Met Enrollment Criteria Research Articles

Survival After Extracorporeal Cardiopulmonary Resuscitation Based on In-Hospital Cardiac Arrest and Cannulation Location: An Analysis of the Extracorporeal Life Support Organization Registry.

Explore whether extracorporeal cardiopulmonary resuscitation (ECPR) mortality differs by in-hospital cardiac arrest location and whether moving patients for cannulation impacts outcome. Retrospective cohort study. ECPR hospitals that report data to the Extracorporeal Life Support Organization (ELSO). Patients having ECPR for in-hospital cardiac arrest between 2020 and 2023 with data in the ELSO registry. None. Patient demographics, comorbidities, pre-cardiac arrest conditions, pre-ECPR vasopressor use, cardiac arrest details, ECPR cannulation information, major complications, and in-hospital mortality were recorded. Multivariable logistic regression model was used to examine the associations between in-hospital mortality and 1) cardiac arrest location and 2) moving a patient for ECPR cannulation. A total of 2515 patients met enrollment criteria. The adjusted odds ratio (aOR) for mortality was increased in patients who had a cardiac arrest in the ICU (aOR, 1.85; 95% CI, 1.45-2.38; p < 0.001) and in patients who had a cardiac arrest in an acute care bed (aOR, 1.68; 95% CI, 1.09-2.58; p = 0.02) compared with the cardiac catheterization laboratory. Moving a patient for cannulation had no association with mortality (aOR, 0.70; 95% CI, 0.18-2.81; p = 0.62). Advanced patient age was associated with increased mortality. Specifically, patients 60-69 and patients 70 years old or older were more likely to die compared with patients younger than 30 years old (aOR, 1.71; 95% CI, 1.17-2.50; p = 0.006 and aOR, 2.27; 95% CI, 1.49-3.48; p < 0.001, respectively). ECPR patients who experienced cardiac arrest in the ICU and in acute care hospital beds had increased odds of mortality compared with other locations. Moving patients for ECPR cannulation was not associated with improved outcomes.

Asymptomatic carotid artery stenosis is associated with increased Alzheimer’s disease and non-Alzheimer’s disease dementia risk

BackgroundIn the absence of a cerebrovascular accident, whether asymptomatic extracranial carotid atherosclerotic disease (aECAD) affects Alzheimer’s disease (AD) and non-AD dementia risk is not clear. Understanding whether aECAD is associated...

Cross-prevalence of multiple sclerosis and stroke evaluated on cohorts of four independent specialty medical centers

BackgroundNumerous sources reported the increased risk of cerebrovascular accidents (CVA) in individuals with multiple sclerosis (MS), without a single study thus far challenging the conclusion. Before addressing hypothesis on potential cause-effect relationships, a question whether there are indeed frequent comorbidities between MS and CVA needed to be answered. MethodsAuthors designed a study to evaluate substantial populations of four independent neurology centers with the purpose to assess the prevalence of CVA diagnosis in patients with MS, and vice versa. Data of subjects meeting enrollment criteria were entered into a single database. Authors compared obtained data with the MS and CVA prevalences in the populations of specific countries. ResultsOf the 1881 subjects’ records, the main diagnosis was MS for 51.5% and CVA for 48.5%. The CVA prevalence as a secondary diagnosis among MS subjects was 1.47% in USA cohort and 1.65% in combined USA+ Russian Federation (RF) cohorts, which is lower than known prevalence of stroke in adult population of these regions. The prevalence of MS as a secondary diagnosis among subjects with stroke in USA cohort was 0.4% and in combined USA+RF cohorts was 0.33%, which is higher, but not statistically different from calculated MS prevalence in both USA and RF populations combined. ConclusionThus, authors found that prevalence of CVA in cohorts with MS of 2 independent centers was at least not higher, than that in general population, which differs from previously published data.

Identification of severely injured children at very low risk of emergent surgery: A national trauma registry study

ObjectiveThe number of pediatric trauma patients requiring surgical interventions has been steadily decreasing allowing for a judicious approach to immediately available resources. This study aimed to derive and validate a prediction rule that reliably identifies injured children who are at very low risk for requiring emergency surgery upon emergency department (ED) arrival. MethodsA retrospective cohort study of data included in the Israeli National Trauma Registry from January 1, 2011, through December 31, 2020, was conducted. We included children aged 0–14 years who presented to EDs from the scene of injury and were hospitalized. We excluded patients transferred between facilities or with isolated burns. The primary outcome was emergency operative intervention (EOI) performed within one hour of ED arrival. We tested mechanism, GCS, heart rate, and blood pressure as candidate predictors. We then randomized patients to two cohorts, derived and internally validated a prediction rule. ResultsDuring the study period, 83,859 children met enrollment criteria. The median age was 6 years (IQR 2–10) and 56,867 (67.8 %) were male; 75,450 (90.0 %) sustained blunt trauma. One hundred sixty-nine (0.20 %) children underwent EOI. In the derivation and validation cohorts, 34,138 (81.4 %) and 34,271 (81.7 %) patients, were classified as low risk based on blunt trauma mechanism, normal GCS (15), and low-risk heart rate (according to age). Of those, 8 (0.02 %) and 13 (0.04 %) required an EOI, respectively. In the validation cohort, the prediction rule for EOI had a sensitivity of 84 % (95 % CI 75–91), a specificity of 82 % (95 % CI 81–82), and a negative predictive value of 99.96 % (95 % CI 99.94–99.98). Among children with an Injury Severity Score>15, the sensitivity was 87 % (95 % CI 77–94), the specificity of 57 % (95 % CI 54–59), and the negative predictive value was 98.97 % (95 % CI 98.13–99.44). ConclusionsA limited set of physiologic parameters, readily available at hospital admission can effectively identify injured children at very low risk for emergent surgery. For these children, immediate deployment of surgical resources may not be necessary.

Rapid Development of a Registry to Accelerate COVID-19 Vaccine Clinical Trials.

The unprecedented scientific response to the SARS-Cov-2 pandemic in 2020 required the rapid development and activation of extensive clinical trial networks to study vaccines and therapeutics. The COVID-19 Prevention Network (CoVPN) coordinated hundreds of sites conducting phase 2 and 3 clinical trials of vaccines and antibody therapeutics. To facilitate these clinical trials, the CoVPN Volunteer Screening Registry (VSR) was created to collect volunteer information at scale, identify volunteers at risk of COVID-19 who met enrollment criteria, distribute candidates across clinical trial sites, and enable monitoring of volunteering and enrollment progress. We developed a secure database to support three primary web-based interfaces: a national volunteer questionnaire intake form, a clinical trial site portal, and an Administrative Portal. The Site Portal supported filters based on volunteer attributes, visual analytics, enrollment status tracking, geographic search, and clinical risk prediction. The Administrative Portal supported oversight and development with pre-specified reports aggregated by geography, trial, and trial site; charts of volunteer rates over time; volunteer risk score calculation; and dynamic, user-defined reports. Over 650,000 volunteers joined the VSR, and 1094 users were trained to utilize the system. The VSR played a key role in recruitment for the Moderna, Oxford-AstraZeneca, Janssen, and Novavax vaccine clinical trials, provided support to the Pfizer and Sanofi vaccine and prophylactic antibody clinical trials, and enhanced the diversity of trial participants. Clinical trial sites selected 166,729 volunteer records for follow-up screening, and of these 47·7% represented groups prioritized for increased enrollment. Despite the unprecedented urgency of its development, the system maintained 99·99% uptime. The success of the VSR demonstrates that information tools can be rapidly yet safely developed through a public-private partnership and integrated into a distributed and accelerated clinical trial setting. We further summarize the requirements, design, and development of the system, and discuss lessons learned for future pandemic preparedness.

Edoxaban for the treatment of hypercoagulability and cerebral thromboembolism associated with cancer: A randomized clinical trial of biomarker targets.

This study aimed compare efficacy of edoxaban and enoxaparin upon biomarkers of hypercoagulability in patients with cancer-related embolic stroke of undetermined source (ESUS). In this open-label, randomized, pilot trial, patients with cancer-related ESUS within 30 days of diagnosis were randomly assigned (1:1) to receive edoxaban (60 mg once daily) or enoxaparin (1 mg/kg twice daily) for 90 days. The primary endpoint was interval change of serum D-dimer level between days 0 and 7. The secondary endpoints were microembolic signals detected by transcranial Doppler at 7 and 90 days, the modified Rankin scale score, and stroke recurrence during 90 days. Safety outcomes included major bleeding and all-cause death at 90 days. Of 303 patients with ischemic stroke and cancer, 40 fully met enrollment criteria and were randomized. Baseline D-dimer levels were numerically higher in the edoxaban group (22.9 ± 15.9 μg/mL vs 16.9 ± 16.9 μg/mL). D-dimer level change (%) between days 0 and 7 was similar in the two groups (53.2 ± 25.7 vs 52.2 ± 52.0; P = 0.11). Microembolic signals were detected in 41.1% and 43.8% at baseline, 41.2% and 42.9% at day 7, and 25.0% and 28.6% at day 90 in the edoxaban and enoxaparin groups, respectively. Non-significantly higher major bleeding (35.0% vs 10.0%, P = 0.06) and 90-day mortality (40.0% vs 25.0%, P = 0.31) were noted in the edoxaban group. Edoxaban and enoxaparin were comparable with respect to the biomarkers of hypercoagulability and cerebral thromboembolism. Larger trials are warranted to compare effects of edoxaban and enoxaparin upon recurrent stroke and major bleeding in patients with cancer-related ESUS. clinicaltrials.gov Identifier: NCT03570281 (https://clinicaltrials.gov/ct2/show/NCT03570281).

Mental Health Assessments in Emergency Department Patients: Assessing Longitudinal Follow-up and Retest Reliability (MCAT-2) [Provisional Baseline Analysis

Background/Objective:The prevalence of anxiety and depression in adults in the United States is high with many experiencing ≥1 episode of anxiety or depression over a given year. Despite this, diagnoses of anxiety and depression in patients presenting to the ED for somatic complaints are seldom, relative to the population prevalence. Current fixed-item anxiety and depression screening tools have variable specificity and sensitivity, but adaptive screening tools such as the Computerized Adaptive Testing-Mental Health tool (CAT-MH) are thought to provide improved diagnostic characteristics and precision over fixed item tools. Our objective is to establish the reliability ofits depression and anxiety severity assessments in patients initially screened in an ED setting and reassessed over 30 days.&#x0D; Methods:We are conducting a longitudinal observational study among adult ED patients presenting with somatic, non-mental health complaints. The CAT-MH, Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-8 (PHQ-8), are administered to randomly selected patients meeting enrollment criteria after informed consent. Participants are reassessed at 1-, 2-, and 4 weeks after ED discharge and analyzed for longitudinal test-retest reliability and sensitivity to change in score severity over time.&#x0D; Results:In this ongoing study, we present baseline anxiety and depression severity assessments for the first 49 enrolled patients (Mean age of 37, 73% female, 49% white, 47% black). Fixed item tools (GAD-7 and PHQ-8) categorized 16% and 6% of patients as moderate and severe anxiety respectively vs 19% and 15% as moderate, and moderately-severe/severe depression. In comparison, CAT-MH categorized 8% and 10% as moderate and severe anxiety.10% and 6% were categorized as moderate and severe depression.&#x0D; Conclusion:In this longitudinal observational study, we present baseline data for the first 49 out of 100 planned patients. Upon completion of the study, we hope to find that the severity assessments from CAT-MH remain stable over 30 days.

Treponema pallidum genetic diversity and its implications for targeted vaccine development: A cross-sectional study of early syphilis cases in Southwestern Colombia.

Venereal syphilis, caused by the spirochete Treponema pallidum subsp. pallidum (TPA), is surging worldwide, underscoring the need for a vaccine with global efficacy. Vaccine development requires an understanding of syphilis epidemiology and clinical presentation as well as genomic characterization of TPA strains circulating within at-risk populations. The aim of this study was to describe the clinical, demographic, and molecular features of early syphilis cases in Cali, Colombia. We conducted a cross-sectional study to identify individuals with early syphilis (ES) in Cali, Colombia through a city-wide network of public health centers, private sector HIV clinics and laboratory databases from public health institutions. Whole blood (WB), skin biopsies (SB), and genital and oral lesion swabs were obtained for measurement of treponemal burdens by polA quantitative polymerase chain reaction (qPCR) and for whole-genome sequencing (WGS). Among 1,966 individuals screened, 128 participants met enrollment criteria: 112 (87%) with secondary (SS), 15 (12%) with primary (PS) and one with early latent syphilis; 66/128 (52%) self-reported as heterosexual, while 48 (38%) were men who have sex with men (MSM). Genital ulcer swabs had the highest polA copy numbers (67 copies/μl) by qPCR with a positivity rate (PR) of 73%, while SS lesions had 42 polA copies/μl with PR of 62%. WB polA positivity was more frequent in SS than PS (42% vs 7%, respectively; p = 0.009). Isolation of TPA from WB by rabbit infectivity testing (RIT) was achieved in 5 (56%) of 9 ES WB samples tested. WGS from 33 Cali patient samples, along with 10 other genomic sequences from South America (9 from Peru, 1 from Argentina) used as comparators, confirmed that SS14 was the predominant clade, and that half of all samples had mutations associated with macrolide (i.e., azithromycin) resistance. Variability in the outer membrane protein (OMP) and vaccine candidate BamA (TP0326) was mapped onto the protein's predicted structure from AlphaFold. Despite the presence of mutations in several extracellular loops (ECLs), ECL4, an immunodominant loop and proven opsonic target, was highly conserved in this group of Colombian and South American TPA isolates. This study offers new insights into the sociodemographic and clinical features of venereal syphilis in a highly endemic area of Colombia and illustrates how genomic sequencing of regionally prevalent TPA strains can inform vaccine development.

A multicenter evaluation of the HeartMate 3 risk score

BackgroundThe Heartmate 3 (HM3) risk score (HM3RS) was derived and validated internally from within the MOMENTUM 3 trial population and provides 1- and 2-year mortality risk prediction for patients in those prior to HM3 left ventricular assist device (LVAD) implantation. We aimed to evaluate the HM3RS in non-trial unselected patients, including those not meeting inclusion criteria for MOMENTUM 3 trial enrollment. MethodsPatients who underwent HM3 LVAD implant at one of 7 US centers between 2017-2021, with at least 1 year follow up, were included in this analysis. Patients were retrospectively assessed for their eligibility for the MOMENTUM 3 trial based on study inclusion and exclusion criteria. HM3RS risk discrimination was evaluated using time-dependent receiver operating characteristic (ROC) curve analysis for 1-year mortality for all patients, and further stratified by MOMENTUM 3 trial eligibility. Kaplan Meier curves were constructed using the HM3RS-based risk categories. ResultsOf 521 patients included in the analysis, 266 (51.1%) would have met enrollment criteria for MOMENTUM 3. The 1- and 2-year survival for the total cohort was 85% and 81%, respectively. There was no statistically significant difference in survival between those who met and did not meet enrollment criteria at 1 (87% vs 83%; P=0.21) and 2 years post-implant (80% vs 78%; P=0.39). For the total cohort, HM3RS predicted 1-year survival with an AUC of 0.63 (95% CI: 0.57-0.69, P<0.001). HM3RS performed better in the subset of patients meeting enrollment criteria: AUC 0.69 (95% CI:0.61-0.77, P<0.001) compared to the subset that did not: AUC 0.58 (95% CI: 0.49-0.66, P= 0.078). ConclusionIn this real-world evidence, multi-center cohort, 1- and 2-year survival after commercial HM3 LVAD implant was excellent, regardless of trial eligibility. The HM3RS provided adequate risk discrimination in “trial-like” patients, but predictive value was reduced in patients who did not meet trial criteria.

Utilization, Steering, and Spending in Vertical Relationships Between Physicians and Health Systems

Vertical relationships (eg, ownership or affiliations, including joint contracting) between physicians and health systems are increasing in the US. To analyze how vertical relationships between primary care physicians (PCPs) and large health systems are associated with changes in ambulatory and acute care utilization, referral patterns, readmissions, and total medical spending for commercially insured individuals. This case-control study with a repeated cross-section, stacked event design analyzed outcomes of patients whose attributed PCP entered a vertical relationship with a large health care system in 2015 or 2017 compared with patients whose attributed PCP was either never or always in a vertical relationship with a large health system from 2013 to 2017 in the state of Massachusetts. The sample consisted of commercially insured patients who met enrollment criteria and who were attributed to PCPs who were included in the Massachusetts Provider Database in 2013, 2015, and 2017 and for whom vertical relationships were measured. Enrollee and claims data were obtained from the 2013 to 2017 Massachusetts All-Payer Claims Database. Statistical analyses were conducted between January 5, 2021, and June 5, 2023. Evaluation-and-management visit with attributed PCP in 2015 to 2017. Outcomes (which were measured per patient-year [ie, per patient per year from January to December] in this sample) were utilization (count of specialist physician visits, emergency department [ED] visits, and hospitalizations overall and within attributed PCP's health system), spending (total medical expenditures and use of high-price hospitals), and readmissions (readmission rate and use of hospitals with a low readmission rate). The sample of 4 030 224 observations included 2 147 303 females (53.3%) and 1 881 921 males (46.7%) with a mean (SD) age of 35.07 (19.95) years. Vertical relationships between PCPs and large health systems were associated with an increase of 0.69 (95% CI, 0.34-1.04; P < .001) in specialist visits per patient-year, a 22.64% increase vs the comparison group mean of 3.06 visits, and a $356.67 (95% CI, $77.16-$636.18; P = .01) increase in total medical expenditures per patient-year, a 6.26% increase vs the comparison group mean of $5700.07. Within the health care system of the attributed PCPs, the number of specialist visits changed by 0.80 (95% CI, 0.56-1.05) per patient year (P < .001), a 29.38% increase vs the comparison group mean of 2.73 specialist visits per patient-year. The number of ED visits changed by 0.02 (95% CI, 0.01-0.03) per patient year (P = .001), a 14.19% increase over the comparison group mean of 0.15 ED visits per patient-year. The number of hospitalizations changed by 0.01 (95% CI, 0.00-0.01) per patient-year (P < .001), a 22.36% increase over the comparison group mean of 0.03 hospitalizations per patient-year. There were no differences in readmission outcomes. Results of this case-control study suggest that vertical relationships between PCPs and large health systems were associated with steering of patients into health systems and increased spending on patient care, but no difference in readmissions was found.

Clinical spectrum and genetic causes of mitochondrial hepatopathy phenotype in children.

Alterations in both mitochondrial DNA (mtDNA) and nuclear DNA genes affect mitochondria function, causing a range of liver-based conditions termed mitochondrial hepatopathies (MH), which are subcategorized as mtDNA depletion, RNA translation, mtDNA deletion, and enzymatic disorders. We aim to enhance the understanding of pathogenesis and natural history of MH. We analyzed data from patients with MH phenotypes to identify genetic causes, characterize the spectrum of clinical presentation, and determine outcomes. Three enrollment phenotypes, that is, acute liver failure (ALF, n = 37), chronic liver disease (Chronic, n = 40), and post-liver transplant (n = 9), were analyzed. Patients with ALF were younger [median 0.8 y (range, 0.0, 9.4) vs 3.4 y (0.2, 18.6), p < 0.001] with fewer neurodevelopmental delays (40.0% vs 81.3%, p < 0.001) versus Chronic. Comprehensive testing was performed more often in Chronic than ALF (90.0% vs 43.2%); however, etiology was identified more often in ALF (81.3% vs 61.1%) with mtDNA depletion being most common (ALF: 77% vs Chronic: 41%). Of the sequenced cohort (n = 60), 63% had an identified mitochondrial disorder. Cluster analysis identified a subset without an underlying genetic etiology, despite comprehensive testing. Liver transplant-free survival was 40% at 2 years (ALF vs Chronic, 16% vs 65%, p < 0.001). Eighteen (21%) underwent transplantation. With 33 patient-years of follow-up after the transplant, 3 deaths were reported. Differences between ALF and Chronic MH phenotypes included age at diagnosis, systemic involvement, transplant-free survival, and genetic etiology, underscoring the need for ultra-rapid sequencing in the appropriate clinical setting. Cluster analysis revealed a group meeting enrollment criteria but without an identified genetic or enzymatic diagnosis, highlighting the need to identify other etiologies.

Preoperative Corticosteroid Injections Are Not Associated with Deep Infection after Unicompartmental Knee Arthroplasty.

Prior to unicompartmental knee arthroplasty (UKA), corticosteroid injections (CSI) are a common nonoperative treatment for arthritis. It is unclear whether CSI prior to UKA impacts the likelihood of postoperative infection. This study sought to determine if there is a time- and/or dose-dependent relationship between preoperative CSI and postoperative infection. An administrative claims database was queried for patients undergoing UKA with more than 1 year of pre-enrollment and follow-up. Of 31,676 patients with a UKA who met enrollment criteria, 8,628 patients had a CSI 0 to 3 months prior to surgery, 111 had a CSI 3 to 12 months prior to surgery, and 22,937 never received an injection. Overall, 246 postoperative deep infections were reported (0.8%). Time-dependent and dose-dependent relationships were modeled using multivariable logistic regressions. Postoperative deep infections occurred in 64 patients with CSI 0 to 3 months prior to surgery (0.7%), compared with 0 patients with CSI 3 to 12 months before surgery (0.0%) and 182 controls (0.8%, p = 0.58). CSI within 1 month prior to UKA was not statistically associated with postoperative infection (p = 0.66). Two or more CSI within 3 months prior to UKA were associated with a twofold elevated odds of infection, compared with receiving a single injection (odds ratio [OR]: 2.08, p = 0.03). Univariable predictors of infection included younger age, increasing Charlson Comorbidity Index, smoking, asthma, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, liver disease, and obesity. Multivariable analysis controlling for these characteristics elicited no relationship between recent CSI administration and postoperative infection. CSI within 3 months of surgery (1.5%) or 3 to 12 months (1.8%) were associated with increased conversion to total knee arthroplasty (TKA) compared with those who did not receive an injection (1.1%, p = 0.01), although TKA for indication of periprosthetic joint infection was not statistically different (p = 0.72). Preoperative CSI within 3 months of UKA is not associated with postoperative infection, although significant medical comorbidity does show an association. Preoperative CSI is associated with increased conversion from UKA to TKA for noninfectious indications.

311 A Feasibility Study for a Multicenter Phase-III Randomized Clinical Trial of Encephaloduroarteriosynagiosis Revascularization for Symptomatic Intracranial Atherosclerosis

INTRODUCTION: Stroke due to intracranial-atherosclerotic-disease (ICAD) remains a major public health concern, accounting for more than one-tenth of all ischemic-strokes in the US. METHODS: New data from advanced cerebral imaging and angiographic studies showed that revascularization after indirect-bypass occurs earlier than appreciated before. A pilot study of EDAS in ICAD patients demonstrated angiographic neovascularization as early as 1 month. An NINDS-funded phase-II objective-performance-criterion trial demonstrated reduction in the rate of stroke and death from 21.1% in the medical group to 9.6% in the surgical group at 2 years, passing the threshold for advancement to phase III. In collaboration with the NIH-StrokeNet, a national feasibility survey was sent to sites across the country to evaluate the feasibility of a phase-III clinical trial of EDAS in ICAD. RESULTS: Among 72 surveys completed by prospective sites, 90% (n = 65) indicated interest in participating and 96% of these (n = 63) had neurosurgeons and anesthesiologists with sufficient experience in EDAS and cerebrovascular disorders. The mean number of direct/indirect cerebral bypass surgeries per year completed at the prospective 40 sites was 19 (Range = 10-37). StrokeNet sites cared for a median of 42.5 patients/site/year (IQR = 25-100 patients/site/year) who met enrollment criteria. With 40 participating sites, the rate of enrollment needed for successful recruitment of 516 patients in a phase-III trial is 0.28 patients/site/month (3-4 patients/year), which is an order of magnitude less than the number of relevant cases receiving care at the sites (3.54 patients/month). CONCLUSIONS: EDAS is a promising technique in the management of ICAD and its performance is feasible within 40 high volume institutions. Engagement of the neurosurgical community on revitalizing a surgical form of revascularization can expand the role of neurosurgery in stroke management.

Ondansetron Safety Regarding Prolong QTc for Children with Head Trauma

BackgroundThere have been recent reports of increased QT interval after head trauma in concussed athletes and adult patients. Ondansetron, which is widely used in treatment of nausea and vomiting symptoms in head injuries, was issued a safety warning from the U.S. Food and Drug Administration regarding QT prolongation and risk of fatal dysrhythmias. ObjectiveThe purpose of this study was to evaluate the safety of ondansetron regarding QT prolongation for patients experiencing nausea or vomiting after head trauma. MethodsPatients aged 1–20 years presenting to a pediatric emergency department with head trauma and who required a dose of ondansetron for nausea or vomiting were enrolled in the study. Patients received a baseline 12-lead electrocardiogram (ECG) prior to administration of either oral or IV ondansetron. A second post-ondansetron 12-lead ECG was performed after administration of ondansetron. All ECGs were reviewed and the QTc calculated manually by a board-certified pediatric cardiologist. ResultsForty-two patients met enrollment criteria. Five patients received IV ondansetron and 37 received oral ondansetron. Mean QTc pre ondansetron was 387.5 ms and mean QTc post ondansetron was 400.9 ms (p = 0.120). We found no statistically significant difference in other ECG parameters pre and post ondansetron. ConclusionsOndansetron is safe in regard to QTc prolongation in patients with head trauma. Based on this research, ondansetron should continue to be used for the treatment of nausea and vomiting in emergency department patients who present with head injury.

Abstract P4-07-47: Real-world practice patterns in the management of metastatic breast cancer in Washington State

Abstract Background: Evidence-based recommendations for the management of metastatic breast cancer (MBC) endorse confirmation of recurrence with biopsy and reassessment of biomarker status. National guidelines support numerous treatment options and do not capture the nuances of real-world practice. Real world data may demonstrate disparities in adherence to guidelines. Methods: We collaborated with Hutchinson Institute for Cancer Outcomes Research (HICOR) to link enrollment and insurance claims records with Washington State cancer registries from 2008-2017. Our cohort comprised of women &amp;gt; 18 years old with MBC who met enrollment criteria in one of four payors (Premara, Regence, Medicare, or Medicaid). We identified receipt of biopsy and biomarker re-assessment at time of recurrence, receipt of first line treatment, categorized as CDK4/6 inhibitors (CDKi), chemotherapy (CT), or hormone therapy (HT) and examined factors influencing these practice patterns. Results: We identified 1,101 patients with MBC (recurrent MBC, N = 715; de novo MBC, N = 386) with a median age of 66 (range 54 – 74). Of the patients with MBC, there were a total of 677 patients with ER+/HER2- MBC. Table 1 shows demographic data. Most of the cohort were White (89%). Approximately 15% of patients lived in areas of high deprivation (area of deprivation index, ADI, 8-10). Patients had either Commercial (47%), Medicaid (4%), Medicare (35%) or multiple (13%) insurance. Of the patients with recurrent MBC, 49.5% received a biopsy to confirm metastatic diagnosis. Similarly, 48.7% of recurrent MBC patients underwent biomarker reassessment. Patients with highest co-morbidity index (2) were more likely to undergo biopsy confirmation (20.3% vs 13.0%, p = 0.02). Biopsy was more often performed at recurrence in patients receiving care at a high-volume center (74.3% vs 67.6%, p = 0.03) compared to low volume center (18.6% vs 26.6%, p = 0.03). First line treatment selection was directly associated with receipt of biopsy and biomarker testing. Hormone therapy only was more common in patients who did not undergo biopsy (62.3% vs 37.7%, p &amp;lt; 0.001) or biomarker reassessment (62.7% vs 37.3%, p &amp;lt; 0.001). Of the patients with ER+/HER2- MBC, the majority of patients received ET alone (69%), followed by chemotherapy (22%), and CDK4/6i + ET (9%). Dual agent CT was the more commonly prescribed compared to single agent in those who received CT (56% vs 44%). The majority of patients who received CDKi + ET were &amp;lt; 65 years old (65.2%, p &amp;lt; 0.02). Insurance influenced first line therapy selection and patients with commercial insurance were more likely to receive CDK4/6i + ET compared to those with Medicare/Medicaid. (60.9% vs 26.1%, p = 0.10). Patients with de novo MBC were more likely to receive CT (43.1% vs 13.4%, p &amp;lt; 0.001) and less likely to receive ET alone (47.9% vs 78.0%, p &amp;lt; 0.001). Almost all patients treated with CDK4/6i + ET received care a high-volume center (91.3%, p = 0.11). Conclusion:Our findings highlight key gaps for future investigations in the management of MBC and serve as a launching point for new patient-centered and quality-promoting research initiatives. Table 1: Baseline Demographics 1# of patients treated annually, high = &amp;gt;100, medium 25-100, low &amp;lt;25. Citation Format: Poorni Manohar, Hannah Linden, Veena Shankaran, Catherine Fedorenko, Jenna Voutsinas, Qin Sun, Vicky Wu. Real-world practice patterns in the management of metastatic breast cancer in Washington State [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-47.

Financial toxicity in BRCA1 and BRCA2 carriers

ObjectiveFinancial toxicity (FT), the cumulative financial burden experienced due to medical care, is a well-established adverse effect of healthcare. Patients with BRCA mutations have significantly increased cancer risks compared to non-affected individuals, requiring more frequent screenings and, at times, prophylactic surgery, increasing their risk for FT. Our primary aim in this study was to describe rates of FT among BRCA carriers. MethodsWe performed a novel, cross-sectional study of FT in BRCA1/2 carriers. Participants were recruited via phone and/or email to complete consents and surveys on REDCap. The FACIT-COST tool, a validated tool for measuring FT, was used to assess FT; scores were divided into tertiles, with high FT defined as COST score < 24. Results265 BRCA positive female participants met enrollment criteria; 76 (28.7%) consented to participate and completed the survey. Participants were primarily non-Hispanic White (97.4%), privately insured (82.9%), and employed full time (67.1%). A significant proportion (22.7%) of participants reported delaying or avoiding care secondary to finances. No statistically significant association was seen between financial toxicity groups and analyzed demographics. Participants with high FT were more likely to engage in all surveyed cost-saving measures, with 41.7% of participants reporting delays/avoidance of care due to cost (p = 0.02). ConclusionsThis study of FT in BRCA carriers shows that financial toxicity exists as an issue in this high-risk patient population. This work serves as the first description of FT in BRCA mutation carriers and highlights the importance of incorporating routine counseling on cost when discussing recommendations for screening and clinical care with this patient population.

Outcomes of Functional Testing Versus Invasive Cardiac Catheterization for the Evaluation of Intermediate Severity Coronary Stenosis Detected on Cardiac Computed Tomography Angiography.

The aim of this study was to evaluate the effectiveness of functional testing in comparison to invasive coronary angiography (ICA) among acute chest pain patients whose first diagnostic modality was a coronary computed tomography angiogram (CCTA) and were found to have intermediate coronary stenosis, defined as 50%-70% luminal stenosis. We conducted a retrospective review of 4763 acute chest pain patients ≥18 years old who received a CCTA as the initial diagnostic modality. Of these, 118 patients met enrollment criteria and proceeded to either stress test (80/118) or directly to ICA (38/118). The primary outcome was 30-day major adverse cardiac event, consisting of acute myocardial infarction, urgent revascularization, or death. There was no difference in 30-day major adverse cardiac event among patients who underwent initial stress testing versus directly referred to ICA (0% vs. 2.6%, P = 0.322) following CCTA. The rate of revascularization without acute myocardial infarction was significantly higher among those who underwent ICA versus stress test [36.8% vs. 3.8%, P < 0.0001; adjusted odds ratio: 9.6, 95% confidence interval, 1.8-49.6]. Patients who underwent ICA had a higher rate of catheterization without revascularization within 30 days of the index admission in comparison to those who underwent initial stress testing (55.3% vs. 12.5%, P < 0.0001; adjusted odds ratio: 26.7, 95% confidence interval, 6.6-109.5). Among patients with intermediate coronary stenosis on CCTA, a functional stress test compared with ICA may prevent unnecessary revascularization and improve cardiac catheterization yield without negatively affecting the 30-day patient safety profile.

Preferred cost communicator in BRCA mutation carriers (483)

<b>Objectives:</b> Prior research has established Financial Toxicity (FT), the cumulative financial burden experienced by patients due to medical care, as a significant adverse outcome of medical treatment. As a result, professional medical societies have encouraged physicians to discuss FT with their patients, but data on patient preference surrounding these conversations are limited. Assessment of FT in <i>BRCA</i> mutation carriers has been largely unstudied. This analysis represents nascent research on FT in this high-risk patient population and examines preferences of <i>BRCA</i> mutation carriers related to their costs of care, including preferred cost communicator (the person with whom they would most prefer to discuss the costs of their medical treatment). <b>Methods:</b> This abstract represents a subanalysis of our novel, crosssectional study of FT in patients with <i>BRCA1/2</i> mutations. <i>BRCA+</i> patients were recruited via phone and/or email; patients who agreed to participate completed consents and surveys on RedCap. The COST tool, a validated measure, was used for the assessment of FT. COST scores were divided into tertiles, with high FT defined as COST score < 24. Cost communication preferences, demographics, and medical history were also assessed. <b>Results:</b> A total of 76 <i>BRCA</i> positive female patients who met enrollment criteria had responded at the time of this analysis. Most patients (58.9%) responded that they would like to know the out- of-pocket (OOP) costs of their treatment before receiving it. When surveyed regarding preferred cost communicator, most patients (32.8%) preferred to speak with a financial counselor, with 27.6% preferring a physician. When dividing patients into high FT <i>(n</i> = 23) and low/medium FT groups (<i>n</i> = 39), no differences were seen in desire to know OOP costs beforehand (60.9% vs 59%, <i>p</i> = 0.61). Preferred cost-communicator did not differ statistically amongst high and low/medium FT groups (<i>p</i> = 0.16). However, a trend was seen where patients with high FT were more likely to want to speak with a physician about the cost of care (31.8% vs 30.8%). In contrast, patients with low FT were more likely than their high FT counterparts to want to speak to a financial counselor (35.9% vs 27.3%) or social worker (20.5% vs 9.1%) about their costs of care. <b>Conclusions:</b> This is the first study of <i>BRCA+</i> patients' cost communication preferences. As previously reported, financial toxicity exists in this high-risk patient population, and there is a strong patient desire to better understand their own OOP costs. Patients' preferences for discussing care with financial counselors, regardless of their FT severity, indicate that multidisciplinary teams may be beneficial for addressing questions about the costs of care. Additional research with larger patient populations is needed to better understand preferred cost communicator trends seen amongst FT groups, with low/ mid FT groups seeming to prefer discussion about costs with nonpractitioners and high FT patients preferring physician counseling.

A Cost, Time, and Demographic Analysis of Participant Recruitment and Urine Sample Collection Through Social Media Optimization.

Clinical research can be expensive and time consuming due to high associated costs and/or duration of the study. We hypothesized that urine sample collection using online recruitment and engagement of research participants via social medial has the potential to reach a large population in a small timeframe, at a reasonable cost. We performed a retrospective cost analysis of a cohort study comparing cost per sample and time per sample for both online and clinically recruited participants for urine sample collection. During this time, cost data were collected based on study associated costs from invoices and budget spreadsheets. The data were subsequently analyzed using descriptive statistics. Each sample collection kit contained 3 urine cups, 1 for the disease sample and 2 for control samples. Out of the 3,576 (1,192 disease + 2,384 control) total sample cups mailed, 1,254 (695 control) samples were returned. Comparatively, the 2 clinical sites collected 305 samples. Although the initial startup cost of online recruitment was higher, cost per sample for online recruited was found to be $81.45 compared to $398.14 for clinic sample. We conducted a nationwide, contactless, urine sample collection through online recruitment in the midst of the COVID-19 pandemic. Results were compared with the samples collected in the clinical setting. Online recruitment can be utilized to collect urine samples rapidly, efficiently, and at a cost per sample that was 20% of an in-person clinic, and without risk of COVID-19 exposure.

Poster 180: Diagnostic Algorithm and Outcomes of Treatment for Neurogenic Pectoralis Minor Syndrome

Objectives:Neurogenic pectoralis minor syndrome can generate chronic anterior shoulder pain and a variety of non – specific neurologic symptoms in an affected upper extremity. This study presents a diagnostic algorithm used to identify neurogenic pectoralis minor syndrome and reports short-term outcomes for a series of patients who underwent either open or arthroscopic, coracoid – based, pectoralis minor tenotomy to treat the condition.Methods:Following IRB approval, the senior investigator’s operative records were queried for pectoralis minor release performed between January 2012 and July 2021. Demographic, surgical, and outcomes data was extracted from each subject’s medical record. Only subjects with a minimum of 30-day follow-up were considered in data analysis. Generalized descriptive statistical analysis, along with ANOVAs and post-hoc t-tests were performed to compare outcomes of pectoralis minor release.Results:Twenty-one subjects were identified meeting enrollment criteria. Mean age at time of diagnosis was 44.3years (range 17-70 years). Subjects had undergone prior shoulder surgery in 16/21 (76.2%) of cases and 18 (85.7%) were Worker’s Compensation related injuries. All patients had undergone a minimum of 3 months of a structured physical therapy program preoperatively. All patients underwent a diagnostic, ultrasound – guided pectoralis minor block with temporary resolution of self – reported symptoms. Symptoms prior to treatment included anterior shoulder pain and neurologic symptoms in 20/21 (95.2%) cases, with a mean duration of 15.7 months (range 3-40 months). Pretreatment ASES score was mean 41.5 (range 13.3-73.3) with mean pain of 4.9/10 (range 1-9/10). At mean 6.8 months post-release, patients reported mean 9.5 point increase in ASES score versus index score (p<0.05) and 85.0% (17/20 with pre-operative neurologic symptoms) reported complete resolution or improvement of neurologic symptoms related to neurogenic pectoralis minor syndrome.Conclusions:Findings of insertional pectoralis minor tenderness to palpation with or without reproduction of neurologic symptoms, a positive diagnostic, ultrasound – guided pectoralis minor block and anterior shoulder pain can be useful findings to establish the difficult diagnosis of neurogenic pectoralis minor syndrome. In select patients either open or arthroscopic release of the pectoralis minor insertion on the medial aspect of the coracoid process can alleviate symptoms.