Evaluation of Tacrolimus Concentrations and Clinical Outcomes Between Extended and Immediate Release Formulations in Kidney Transplant.

Objectives: Tacrolimus remains the mainstay of immunosuppression in kidney transplantation. Understanding the relationship between therapeutic tacrolimus levels and outcomes of acute rejection, patient/graft survival, and tolerability are important. The relationship between time to therapeutic tacrolimus levels and outcomes has not been well established, specifically with the use of extended release tacrolimus formulation (LCP-Tac). This study investigated time to therapeutic tacrolimus levels of 2 tacrolimus formulations, LCP-Tac and immediate release tacrolimus (IR-Tac), as a predictor of clinical outcomes. Methods: This was a single-center, retrospective, cohort study of kidney transplant recipients at Duke Hospital between 2013-2021. The primary objective evaluated the difference in time to therapeutic tacrolimus levels with LCP-Tac vs IR-Tac regimens. Secondary endpoints included time within therapeutic range during the first 3 months post-transplant, incidence of biopsy-proven rejection, development of de novo donor specific antibodies, and patient and allograft survival at 12 months post-transplant. Results: 128 patients were included (63 in LCP-Tac group and 65 in IR-Tac group). The time to therapeutic tacrolimus level was similar between formulations (7.2 days with LCP-Tac compared to 6.7 days with IR-Tac, P = .63). The time within therapeutic range during the first 3 months post-transplant, via modified Rosendaal, was similar with LCP-Tac and IR-Tac (56.1% vs 64.8%, respectively). Rates of biopsy-proven acute rejection at 12 months were similar (7/63 (11.1%) compared to 4/65 (6.2%)). There was no difference in patient/graft survival between groups. Conclusions: The time to therapeutic tacrolimus levels did not differ based on tacrolimus formulation and was not correlated with clinical outcomes.

Demographics of focused ultrasound thalamotomy for essential tremor and trends in deep brain stimulation surgery after its introduction in the USA.

Background: Essential tremor (ET) is a movement disorder that affects 4%-5% of adults >65 years. For patients with medically refractory ET, neurosurgical interventions such as deep brain stimulation (DBS) and unilateral MR-guided focused ultrasound thalamotomy (MRgFUS) are available. In this retrospective cohort study, we examined the demographics of patients with ET who have received MRgFUS and evaluated trends in DBS usage in the USA after the introduction of MRgFUS in 2016. Methods: We used multiple databases to examine the demographics of patients who received DBS and MRgFUS, and trends in DBS. To assess the demographics, we queried the TriNetX database from 2003 to 2022 to identify patients diagnosed with ET and stratify them by DBS or MRgFUS treatment by using Current Procedural Terminology codes. Patient demographics were reported as frequencies and percentages. To examine the trends in DBS for ET, the yearly frequency of DBS procedures done for ET between 2012 and 2019 was extracted from the National Inpatient Sample (NIS) database, and breakpoint analysis was performed. Additionally, the yearly frequency of MRgFUS procedures for ET was obtained from Insightec Exlabate. Results: Most of the patients (88.69%) in the cohort extracted from TriNetX database self-identified as white, followed by black or African American (2.40%) and Asian (0.52%). A higher percentage of black patients received MRgFUS treatment than DBS (4.10% vs 1.88%). According to the NIS database, from 2012 to 2020, 13 525 patients received DBS for ET. Conclusion: This study provides an overview of the characteristics of patients who undergo DBS or MRgFUS. We found notable differences in sex and race among patients who underwent each treatment type. Additionally, until at least the beginning of 2020, the number of DBS procedures for ET was not negatively affected after the introduction of MRgFUS.

Disparities in the treatment of movement disorders using deep brain stimulation.

OBJECTIVE: Deep brain stimulation (DBS) is a well-established treatment for Parkinson's disease (PD) and essential tremor (ET). Although the prevalence of PD and ET can vary by sex and race, little is known about the accessibility of neurosurgical treatments for these conditions. In this nationwide study, the authors aimed to characterize trends in the use of DBS for the treatment of PD and ET and to identify disparities in the neurosurgical treatment of these diseases based on ethnic, racial, sex, insurance, income, hospital, and geographic factors. METHODS: Using the dates January 1, 2012, to December 31, 2019, the authors queried the National Inpatient Sample database for all discharges with an ICD-9 or ICD-10 diagnosis of PD or ET. Among these discharges, the DBS rates were reported for each subgroup of race, ethnicity, and sex. To develop national estimates, all analyses were weighted. RESULTS: Among 2,517,639 discharges with PD, 29,820 (1.2%) received DBS, and among 652,935 discharges with ET, 11,885 (1.8%) received DBS. Amid the PD cases, Black patients (n = 405 [0.2%], OR 0.16, 95% CI 0.12-0.20) were less likely than White patients (n = 23,975 [1.2%]) to receive DBS treatment, as were Hispanic patients (n = 1965 [1.1%], OR 0.76, 95% CI 0.65-0.88), whereas Asian/Pacific Islander patients (n = 855 [1.5%]) did not statistically differ from White patients. Amid the ET cases, Black (n = 230 [0.8%], OR 0.39, 95% CI 0.27-0.56), Hispanic (n = 215 [1.0%], OR 0.39, 95% CI 0.28-0.55), and Asian/Pacific Islander (n = 55 [1.0%], OR 0.51, 95% CI 0.28-0.93) patients were less likely than White patients (n = 10,440 [1.9%]) to receive DBS. Females were less likely than males to receive DBS for PD (OR 0.69, p < 0.0001) or ET (OR 0.70, p < 0.0001). CONCLUSIONS: The authors describe significant racial and sex-based differences in the utilization of DBS for the treatment of PD and ET. Further research is required to ascertain the causes of these disparities, as well as any differences in access to specialty neurosurgical care and referral for neuromodulation approaches.

Healthcare resource utilization for chronic low back pain among high-utilizers.

BACKGROUND: Chronic low back pain is a leading cause of morbidity and is among the largest cost drivers for the healthcare system. Research on healthcare resource utilization of patients with low back pain who are not surgical candidates is limited, and few studies follow individuals who generate high healthcare costs over time. PURPOSE: This claims study aimed to identify patients with high-impact mechanical, chronic low back pain (CLBP), quantify their low back pain-related health resource utilization, and explore associated patient characteristics. We hypothesize that patients in the top quartile of healthcare resource utilization in the second year after initial diagnosis will continue to generate considerable back pain-related costs in subsequent years. STUDY DESIGN/SETTING: IBM MarketScan Research Databases from 2009-2019 were retrospectively analyzed. PATIENT SAMPLE: Adults in the United States with an initial diagnosis of low back pain between 2010 and 2014 who did not have cancer, spine surgery, recent pregnancy, or inflammatory spine conditions, were identified using the International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes. To ensure patients had chronic low back pain, it was required that individuals had additional claims with a low back pain diagnosis 6 to 12 and 12 to 24 months after initial diagnosis. OUTCOME MEASURES: Cost and utilization of inpatient visits, outpatient visits, emergency room visits, pharmacologic and nonpharmacologic treatment options and imaging for chronic low back pain. METHODS: Annual back pain-related costs and the use of pharmacologic and nonpharmacologic treatments for 5 years were analyzed. Logistic regression was utilized to identify factors associated with persistent high spending. RESULTS: Of 16,917 individuals who met the criteria for chronic low back pain, 4,229 met the criteria for having high healthcare utilization, defined as being in the top quartile of back pain-related costs in the 12 to 24 months after their initial diagnosis. The mean and median back pain-related cost in the first year after an initial diagnosis was $7,112 (SD $9,670) and $4,405 (Q1 $2,147, Q3 $8,461). Mean and median back pain related costs in the second year were $11,989 (SD $20,316) and $5,935 (Q1 $3,892, Q3 $10,678). Costs continued to be incurred in years 3 to 5 at a reduced rate. The cumulative mean cost for back pain over the 5 years following the initial diagnosis was $31,459 (SD $39,545). The majority of costs were from outpatient services. Almost a quarter of the high utilizers remained in the top quartile of back pain-related costs during years 3 to 5 after the initial diagnosis, and another 19% remained in the top quartile for 2 of the 3 subsequent years. For these two groups combined (42%), the 5-year cumulative mean cost for back pain was $43,818 (SD $48,270). Patient characteristics associated with a higher likelihood of remaining as high utilizers were diabetes, having a greater number of outpatient visits and pharmacologic prescriptions, and lower utilization of imaging services. CONCLUSION: This is one of the first studies to use an administrative claims database to identify high healthcare resource utilizers among a population of United States individuals with nonsurgical, chronic low back pain and follow their utilization over time. There was a population of individuals who continued to experience high costs 5 years beyond their initial diagnosis, and the majority of individuals continued to seek outpatient services. Further longitudinal claims research that incorporates symptom severity is needed to understand the economic implications of this condition.

Disparities in Access to Deep Brain Stimulation and Responsive Neurostimulation Approaches to Drug-Resistant Epilepsy.

BACKGROUND: Epilepsy affects 1% to 2% of the global population, and those who are resistant to medical treatment may be candidates for neuromodulation. In select populations, brain stimulation approaches including deep brain stimulation (DBS) and responsive neurostimulation (RNS) are used. Although studies have shown that patients from Black, Hispanic, lower income, and rural communities have less access to epilepsy care and have lower rates of epilepsy surgery, disparities in the use of brain stimulation for epilepsy treatment are currently not known. MATERIALS AND METHODS: We queried the US National Inpatient Sample data base from January 1, 2014 to December 31, 2019 for all patients discharged with an International Classification of Diseases (ICD) Ninth Revision or ICD Tenth Revision diagnosis of drug-resistant epilepsy. Among these patients discharged, the rates of brain stimulation treatment, including DBS and RNS, were reported in each subgroup of race, ethnicity, and insurance. To generate national estimates, all analyses were weighted. RESULTS: A total of 237,895 patients discharged with drug-resistant epilepsy were identified, of whom 4,925 (2.1%) received brain stimulation treatment for drug-resistant epilepsy. Black patients (n = 420, 0.9%, odds ratio [OR] = 0.51, 95% CI [0.40, 0.64]) were less likely to receive brain stimulation treatment than were White patients (n = 3300, 2.4%). There was no significant difference between Asian (n = 105, 2.3%, OR = 0.80, 95% CI [0.53, 1.33]) and Hispanic (n = 655, 2.6%, OR = 0.95, 95% CI [0.77, 1.17]) patients and White patients. No significant difference was observed between female (n = 2515, 2.1%, OR = 1.02, 95% CI [0.89, 1.17]) and male (n = 2410, 2.0%) patients either. Patients with Medicare (n = 1150, 1.2%, OR = 0.69, 95% CI [0.57, 0.84]) or Medicaid (n = 1150, 1.8%, OR = 0.52, 95% CI [0.44, 0.62]) were less likely to receive brain stimulation treatment than were those with private insurance as the primary payer (n = 2370, 3.9%). CONCLUSIONS: We discovered significant disparities in the use of brain stimulation treatments for drug-resistant epilepsy based on race and insurance status. More research will be required to determine the cause of these disparities.

Utility of Routine Preoperative Urinalysis in the Prevention of Surgical Site Infections.

OBJECTIVE: Preoperative assessment is important for neurosurgical risk stratification, but the level of evidence for individual screening tests is low. In preoperative urinalysis (UA), testing may significantly increase costs and lead to inappropriate antibiotic treatment. We prospectively evaluated whether eliminating preoperative UA was noninferior to routine preoperative UA as measured by 30-day readmission for surgical site infection in adult elective neurosurgical procedures. METHODS: A single-institution prospective, pragmatic study of patients receiving elective neurosurgical procedures from 2018 to 2020 was conducted. Patients were allocated based on same-day versus preoperative admission status. Rates of preoperative UA and subsequent wound infection were measured along with detailed demographic, surgical, and laboratory data. RESULTS: The study included 879 patients. The most common types of surgery were cranial (54.7%), spine (17.4%), and stereotactic/functional (19.5%). No preoperative UA was performed in 315 patients, while 564 underwent UA. Of tested patients, 103 (18.3%) met criteria for suspected urinary tract infection, and 69 (12.2%) received subsequent antibiotic treatment. There were 14 patients readmitted within 30 days (7 without UA [2.2%] vs. 7 with UA [1.2%]) for subsequent wound infection with a risk difference of 0.98% (95% confidence interval -0.89% to 2.85%). The upper limit of the confidence interval exceeded the preselected noninferiority margin of 1%. CONCLUSIONS: In this prospective study of preoperative UA for elective neurosurgical procedures using a pragmatic, real-world design, risk of readmission due to surgical site infection was very low across the study cohort, suggesting a limited role of preoperative UA for elective neurosurgical procedures.

Two-Year Clinical and Radiographic Outcomes for Percutaneous Lumbar Interbody Fusion With an Expandable Titanium Cage Through Kambin's Triangle Without Facetectomy.

BACKGROUND: There has been heightened interest in performing percutaneous lumbar interbody fusions (percLIFs) through Kambin's triangle, an anatomic corridor allowing entrance into the disc space. However, due to its novelty, there are limited data regarding the long-term benefits of this procedure. Our objective was to determine the long-term efficacy and durability of the percutaneous insertion of an expandable titanium cage through Kambin's triangle without facetectomy. METHODS: A retrospective review of patients undergoing percLIF via Kambin's triangle using an expandable titanium cage was performed. Demographics, visual analog scale (VAS) scores, Oswestry Disability Index (ODI), radiographic measurements, perioperative variables, and complications were recorded. VAS, ODI, and radiographic measurements were compared with baseline using the generalized estimating equations assuming normally distributed data. Fusion was assessed with computed tomography (CT) at 1 and 2 years after the procedure. RESULTS: A total of 49 patients were included. Spondylolisthesis, lumbar lordosis (LL), sacral slope, pelvic tilt, and anterior/posterior disc space height were all significantly improved postoperatively at each time point of 3, 6, 12, and 24 months (P < 0.001). Pelvic incidence-LL mismatch decreased significantly at each follow-up (P < 0.001) with a mean reduction of 4° by 24 months. VAS back scores reduced by >2 points at the 6, 12, and 24 month follow-ups. ODI scores reduced by >15 points at the 12- and 24-month follow-ups. Of the patients who had 1- and 2-year CT images, fusion rates at those time points were 94.4% (17/18) and 87.5% (7/8), respectively. The mean annual rate of surgically significant adjacent segment disease was 2.74% through an average follow-up of 2.74 years. CONCLUSION: These results highlight that percLIF, a procedure done without an endoscope or facetectomy, can be performed using an expandable titanium cage through Kambin's triangle with excellent radiographic and clinical results. CLINICAL RELEVANCE: percLIF via Kambin's triangle is a safe and succesful procedure with long-term improvements in both clinical and radiographic outcomes.

Revisiting flow augmentation bypass for cerebrovascular atherosclerotic vaso-occlusive disease: Single-surgeon series and review of the literature.

OBJECTIVE: Despite advances in the nonsurgical management of cerebrovascular atherosclerotic steno-occlusive disease, approximately 15-20% of patients remain at high risk for recurrent ischemia. The benefit of revascularization with flow augmentation bypass has been demonstrated in studies of Moyamoya vasculopathy. Unfortunately, there are mixed results for the use of flow augmentation in atherosclerotic cerebrovascular disease. We conducted a study to examine the efficacy and long term outcomes of superficial temporal artery to middle cerebral artery (STA-MCA) bypass in patients with recurrent ischemia despite optimal medical management. METHODS: A single-institution retrospective review of patients receiving flow augmentation bypass from 2013-2021 was conducted. Patients with non-Moyamoya vaso-occlusive disease (VOD) who had continued ischemic symptoms or strokes despite best medical management were included. The primary outcome was time to post-operative stroke. Time from cerebrovascular accident to surgery, complications, imaging results, and modified Rankin Scale (mRS) scores were aggregated. RESULTS: Twenty patients met inclusion criteria. The median time from cerebrovascular accident to surgery was 87 (28-105.0) days. Only one patient (5%) had a stroke at 66 days post-op. One (5%) patient had a post-operative scalp infection, while 3 (15%) developed post-operative seizures. All 20 (100%) bypasses remained patent at follow-up. The median mRS score at follow up was significantly improved from presentation from 2.5 (1-3) to 1 (0-2), P = .013. CONCLUSIONS: For patients with high-risk non-Moyamoya VOD who have failed optimal medical therapy, contemporary approaches to flow augmentation with STA-MCA bypass may prevent future ischemic events with a low complication rate.

Quantifying the Opportunity Cost of Neurosurgical Resident Education.

BACKGROUND/OBJECTIVE: Education is at the core of neurosurgical residency, but little research in to the cost of neurosurgical education exists. This study aimed to quantify costs of resident education in an academic neurosurgery program using traditional teaching methods and the Surgical Autonomy Program (SAP), a structured training program. METHODS: SAP assesses autonomy by categorizing cases into zones of proximal development (opening, exposure, key section, and closing). All first-time, 1-level to 4-level anterior cervical discectomy and fusion (ACDF) cases between March 2014 and March 2022 from 1 attending surgeon were divided into 3 groups: independent cases, cases with traditional resident teaching, and cases with SAP teaching. Surgical times for all cases were collected and compared within levels of surgery between groups. RESULTS: The study found 2140 ACDF cases, with 1758 independent, 223 with traditional teaching, and 159 with SAP. For 1-level to 4-level ACDFs, teaching took longer than it did with independent cases, with SAP teaching adding additional time. A 1-level ACDF performed with a resident (100.1 ± 24.3 minutes) took about as long as a 3-level ACDF performed independently (97.1 ± 8.9 minutes). The average time for 2-level cases was 72.0 ± 18.2 minutes independently, 121.7 ± 33.7 minutes traditional, and 143.4 ± 34.9 minutes SAP, with significant differences among all groups. CONCLUSIONS: Teaching takes significant time compared with operating independently. There is also a financial cost to educating residents, because operating room time is expensive. Because attending neurosurgeons lose time to perform more surgeries when teaching residents, there is a need to acknowledge surgeons who devote time to training the next generation of neurosurgeons.

Short-Term Health Care Costs of High-Frequency Spinal Cord Stimulation for the Treatment of Postsurgical Persistent Spinal Pain Syndrome.

OBJECTIVE: High-frequency spinal cord stimulation (HF-SCS) is a treatment option for postsurgical persistent spinal pain syndrome (type 2 PSPS). We aimed to determine the health care costs associated with this therapy in a nationwide cohort. MATERIALS AND METHODS: IBM Marketscan® Research Databases were used to identify patients who underwent HF-SCS implantation from 2016 to 2019. Inclusion criteria included prior spine surgery or diagnoses of PSPS or postlaminectomy pain syndrome any time within the two years before implantation. Inpatient and outpatient service costs, medication costs, and out-of-pocket costs were collected six months before implantation (baseline) and one, three, and six months after implantation. The six-month explant rate was calculated. Costs were compared between baseline and six months after implant via Wilcoxon sign rank test. RESULTS: In total, 332 patients were included. At baseline, patients incurred median total costs of $15,393 (Q1: $9,266, Q3: $26,216), whereas the postimplant median total costs excluding device acquisition were $727 (Q1: $309, Q3: $1,765) at one month, $2,840 (Q1: $1,170, Q3: $6,026) at three months, and $6,380 (Q1: $2,805, Q3: $12,637) at six months. The average total cost was reduced from $21,410 (SD $21,230) from baseline to $14,312 (SD $25,687) at six months after implant for an average reduction of $7,237 (95% CI = $3212-$10,777, p < 0.001). The median device acquisition costs were $42,937 (Q1: $30,102, Q3: $65,880). The explant rate within six months was 3.4% (8/234). CONCLUSIONS: HF-SCS for PSPS was associated with significant decreases in total health care costs and offsets acquisition costs within 2.4 years. With the rising incidence of PSPS, it will be critical to use clinically effective and cost-efficient therapies for treatment.

Needles in a Haystack: Finding Qualitative and Quantitative Collaborators in Academic Medical Centers.

Translational research is a data-driven process that involves transforming scientific laboratory- and clinic-based discoveries into products and activities with real-world impact to improve individual and population health. Successful execution of translational research requires collaboration between clinical and translational science researchers, who have expertise in a wide variety of domains across the field of medicine, and qualitative and quantitative scientists, who have specialized methodologic expertise across diverse methodologic domains. While many institutions are working to build networks of these specialists, a formalized process is needed to help researchers navigate the network to find the best match and to track the navigation process to evaluate an institution's unmet collaborative needs. In 2018, a novel analytic resource navigation process was developed at Duke University to connect potential collaborators, leverage resources, and foster a community of researchers and scientists. This analytic resource navigation process can be readily adopted by other academic medical centers. The process relies on navigators with broad qualitative and quantitative methodologic knowledge, strong communication and leadership skills, and extensive collaborative experience. The essential elements of the analytic resource navigation process are as follows: (1) strong institutional knowledge of methodologic expertise and access to analytic resources, (2) deep understanding of research needs and methodologic expertise, (3) education of researchers on the role of qualitative and quantitative scientists in the research project, and (4) ongoing evaluation of the analytic resource navigation process to inform improvements. Navigators help researchers determine the type of expertise needed, search the institution to find potential collaborators with that expertise, and document the process to evaluate unmet needs. Although the navigation process can create a basis for an effective solution, some challenges remain, such as having resources to train navigators, comprehensively identifying all potential collaborators, and keeping updated information about resources as methodologists join and leave the institution.

Assessment of Health Care Costs and Total Baclofen Use Associated With Targeted Drug Delivery for Spasticity.

BACKGROUND: Chronic spasticity causes significant impairment and financial burden. Oral baclofen, the first-line therapy, can have intolerable, dose-dependent side effects. Targeted drug delivery (TDD) through intrathecal baclofen delivers smaller amounts of baclofen into the thecal sac via an implanted infusion system. However, the health care resource utilization of patients with spasticity receiving TDD has not been studied extensively. MATERIALS AND METHODS: Adult patients who received TDD for spasticity between 2009 and 2017 were identified using the IBM MarketScan® data bases. Patients' use of oral baclofen and health care costs were examined at baseline (one year before implantation) and three years after implantation. A multivariable regression model using the generalized estimating equations method and a log link function was used to compare postimplantation costs with those at baseline. RESULTS: The study identified 771 patients with TDD for medication analysis and 576 for cost analysis. At baseline, the median costs were $39,326 (interquartile range [IQR]: $19,526-$80,679), which increased to $75,728 (IQR: $44,199-$122,676) in year 1, decreased to $27,160 (IQR: $11,896-$62,427) in year 2, and increased slightly to $28,008 (IQR: $11,771-$61,885) in year 3. In multivariable analysis, the cost was 47% higher than at baseline (cost ratio [CR] 1.47, 95% CI: 1.32-1.63) in year 1 but was 25% lower (CR 0.75, 95% CI: 0.66-0.86) in year 2 and 32% lower (CR 0.68, 95% CI: 0.59-0.79) in year 3. Before implant, 58% of patients took oral baclofen, which decreased to 24% by year 3. The median daily baclofen dose decreased from 61.8 mg (IQR: 40-86.4) before TDD to 32.8 mg (IQR: 30-65.7) three years later. CONCLUSIONS: Our findings indicate that patients who undergo TDD use less oral baclofen, potentially reducing the risk of side effects. Although total health care costs increased immediately after TDD, most likely owing to device and implantation costs, they decreased below baseline after one year. The costs of TDD reach cost neutrality approximately three years after implant, indicating its potential for long-term cost savings.

Health Care Resource Utilization of High-Frequency Spinal Cord Stimulation for Treatment of Chronic Refractory Low Back Pain.

INTRODUCTION: Chronic refractory low back pain (CRLBP) is a diagnosis characterized by chronic low back pain in patients who are poor candidates for surgery and fail conservative management. High-frequency spinal cord stimulation (HF-SCS) is a new advance in neuromodulation that may be effective in treating these patients. However, the cost burden of this therapy is yet undetermined. MATERIALS AND METHODS: IBM MarketScan® (IBM, Armonk, NY) data bases were used to retrospectively identify patients with HF-SCS implantation between 2016 and 2019 in the United States. Those with low back pain diagnosis without history of surgery were included in the cohort. Cost data, including inpatient and outpatient service, medication, and out-of-pocket costs, were collected at six months before HF-SCS implantation and one, three, and six months after implantation. The explant rate within six months was evaluated. RESULTS: A total of 119 patients met the inclusion criteria. Most patients were female (73.1%) and owned commercial insurance (83.2%). Common comorbidities included inflammatory arthritis (22.7%), depression (26.1%), hypertension (44.5%), and obesity (26.1%). In the six months before HF-SCS implantation, patients incurred median total costs of $15,766 (first quartile [Q1]: $8,847; third quartile [Q3]: $24,947), whereas the postimplant median total cost excluding device acquisition was $398 (Q1: $145, Q3: $1,272) at one month, $2,569 (Q1: $823, Q3: $5,266) at three months, and $5,840 (Q1: $2,160; Q3: $14,607) at six months. The average reduction in total cost was $6,914 (95% CI: $588, $12,458, p < 0.001). The median total acquisition cost was $43,586 (Q1: $29,506, Q3: $69,426), with most coming from outpatient services. Of 88 patients with six-month continuous enrollment, two (2.3%) had device explant. CONCLUSIONS: We present an analysis using large claims data bases of the cost of HF-SCS for treating CRLBP and show that it may be associated with a significant decrease in total health care costs, offsetting device acquisition costs in 27 months. As advances in neuromodulation expand therapy options for patients, it will be important to understand their financial implications.

Association between Gentrification and Health and Healthcare Utilization.

There is tremendous interest in understanding how neighborhoods impact health by linking extant social and environmental drivers of health (SDOH) data with electronic health record (EHR) data. Studies quantifying such associations often use static neighborhood measures. Little research examines the impact of gentrification-a measure of neighborhood change-on the health of long-term neighborhood residents using EHR data, which may have a more generalizable population than traditional approaches. We quantified associations between gentrification and health and healthcare utilization by linking longitudinal socioeconomic data from the American Community Survey with EHR data across two health systems accessed by long-term residents of Durham County, NC, from 2007 to 2017. Census block group-level neighborhoods were eligible to be gentrified if they had low socioeconomic status relative to the county average. Gentrification was defined using socioeconomic data from 2006 to 2010 and 2011-2015, with the Steinmetz-Wood definition. Multivariable logistic and Poisson regression models estimated associations between gentrification and development of health indicators (cardiovascular disease, hypertension, diabetes, obesity, asthma, depression) or healthcare encounters (emergency department [ED], inpatient, or outpatient). Sensitivity analyses examined two alternative gentrification measures. Of the 99 block groups within the city of Durham, 28 were eligible (N = 10,807; median age = 42; 83% Black; 55% female) and 5 gentrified. Individuals in gentrifying neighborhoods had lower odds of obesity (odds ratio [OR] = 0.89; 95% confidence interval [CI]: 0.81-0.99), higher odds of an ED encounter (OR = 1.10; 95% CI: 1.01-1.20), and lower risk for outpatient encounters (incidence rate ratio = 0.93; 95% CI: 0.87-1.00) compared with non-gentrifying neighborhoods. The association between gentrification and health and healthcare utilization was sensitive to gentrification definition.

Characteristics of toxicity occurrence patterns in concurrent chemoradiotherapy after induction chemotherapy for patients with locally advanced non-small cell lung cancer: a pooled analysis based on individual patient data of CALGB/Alliance trials.

Background: For patients with locally advanced non-small cell lung cancer (NSCLC), concurrent chemoradiotherapy is the foundational treatment strategy. Adding induction chemotherapy did not achieve a superior efficacy but increased the burden from toxicity. Accordingly, we retrospectively investigated the toxicity patterns through pooling individual patient data of the Cancer and Leukemia Group B (CALGB)/Alliance trials. Methods: We included a total of 637 patients with unresectable stage III NSCLC who received induction chemotherapy with a platinum doublet and concurrent chemoradiotherapy and experienced at least one adverse event (AE) in CALGB 9130, 9431, 9534, 30105, 30106 and 39801 trials. The following toxicity occurrence patterns were evaluated: top 10 most frequent AEs, AE distribution by grade, rate of treatment discontinuation due to AEs, associations of AE occurrence with patient characteristics and treatment phase, the time to the first grade ≥3 AE occurrence and its associations with patient characteristics and treatment phase. Results: The occurrence of AEs was the main reason accounting for treatment discontinuation (60 of 637 among all patients; 18 of 112 patients who experienced the induction phase only; 42 of 525 patients who experienced both phases). All patients experienced a total of 11,786 AEs (grade ≥3: 1,049 of 5,538 in induction phase, 1,382 of 6,248 in concurrent phase). Lymphocytes and white blood count were of top 3 grade ≥3 AEs that patients experienced the most in the either phase. Multivariable analysis found AE occurrence was associated with age ≥65 [any grade: odds ratio (OR) =1.44, 95% confidence interval (CI): 1.12-1.86] and the concurrent phase (grade ≥3: OR =1.86, 95% CI: 1.41-2.47; any grade: OR =1.47, 95% CI: 1.19-1.81). Patients in the concurrent phase were more likely and earlier to develop grade ≥3 AEs than those in the induction phase [hazard ratio (HR) =4.37, 95% CI: 2.52-7.59]. Conclusions: The report provides a better understanding regarding the toxicity occurrence patterns in concurrent chemoradiotherapy after induction chemotherapy.

Health Care Economics of High-Frequency Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy.

BACKGROUND: Painful diabetic peripheral neuropathy (pDPN) is a debilitating complication of long-term diabetes. High-frequency spinal cord stimulation (HF-SCS) was recently shown to be an effective treatment option, but the associated health care resource utilization (HCRU) on real-world patient populations with pDPN is unknown. METHODS: Using IBM MarketScan databases, we identified patients with HF-SCS implantation between January 2016 and December 2019 who had a diagnosis of diabetes or diabetic neuropathy within two years before implant. Cost data were collected for the six months before HF-SCS implantation (baseline) and for the periods of one, three, and six months post-implantation. The six-month explant rate was calculated. RESULTS: A total of 132 patients met inclusion criteria. The median total cost at baseline was $19 220 and was $1356 at one month post-implant, $4858 at three months post-implant, and $13 305 at six months post-implant. The median baseline out-of-pocket cost was $1477 and was $710 at six months post-implant. The average total cost reduction from baseline to six months post-implant was $5118 (P < .001), or $853 per month. The median device acquisition cost was $35 755. The explant rate within six months was 2.1%. CONCLUSIONS: High-frequency spinal cord stimulation significantly reduces total HCRU in patients with pDPN, and based on the average monthly cost reduction of $853, we estimate that the therapy recoups acquisition costs within 3.5 years. As policy increasingly focuses on value-based care, it will be critical to consider the cost and outcomes of innovative therapies.

Image Quality and Dose Comparison of 3 Mobile Intraoperative Three-Dimensional Imaging Systems in Spine Surgery.

OBJECTIVE: To evaluate radiation exposure and image quality (IQ) for 3 intraoperative imaging systems (Airo TruCT, Cios Spin, O-arm) using varying radiation dose settings in a single cadaveric model. METHODS: Axial images of L4-5 instrumentation were obtained using 3 manufacturer dose protocols for each system. Measurements included scattered radiation dose, subjective and objective IQ, and estimates of patient effective dose (ED). Four images per system were selected at each dose level. Using the Likert scale (1 = best, 5 = worst), 9 reviewers rated the same 36 images. Objective IQ measures included the degree of streak artifacts (lines with incorrect data from metal objects) in each image. A composite figure of merit was derived based on ED and subjective and objective scores. RESULTS: The best subjective IQ scores were 1.44 (Cios Spin medium dose), 1.78 (Cios Spin high dose) and 2.22 (Airo TruCT low dose). The best objective IQ scores were 87.3 (Airo TruCT) and 89.1 (Cios Spin). ED low-dose results in mSv included 1.6 (Airo TruCT), 1.9 (Cios Spin), and 3.3 (O-arm). ED high-dose results in mSv included 4.6 (Cios Spin), 9.7 (Airo TruCT), and 9.9 (O-arm). Scatter radiation measurements for low dose in µGy included 21.9 (Cios Spin), 31.8 (Airo TruCT), and 33.9 (O-arm). Scatter radiation for high dose in µGy included 55.9 (Cios Spin), 104.5 (O-arm), and 200 (Airo TruCT). The best figure of merit score was for the Airo TruCT low dose, followed by Cios Spin medium dose and high dose. CONCLUSIONS: Selection of intraoperative imaging systems requires a greater understanding of the risks and benefits of radiation exposure and IQ.

Experiential Learning Methods for Biostatistics Students: A Model for Embedding Student Interns in Academic Health Centers.

This manuscript describes an experiential learning program for future collaborative biostatisticians (CBs) developed within an academic medical center. The program is a collaborative effort between the Biostatistics, Epidemiology, and Research Design (BERD) Methods Core and the Master of Biostatistics (MB) program, both housed in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine and supported in partnership with the Duke Clinical and Translational Science Institute. To date, the BERD Core Training and Internship Program (BCTIP) has formally trained over 80 students to work on collaborative teams that are integrated throughout the Duke School of Medicine. This manuscript focuses on the setting for the training program, the experiential learning model on which it is based, the structure of the program, and lessons learned to date.

Psychosocial determinants of cardiovascular events among black Americans with chronic kidney disease or associated risk factors in the Jackson heart study.

BACKGROUND: Individuals with chronic kidney disease (CKD), hypertension (HTN), or diabetes mellitus (DM) are at increased risk for cardiovascular disease (CVD). The extent to which psychosocial factors are associated with increased CVD risk within these individuals is unclear. Black individuals experience a high degree of psychosocial stressors due to socioeconomic factors, environment, racism, and discrimination. We examined the association between psychosocial factors and risk of CVD events among Black men and women with CKD and CKD risk factors in the Jackson Heart Study. METHODS AND RESULTS: We identified 1919 participants with prevalent CKD or CKD risk factors at baseline. We used rotated principal component analysis - a form of unsupervised machine learning that may identify constructs not intuitively identified by a person - to describe five groups of psychosocial components (including negative moods, religiosity, discrimination, negative outlooks, and negative coping resources) based on a battery of questionnaires. Multiple imputation by chained equation (MICE) was used to impute missing covariate data. Cox models were used to quantify the association between psychosocial components and incident CVD, defined as a fatal coronary heart disease event, myocardial infarction, cardiac procedure (angiography or revascularization procedure), or stroke. Of the 929 participants in the analysis, 67% were female, 28% were current/former smokers with mean age of 56 years and mean BMI of 33 kg/m2. Over a median follow-up of 8 years, 6% had an incident CVD event. In multivariable models, each standard deviation (SD) increase in the religiosity component was associated with an increased hazard for CVD event (hazard ratio [HR] = 1.52, 95% CI: 1.09-2.13). CONCLUSIONS: Religiosity was associated with CVD among participants with prevalent CKD or CKD risk factors. Studies to better understand the mechanisms of this relationship are needed.

Impact of US hospital center and interhospital transfer on spinal cord injury management: An analysis of the National Trauma Data Bank.

BACKGROUND: Traumatic spinal cord injury (SCI) is a serious public health problem. Outcomes are determined by severity of immediate injury, mitigation of secondary downstream effects, and rehabilitation. This study aimed to understand how the center type a patient presents to and whether they are transferred influence management and outcome. METHODS: The National Trauma Data Bank was used to identify patients with SCI. The primary objective was to determine association between center type, transfer, and surgical intervention. A secondary objective was to determine association between center type, transfer, and surgical timing. Multivariable logistic regression models were fit on surgical intervention and timing of the surgery as binary variables, adjusting for relevant clinical and demographic variables. RESULTS: There were 11,744 incidents of SCI identified. A total of 2,883 patients were transferred to a Level I center and 4,766 presented directly to a level I center. Level I center refers to level I trauma center. Those who were admitted directly to level I centers had a higher odd of receiving a surgery (odds ratio, 1.703; 95% confidence interval, 1.47-1.97; p < 0.001), but there was no significant difference in terms of timing of surgery. Patients transferred into a level I center were also more likely to undergo surgery than those at a level II/III/IV center, although this was not significant (odds ratio, 1.213; 95% confidence interval, 0.099-1.48; p = 0.059). CONCLUSION: Patients with traumatic SCI admitted to level I trauma centers were more likely to have surgery, particularly if they were directly admitted to a level I center. This study provides insights into a large US sample and sheds light on opportunities for improving pre hospital care pathways for patients with traumatic SCI, to provide the timely and appropriate care and achieve the best possible outcomes. LEVEL OF EVIDENCE: Care management, Level IV.