Total Enrollment Research Articles

Alliance A021806: A phase III trial evaluating perioperative versus adjuvant therapy for resectable pancreatic cancer.

TPS4204 Background: The role of neoadjuvant chemotherapy in resectable pancreatic cancer has yet to be defined. Recent phase II trial results demonstrate a median overall survival time (mOS) of only 22.4 months after treatment with perioperative modified FOLFIRINOX (mFOLFIRINOX) with 36% not reaching surgery due to disease progression during neoadjuvant therapy. While potential benefits and shortcomings of neoadjuvant chemotherapy have been well documented, to date, no phase III trial has directly compared a perioperative versus an adjuvant chemotherapy strategy in resectable pancreatic cancer. Alliance for Clinical Trials in Oncology A021806 is an actively accruing randomized controlled phase III trial evaluating the efficacy of perioperative chemotherapy with mFOLFIRINOX in patients with resectable pancreatic cancer. Methods: To qualify for enrollment, patients must have biopsy-proven localized resectable pancreatic adenocarcinoma as defined by the National Comprehensive Cancer Network. Patients must have good performance status (ECOG 0 or 1) and be candidates to receive mFOLFIRINOX treatment. All patients enrolled undergo central radiologic eligibility review for quality control and are then randomized to either Arm 1 which consists of 8 cycles of neoadjuvant mFOLFIRINOX followed by 4 cycles of adjuvant mFOLFIRINOX or Arm 2 which includes upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX. The primary endpoint of the trial is overall survival with secondary endpoints evaluating disease-free survival, margin-negative resection rate, surgical complications, and chemotherapeutic adverse events. Additional correlative endpoints include quality of life and radiomic imaging assessments. A total enrollment of 352 patients is planned from the US and Canada; current enrollment for this trial is at 145 patients. An OS interim analysis will be performed when 50% of the events (124) are observed combining the two arms. If the trial continues after interim analysis, the final OS analysis will be performed with a total of 248 events (combined arms). If the Cox model (stratified by tumor location and ECOG PS) comparing OS between arms produces a one-sided p-value < 0.05, then we will conclude that the OS of the perioperative therapy arm is superior to adjuvant therapy. The Alliance A021806 phase III trial aims to define a new standard of care for patients with resectable pancreatic cancer. Clinical trial information: NCT04340141 .

Evaluation of ICI sensitivity for pembrolizumab in combination with anti-platelet therapy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC).

6041 Background: This study was proposed to elucidate the impact of combining anti-platelet therapy with an immune checkpoint inhibitor (ICI) in altering the CD8+ T cell function in patients with head and neck squamous cell carcinoma (HNSCC). With a total enrollment of 15 of out an expected 20 patients, this report characterizes the findings thus far from the ongoing study. Methods: This crossover trial consisted of two different treatment regimens for two groups. Regimen A involved treatment with a PD-1 inhibitor pembrolizumab (200 mg iv over 30 min) every 3 weeks in combination of daily aspirin (81 mg orally) and clopidogrel (75 mg orally) for a total of 6 weeks. Regimen B involved pembrolizumab monotherapy (200 mg iv over 30 min) every 3 weeks for two cycles. Thus far, 15 patients with recurrent or metastatic HNSCC were randomized into the two groups, with Group 1 receiving Regimen A followed by Regimen B, while Group 2 received Regimen B followed by Regimen A. In addition to clinical endpoint, in depth analysis of the peripheral blood mononuclear cells (PBMCs) was also implemented using samples obtained prior to treatment, in between regimens, and at the end of treatment. These samples were then analyzed using a spectral flow cytometer panel specific for human CD8+ T cells. Given the 75 percent accrual, we performed analysis with the obtained clinical samples and data. Results: Of the 15 patients enrolled into the study, 14 remained on study and completed the trial till endpoint. All 14 patients presented with no overtly significant adverse events (AEs). In terms of clinical response, we observed in Group 1 patients (n=7) a total of 1 CR (complete response), 1 PR (partial response), 2 SD (stable disease), and 3 PD (progressive disease), while Group 2 (n=7) presented with 2 PR, 2 SD, and 3 PD. Spectral flow analysis performed on Group 1 patient samples revealed an increase in the Ki67+PD1+ proliferative subset post combination treatment (p value < 0.05, paired Student’s t-test). This finding indicates a potential increase in proliferation among CD8+ T cells after antigen stimulation that may pertain to the combination of anti-PD-1 and anti-platelet therapy. In addition, a higher frequency of Ki67+TIGIT+ CD8+ population (p value < 0.05, paired Student’s t-test) was also observed after combination therapy compared to pre-treatment; however, this level was not sustained after combination therapy was ceased, implying that ongoing anti-platelet therapy may be necessary for augmenting ICI. Conclusions: Combination of anti-PD1 and anti-platelet therapy demonstrates potential for remodeling the immune compartment pertaining to CD8+ T cells without resulting in overt toxicity. Further analysis of the effects of this combination regimen will be essential to better characterize tumor specific impact. Clinical trial information: NCT03245489 .

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Introduction: Mosunetuzumab (mosun) is a CD3:CD20 bispecific antibody that has been FDA-approved for relapsed/refractory follicular lymphoma after two prior lines of therapy. We hypothesized that mosun would be even more active in patients (pts) without prior lymphotoxic therapy. Therefore, we designed a response adapted study for pts with untreated follicular lymphoma (FL) and marginal zone lymphoma (MZL). Methods: This is a single center, open label, investigator initiated clinical trial in untreated pts with FL or MZL with indication for treatment. Pts received subcutaneous mosunetuzumab monotherapy for 8 cycles (21 day cycle, Part A) employing step up dosing in cycle 1 (5 mg, 45 mg, 45 mg). A PET/CT was performed after 8 cycles, and pts in CR were observed without further treatment. Pts with SD or PR could receive 6 cycles (21 day cycle, Part B) of polatuzumab vedotin and obinutuzumab, followed by an end of treatment (EOT) PET/CT. Total planned accrual is 42 pts. The primary endpoint is complete response (CR) rate. A pre-planned interim efficacy analysis is being performed after 20 enrolled pts. If 14 or fewer of the first 20 subjects do not achieve an objective response, the study will be suspended to enrollment. Results: 20 pts enrolled on study between March 24, 2022, and March 11, 2023, and as of the submission date 17 pts are evaluable for safety, and 15 pts are evaluable for efficacy. Patient characteristics are listed in the table. All treatment was delivered as an outpatient. Two pts experienced SAEs (one pt with G3 lung infection followed by G3 shingles, and one pt observed overnight with G1 cytokine release syndrome (CRS). The only other G3 AE observed was diarrhea (1, 6%). Seven (41%) pts experience G1 CRS, with no G2 or higher CRS observed or any grade ICANS observed. No pts required tocilizumab. All CRS events occurred during cycle 1. No heme toxicity greater than Grade 1 was observed (neutropenia 12%, anemia 6%, thrombocytopenia 59%). Three (18%) pts experienced a treatment delay due to G2 hyperglycemia, G2 upper respiratory infection, and G3 pneumonia. No dose modifications were required and all pts have received expected doses of mosun. Nearly all pts (94%) experienced at least one injection site reaction, which were all G1. Since 14/15 (93%) pts so far have achieved an objective response at any time point meeting the interim efficacy threshold, the study is proceeding with total enrollment of up to 42 pts. Among patients who have received all 8 cycles of mosun, 9/11 (82%) have achieved a CR. All pts remain alive and progression-free. Updated data will be presented at the meeting. Conclusion: Mosun is safe and highly active in untreated pts with follicular lymphoma with no G2+ CRS and no ICANS of any grade. The trial met its initial efficacy target allowing full study accrual to proceed. To our knowledge this represents the first presented safety and efficacy data for mosunetuzumab in untreated pts with FL or MZL. The research was funded by a research grant from Genentech Keywords: Combination Therapies, Immunotherapy, Indolent non-Hodgkin lymphoma Conflicts of interests pertinent to the abstract. R. C. Lynch Consultant or advisory role: Cancer Study Group, SeaGen, Foresight Diagnostics Research funding: TG Therapeutics, Incyte, Bayer, Cyteir, Genentech, SeaGen, Rapt M. Shadman Consultant or advisory role: Genentech Research funding: Genentech B. G. Till Consultant or advisory role: Mustang Bio, Proteios Technology Research funding: Mustang Bio, BMS Other remuneration: Patent- Mustang Bio S. D. Smith Consultant or advisory role: Genentech, Abbvie Research funding: Genentech C. Ujjani Consultant or advisory role: Genentech A. K. Gopal Consultant or advisory role: Incyte, Kite, Morphosys/Incyte, ADCT, Acrotech, Merck, Karyopharm, Servier, Beigene, Cellectar, Janssen, SeaGen, Epizyme, I-Mab bio, Gilead, Genentech, Lilly, Caribou, Fresenius-Kabi Research funding: Merck, I-Mab bio, IgM Bio, Takeda, Gilead, Astra-Zeneca, Agios, Janssen, BMS, SeaGen, Teva, Genmab Other remuneration: Stock Options: Compliment Corporation

Oral NRC-2694-A in combination with paclitaxel as therapy for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M-HNSCC) that progressed on or after an immune checkpoint inhibitor (ICI): A multi-center, single-arm, phase 2 trial.

TPS6108 Background: HNSCC is the seventh most common cancer worldwide. Patients with R/M disease have limited treatment options and a poor prognosis. The USFDA has approved two ICI agents to treat R/M-HNSCC: pembrolizumab given as monotherapy or with platinum-based chemotherapy for first-line treatment of R/M disease and nivolumab (or pembrolizumab) monotherapy for treatment of disease that progressed on or after platinum-containing chemotherapy. In each setting, the ICI improved overall survival (OS); however, the absolute magnitude of the OS benefit was modest and most patients experienced disease progression within one year. There are no agents with regulatory agency-approval that are used to treat R/M-HNSCC that progressed on or after an ICI. Drugs commonly used in this setting have limited activity and include cetuximab (an epidermal growth factor receptor [EGFR] inhibitor), paclitaxel, docetaxel, a platinum, or 5-fluorouracil. Hence, there is an important unmet medical need to develop more effective treatments for R/M-HNSCC that progressed on or after an ICI. NRC-2694-A is an orally administered EGFR tyrosine kinase inhibitor, discovered and developed by NATCO Pharma Ltd., India. Based on the responses from Phase-I and Phase-II trials of NRC-2694-A in India, NAT2694US study is designed to evaluate the safety and efficacy of Oral NRC-2694-A in combination with paclitaxel in patients with R/M-HNSCC, who progressed on or after ICI therapy. Methods: NAT2694US is a multi-center, single-arm, Phase 2 study (NCI ClinicalTrials.gov Identifier: NCT05283226) with an estimated enrolment of 46 patients. Eligible patients are >18 years of age with an ECOG performance status of 0-2 and histologically confirmed unresectable, measurable R/M-HNSCC (of the oral cavity, oropharynx, hypopharynx, and larynx), radiological disease progression on or after ICI therapy, and no prior taxane for R/M disease. Patients receive 300 mg of oral NRC-2694-A once daily and 175 mg/m² of paclitaxel IV infusion once every 21-day cycle for 6 cycles or more. Tumor response assessment with CT/MRI scans is performed every 6 weeks. The primary endpoint is objective response rate (ORR) using RECIST v1.1 performed by the investigator. The study uses a Simon’s 2-stage design with ORR H0: 30% and H1: 50% using a one-sided Type-1 error rate = 0.05). In Stage 1, fifteen patients are to be enrolled for tumor assessment. If objective response is observed in at least 6 of these 15 patients, then Stage 2 would be opened with the inclusion of 31 additional patients, leading to a total enrolment of 46 patients. The observation of objective response in at least 19 of 46 patients would reject the null hypothesis in favour of the alternative hypothesis. Enrolment to the NAT2694US trial is currently ongoing in USA. Clinical trial information: NCT05283226 .

0863 Evaluation of sleep apnea among consecutive patients with all patterns of atrial fibrillation

Abstract Introduction Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is associated with significant morbidity, mortality, and financial burden. Obstructive sleep apnea is more common in individuals with AF and may impair AF treatment efficacy including with catheter ablation. However, the prevalence of undiagnosed OSA in all-comers with AF is unknown. Methods This pragmatic, phase IV prospective cohort study will test 250-300 consecutive ambulatory AF patients with all patterns of atrial fibrillation (paroxysmal, persistent, and long-term persistent) and no prior sleep testing for OSA using the WatchPAT system, a home sleep test. Results We report the design, methodology, and results from the initial pilot enrollment of approximately 25% (N=52) of the planned sample size. The primary outcome is the prevalence of undiagnosed OSA in all-comers with AF. Additional outcomes of interest include the sensitivity and specificity of clinical screening instruments for OSA in the AF population and AF-related quality of life measurements among those with and without OSA. Results of the pilot dataset demonstrate a 77.5% prevalence of at least mild (AHI≥5) OSA or greater in all-comers with AF. Conclusion Based on our preliminary dataset representing one quarter of the planned total enrollment size of 250-300, there is a high prevalence of OSA in all-comers with AF. Support (if any) Zoll Medical

Reducing meat and/or dairy consumption in adults: a systematic review and meta-analysis of effects on protein intake, anthropometric values, and body composition.

Consumers are increasingly encouraged to reduce meat and dairy consumption. However, few meta-analyses of randomized controlled trials (RCTs) on the effect of reducing meat and/or dairy on (absolute) protein intake, anthropometric values, and body composition are available. The aim of this systematic review and meta-analysis was to evaluate the effect of reducing meat and/or dairy consumption on (absolute) protein intake, anthropometric values, and body composition in adults aged ≥ 45 years. The MEDLINE, Cochrane CENTRAL, Embase, ClinicalTrials.gov, and International Clinical Trials Registry Platform databases were searched up to November 24, 2021. Randomized controlled trials reporting protein intake, anthropometric values, and body composition were included. Data were pooled using random-effects models and expressed as the mean difference (MD) with 95%CI. Heterogeneity was assessed and quantified using Cochran's Q and I2 statistics. In total, 19 RCTs with a median duration of 12 weeks (range, 4-24 weeks) and a total enrollment of 1475 participants were included. Participants who consumed meat- and/or dairy-reduced diets had a significantly lower protein intake than those who consumed control diets (9 RCTs; MD, -14 g/d; 95%CI, -20 to -8; I2 = 81%). Reducing meat and/or dairy consumption had no significant effect on body weight (14 RCTs; MD, -1.2 kg; 95%CI, -3 to 0.7; I2 = 12%), body mass index (13 RCTs; MD, -0.3 kg/m2; 95%CI, -1 to 0.4; I2 = 34%), waist circumference (9 RCTs; MD, -0.5 cm; 95%CI, -2.1 to 1.1; I2 = 26%), amount of body fat (8 RCTs; MD, -1.0 kg; 95%CI, -3.0 to 1.0; I2 = 48%), or lean body mass (9 RCTs; MD, -0.4 kg; 95%CI, -1.5 to 0.7; I2 = 0%). Reduction of meat and/or dairy appears to reduce protein intake. There is no evidence of a significant impact on anthropometric values or body composition. More long-term intervention studies with defined amounts of meat and dairy are needed to investigate the long-term effects on nutrient intakes and health outcomes. PROSPERO registration no. CRD42020207325.

Race and Ethnicity Reporting and Enrollment Disparities in Clinical Trials Leading to FDA Approvals for Breast Cancer Between 2010 and 2020

BackgroundWe determined the race and ethnicity demographics and reporting trends of clinical trials leading to Food and Drug Administration (FDA) approvals for breast cancer. MethodsWe collected enrollment and reporting data from clinical trials leading to FDA novel and new use approvals for breast cancer from 2010 to 2020 from Drugs@FDA, ClinicalTrials.gov, and associated journal manuscripts. Enrollment demographics were compared to the US cancer population estimates obtained using National Cancer Institute-Surveillance, Epidemiology, and End Results and 2010 US Census databases. ResultsSeventeen drugs received approval based on 18 clinical trials with a total enrollment of 12,334. For approvals from 2010 to 2015 and from 2016 to 2020, there was no significant difference in race (80% vs. 91.6%, P = .34) or ethnicity reporting (20% vs. 33.3%, P = .5) on ClinicalTrials.Gov, manuscripts, and FDA labels. For trials that reported race and ethnicity, White, Asian, Black, and Hispanic patients represented 73.8%, 16.4%, 3.7%, and 10.4% of trial participants. Relative to their US cancer incidence, Black (31% of expected) patients were underrepresented compared with White (90% of expected), Hispanic (115%), and Asian (327% of expected) patients. ConclusionWe observed no significant difference in race and ethnicity reporting in pivotal clinical trials leading to FDA approval for breast cancer from 2010 to 2020. Black patients were underrepresented in these pivotal trials relative to White, Hispanic, and Asian patients. Ethnicity reporting remained low throughout the study period. Innovative approaches are needed to ensure equitable benefit of novel therapeutics.

Nursery Services for Children Under 3 in Sichuan Province

To study the current status of nursery services for children under 3 in Sichuan Province, to analyze the problems and causes, and to provide policy recommendations for the high-quality development of nursery services in Sichuan Province for children under the age of 3. Using a combination of qualitative and quantitative methods, we analyzed the current status of nursery services in Sichuan Province and the problems encountered in the development of nursery services in Sichuan Province by collecting information on relevant government policies of Sichuan and the status quo of nursery services for children under 3 in the 21 cities/prefectures of Sichuan through policy research, interviews conducted at nursery service institutions, questionnaire surveys, and expert panel discussions. The supply of nursery services, or nursery enrollment capacity, in Sichuan Province reached 3 nursery enrollment opportunities per thousand people, with the enrollment utilization rate reaching 48.2%. Among all the nursery service institutions in the province, 55.4% were concentrated in the Chengdu, Mianyang, and Meishan regions. There were 1667 pilot nursery service institutions providing government-subsidized affordable nursery services and supplying 72971 subsidized affordable enrollment opportunities, accounting for 28.7% of the total number of all nursery service institutions and 29.1% of their total enrollment. There were a total of 37995 nursery service professionals, including 28468 caregivers (including teachers), with an average of 6 employees per institution and 5 caregivers per institution. 49.6% of the nursery service institutions hired healthcare workers on a part-time basis and 11.3% of them did not have healthcare workers on their staffs. Nursery services for children under 3 years old have developed rapidly in Sichuan Province, but there are a number of problems, including uneven distribution of resources in different regions, inadequate supply of government-subsidized affordable nursery services, mismatch between supply and demand, insufficient utilization of services, lack of professionals, and insufficient driving force for sustainable development in the industry. We have suggested that actions be taken to improve the policy and regulatory system for nursery services, actively develop care facilites that are government-subsidized affordable services, integrated daycare service for all preschool children, and integrated medical and education facilites, provide support for home care, establish an information system for nursery services, optimize the professional training and development system, strengthen scientific research and international exchanges on nursery services, and comprehensively promote the high-quality development of nursery services and the construction of a childrearing-friendly environment in Sichuan Province.

Research on the evaluation system of tourism management classroom teaching based on multimedia big data analysis

Abstract To improve the quality of tourism management classroom teaching and then improve the quality of undergraduate tourism management professionals, this paper analyzes tourism management classroom teaching evaluation based on big multimedia data. The mean and autocovariance matrix are determined by multivariate statistical analysis, and the effective learning behavior evaluation index and survey data are determined by entropy analysis, and then the evaluation index of tourism management classroom teaching quality is established to explore the improvement of teaching quality after big multimedia data is applied to tourism management classroom. According to the statistics related to the basic tourism education and training statistics of the China Tourism Administration, as of 2017, there were 608 general higher education institutions offering tourism management undergraduate majors with a total enrollment of 59,000; 1086 general higher education institutions offering tourism management higher education majors with a total enrollment of 113,000; 947 secondary vocational The total number of enrollment in 947 secondary vocational schools with tourism-related majors is 103,000, and the scale of tourism talent training has expanded, and the education problem of tourism management majors has gradually come to the fore. Therefore, it is timely and necessary to analyze the evaluation of tourism management classroom teaching based on big multimedia data, and to a certain extent, it can promote the improvement of the education level of tourism management majors in colleges and universities.

Teaching neurologists through microlearning: the first 4 years of the eLearning experience with NeuroBytes (P13-2.001)

<h3>Objective:</h3> Determine the impact of the AAN NeuroBytes eLearning program on learning and neurological practice. <h3>Background:</h3> NeuroBytes are brief multimedia videos that provide focused, clinically relevant topic updates in neurology. Neurobytes were launched in January 2019 to deliver microlearning in neurology. We assessed the impact of Neurobytes on satisfaction, learning, and practice. <h3>Design/Methods:</h3> We conducted a programmatic review to evaluate all NeuroBytes from January 2019 (launch) to date of analysis (October 2022). Each NeuroByte course included the video and a survey. Assessment data included: course enrollments, completion rate, satisfaction, and influence on practice. Course enrollment was defined as opening for viewing; course completion required completing the post-course survey which assessed user satisfaction and influence on practice. Data were stratified by user type. To assess the program’s impact, four primary outcomes were defined: (1) course enrollments, (2) course completion rate, (3) satisfaction rate, and (4) percent reporting a change in practice. Descriptive statistics were performed. <h3>Results:</h3> From Jan 2019 – Sept 2022 104 NeuroBytes were released. Total enrollments were 65,089; mean enrollments of 598±377 per course. Mean course completion was 39% (range 7% to 92%). On post-course survey, 87% were satisfied/extremely satisfied. Courses covered 20 subspecialties and COVID-19. The most frequent topics were neuromuscular (n=10) and vascular (n=9). The most popular NeuroByte courses were ‘Dual antiplatelet therapy in ischemic stroke’ (n=1,851 enrollments) and ‘The neurologic exam via telemedicine’ (n=1,848). Member neurologists accounted for 55% of course enrollments, followed by juniors (18%), non-AAN members (13%), APP (6%), or student (3%). <h3>Conclusions:</h3> NeuroBytes are a successful microlearning tool for delivering continuing professional development. The primary strengths of the program are accessibility, high-yield learning, breadth of topics, and appeal to a range of learners. Not all content is conducive to micro-delivery. Ongoing efforts will define how this program influences daily practice and lifelong learning. <b>Disclosure:</b> The institution of Dr. Quick has received research support from NINDS. The institution of Dr. Quick has received research support from NEALS. Dr. Miller has nothing to disclose. Dr. Siegler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Ceribell. Dr. Siegler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AstraZeneca. Mr. Rook has nothing to disclose. Ms. Morris has nothing to disclose. Mr. Cramer has nothing to disclose. Xiaoyu Sun has received personal compensation for serving as an employee of American Academy of Neurology. An immediate family member of Xiaoyu Sun has received personal compensation for serving as an employee of Syneos Health. An immediate family member of Xiaoyu Sun has stock in Syneos Health. An immediate family member of Xiaoyu Sun has stock in BioNTech. Dr. Cook has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Cook has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Cook has a non-compensated relationship as a Board Member with Alliance for Patient Access that is relevant to AAN interests or activities. Dr. Sabayan has nothing to disclose. The institution of Dr. Kraakevik has received research support from Parkinson Foundation. Dr. Moeller has received publishing royalties from a publication relating to health care. The institution of Dr. Isaacson has received research support from National Institutes of Health. The institution of Dr. Isaacson has received research support from Women’s Alzheimer’s Movement. The institution of Dr. Isaacson has received research support from Aces for Alzheimer’s. Dr. Isaacson has received publishing royalties from a publication relating to health care. Dr. London has nothing to disclose. Dr. Strowd has received personal compensation for serving as an employee of Kaplan. Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Monteris Medical, Inc. Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novocure. Dr. Strowd has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Academy of Neurology. The institution of Dr. Strowd has received research support from Southeastern Brain Tumor Foundation. The institution of Dr. Strowd has received research support from Jazz Pharmaceuticals. The institution of Dr. Strowd has received research support from National Institutes of Health. The institution of Dr. Strowd has received research support from Alpha Omega Alpha. The institution of Dr. Strowd has received research support from American Board of Psychiatry and Neurology. Dr. Strowd has received publishing royalties from a publication relating to health care. Dr. Strowd has received publishing royalties from a publication relating to health care.

115 State-to-State Variation in Medicaid and Medicare Reimbursement: Implications for Healthcare Access Among Vulnerable Populations

INTRODUCTION: Medicaid and Medicare are social insurance programs providing coverage for specific populations, namely low-income and aged individuals. While Medicare is a federally indexed health insurance program, Medicaid is largely administered by individual states resulting in varying policies and practices. METHODS: Maximum allowed physician reimbursement fees for twenty common neurosurgical codes were obtained from the 2022 Medicare Physician Fee Schedule and individual state Medicaid Fee-for-Service Schedules. The Medicaid-Medicare Index (MMI), which measures Medicaid reimbursement as a fraction of Medicare allowed amounts, was calculated for each procedure across 49 states and the District of Columbia. MMI &lt;1 or &gt;1 indicates that Medicaid reimburses less than or greater than Medicare, respectively. The proportion of providers accepting new Medicaid patients and total Medicaid enrollment were compared across states as a function of MMI. RESULTS: Maximum allowed amounts for Medicare reimbursement (CV = 0.09) were less variable than Medicaid (CV = 0.26, p &lt; 0.01). The average national MMI was 0.79 with a range of 0.37 in NY/NJ to 1.43 in NE. The largest absolute disparity was observed for intracranial aneurysm clipping in NY, where the maximum Medicaid reimbursement is $3,496.52 less than that of Medicare. Higher MMI was associated with a significantly larger proportion of providers accepting new Medicaid patients (R2 = 0.43, p &lt; 0.01). Moreover, MMI varied inversely with the number of Medicaid beneficiaries (R2 = 0.12, p = 0.01). CONCLUSIONS: Medicaid reimbursement varies drastically between states reflecting the disparate methods of fee calculation. Lower reimbursement is associated with more limited provider enrollment, especially in states with a greater number of beneficiaries. While more limited access to Medicaid-accepting neurosurgeons may contribute to poorer outcomes, this is an issue that warrants further exploration.

Increased Medicare Advantage Penetration Is Associated With Lower Postacute Care Use For Traditional Medicare Patients.

Medicare Advantage (MA) plans, which accounted for 45percent of total Medicare enrollment in 2022, are incentivized to minimize spending on low-value services. Prior research indicates that MA plan enrollment is associated with reduced postacute care use without adverse impacts on patient outcomes. However, it is unclear whether a rising MA enrollment level is associated with a change in postacute care use in traditional Medicare, especially given growing participation in traditional Medicare Alternative Payment Models that have been found to be associated with lower postacute care spending. We hypothesize that market-level MA expansion is associated with reduced postacute care use among traditional Medicare beneficiaries-a "spillover" effect of providers modifying their practice patterns in response to MA plans' incentives. We found increased MA market penetration associated with reduced postacute care use among traditional Medicare beneficiaries, without a corresponding increase in hospital readmissions. This association was generally stronger in markets with a greater share of traditional Medicare beneficiaries attributed to accountable care organizations, suggesting that policy makers should account for MA penetration when evaluating potential savings in Alternative Payment Models within traditional Medicare.

Job Satisfaction and Perception Among Female Academics During COVID-19 Pandemic: A Systematic Review

The COVID-19 pandemic gave off a huge impact on face-to-face or physical learning and the world now is going virtual online learning and teaching until this pandemic settles. The COVID-19 epidemic has created new obstacles for employees in terms of change adaptation and job security, as well as a significant impact on employee well-being and satisfaction, especially for women. Since 2005, female enrolment in academia has continued to grow, and in many countries, females make up more than fifty per cent of the total enrolment in higher education. However, women remain underrepresented in top academic positions globally. This systematic review aimed to look for available articles related to the job satisfaction and perception of female academics before and during the COVID-19 pandemic. The PRISMA flow diagram was used to search the literature systematically, and the study's inclusion and exclusion criteria were established prior to the search. The CASP and MMAT were used to conduct the quality assessment. There are six themes emerged from 26 articles in this review and those are an overview of job satisfaction, factors that contribute to job satisfaction, gender gaps related to job satisfaction, academics perception, the mental health of academicians, and the relationship between work from home and job satisfaction. This study recommended for the faculty and university have a serial discussion about maintaining and increasing female academics’ job satisfaction. Therefore, surveys for academicians were vital to learn about their current circumstances, whether in teaching and learning or their psycho-social well-being. Although the university already provides the guidelines for online teaching, it was advisable to review the efficacy of the teaching modalities and infrastructure for the academicians.

Expanded targeted screening for congenital cytomegalovirus infection.

An early diagnosis and intervention for congenital cytomegalovirus infection can reduce long-term disability; however, the introduction of universal neonatal screening has been controversial worldwide. The present study clarified the outcome of a targeted screening protocol for detecting congenital cytomegalovirus infection based on suggestive perinatal conditions. In addition, the positive rate was compared to those from the reported studies and the validity of the targeted screening criteria was discussed. A total of 2121 newborn infants were admitted to our hospital between October 2018 and October 2021. Cytomegalovirus DNA was examined by the isothermal nucleic acid amplification method for urine samples from newborns with any of the following: microcephaly, abnormal ultrasound findings in the brain and visceral organs, repeated failure in neonatal hearing screening, suspicious maternal cytomegalovirus infection during pregnancy, and other abnormal findings suggestive of congenital cytomegalovirus infection. Among 2121 newborns, 102 (4.8%) were subject to the urine cytomegalovirus DNA test based on the abovementioned criteria. Of them, three were cytomegalovirus DNA-positive. According to the protocol, the cytomegalovirus DNA-positive rates were 0.14% among the total enrollment of 2121 newborns and 2.9% (3/102) among the targeted newborns. This protocol may overlook congenital cytomegalovirus infection that is asymptomatic or exhibits inapparent clinical manifestations only at birth; however, it is feasible and helps lead to the diagnosis of congenital cytomegalovirus infection that may otherwise be overlooked.

The effect of COVID-19 pandemic on college enrollment: How has enrollment in criminal justice programs been affected by the pandemic in comparison to other college programs

The COVID-19 pandemic has affected various aspects of our lives. For many, it has affected their ability to attend school. While some have switched to online classes, others have had to drop or delay college until later. Using official enrollment data for 12 public universities in the State of Texas, this study explores the impact the COVID-19 pandemic has had on student enrollment in criminal justice programs. A series of statistical techniques, including t-tests comparing pre- and post-pandemic enrollment numbers and panel data analysis models, are utilized to investigate the trends and changes in the program enrollments between 2009 and 2021. While in alignment with the existing research on the effect of the COVID-19 pandemic on college enrollment in general the authors have found a negative statistically significant effect of the pandemic on total college enrollment for all universities in the sample, no statistically significant effect of the pandemic was found on enrollment in criminal justice programs at 12 public universities. The effect was also non-existent for engineering and all social science programs combined. In contrast to all other programs studied herein, enrollment in natural science programs was found to be positively associated with the pandemic. Authors offer an explanation for these findings as well as suggest ideas for future research.

A Mismatch between the Scale of Higher Education and the Level of Household Incomes: Causes of Proliferation of Online College Student Loans in China

Over the past decades, Chinese higher education has undergone a dramatic expansion. According to An Overview of Chinese Education: National Education Development in 2020 issued by the Ministry of Education of P. R. China, there were 2738 higher education institutions in China in 2020, with an admission rate of 54.4% and a total enrollment of 41.83 million students (1). With the rapid popularization of higher education, numerous issues have emerged on college campuses. The unreasonable proliferation of online student loads is one of them.

Evaluation of a combined school-based vision screening and mobile clinic program

Effective vision screening programs for children require follow-up with eye care providers, but studies demonstrate poor follow-up rates after failed screenings. Programs have attempted to address this issue by providing free examinations and glasses after failed screenings. This study presents data from a mobile clinic program that provides instrument-based vision screening, eye examinations, and free glasses directly to children at school. Between 2018 and 2021, a nonprofit organization provided in-school instrument-based screening and noncycloplegic examinations and refractions in elementary, middle, and high schools. Deidentified screening and clinic data were reviewed retrospectively. Information about each school regarding total student enrollment, enrollment based on race, and number of economically disadvantaged students was obtained from the Virginia Department of Education. In the 2019-2020 school year, 14,006 students from 58 schools were screened, and 4,238 (30.3%) were referred. The percentage of economically disadvantaged students was positively correlated to referral rate (R2 = 0.406). Between 2019 and 2020, the mobile clinic examined 3,095 students from the same 58 schools. Of these, 72.9% were prescribed glasses, and 16.3% were referred for a more comprehensive eye examination and treatment. Students were also diagnosed with cataracts, nystagmus, amblyopia, and strabismus. A combined screening program and mobile clinic traveling directly to schools can provide a pipeline for delivering eye care to vulnerable populations.

Darolutamide plus androgen-deprivation therapy (ADT) versus ADT in metastatic hormone-sensitive prostate cancer: Open-label single-arm study with an external control arm (ARASEC).

TPS297 Background: Darolutamide (DARO) is a structurally distinct and highly potent androgen receptor inhibitor. In the phase 3 ARAMIS study (NCT02200614) in nonmetastatic castration-resistant prostate cancer (CRPC), DARO + ADT significantly improved metastasis-free survival and overall survival (OS) vs placebo + ADT, with a favorable tolerability and safety profile. In the phase 3 ARASENS study (NCT02799602) in metastatic hormone-sensitive prostate cancer (mHSPC), DARO + ADT + docetaxel significantly reduced the risk of death by 32.5% vs ADT + docetaxel (hazard ratio 0.68; 95% confidence interval 0.57–0.80; P&lt;0.0001), with no additional adverse events. DARO + ADT vs ADT alone in patients (pts) with mHSPC is being evaluated in the ongoing, global (ex-US), phase 3 ARANOTE study (NCT04736199). The phase 2 ARASEC study (NCT05059236) will complement ARANOTE by evaluating DARO + ADT in US pts with mHSPC. Given that ADT alone is no longer an acceptable comparator in the US, an external control arm will be derived from a historical study. Methods: To participate in ARASEC, pts must have confirmed adenocarcinoma of the prostate, metastatic disease on conventional imaging for which they have not received prior systemic therapy, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0–2. Pts will receive DARO 600 mg twice daily + ADT (luteinizing hormone-releasing hormone agonist/antagonist or orchiectomy). ADT can be started ≤4 months before DARO, and there must be no evidence of progression on ADT before DARO initiation. The external control arm will be derived from 394 pts with mHSPC treated with ADT alone in CHAARTED (NCT00309985). Pts in the active and control arms will be matched 1:1 on baseline characteristics such as age, ECOG PS, CHAARTED-defined extent of disease, prior therapy, and Gleason score. The propensity score (ie, the assessed probability that a pt is allocated to the DARO + ADT arm based on baseline profile) will be used to address bias in estimating differential effects, by matching pts with scores within a narrow window across the cohorts. The primary endpoint is progression-free survival (PFS), defined as the time from enrollment to prostate-specific antigen (PSA) progression, radiologic or symptomatic progression, clinical deterioration, or death, whichever occurs first, as defined in CHAARTED. Secondary endpoints are OS, radiographic PFS, time to CRPC, 6-month PSA response (&lt;0.2 ng/mL), and safety. The study will continue until either the event count threshold triggering the primary endpoint analysis (161 PFS events) has been met or all pts have been followed for ≥2 years after enrollment, whichever occurs later. ARASEC is enrolling, with the first pt enrolled in November 2021. As of September 10, 2022, 59 pts have been enrolled. The target total enrollment is 200 pts at 30 sites. Clinical trial information: NCT05059236 .

Evaluating Demand for Full-Time Enrollment in Public Higher Education

There is distinct competition for full-time student enrollment in higher education. With the wide availability of online degrees and course offerings, students can consider multiple options as consumers of higher education. With increased competition in higher education, reaching prospective undergraduate students highlights the importance of market segmentation as a vital step toward increasing full-time enrollment. A critical step to attracting potential undergraduate students requires a deeper understanding of student segment populations. The purpose of this study is to investigate how distinct student segments and demand factors influence higher education enrollment within public higher education institutions. The study examined three types of undergraduate student segments: traditional, non-traditional, and transfer students to evaluate how online course modalities as well as major fields of study influence student demand for full-time enrollment. Historical and publicly available secondary data were examined for the academic years 2014-2015 through 2018-2019 to describe relationships between total full-time enrollment (dependent) with online course enrollment and major fields of study (independent) variables. Administrators in public higher education institutions will be able to use the findings from this study for the development of an enrollment framework focusing on student segmentation strategies.

Hybrid epicardial-endocardial ablation for long-standing persistent atrial fibrillation: A subanalysis of the CONVERGE Trial.

Favorable clinical outcomes are difficult to achieve in long-standing persistent atrial fibrillation (LSPAF) with catheter ablation (CA). The CONVERGE (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent Atrial FIbrillation) trial evaluated the effectiveness of hybrid convergent (HC) ablation vs endocardial CA. The study sought to evaluate the safety and effectiveness of HC vs CA in the LSPAF subgroup from the CONVERGE trial. The CONVERGE trial was a prospective, multicenter, randomized trial that enrolled 153 patients at 27 sites. A post hoc analysis was performed on LSPAF patients. The primary effectiveness was freedom from atrial arrhythmias off new or increased dose of previously failed or intolerant antiarrhythmic drugs (AADs) through 12 months. The primary safety endpoint was major adverse event incidence through 30 days with HC. Key secondary effectiveness measures included (1) percent of patients achieving ≥90% AF burden reduction vs baseline and (2) AF freedom. Sixty-five patients (42.5% of total enrollment) had LSPAF; 38 in HC and 27 in CA. Primary effectiveness was 65.8% (95% confidence interval [CI] 50.7%-80.9%) with HC vs 37.0% (95% CI 5.1%-52.4%) with CA (P = .022). Through 18 months, these rates were 60.5% (95% CI 50.0%-76.1%) with HC vs 25.9% (95% CI 9.4%-42.5%) with CA (P = .006). Secondary effectiveness rates were higher than CA with HC at 12 and 18 months. Freedom from atrial arrhythmias off AADs was 52.6% (95% CI 36.8%-68.5%) and 47.4% (95% CI 31.5%-63.2%) with HC at 12 and 18months vs 25.9% (95% CI 9.4%-42.5%) and 22.2% (95% CI 6.5%-37.9%) with CA, respectively (12 months: P = .031; 18 months: P = .038). Three (7.9%) major adverse events occurred within 30 days of HC. Post hoc analysis demonstrated effectiveness and acceptable safety of HC compared with CA in LSPAF.