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Abstract Background Acute pancreatitis, a prevalent gastrointestinal condition, frequently necessitates hospitalization and is associated with potential adverse in-hospital outcomes. Recent data showed the detrimental effects of COVID-19 infection on acute pancreatitis, particularly in patients with severe COVID-19 infections. However, limited information exists on the specific impacts of COVID-19 infection in patients hospitalized for acute pancreatitis. Methods We analyzed the 2020 U.S. National Inpatient Sample (NIS) to investigate the effects of COVID-19 infection on cases primarily admitted due to acute pancreatitis. Participants aged 18 and above were identified using relevant ICD-10 CM codes. Adjusted odds ratios (aORs) for specified outcomes were calculated through multivariable logistic and linear regression analyses. The primary outcome was inpatient mortality, with secondary outcomes including system-based complications. Statistical significance was established at a P value of 0.05. Results We identified 252,435 patients with a primary discharge diagnosis of acute pancreatitis. The mean age was 50.1 years; 48.6% were female. Caucasians accounted for 41%, followed by Hispanics. Of these, 1.05% (2,675/252,435) had a concurrent diagnosis of COVID-19 infection. In a survey multivariable logistic and linear regression model adjusting for patient and hospital factors, COVID-19 infection was associated with higher in-hospital mortality (aOR 3.71; 95% CI 2.01, 6.84, P < 0.001), prolonged length of stay (β LOS 1.05; 95% CI 0.46, 1.64, P < 0.001), increased hospitalization charge ( β charge 9,327; 95% CI 820, 17834, P < 0.001), and acute respiratory failure (aOR 2.49; 95% CI 1.75, 3.53, P < 0.001), We observed non-significant, but increased, risks of shock, acute kidney injury (AKI), pancreatic pseudocyst, acute respiratory distress syndrome (ARDS), and mechanical ventilation in COVID-19 positive patients. Conclusion In conclusion, our study underscores that COVID-19 infection is associated with higher in-hospital mortality, prolonged hospital stays, and increased incidence of acute respiratory failure in patients diagnosed with acute pancreatitis. Future longitudinal studies are warranted to comprehensively assess the long-term health sequelae in this population. Disclosures All Authors: No reported disclosures

Abstract Background Acute diverticulitis, a prevalent gastrointestinal condition, frequently necessitates hospitalization and is associated with potential adverse in-hospital outcomes. Recent data showed the detrimental effects of COVID-19 infection on acute diverticulitis, particularly in patients with severe COVID-19 infections. However, limited information exists on the specific impacts of COVID-19 infection in patients hospitalized for acute diverticulitis. Methods We analyzed the 2020 U.S. National Inpatient Sample (NIS) to investigate the effects of COVID-19 infection on cases primarily admitted due to acute diverticulitis. Participants aged 18 and above were identified using relevant ICD-10 CM codes. Adjusted odds ratios (aORs) for specified outcomes were calculated through multivariable logistic and linear regression analyses. The primary outcome was inpatient mortality, with secondary outcomes including system-based complications. Statistical significance was established at a P value of 0.05. Results We identified 167,170 patients with a primary discharge diagnosis of acute pancreatitis. The mean age was 60.1 years; 56.8% were female. Caucasians accounted for the majority, followed by Hispanics. Of these, 0.90% (1,504/167,170) had a concurrent diagnosis of COVID-19 infection. In a survey multivariable logistic and linear regression model adjusting for patient and hospital factors, COVID-19 infection was associated with higher in-hospital mortality (aOR 8.43; 95% CI 4.32, 16.42, P < 0.001), prolonged length of stay (β LOS 2.02; 95% CI 1.27, 2.77, P < 0.001) and increased hospitalization charge ( β charge 17,813.27; 95% CI 4,080, 31,546, P < 0.001), We observed non-significant, but increased, risks of shock, acute kidney injury (AKI), acute respiratory distress syndrome (ARDS), and mechanical ventilation in COVID-19 positive patients. Conclusion In conclusion, our study revealed that COVID-19 infection is associated with higher in-hospital mortality, prolonged hospital stays, and increased hospitalization charges in patients diagnosed with acute diverticulitis. Future longitudinal studies are warranted to comprehensively assess the long-term health sequelae in this population. Disclosures All Authors: No reported disclosures

ABSTRACTObjectiveTo assess how patient and caregiver factors influence caregiver readiness for hospital discharge in palliative care patients.Study Setting and DesignThis transitional care study uses cross‐sectional data from a randomized controlled trial conducted from 2018 to 2023 testing an intervention for caregivers of hospitalized adult patients with a serious or life‐limiting illness who received a palliative care consult prior to transitioning out of the hospital.Data Sources and Analytical SampleCaregiver readiness was measured with the Family Readiness for Hospital Discharge Scale (n = 231). Caregiver demographic, intra‐ and interpersonal factors were self‐reported. Patient demographic, comorbidity score, and risk score for complicated discharge planning were extracted from electronic health records. Stepwise regression models estimated variance explained (r2) in caregiver readiness for patient hospital discharge.Principal FindingsPatient demographics and complexity were not statistically associated with caregiver readiness for discharge. Caregiver depressive symptoms, poor caregiver‐patient relationship quality, and fewer hours spent caregiving prior to hospitalization explained 29% of the variance in caregiver readiness.ConclusionsReliance on patient data may not be sufficient for explaining caregiver readiness for discharge. Assessing caregiver factors may be a better alternative for identifying caregivers at risk for low discharge readiness and those in need of additional support.Trial Registration: ClinicalTrials.gov on November 13, 2017, (No. NCT03339271)

AbstractIntroductionCastleman disease (CD) refers to a heterogeneous group of lymphoproliferative disorders, which rarely involves the larynx. Our goal in this study is to elucidate the clinical presentation, diagnostic techniques, and treatment methods of laryngeal CD through a scoping review and the addition of a new case.MethodsDue to limited existing literature, we employed a mixed methodology for review. First, we searched Google Scholar using terms related to laryngeal CD. Subsequently, we screened abstracts using Covidence, drawing from databases such as PubMed, Science Direct, ProQuest, and EMBASE. We shortlisted studies for data extraction, focusing on clinical presentations, diagnostics, and treatment methodologies. Finally, we described our additional case.ResultsScoping review revealed five qualifying laryngeal CD articles. Presenting symptoms included dysphagia, hoarseness, and dyspnea. Diagnosis was always established through histopathologic analysis. Management included local excision or radiotherapy. In our additional case, a 71‐year‐old male with known CD presented with neck swelling, dysphagia, and dysphonia. Exam revealed lymphoid laryngeal and supraglottic hyperplasia and edema. Laryngeal symptoms improved with medical management of CD.DiscussionGiven the rarity of laryngeal CD, its identification and management can be a challenge. Practitioners should be aware of characteristic points in a CD patient's history, physical exam, imaging, and biopsies. Local excision of obstructive lymphoid tissue and radiation are the best‐supported therapies. This study aims to build toward improvements in accurate diagnosis and appropriate treatment for laryngeal CD.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, impacting approximately 6.1 million adults in the United States, with projections to increase two-fold by 2030. AF significantly increases the risk of stroke and other adverse cardiovascular events, leading to increased morbidity and mortality. The 2023 ACC/AHA/ACCP/HRS guidelines present a paradigm shift in AF management, moving from a duration-based classification to a more comprehensive, patient-centered approach. This includes a novel AF classification system that emphasizes early detection and intervention, including risk factors and lifestyle modification tailored to each patient’s risk profile. Moreover, the recommendations advocate for a multidisciplinary care model, ensuring coordinated management involving primary care providers and specialists. Primary care providers play a crucial role in initiating risk factor management and lifestyle interventions, even before the development of AF. This review aims to thoroughly examine the guidelines for the diagnosis and management of AF and equip general internists with the necessary insights to navigate the evolving landscape of AF care effectively.

Multigene panel testing has allowed for the detection of a growing number of inherited pathogenic/likely pathogenic variants in people at high risk of cancer, including endometrial cancer (EC). Hereditary syndromes associated with EC include Lynch syndrome, PTEN hamartoma tumor syndrome, and Peutz-Jeghers syndrome. This manuscript provides the latest recommendations from the NCCN Guidelines for Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric on the screening and management of EC in patients at high risk for these syndromes, as well as the advantages and limitations of multigene panel testing. This manuscript also describes recent updates to these guidelines regarding de-implementation of colon cancer screening in individuals with CHEK2 pathogenic/likely pathogenic variants, based on the most up-to-date evidence regarding the association between CHEK2 pathogenic/likely pathogenic variants and colon cancer risk.

Background: The COVID-19 pandemic had an outsized impact on individuals with immune compromise, such as multiple myeloma, leading to increased rates of severe COVID, hospitalization, and death in these groups. The pandemic also demonstrated the need for rapid and efficient evidence generation to address rapidly changing medical needs and accelerated the use of innovative trial designs to accomplish this goal. Methods: We designed and established a prospective, decentralized study within a site-based provider network, COVID-19 OutcomeS in Myeloma and the Impact of VaCcines (COSMIC), for patients with multiple myeloma at ASH Research Collaborative sites to monitor outcomes related to COVID-19 infection and vaccination. The direct-to-patient approach was accomplished using a study application accessed with a QR code provided to patients during usual clinical care. All study activities occurred within the patient portal at Baseline, Day 30, and Day 180, minimizing burden on site personnel and staff. Study activities included eligibility confirmation, consenting, electronic health record (EHR) data permissions, and patient-reported outcome (PRO) surveys. PRO data (EORTC QLQ-C30, EORTC QLQ MY-20) were made available to clinicians through the portal to visualize results from their patients. Patients shared if they received a COVID-19 vaccination or booster and if they had a COVID-19 infection. Patients with a history of COVID-19 infection included method of confirmation and if hospitalization was required. Patients were provided compensation for participation. Automated text and email messages were sent at three separate intervals: 24 hours, Day 8, and Day 15 for participants who initiated but did not complete study activities. A personal email reminder per participant was sent for those whose second study visit window was approaching. ASH Research Collaborative clinicians met regularly to share best practices related to enrollment and study conduct, thereby creating an innovative evidence generation learning community. We studied the feasibility of data collection in a decentralized format by focusing on the number of participants who interacted with the system, those who consented, and those who completed baseline PRO assessments. Results: The COSMIC study rapidly accrued and consented 200 patients from eight participating ASH Research Collaborative sites over four months (1/22/2024 through 5/17/2024): 69% self-reported as non-Hispanic White (NHW). Of enrolled participants, 57.5% opted to permission sharing of their EHR data, which included disease and treatment-related clinical data, laboratory results, pathology reports, and imaging reports. A total of 196 patients (98%) provided demographic and COVID-related disease and vaccine data at baseline; nearly all of these patients (n=195) provided baseline PRO data, and 150 patients provided further information at Day 30 at the time of this analysis. Those who did not provide Day 30 data were not significantly different from those who did in terms of age (median: 68 [no Day 30 data] vs. 67 [Day 30 data] years; p=0.44), sex (41% [no Day 30 data] vs. 47% [Day 30 data] Female; p=0.47), or race (65% [no Day 30 data] vs. 71% [Day 30 data] NHW; p=0.60). A higher proportion of Hispanic patients were retained at Day 30 (13/15=87%) vs. 78% of non-Hispanic patients or those who declined reporting ethnicity (2/7=29%; p=0.007). COVID-19 vaccination data were submitted by 196 patients, 186 of whom had ever received a COVID-19 vaccination. Data on number, type, brand, and dates for these vaccinations were provided. Conclusions: The COSMIC study conducted by the ASH Research Collaborative was able to rapidly accrue a diverse cohort of patients using a decentralized workflow within a site-based provider network, with high consent and compliance rates. This platform, and the innovative evidence generation learning community of ASH Research Collaborative investigators and patients, sets a precedent to address a variety of real-world questions related to disease management, infections, vaccinations, and PROs in this population of patients with multiple myeloma.

Background: Hypomethylating agent (HMA) and venetoclax (VEN) therapy is a standard of care frontline treatment of acute myeloid leukemia (AML) amongst patients (pts) ineligible for intensive therapy. Despite its convenient flat dose, oral nature, and static excretion irrespective of body weight (wt), VEN has a large, variable volume of distribution and extensive protein binding (Yang, Molecules, 2022). Body mass index (BMI) is a more accurate, albeit imperfect, indicator of body fat that has not been evaluated as an independent predictor of differential VEN exposures and clinical outcomes. We sought to evaluate this possibility amongst pts treated with frontline HMA+VEN in a multi-center, real-world, retrospective study. Methods: We conducted a multi-center, retrospective study through four US academic centers in the Consortium on Myeloid Malignancies and Neoplastic Diseases (COMMAND). 368 pts treated with frontline HMA+VEN from 6/2016-8/2023were evaluated based on BMI within 30 days of induction. Responses were defined by European LeukemiaNet (ELN) 2022 criteria. Pearson's chi-squared test and Wilcoxon rank-sum test were used for comparison between groups. The Kaplan-Meier method and multivariable Cox regression model were applied to overall survival (OS). Continuous variables were summarized as a median with interquartile range (IQR), and categorical variables were reported as a frequency (percentage). Results: The median age was 75 (IQR: 70-79) years, 58% were male, and 76% were white. 107 (29%) had a normal BMI of 18-25 kg/m2, 141 (38%) were overweight (BMI 25-30 kg/m2), and 120 (33%) were obese (BMI >30 kg/m2). There were no significant differences in baseline pt-, disease-, and treatment-specific factors when comparing pts with normal wt to BMI >25.The cohort was enriched for complex karyotype and TP53-mutated disease (27% and 32%, respectively), with 73% categorized as adverse risk by ELN 2022. There was no difference in 30-, 60-, and 90-day mortality rates (6-8%, 14-18%, 19-29%, respectively) by BMI group. Complete remission (CR/CRi) rate was 50% overall and was not impacted by BMI (41%, normal wt; 55%, overweight; 52%, obese) (p=0.10). Overall response rate (ORR) (CR/CRi/MLFS) was 59% overall and differed by BMI groups (50%, normal wt; 66%, overweight; 58%, obese) (p= 0.047). The median OS was 6.6 months for normal wt, 13.7 months for overweight, and 8.3 months for obese pts, and not significantly different when comparing normal to overweight (p=0.052) or obese pts (p=0.756). In multivariable analysis, the effect of BMI varied by the composite remission rate used. Overweight was borderline significantly associated with higher likelihood of achieving CR compared to normal wt (odds ratio [OR] 1.98, 95% confidence interval [CI] 0.99-4.03; p=.056), whereas obesity was not (OR 1.78, CI 0.86-3.74; p=.13). Other co-variates with a significant association with achieving CR included diagnosis of secondary AML (sAML) (OR 0.37, CI 0.18-0.74; p=.006) and presence of IDH (OR 2.81, CI 1.30-6.15; p=.009), ASXL (OR 0.39, CI 0.15-0.96; p=.046), TET2 (OR 2.43, CI 1.17-5.09; p=.02), and DNMT3A (OR 2.37, CI 1.19-4.78; p=.02) mutations. There was a trend towards higher likelihood of achieving CR/CRi for both overweight (OR 1.74, CI 0.92-3.32; p=.09) and obese pts (OR 1.88, CI 0.96-3.74; p=.07). Diagnosis of sAML and presence of TET2, ASXL, and DNMT3A mutations no longer had a significant association with achieving CR/CRi, while IDH mutations maintained an association (p=.01). None of these variables demonstrated a significant impact on ORR (inclusive of MLFS) except overweight (OR: 1.99, CI 1.06-3.80; p=.03) and sAML vs de novo (OR: 0.53, CI 0.29-0.99; p=.047). In multivariable logistic regression, higher ECOG score was associated with risk of early mortality within 60 (p=.01) and 90 (p=.01) days, but not 30 days. sAML vs de novo associated with higher 90-day mortality, presence of NPM and TP53 mutation associated with higher 30-day mortality, and cytogenetic risk associated with higher 60- and 90-day mortality. Conclusions: This multi-center, real-world study demonstrates that BMI may not have a linear effect on response to frontline HMA+VEN, with some indication of negative impact at both lower and higher BMI categories. However, additional dedicated studies are needed to determine if differences in BMI is associated with altered drug exposure as an explanation for these differences.

Background: Data from the ASH Research Collaborative COVID-19 Registry for Hematology demonstrated that patients with multiple myeloma and other immune compromise had elevated risk for severe complications from COVID-19 infection. To address current evidence gaps and to demonstrate proof of concept for a pandemic preparedness and response network, the ASH Research Collaborative Multiple Myeloma Program developed a prospective, decentralized study within a site-based provider network to investigate COVID-19 infections, vaccinations, and quality of life in patients with multiple myeloma. Methods: We designed and established the COVID-19 OutcomeS in Myeloma and the Impact of VacCines (COSMIC) to study COVID-19 in patients with multiple myeloma at ASH Research Collaborative network sites. A study application was accessed with a QR code and shared with patients during usual clinical care. Patients provided consent, optionally gave permission for electronic health record data collection, and completed patient-reported outcomes (EORTC QLQ-C30 and MY20) at baseline, Day 30, and Day 180 through the study portal. Clinicians at participating sites facilitated study enrollment and shared best practices monthly to accelerate study execution. Study objectives related to feasibility of data collection in a decentralized format are reported in a separate abstract. Here, we report interim results related to SARS-CoV-2 vaccination history, COVID-19 infection, and how these relate to patient reported outcomes and clinical outcomes in enrolled participants. Results: The COSMIC study rapidly accrued and consented 200 patients from eight participating ASH Research Collaborative sites over four months (1/22/2024 through 5/17/2024). Consented participants' ages ranged from 29 to 93 years, with median of 67 years; 46% were female, 69% were non-Hispanic White (NHW), 17% were non-Hispanic Black (NHB), and 8% were Hispanic/Latino. Of the 196 patients who reported COVID-19 data, 111 (57%) reported at baseline that they had a history of COVID-19 infection, with 12 having required hospitalization for this (12/111=11%). Overall, 95% (186/196) reported a history of COVID-19 vaccination, where the median number of vaccinations was 4 (range: 1 to 6); 44 patients (23%) expressed willingness to discuss getting a yearly booster vaccine with their provider. At 1-month follow-up, there were 3 additional patients who reported a COVID-19 infection and 18 patients who received an additional COVID-19 vaccination. The baseline EORTC QLQ-C30 median Global Health Status/QOL score was 66.7 (mean=64.4, range: 8.3 - 100, n=196). This overall global QOL score was not significantly different between those who did vs. did not have a history of COVID-19 infection (mean [SD]: 63.7 [19.3] vs. 65.8 [17.6]; p=0.57). In analyses adjusted for age, biological sex, and race/ethnicity group, history of COVID-19 infection was not associated with HRQOL (odds ratio=0.93, 95% CI: 0.78 - 1.10; p=0.38). Data collection is ongoing and final study results will be reported at a later date. Conclusion: COSMIC is a prospective, decentralized study within a site-based provider network conducted by the ASH Research Collaborative Multiple Myeloma Program that demonstrates the feasibility of using an innovative evidence generation strategy to drive rapid accrual of patients to address a rapidly evolving area of need. The COSMIC study also provides proof of concept that a real-world evidence generation network can play an important role in national pandemic preparedness and response. The COSMIC experience reinforces the ability to accrue diverse patient populations representing the demographic of myeloma patients in the US.