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Importance: Glioblastoma is the most devastating primary malignancy of the central nervous system in adults. Most patients die within 1 to 2 years of diagnosis. Tumor-treating fields (TTFields) are a locoregionally delivered antimitotic treatment that interferes with cell division and organelle assembly.Objective: To evaluate the efficacy and safety of TTFields used in combination with temozolomide maintenance treatment after chemoradiation therapy for patients with glioblastoma.Design, Setting, and Participants: After completion of chemoradiotherapy, patients with glioblastoma were randomized (2:1) to receive maintenance treatment with either TTFields plus temozolomide (n = 466) or temozolomide alone (n = 229) (median time from diagnosis to randomization, 3.8 months in both groups). The study enrolled 695 of the planned 700 patients between July 2009 and November 2014 at 83 centers in the United States, Canada, Europe, Israel, and South Korea. The trial was terminated based on the results of this planned interim analysis.Interventions: Treatment with TTFields was delivered continuously (>18 hours/day) via 4 transducer arrays placed on the shaved scalp and connected to a portable medical device. Temozolomide (150-200 mg/m2/d) was given for 5 days of each 28-day cycle.Main Outcomes and Measures: The primary end point was progression-free survival in the intent-to-treat population (significance threshold of .01) with overall survival in the per-protocol population (n = 280) as a powered secondary end point (significance threshold of .006). This prespecified interim analysis was to be conducted on the first 315 patients after at least 18 months of follow-up.Results: The interim analysis included 210 patients randomized to TTFields plus temozolomide and 105 randomized to temozolomide alone, and was conducted at a median follow-up of 38 months (range, 18-60 months). Median progression-free survival in the intent-to-treat population was 7.1 months (95% CI, 5.9-8.2 months) in the TTFields plus temozolomide group and 4.0 months (95% CI, 3.3-5.2 months) in the temozolomide alone group (hazard ratio [HR], 0.62 [98.7% CI, 0.43-0.89]; P = .001). Median overall survival in the per-protocol population was 20.5 months (95% CI, 16.7-25.0 months) in the TTFields plus temozolomide group (n = 196) and 15.6 months (95% CI, 13.3-19.1 months) in the temozolomide alone group (n = 84) (HR, 0.64 [99.4% CI, 0.42-0.98]; P = .004).Conclusions and Relevance: In this interim analysis of 315 patients with glioblastoma who had completed standard chemoradiation therapy, adding TTFields to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival.Trial Registration: clinicaltrials.gov Identifier: NCT00916409. [ABSTRACT FROM AUTHOR]

This article compares the U.S. and British systems of business organization and corporate governance for the period 1950-2000. Of particular interest is the contrasting relationship between governance systems and the pursuit of diversification and refocusing strategies. In order to explain these relationships, a theoretical model integrating the firm's resource base with the main aspects of corporate governance to explain strategy, structure and managerial behavior, is developed. It is then applied to examine changes in the U.S. and British corporate economies in the period. The first part of the article will review relevant theories incorporating the resource-based view of the firm and theories of corporate governance as a synthesized model to explain dynamic aspects of managerial behavior. The synthesis is then tested with reference to two contrasting historical episodes in each country: diversification, conglomeration and the multi-divisional, 1950-1980 and divestment and restructuring, 1980-2000. A final section summarizes the significant contrasts in the evolution of business organization in the two countries. The main area of contrast presented here is the relationship between changes in corporate governance and changes in available scale and scope economies, to explain the exploitation of the firm's strategic resource base by entrepreneurial and managerial groups.

• The stringency of motorcycle helmet safety legislation varies widely across the US. • States with more stringent laws had significantly lower unhelmeted fatalities per 100,000 people and 100,000 motorcycles. • Exemptions to helmet wearing for certain riders and motorcycle-like vehicles significantly predicted higher fatalities. Motorcycle collisions comprise a large portion of motor vehicle injuries and fatalities with over 80,000 injuries and 5,500 fatalities per year in the United States. Unhelmeted riders have poor medical outcomes and generate billions in costs. Despite helmet use having been shown to lower the risk of neurological injury and death, helmet compliance is not universal, and legislation concerning helmet use also varies widely across the United States. In this study, we systematically reviewed helmet-related statutes from all US jurisdictions. We evaluated the stringency of these statutes using a legislative scoring system termed the Helmet Safety Score (HSS) ranging from 0–7 points, with higher scores denoting more stringent statutes. Regression modeling was used to predict unhelmeted mortality using our safety scores. The mean score across all jurisdictions was 4.73. We found jurisdictions with higher HSS's generally had lower percentages of unhelmeted fatalities in terms of total fatalities as well as per 100,000 people and 100,000 registered motorcycles. In contrast, some lower-scoring jurisdictions had over 100 times more unhelmeted fatalities than higher-scoring jurisdictions. Our HSS significantly predicted unhelmeted motorcycle fatalities per 100,000 people (β = -0.228 per 1-point increase, 95% CI: -0.288 to -0.169, p <.0001) and per 100,000 registered motorcycles (β = -6.17 per 1-point increase, 95% CI: -8.37 to -3.98, p <.0001) in each state. Aspects of our score concerning helmet exemptions for riders and motorcycle-type vehicles independently predicted higher fatalities (p <.0001). Higher safety scores predicted lower unhelmeted fatalities. Stringent helmet laws may be an effective mechanism for decreasing unhelmeted mortality. Therefore, universal helmet laws may be one such mechanism to decrease motorcycle-related neurological injury and fatality burden. In states with existing helmet laws, elimination of exemptions for certain riders and motorcycle-type vehicles may also decrease fatalities. [ABSTRACT FROM AUTHOR]

The National Inpatient Sample (NIS) (the largest all-payer inpatient database in the United States) is an important instrument for big data analysis of neurosurgical inquiries. However, earlier research has determined that many NIS studies are limited by common methodological pitfalls. In this study, we provide the first primer of NIS methodological procedures in the setting of neurosurgical research and review all reported neurosurgical studies using the NIS. We designed a protocol for neurosurgical big data research using the NIS, based on our subject matter expertise, NIS documentation, and input and verification from the Healthcare Cost and Utilization Project. We subsequently used a comprehensive search strategy to identify all neurosurgical studies using the NIS in the PubMed and MEDLINE, Embase, and Web of Science databases from inception to August 2021. Studies underwent qualitative categorization (years of NIS studied, neurosurgical subspecialty, age group, and thematic focus of study objective) and analysis of longitudinal trends. We identified a canonical, 4-step protocol for NIS analysis: study population selection; defining additional clinical variables; identification and coding of outcomes; and statistical analysis. Methodological nuances discussed include identifying neurosurgery-specific admissions, addressing missing data, calculating additional severity and hospital-specific metrics, coding perioperative complications, and applying survey weights to make nationwide estimates. Inherent database limitations and common pitfalls of NIS studies discussed include lack of disease process–specific variables and data after the index admission, inability to calculate certain hospital-specific variables after 2011, performing state-level analyses, conflating hospitalization charges and costs, and not following proper statistical methodology for performing survey-weighted regression. In a systematic review, we identified 647 neurosurgical studies using the NIS. Although almost 60% of studies were reported after 2015, <10% of studies analyzed NIS data after 2015. The average sample size of studies was 507,352 patients (standard deviation = 2,739,900). Most studies analyzed cranial procedures (58.1%) and adults (68.1%). The most prevalent topic areas analyzed were surgical outcome trends (35.7%) and health policy and economics (17.8%), whereas patient disparities (9.4%) and surgeon or hospital volume (6.6%) were the least studied. We present a standardized methodology to analyze the NIS, systematically review the state of the NIS neurosurgical literature, suggest potential future directions for neurosurgical big data inquiries, and outline recommendations to improve the design of future neurosurgical data instruments. [ABSTRACT FROM AUTHOR]

Introduction: Falls from cribs resulting in head injury are understudied and poorly characterized. The purpose of this study was to advance current understanding of the prevalence, descriptive characteristics of injury victims, and the types of crib fall-related head injuries (CFHI) using queried patient cases from the National Electronic Injury Surveillance System (NEISS) database., Methods: Using the US Consumer Product Safety Commission's System NEISS database, we queried all CFHIs among children from over 100 emergency departments (EDs). Patient information regarding age, race, sex, location of the incident, diagnoses, ED disposition, and sequelae were analyzed. The number of CFHI from all US EDs during each year was also collected from the database., Results: There were an estimated 54,799 (95% CI: 30,228-79,369) total visits to EDs for CFHIs between 2012 and 2021, with a decrease in incidence of approximately 20% during the onset of the COVID-19 pandemic (2019: 5616 cases, 2020: 4459 cases). The annual incidence of injuries showed no significant trend over the 10-year study period. An available subset of 1782 cases of head injuries from approximately 100 EDs was analyzed, and 1442 cases were included in final analysis. Injuries were sorted into three primary categories: unspecified closed head injury (e.g., closed head injury, blunt head trauma, or traumatic brain injury), concussion, or open head injury and skull fracture. Unspecified closed head injuries were the most common of all head injuries (95.4%, 1376/1442). Open head injuries (14/1442, 0.97%) and concussions 3.6% (52/1442, 3.6%) were rare. Most injuries involved children under the age of 1 (42.6%) compared to children who were 1, 2, 3, or 4-years old. About a fourth of patients had other diagnoses in addition to their primary injury including scalp/forehead hematomas, emesis, and contusions. Female patients were more likely to present with other diagnoses in addition to their primary head injury (Difference: 12.3%, 95% CI: 9.87%-15.4%, p < .0001)., Conclusion: Despite minimum rail height requirements set by the Consumer Safety Product Commission (CPSC), head injuries associated with crib falls are prevalent in the United States. However, most injuries were minor with a vast majority of patients being released following examination and treatment., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023. Published by Elsevier Inc.)

Background: Cranioplasty can be performed with either autologous or synthetic materials. No clear consensus has been reached regarding which material is superior and which social factors might influence the choice of treatment modality and the outcomes. We investigated the effects of race and socioeconomic status on the implant choice and outcomes., Methods: We conducted a cross-sectional study of adult cranioplasty patients from 2002 to 2017 using the National Inpatient Sample. Autologous implant use, admission costs, length of stay (LOS), and home discharge were analyzed by race, income quartile, and insurance type using multivariable regression models., Results: A total of 105,714 admissions met the inclusion criteria. Most of the patients were women (50.3%) and White (73.7%). Black, other race, and Medicaid patients had greater odds of autologous graft usage, and patients in the 76th-100th income quartile had lower usage. Higher income patients (51th-75th and 76th-100th) had had significantly higher hospitalization costs, amounting to a $1547.2 increase, compared with the bottom quartile. The Medicaid patients had a longer LOS (odds ratio, 1.06; P = 0.008) and decreased rates of home discharge (odds ratio, 0.41; P < 0.001)., Conclusions: We found increased autologous cranioplasty usage for non-White and Medicaid patients and increased use of higher cost synthetic implants for high-income patients. Non-White patients and those from higher income quartiles incurred higher admission costs. Medicaid patients had a longer LOS and decreased rates of home discharge., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Introduction: Dual-eligible (DE) patients, simultaneous Medicare and Medicaid beneficiaries, have been shown to have poorer clinical outcomes while incurring higher resource utilization. However, neurosurgical oncology outcomes for DE patients are poorly characterized. Accordingly, we examined the impact of DE status on perioperative outcomes following glioma, meningioma, or metastasis resection., Methods: We identified all admissions undergoing a craniotomy for glioma, meningioma, or metastasis resection in the National Inpatient Sample from 2002 to 2011. Assessed outcomes included inpatient mortality, complications, discharge disposition, length of stay (LOS), and hospital costs. Multivariable regression adjusting for 13 patient, severity, and hospital characteristics assessed the association between DE status and outcomes, relative to four reference insurance groups (Medicare-only, Medicaid-only, private insurance, self-pay)., Results: Of 195,725 total admissions analyzed, 3.0% were dual-eligible beneficiaries (n = 5933). DEs were younger than Medicare admissions (P < 0.001) but older than Medicaid, private, and self-pay admissions (P < 0.001). Relative to other insurance groups, DEs also exhibited higher severity of illness, risk of mortality, and Charlson Comorbidity Index scores as well as treatment at low-volume hospitals (all P < 0.001). DEs had lower mortality than self-pay admissions (odds ratio [OR] 0.47, P = 0.017). Compared to Medicare, Medicaid, private, and self-pay admissions, DEs had lower rates of discharge disposition (OR 0.53, 0.50, 0.34, and 0.27, respectively, all P < 0.001). DEs also had higher complications (OR 1.23 and 1.20, respectively, both P < 0.05) and LOS (β = 1.06 and 1.13, respectively, both P < 0.01) than Medicare and private insurance beneficiaries. Differences in discharge disposition remained significant for all three tumor subtypes, but only glioma DE admissions continued to exhibit higher complications and LOS., Conclusions: DEs undergoing definitive craniotomy for brain tumor had higher rates of unfavorable discharge disposition compared to all other insurance groups and, especially for glioma surgery, had higher inpatient complication rates and LOS. Practice and policy reforms to improve outcomes for this vulnerable clinical population are warranted., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Dual-eligible beneficiaries, individuals with both Medicare and Medicaid coverage, represent a high-cost and vulnerable population; however, literature regarding outcomes is sparse. We characterized outcomes in dual-eligible beneficiaries treated for aneurysmal subarachnoid hemorrhage (aSAH) compared to Medicare only, Medicaid only, private insurance, and self-pay. A 10-year cross-sectional study of the National Inpatient Sample was conducted. Adult aSAH emergency admissions treated by neurosurgical clipping or endovascular coiling were included. Multivariable regression was used to adjust for confounders. A total of 57,666 patients met inclusion criteria. Dual-eligibles comprised 2.8% of admissions and were on average younger (62.4 years) than Medicare (70.0 years), older than all other groups, and had higher mean National Inpatient Sample-Subarachnoid Hemorrhage Severity Scores than all other groups (p ≤ 0.001). Among patients treated by clipping, dual-eligibles were less often discharged to home compared to Medicare (adjusted odds ratio (aOR) = 0.51, 95% CI = 0.30-0.87, p < 0.05) and all other insurance groups, p < 0.01. Likewise, those who received coiling were less often discharged to home compared to Medicaid (aOR = 0.41, 95% CI = 0.23-0.73), private (aOR = 0.42, 95% CI = 0.23-0.76) and self-pay patients (aOR = 0.24, 95% CI = 0.12-0.46). They also had increased odds of poor National Inpatient Sample-Subarachnoid Hemorrhage Outcome Measures compared to Medicaid, private, and self-pay patients, all p < 0.05. There were no differences in inpatient mortality or total complications. In conclusion, dual-eligible patients had higher aSAH severity scores, less often discharged home, and among patients who received coiling, dual-eligibles had increased odds of poor outcome. Dual-eligible patients with aSAH represent a vulnerable population that may benefit from targeted clinical and public policy initiatives., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

With longevity increasing in the United States, more older individuals are presenting with supratentorial brain tumors. Despite improved perioperative management, there is persistent disparity in surgical resection rates among patients aged 65 years or older. We aim to assess the effects of advanced age (≥65 years) on 30-day outcomes in patients with supratentorial tumors who underwent craniotomy for supratentorial tumor resection. Data obtained in adults who underwent supratentorial tumor resections was extracted from the prospectively-collected American College of Surgeons: National Surgical Quality Improvement Program (NSQIP; 2012-2018) database. Using multivariate regression, we compared odds of major and minor complications; prolonged length-of-stay (LOS); discharge anywhere other than home; and 30-day readmission, reoperation, and mortality rates between patients aged 18-64 years (the control cohort) and those 65-74 years or ≥75 years of age. Of the 14,234 patients who underwent craniotomy for supratentorial tumors and met inclusion criteria, 30.7% were ≥65 years of age; 71.4% of these were 65-74 years and 28.6% were ≥75 years old. Compared to the control group, both older subpopulations had more medical comorbidities. Both older subgroups had increased odds of major complications and prolonged LOS relative to the control group. Older patients had greater odds of mortality at 30 days. Advanced age, defined as ≥65 years, was significantly associated with higher odds of complications, prolonged LOS, and mortality within the 30-day post- operative period after adjusting for potential confounders. Age is one important consideration when prospectively risk-stratifying patients to minimize and mitigate suboptimal perioperative outcomes., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)