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BACKGROUND:The setting of a randomized trial can determine whether its findings aregeneralizable and can therefore apply to different settings. The contribution of low- andmiddle-income countries (LMICs) to neurosurgical randomized trials has not been system-atically described before.OBJECTIVE:To perform a systematic analysis of design characteristics and methodology,funding source, and interventions studied between trials led by and/or conducted in high-income countries (HICs) vs LMICs.METHODS:From January 2003 to July 2016, English-language trials with>5 patientsassessing any one neurosurgical procedure against another procedure, nonsurgicaltreatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library.Income classification for each country was assessed using the World Bank Atlas method.RESULTS:A total of 73.3% of the 397 studies that met inclusion criteria were led by HICs,whereas 26.7% were led by LMICs. Of the 106 LMIC-led studies, 71 were led by China. If Chinais excluded, only 8.8% were led by LMICs. HIC-led trials enrolled a median of 92 patients vsa median of 65 patients in LMIC-led trials. HIC-led trials enrolled from 7.6 sites vs 1.8 sitesin LMIC-led studies. Over half of LMIC-led trials were institutionally funded (54.7%). Themajority of both HIC- and LMIC-led trials evaluated spinal neurosurgery, 68% and 71.7%,respectively.CONCLUSION:We have established that there is a substantial disparity between HICsand LMICs in the number of published neurosurgical trials. A concerted effort to investin research capacity building in LMICs is an essential step towards ensuring context- andresource-specific high-quality evidence is generated.

Background To define the efficacy, complication profile and cost of surgical options for treating idiopathic intracranial hypertension (IIH) with respect to the following endpoints: vision and headache improvement, normal CSF pressure restoration, papilloedema resolution, relapse rate, operative complications, cost of intervention and quality of life. Methods A systematic review of the surgical treatment of IIH was carried out. Cochrane Library, MEDLINE and EMBASE databases were systematically searched from 1985 to 2014 to identify all relevant manuscripts written in English. Additional studies were identified by searching the references of retrieved papers and relative narrative reviews. Results Forty-one (41) studies were included (36 case series and 5 case reports), totalling 728 patients. Three hundred forty-one patients were treated with optic nerve sheath fenestration (ONSF), 128 patients with lumboperitoneal shunting (LPS), 72 patients with ventriculoperitoneal shunting (VPS), 155 patients with venous sinus stenting and 32 patients with bariatric surgery. ONSF showed considerable efficacy in vision improvement, while CSF shunting had a superior headache response. Venous sinus stenting demonstrated satisfactory results in both vision and headache improvement along with the best complication profile and low relapse rate, but longer follow-up periods are needed. The complication rate of bariatric surgery was high when compared to other interventions and visual outcomes have not been reported adequately. ONSF had the lowest cost. Conclusions No surgical modality proved to be clearly superior to any other in IIH management. However, in certain contexts, a given approach appears more justified. Therefore, a treatment algorithm has been formulated, based on the extracted evidence of this review. The traditional treatment paradigm may need to be re-examined with sinus stenting as a first-line treatment modality.

Background Atypical meningiomas are an intermediate grade brain tumour with a recurrence rate of 39–58 %. It is not known whether early adjuvant radiotherapy reduces the risk of tumour recurrence and whether the potential side-effects are justified. An alternative management strategy is to perform active monitoring with magnetic resonance imaging (MRI) and to treat at recurrence. There are no randomised controlled trials comparing these two approaches. Methods/Design A total of 190 patients will be recruited from neurosurgical/neuro-oncology centres across the United Kingdom, Ireland and mainland Europe. Adult patients undergoing gross total resection of intracranial atypical meningioma are eligible. Patients with multiple meningioma, optic nerve sheath meningioma, previous intracranial tumour, previous cranial radiotherapy and neurofibromatosis will be excluded. Informed consent will be obtained from patients. This is a two-stage trial (both stages will run in parallel): Stage 1 (qualitative study) is designed to maximise patient and clinician acceptability, thereby optimising recruitment and retention. Patients wishing to continue will proceed to randomisation. Stage 2 (randomisation) patients will be randomised to receive either early adjuvant radiotherapy for 6 weeks (60 Gy in 30 fractions) or active monitoring. The primary outcome measure is time to MRI evidence of tumour recurrence (progression-free survival (PFS)). Secondary outcome measures include assessing the toxicity of the radiotherapy, the quality of life, neurocognitive function, time to second line treatment, time to death (overall survival (OS)) and incremental cost per quality-adjusted life year (QALY) gained. Discussion ROAM/EORTC-1308 is the first multi-centre randomised controlled trial designed to determine whether early adjuvant radiotherapy reduces the risk of tumour recurrence following complete surgical resection of atypical meningioma. The results of this study will be used to inform current neurosurgery and neuro-oncology practice worldwide. Trial registration ISRCTN71502099 on 19 May 2014.

Abstract BACKGROUND Several studies suggest significant variation in cost for spine surgery, but there has been little research in this area for spinal deformity. OBJECTIVE To determine the utilization, cost, and factors contributing to cost for spinal deformity surgery. METHODS The cohort comprised 55 599 adults who underwent spinal deformity fusion in the 2001 to 2013 National Inpatient Sample database. Patient variables included age, gender, insurance, median income of zip code, county population, severity of illness, mortality risk, number of comorbidities, length of stay, elective vs nonelective case. Hospital variables included bed size, wage index, hospital type (rural, urban nonteaching, urban teaching), and geographical region. The outcome was total hospital cost for deformity surgery. Statistics included univariate and multivariate regression analyses. RESULTS The number of spinal deformity cases increased from 1803 in 2001 (rate: 4.16 per 100 000 adults) to 6728 in 2013 (rate: 13.9 per 100 000). Utilization of interbody fusion devices increased steadily during this time period, while bone morphogenic protein usage peaked in 2010 and declined thereafter. The mean inflation-adjusted case cost rose from $32 671 to $43 433 over the same time period. Multivariate analyses showed the following patient factors were associated with cost: age, race, insurance, severity of illness, length of stay, and elective admission (P < .01). Hospitals in the western United States and those with higher wage indices or smaller bed sizes were significantly more expensive (P < .05). CONCLUSION The rate of adult spinal deformity surgery and the mean case cost increased from 2001 to 2013, exceeding the rate of inflation. Both patient and hospital factors are important contributors to cost variation for spinal deformity surgery.

Failed back surgery syndrome (FBSS) is a cause of significant morbidity for up to 40% of patients following spine surgery, and is estimated to cost almost $20 billion. Treatment options for these patients currently include conventional medical management (CMM), repeat operation, or spinal cord stimulation (SCS). Much of the published data regarding cost effectiveness of SCS comprise smaller scale randomized controlled trials (RCTs) rather than large databases capturing practices throughout the US. SCS has been shown to have superior outcomes to CMM or repeat spinal operation in several landmark studies, yet there are few large studies examining its long-term economic impact. This study compares health care utilization for SCS compared to other management in patients with FBSS. Retrospective. Inpatient and outpatient sample. Patients with a history of FBSS from 2000 to 2012 were selected. We compared those who received SCS to those who underwent conventional management. A longitudinal analysis was used to model the value of log(cost) in each one year interval using a generalized estimating equations (GEE) model to account for the correlation of the same patient's cost in multiple years. Similarly, a Poisson GEE model with the log link was applied to correlated count outcomes. We identified 122,827 FBSS patients. Of these, 5,328 underwent SCS implantation (4.34%) and 117,499 underwent conventional management. Total annual costs decreased over time following implantation of the SCS system, with follow-up analysis at 1, 3, 6, and 9 years. The longitudinal GEE model demonstrated that placement of an SCS system was associated with an initial increase in total costs at the time of implantation (cost ratio [CR]: 1.74; 95% confidence interval [CI]: 1.41, 2.15, P < 0.001), however there was a significant and sustained 68% decrease in cost in the year following SCS placement (CR: 0.32; 95% CI: 0.24, 0.42, P < 0.001) compared to CMM. There was also an aggregate time trend that for each additional year after SCS, cost decreased on average 40% percent annually (CR: 0.60; 95% CI: 0.55, 0.65, P < 0.001), with follow-up up to 1, 3, 6, and 9 years post-procedure. Costs are not correlated with patient outcomes, patients are not stratified in terms of complexity of prior back surgery, as well as inherent limitations of a retrospective analysis. We found that from 2000 to 2012, only 4.3% of patients across the United States with FBSS were treated with SCS. Long-term total annual costs for these patients were significantly reduced compared to patients with conventional management. Although implantation of an SCS system results in a short-term increase in costs at one year, the subsequent annual cumulative costs were significantly decreased long-term in the following 9 years after implantation. This study combines the largest group of FBSS patients studied to date along with the longest follow-up interval ever analyzed. Since SCS has repeatedly been shown to have superior efficacy to CMM in randomized clinical trials, the current study demonstrating improved long-term health economics at 1, 3, 6, and 9 years supports the long-term cost utility of SCS in the treatment of FBSS patients. Key words: Failed back surgery syndrome, spinal cord stimulation, back pain, leg pain, neuromodulation, FBSS, SCS.

BackgroundEnhanced recovery after surgery (ERAS) is a constant motivation. There is growing evidence that an endoscopic (rather than microscopic) transsphenoidal approach to pituitary tumours can play a role, facilitating faster recovery and a commensurate reduction in length of stay (LOS). Reducing LOS is beneficial to both patients and healthcare systems. We sought to assess the safety, patient feedback, and resource implications of adopting an enhanced recovery and accelerated discharge policy for elective pituitary surgery.MethodsWe retrospectively assessed two consecutive cohorts of patients undergoing elective surgery for pituitary adenoma in a single UK centre between July 2016 and November 2019. The pre-ERAS cohort included 52 sequential patients operated prior to protocol change. The ERAS cohort included 55 sequential patients operated after a protocol change. Patient demographic data, tumour characteristics, intra- and post-operative CSF leak, the rate and cause of readmission (within 30 days), and the mean and median LOS were recorded. Patient feedback was collected from a subset of patients (n = 23) in the ERAS group.ResultsThe two cohorts were well-matched with respect to their demographic, pathological, and operative characteristics. The rates of readmission within 30 days of discharge were similar between the two groups (8% pre-ERAS cohort, 9% ERAS cohort, p = 0.75). In the pre-ERAS cohort, the mean LOS was 4.5 days and median LOS was 3 days. This compares with significant reduction in LOS for the ERAS group: mean of 1.7 days and median of 1 day (p < 0.05). Thirty-nine of 55 patients in the ERAS group were discharged on post-operative day 1. Patient feedback was very positive in the ERAS group (mean patient satisfaction score of 9.7/10 using a Likert scale).ConclusionsAn enhanced recovery protocol after elective endoscopic pituitary surgery is safe, reduces length of stay, and is associated with high patient satisfaction.

Abstract BACKGROUND Pituitary adenomas are among the most common primary brain tumors. Recently, overlapping surgery has been curbed in many institutions because of the suggestion there might be more significant adverse events, despite several studies showing that complication rates are equivalent. OBJECTIVE To assess complications and costs associated with overlapping surgery during the transsphenoidal resection of pituitary adenomas. METHODS A single-center, retrospective cohort study was performed to evaluate the cases of patients who underwent a transsphenoidal approach for pituitary tumor resection. Patient, surgical, complication, and cost (value-driven outcome) variables were analyzed. RESULTS A total of 629 patients (302 nonoverlapping, 327 overlapping cases) were identified. No significant differences in age (P = .6), sex (P = .5), tumor type (P = .5), or prior rates of pituitary adenoma resection (P = .5) were seen. Similar presenting symptoms were observed in the 2 groups, and follow-up length was comparable (P = .3). No differences in tumor sizes (P = .5), operative time (P = .4), fat/fascia use (P = .4), or cerebrospinal fluid diversion (P = .8) were seen between groups. The gross total resection rate was not significantly different (P = .9), and no difference in recurrence rate was seen (P = .4). A comparable complication rate was seen between groups (P = .6). No differences in total or subtotal costs were seen either. CONCLUSION The results of this study offer additional evidence that overlapping surgery does not result in worsened complications, lengthened surgery, or increased patient cost for patients undergoing transsphenoidal resection of pituitary adenomas. Thus, studies and policy aiming to improve patient safety and cost should focus on optimizing other aspects of healthcare delivery.

Background Postoperative delirium is a frequent complication with negative consequences for neurosurgical patients. Recorded music has been shown to reduce the incidence of delirium, however its economic benefit remains unclear. This study aimed to investigate the cost-effectiveness of perioperative music in preventing postoperative delirium. Methods This study used data from a randomized controlled trial (Clinical Trials.gov; NCT04649450) that compared the effect of perioperative music with standard of clinical care on the occurrence of postoperative delirium in patients undergoing craniotomy at the Erasmus Medical Centre. The primary outcome of this study is the cost-effectiveness of the music intervention. A trial-based cost-effectiveness analysis (CEA) was conducted from a societal perspective. Mean costs were calculated using bootstrapping with 95% confidence intervals. Secondary outcomes included postoperative complications, mortality, cognitive functioning, and quality of life. Costs and patient outcomes were assessed separately for the initial hospital admission and long-term follow-up until 6 months after discharge. Results This study included 91 patients in the intervention group and 93 in the control group. On average, medical costs during initial admission were lower, albeit not statistically significant, in the music group compared to the control group (€ 11,819 vs. € 13,106), mostly due to a shorter length of stay. Total costs over the 6-month period were nearly identical between the groups, at € 18,587 and € 18,571 in the music and control group, respectively. Conclusions Pre-recorded perioperative music may be a cost-effective intervention for reducing postoperative delirium in neurosurgical patients, possibly by decreasing healthcare utilization and costs during primary admission. Further studies are needed to confirm its potential as a cost-effective intervention.

Bone wax is an important hemostatic agent used in neurosurgical practice from more than a century. It acts by mechanical tamponade effect to stop the oozing from cancellous bone. Bone wax application over the skull surface over the vertex is easy and can be applied with fingers. In deeper areas, one uses dissector to apply the bone wax; however, it becomes difficult at times to apply in transnasal surgery using the same dissectors. Author designed a cost-effective 20-cm-long different angled bone wax applicator for skull base transnasal surgery. This applicator is cost-effective and not described previously in English literature.

MRI-guided laser interstitial thermal therapy (MRgLITT) is a new minimally invasive treatment for temporal lobe epilepsy (TLE), with limited effectiveness data. It is unknown if the cost savings associated with shorter hospitalization could offset the high equipment cost of MRgLITT. We examined the cost-utility of MRgLITT versus surgery for TLE from healthcare payer perspective, and the value of additional research to inform policy decision on MRgLITT. We developed a microsimulation model to evaluate quality adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) of MRgLITT versus surgery in TLE, assuming life-time horizon and 1.5% discount rate. Model inputs were derived from the literature. We conducted threshold and sensitivity analyses to examine parameter uncertainties, and expected value of partial perfect information analyses to evaluate the expected monetary benefit of eliminating uncertainty on probabilities associated with MRgLITT. MRgLITT yielded 0.08 more QALYs and cost $7,821 higher than surgery, with ICER of $94,350/QALY. Influential parameters that could change model outcomes include probabilities of becoming seizure-free from disabling seizures state and returning to disabling seizures from seizure-free state 5 years after surgery and MRgLITT, cost of MRgLITT disposable equipment, and utilities of disabling seizures and seizure-free states of surgery and MRgLITT. The cost-effectiveness acceptability curve showed surgery was preferred in more than 50% of iterations. The expected monetary benefit of eliminating uncertainty for probabilities associated with MRgLITT was higher than for utilities associated with MRgLITT. MRgLITT resulted in more QALYs gained and higher costs compared to surgery in the base-case. The model was sensitive to variations in the cost of MRgLITT disposable equipment. There is value in conducting more research to reduce uncertainty on the probabilities and utilities of MRgLITT, but priority should be given to research focusing on improving the precision of estimates on effectiveness of MRgLITT.