Patients Research Articles

Treatment preferences in advanced pancreatic ductal adenocarcinoma (PDAC) from qualitative patient (PT), caregiver (CG), and oncologist (OC) interviews.

712 Background: Most treatment regimens for patients with PDAC focus on extending survival while managing symptoms and maintaining quality of life (QoL). Here we report insights from PT, CG, and OC interviews on PDAC treatment preferences. Methods: A targeted literature review of 7 quantitative/preference and 12 qualitative/patient-reported outcome studies was used to develop semi-structured interview guides. Single 60-minute interviews of US PTs with stage 4 PDAC, CGs, and OCs with ≥5 years’ experience treating PDAC were undertaken virtually by staff from March to April 2024. Interviews had 5 sections: background/clinical experience (OC only); key treatment benefits and risks to avoid (ranked by importance); treatment convenience; and 2 hypothetical treatment preference questions. Participants completed a sociodemographic and clinical questionnaire. Interviews were recorded with permission, transcribed, and analyzed with ATLAS.ti v8+. Results: Ten PTs, CGs, and OCs completed interviews (N=30 total), including 4 PT/CG dyads. Mean PT age was 56.8 (standard deviation [SD] 12.15) years; 6 were men and 4 did not have CGs. Mean CG age was 51.1 (SD 14.2) years; 9 were women and 7 cared for their partners. OCs had mean 18.5 (SD 6.9) years’ clinical experience and 10 were men. Top-ranked treatment benefits were increased overall survival (OS) (6 PTs [60%], 8 CGs [80%], 7 OCs [70%]); improved QoL (6 PTs [60%], 5 CGs [50%], 7 OCs [70%]); stopping disease progression (5 PTs [50%], 3 CGs [30%], 7 OCs [70%]), and increased life expectancy (7 PTs [70%], 5 CGs [50%], 3 OCs [30%]). PTs’ top 3-ranked side effects to avoid included fatigue (n=4 [40%]), nausea (n=4 [40%]), and vomiting (n=3 [30%]). CGs ranked trouble remembering (n=4 [40%]), neutropenia (n=4 [40%]), and neuropathy (n=3 [30%]) in the top 3, while OCs ranked vomiting (n=5 [50%]), neuropathy [n=5 [50%]), and neutropenia (n=4 [40%]) highest. Most PTs/CGs were indifferent to ≥1 infusion/visit and infusion duration. In the first hypothetical treatment preference question, the treatment with higher efficacy but higher side effect risk and longer infusion time was preferred by 80% of PTs/CGs and 70% of OCs. In the second hypothetical treatment question, treatments had the same efficacy; 90% of PTs/CGs/OCs preferred the treatment with shorter infusion time and lower risk of gastrointestinal side effects and hypersensitivity reactions, despite higher risk of severe hypokalemia and severe neutropenia. Conclusions: OS and QoL were ranked as similarly important by participants, suggesting that extending survival is insufficient without acceptable QoL. Avoiding side effects was important to all participants, though PTs, CGs, and OCs ranked specific risks with differing importance. More studies are needed to quantify tradeoffs between treatment efficacy and side effects in the care of patients with advanced PDAC.

Short-term costs of alcohol-associated hepatitis care in different clinical settings.

Alcohol-associated hepatitis (AH) leads to high rates of mortality and health care costs. Understanding the immediate costs after an AH diagnosis and identifying key cost factors is crucial for health care policies and clinical decisions. This study quantifies medical costs within 30 days of an AH diagnosis across outpatient (OP), emergency department (ED), and inpatient (IP) settings. It also explores concurrent diagnoses and their effects on care costs. We conducted a retrospective cohort study using deidentified data from Optum's Clinformatics Data Mart. The cohort included individuals aged 21 years and older diagnosed with AH from January 1, 2016, to September 30, 2023. Patients were categorized by care setting (OP, ED, or IP). Costs were calculated for the 30 days before and after AH diagnosis and adjusted to 2023-dollar values. Comorbidities were identified using Elixhauser comorbidity software, and multivariable linear regression models were used to analyze medical costs. The cohort included 34,974 individuals diagnosed with AH: 8048 in OP (23%), 2736 in ED (7.8%), and 24,190 in IP (69.2%). Average spending in the 30 days prior to AH diagnosis was $7334 for OP, $5740 for ED, and $14,458 for IP. Following AH diagnosis, average costs rose to $8345 for OP, $20,990 for ED, and $88,655 for IP, reflecting increases of 14%, 266%, and 413%, respectively. Significant cost drivers in IP included comorbidities associated with moderate-to-severe liver disease, metabolic syndrome, liver transplant, and mortality during the 30-day follow-up period. Immediate costs following an AH diagnosis are substantial, particularly for IP care. Costs increase significantly with high-cost comorbidity clusters and among patients who die, underscoring the need for effective management of comorbidities in AH care.

Validity of patient-reported information: agreement rate between patient reports and registry data

BackgroundThe accuracy of patient-reported clinical information, including cancer stage, is not well understood. This study aims to evaluate the agreement between patient-reported survey data and clinical information recorded in hospital-based cancer registries (HBCR).MethodsA total of 730 patients from 166 hospitals in Japan were randomly selected and informed that their survey responses would be validated against HBCR data. Demographic details, including age, sex, cancer stage, and cancer site, were recorded and compared with clinical data from the HBCR. Agreement rates between patients’ self-reported demographic and clinical data and the corresponding HBCR records were analyzed. Logistic regression analysis was conducted to identify factors associated with accurate reporting of cancer stage information.ResultsAgreement rates for age, sex, and cancer site were 99.4%, 99.8%, and over 90% across all cancer sites, respectively. The agreement rate for cancer stage reporting was 49.9%. Patients with stage IV cancer had the highest agreement rate at 68.4%. Patients under 75 years of age and those with specific cancer types demonstrated higher odds of reporting data consistent with HBCR records.ConclusionsFor cancer stage data, relying on more credible sources, such as cancer registries, is recommended over patient-reported information to ensure accuracy.

Impact of discontinuation of cephazolin prophylaxis on the incidence of postoperative adverse events in cataract surgery

BackgroundCataract surgeries are increasing annually, making appropriate medical management essential. The routine use of systemic antimicrobial agents for preventing surgical site infections lacks strong evidence and may increase the risk of drug-resistant bacteria and adverse events. This study examined the impact of discontinuing cefazolin (CEZ) administration during the perioperative period of cataract surgery on the incidence of postoperative adverse events and medical costs.MethodsInpatient cataract surgery patients were divided into two groups: the CEZ-use group (April 2021 to March 2022) and the non-CEZ-use group (April 2022 to March 2023). The primary endpoints were the incidence of adverse events and medical costs, while the secondary endpoint was the incidence of endophthalmitis.ResultsA total of 265 patients were in the CEZ group, and 316 were in the non-CEZ group. Six postoperative adverse events (2.3%, 95% confidence interval: 0.8–4.9) occurred in the CEZ group, with an estimated 230 patients (80–490 from the 95% confidence interval) expected to experience adverse events per 10,000 patients using CEZ. The non-CEZ group had no adverse events and reduced drug costs by approximately 46,000 yen. Insurance claim amounts were also reduced. No cases of early postoperative endophthalmitis were observed in either group.ConclusionsDiscontinuation of CEZ prophylaxis during the perioperative period of cataract surgery effectively reduced the risk of adverse events. Medical for the period after discontinuing CEZ did not increase.Trial registrationRetrospectively registered.

P-2329. Diversity of Rhinovirus Types in Children During the COVID-19 Pandemic, New Vaccine Surveillance Network, 03/01/20-02/28/21

Abstract Background During the COVID-19 pandemic, seasonal respiratory virus detections decreased. However, rhinoviruses (RV) continued to circulate in high numbers. Previous data suggest that RV type circulation is heterogenous and diverse. We characterized the distribution of RV species and the diversity of RV types among children with medically attended acute respiratory infection (ARI) during the first year of the pandemic. *Spring: Feb to Apr, Summer: May to July, Fall: Aug to Oct, Winter: Nov to Jan.Table 1.Age, seasonal distribution and ED/hospitalization status based on RV species, New Vaccine Surveillance Network, 03/01/20-02/28/21 Methods During March 1, 2020 - February 28, 2021, we enrolled children (< 18 years) with ARI seen as either inpatients (IP) or in the emergency department (ED) via prospective surveillance at 7 sites comprising the New Vaccine Surveillance Network. Respiratory specimens were tested for multiple viral pathogens by RT-PCR at each site. A subset of RV/enterovirus (EV) positive specimens were further processed for Sanger sequencing. To obtain a representative subgroup of specimens to sequence within each site, every odd numbered specimen (including co-detections) from ED and IP from every month was selected. Sequenced regions were analyzed using Lasergene software and compared against GenBank sequences using BLAST. Selected demographic data were analyzed by RV species, month, and setting. Results Among 4881 enrolled children, RV and/or EV was detected in 1508 (31%). Of these, 675 samples (335 IP and 340 ED) were selected for sequencing based on sampling scheme. Sequencing was successful in 595/675 (88%) extracts including 257 RV-A (43.2%), 32 RV-B (5.4%) and 298 RV-C (50.1%); 7 (1.2%) were EV and 1 was a non-typeable RV. Four of the seven EV samples were reported as EV-D68 on sequencing. Overall, 37 RV-A types, 10 RV-B types and 36 types of RV-C species were identified with A101 (44, 17.1%), B6 (10, 31.1%) and C56 (34, 11.4%) as the most common RV-A, B and C types, respectively. Age, seasonal distribution, and ED/IP status by RV species are described in Table 1 with higher detections reported in children < 5 years. Conclusion Among children with medically attended ARI with RV detections, RV-C and RV-A predominated with high type diversity. Most detections were in younger children but occurred similarly in the IP and ED settings. Both species exhibited seasonal trends and high RV diversity that were similar to trends reported in pre-pandemic period. Disclosures Janet A. Englund, MD, Abbvie: Advisor/Consultant|AstraZeneca: Advisor/Consultant|AstraZeneca: Grant/Research Support|GlaxoSmithKline: Advisor/Consultant|GlaxoSmithKline: Grant/Research Support|Meissa Vaccines: Advisor/Consultant|Merck: Advisor/Consultant|Pfizer: Board Member|Pfizer: Grant/Research Support|Pfizer: Speaker at meeting|SanofiPasteur: Advisor/Consultant|Shinogi: Advisor/Consultant Mary A. Staat, MD, MPH, Cepheid: Grant/Research Support|Merck: Grant/Research Support|Pfizer: Grant/Research Support|Up-To-Date: Honoraria Elizabeth P. Schlaudecker, MD, MPH, Pfizer: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant Natasha B. Halasa, MD, MPH, Merck: Grant/Research Support Geoffrey A. Weinberg, MD, Inhalon: Advisor/Consultant|Merck & Company: Honoraria for textbook chapter preparation Mary E. Moffatt, M.D., Child Abuse Pediatrics (CAP) representative to Council of Pediatric Subspecialties (CoPS); Current Chair of CoPS Executive Committee: Board Member|I am a volunteer member of the Board of Directors, Kansas Children’s Service League: Board Member|My institution, Children’s Mercy Hospital, Kansas City, receives grant support from CDC for my participation/time dedicated to this research.: Grant/Research Support|My institution, Children’s Mercy Hospital, Kansas City, receives grant support from HRSA for my participation/time dedicated to work on research: Grant/Research Support|My institution, Children’s Mercy Hospital, Kansas City, receives grant support from NIH for my participation/time dedicated to work on research: Grant/Research Support Rangaraj Selvarangan, BVSc, PhD, D(ABMM), FIDSA, FAAM, Abbott: Grant/Research Support|Abbott: Honoraria|BioMerieux: Grant/Research Support|Cepheid: Grant/Research Support|Diasorin: Grant/Research Support|GSK: Advisor/Consultant|Hologic: Grant/Research Support|Luminex: Grant/Research Support|Qiagen: Grant/Research Support

Lifestyle interventions for depression in primary care: a qualitative study.

In individuals with depression a vicious circle tends to occur in which depressive symptoms cause an unhealthy lifestyle, which reversibly causes an increase in depressive symptoms; both of which are associated with a decreased life expectancy. A potential way to break this circle entails a multicomponent lifestyle intervention (MLI). Exploring the barriers and facilitators for an MLI in patients with depressive symptoms from the perspective of general practitioners (GP), chronic disease practice nurses (CD-PN), mental health nurses (MHN), lifestyle coaches (LC) and patients (PT). Qualitative study using semi-structured interviews in Dutch primary care. Methods We interviewed 5 GPs, 6 MHNs, 5 CD-PNs, 5 LCs and 7 PTs. Focus was on possible barriers and facilitators for an MLI. Data were analyzed using thematic analysis. A focus group was used as a member check. Five themes were identified: 'expectations of effectiveness, 'motivation', 'stigma', 'logistics and organization' and 'communication by professionals'. Ideas on effectiveness were crucial and could be either a facilitator or a barrier for a DT-MLI. Professionals often had high expectations, based on work experience, making this a facilitator. Other facilitators are motivating participants, good logistics and good communication by professionals, thus destigmatizing depression. Patients considered being motivated by the program as a reason for participating, as they did not expect a DT-MLI would give them new information. Support from others was considered a motivator to participate.

P-1170. Impact of Healthcare-associated Respiratory Virus Infections in Children

Abstract Background Respiratory viruses can spread within healthcare facilities despite stringent infection prevention measures. Although healthcare-associated respiratory virus infections (HARVI) pose a significant risk to children, pediatric HARVI are understudied. The present study aimed to evaluate the impact of HARVI on children following the SARS-CoV-2 pandemic at a tertiary children’s hospital. Methods This retrospective study enrolled pediatric inpatients aged ≤18 years who were hospitalized at Tokyo Metropolitan Children's Medical Center between April 2020 and March 2024. HARVI was defined as a viral infection with a new onset of respiratory symptoms past the incubation period following hospitalization. The causative virus was detected using multiplex PCR (FilmArray Respiratory Panel 2.1, BioFire). Patients with other infections were excluded. The primary outcome was the 30-day mortality rate. The secondary outcomes included PICU admission, escalation of respiratory support, and the postponement of discharge, planned surgery or chemotherapy. Results In total, 265 patients with HARVI were enrolled. Male patients comprised 31% of the cohort, and the median age was 31 (IQR [interquartile range]: 12-77) months. Underlying neurologic, cardiac, and congenital or genetic disorders had in 42%, 28%, and 24% of the cohort, respectively. The respiratory viruses detected were the rhinovirus/enterovirus (44%), parainfluenza virus type 3 (15%), and HKU1, NL63, 229E and OC43 coronaviruses (8%). The 30-day mortality rate was 1% in three patients with parainfluenza virus type 3, RSV, and SARS-CoV-2. The PICU admission rate was 2%. The rate of respiratory support escalation was 17%. Postponement of discharge was required in 7% of the cohort for a median period of seven (IQR: 5-8) days. Postponement of surgery was required in 3% of the cohort for a median period of 46 (IQR: 21-82) days. There was no postponement of chemotherapy. Conclusion Pediatric HARVI was associated with mortality and additional medical care. Therefore, strict infection prevention measures are essential. Disclosures Hanako Funakoshi, MD, Pfizer Japan: Husband is an employee.

P-473. Health Care Resource Use Burden Among People With HIV (PWH) and Concurrent Mental Health Disorders (MHDs): Claims Analysis of Treatment-Naïve Medicaid Population Initiating Multi-Tablet Regimens (MTRs) vs. Single-Table Regimens (STRs)

Abstract Background Multi-tablet antiretroviral (ART) regimens (MTRs) have been largely replaced by single-tablet ART regimens (STRs) for treating people with HIV(PWH). STRs provide lower pill burden, increased patient adherence, and lower health care resource utilization (HCRU) among PWH. However, their effects among vulnerable sub-populations of PWH with coexisting mental health disorders (PWH/MHDs) in real-world settings are not well understood. This analysis examined the characteristics and HCRU patterns among PWH/MHDs who initiated MTRs vs STRs in a US Medicaid population. Methods A retrospective analysis of treatment-naïve Medicaid PWH/MHDs (based on claims for MHD-related diagnosis or treatments) using Anlitiks All Payor Claims database from 01/01/16-06/30/23 was conducted. The study included MTR or STR initiators (i.e., MTR/STR initiation date=index date) with ≥12-months pre- and post-index continuous enrollment. Baseline characteristics and post-index all-cause HCRU outcomes (PWH/MHD with ≥1 inpatient (IP) hospitalization, outpatient (OP) visits, emergency department (ED) visits, office visits, and other visits) were described using Chi-square, t-tests and Wilcoxon rank-sum tests as appropriate. HCRU outcomes were assessed using multivariate logistic regression models and reported as adjusted odds ratios (aOR) and 95% confidence intervals (CI). Results Among PWH/MHDs, MTR initiators (n=7,874) vs. STR initiators (n=46,024) were younger (43.6 vs. 47.2 years; p< 0.05), more likely to be female (64.3% vs. 53.6%; p< 0.05), and more likely to use substances (32.1% vs 29.4%; p< 0.05). MTR initiators had significantly higher aOR for: IP hospitalizations (1.49; CI:1.41-1.56), ER visits (1.38; CI: 1.31-1.44), OP visits (1.19; 1.44-1.26), and other visits (1.19; 1.44-1.26) compared to STR initiators. However, MTR initiators had significantly lower aOR (0.94; 0.89-0.99) for office visits compared to STR initiators. Conclusion This analysis indicates that PWH with MHDs in the Medicaid population are more likely to have higher HCRU while taking MTR compared to STR. The analysis also highlights that PWH with MHDs may be the underserved population who may benefit from receiving more tailored and simplified ART regimens. Disclosures Megan Chen, MSPH, Gilead Sciences, Inc.: Honoraria|Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Mary J. Christoph, PhD, MPH, AstraZeneca: Advisor/Consultant|AstraZeneca: Former employee|AstraZeneca: Stocks/Bonds (Private Company)|Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Seojin Park, PharmD, MS, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Woodie Zachry, RPh, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Amy Weinberg, DNP, MS, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Cassidy Trom, PharmD, AAHIVE, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Joshua Gruber, PhD MPH, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Krithika Rajagopalan, PhD, Gilead Sciences, Inc.: Advisor/Consultant

Long short-term memory autoencoder based network of financial indices

We present a novel approach for analyzing financial time series data using a Long Short-Term Memory Autoencoder (LSTMAE), a deep learning method. Our primary objective is to uncover intricate relationships among different stock indices, leading to the extraction of stock networks. We examine time series data spanning from 2000 to 2022, encompassing multiple financial crises within the S&P 500 stock indices. By training a modified LSTMAE with normalized stock index returns, we extract the inherent correlations embedded in the model weights. We create directional threshold networks by applying a fixed threshold, calculated as the sum of the mean and standard deviation of matrices from various years. Our investigation explores the topological characteristics of these threshold networks across different years. Notably, the observed network properties exhibit unique responses to the various financial crises that occurred between 2000 and 2022. Furthermore, our sector analysis reveals substantial sectoral influences during times of crisis. For example, during global financial crises, the financial sector assumes a prominent role, exerting significant influence on other sectors, particularly during the European Sovereign Debt (ESD) crisis. During the COVID-19 pandemic, the health care and consumer discretionary sectors are predominantly impacted by other sectors. Our proposed method effectively captures the underlying network structure of financial markets and is validated by a comprehensive analysis of network metrics, demonstrating its ability to identify significant financial crises over time.

Use of a Stylet Driven Lead With a Flexible Neck for Left Bundle Branch Area Pacing: A Single Center Experience.

The majority of data on left bundle branch area pacing (LBBAP) are on a lumenless lead. Data on the safety and effectiveness of stylet driven leads are comparatively lacking. We retrospectively analyzed 265 patients who underwent attempted LBBAP with an 7842 (Boston Scientific, Marlborough, MA) lead in the Duke University Health System between 1/1/2020 and 9/1/2023. Outcomes of interest included post-operative 7842 helix extension (≥2 helix rotations beyond the lead tip), complications, and lead parameters. A nested analysis of single and dual chamber LBBAP attempts was performed to compare outcomes among similar patients who underwent attempted LBBAP with the lumenless 3830 (Medtronic, Mineappolis, MN) lead. LBBAP success with 7842 was 89.8%. Characteristics were similar among patients with (n = 238) and without (n = 27) successful implants. Helix extension was evaluable for 222 of 238 successful 7842 implants. Of evaluable leads, helix extension was complete for 174 leads (78%), and partial for 48 (21.6%). A trend towards lower dislodgement rates was observed in patients with full versus partial extension (2.9% vs. 8.3%, p = 0.0895) and the rate of full helix extension increased over time (64.1% over 24 months vs. 81.4% over 21 months, p = 0.0162). The success rate of 3830 LBBAP implants (n = 140) was 92.8% (p = 0.069 vs. 7842). At implant, R waves were similar for 7842 and 3830 leads but were greater for 7842 during follow-up (14.4 + /-0.77 vs. 11.3 + /-0.68, p = 0.004). Pacing impedances were higher with 7842 compared with 3830 at baseline (838 + /-10.44 ohms vs. 772 + /-14.58 ohms, p < 0.001) and during follow-up (652 + /-11.0 ohms vs. 513 + /-9.18 ohms, p < 0.001); similarly, 7842 pacing thresholds (@ 0.4 ms) were slightly higher at baseline (0.85 V + /-0.03 vs. 0.68 V + /-0.03, p < 0.001) and 6 months (0.95 V + /-0.03 vs. 0.80 V + /-0.03, p < 0.001) compared with those for the lumenless 3830. LBBAP implant success rates, complications, and pacing parameters using the 7842 lead are stable over time, and appeared overall similar to the 3830 lead. Incomplete 7842 helix extension is a modifiable risk factor for lead dislodgement.

82. Comparative Evaluation of Low Versus High Doses of Rifampin for the Treatment of Staphylococcal Bone and Joint Infections: an open-label, randomized, controlled non-inferiority trial (EVRIOS)

Abstract Background The antibiotic management of staphylococcal bone and joint infection usually relies on rifampin associated with another antibiotic for susceptible strains. The appropriate dose of rifampin remains unclear and diverges in international recommendations. 543 patients were randomized, 530 were included in the Intent-to-Treat analysis and 327 in the per-protocol analysis. Methods We performed an open-label, randomized, controlled, noninferiority trial to compare a daily dose of 10 mg/kg (Low-dose) qd and 20 mg/kg (High-dose, divided in 10mg/kg bid for high BMIs) of rifampin in association with another antibiotic in patients with microbiologically confirmed bone and joint infections due to Staphylococcus sp. Surgical procedures were performed as needed. The primary outcome was persistent infection, defined as the persistence or recurrence of infection with the initial causative bacteria within 1 year after the completion of antibiotic therapy. Results A total of 543 patients from 18 French centers were randomly assigned to receive either Low-dose (252 patients) or High-dose (291 patients) of rifampin associated with another antibiotic. Thirteen patients who withdrew consent were not included in the analysis. The main antibiotics associated with rifampin were levofloxacin/ofloxacin (82%, 435 out of 530 patients). Mean age was 59.8 ± 16.4 years, and mean BMI 27.9 ± 5.8 kg/m2; 24.6% [n=130] had osteosynthesis and 34% [n=180] prostheses at the site of infection. Staphylococcus aureus was present in 75.8% of patients [n=402]. In the ITT analysis, persistent infection occurred in 8 of 227 patients (3.5%) in the Low-dose group and in 10 of 265 patients (3,8%) in the High-dose group (risk difference, 0.0019; 95% confidence interval [-0.032 – 0.036], thus, noninferiority was shown. Serious adverse events linked to rifampin where more frequent in the High-dose group (7%) than in the Low-dose group (1.6%, p=0.0043). Patients in the High-dose group were less likely to remain in the per-protocol analysis (57%, versus 67% in the Low-dose group). Noninferiority was also shown in the per-protocol analysis. Conclusion Among patients with confirmed Staphylococcus sp. bone and joint infection that were managed with standard surgical procedures, antibiotic therapy with daily 10 mg/kg of rifampin was shown to be noninferior to 20 mg/kg. Severe adverse events linked to rifampin where more frequent in the 20 mg/kg group. Disclosures Cedric Arvieux, MD, GILEAD: Advisor/Consultant|ViiV: Advisor/Consultant Florian Lemaitre, PharmD, Astellas: Grant/Research Support|Chiesi: Grant/Research Support|Pfizer: Scientific meeting fees|ViiV: Scientific meeting fees Aurélien Lorleac'h, MD, Gilead: Hospitality|GSK: Hospitality|Nestlé Home Care: Hospitality|ViiV Healthcare: Hospitality Thomas Guimard, MD, Gilead: Convention invitation|Menarini France: Hospitality|MSD: Hospitality|Pfizer: Advisor/Consultant|Shionogi BV: Hospitality Gwenael Lemoal, MD, Gilead: Hospitality|MSD: Hospitality|Viiv Heathcare: Advisor/Consultant

P-821. Invasive Streptococcus pyogenes Infections: Is Anti-toxin Therapy Necessary?

Abstract Background Invasive Streptococcus pyogenes or group A Streptococcus (GAS) carries a high morbidity and mortality rate. In addition to penicillin, adjunct anti-toxin therapy (AT) with linezolid or clindamycin is the standard of care. Although the use of AT is supported by in vitro data and observational studies, there are limited conclusive data supporting its efficacy in reducing GAS mortality. Our study aimed to compare clinical outcomes of patients receiving AT versus those who did not. Methods This was a retrospective cohort study of hospitalized patients with positive blood cultures for GAS at our five-hospital system from June 2013 to August 2023. Patients were identified through Microsoft SQL Server. Patients who received AT therapy for &amp;gt; 48 hours were defined as the AT group; the control group did not receive AT therapy. Patients who received AT for &amp;lt; 48 hours were excluded. Collected variables included demographics, infection &amp; microbiological characteristics, and clinical outcomes. Data was analyzed using SPSS. Results 265 patients were included in the study of whom 179 (68%) received AT (Table 1). About half were female, and the median age was 58 years. Comorbidities were overall similar between the two groups. Persons who inject drugs or with chronic hepatitis C were more common in the control group. Abscess/cellulitis was the most common clinical syndrome in both groups. Shock requiring vasopressors, need for dialysis and mechanical ventilation, and toxic shock syndrome were prevalent in the AT group. There was no difference in the duration of bacteremia, clindamycin resistance, and management between the two groups except for receipt of intravenous immunoglobulin (IVIG), which was more common in the AT group (Table 2). Outcomes, including length of stay, readmission for infection-related complications, and 30-day mortality, were similar between the two groups. Conclusion Utilization of AT for invasive GAS infections correlated with severity of illness, but clinical outcomes did not significantly differ between patients receiving AT and those who did not, suggesting a potential opportunity for antimicrobial stewardship. Further research is needed to determine whether AT should be reserved for patients with select infectious syndromes Disclosures Rachel M. Kenney, PharmD, BCIDP, Medtronic Inc: Spouse is an employee, stockholder

P-1328. Contribution of Antimicrobial Resistance Data of NARMS Retail Meat in the Investigation of Persistent Strain of Salmonella Hadar Infections, Tennessee, 2021-2023

Abstract Background Reoccurring, Emerging, and Persisting (REP) strains of Salmonella have caused illness for several years and are linked to multiple sources. Some REP isolates have been detected in food products like MDR Salmonella Infantis (REPJFX01) in retail chicken. Tennessee participates in the FDA’s National Antimicrobial Resistance Monitoring System (NARMS) Retail Meat Surveillance to monitor the antimicrobial resistance of retail meat enteric bacteria isolates. We reviewed the contribution of TN NARMS data in the investigations of multistate (MS) outbreaks caused by persistent strain of S. Hadar (REPTDK01). Methods Tennessee submits every 20thSalmonella isolates from humans statewide, and all Salmonella isolates from retail meat (retail chicken, ground turkey, ground beef and pork products) purchased from 13 counties to NARMS. Sequenced isolates are uploaded to PulseNet, and resistance determinants are monitored. TN responds to CDC/FDA requests on isolates with persisting strains matching MS outbreaks. Results REPTDK01 strain was detected in 4 ground turkey (GT) isolates from TN as part of 2 multistate outbreaks in 2021 (2102MLTDK-1) and 2023 (2302MLTDK-1). Over 95% of human and non-human isolates in both outbreaks were resistant to tetracycline, streptomycin, or both, and 0.2-0.4 % to ciprofloxacin and ceftriaxone respectively. Three of the 4 GT samples were purchased from grocery stores in different counties in 2021, and two of them had the same producer establishment number. USDA issued a public health consumer alert for over 211,406 pounds of raw GT products produced by the establishment. An additional GT sample was purchased in 2023 with a different establishment number. Consumption of GT was reported by 20 (60%) of 33 cases in 2021, while no signal of GT consumption among 55 cases in 2023. TN had no human cases in both outbreaks. However, a total of 49 cases from TN were linked to another three MS outbreaks of REPTDK01 associated with backyard poultry contact between 2019 and 2023 with one death in 2022. Conclusion NARMS retail meat routine surveillance data contributes to a better understanding of source attributions of REP bacterial strains. Sharing of TN data with federal partners helped in traceback efforts, regulatory actions, and alerting the public. Disclosures All Authors: No reported disclosures

Patterns of willingness to share health data with key stakeholders in US consumers: a latent class analysis.

To identify distinct patterns in consumer willingness to share health data with various stakeholders and analyze characteristics across consumer groups. Data from the Rock Health Digital Health Consumer Adoption Survey from 2018, 2019, 2020, and 2022 were analyzed. This study comprised a Census-matched representative sample of U.S. adults. Latent class analysis (LCA) identified groups of respondents with similar data-sharing attitudes. Groups were compared by sociodemographics, health status, and digital health utilization. We identified three distinct LCA groups: (1) Wary (36.8%), (2) Discerning (47.9%), and (3) Permissive (15.3%). The Wary subgroup exhibited reluctance to share health data with any stakeholder, with predicted probabilities of willingness to share ranging from 0.07 for pharmaceutical companies to 0.34 for doctors/clinicians. The Permissive group showed a high willingness, with predicted probabilities greater than 0.75 for most stakeholders except technology companies and government organizations. The Discerning group was selective, willing to share with healthcare-related entities and family (predicted probabilities >0.62), but reluctant to share with other stakeholders (predicted probabilities <0.29). Individual characteristics were associated with LCA group membership. Findings highlight a persistent trust in traditional healthcare providers. However, the varying willingness to share with non-traditional stakeholders suggests that while some consumers are open to sharing, others remain hesitant and selective. Data privacy policies and practices need to recognize and respond to multifaceted and stakeholder-specific attitudes. LCA reveals significant heterogeneity in health data-sharing attitudes among U.S. consumers, providing insights to inform the development of data privacy policies.

Risk Prediction Model of Peristomal Skin Complications Among Patients with Colorectal Cancer and an Ostomy: A Cross-sectional Study in Shanghai, China.

To analyze the risk factors for peristomal skin complications (PSCs) in patients with colorectal cancer and an ostomy, construct a prediction model, and verify its effectiveness. In this cross-sectional study, researchers recruited 265 patients with an ostomy at the stoma clinic of a tertiary hospital, from May 2022 to August 2023. Patients were divided into two groups: complications group (n = 81) and no complications group (n = 184). Researchers constructed a logistic regression prediction model using univariate and multivariate analyses. From May 2023 to August 2023, a validation group of 135 patients with an ostomy was selected for external validation of the model. The incidence of PSCs was 30.57% in the modeling group and 30.37% in the validation group. The predictor variables were preoperative and postoperative health education, tumor therapy within 3 months, preoperative stoma positioning, stoma height, stoma type, and excrement state. The Hosmer-Lemeshow test yielded a P value of .513, the area under the ROC curve was 0.872, the Youden index was 0.561, and the sensitivity and specificity were 0.827 and 0.734. For external validation, the Hosmer-Lemeshow test yielded a P value of .835, the area under the ROC curve was 0.887, and the sensitivity and specificity were 0.905 and 0.720, respectively. The prediction model demonstrates good predictive efficacy and can serve as a reference for clinical caregivers in identifying patients at high risk of PSCs.

A Cross-sectional Study of the Length of Stay of Persons with Mental Illnesses and Revenue to a Government Tertiary Neuropsychiatric Hospital Under Ayushman Bharat.

Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) is a health insurance scheme launched by the Government of India (GOI) in 2018 to cover the in-patient (IP) treatment expenditures, including mental illness treatment expenditures, for 500 million Indians. AB-PMJAY pays 100% of treatment expenditures for persons below the poverty line (BPL) and 30% for people above the poverty line (APL). Ayushman Bharat Arogya Karnataka (ABAK) trust implements this scheme in Karnataka, a southern Indian state. Data of persons with mental illness (PMI) admitted under AB-PMJAY at a tertiary care neuropsychiatric hospital between 2018 and 2021 was analyzed to understand the socio-demographic and clinical variables, the average length of stay (LOS), and the amount claimed by the hospital. Median LOS for PMI with any clinical diagnoses was 18 days (range 2-145),14 for those with substance use or mood disorders, and 24 days for those with schizophrenia and other psychotic disorders. The hospital claimed an amount of Indian Rupees (INR) 15,291,349 for treating 868 PMI under AB-PMJAY. The minimum and maximum LOS varied 70-fold, and there was a significant difference between different PMIs based on their clinical diagnosis. ABAK paid ₹3,488-12,750 per PMI for their treatment. Further research is needed to determine the variables influencing the LOS and the cost to the implementing agency.

Performance of the 2023 diagnostic criteria for MOGAD: real-world application in a Chinese multicenter cohort of pediatric and adult patients

BackgroundThe clinical phenotypes of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) have been found to overlap with several other diseases. The new criteria proposed in 2023 were designed to better identify the disease but require validation across various populations to ascertain its clinical utility. We aimed to investigate the diagnostic performance in phenotypically diverse patients.MethodsThis multicenter study retrospectively included adult and pediatric patients who were hospitalized for a first suspected demyelinating event and tested positive for MOG immunoglobulin G (IgG) during the acute phase. The 2023 Lancet Neurology criteria were assessed against the benchmark of empirical clinical diagnosis, and the 2018 JAMA Neurology and Journal of Neuroinflammation criteria were also evaluated for comparative analysis.ResultsAmong the 291 eligible patients (82 adults, 209 children), 282 (96.9%) were clinically diagnosed as definite MOGAD (77 adults, 205 children), while 262 (90.0%) fulfilled the 2023 diagnostic criteria (78 adults, 184 children). A total of 265 patients met the criteria for core clinical demyelinating events, and 76 (26.1%) had serum clear positive MOG-IgG (≥ 1:100). The sensitivity of the 2023 criteria was 0.91 (adults vs. children = 0.97 vs. 0.89), the specificity was 0.56 (adults vs. children = 0.40 vs. 0.75), positive likelihood ratio was 2.06 (adults vs. children = 1.62 vs. 3.57), and negative likelihood ratio (NLR) was 0.15 (adults vs. children = 0.06 vs. 0.14). Additionally, 264 and 256 cases were classified as definite MOGAD by the 2018 JAMA Neurology and Journal of Neuroinflammation criteria, respectively. Compared to the 2023 diagnostic criteria, the 2018 JAMA Neurology criteria demonstrated similar diagnostic performance. However, the 2018 Journal of Neuroinflammation criteria exhibited comparable sensitivity (0.92, adults vs. children = 0.96 vs. 0.89), higher specificity (1.00, adults vs. children = 1.00 vs. 1.00) and better NLR (0.09, adults vs. children = 0.04 vs. 0.11).ConclusionsThe 2023 criteria demonstrated good sensitivity in adult and pediatric patients in China yet modest specificity. Close follow-up is needed for patients with atypical phenotypes but high-titer MOG-IgG to avoid underdiagnosis.

DOP094 Improvement in biomarkers in patients with ulcerative colitis treated with vedolizumab: Results from the continuing VERDICT trial

Abstract Background Treatment targets in ulcerative colitis (UC) include symptomatic remission, endoscopic remission, and histologic remission. The ongoing VERDICT trial (NCT04259138) aims to determine the optimal treatment target in patients with moderately-to-severely active UC.1,2 Patients follow treatment algorithms involving early use of vedolizumab (VDZ). Here we report biomarker changes (fecal calprotectin [FCP] and C-reactive protein [CRP]) from baseline to weeks 8, 16, 32 and 48. Methods VDZ 300 mg was administered intravenously following a treatment algorithm related to baseline UC treatment until assigned treatment target was reached, with an escalation step between week 16, 32 and 48 as indicated. Treatment targets were as follows: Group 1 (corticosteroid-free [CSF] symptomatic remission), Group 2 (CSF symptomatic remission + CSF endoscopic remission), and Group 3 (CSF symptomatic remission + CSF endoscopic remission + CSF histologic remission, also termed disease clearance). CSF symptomatic remission was defined as Mayo rectal bleeding subscore=0, CSF endoscopic remission was defined as Mayo Endoscopic Score [MES]≤1, and CSF histologic remission was defined as Geboes score&amp;lt;2B.0. Biomarker assessments included FCP and CRP at weeks 8, 16, 32, and 48. Biomarker remission was defined as FCP ≤250 mg/kg and CRP ≤5 mg/l. Results As of 1st October 2024, 672 patients were enrolled, with 185, 222, and 265 patients in Groups 1, 2, and 3, respectively. Biomarkers improved from baseline to Week 16 and incrementally through to Week 48 (Table). Mean changes from baseline to Week 48 in FCP in groups 1, 2, and 3 were: -1268.8 mg/kg, -1515.9 mg/kg, and -1230.1 mg/kg (Table). For CRP, mean changes from baseline to Week 48 were -1.5 mg/l (Group 1), -3.4 mg/l (Group 2), and -1.8 mg/l (Group 3). For FCP, mean changes to Week 48 in all 3 groups were greater in bio-exposed than bionaïve patients, whereas mean change in CRP was greater in bio-exposed patients in Group 1 only (Table). In patients who achieved biomarker remission (FCP≤ 250 mg/kg + CRP ≤5 mg/l) at Week 48, the proportions who had met their treatment target were 51.6% (Group 1), 57.1% (Group 2), and 48.6% (Group 3) [Figure]. Higher baseline FCP was associated with lower odds of histologic remission at Week 16, 32, and 48, with corresponding odds ratios (95% CI) for histologic remission per 100 µg/g increase of baseline FCP of 0.89 (0.86, 0.93), 0.89 (0.86, 0.93), and 0.82 (0.76, 0.87). Conclusion Biomarker data from VERDICT shows improvements in FCP and CRP concentrations from baseline to Week 16, with incremental improvements through to Week 48. Almost half or more of all patients who achieved biomarker remission achieved their assigned treatment target.

DOP007 Change in Histological inflammation in patients with ulcerative colitis treated with vedolizumab: Results from the continuing VERDICT trial

Abstract Background Ulcerative colitis (UC) treatment targets include symptomatic, endoscopic, or histologic remission. The aim of the continuing VERDICT trial (NCT04259138) is to determine the optimal treatment target in patients with moderately-to-severely active UC.1,2 Patients follow treatment algorithms involving early introduction of vedolizumab (VDZ). In this analysis, we report changes in histology indices: Nancy index (NI), Robarts Histopathological index (RHI) and Geboes score from baseline to weeks 16, 32 and 48 in patients for whom histologic remission was included as a treatment target. Methods Patients received VDZ 300 mg IV, as per a treatment algorithm related to baseline UC treatment, until assigned treatment target was reached, with escalation steps between week 16,32 and 48, as indicated. Treatment target groups were as follows: Group 1 (corticosteroid-free [CSF] symptomatic remission), Group 2 (CSF symptomatic remission + CSF endoscopic remission), and Group 3 (CSF symptomatic remission + CSF endoscopic remission + CSF histologic remission, also termed disease clearance). CSF symptomatic remission was defined as Mayo rectal bleeding subscore=0, CSF endoscopic remission was defined as Mayo Endoscopic Score ≤1, and CSF histologic remission was defined as Geboes score&amp;lt;2B.0. For this analysis, we report the findings for Group 3, the only group with histologic remission included as a treatment target. Results At the interim data cutoff point for this analysis 672 patients were enrolled, with 265 patients in Group 3. Histologic scores improved by Week 16, with mean changes from baseline in NI of -1.4, and changes in RHI of -9.0. Histologic improvements continued to increase incrementally at Weeks 32 and 48 (Table). By Week 48, mean change from baseline in NI was -1.9 (Table). For RHI, mean change from baseline to Week 48 was -12.2. For both NI and RHI, mean change from baseline to Week 48 was greater in bionaïve than bio-exposed patients (Table). Histologic remission assessments were similar for NI, RHI, and Geboes score, with 50% of patients achieving corticosteroid-free histologic remission at Week 16, and 66.7% at Week 48 (Figure). Conclusion Vedolizumab treatment was associated with rates of corticosteroid-free histologic remission that were evident as early as Week 16 and increased incrementally through to Week 48, when it reached two thirds. The magnitude of histologic improvement was similar for all three scoring methods.

Healthcare resource utilization and costs of using cariprazine as the first versus subsequent adjunctive therapy for major depressive disorder

Aim Inadequate response to antidepressant therapy (ADT) is common in major depressive disorder (MDD); atypical antipsychotic (AA) adjunctive therapy may be effective for these patients. This study aimed to compare healthcare resource utilization (HRU) and costs between patients initiating the AA cariprazine as their first adjunctive therapy vs those initiating cariprazine subsequently. Methods The Merative MarketScan Commercial Database (January 1, 2015, to June 30, 2021) was used to identify US adults with MDD and ≥1 pharmacy claim for cariprazine adjunctive to ADT in 2018 or after. Rates of mental health (MH)‑related and all‑cause HRU per patient-year (PPY) and mean healthcare costs per-patient-per-year (PPPY) were assessed after patients first initiated adjunctive therapy. HRU and costs were compared between cohorts using rate ratios (RRs) and mean cost differences, respectively, estimated from multivariable regression models. Results Of 838 patients receiving cariprazine, 44.7% initiated cariprazine as their first adjunctive therapy to ADT, and 55.3% initiated it subsequently. Those initiating cariprazine first had significantly lower rates of MH‑related hospitalizations (RR [95% confidence interval] = 0.55 [0.30, 0.90], p = .020) and outpatient (OP) visits (0.67 [0.57, 0.82], p < .001) PPY than those initiating cariprazine subsequently. Moreover, patients initiating cariprazine as their first adjunctive therapy had lower annual total MH‑related healthcare costs (mean cost difference [95% confidence interval] −$2,182 [−$4,206, −$69], p = .040), driven primarily by lower OP visit costs (−$1,511 [−$2,330, −$615], p < .001). Similar trends were observed for all-cause HRU and costs. Limitations This was a retrospective analysis of secondary data with limited follow-up. Claims were a proxy for cariprazine use. Conclusions Results from this real‑world study of commercially insured US adults suggest that initiating cariprazine as the first adjunctive therapy rather than a subsequent therapy could help mitigate the considerable economic burden of MDD for appropriate patients.