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.

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.

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.

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.

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.

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.

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.

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.

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.

Image quality of EOS low-dose radiography in comparison with conventional radiography for assessment of ventriculoperitoneal shunt integrity.

OBJECTIVE: Patients with shunted hydrocephalus often accumulate high levels of radiation over their lifetimes during evaluation of hardware integrity. Current practice involves the use of a series of conventional radiographs for this purpose. Newer low-dose EOS radiography is currently used to evaluate scoliosis but has not been explored to evaluate shunt integrity on a large scale. The goal of this study was to compare the quality of imaging using EOS low-dose radiography to conventional radiography to evaluate shunt tubing. METHODS: A retrospective chart review was performed on 57 patients who previously had both conventional radiographs and low-dose EOS images of their cerebral shunt tubing from 2000 to 2018. Patient demographics (age, sex, type of shunt tubing, primary diagnosis) were collected. Conventional radiographic images and low-dose EOS images were independently analyzed by a neurosurgeon and neuroradiologist in three categories: image quality, delineation of shunt, and distinction of shunt compared to adjacent anatomy. RESULTS: All patients had shunted hydrocephalus due to spina bifida and Chiari type II malformation. Ratings of EOS and conventional radiographic images by both raters did not differ significantly in terms of image quality (rater 1, p = 0.499; rater 2, p = 0.578) or delineation of shunt (p = 0.107 and p = 0.256). Conventional radiographic images received significantly higher ratings than EOS on the ability to distinguish the shunt versus adjacent anatomy by rater 1 (p = 0.039), but not by rater 2 (p = 0.149). The overall score of the three categories combined was not significantly different between EOS and conventional radiography (rater 1, p = 0.818; rater 2, p = 0.186). In terms of cost, an EOS image was less costly than a conventional radiography shunt series ($236-$366 and $1300-$1547, respectively). The radiation dose was also lower for EOS images, with an effective dose of 0.086-0.140 mSv compared to approximately 1.6 mSv for a similar field of view with conventional radiography. CONCLUSIONS: The image quality of low-dose EOS radiography does not significantly differ from conventional radiography for the evaluation of cerebral shunts. In addition, EOS affords a much lower radiation dose and a lower cost.

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.