BACKGROUND:Penetrating traumatic brain injury (pTBI) affects civilian and military populations resulting in significant morbidity, mortality, and health care costs. No up-to-date and evidence-based guidelines exist to assist modern medical and surgical management of these complex injuries. METHODS:A preliminary literature search informed a need for updated guidelines. Methodologists experienced in TBI guidelines supported 2 co-chairs, a diverse steering committee and three expert working groups. Over half of our panelists were active service military or military veterans and they addressed twenty-six Key Questions (KQs). We searched Ovid MEDLINE®, EMBASE, and Cochrane CENTRAL from inception to August 31, 2022, reference lists, and clinical trial registries. Penetrating, perforating and tangential penetrating brain injuries were included. Predefined criteria were used to identify studies; pre-specified methods were used to assess study quality and strength of evidence for key outcomes. Effects were analyzed qualitatively and quantitatively where appropriate. RESULTS:125 studies provided evidence and another 80 studies provided contextual data for these guidelines. In general there was a paucity of literature and most of the identified evidence was judged to be high risk of bias due to study design. We did not identify any studies meeting inclusion criteria for 12 KQs. The highest quality evidence, rated moderate in strength, was identified for four KQs that covered: cerebral angiography vs computed tomography angiography, the relationship between bihemispheric injury in adult pTBI and mortality, the ability of the Surviving Penetrating Injury to the Brain (SPIN) score to predict mortality, and the relationship between infection and cerebrospinal fluid fistula. Evidence for most KQs came from case series. CONCLUSIONS:The development of up-to-date evidence and consensus based clinical care guidelines and algorithms for pTBI provide guidance to care providers in the prehospital and emergency medicine, surgical and intensive care settings. Few moderately strong conclusions on the benefit of specific management strategies for penetrating brain injury could be made. Detailed reporting of patient outcomes in future studies could advance the field by providing greater evidence for specific treatments by patient population, mechanism of injury, severity of injury, and specific interventions employed.
Introduction Spinal disease is prevalent, yet education regarding these disorders in undergraduate medical education is limited. Objective This study assesses medical students' exposure, confidence, competence, and attitudes regarding their spine anatomy and pathology curricula. Methods US allopathic and osteopathic medical students completed an anonymous, uncompensated survey, including 17 questions on attitudes towards spine education and 15 on spine anatomy and pathology. Surveys completed in <180 seconds or <80% complete were excluded. Students estimated their hours of spine education and rated their comfort in diagnosing spine pathology. Data was analyzed using Stata (StataCorp, College Station, TX, USA) and RStudio (Posit PBC, Boston, MA, USA). Results Of 491 survey respondents, 252 (51.2% allopathic, 48.8% osteopathic) met the inclusion criteria. Surgery and medicine were the most common specialty interests. Students scored significantly higher in lumbar competence (2.20 vs. 1.96; p<0.001, F = 7.40) and confidence (1.72 vs. 0.82; p<0.001, F = 38.66) questions than in cervical spine. Students who reported over 20 hours of spine anatomy teaching answered more lumbar spine questions correctly and reported more confidence answering both cervical and lumbar spine questions. Students with reported interest in either neurosurgery or orthopedics had a non-significant trend to answer more questions correctly overall but were significantly more confident with cervical spine questions (p=0.02, x2 = 19.58, df = 4). A majority (59.1%) of participants wished for more didactic time on spine pathology, and 39.5% of participants expressed dissatisfaction with clinical rotation didactics. Conclusions US medical students demonstrated disparity in recognizing cervical versus lumbar spine pathologies. Most respondents desired more spine-focused didactics, suggesting an area of improvement in medical education by balancing spine education to reflect disease prevalence.
BACKGROUND:Utilization of the emergency department (ED) is associated with medical and social comorbidities. These factors may also be associated with medical complications after complex surgeries. This study investigated how preoperative ED use increases risk of posterior lumbar interbody fusion (PLIF) complications. METHODS:We identified adult PLIF patients treated between 2016 and 2019 in the PearlDiver Claims Database. Clinical variables including preoperative ED use within 180 days were collected using International Classification of Disease (ICD-10) codes. Risk difference was calculated, and multivariable regression was performed. RESULTS:This study included 13,010 (21.1%) patients who went to the ED before surgery and 48,065 (78.9%) who did not. Having a preoperative ED visit significantly increased risk of a postoperative ED visit by 28.7 percentage points, 90-day readmission by 3.8 percentage points, and 30-day major-medical complications by 3.4 percentage points. Risk of these outcomes increased in a dose-dependent fashion. Compared with patients with zero preoperative ED visits, patients who had 6 or more preoperative ED visits had an 82.0 percentage point increase in risk for a postoperative ED visit, a 46.5 percentage point increase for six or more ED visits, a 6.1 percentage point increase for major medical complications, and 10.6% increase for readmission. CONCLUSIONS:Patients with any preoperative ED visit had an increased risk for postoperative ED use, readmission, and medical complications. The risk difference increased with each additional preoperative visit. Patient counseling and protocols that reduce preventable ED visit in the preoperative period may reduce a patient's risk for costly postoperative complications.
INTRODUCTION: Neurosurgeons are often asked to give clinical advice to other physicians through curbside consultation and are also considered as the gatekeeper for whether to accept a patient transfer with a neurological condition. Such interactions occur prior to establishment of a direct doctor-patient relationship. However, recent legal cases ruled that a doctor-patient relationship is not a necessary element of medical negligence claims in certain state(s), rendering potential medico-legal liability through such transactions. METHODS: The Council of State Neurosurgical Societies surveyed practicing AANS-registered neurosurgeons via email link using the SurveyMonkey platform to assess practice pattern and frequency of transfer requests and informal consults. One hundred fourteen responses were obtained. RESULTS: Of the 114 survey responses, most of the respondents were either employed by a hospital/hospital foundation (32%) or in an academic practice (28%). Ninety-four percent of respondents participated in trauma neurosurgery calls. Most frequently, the on-call neurosurgeon would get 2-3 transfer requests (47%) per day. Similarly, respondents typically received 1-3 curbside consults (66%) per day. While most curbside consults came from the primary call hospital, 21% of the respondents also participated in curbside consults from out of state. Majority (69%) of the respondents were able to document the transfer requests through a recorded conversation with the transfer center. Notably, 71% of the respondents did not document their curbside consultation interaction. Importantly, 7% of respondents reported having had a malpractice lawsuit or medical board/hospital complaint against them arising from curbside consults. CONCLUSIONS: Transfer requests and informal consults are common aspects of neurosurgical practice. However, the lack of complete clinical and radiographical data available to the neurosurgeon for clinical decision-making and the lack of documentation expose the providers to potential medico-legal consequences.
Myxopapillary ependymomas (MPEs) are rare spinal cord tumors with low rates of metastasis outside of the neuraxis. Gross total resection of MPEs can significantly improve progression-free survival; however, adjunctive treatment remains unstandardized. A 29-year-old female with a history of spina bifida occulta surgical correction and lower back pain presented with dyspnea and tachycardia. A large pulmonary artery mass was discovered consistent with pulmonary thromboembolism. It was subsequently determined to be an intravascular metastasis secondary to sacral MPE. Standardization of MPE treatment and clinical suspicion of spinal neoplasm in the setting of chronic back pain with undetermined origin are of value.
Background: In endurance cycling, both high-intensity interval training (HIIT) and sprint interval training (SIT) have become popular training modalities due to their ability to elicit improvements in performance. Studies have attempted to ascertain which form of interval training might be more beneficial for maximising cycling performance as well as a range of physiological parameters, but an amalgamation of results which explores the influence of different interval training programming variables in trained cyclists has not yet been conducted. Objective: The aims of this study were to: (1) systematically investigate training interventions to determine which training modality, HIIT, SIT or low- to moderate-intensity continuous training (LIT/MICT), leads to greater physiological and performance adaptations in trained cyclists; and (2) determine the moderating effects of interval work-bout duration and intervention length on the overall HIIT/SIT programme. Data Sources: Electronic database searches were conducted using SPORTDiscus and PubMed. Study Selection: Inclusion criteria were: (1) at least recreationally-trained cyclists aged 18–49 years (maximum/peak oxygen uptake [V̇O2max/V̇O2peak] ≥45 mL·kg-1·min-1); (2) training interventions that included a HIIT or SIT group and a control group (or two interval training groups for direct comparisons); (3) minimum intervention length of 2 weeks; (4) interventions that consisted of 2–3 weekly interval training sessions. Results: Interval training leads to small improvements in all outcome measures combined (overall main effects model, SMD: 0.33 [95%CI = 0.06 to 0.60]) when compared to LIT/MICT in trained cyclists. At the individual level, point estimates favouring HIIT/SIT were negligible (Wingate model: 0.01 [95%CI = -3.56 to 3.57]), trivial (relative V̇O2max/V̇O2peak: 0.10 [95%CI = -0.34 to 0.54]), small (absolute V̇O2max/V̇O2peak: 0.28 [95%CI = 0.15 to 0.40], absolute maximum aerobic power/peak power output: 0.38 [95%CI = 0.15 to 0.61], relative absolute maximum aerobic power/peak power output: 0.43 [95%CI = -0.09 to 0.95], physiological thresholds: 0.46 [95%CI = -0.24 to 1.17]), and large (time-trial/time-to-exhaustion: 0.96 [95%CI = -0.81 to 2.73]) improvements in physiological/performance variables compared to controls, with very imprecise interval estimates for most outcomes. In addition, intervention length did not contribute significantly to the improvements in outcome measures in this population, as the effect estimate was only trivial (βDuration: 0.04 [ 95%CI = -0.07 to 0.15]). Finally, the network meta-analysis did not reveal a clear superior effect of any HIIT/SIT types when directly comparing interval training differing in interval work-bout duration. Conclusion: The results of the meta-analysis indicate that both HIIT and SIT are effective training modalities to elicit physiological adaptations and performance improvements in trained cyclists. Our analyses highlight that the optimisation of interval training prescription in trained cyclists cannot be solely explained by interval type or interval work-bout duration and an individualised approach that takes into account the training/competitive needs of the athlete is warranted.
Growth differentiation factor 15 (GDF15) is a cytokine of the TGFβ family. Here, we analyzed GDF15 levels in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who participated in OCOG-ALMERA (NCT02115464), a phase II randomized clinical trial, that investigated metformin in combination with standard of care concurrent chemoradiotherapy (cCRT). OCOG-ALMERA was not able to demonstrate benefit in the metformin arm. Therefore, biomarker studies are needed to better define stratification parameters for future trials. Patients were randomized to treatment with platinum-based chemotherapy and concurrent chest radiotherapy (60–66 Gy), with or without metformin (2000 mg/d). The trial collected tumor volume parameters, survival outcomes, and patient blood plasma at baseline, during (weeks 1 and 6) and 6 months after cCRT. Plasma GDF15 levels were assayed with the ELISA method. Statistical analyses explored associations between GDF15, survival outcomes, and radiotherapy tumor volumes. Baseline plasma levels of GDF15 were elevated in study patients, they increased during cCRT (p < 0.001), and the addition of metformin was associated with a further increase (week 6, p = 0.033). Baseline GDF15 levels correlated with the radiotherapy gross target volume (GTV, p < 0.01), while week 1 of radiotherapy levels correlated with radiotherapy planned target volume (PTV, p < 0.006). In multivariate analysis, baseline plasma GDF15 was prognostic for poor relapse-free (RFS) and overall survival (OS) (p = 0.005 and p = 0.002, respectively). GDF15 is a plasma marker that responds to the treatment of unresected LA-NSCLC with cCRT and metformin. GDF15 levels correspond with tumor volume and increased GDF15 levels predict for poor RFS and OS. These results require validation in larger clinical trial datasets. Analysis of plasma specimens of OCOG-ALMERA, a phase II clinical trial that investigated metformin in combination with standard of care concurrent chemoradiotherapy, suggests that the cytokine growth differentiation factor 15 (GDF15) may be a promising biomarker in unresected locally advanced non-small cell lung cancer (LA-NSCLC). GDF15 levels increased during chemoradiotherapy, did more so in metformin-treated patients and corresponded with the radiotherapy clinical target volumes. Baseline plasma levels of GDF15 predicted overall and relapse-free survival. Validation of these results within larger clinical trials could lead to the establishment of an easily assessable plasma biomarker that could guide LA-NSCLC treatment in the future.
BACKGROUND: Elite-level football requires an array of physical, technical, psychological, and tactical skills. The aim of this study was to measure the association between physical outputs (distance, decelerations, accelerations) and the match outcome (win, draw, lose) in professional football. This research also examined whether the same association is influenced if a team adopts a possession or transition-based playing style. METHODS: Thirty-six elite-outfield football players from an English Championship team participated in the study during the 2020/2021 and 2021/2022 seasons using physical and event data collected from an English Championship club over the 2020-2021 and 2021-2022 seasons, this study conducted a univariate analysis of variance (ANOVA) and Hedge g effect size (ES) to measure the research aims. RESULTS: The results showed no significant differences were found between match outcomes for each physical output metric calculated. There was a trivial ES shown for all conditions except decelerations, with win/lose having a moderate ES (g=0.53). g =0.53). When playing a possession-based playing style there was no significant difference or non-trivial ES found for any physical output and match outcomes. When playing a transitionbased playing style there was a moderate ES found for win/draw (P=0.38, g =0.90) and win/loss (P=0.98, g =0.64). CONCLUSIONS: This research provides important evidence for utilizing intense deceleration actions as a physical KPI during match play for teams adopting a transitional playing style. Subsequently, training interventions should be adopted to physically prepare players to complete and sustain intense deceleration actions during match play.
BACKGROUND AND PURPOSE:Stereotactic body radiotherapy (SBRT) carries potentially higher risks for ultracentral (UC) NSCLC with limited prospective data to guide decision making. We conducted a secondary analysis from a randomized trial of SBRT and conventionally hypofractionated radiation (CRT) to assess these risks. MATERIALS AND METHODS:Patients (n = 233) with medically inoperable stage I NSCLC were recruited from 2014 to 2020. Patients with UC targets directly overlapping the proximal bronchial tree (PBT) were identified. The primary objective was the occurrence of related grade 3-5 toxicity > 3 months following radiation. Secondary endpoints included local control, survival, and evaluation of PBT dose and its association with late toxicity. RESULTS:Thirty UC tumors were identified (23 - SBRT 60 Gy/8 fractions, 7 - CRT 60 Gy/15 fractions). Median age was 72 years, and median tumor size was 2.8 cm. Most patients (67 %) had histologically confirmed NSCLC. At a median follow-up of 2.9 years, 3 and 1 patients developed grade 3 and 5 toxicity respectively (all SBRT). 3-year local control was 85 %. Mean PBT dose (converted to 2 Gy dose equivalents) was higher in patients with grade ≥ 3 toxicity, particularly for 4 cc (105.5 vs 51.8 Gy, p = 0.0004), 5 cc (84 vs 46.1 Gy, p = 0.003), and volumetric doses (V65 - V100Gy). The patient with grade 5 toxicity had the highest 5 cc dose (117 Gy), V90Gy (8.2 cc), and V100Gy (7 cc). CONCLUSIONS:SBRT for UC NSCLC provides good local control but carries a high rate of late grade 3-5 toxicity. An apparent association between toxicity and PBT volumetric dose was observed, which should be considered if SBRT is offered.
INTRODUCTION:Interspinous process devices (IPDs) were developed as minimally invasive alternatives to open decompression surgery for spinal stenosis. However, given high treatment failure and reoperation rates, there has been minimal adoption by spine surgeons. This study leveraged a national claims database to characterize national IPD usage patterns and postoperative outcomes after IPD implantation. METHOD:Using the PearlDiver database, we identified all patients who underwent 1- or 2-level IPD implantation between 2010 and 2018. Univariate and multivariable logistic regression was performed to identify predictors of the number of IPD levels implanted and reoperation up to 3 years after the index surgery. Right-censored Kaplan-Meier curves were plotted for duration of reoperation-free survival and compared with log-rank tests. RESULTS:Patients (n = 4865) received 1-level (n = 3246) or 2-level (n = 1619) IPDs. Patients who were older (adjusted odds ratio [aOR] 1.02, 95% confidence interval [CI] 1.01-1.03, P < .001), male (aOR 1.31, 95% CI 116-1.50, P < .001), and obese (aOR 1.19, 95% CI 1.05-1.36, P < .01) were significantly more likely to receive a 2-level IPD than to receive a 1-level IPD. The 3-year reoperation rate was 9.3% of patients when mortality was accounted for during the follow-up period. Older age decreased (aOR 0.97, 95% CI 0.97-0.99, P = .0039) likelihood of reoperation, whereas 1-level IPD (aOR 1.37, 95% CI 1.01-1.89, P = .048), Charlson Comorbidity Index (aOR 1.07, 95% CI 1.01-1.14, P = .018), and performing concomitant open decompression increased the likelihood of reoperation (aOR 1.68, 95% CI 1.35-2.09, P = .0014). CONCLUSION:Compared with 1-level IPDs, 2-level IPDs were implanted more frequently in older, male, and obese patients. The 3-year reoperation rate was 9.3%. Concomitant open decompression with IPD placement was identified as a significant risk factor for subsequent reoperation and warrants future investigation.
STUDY DESIGN:Retrospective database analysis. OBJECTIVE:Determine risk factors and failure rate of anterior odontoid screw fixation surgery. SUMMARY OF BACKGROUND DATA:Anterior odontoid screw fixation (AOSF) stabilizes type II dens fractures while preserving cervical motion. Despite having potential advantages, AOSF's failure rate and factors contributing to failure remain unknown. MATERIALS AND METHODS:We identified AOSF patients in the national claims database Pearldiver using CPT code 22318. Failure was defined as the requirement of supplementary posterior fusion surgery in the C1-C2 or occiput-C2 region after the AOSF. We considered potential predictors of failure including age, sex, Charlson Comorbidity Index (CCI), surgeon experience, history of osteoporosis, obesity, and tobacco use. Univariate comparison analysis and logistic regression were conducted to identify factors associated with the need for additional posterior surgery. RESULTS:For 2008 identified cases of AOSF, 249 cases (12.4%) required additional posterior fusion. Seventy-one of the 249 cases (28.5%) underwent revision surgery on the same day as the AOSF. Over 86% of revisions (215 cases) occurred within 200 days of the initial procedure. Posterior fusion rates are inversely correlated with surgeon experience, with the most experienced surgeons having a rate of 10.0%, followed by 11.5% for moderately experienced surgeons, and 15.0% for the least experienced surgeons. When comparing moderate and inexperienced surgeons to experienced surgeons, the odds ratios for posterior fusion were 1.18 ( P >0.05) and 1.61 ( P <0.006), respectively. Logistic regression revealed that both lesser experience (odds ratio=1.50) and osteoporosis (odds ratio=1.44) were the only factors significantly associated with failure ( P <0.05). CONCLUSIONS:Our findings indicate a correlation between AOSF success and surgeon experience. While currently published results suggest higher success rates, most of this data originates from experienced surgeons and specialized centers, therefore, they may not accurately reflect the failure rate encountered in a more general practice setting. LEVEL OF EVIDENCE:Level III.
BACKGROUND:Our study explores the efficacy and economic benefits of neurosurgical teleconsultations in managing intracerebral hemorrhage (ICH), focusing on reducing unnecessary patient transfers and associated costs. METHODS:We conducted a cost-savings analysis at our institution of a previously published pilot study involving a cohort of patients with ICH who were potential candidates for airlift to our tertiary care center but instead received neurosurgical consultation via teleconsultation to avoid the transfer. Data on patient demographics, distances, and costs were collected and analyzed to assess the economic impact of teleconsultations. RESULTS:The cohort comprised 14 patients; we noted significant cost savings from avoiding interhospital transfers, ranging from $84,346.52 to $120,495.03 per patient. Teleconsultations facilitated immediate, collaborative decision-making between healthcare providers at community hospitals and a tertiary care center, reducing the need for expensive air transportation and unnecessary hospital transfers. CONCLUSIONS:Neurosurgical teleconsultations offer a cost-effective alternative to traditional patient transfer methods for ICH management, providing substantial economic benefits while maintaining high physician and patient-family satisfaction levels. This study underscores the potential of our teleneurosurgery program to significantly reduce costs by reducing unnecessary financial burdens on patients' families and healthcare systems.
Importance:Stereotactic body radiotherapy (SBRT) is widely used for stage I medically inoperable non-small cell lung cancer (NSCLC), yet varied results from randomized clinical trials (RCTs) and concerns in treating centrally located tumors persist. Objective:To examine whether SBRT would improve local control (LC) compared with hypofractionated conventional radiotherapy (CRT). Design Setting and Participants:This phase 3 RCT was conducted in 16 Canadian centers. Patients with medically inoperable stage I (≤5 cm) NSCLC were randomized 2:1 to SBRT of 48 Gy in 4 fractions (peripheral NSCLC) or 60 Gy in 8 fractions (central NSCLC) vs CRT of 60 Gy in 15 fractions. Data were collected from May 2014 to January 2020, and data were analyzed from July 2022 to July 2023. Interventions:SBRT or CRT. Main Outcomes and Measures:The primary objective was to determine the effectiveness of SBRT compared with CRT based on LC at 3 years. Secondary outcomes included event-free survival, overall survival, and toxic effects. All radiation plans were subject to real-time/final review. Local failures were centrally adjudicated. The study was designed to detect a 3-year LC improvement of SBRT from 75% to 87.5%. The target sample size was 324 patients. Results:Of 233 included patients, 119 (51.1%) were male, and the mean (SD) age was 75.4 (7.7) years; the median (IQR) follow-up was 36.1 (26.4-52.8) months. A total of 154 patients received SBRT and 79 received CRT. The 3-year LC was 87.6% (95% CI, 81.9%-93.4%) for SBRT and 81.2% (95% CI, 71.9%-90.5%) for CRT (hazard ratio [HR], 0.61; 95% CI, 0.31-1.20; P = .15). The HR was 1.02 (95% CI, 0.72-1.45; P = .87) for event-free survival and 1.18 (95% CI, 0.80-1.76; P = .40) for overall survival. Minimal acute toxic effects were observed. Among those randomized to SBRT, late grade 3 or 4 toxic effects occurred in 5 of 45 (11%) with central NSCLC and 2 of 109 (1.8%) with peripheral NSCLC; among those randomized to CRT, in 1 of 19 (5%) with central NSCLC and 1 of 60 (2%) with peripheral NSCLC. One patient who received SBRT for an ultracentral lesion (target overlapping proximal bronchus) experienced a possible treatment-related grade 5 event (hemoptysis). Conclusions and Relevance:This RCT compared lung SBRT with hypofractionated CRT that included central/ultracentral tumors. No difference was detected in LC between groups. Severe toxic effects were limited, including patients with central tumors. The trial provides important prospective data evaluating SBRT; however, further research is necessary to determine if SBRT is more effective than CRT for peripheral and central NSCLC. Trial Registration:ClinicalTrials.gov Identifier: NCT03924869.
INTRODUCTION:Cervical spine defects result in spinal instability, putting the spinal cord and vertebral arteries at risk of damage and possibly devastating neurological injuries. The fibula free flap can span the spinal defects for stability. There is a paucity of literature on this technique. METHOD:Multi-institutional retrospective case series reviewing patients who underwent cervical spine reconstruction with a fibula free flap. Patient demographic information, comorbidities, characteristics of cervical spine defects, and free flap complications were collected. RESULTS:A total of 1187 fibula free flaps across 10 different institutions were reviewed. Thirteen patients (1.09%) underwent cervical spine reconstruction with a fibula free flap. Average age was 52.3 years old with an age range of 12-79 years. There were six males (46.1%) and seven females (53.8%). The most common defect etiology was infection (n = 6, 46.1%). Most commonly involved cervical spine level of the defect was C5 (n = 10) followed by C6 (n = 9) and C4 (n = 8). The majority of reconstructed defects spanned three or more cervical levels, (n = 9, 69.2%). Facial artery was the most common arterial anastomosis (n = 8). Eight patients (61.5%) required a tracheostomy during their postoperative course. None of the patients had symptomatic or radiographic nonunion. CONCLUSION:This case series demonstrates that a vascularized fibula flap is a potential reconstructive option for cervical spine defects, especially in defects greater than three cervical levels, in the setting of infection, and previously radiated patients. LEVEL OF EVIDENCE:4 Laryngoscope, 134:4923-4928, 2024.
Cancers of the head and neck region are often characterized by locally advanced, non-metastatic disease. Standard treatments for advanced cervico-facial cancers of the skin or primary head and neck squamous cell carcinoma (HNSCC) include combinations of surgery, radiation and chemotherapy, which are associated with high rates of acute toxicity and complications. Stereotactic body radiotherapy (SBRT) has been shown to be a promising modality of treatment for this patient population in retrospective studies; to our knowledge, there are no prospective clinical studies evaluating the safety and efficacy of SBRT in these patients. This phase 2, single institution, single arm study aims to evaluate response rates to SBRT in older age patients with locally advanced HNSCC for whom primary surgery is not recommended or performed. The intervention is SBRT 45 Gy in 5 fractions given every 3–4 days. Toxicity, quality of life and patient outcomes will be recorded regularly up to 24 months after completion of SBRT. For this patient population, SBRT may offer a shorter and more effective treatment than the current standard of care palliative regimens. If the study demonstrates that SBRT is safe and effective, then this may lead to randomized studies comparing conventional radiotherapy to SBRT for selected head and neck cancer patients. ClinicalTrials.gov Identifier: NCT04435938 . Date registered: June 17, 2020.
OBJECTIVE:The authors' objective was to investigate the impact of the global COVID-19 pandemic on hospital presentation and process of care for the treatment of traumatic brain injuries (TBIs). Improved understanding of these effects will inform sociopolitical and hospital policies in response to future pandemics.METHODS:The Michigan Trauma Quality Improvement Program (MTQIP) database, which contains data from 36 level I and II trauma centers in Michigan and Minnesota, was queried to identify patients who sustained TBI on the basis of head/neck Abbreviated Injury Scale (AIS) codes during the periods of March 13 through July 2 of 2017-2019 (pre-COVID-19 period) and March 13, 2020, through July 2, 2020 (COVID-19 period). Analyses were performed to detect differences in incidence, patient characteristics, injury severity, and outcomes.RESULTS:There was an 18% decrease in the rate of encounters with TBI in the first 8 weeks (March 13 through May 7), followed by a 16% increase during the last 8 weeks (May 8 through July 2), of our COVID-19 period compared with the pre-COVID-19 period. Cumulatively, there was no difference in the rates of encounters with TBI between the COVID-19 and pre-COVID-19 periods. Severity of TBI, as measured with maximum AIS score for the head/neck region and Glasgow Coma Scale score, was also similar between periods. During the COVID-19 period, a greater proportion of patients with TBI presented more than a day after sustaining their injuries (p = 0.046). COVID-19 was also associated with a doubling in the decubitus ulcer rate from 1.0% to 2.1% (p = 0.002) and change in the distribution of discharge status (p = 0.01). Multivariable analysis showed no differences in odds of death/hospice discharge, intensive care unit stay of at least a day, or need for a ventilator for at least a day between the COVID-19 and pre-COVID-19 periods.CONCLUSIONS:During the early months of the COVID-19 pandemic, the number of patients who presented with TBI was initially lower than in the years 2017-2019 prior to the pandemic. However, there was a subsequent increase in the rate of encounters with TBI, resulting in overall similar rates of TBI between March 13 through July 2 during the COVID-19 period and during the pre-COVID-19 period. The COVID-19 cohort was also associated with negative impacts on time to presentation, rate of decubitus ulcers, and discharge with supervision. Policies in response to future pandemics must consider the resources necessary to care for patients with TBI.
Background There is evidence that frailty is an independent predictor of worse outcomes after stroke. Similarly, although obesity is associated with a higher risk for stroke, there are multiple reports describing improved mortality and functional outcomes in higher body mass index (BMI) patients in a phenomenon known as the obesity paradox. We investigated the effect of low BMI on outcomes after mechanical thrombectomy (MT).Methods We conducted a retrospective analysis of 231 stroke patients who underwent MT at an academic medical center between 2020-2022. The patients' BMI data were collected from admission records and coded based on the Centers for Disease Control and Prevention (CDC) obesity guidelines. Recursive partitioning analysis (RPA) in R software was employed to automatically detect a BMI threshold associated with a significant survival benefit. Frailty was quantified using the Modified Frailty Index 5 and 11.Results In our dataset, by CDC classification, 2.6% of patients were underweight, 27.3% were normal BMI, 30.7% were overweight, 19.9% were class I obese, 9.5% were class II obese, and 10% were class III obese. There were no significant differences between these groups. RPA identified a clinically significant BMI threshold of 23.62 kg/m(2). Independent of frailty, patients with a BMI <= 23.62 kg/m(2) had significantly worse overall survival (P<0.001) and 90-day modified Rankin Scale (P=0.027) than patients above the threshold.Conclusions Underweight patients had worse survival and functional outcomes after MT. Further research should focus on the pathophysiology underlying poor prognosis in underweight MT patients, and whether optimizing nutritional status confers any neuroprotective benefit.
BACKGROUND:Adjuvant radiotherapy is prescribed after breast-conserving surgery to reduce the risk of local recurrence. However, radiotherapy is inconvenient, costly, and associated with both short-term and long-term side effects. Clinicopathologic factors alone are of limited use in the identification of women at low risk for local recurrence in whom radiotherapy can be omitted. Molecularly defined intrinsic subtypes of breast cancer can provide additional prognostic information. METHODS:We performed a prospective cohort study involving women who were at least 55 years of age, had undergone breast-conserving surgery for T1N0 (tumor size <2 cm and node negative), grade 1 or 2, luminal A-subtype breast cancer (defined as estrogen receptor positivity of ≥1%, progesterone receptor positivity of >20%, negative human epidermal growth factor receptor 2, and Ki67 index of ≤13.25%), and had received adjuvant endocrine therapy. Patients who met the clinical eligibility criteria were registered, and Ki67 immunohistochemical analysis was performed centrally. Patients with a Ki67 index of 13.25% or less were enrolled and did not receive radiotherapy. The primary outcome was local recurrence in the ipsilateral breast. In consultation with radiation oncologists and patients with breast cancer, we determined that if the upper boundary of the two-sided 90% confidence interval for the cumulative incidence at 5 years was less than 5%, this would represent an acceptable risk of local recurrence at 5 years. RESULTS:Of 740 registered patients, 500 eligible patients were enrolled. At 5 years after enrollment, recurrence was reported in 2.3% of the patients (90% confidence interval [CI], 1.3 to 3.8; 95% CI, 1.2 to 4.1), a result that met the prespecified boundary. Breast cancer occurred in the contralateral breast in 1.9% of the patients (90% CI, 1.1 to 3.2), and recurrence of any type was observed in 2.7% (90% CI, 1.6 to 4.1). CONCLUSIONS:Among women who were at least 55 years of age and had T1N0, grade 1 or 2, luminal A breast cancer that were treated with breast-conserving surgery and endocrine therapy alone, the incidence of local recurrence at 5 years was low with the omission of radiotherapy. (Funded by the Canadian Cancer Society and the Canadian Breast Cancer Foundation; LUMINA ClinicalTrials.gov number, NCT01791829.).