Primary care team member's perceptions of credentialed and privileged clinic pharmacists and impact on clinic workload in a pediatric primary care network.

BACKGROUND: Pharmacists provide increased access to care, vaccinations, and medication management for patients. Credentialing and privileging of pharmacists allows pharmacists to practice at the top of their licenses and elevate pharmacy practice. OBJECTIVE: The primary objective of this study was to assess the perception of healthcare team members of credentialed and privileged pharmacists working in a pediatric primary care network before and after implementation of pharmacist privileges. The secondary objective was to determine team members' perceptions on the amount of time spent refilling medications, resolving medication access issues, and ordering vaccines before and after implementation of pharmacist privileges. METHODS: This was a prospective pre-post study utilizing surveys to capture healthcare team members' perceptions of credentialed and privileged ambulatory care pharmacists. Surveyed participants included attending physicians, advanced practice nurses, registered nurses, licensed practical nurses, medical assistants, and patient care assistants. Summary statistics are reported as frequencies and percentages. Statistical analysis was conducted using SAS version 9.4. RESULTS: Fifty-eight pre-privileging and 56 post-privileging surveys were distributed. The return rate was 79.3% (n=46) for pre-privileging and 80.4% (n=45) for post-privileging surveys. More than 90% of respondents had a favorable perception of credentialed and privileged pharmacists in the clinic. There was a significant difference in the perception of the amount of time spent on medication access issues after pharmacist privileges were implemented (p = 0.0296). CONCLUSION: Credentialed and privileged pharmacists in a pediatric primary care network are viewed favorably by clinic team members and can have a positive impact on clinic workload.

A porcine model of thoracic aortic aneurysms created with a retrievable drug infusion stent graft mirrors human aneurysm pathophysiology.

Objective: Aneurysm pathophysiology remains poorly understood, in part from the disparity of murine models with human physiology and the requirement for invasive aortic exposure to apply agents used to create aneurysm models. A retrievable drug infusion stent graft (RDIS) was developed to isolate the aortic wall intraluminally for drug exposure. We hypothesized that an RDIS could deliver aneurysm-promoting enzymes to create a porcine model of thoracic aneurysms without major surgical exposure. Methods: Retrievable nitinol stent graft frames were designed with an isolated drug delivery chamber, covered with polytetrafluoroethylene, and connected to a delivery wire with a drug infusion catheter installed to the outer chamber. Institutional Animal Care and Use Committee-approved Yorkshire pigs (n = 5) underwent percutaneous access of the femoral artery, baseline aortogram and stent placement in the thoracic aorta followed by 30-minute exposure to a cocktail of elastase, collagenase, and trypsin. After aspiration of excess drug, stent retrieval, and femoral artery repair, animals were recovered, with angiograms at 1 and 4 weeks followed by explant. Histological analysis, in situ zymography, and multiplex cytokine assays were performed. Results: The RDIS isolated a segment of anterior aorta angiographically, while the center lumen preserved distal perfusion during drug treatment (baseline femoral mean arterial pressure, 70 ± 14 mm Hg; after RDIS, 75 ± 12; P = .55). Endovascular induction of thoracic aneurysms did not require prior mechanical injury and animals revealed no evidence of toxicity. Within 1 week, significant aneurysmal growth was observed in all five animals (1.4 ± 0.1 cm baseline to 2.9 ± 0.7 cm; P = .002) and only within the treated region of the aorta. Aneurysms persisted out to 4 weeks. Aneurysm histology demonstrated loss of elastin and collagen that was otherwise preserved in untreated aorta. Proinflammatory cytokines and increased matrix metalloproteinase activity were increased significantly within the aneurysm. Conclusions: An RDIS achieves isolated drug delivery while preserving distal perfusion to achieve an endovascular porcine model of thoracic aneurysms without major surgery. This model may have value for surgical training, device testing, and to better understand aneurysm pathogenesis. Most important, although the RDIS was used to simulate aortic pathology, this tool offers intriguing horizons for focused therapeutic drug delivery directly to aneurysms and, more broadly, focused locoregional drug delivery to vessels and vascular beds.

Pain intensity and opioid consumption after temporary and permanent peripheral nerve stimulation: a 2-year multicenter analysis.

OBJECTIVE: Peripheral nerve stimulation (PNS) is an emerging neuromodulation modality, yet there remains limited data highlighting its long-term effectiveness. The objective of this study was to report real-world data on pain intensity and opioid consumption after temporary and permanent PNS for chronic pain up to 24 months postimplantation. METHODS: A retrospective study was conducted on all patients who received PNS implants at a multi-centered enterprise between January 1, 2014 and February 24, 2022. The two co-primary outcomes were: (1) change in pain intensity (11-point Numerical Rating Scale) from baseline to 12 months postimplant; and (2) comparison of the change in pain intensity between temporary and permanent PNS cohorts 12 months postimplant. RESULTS: 126 patients were included in this analysis. Pain intensity significantly decreased 12 months postimplant in the overall cohort (mean difference (MD) -3.0 (95% CI -3.5 to -2.4), p<0.0001). No significant difference in this reduction was identified between temporary and permanent PNS cohorts (MD 0.0 (95% CI -1.1 to 1.0), p=1.00) 12 months postimplantation. Pain intensity significantly decreased in the overall, temporary, and permanent cohorts at all secondary time points (3, 6, and 24 months). No change in daily opioid consumption was observed at 6 and 12 months postimplant in the overall cohort. CONCLUSION: This study found that both temporary and permanent PNS may be effective for reducing pain intensity in patients with chronic pain up to 24 months postimplantation, although no changes in opioid consumption were observed. The decrease in pain intensity was comparable between patients receiving temporary versus permanent implants, highlighting that temporary PNS may achieve long-lasting clinical benefits. However, given the substantial loss to follow-up, further large-scale studies are needed to solidify conclusions about the efficacy of PNS.

Clinical impacts of immunomodulator withdrawal from anti-tumor necrosis factor combination therapy in pediatric inflammatory bowel disease.

OBJECTIVES: Combination therapy consists of both anti-tumor necrosis factor (anti-TNF) and an immunomodulator (IMM) and has been shown to improve outcomes in patients with inflammatory bowel disease (IBD). This study assesses the impacts of IMM withdrawal from combination therapy to anti-TNF monotherapy in children with IBD. METHODS: This single-center retrospective cohort study included children with IBD initiated on combination therapy between 2014 and 2019 who discontinued the IMM. We evaluated whether IMM withdrawal impacts laboratory values and disease activity. Linear mixed effects models with random intercepts were used to compare differences between groups. Chi-square and Kruskal-Wallis tests were used for comparisons between patients who did and did not require subsequent escalation of therapy. RESULTS: One hundred and fifty-two patients discontinued the IMM which did not significantly affect disease activity. However, 18% of patients escalated therapy after IMM withdrawal, primarily due to low anti-TNF levels. Lower anti-TNF and higher erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels before IMM withdrawal were associated with subsequent escalation of therapy. Overall, there was no statistically significant effect on anti-TNF drug levels. Patients with Crohn's disease (CD) on infliximab (IFX) and methotrexate (MTX) who discontinued the IMM had an increase in mean ESR and CRP (p < 0.05). CONCLUSIONS: IMM withdrawal from anti-TNF combination therapy may be considered safe in the setting of higher anti-TNF levels and normal serum inflammatory markers. Clinicians should consider assessing anti-TNF levels and inflammatory markers after IMM withdrawal, especially in patients with CD receiving IFX who discontinued MTX.

Antibody-Suppressor CXCR5+CD8+ T Cells Are More Potent Regulators of Humoral Alloimmunity after Kidney Transplant in Mice Compared to CD4+ Regulatory T Cells.

Adoptive cell therapy (ACT), especially with CD4+ regulatory T cells (CD4+ Tregs), is an emerging therapeutic strategy to minimize immunosuppression and promote long-term allograft acceptance, although much research remains to realize its potential. In this study, we investigated the potency of novel Ab-suppressor CXCR5+CD8+ T cells (CD8+ TAb-supp) in comparison with conventional CD25highFoxp3+CD4+ Tregs for suppression of humoral alloimmunity in a murine kidney transplant (KTx) model of Ab-mediated rejection (AMR). We examined quantity of peripheral blood, splenic and graft-infiltrating CD8+ TAb-supp, and CD4+ Tregs in KTx recipients and found that high alloantibody-producing CCR5 knockout KTx recipients have significantly fewer post-transplant peripheral blood and splenic CD8+ TAb-supp, as well as fewer splenic and graft-infiltrating CD4+ Tregs compared with wild-type KTx recipients. ACT with alloprimed CXCR5+CD8+ T cells reduced alloantibody titer, splenic alloprimed germinal center (GC) B cell quantity, and improved AMR histology in CCR5 knockout KTx recipients. ACT with alloprimed CD4+ Treg cells improved AMR histology without significantly inhibiting alloantibody production or the quantity of splenic alloprimed GC B cells. Studies with TCR transgenic mice confirmed Ag specificity of CD8+ TAb-supp-mediated effector function. In wild-type recipients, CD8 depletion significantly increased alloantibody titer, GC B cells, and severity of AMR pathology compared with isotype-treated controls. Anti-CD25 mAb treatment also resulted in increased but less pronounced effect on alloantibody titer, quantity of GC B cells, and AMR pathology than CD8 depletion. To our knowledge, this is the first report that CD8+ TAb-supp cells are more potent regulators of humoral alloimmunity than CD4+ Treg cells.

Patient-perceived understanding of home-going medication with transitions of care services at a pediatric institution.

BACKGROUND: Transitions of care (TOC) is the coordination and continuity of health care as a patient transfers between different settings. This can include a wide range of services, such as medication reconciliation, patient counseling, bedside delivery of medications, and others that meet individual patient needs. In the pediatric population, patients are at increased risk of potential medication errors and subsequent harm owing to reduced patient and caregiver health literacy, limited dosage form availability, and errors in medication administration. The use of TOC services at the time of hospital discharge in this population has the potential to make a positive impact on patient safety and the treatment of medical conditions. OBJECTIVES: The primary objective of this study was to determine whether patient-perceived understanding of home-going medications was greater in patients and/or caregivers who received medication bedside delivery and education from a pharmacy-led TOC service at a large pediatric academic medical center. The secondary objective was to determine whether the primary practice area of the pharmacist providing medication education led to changes in understanding of home-going medication(s). METHODS: Using institution-wide, patient satisfaction surveys from January 1, 2021, to December 31, 2021, patient and caregiver responses were queried for 2 questions about home-going medications, relating to the understanding of administration and the potential adverse effects. Patients were divided into 2 groups depending on TOC services received, as documented in the electronic medical record (EMR). Survey responses for each of the 2 questions were categorized as top-box percentage by study group. Hypothesis testing between study groups for the primary and secondary outcomes were conducted using chi-squared tests at an alpha of 0.05. Statistical analyses were conducted using SAS version 9.4. RESULTS: Of the 1159 patients included in the study, 441 received TOC services, deemed the intervention group, and 718 did not receive TOC services, deemed the control group. When the intervention and control group were asked about understanding of medication administration, 96.37% versus 93.18% of patients (P = 0.007) gave the most favorable response of "yes, definitely," respectively. Furthermore, 78.51% versus 77.44% of patients (P = 0.053) gave the most favorable response when asked about understanding potential medication adverse effects, respectively. CONCLUSION: Patients receiving TOC services by a member of the pharmacy team had a greater score for understanding of both medication administration and adverse effects. Furthermore, this greater score was consistent among the education provided by the inpatient and outpatient pharmacist.

Clinical outcomes and cost savings of a nonmedical switch to a biosimilar in children/young adults with inflammatory bowel disease.

OBJECTIVES: The safety, efficacy, and cost savings associated with biosimilar medications are well established. However, a lack of pediatric data exists surrounding clinical outcomes when switching from an originator to a biosimilar. Our primary aim is to evaluate clinical outcomes following a nonmedical switch from the infliximab originator to a biosimilar in children and young adults with inflammatory bowel disease (IBD). Our secondary aim is to estimate cost savings associated with this switch. METHODS: A quality improvement project was implemented to establish safe switching protocols, then those patients who underwent a nonmedical switch from the infliximab originator to the biosimilar were retrospectively reviewed. Demographic data, physician global assessments (PGAs), and laboratory values were recorded 1 year pre- and post-switch. Continuation rates on the biosimilar were reported at 6 and 12 months. Cost savings were estimated using two different pricing models. RESULTS: Fifty-three patients underwent a nonmedical switch. Laboratory values including inflammatory markers, infliximab levels, and PGA scores remained similar when assessed pre- and post-switch. No infusion reactions or antidrug antibody development occurred. Two patients reported psoriasis-like rashes. Five patients switched back to the originator during the study period. There were 379 biosimilar infusions completed with an estimated total cost savings of $11,260 (average sales price) and $566,223 (wholesale acquisition cost). CONCLUSIONS: Clinical remission rates, inflammatory laboratory markers, serious adverse events, infliximab levels, and antidrug antibodies remained similar after a one-time nonmedical switch to an infliximab biosimilar. Nonmedical switching to biosimilars resulted in significant cost savings.

CXCR5 + CD8 + T Cell-mediated Suppression of Humoral Alloimmunity and AMR in Mice Is Optimized With mTOR and Impaired With Calcineurin Inhibition.

BACKGROUND: Adoptive cellular therapy (ACT) with antibody-suppressor CXCR5 + CD8 + T cells (CD8 + T Ab-supp ) inhibits alloantibody production, antibody-mediated rejection (AMR), and prolongs graft survival in multiple transplant mouse models. However, it is not known how conventional immunosuppressive agents impact the efficacy of CD8 + T Ab-supp ACT. METHODS: We investigated the efficacy of CD8 + T Ab-supp cell ACT when combined with calcineurin inhibitor (CNi) or mammalian target of rapamycin inhibitor (mTORi) in a murine model of kidney transplant. RESULTS: ACT-mediated decrease in germinal center B cells, posttransplant alloantibody titer, and amelioration of AMR in high alloantibody-producing CCR5 knockout kidney transplant recipients were impaired when ACT was combined with CNi and enhanced when combined with mTORi. CNi (but not mTORi) reduced ACT-mediated in vivo cytotoxicity of IgG + B cells and was associated with increased quantity of germinal center B cells. Neither CNi nor mTORi treatment impacted the expression of cytotoxic effector molecules (FasL, Lamp1, perforin, granzyme B) by CD8 + T Ab-supp after ACT. Concurrent treatment with CNi (but not mTORi) reduced in vivo proliferation of CD8 + T Ab-supp after ACT. The increase in quantity of splenic CD44 + CXCR5 + CD8 + T cells that occurs after ACT was reduced by concurrent treatment with CNi but not by concurrent treatment with mTORi (dose-dependent). CONCLUSIONS: Impaired efficacy of ACT by CNi is attributed to reduced persistence and/or expansion of CD8 + T Ab-supp cells after ACT. In contrast, concurrent immunosuppression with mTORi preserves CD8 + T Ab-supp cells quantity, in vivo proliferation, and in vivo cytotoxic effector function after ACT and enhances suppression of humoral alloimmunity and AMR.

Incidence of subsequent surgical decompression following minimally invasive approaches to treat lumbar spinal stenosis: A retrospective review.

BACKGROUND CONTEXT: Surgical decompression is the definitive treatment for managing symptomatic lumbar spinal stenosis; however, select patients are poor surgical candidates. Consequently, minimally invasive procedures have gained popularity, but there exists the potential for failure of therapy necessitating eventual surgical decompression. PURPOSE: To evaluate the incidence and characteristics of patients who require surgical decompression following minimally invasive procedures to treat lumbar spinal stenosis. STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: Patients who underwent minimally invasive procedures for lumbar spinal stenosis (Percutaneous Image-guided Lumbar Decompression [PILD] or interspinous spacer device [ISD]) and progressed to subsequent surgical decompression within 5 years. OUTCOME MEASURES: The primary outcome was the rate of surgical decompression within 5 years following the minimally invasive approach. Secondary outcomes included demographic and comorbid factors associated with increased odds of requiring subsequent surgery. METHODS: Patient data were collected using the PearlDiver-Mariner database. The rate of subsequent decompression was described as a percentage while univariable and multivariable regression analysis was used for the analysis of predictors. RESULTS: A total of 5278 patients were included, of which 3222 (61.04%) underwent PILD, 1959 (37.12%) underwent ISD placement, and 97 (1.84%) had claims for both procedures. Overall, the incidence of subsequent surgical decompression within 5 years was 6.56% (346 of 5278 patients). Variables associated with a significantly greater odds ratio (OR) [95% confidence interval (CI)] of requiring subsequent surgical decompression included male gender and a prior history of surgical decompression by 1.42 ([1.14, 1.77], p = 0.002) and 2.10 times ([1.39, 3.17], p < 0.001), respectively. In contrast, age 65 years and above, a diagnosis of obesity, and a Charlson Comorbidity Index score of three or greater were associated with a significantly reduced OR [95% CI] by 0.64 ([0.50, 0.81], p < 0.001), 0.62 ([0.48, 0.81], p < 0.001), and 0.71 times ([0.56, 0.91], p = 0.007), respectively. CONCLUSIONS: Minimally invasive procedures may provide an additional option to treat symptomatic lumbar spinal stenosis in patients who are poor surgical candidates or who do not desire open decompression; however, there still exists a subset of patients who will require subsequent surgical decompression. Factors such as gender and prior surgical decompression increase the likelihood of subsequent surgery, while older age, obesity, and a higher Charlson Comorbidity Index score reduce it. These findings aid in selecting suitable surgical candidates for better outcomes in the elderly population with lumbar spinal stenosis.

National learning curves among robotic thoracic surgeons in the United States: Quantifying the impact of procedural experience on efficiency and productivity gains.

OBJECTIVE: This study aims to characterize the aggregate learning curves of US surgeons for robotic thoracic procedures and to quantify the impact on productivity. METHODS: National average console times relative to cumulative case number were extracted from the My Intuitive application (Version 1.7.0). Intuitive da Vinci robotic system data for 56,668 lung resections performed by 870 individual surgeons between 2021 and 2022 were reviewed. Console time and hourly productivity (work relative value units/hour) were analyzed using linear regression models. RESULTS: Average console times improved for all robotic procedures with cumulative case experience (P = .003). Segmentectomy and thymectomy had the steepest initial learning curves with a 33% and 34% reduction of the average console time for proficient (51-100 cases) relative to novice surgeons (1-10 cases), respectively. The hourly productivity increase for proficient surgeons ranged from 11.4 work relative value units/hour (+26%) for lobectomy to 17.0 work relative value units/hour (+50%) for segmentectomy. At the expert level (101+ cases), average console times continued to decrease significantly for esophagectomy (-18%) and lobectomy (-23%), but only minimally for wedge resections (-1%) (P = .003). The work relative value units/hour increase at the expert level reached 50% for lobectomy and 40% for esophagectomy. Surgeon experience level, dual console use, system model, and robotic stapler use were factors independently associated with console time for robotic lobectomy. CONCLUSIONS: The aggregate learning curve for robotic thoracic surgeons in the United States varies significantly by procedure type and demonstrate continued improvements in efficiency beyond 100 cases for lobectomy and esophagectomy. Improvements in efficiency with growing experiences translate to substantial productivity gains.

Discrepancy Between Reported and Calculated Pain Reduction in Patients With Spinal Cord Stimulation Therapy and Lack of Agreement Between Patient Satisfaction and Degree of Pain Relief.

OBJECTIVES: This study aimed to determine agreement between reported percentage pain reduction (RPPR) and calculated percentage pain reduction (CPPR) in patients with percutaneous spinal cord stimulation (SCS) implants, and to correlate RPPR and CPPR with patient satisfaction. We also sought to determine which patient-reported outcome measures are most improved in patients with SCS. MATERIALS AND METHODS: Fifty patients with percutaneous spinal cord stimulator implants with a mean follow-up of 51.1 months were interviewed and surveyed to assess their pain level, impression of degree of pain relief, satisfaction with the therapy, and desire to have the device again. Baseline pain level was obtained from their preimplant records. RESULTS: Overall, RPPR was found to be 53.3%, whereas CPPR was 44.4%. Of all patients, 21 reported <50% pain reduction; however, most of these (12/21, 57%) were satisfied with the outcome of therapy. In terms of individual improvement in outcomes, activities of daily life was the most improved measure at 82%, followed by mood, sleep, medication use, and health care utilization at 74%, 62%, 50%, and 48%, respectively. CONCLUSIONS: RPPR appears to be a complex outcome measure that may not agree with CPPR. Overall RPPR is greater than the CPPR. On the basis of our data, these independently valid measures should not be used interchangeably. A 50% pain reduction threshold is not a requisite for patient satisfaction and desire to have the device again. Activities of daily living was the most improved measure in this cohort, followed by mood, sleep, medication usage, and decrease in health care utilization.

A self calibrating, magnetic sensor approach accurately positions an aortic damage control stent in a porcine model.

Objectives: Non-compressible torso hemorrhage remains a high mortality injury, with difficulty mobilizing resources before exsanguination. Previous studies reported on a retrievable stent graft for damage control and morphometric algorithms for rapid placement, yet fluoroscopy is impractical for the austere environment. We hypothesized that magnetic sensors could be used to position stents relative to an external magnet placed on an anatomic landmark, whereas an electromagnet would allow self-calibration to account for environmental noise. Methods: A magnetic sensor alone (MSA) and with integrated stent (MSIS) were examined in a porcine model under anesthesia. A target electromagnet was placed on the xiphoid process (position 0 cm). Sensors were placed in the aorta and measurements obtained at positions 0 cm, +4 cm, and +12 cm from the magnet and compared with fluoroscopy. Sensors were examined under conditions of tachycardia/hypertension, hypotension, vibration, and metal shrapnel to simulate environmental factors that might impact accuracy. General linear models compared mean differences between fluoroscopy and sensor readings. Results: Both sensors were compatible with a 10 French catheter system and provided real-time assessment of the distance between the sensor and magnetic target in centimeters. Mean differences between fluoroscopy and both magnetic sensor readings demonstrated accuracy within ±0.5 cm for all but one condition at 0 cm and +4 cm, whereas accuracy decreased at +12 cm from the target. Using the control as a reference, there was no significant difference in mean differences between fluoroscopy and both MSA or MSIS readings at 0 cm and +4 cm for all conditions. The system retained effectiveness if the target was overshot. Conclusion: Magnetic sensors achieved the highest accuracy as sensors approached the target. Oscillation of the electromagnet on and off effectively accounts for environmental noise.This approach is promising for rapid and accurate placement of damage control retrievable stent grafts when fluoroscopy is impractical. Level of evidence: Not applicable.

Bariatric Patient Engagement in a Pre-surgery Virtual Patient Navigation Platform (VPNP).

BACKGROUND: This study analyzed patient engagement with a virtual patient navigation platform (VPNP) designed to help guide bariatric surgery candidates through the complex pre-operative workup for surgery. METHODS: Data on baseline sociodemographic and medical history was collected on patients enrolled in the bariatric program at a single academic institution between March and May 2021. The System Usability Scale (SUS) survey was administered to assess VPNP usability. Two groups emerged: "engaged" (ENG; n = 30) who activated their accounts and completed the SUS, and "not-engaged" (NEG; n = 35) who did not activate their accounts (n = 13) or did not use the app (n = 22) and were therefore ineligible for the SUS survey. RESULTS: Analyses demonstrated that only insurance status differed between groups (private insurance: 60% versus 34.3% for ENG versus NEG, respectively; p = 0.038). SUS survey analysis demonstrated high perceived usability (median score = 86.3), corresponding to the 97th percentile of usability. The top three reasons for disengagement included being too busy (22.9%), not being interested (20%), and being unsure about the purpose of the app (20%). CONCLUSIONS: The VPNP scored in the 97th percentile of usability. However, given a majority of patients did not engage with the app, and engagement was associated with completing pre-surgery requirements faster (unpublished), future work will focus on mitigating identified reasons for patients not engaging.

Similar Growth Outcomes in Children with Inflammatory Bowel Disease Initiated on Infliximab Originator or Biosimilar.

BACKGROUND: Growth is an important clinical outcome, especially in childhood-onset inflammatory bowel disease (IBD). Prior research has demonstrated growth improvements with infliximab therapy. There are limited studies evaluating whether clinical and growth outcomes in children initiated on the infliximab originator and infliximab biosimilar are similar. METHODS: This was a single-center retrospective review of patients with IBD, younger than 17 years old, and initiated on the infliximab originator or biosimilar for at least 12 months between April 2016 and February 2021. Propensity score matching was utilized. Laboratory values, disease activity scores, and growth values were collected at baseline (prior to infliximab initiation), 6 months, and 12 months post initiation. Linear mixed models with random intercepts were used to test differences in measures over time and between study groups. RESULTS: There were 113 patients on the originator and 39 patients on a biosimilar who met eligibility criteria. Propensity score methodology identified 37 dyads (1:1 match). Weight, height, and body mass index z scores increased over time (from baseline to 12 months) for both groups ( P < 0.05) and there was a similar rate of change between study groups. Clinical outcomes of lab values (albumin, C-reactive protein, and hemoglobin) and disease activity scoring were similar from baseline to 12 months between study groups. CONCLUSIONS: There were similar improvements in growth and clinical outcomes in patients initiated on the infliximab originator compared to an infliximab biosimilar agent. This study adds to the limited research evaluating whether infliximab biosimilars have similar growth outcomes in children with IBD.

Impact of pharmacist alternative therapy interventions in a pediatric Medicaid population.

BACKGROUND: Ambulatory clinical pharmacists are viewed as the medication experts on the health care team and frequently assist with medication access concerns. However, medication access and insurance navigation are difficult because of wide variations in insurance formularies. Accountable care organizations (ACOs) incorporate pharmacists as members of their population health teams to assist with these efforts. These ACO pharmacists are uniquely positioned to assist pediatric ambulatory care pharmacists with medication access concerns. This collaboration has the potential to not only improve patient care but also provide cost savings. OBJECTIVE: To estimate cost savings to an ACO derived from alternative therapy interventions made by pharmacists embedded in pediatric ambulatory clinics, using resources created by ACO pharmacists, within a pediatric Medicaid population. The secondary objectives were to quantify the frequency of alternative therapy interventions provided by these pharmacists, evaluate the impact on medication access through the avoidance of prior authorizations (PAs), and assess the frequency and cost savings of alternative therapy interventions per treatment category. METHODS: This was a retrospective review of alternative therapy interventions provided by pediatric ambulatory care pharmacists within a health-system in central Ohio. Interventions were collected within an electronic health record from January 1, 2020, to December 31, 2020. Cost savings were calculated using average wholesale pricing, and PA avoidance was quantified. RESULTS: A total of 278 alternative therapy interventions were made with an estimated cost savings of $133,191.43. Primary care clinics (n = 181, 65%) had the most documented interventions. A total of 174 (63%) interventions resulted in the avoidance of a PA. The antiallergen (28%) treatment category had the most documented interventions. CONCLUSIONS: Alternative therapy interventions were provided by pediatric ambulatory care pharmacists in collaboration with pharmacists working for an ACO. The use of ACO prescribing resources can result in cost savings to an ACO and PA avoidance within a pediatric Medicaid population. DISCLOSURES: The statistical analysis of this work was supported by the National Center for Advancing Translational Sciences (CTSA Grant UL1TR002733). Dr Sebastian discloses her role as a pharmacy consultant for Molina Healthcare Pharmacy and Therapeutics Committee. All other authors declare no relevant conflicts of interest or financial relationships.

A dumbbell rescue stent graft facilitates clamp-free repair of aortic injury in a porcine model.

Objective: Noncompressible torso hemorrhage is a high-mortality injury. We previously reported improved outcomes with a retrievable rescue stent graft to temporize aortic hemorrhage in a porcine model while maintaining distal perfusion. A limitation was that the original cylindrical stent graft design prohibited simultaneous vascular repair, given the concern for suture ensnarement of the temporary stent. We hypothesized that a modified, dumbbell-shaped design would preserve distal perfusion and also offer a bloodless plane in the midsection, facilitating repair with the stent graft in place and improve the postrepair hemodynamics. Methods: In an Institutional Animal Care and Use Committee-approved terminal porcine model, a custom retrievable dumbbell-shaped rescue stent graft (dRS) was fashioned from laser-cut nitinol and polytetrafluoroethylene covering and compared with aortic cross-clamping. Under anesthesia, the descending thoracic aorta was injured and then repaired with cross-clamping (n = 6) or dRS (n = 6). Angiography was performed in both groups. Operations were divided into phases: (1) baseline, (2) thoracic injury with either cross-clamp or dRS deployed, and (3) recovery, after which the clamp or dRS were removed. Target blood loss was 22% to simulate class II or III hemorrhagic shock. Shed blood was recovered with a Cell Saver and reinfused for resuscitation. Renal artery flow rates were recorded at baseline and during the repair phase and reported as a percentage of cardiac output. Phenylephrine pressor requirements were recorded. Results: In contrast with cross-clamped animals, dRS animals demonstrated both operative hemostasis and preserved flow beyond the dRS angiographically. Recovery phase mean arterial pressure, cardiac output, and right ventricular end-diastolic volume were significantly higher in dRS animals (P = .033, P = .015, and P = .012, respectively). Whereas distal femoral blood pressures were absent during cross-clamping, among the dRS animals, the carotid and femoral MAPs were not significantly different during the injury phase (P = .504). Cross-clamped animals demonstrated nearly absent renal artery flow, in contrast with dRS animals, which exhibited preserved perfusion (P<.0001). Femoral oxygen levels (partial pressure of oxygen) among a subset of animals further confirmed greater distal oxygenation during dRS deployment compared with cross-clamping (P = .006). After aortic repair and clamp or stent removal, cross-clamped animals demonstrated more significant hypotension, as demonstrated by increased pressor requirements over stented animals (P = .035). Conclusions: Compared with aortic cross-clamping, the dRS model demonstrated superior distal perfusion, while also facilitating simultaneous hemorrhage control and aortic repair. This study demonstrates a promising alternative to aortic cross-clamping to decrease distal ischemia and avoid the unfavorable hemodynamics that accompany clamp reperfusion. Future studies will assess differences in ischemic injury and physiological outcomes. Clinical Relevance: Noncompressible aortic hemorrhage remains a high-mortality injury, and current damage control options are limited by ischemic complications. We have previously reported a retrievable stent graft to allow rapid hemorrhage control, preserved distal perfusion, and removal at the primary repair. The prior cylindrical stent graft was limited by the inability to suture the aorta over the stent graft owing to risk of ensnarement. This large animal study explored a dumbbell retrievable stent with a bloodless plane to allow suture placement with the stent in place. This approach improved distal perfusion and hemodynamics over clamp repair and heralds the potential for aortic repair while avoiding complications.

Primary care Providers' approaches to cervical cancer screening in Muslim females.

The utilization of the Papanicolaou (Pap) test and the human papillomavirus (HPV) vaccine has significantly decreased rates of cervical cancer and related mortality. Disparities in receiving these preventive screenings are scarcely studied in Muslim females. Our study explores primary care providers' (PCP) approaches to cervical cancer screening in Muslim females. We created a cross-sectional Qualtrics survey using convenience sampling of PCPs who perform Pap tests in central Ohio. Recruitment emails were disseminated via departmental email listservs. We had 200 analyzable responses and 78% of respondents reported having Muslim patients. Bivariate analysis was used to identify predictors of providers' approaches. Providers younger than 35 years obtained a sexual history from Muslim females less frequently, family medicine providers were more likely to obtain a sexual history from Muslim females, and gynecologists were more likely to offer the HPV vaccine to Muslim females. Providers who counseled patients about Pap tests (P<0.001) and HPV modes of transmission (P<0.004) were more likely to offer cervical cancer screening for Muslim females. Our findings suggested that providers' age and specialty may be predictors of proactive cervical cancer screening and prevention in Muslim females and that there is a gap between current guidelines and preventive clinical practices regarding the HPV vaccine and transmission counseling.

Prevalence and Predictability of Occult Satellite Nodules in Clinical Stage Ia Non-small Cell Lung Cancer following Lobectomy.

INTRODUCTION: We sought to assess the prevalence and clinical predictors of satellite nodules in patients undergoing lobectomy for clinical stage Ia disease. PATIENTS AND METHODS: The National Cancer Database was queried for patients who underwent lobectomy for clinical stage cT1N0 NSCLC. Collaborative staging information was used to identify patients who were pathologically upstaged based on having separate tumor nodules in the same lobe as the primary tumor. Multivariable logistic regression was used to assess the association of clinical factors with the detection of separate nodules. RESULTS: A separate tumor nodule was recorded in 2.8% (n = 1284) of 45,842 clinical stage Ia patients treated with lobectomy or bilobectomy. Female gender (3.1% vs. male 2.5%; P = .002) and non-squamous histology (adenocarcinoma 3.2% and large cell neuroendocrine 3.0% vs. squamous cell 1.9% tumors; P < .001) were associated with the presence of separate nodules. The frequency increased for tumors larger than 3 cm (≤ 3cm, 2.7% vs. > 3cm, 3.8%; P < .001). Other factors associated with separate nodules were upper lobe location, pleural and/or lymphovascular invasion and occult lymph node disease. The best predictive model for separate nodules based on the available clinical variables resulted in an area under the curve of 0.645 (95% CI 0.629-0.660). CONCLUSION: Separate tumor nodules may be detected with a low but relatively consistent frequency across the spectrum of patients with clinical stage Ia NSCLC. The predictive ability using basic clinical factors in the database is limited.

Mouse Model of Spinal Cord Hypoperfusion with Immediate Paralysis Caused by Endovascular Repair of Thoracic Aortic Aneurysm.

BACKGROUND: A clinically relevant mouse model of thoracic endovascular aortic repair-induced ischemic spinal cord injury has been lacking since the procedure was first employed in 1991. The hypothesis was that ligation of mouse intercostal arteries would simulate thoracic endovascular aortic repair-induced ischemic spinal cord injury and behavioral deficit. The aim was to create a mouse model of thoracic endovascular aortic repair-induced spinal cord hypoperfusion by ligating five pairs of mouse intercostal vessels. METHODS: Mice were divided into sham (n = 53) and ligation (n = 60) groups. The procedures called for double ligation of three pairs and single ligation of two pairs of thoracic intercostal arteries in adult C57BL/6 mice. A laser Doppler probe was used in vivo on the spinal cords and intercostal arteries to document the extent of arterial ligation and spinal cord hypoperfusion. The Basso Mouse Scale for Locomotion, histological studies, and electron microscopy demonstrated postligation locomotive and histopathological changes. RESULTS: Ligation induced a significant and instantaneous drop in blood flow in the intercostal arteries (% change; mean = -63.81; 95% CI, -72.28 to -55.34) and the thoracic spinal cord (% change; mean = -68.55; 95% CI, -80.23 to -56.87). Paralysis onset was immediate and of varying degree, with behavioral deficit stratified into three groups: 9.4% exhibited severe paralysis, 37.5% moderate paralysis, and 53.1% mild paralysis at day 1 (n = 32; P < 0.001). Mild and moderate paralysis was transient, gradually improving over time. Severe paralysis showed no improvement and exhibited a higher mortality rate (83%; n = 15 of 18) compared to moderately (33%; n = 6 of 18) and mildly (24%; n = 6 of 25) paralyzed mice (P < 0.001). The overall ligation group survival rate (84%; n = 46 of 55) was significantly lower than the sham group (100%; n = 48 of 48) with P = 0.003. CONCLUSIONS: The mouse model generates reproducible spinal cord hypoperfusion and accompanying histopathological ischemic spinal cord damage. The resulting anatomical changes and variable behavioral deficits mimic the variability in radiological and clinical findings in human patients.

Analysis of trends in perioperative outcomes in over 1000 robotic-assisted anatomic lung resections.

Robotic-assisted surgery is gaining popularity as a minimally invasive approach for anatomic lung resection. We investigated the temporal changes in case volume, costs, and postoperative outcomes for robotic-assisted anatomic lung resection in over 1000 cases. We reviewed our institutional STS database for patients who had undergone robotic-assisted lobectomy, bi-lobectomy, or segmentectomy as the primary procedure between years 2009-2021. The patients were divided into two groups: first 500 cases (n = 501) and second 500 cases (n = 500). Temporal trends of case volume, surgical indications, hospital length of stay, costs, and perioperative outcomes were analyzed. A total of 1001 patients were analyzed, of which 968 (96.7%) patients underwent robotic-assisted lobectomy, 21 (2.1%) patients underwent bi-lobectomy, 10 (1.0%) patients underwent segmentectomy, and 3 (0.3%) patients underwent sleeve lobectomy. Primary lung cancer was the most common indication (87.7%), followed by metastatic lung tumors (7.1%), and benign diagnosis (5.2%). The overall postoperative complication rate decreased from 46.1% for the first 500 cases compared to 29.6% for the second 500 cases (p < 0.0001). The median hospital length of stay was down trending, which was 4 days [IQR: 3-7] for the first 500 cases and 3 days [IQR: 3-5] (p = 0.0001) for the second. The inflation-adjusted direct and indirect hospital costs were significantly lower in the second 500 cases (p < 0.0001). The complications rates, hospital costs, and hospital length of stay for robotic-assisted anatomic pulmonary resection decreased significantly over time at a single institution. Continuous improvement in perioperative outcomes may be observed with increasing institutional experience.