analysis seeks to systematically break down operations into hierarchal components. It facilitates education, training, and understanding of surgical variations. There are known educational demands and variations in surgical practice in endoscopic transsphenoidal approaches to pituitary adenomas. Through an iterative consensus process, we generated a surgical workflow reflective of contemporary surgical practice. Methods: A mixed-methods consensus process composed of a literature review and iterative Delphi surveys was carried out within the Pituitary Society. Each round of the survey was repeated until data saturation and > 90% consensus was reached. Results: There was a 100% response rate and no attrition across both Delphi rounds. Eighteen international expert panel members participated. An extensive workflow of 4 phases (nasal, sphenoid, sellar and closure) and 40 steps, with associated technical errors and adverse events, were agreed upon by 100% of panel members across rounds. Both core and case-specific or surgeon-specific variations in operative steps were captured. Conclusions: Through an international expert panel consensus, a workflow for the performance of endoscopic transsphenoidal pituitary adenoma resection has been generated. This workflow captures a wide range of contemporary operative practice. The agreed “core” steps will serve as a foundation for education, training, assessment and technological development (e.g. models and simulators). The “optional” steps highlight areas of heterogeneity of practice that will benefit from further research (e.g. methods of skull base repair). Further adjustments could be made to increase applicability around the world

Proposal for a prospective multi-centre audit of chronic subdural haematoma management in the United Kingdom and Ireland

Background. Chronic subdural haematoma (CSDH) is a common condition that increases in incidence with rising age. Evacuation of a CSDH is one of the commonest neurosurgical procedures; however the optimal peri-operative management, surgical technique, post-operative care and the role of adjuvant therapies remain controversial. Aim. We propose a prospective multi-centre audit in order to establish current practices, outcomes and national benchmarks for future studies. Methods. Neurosurgical units (NSU) in the United Kingdom and Ireland will be invited to enrol patients to this audit. All adult patients aged 16 years and over with a primary or recurrent CSDH will be eligible for inclusion. Outcome measures and analysis. The proposed outcome measures are (1) clinical recurrence requiring re-operation within 60 days; (2) modified Rankin scale (mRS) score at discharge from NSU; (3) morbidity and mortality in the NSU; (4) destination at discharge from NSU and (5) length of stay in the NSU. Audit standards have been derived from published systematic reviews and a recent randomised trial. The proposed standards are clinical recurrence rate < 20%; unfavourable mRS (4–6) at discharge from NSU < 30%; mortality rate in NSU < 5%; morbidity rate in NSU < 10%. Data will be submitted directly into a secure online database and analysed by the study's management group. Conclusions. The audit will determine the contemporary management and outcomes of patients with CSDH in the United Kingdom and Ireland. It will inform national guidelines, clinical practice and future studies in order to improve the outcome of patients with CSDH

Proposal for a prospective multi-centre audit of chronic subdural haematoma management in the United Kingdom and Ireland

Background: chronic subdural haematoma (CSDH) is a common condition that increases in incidence with rising age. Evacuation of a CSDH is one of the commonest neurosurgical procedures; however the optimal peri-operative management, surgical technique, post-operative care and the role of adjuvant therapies remain controversial. Aim: we propose a prospective multi-centre audit in order to establish current practices, outcomes and national benchmarks for future studies. Methods: neurosurgical units (NSU) in the United Kingdom and Ireland will be invited to enrol patients to this audit. All adult patients aged 16 years and over with a primary or recurrent CSDH will be eligible for inclusion. Outcome measures and analysis: the proposed outcome measures are (1) clinical recurrence requiring re-operation within 60 days; (2) modified Rankin scale (mRS) score at discharge from NSU; (3) morbidity and mortality in the NSU; (4) destination at discharge from NSU and (5) length of stay in the NSU. Audit standards have been derived from published systematic reviews and a recent randomised trial. The proposed standards are clinical recurrence rate &lt; 20%; unfavourable mRS (4–6) at discharge from NSU &lt; 30%; mortality rate in NSU &lt; 5%; morbidity rate in NSU &lt; 10%. Data will be submitted directly into a secure online database and analysed by the study's management group. Conclusions: the audit will determine the contemporary management and outcomes of patients with CSDH in the United Kingdom and Ireland. It will inform national guidelines, clinical practice and future studies in order to improve the outcome of patients with CSD<br/

Risk of Aneurysm Rupture (ROAR) study: protocol for a long-term, longitudinal, UK multicentre study of unruptured intracranial aneurysms

Introduction Unruptured intracranial aneurysms (UIA) are common in the adult population, but only a relatively small proportion will rupture. It is therefore essential to have accurate estimates of rupture risk to target treatment towards those who stand to benefit and avoid exposing patients to the risks of unnecessary treatment. The best available UIA natural history data are the PHASES study. However, this has never been validated and given the known heterogeneity in the populations, methods and biases of the constituent studies, there is a need to do so. There are also many potential predictors not considered in PHASES that require evaluation, and the estimated rupture risk is largely based on short-term follow-up (mostly 1 year). The aims of this study are to: (1) test the accuracy of PHASES in a UK population, (2) evaluate additional predictors of rupture and (3) assess long-term UIA rupture rates.Methods and analysis The Risk of Aneurysm Rupture study is a longitudinal multicentre study that will identify patients with known UIA seen in neurosurgery units. Patients will have baseline demographics and aneurysm characteristics collected by their neurosurgery unit and then a single aggregated national cohort will be linked to databases of hospital admissions and deaths to identify all patients who may have subsequently suffered a subarachnoid haemorrhage. All matched admissions and deaths will be checked against medical records to confirm the diagnosis of aneurysmal subarachnoid haemorrhage. The target sample size is 20 000 patients. The primary outcome will be aneurysm rupture resulting in hospital admission or death. Cox regression models will be built to test each of the study’s aims.Ethics and dissemination Ethical approval has been given by South Central Hampshire A Research Ethics Committee (21SC0064) and Confidentiality Advisory Group support (21CAG0033) provided under Section 251 of the NHS Act 2006. The results will be disseminated in peer-reviewed journals.Trial registration number ISRCTN17658526

Management practices for postdural puncture headache in obstetrics: a prospective, international, cohort study

© 2020 British Journal of AnaesthesiaBackground: Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache (PDPH). We aimed to describe management practices and outcomes after PDPH treated by epidural blood patch (EBP) or no EBP. Methods: Following ethics committee approval, patients who developed PDPH after accidental dural puncture were recruited from participating countries and divided into two groups, those receiving EBP or no EBP. Data registered included patient and procedure characteristics, headache symptoms and intensity, management practices, and complications. Follow-up was at 3 months. Results: A total of 1001 patients from 24 countries were included, of which 647 (64.6%) received an EBP and 354 (35.4%) did not receive an EBP (no-EBP). Higher initial headache intensity was associated with greater use of EBP, odds ratio 1.29 (95% confidence interval 1.19–1.41) per pain intensity unit increase. Headache intensity declined sharply at 4 h after EBP and 127 (19.3%) patients received a second EBP. On average, no or mild headache (numeric rating score≤3) was observed 7 days after diagnosis. Intracranial bleeding was diagnosed in three patients (0.46%), and backache, headache, and analgesic use were more common at 3 months in the EBP group. Conclusions: Management practices vary between countries, but EBP was more often used in patients with greater initial headache intensity. EBP reduced headache intensity quickly, but about 20% of patients needed a second EBP. After 7 days, most patients had no or mild headache. Backache, headache, and analgesic use were more common at 3 months in patients receiving an EBP

Management practices for postdural puncture headache in obstetrics : a prospective, international, cohort study

Background: Accidental dural puncture is an uncommon complication of epidural analgesia and can cause postdural puncture headache (PDPH). We aimed to describe management practices and outcomes after PDPH treated by epidural blood patch (EBP) or no EBP. Methods: Following ethics committee approval, patients who developed PDPH after accidental dural puncture were recruited from participating countries and divided into two groups, those receiving EBP or no EBP. Data registered included patient and procedure characteristics, headache symptoms and intensity, management practices, and complications. Follow-up was at 3 months. Results: A total of 1001 patients from 24 countries were included, of which 647 (64.6%) received an EBP and 354 (35.4%) did not receive an EBP (no-EBP). Higher initial headache intensity was associated with greater use of EBP, odds ratio 1.29 (95% confidence interval 1.19-1.41) per pain intensity unit increase. Headache intensity declined sharply at 4 h after EBP and 127 (19.3%) patients received a second EBP. On average, no or mild headache (numeric rating score <= 3) was observed 7 days after diagnosis. Intracranial bleeding was diagnosed in three patients (0.46%), and backache, headache, and analgesic use were more common at 3 months in the EBP group. Conclusions: Management practices vary between countries, but EBP was more often used in patients with greater initial headache intensity. EBP reduced headache intensity quickly, but about 20% of patients needed a second EBP. After 7 days, most patients had no or mild headache. Backache, headache, and analgesic use were more common at 3 months in patients receiving an EBP