Patient-Reported and Clinical Outcomes of Surgically Treated Patients With Symptomatic Spinal Metastases: Results From Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO), a Prospective, Multi-Institutional and International Study.

BACKGROUND AND OBJECTIVES: The palliative impact of spine surgery for metastatic disease is evolving with improvements in surgical technique and multidisciplinary cancer care. The goal of this study was to prospectively evaluate long-term clinical outcomes including health-related quality-of-life (HRQOL) measures, using spine cancer-specific patient-reported-outcome (PRO) measures, in patients with symptomatic spinal metastases who underwent surgical management. METHODS: The Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO, ClinicalTrials.gov identifier: NCT01825161) trial is a prospective-observational cohort study that included 10 specialist centers in North America and Europe. Patients aged 18 to 75 years who underwent surgery for spinal metastases were included. Prospective assessments included both spine tumor-specific and generic PRO tools which were collected for a minimum of 2 years post-treatment or until death. RESULTS: Two hundred and eighty patients (51.8% female, mean age 57.9 years) were included. At presentation, the mean Charlson Comorbidity Index was 6.0, 35.7% had neurological deficits as defined by the American Spinal Cord Injury Association scores, 47.2% had high-grade epidural spinal cord compression (2-3), and 89.6% had impending or frank instability as measured by a Spinal Instability Neoplastic Score of ≥7. The most common primary tumor sites were breast (20.2%), lung (18.8%), kidney (16.2%), and prostate (6.5%). The median overall survival postsurgery was 501 days, and the 2-year progression-free-survival rate was 38.4%. Compared with baseline, significant and durable improvements in HRQOL were observed at the 6-week, 12-week, 26-week, 1-year, and 2-year follow-up assessments from a battery of PRO questionnaires including the spine cancer-specific, validated, Spine Oncology Study Group Outcomes Questionnaire v2.0, the Short Form 36 version 2, EuroQol-5 Dimension (3L), and pain numerical rating scale score. CONCLUSION: Multi-institutional, prospective-outcomes data confirm that surgical decompression and/or stabilization provides meaningful and durable improvements in multiple HRQOL domains, including spine-specific outcomes based on the Spine Oncology Study Group Outcomes Questionnaire v2.0, for patients with metastatic spine disease.

Multi-institutional review of characteristics and management of gunshot wounds to the spine.

BACKGROUND CONTEXT: Gunshot wounds (GSWs) to the vertebral column represent an important cause of morbidity and mortality in the United States, constituting approximately 20% of all spinal injuries. The management of these injuries is an understudied and controversial topic, given its heterogeneity and lack of follow-up data. PURPOSE: To characterize the management and follow-up of GSWs to the spine. STUDY DESIGN/SETTING: A multi-institutional retrospective review of the experience of two urban Level 1 trauma centers. PATIENT SAMPLE: Patients with GSWs to the spine between 2010-2021. OUTCOME MEASURES: Measures included work status, follow-up healthcare utilization, and pain management were collected. METHODS: Charts were reviewed for demographics, injury characteristics, surgery and medical management, and follow-up. Statistical analysis included T-tests and ANOVA for comparisons of continuous variables and chi-square testing for categorical variables. All statistics were performed on SPSS v24 (IBM, Armonk, NY). RESULTS: A total of 271 patients were included for analysis. The average age was 28 years old, 82.7% of patients were black, 90% were male, and 76.4% had Medicare/Medicaid. The thoracic spine (35%) was most commonly injured followed by lumbar (33.9%) and cervical (25.6%). Cervical GSW was associated with higher mortality (p<.001); 8.7% of patients developed subsequent osteomyelitis/discitis, 71.3% received prophylactic antibiotics, and 56.1% of cervical GSW had a confirmed vertebral or carotid artery injury. ASIA scores at presentation were most commonly A (26.9%), D (20.7%), or E (19.6%), followed by C (7.4%) and B (6.6%). 18.8% of patients were unable to be assessed at presentation. ASIA score declined in only 2 patients, while 15.5% improved over their hospital stay. Those who improved were more likely to have ASIA B injury (p<.001). Overall, 9.2% of patients underwent spinal surgery. Of these, 33% presented as ASIA A, 21% as ASIA B, 29% as ASIA C, and 13% as ASIA D. Surgery was not associated with an improvement in ASIA score. CONCLUSIONS: Given the ubiquitous and heterogeneous experience with GSWs to the spine, rigorous attempts should be made to define this population and its clinical and surgical outcomes. Here, we present an analysis of 11 years of patients presenting to two large trauma centers to elucidate patterns in presentation, management, and follow-up. We highlight that GSWs to the cervical spine are most often seen in young black male patients. They were associated with high mortality and high rates of injury to vertebral arteries and that surgical intervention did not alter rates of discitis/osteomyelitis or propensity for neurologic recovery; moreover, there was no incidence of delayed spinal instability in the study population.

A telemedicine bridge clinic improves access and reduces cost for opioid use disorder care.

Objective: We evaluated the impact of a telemedicine bridge clinic on treatment outcomes and cost for patients with opioid use disorder. Telemedicine bridge clinics deliver low-barrier rapid assessment of patients with opioid use disorder via audio-only and audiovisual telemedicine to facilitate induction on medication therapy and connection to ongoing care. Methods: A pre-post analysis of UPMC Health Plan member claims was performed to evaluate the impact of this intervention on the trajectory of care for patients with continuous coverage before and after bridge clinic visit(s). Results: Analysis included 150 UPMC Health Plan members evaluated at the bridge clinic between April 2020 and October 2021. At least one buprenorphine prescription was filled within 30 days by 91% of patients; median proportion of days covered by buprenorphine was 73.3%, 54.4%, and 50.6% at 30, 90, and 180 days after an initial visit compared to median of no buprenorphine claims 30 days prior among the same patients. Patients had an 18% decline in unplanned care utilization 30 days after initial Bridge Clinic visit, with a 62% reduction in unplanned care cost per member per month (PMPM), 38% reduction in medical cost PMPM, and 10% reduction in total PMPM (medical + pharmacy cost) at 180 days. Primary care, outpatient behavioral health, and laboratory costs increased while emergency department, urgent care, and inpatient costs declined. Conclusion: Utilization of a telemedicine bridge clinic was associated with buprenorphine initiation, linkage to ongoing care with retention including medication treatment, reduced unplanned care cost, and overall savings.

A Prospective Phase I/II Clinical Trial of High-Dose Proton Therapy for Chordomas and Chondrosarcomas.

Purpose: The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and chondrosarcomas of the skull base and spine. Methods: A prospective cohort of 54 patients (42 with chordomas and 12 with chondrosarcomas) was enrolled between 2010 and 2018. The primary endpoints were feasibility and <20% rate of acute grade ≥3 toxicity, and secondary endpoints included cancer-specific outcomes and toxicities. Patients were followed with magnetic resonance imaging or computed tomography at 3-month intervals. Proton beam therapy was delivered with doses up to 79.2 Gy using protons only, combination protons/intensity modulated radiation therapy (IMRT), or IMRT only. Results: Feasibility endpoints were met, with only 2 out of 54 patient radiation therapy plans failing to meet dosimetric constraints with protons, and 4 out of 54 experiencing a delay or treatment break >5 days, none for toxicities related to treatment. There were no grade 4 acute toxicities and 1 grade 3 acute toxicity (sensory neuropathy). The only 2 grade 3 late toxicities recorded, osteoradionecrosis and intranasal carotid blowout (mild and not emergently treated), occurred in a single patient. We report overall survival as 83% at 5 years, with local failure-free survival and progression-free survival rates of 72% and 68%, respectively. Five patients developed distant disease, and among the 9/54 patients who died, 4 deaths were not attributed to treatment or recurrence. Conclusions: Our findings suggest that high-dose proton therapy alone or in combination with IMRT is a safe and effective treatment option for chordomas and chondrosarcomas of the skull base and spine.

Racial disparities in short-term spinal fusion outcomes across 4263 consecutive patients.

OBJECTIVE: Race plays a salient role in access to surgical care. However, few investigations have assessed the impact of race within surgical populations after care has been delivered. The objective of this study was to employ an exact matching protocol to a homogenous population of spine surgery patients in order to isolate the relationships between race and short-term postoperative outcomes. METHODS: In total, 4263 consecutive patients who underwent single-level, posterior-only lumbar fusion at a single multihospital academic medical center were retrospectively enrolled. Of these patients, 3406 patients self-identified as White and 857 patients self-identified as non-White. Outcomes were initially compared across all patients via logistic regression. Subsequently, White patients and non-White patients were exactly matched on the basis of key demographic and health characteristics (1520 matched patients). Outcome disparities were evaluated between the exact-matched cohorts. Primary outcomes were readmissions, emergency department (ED) visits, reoperations, mortality, intraoperative complications, and discharge disposition. RESULTS: Before matching, non-White patients were less likely to be discharged home and more likely to be readmitted, evaluated in the ED, and undergo reoperation. After matching, non-White patients experienced higher rates of nonhome discharge, readmissions, and ED visits. Non-White patients did not have more surgical complications either before or after matching. CONCLUSIONS: Between otherwise similar cohorts of spinal fusion cases, non-White patients experienced unfavorable discharge disposition and higher risk of multiple adverse postoperative outcomes. However, these findings were not accounted for by differences in surgical complications, suggesting that structural factors underlie the observed disparities.

Association of Frailty with Healthcare Utilization for Patients over One Year Following Surgical Evaluation.

OBJECTIVE: Characterize the distribution of healthcare utilization associated with pre-operative frailty in the year following evaluation by a surgeon. SUMMARY BACKGROUND DATA: Frailty is associated with increased morbidity, mortality, and costs for surgical patients. However, the total financial burden for frail patients beyond the index surgery and inpatient stay remains unknown. METHODS: Prospective cohort assembled from February 2016 to December 2020 within a multi-hospital integrated healthcare delivery and finance system (IDFS), from patients evaluated with the Risk Analysis Index (RAI) of frailty. Inclusion criteria: age greater than 18, valid RAI, membership in the IDFS Health Plan. Data were stratified by frailty and surgical status. RESULTS: The mean (SD) age was 54.7 (16.1) and 58.2% female of the cohort (n=86,572). For all patients with reimbursement for surgery (n=53,856), frail and very frail patients incurred respective increases of 8% ( P =0.027) and 29% ( P <0.001) on utilization relative to the normal group. Robust patients saw a 52% ( P <0.001) decrease. This pattern was more pronounced in the cohort without surgery (n=32,716). The increase over normal utilization for frail and very frail patients increased to 23% ( P =0.004) and 68% ( P <0.001), respectively. Utilization among robust patients decreased 62% ( P <0.001). Increases among the frail were primarily due to increased inpatient medical and post-acute care services (all P <0.001). CONCLUSIONS: Patient frailty is associated with increased total healthcare utilization, primarily via increased inpatient medical and post-acute care following surgery. Quantifying these frailty-related financial burdens may inform clinical decision making as well as the design of value-based reimbursement strategies.

Risk of Thromboembolism in Patients Receiving Immunotherapy-Based Combinations as Front-Line Therapy for Metastatic Renal Cell Carcinoma.

BACKGROUND: Most patients with treatment-naïve metastatic renal cell carcinoma (mRCC) receive combination-based immunotherapy with either 2 immune-oncology checkpoint inhibitors (IO/IO) or an IO agent in combination with a vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor (IO/TKI). The rates of thromboembolism (TE) in these cohorts are not clearly described and can potentially impact decision-making between IO/IO and IO/TKI. METHODS: We conducted a retrospective investigation of patients with treatment-naïve mRCC treated with IO-based combinations between January 2015 and April 2021 at the Cleveland Clinic. TE events, including venous and arterial, were identified in each group. Competing risk regression was done to identify factors associated with the development of TE following therapy, with all-cause mortality treated as a competing event. RESULTS: Of 180 patients identified, 77 (43%) received IO/TKI and 103 (57%) received IO/IO. Median age was 65 years, 75% were male, and 80% had clear cell histology. Baseline characteristics were similar between the 2 groups. At a median follow-up of 22.0 months, 10.0% of all patients had a TE. The one-year incidence of TE was 8.1% (95% CI: 3.3%-15.8%) with IO/TKI and 9.8% (95% CI: 5.0%-16.5%) with IO/IO and was not significantly different between the 2 groups (HR 0.89, 95% CI: 0.35%-2.28%). Occurrence of TE was associated with decreased overall survival regardless of IO/IO or IO/TKI therapy (HR 2.80, 95% CI: 1.57-5.02). There was no difference in incidence of TE based on patient age, gender, prior history of TE, International Metastatic Renal Cell Carcinoma (IMDC) risk group, or Khorana score. CONCLUSIONS: Incidence of TE is similar between IO/IO and IO/TKI regimens in treatment-naïve mRCC and is also associated with decreased overall survival. While risk of TE may not guide decision-making in choice of front-line mRCC therapy, careful attention should be given to the high risk of TE in this population.

Trajectory Analysis of Healthcare Utilization Before and After Major Surgery.

OBJECTIVE: To characterize patterns of healthcare utilization before and after surgery and determine any association with pre-operative frailty. SUMMARY BACKGROUND DATA: Frail patients experience worse post-operative outcomes and increased costs during the surgical encounter. Evidence is comparatively lacking for longer-term effects of frailty on post-operative healthcare utilization. METHODS: Retrospective, longitudinal cohort analysis of adult patients undergoing any elective surgical procedure following pre-operative frailty assessment with the Risk Analysis Index (RAI) from 02/2016-12/2020 at a large integrated healthcare delivery and financing system. Group-based trajectory modeling of claims data estimated distinct clusters of patients with discrete utilization trajectories. Multivariable regression predicted membership in trajectories of interest using preoperative characteristics, including frailty. RESULTS: Among 29,067 surgical encounters, four distinct utilization trajectories emerged in longitudinal data from the 12 months before and after surgery. All cases exhibited a surge in utilization during the surgical month, after which most patients returned to "low" [25,473 (87.6%)], "medium" [1,403 (4.8%)], or "high" [528 (1.8%)] baseline utilization states established before surgery. The fourth trajectory identified 1,663 (5.7%) cases where surgery occasioned a transition from "low" utilization before surgery to "high" utilization afterward. RAI score alone did not effectively predict membership in this transition group, but a multivariable model with other preoperative variables was effective (c=0.859, max re-scaled R-squared 0.264). CONCLUSIONS AND RELEVANCE: Surgery occasions the transition from low to high healthcare utilization for a substantial subgroup of surgical patients. Multivariable modeling may effectively discriminate this utilization trajectory, suggesting an opportunity to tailor care processes for these patients.

Gender and Sex Differences in Health-related Quality of Life, Clinical Outcomes and Survival after Treatment of Metastatic Spine Disease.

STUDY DESIGN: Retrospective review of prospective, multicenter and international cohort study. OBJECTIVE: To describe the effect of gender on HRQoL, clinical outcomes and survival for patients with spinal metastases treated with either surgery and/or radiation. SUMMARY OF BACKGROUND DATA: Gender differences in health-related outcomes are demonstrated in numerous studies, with women experiencing worse outcomes and receiving lower standards of care than men, however, the influence that gender has on low health-related quality of life (HRQoL) and clinical outcomes after spine surgery remains unclear. METHODS: Patient demographic data, overall survival, treatment details, perioperative complications, and HRQoL measures including EQ-5D, pain NRS, the short form 36 version 2 (SF-36v2) and the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) were reviewed. Patients were stratified by sex, and a separate sensitivity analysis that excluded gender-specific cancers (i.e., breast, prostate, etc.) was performed. RESULTS: The study cohort included 207 female and 183 male patients, with age, smoking status, and site of primary cancer being significantly different between the two cohorts (P<0.001). Both males and females experienced significantly improved SOSGOQ2.0, EQ-5D, and pain NRS scores at all study time points from baseline (P<0.001). Upon sensitivity analysis, (gender-specific cancers removed from analysis), the significant improvement in SOSGOQ physical, mental, and social subdomains and on SF-36 domains disappeared for females. Males experienced higher rates of postoperative complications. Kaplan-Meier survival analysis of both the overall and sensitivity analysis cohorts showed females lived longer than males after treatment (P=0.001 and 0.043, respectively). CONCLUSION: Both males and females experienced significantly improved HRQoL scores after treatment, but females demonstrated longer survival and a lower complication rate. This study suggests that gender may be a prognostic factor in survival and clinical outcomes for patients undergoing treatment for spine metastases and should be taken into consideration when counseling patients accordingly.

The Device for Intraventricular Entry guide: a novel solution to a perpetual problem.

OBJECTIVE: The authors designed a low-profile device for reliable ventricular access and prospectively studied its safety, efficacy, and accuracy at a large academic center. METHODS: A novel device for ventricular entry, the Device for Intraventricular Entry (DIVE) guide, was designed and created by the first and senior authors. Fifty patients undergoing external ventricular drainage (EVD) or shunt placement were prospectively enrolled for DIVE-assisted catheter placement at a single academic center. The primary outcome was the catheter tip location on postprocedural CT. Secondary outcomes included number of catheter passes, clinically significant hemorrhages, and procedure-related infections. RESULTS: Fifty patients were enrolled. Indications included subarachnoid hemorrhage, intraventricular hemorrhage, traumatic brain injury, hydrocephalus, pseudotumor, and postsurgical wound drainage. In total, 76% (38/50) of patients underwent right-sided placement and 24% (12/50) underwent left-sided placement. All 100% (50/50) of patients had successful cannulation with an average of 1.06 passes. Postprocedural head CT confirmed ipsilateral frontal horn or third ventricle placement (Kakarla grade 1) in 92% (46/50) of patients and placement in the contralateral lateral ventricle in 8% (4/50) (Kakarla grade 2). There were no clinically significant track hemorrhages or procedural infections. CONCLUSIONS: This single-center prospective study investigated the safety and efficacy of DIVE-assisted ventricular access. In total, 100% of procedures had successful ventricular cannulation, with 92% achieving Kakarla grade 1, with an average of 1.06 passes without any clinical complications.

Bias-corrected and doubly robust inference for the three-level longitudinal cluster-randomized trials with missing continuous outcomes and small number of clusters: Simulation study and application to a study for adults with serious mental illnesses.

Longitudinal cluster-randomized designs have been popular tools for comparative effective research in clinical trials. The methodologies for the three-level hierarchical design with longitudinal outcomes need to be better understood under more pragmatic settings; that is, with a small number of clusters, heterogeneous cluster sizes, and missing outcomes. Generalized estimating equations (GEEs) have been frequently used when the distribution of data and the correlation model are unknown. Standard GEEs lead to bias and an inflated type I error rate due to the small number of available clinics and non-completely random missing data in longitudinal outcomes. We evaluate the performance of inverse probability weighted (IPW) estimating equations, with and without augmentation, for two types of missing data in continuous outcomes and individual-level treatment allocation mechanisms combined with two bias-corrected variance estimators. Our intensive simulation results suggest that the proposed augmented IPW method with bias-corrected variance estimation successfully prevents the inflation of false positive findings and improves efficiency when the number of clinics is small, with moderate to severe missing outcomes. Our findings are expected to aid researchers in choosing appropriate analysis methods for three-level longitudinal cluster-randomized designs. The proposed approaches were applied to analyze data from a longitudinal cluster-randomized clinical trial involving adults with serious mental illnesses.

Relationship Between Comorbidity Burden and Short-Term Outcomes Across 4680 Consecutive Spinal Fusions.

OBJECTIVE: Preoperative management requires the identification and optimization of modifiable medical comorbidities, though few studies isolate comorbid status from related patient-level variables. This study evaluates Charlson Comorbidity Index (CCI)-an easily derived measure of aggregate medical comorbidity-to predict outcomes from spinal fusion surgery. Coarsened exact matching is employed to control for key patient characteristics and isolate CCI. METHODS: We retrospectively assessed 4680 consecutive patients undergoing single-level, posterior-only lumbar fusion at a single academic center. Logistic regression evaluated the univariate relationship between CCI and patient outcomes. Coarsened exact matching generated exact demographic matches between patients with high comorbid status (CCI >6) or no medical comorbidities (matched n = 524). Patients were matched 1:1 on factors associated with surgical outcomes, and outcomes were compared between matched cohorts. Primary outcomes included surgical complications, discharge status, 30- and 90-day risk of readmission, emergency department (ED) visits, reoperation, and mortality. RESULTS: Univariate regression of increasing CCI was significantly associated with non-home discharge, as well as 30- and 90-day readmission, ED visits, and mortality (all P < 0.05). Subsequent isolation of comorbidity between otherwise exact-matched cohorts found comorbid status did not affect readmissions, reoperations, or mortality; high CCI score was significantly associated with non-home discharge (OR = 2.50, P < 0.001) and 30-day (OR = 2.44, P = 0.02) and 90-day (OR = 2.29, P = 0.008) ED evaluation. CONCLUSIONS: Comorbidity, measured by CCI, did not increase the risk of readmission, reoperation, or mortality. Single-level, posterior lumbar fusions may be safe in appropriately selected patients regardless of comorbid status. Future studies should determine whether CCI can guide discharge planning and postoperative optimization.

A Novel Framework to Address the Complexities of Housing Insecurity and Its Associated Health Outcomes and Inequities: "Give, Partner, Invest".

The association between housing insecurity and reduced access to healthcare, diminished mental and physical health, and increased mortality is well-known. This association, along with structural racism, social inequities, and lack of economic opportunities, continues to widen the gap in health outcomes and other disparities between those in higher and lower socio-economic strata in the United States and throughout the advanced economies of the world. System-wide infrastructure failures at municipal, state, and federal government levels have inadequately addressed the difficulty with housing affordability and stability and its associated impact on health outcomes and inequities. Healthcare systems are uniquely poised to help fill this gap and engage with proposed solutions. Strategies that incorporate multiple investment pathways and emphasize community-based partnerships and innovation have the potential for broad public health impacts. In this manuscript, we describe a novel framework, "Give, Partner, Invest," which was created and utilized by the University of Pittsburgh Medical Center (UPMC) Insurance Services Division (ISD) as part of the Integrated Delivery and Finance System to demonstrate the financial, policy, partnership, and workforce levers that could make substantive investments in affordable housing and community-based interventions to improve the health and well-being of our communities. Further, we address housing policy limitations and infrastructure challenges and offer potential solutions.

Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.

Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.

Navigated lumbar drain placement: A description of technique and case example.

Background: Lumbar drain (LD) placement can be a difficult procedure leading to postprocedure complications, particularly in patients with persistent cerebrospinal fluid leaks or a large body habitus. The objective of this technical case report is to describe the use of Medtronic's SureTrak Navigation system for navigated LD placement. Case Description: The patient was an 18-year-old morbidly obese male who initially underwent a suboccipital craniectomy with duraplasty and a C1 laminectomy for Chiari Malformation. Postoperatively, he developed a pseudomeningocele and was taken to the operating room for wound revision, duraplasty repair, and LD placement. Medtronic's SureTrak Navigation system was used for LD placement before wound revision. Successful LD placement was achieved in a single pass using the SureTrak Navigation. The patient did well postoperatively, and LD removal occurred on postoperative day 6. The patient was discharged in good condition without evidence of a cerebral spinal fluid leak. Conclusion: Navigation using the SureTrak system is a reasonable option to use in patients with a high body mass index and a persistent cerebrospinal fluid leak. When the patient is already undergoing an operative procedure, it can aid in an efficient low-risk intervention completed in a single prone positioning.

A Payer-Provider Partnership for Endocrine Targeted Automatic eConsults: Implementation and Early Impact on Diabetes and Cost Outcomes.

In the United States, many individuals with diabetes mellitus (DM) do not achieve treatment goals despite the availability of effective interventions. Provider clinical inertia is one cause of these unfavorable outcomes. Targeted automatic eConsults (TACos) are an emerging technology-based intervention with potential to address clinical inertia in primary care (PC). TACos prospectively identify at-risk patients and use unsolicited specialist recommendations to prompt treatment intensification. Through a payer-provider collaboration, a TACos intervention was piloted for adults with uncontrolled DM (HbA1c >8%) to understand impact on DM clinical inertia and outcomes. Clinical inertia was assessed by measuring whether a PC provider implemented recommended therapeutic changes. Six-month changes in HbA1c and health care costs per member per month were evaluated using an observational matched design and intention-to-treat (ITT) analysis. The analysis included 196 individuals who received a TACos between February 2021 and August 2021 (ITT group) matched to 392 controls based on clinical and demographic criteria. TACos recommendations were implemented 65% of the time. Median percent change in HbA1c was significantly greater for the ITT group versus controls (-10.9% vs. -10.2%; P = 0.0359). Median total costs were 7.9% lower in the ITT group (P = 0.0900). A per protocol analysis was done to examine effects between ITT group individuals with an implemented TACos recommendation (n = 126) and controls. Median percent change in HbA1c was significantly greater (-19.5% vs. -10.2%; P < 0.0001), but there was no difference in total costs (-7.9%; P = 0.1753). TACos may feasibly address clinical inertia in PC and improve HbA1c for uncontrolled DM.

Human Services and Behavioral Health Integration: A Model for Whole-Person Medicaid Managed Care.

A comprehensive, whole-person approach to individuals' health care can be achieved by aligning, integrating, and coordinating health services with other human services. HealthChoices, Pennsylvania's managed Medicaid program, delegates responsibility for Medicaid-funded behavioral health service management to individual counties or multicounty collaboratives. County administrators' programmatic and fiscal oversight of Medicaid-funded services allows them to create synergies between behavioral health and other human service delivery systems and to set priorities on the basis of local needs. This model supports access to community-based care, integration of general medical and behavioral health services, and programs that address social determinants of health.

Preoperative Predictors of Survival in Patients With Spinal Metastatic Disease.

BACKGROUND: There remains a number of factors thought to be associated with survival in spinal metastatic disease, but evidence of these associations is lacking. In this study, we examined factors associated with survival among patients undergoing surgery for spinal metastatic disease. METHODS: We retrospectively examined 104 patients who underwent surgery for spinal metastatic disease at an academic medical center. Of those patients, 33 received local preoperative radiation (PR) and 71 had no PR (NPR). Disease-related variables and surrogate markers of preoperative health were identified, including age, pathology, timing of radiation and chemotherapy, mechanical instability by spine instability neoplastic score, American Society of Anesthesiologists (ASA) classification, Karnofsky performance status (KPS), and body mass index (BMI). We performed survival analyses using a combination of univariate and multivariate Cox proportional hazards models to assess significant predictors of time to death. RESULTS: Local PR (Hazard Ratio [HR] = 1.84, P = 0.034), mechanical instability (HR = 1.11, P = 0.024), and melanoma (HR = 3.60, P = 0.010) were significant predictors of survival on multivariate analysis when controlling for confounders. PR vs NPR cohorts exhibited no statistically significant differences in preoperative age (P = 0.22), KPS (P = 0.29), BMI (P = 0.28), or ASA classification (P = 0.12). NPR patients had more reoperations for postoperative wound complications (11.3% vs 0%, P < 0.001). CONCLUSIONS: In this small sample, PR and mechanical instability were significant predictors of postoperative survival, independent of age, BMI, ASA classification, and KPS and in spite of fewer wound complications in the PR group. It is possible that PR was a surrogate of more advanced disease or poor response to systemic therapy, independently portending a worse prognosis. Future studies in larger, more diverse populations are crucial for understanding the relationship between PR and postoperative outcomes to determine the optimal timing for surgical intervention. CLINICAL RELEVANCE: These findings are clinically relevent as they provide insight into factors associated with survival in metastatic spinal disease.

Correlation Between the Spinal Instability Neoplastic Score (SINS) and Patient Reported Outcomes.

STUDY DESIGN: International multicenter prospective observational cohort study on patients undergoing radiation +/- surgical intervention for the treatment of symptomatic spinal metastases. OBJECTIVES: To investigate the association between the total Spinal Instability Neoplastic Score (SINS), individual SINS components and PROs. METHODS: Data regarding patient demographics, diagnostics, treatment, and PROs (SF-36, SOSGOQ, EQ-5D) was collected at baseline, 6 weeks, and 12 weeks post-treatment. The SINS was assessed using routine diagnostic imaging. The association between SINS, PRO at baseline and change in PROs was examined with the Spearmans rank test. RESULTS: A total of 307 patients, including 174 patients who underwent surgery+/- radiotherapy and 133 patients who underwent radiotherapy were eligible for analyses. In the surgery+/- radiotherapy group, 18 (10.3%) patients with SINS score between 0-6, 118 (67.8%) with a SINS between 7-12 and 38 (21.8%) with a SINS between 13-18, as compared to 55 (41.4%) SINS 0-6, 71(53.4%) SINS 7-12 and 7 (5.2%) SINS 13-18 in the radiotherapy alone group. At baseline, the total SINS and the presence of mechanical pain was significantly associated with the SOSGOQ pain domain (r = -0.519, P < 0.001) and the NRS pain score (r = 0.445, P < 0.001) for all patients. The presence of mechanical pain demonstrated to be moderately associated with a positive change in PROs at 12 weeks post-treatment. CONCLUSION: Spinal instability, as defined by the SINS, was significantly correlated with PROs at baseline and change in PROs post-treatment. Mechanical pain, as a single SINS component, showed the highest correlations with PROs.

Anticoagulation Holiday: Resumption of Direct Oral Anticoagulants for Atrial Fibrillation in Patients with Index Traumatic Intracranial Hemorrhage.

Background: The optimal time to restart direct oral anticoagulants (DOACs) for nonvalvular atrial fibrillation (NVAF) after traumatic intracranial hemorrhage (tICH) is unknown. Physicians must weigh the risk of recurrent hemorrhage against ischemic stroke. We investigated rates of stroke while holding anticoagulation, hemorrhage after anticoagulation resumption, and factors associated with the decision to restart anticoagulation. Methods: Patients presenting to our level I trauma center for tICH while on a DOAC for NVAF were retrospectively reviewed over 2 years. Age, sex, DOAC use, antiplatelet use, congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease, sex score for stroke risk in NVAF, injury mechanism, bleeding pattern, Injury Severity Score, use of a reversal agent, Glasgow Coma Scale at 24 hours, hemorrhage expansion, neurosurgical intervention, Morse Fall Risk, DOAC restart date, rebleed events, and ischemic stroke were recorded to study rates of recurrent hemorrhage and stroke, and factors that influenced the decision to restart anticoagulation. Results: Twenty-eight patients sustained tICH while on a DOAC. Fall was the most common mechanism (89.3%), and subdural hematoma was the predominant bleeding pattern (60.7%). Of the 25 surviving patients, 16 patients (64%) restarted a DOAC a median 29.5 days after tICH. One patient had recurrent hemorrhage after resuming anticoagulation. One patient had an embolic stroke after 118 days off anticoagulation. Age >80, Injury Severity Score ≥16, and expansion of tICH influenced the decision to indefinitely hold anticoagulation. Conclusion: The low stroke rate observed in this study suggests that holding DOACs for NVAF for 1 month is sufficient to reduce the risk of stroke after tICH. Additional data are required to determine optimal restart timing.