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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.

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.

Abstract BACKGROUND: Direct cost comparisons between minimally invasive spine surgeries and the open options are rare. OBJECTIVE: To compare healthcare costs associated with open transforaminal lumbar interbody fusion (TLIF) and minimally invasive lateral lumbar interbody fusion (LLIF) by calculating the incremental cost-effectiveness ratio (ICER) and to calculate the thresholds for minimum clinically important difference and minimum cost-effective difference for patient-reported outcome measures at the 2-year follow-up. METHODS: Forty-five patients who underwent single-level TLIF and 29 patients who underwent single-level stand-alone LLIF were included in the comparison. All costs from diagnosis through the 2-year follow-up were available from a comprehensive single-center data bank within a unified hospital system. Payment provided for all spine-related medical resource use from the time of diagnosis through 2 years was recorded. A 0% discount rate was applied. Quality-adjusted life-years (QALYs) were calculated from the EuroQol-5D collected in an unbiased manner. Difference in total cost per QALY gained for LLIF minus that for TLIF was assessed as the estimate of the ICER from a US perspective. RESULTS: Significant improvements were observed at the 2-year follow-up for both TLIF and LLIF with the Short Form-36 physical component summary, Oswestry Disability Index, visual analog scale back pain and leg pain scores, and EuroQol-5D. ICER calculations revealed similar mean cumulative QALYs gained at the 2-year interval (0.67 for TLIF and 0.60 for LLIF; P = .33). Median total costs of care after TLIF and LLIF were $44 068 and $45 574, respectively (P = .96). Minimum cost-effective difference thresholds with an anchor of <$50 000 per QALY were higher than minimum clinically important difference thresholds for all patient-reported outcome measures. Total mean cost and EuroQol-5D were statistically equivalent between the 2 treatment groups. CONCLUSION: TLIF and LLIF produced equivalent 2-year patient outcomes at an equivalent cost-effectiveness profile.

Pediatric surgical trials are rare and the impact of such trials on the institutions in which they are conducted is unknown. The purpose of this study was to analyze the clinical and financial impact of The Re-MATCH trial, a Phase I clinical trial requiring the biopsy or resection of recurrent medulloblastoma or PNET for enrollment. Inpatient financial and clinical volume information was collected during the 3 years of trial enrollment and the years preceding and following it. The primary endpoints were the difference in direct contribution margin (DCM), or net gain, of study and non-study patients and the difference in surgical volume during the study and non-study periods. The trial enrolled 18 patients; 15 had surgery at the sponsor institution and three had surgery at their home institution, then transferred tumor material to the sponsor institution. There were no differences between the two groups for potentially confounding variables such as neurosurgical procedure work relative value units (P = 0.13) or insurance provider (P = 0.26). There was no difference between the inpatient DCM per case for the institution for non-study patients (mean ± SD, $9039 ± $28,549) and study patients ($14,332 ± $20,231) (P = 0.4819). During the non-study period, there were a mean of 2.78 ± 1.65 pediatric brain tumor resections per month compared to 3.34 ± 1.66 cases per month during the study period, a 17% increase. When the 15 study patients were excluded, there were 2.97 ± 1.64 cases per month, a 7% increase. However, this increase in total case volume including study and non-study patients was not significant (P = 0.121). Phase I investigator-initiated surgically-based clinical trials may increase institutional surgical volume without imposing a financial burden. Finances are unlikely to be a barrier for researchers negotiating for resources to conduct such trials.

Abstract BACKGROUND: Postoperative fever is a common sequel of spine surgery. In the presence of rigid nationally mandated clinical guidelines, fever management may consume more health care resources than is reasonably appropriate. OBJECTIVE: To study the relationship between postoperative fever, infection rate, and hospital charges in a cohort of spine surgery patients. METHODS: We retrospectively reviewed 578 spine surgery patients (lumbar microdiskectomy [LMD], anterior cervical decompression and fusion [ACDF], and lumbar decompression and fusion [LDF]). Differences in length of stay and hospital charges as well as risk factors and correlation with infection and readmission rates were studied. RESULTS: Postoperative fever occurred in 41.7% of all spine surgery patients and more often in LDF patients (77.2%). Type of surgery was the most important variable affecting the prevalence of postoperative fever. Significant differences in length of stay were elicited between patients with and without postoperative fever in the ACDF and LMD groups and in hospital cost in the LMD group. The average length of stay was 2.41 vs 4.47 (P < .01) in the LMD group, 1.67 vs 2.80 (P < .05) in the ACDF group, and 5.03 vs 5.65 (P > .05) in the LDF group. The average hospital charges were $16 261 vs $22 166 (P < .01) in the LMD group, $26 021 vs $29 125 (P > .05) in the ACDF group, and $53 627 vs $53 210 (P > .05) in the LDF group. Obesity, female sex, and ≥102°F postoperative temperature were the most significant predictors of infection. Delayed discharge referable to postoperative fever did not seem to influence the infection readmission rate. CONCLUSION: Postoperative fever in spine surgery patients is associated with a delay in patient discharge and increases in hospital charges. Postoperative fever discharge guidelines should be regularly and publicly subjected to appropriate cost-benefit analysis.

Introduction Chiari malformation type I (CM-I) is a congenital hindbrain anomaly that requires surgical decompression in symptomatic patients. Posterior fossa decompression with duraplasty (PFDD) has been widely practiced in Chiari decompression, but dural opening carries a high risk of surgical complications. A minimally invasive technique, dural splitting decompression (DSD), preserves the inner layer of the dura without dural opening and duraplasty, potentially reducing surgical complications, length of operative time and hospital stay, and cost. If DSD is non-inferior to PFDD in terms of clinical improvement, DSD could be an alternative treatment modality for CM-I. So far, no randomised study of surgical treatment of CM-I has been reported. This study aims to evaluate if DSD is an effective, safe and cost-saving treatment modality for adult CM-I patients, and may provide evidence for using the minimally invasive procedure extensively. Methods and analysis DECMI is a randomised controlled, single-masked, non-inferiority, single centre clinical trial. Participants meeting the criteria will be randomised to the DSD group and the PFDD group in a 1:1 ratio. The primary outcome is the rate of clinical improvement, which is defined as the complete resolution or partial improvement of the presenting symptoms/signs. The secondary outcomes consist of the incidence of syrinx reduction, postoperative morbidity rates, reoperation rate, quality of life (QoL) and healthcare resource utilisation. A total of 160 patients will be included and followed up at 3 and 12 months postoperatively. Ethics and dissemination The study protocol was approved by the Biological and Medical Ethics Committee of West China Hospital. The findings of this trial will be published in a peer-reviewed scientific journal and presented at scientific conferences. Trial registration number ChiCTR-TRC-14004099.

Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH); subdural (SDH); and intraparenchymal (TICH). Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial), but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma) to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH) requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/−2 days) to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients. Trial registration Current Controlled Trials ISRCTN19321911

Abstract BACKGROUND The setting of a randomized trial can determine whether its findings are generalizable and can therefore apply to different settings. The contribution of low- and middle-income countries (LMICs) to neurosurgical randomized trials has not been systematically 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 patients assessing any one neurosurgical procedure against another procedure, nonsurgical treatment, 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 China is excluded, only 8.8% were led by LMICs. HIC-led trials enrolled a median of 92 patients vs a median of 65 patients in LMIC-led trials. HIC-led trials enrolled from 7.6 sites vs 1.8 sites in LMIC-led studies. Over half of LMIC-led trials were institutionally funded (54.7%). The majority 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 HICs and LMICs in the number of published neurosurgical trials. A concerted effort to invest in research capacity building in LMICs is an essential step towards ensuring context- and resource-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.

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.