Veterans Affairs Corporate Data Warehouse Research Articles

Organizational and Implementation Factors Associated with Cirrhosis Care in the Veterans Health Administration.

The Veterans Health Administration provides care to more than 100,000 Veterans with cirrhosis. This implementation evaluation aimed to understand organizational resources and barriers associated with cirrhosis care. Clinicians across 145 Department of Veterans Affairs (VA) medical centers (VAMCs) were surveyed in 2022 about implementing guideline-concordant cirrhosis care. VA Corporate Data Warehouse data were used to assess VAMC performance on two national cirrhosis quality measures: HCC surveillance and esophageal variceal surveillance or treatment (EVST). Organizational factors associated with higher performance were identified using linear regression models. Responding VAMCs (n = 124, 86%) ranged in resource availability, perceived barriers, and care processes. In multivariable models, factors independently associated with HCC surveillance included on-site interventional radiology and identifying patients overdue for surveillance using a national cirrhosis population management tool ("dashboard"). EVST was significantly associated with dashboard use and on-site gastroenterology services. For larger VAMCs, the average HCC surveillance rate was similar between VAMCs using vs. not using the dashboard (47% vs. 41%), while for smaller and less resourced VAMCs, dashboard use resulted in a 13% rate difference (46% vs. 33%). Likewise, higher EVST rates were more strongly associated with dashboard use in smaller (55% vs. 50%) compared to larger (57% vs. 55%) VAMCs. Resources, barriers, and care processes varied across diverse VAMCs. Smaller VAMCs without specialty care achieved HCC and EVST surveillance rates nearly as high as more complex and resourced VAMCs if they used a population management tool to identify the patients due for cirrhosis care.

Emergency Department Use Among Combat and Non-Combat Post-9/11 Military Veterans.

Most post-9/11 Veterans have completed at least 1 combat deployment-a known factor associated with adverse health outcomes. Such Veterans are known to have unmet health care needs, and the emergency department (ED) may serve as a safety net, yet little is known about whether combat status is associated with more frequent ED use. We sought to evaluate the relationship between combat status and frequency of ED use among post-9/11 Veterans and assess the most common reasons for ED visits. This retrospective cohort study consisted of post-9/11 Veterans who enrolled in U.S. Department of Veterans Affairs (VA) care between fiscal years (FYs) 2005 and 2015. Data were obtained from the VA Corporate Data Warehouse. Incidence rates for ED visits for combat and non-combat Veterans were compared from FY 2010 to 2019 using zero-inflated negative binomial regression. The most frequent reasons for ED visits were determined using International Classification of Diseases codes. This study was approved by the Stanford Institutional Review Board. Among 1.3 million Veterans included in analyses, 70.4% had deployed to a combat zone. The mean (SD) age of our cohort was 32.6 (5.0) years and 83.5% of Veterans were male. After controlling for other factors, combat Veterans had 1.84 times the rate of ED visits compared to non-combat Veterans (95% CI, 1.83-1.85). Only combat Veterans had a mental health-related ED visit (suicidal ideations) among the top 3 reasons for ED presentation. Those who deployed to a combat zone had a significantly higher rate of ED use compared to those who did not. Further, mental health-related ED diagnoses appeared to be more prevalent in combat Veterans. These findings highlight the unique health care needs faced by combat Veterans and emphasize the importance of tailored interventions and support services for this specific population.

Question-answering system extracts information on injection drug use from clinical notes

BackgroundInjection drug use (IDU) can increase mortality and morbidity. Therefore, identifying IDU early and initiating harm reduction interventions can benefit individuals at risk. However, extracting IDU behaviors from patients’ electronic health records (EHR) is difficult because there is no other structured data available, such as International Classification of Disease (ICD) codes, and IDU is most often documented in unstructured free-text clinical notes. Although natural language processing can efficiently extract this information from unstructured data, there are no validated tools.MethodsTo address this gap in clinical information, we design a question-answering (QA) framework to extract information on IDU from clinical notes for use in clinical operations. Our framework involves two main steps: (1) generating a gold-standard QA dataset and (2) developing and testing the QA model. We use 2323 clinical notes of 1145 patients curated from the US Department of Veterans Affairs (VA) Corporate Data Warehouse to construct the gold-standard dataset for developing and evaluating the QA model. We also demonstrate the QA model’s ability to extract IDU-related information from temporally out-of-distribution data.ResultsHere, we show that for a strict match between gold-standard and predicted answers, the QA model achieves a 51.65% F1 score. For a relaxed match between the gold-standard and predicted answers, the QA model obtains a 78.03% F1 score, along with 85.38% Precision and 79.02% Recall scores. Moreover, the QA model demonstrates consistent performance when subjected to temporally out-of-distribution data.ConclusionsOur study introduces a QA framework designed to extract IDU information from clinical notes, aiming to enhance the accurate and efficient detection of people who inject drugs, extract relevant information, and ultimately facilitate informed patient care.

Adopting the RE-AIM analytic framework for rural program evaluation: experiences from the Advance Care Planning via Group Visits (ACP-GV) national evaluation.

To support rigorous evaluation across a national portfolio of grants, the United States Department of Veterans Affairs (VA) Office of Rural Health (ORH) adopted an analytic framework to guide their grantees' evaluation of initiatives that reach rural veterans and to standardize the reporting of outcomes and impacts. Advance Care Planning via Group Visits (ACP-GV), one of ORH's Enterprise-Wide Initiatives, also followed the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. ACP-GV is a national patient-centered intervention delivered in a large, veterans integrated healthcare system. This manuscript describes how RE-AIM was used to evaluate this national program and lessons learned from ORH's annual reporting feedback to ACP-GV on their use of the framework to describe evaluation impacts. We used patient, provider, and site-level administrative health care data from the VA Corporate Data Warehouse and national program management databases for federal fiscal years (FY) spanning October 1, 2018-September 30, 2023. Measures included cumulative and past FY metrics developed to assess program impacts. RE-AIM constructs included the following cumulative and annual program evaluation results. ACP-GV reached 54,167 unique veterans, including 19,032 unique rural veterans between FY 2018 to FY 2023. During FY 2023, implementation adherence to the ACP-GV model was noted in 91.7% of program completers, with 55% of these completers reporting a knowledge increase and 14% reporting a substantial knowledge increase (effectiveness). As of FY 2023, 66 ACP-GV sites were active, and 1,556 VA staff were trained in the intervention (adoption). Of the 66 active sites in FY 2023, 27 were sites previously funded by ORH and continued to offer ACP-GV after the conclusion of three years of seed funding (maintenance). Lessons learned developing RE-AIM metrics collaboratively with program developers, implementers, and evaluators allowed for a balance of clinical and scientific input in decision-making, while the ORH annual reporting feedback provided specificity and emphasis for including both cumulative, annual, and rural specific metrics. ACP-GV's use of RE-AIM metrics is a key step towards improving rural veteran health outcomes and describing real world program impacts.

Association of Posttraumatic Stress Disorder and Race on Readmissions After Stroke.

There is limited research on outcomes of patients with posttraumatic stress disorder (PTSD) who also develop stroke, particularly regarding racial disparities. Our goal was to determine whether PTSD is associated with the risk of hospital readmission after stroke and whether racial disparities existed. The analytical sample consisted of all veterans receiving care in the Veterans Health Administration who were identified as having a new stroke requiring inpatient admission based on the International Classification of Diseases codes. PTSD and comorbidities were identified using the International Classification of Diseases codes and given the date of first occurrence. The retrospective cohort data were obtained from the Veterans Affairs Corporate Data Warehouse. The main outcome was any readmission to Veterans Health Administration with a stroke diagnosis. The hypothesis that PTSD is associated with readmission after stroke was tested using Cox regression adjusted for patient characteristics including age, sex, race, PTSD, smoking status, alcohol use, and comorbidities treated as time-varying covariates. Our final cohort consisted of 93 651 patients with inpatient stroke diagnosis and no prior Veterans Health Administration codes for stroke starting from 1999 with follow-up through August 6, 2022. Of these patients, 12 916 (13.8%) had comorbid PTSD. Of the final cohort, 16 896 patients (18.0%) with stroke were readmitted. Our fully adjusted model for readmission found an interaction between African American veterans and PTSD with a hazard ratio of 1.09 ([95% CI, 1.00-1.20] P=0.047). In stratified models, PTSD has a significant hazard ratio of 1.10 ([95% CI, 1.02-1.18] P=0.01) for African American but not White veterans (1.05 [95% CI, 0.99-1.11]; P=0.10). Among African American veterans who experienced stroke, preexisting PTSD was associated with increased risk of readmission, which was not significant among White veterans. This study highlights the need to focus on high-risk groups to reduce readmissions after stroke.

The impact of COVID-19 and vaccination status on outcomes in veterans with head and neck squamous cell carcinoma.

The impact of both COVID-19 infection and vaccination status on patients with head and neck squamous cell carcinoma (HNSCC) remains unknown. To determine the impact of COVID-19 infection and vaccination status on 60-day mortality, cardiovascular, and respiratory complications in patients with a prior diagnosis of HNSCC. This was a retrospective cohort study through the Veterans Affairs (VA) Corporate Data Warehouse of Veterans with HNSCC who were tested for COVID-19 during any inpatient VA medical center admission. A cohort of patients was created of Veterans with a diagnosis of HNSCC of the oral cavity,oropharynx, hypopharynx, larynx, and nasopharynx based on International Classification of Disease (ICD) codes. Data collected included clinical/demographic data, vaccination status, and incidence of 60-day mortality, 60-day cardiovascular complication (including myocardial infarction, venous thromboembolism, cerebrovascular accident), and 60-day respiratory complication (including acute respiratory failure, acute respiratory distress syndrome, and pneumonia). The interactions between COVID-19 infection, vaccination status, morbidity and mortality were investigated. Of the 14 262 patients with HNSCC who were tested for COVID-19 during inpatient admission, 4754 tested positive (33.3%), and 9508 (67.7%) tested negative. Patients who tested positive demonstrated increased 60-day mortality (4.7% vs. 2.0%, respectively; p < 0.001), acute respiratory failure (ARF; 15.4% vs. 7.1%, p < 0.001), acute respiratory distress syndrome (ARDS; 0.9% vs. 0.2%, p < 0.001), and pneumonia (PNA; 20.0% vs. 6.4%, p < 0.001) compared to those who never tested positive, respectively. Patients who received COVID-19 vaccination between 2 weeks and 6 months prior to a positive test demonstrated decreased rates of ARF (13.2% vs. 16.0%, p = 0.034) and PNA (16.7% vs. 20.9%, p = 0.003) compared to the unvaccinated group. A logistic regression of patients with COVID-19 infections who died within 60 days was performed, with no significant survival advantage among patients vaccinated between 2 weeks and 6 months prior to the positive test. COVID-19 infection may significantly increase rates of 60-day mortality and respiratory complications in patients with HNSCC. COVID-19 vaccination between 2 weeks and 6 months prior to infection may decrease severity of respiratory complications but did not show significant mortality benefits in this study. These data highlight the need for surveillance of respiratory infection and vaccination in this vulnerable population.

Changes in Outpatient Health Care Use After COVID-19 Infection Among Veterans

The association of COVID-19 infection with outpatient care utilization is unclear. Many studies reported population surveillance studies rather than comparing outpatient health care use between COVID-19-infected and uninfected cohorts. To compare outpatient health care use across 6 categories of care (primary care, specialty care, surgery care, mental health, emergency care, and diagnostic and/or other care) between veterans with or without COVID-19 infection. In a retrospective cohort study of Veterans Affairs primary care patients, veterans with COVID-19 infection were matched to a cohort of uninfected veterans. Data were obtained from the Veterans Affairs Corporate Data Warehouse and the Centers for Medicare & Medicaid Services Fee-for-Service Carrier/Physician Supplier file from January 2019 through December 2022. Data analysis was performed from September 2022 to April 2023. COVID-19 infection. The primary outcome was the count of outpatient visits after COVID-19 infection. Negative binomial regression models compared outpatient use over a 1-year preinfection period, and peri-infection (0-30 days), intermediate (31-183 days), and long-term (184-365 days) postinfection periods. The infected (202 803 veterans; mean [SD] age, 60.5 [16.2] years; 178 624 men [88.1%]) and uninfected (202 803 veterans; mean [SD] age, 60.4 [16.5] years; 178 624 men [88.1%]) cohorts were well matched across all covariates. Outpatient use in all categories (except surgical care) was significantly elevated during the peri-infection period for veterans with COVID-19 infection compared with the uninfected cohort, with an increase in all visits of 5.12 visits per 30 days (95% CI, 5.09-5.16 visits per 30 days), predominantly owing to primary care visits (increase of 1.86 visits per 30 days; 95% CI, 1.85-1.87 visits per 30 days). Differences in outpatient use attenuated over time but remained statistically significantly higher at 184 to 365 days after infection (increase of 0.25 visit per 30 days; 95% CI, 0.23-0.27 visit per 30 days). One-half of the increased outpatient visits were delivered via telehealth. The utilization increase was greatest for veterans aged 85 years and older (6.1 visits, 95% CI, 5.9-6.3 visits) vs those aged 20 to 44 years (4.8 visits, 95% CI, 4.7-4.8 visits) and unvaccinated veterans (4.5 visits, 95% CI, 4.3-4.6 visits) vs vaccinated veterans (3.2 visits; 95% CI, 3.4-4.8 visits). This study found that outpatient use increased significantly in the month after infection, then attenuated but remained greater than the uninfected cohorts' use through 12 months, which suggests that there are sustained impacts of COVID-19 infection.

MULTIPLE BIOSIMILAR INFLIXIMAB SWITCHING IS NOT ASSOCIATED WITH DISEASE FLARE IN INFLAMMATORY BOWEL DISEASE: A REAL-WORLD EFFECTIVENESS ANALYSES IN A NATIONAL U.S. COHORT

Abstract BACKGROUND Infliximab (IFX) biosimilars are available for inflammatory bowel disease (IBD). Many options of IFX biosimilars exist, however there is a paucity of data on the safety and efficacy of switching between multiple IFX biosimilars. The goal of this study is to evaluate the safety and outcomes in patients who received multiple IFX biosimilars in a National U.S. Cohort of patients with IBD. METHODS We conducted a retrospective cohort study of IBD patients who received maintenance IFX originator from 2017- 2019 in the national Veterans Affairs (VA) healthcare system. Crohn’s disease (CD) and ulcerative colitis (UC) patients were identified using a previously validated algorithm. All cases, exposures and outcomes were confirmed by chart review. Patents on IFX originator were identified by dispensed medication from the VA Corporate Data Warehouse. Patients were classified as no-switch (NS)- receiving originator but no biosimilar during study period, Single Switch (SS)- switch from IFX originator to one biosimilar, or Double Switch (DS)- switch from IFX originator to two different biosimilars. Primary outcome was IBD flare, defined as escalation of steroid, IBD-related Emergency department visit or hospitalization within 12 months. Secondary outcomes were immunogenicity, serious infection, and infusion reaction. Event rates of the DS group were compared to NS and SS groups using univariate and multivariate logistic regression models adjusting for patient and non-patient factors. RESULTS A total of 789 patients (487 CD, 298 UC, 4 IBDU) on maintenance IFX originator were identified during the study period. Of these, 410 patients were categorized as NS, 249 as SS, and 130 as DS. Overall, the rate of flare within 12 months was 19.9% (22.2% NS, 15.3% SS, 21.5% DS, p= 0.08), rate of infection was 11.2% (11.5% NS, 8% SS, 16.2% DS, p= 0.056). No statistically significant differences in rates of immunogenicity or infusion reaction were identified between the DS and NS or SS groups. In multivariate (MV) logistic regression including age, race, gender, concomitant medication, comorbidity, and VA priority status, no significant differences in flares at 12 months was observed between the DS (ref) and NS (aOR 1.12, 95% CI 0.68-1.84), or SS groups (aOR 0.64, 95% CI 0.36-1.12). In MV analyses, SS was associated with lower rate of infection compared to DS (aOR 0.41, 95% CI 0.21-0.82). CONCLUSION In a national U.S. cohort of patients with IBD, multiple IFX biosimilar switching was not associated with flare at 12 months compared to patients continued on IFX originator or with a single IFX biosimilar switch. However, double switch was associated with increased odds of infection compared to single switch. These findings provide reassurance that multiple IFX biosimilar switching for IBD is effective but further study on infection risks may be warranted.

P708 Multiple Biosimilar Infliximab Switching is Not Associated with Adverse Outcomes in Inflammatory Bowel Disease: A Real-World Effectiveness Analysis in a National U.S. Cohort

Abstract Background Infliximab (IFX) biosimilars are available for inflammatory bowel disease (IBD). Many options of IFX biosimilars exist, however there is a paucity of data on the safety and efficacy of switching between multiple IFX biosimilars. The goal of this study is to evaluate the safety and outcomes in patients who received multiple IFX biosimilars in a National U.S. Cohort of patients with IBD. Methods We conducted a retrospective cohort study of IBD patients on maintenance IFX originator from 2017- 2019 in the national Veterans Affairs (VA) healthcare system. Crohn’s disease (CD) and ulcerative colitis (UC) patients were identified using a previously validated algorithm. Cases, exposures and outcomes were confirmed by chart review. Patents on IFX originator were identified by dispensed medication from the VA Corporate Data Warehouse. Patients were classified as no-switch (NS)- receiving originator but no biosimilar during study period, Single Switch (SS)- switch from originator to one biosimilar, or Double Switch (DS)-switch from IFX originator to two different biosimilars. Primary outcome was IBD flare, defined as escalation of steroid, IBD-related Emergency department visit or hospitalization within 12 months. Secondary outcomes were immunogenicity, serious infection, and infusion reaction. Event rates of the DS group were compared to NS and SS groups using univariate and multivariate (MV) logistic regression models adjusting for patient and non-patient factors. Results 789 patients (487 CD, 298 UC) on maintenance IFX originator were identified. Of these, 410 patients were categorized as NS, 249 as SS, and 130 as DS. Overall, the rate of flare within 12 months was 19.9% (22.2% NS, 15.3% SS, 21.5% DS, p= 0.08), rate of infection was 11.2% (11.5% NS, 8% SS, 16.2% DS, p= 0.056). No statistically significant differences in rates of immunogenicity or infusion reaction were identified between the DS and NS or SS groups. In MV logistic regression including age, race, gender, medication, comorbidity and VA priority status, no significant differences in flares at 12 months was observed between DS (ref) and NS (aOR 1.12, 95% CI 0.68-1.84), or SS groups (aOR 0.64, 95% CI 0.36-1.12). In MV analyses, SS was associated with lower rate of infection compared to DS (aOR 0.41, 95% CI 0.21-0.82). Conclusion In a national U.S. cohort of patients with IBD, multiple IFX biosimilar switching was not associated with flare at 12 months compared to patients continued on IFX originator or with a single IFX biosimilar switch. However, DS was associated with increased odds of infection compared to single switch. These findings provide reassurance that multiple IFX biosimilar switching for IBD is effective but further study on infection risks may be warranted.

Case Sampling for Evaluating Hospital Postoperative Morbidity in US Surgical Quality Improvement Programs

US surgical quality improvement (QI) programs use data from a systematic sample of surgical cases, rather than universal review of all cases, to assess and compare risk-adjusted hospital postoperative complication rates. Given decreasing postoperative complication rates over time and the types of cases eligible for abstraction, it is unclear whether case sampling is robust for identifying hospitals with higher than expected complications. To compare the assessment of hospital 30-day complication rates derived from sampling strategy used by some US surgical QI programs relative to universal review of all cases. This US hospital-level analysis took place from January 1, 2016, through September 30, 2020. Data analysis was performed from July 1, 2022, through December 21, 2022. Quarterly, risk-adjusted, 30-day complication observed to expected (O-E) ratios were calculated for each hospital using the sample (n = 502 730) and universal review (n = 1 725 364). Outlier hospitals (ie, those with higher than expected mortality) were identified using an O-E ratio significantly greater than 1.0. Patients 18 years and older who underwent a noncardiac operation at US Department of Veterans Affairs (VA) hospitals with a record in the VA Surgical Quality Improvement Program (systematic sample) and the VA Corporate Data Warehouse surgical domain (100% of surgical cases) were included. Thirty-day complications. Most patients in both the representative sample and the universal sample were men (90.2% vs 91.2%) and White (74.7% vs 74.5%). Overall, 30-day complication rates were 7.6% and 5.3% for the sample and universal review cohorts, respectively (P < .001). Over 2145 hospital quarters of data, hospitals were identified as an outlier in 15.0% of quarters using the sample and 18.2% with universal review. Average hospital quarterly complication rates were 4.7%, 7.2%, and 7.4% for outliers identified using the sample only, universal review only, and concurrent identification in both data sources, respectively. For nonsampled cases, average hospital quarterly complication rates were 7.0% at outliers and 4.4% at nonoutliers. Among outlier hospital quarters in the sample, 54.2% were concurrently identified with universal review. For those identified with universal review, 44.6% were concurrently identified using the sample. In this observational study, case sampling identified less than half of hospitals with excess risk-adjusted postoperative complication rates. Future work is needed to ascertain how to best use currently collected data and whether alternative data collection strategies may be needed to better inform local QI efforts.

Daratumumab Combinations in US Veterans: Patient Characteristics and Outcomes

Background: Daratumumab is an anti-CD38 antibody with efficacy both in relapsed and newly diagnosed multiple myeloma (NDMM).Clinical trials evaluating daratumumab have demonstrated improved outcomes when combined with lenalidomide (DRd) or bortezomib (DVd) and with dexamethasone, as well as using all four drugs (D-VRd). We evaluated characteristics and outcomes of veterans treated with daratumumab combination in NDMM. Methods: This retrospective, cross-sectional study analyzed electronic medical record data from the Veterans Affairs (VA) Corporate Data Warehouse (CDW). We identified veterans by evidence of daratumumab administration in prescription records in combination with a second agent within 30 days and who did not receive any anti-myeloma agents prior to 30 days. Age, race, Quan's Charlson Comorbidity Index (CCI), the time to next treatment (TTNT), and overall survival (OS) were assessed. Patient characteristics were compared using ANOVA or chi-square and overall survival was estimated using Kaplan-Meier. Analyses were conducted using SAS 9.x. Results: There were 428 veterans who received daratumumab containing regimens. Mean age was 69.5 years and 36.2% self-identified as African American. There were 147 patients who received DRd, 190 DVd, and 91 D-VRd. Veterans who received DRd were significantly older than veterans receiving DVd (mean 73.0 vs. 69.1 years) and D-VRd(73.0 vs. 64.9 years, p&amp;lt;0.001). Use of daratumumab combinations has increased yearly since FDA approval (see table). There was no significant difference in use of regimens by race or comorbidity, measured by CCI. TTNT displayed distinct variations among the regimens, with DRd showing the most extended duration at a median of 316 days, followed by D-VRd at 231 days, and DVd at 40 days. These observed differences in TTNT may be attributed to changes in regimen, such as starting lenalidomide after 1-2 cycles of DVd. Median overall survival with DRd at 45 months (95% CI 38-not reached (NR)) and with DVd was 28 months (95% CI 20-39). Median survival in D-VRd was not reached. Conclusion: Daratumumab combinations are increasingly used to treat multiple myeloma in the VHA. DRd is used more commonly in older veterans and D-VRd in younger veterans. DVd is used more frequently than other combinations and veterans may transition or other treatments.

Tolerability and Outcomes of Bruton Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukemia in Patients with Severe Renal Dysfunction

Introduction: There is limited data on the outcomes and tolerability of Bruton Tyrosine Kinase (BTK) inhibitors for chronic lymphocytic leukemia (CLL) in patients with severe renal dysfunction, particularly older adults. The most commonly prescribed BTK inhibitor, ibrutinib, is believed to be safe for mild to moderate renal dysfunction. However, severe renal failure has been excluded from prospective studies, and there is no guidance on dosing under the FDA label. Furthermore, ibrutinib itself can cause kidney injury and worsen existing renal dysfunction. This national Veterans Affairs (VA) analysis aims to review the safety and tolerability of BTK inhibitors in severe renal impairment. Methods: An electronic query of the VA Corporate Data Warehouse and retrospective chart review were performed to identify patients with CLL treated with a BTK inhibitor between 2013-2022 and who had severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) &amp;lt; 30 ml/min/1.73 m 2 overlapping with their treatment period. Isolated acute kidney injuries lasting &amp;lt; 1 month were excluded. Fisher's exact test was utilized to evaluate categorical variables, logistic regression for binary outcomes, and log-rank and Cox regression for time-to-event analyses. Results: A total of 115 patients across 68 VA medical centers received 124 lines of BTK inhibitors with an eGFR &amp;lt; 30 (Table 1). The median duration of follow-up from the start of therapy was 26 months (range, 0.5 - 94). The median age was 74, and 98% were male, reflecting the U.S. veteran population. 64% had an eGFR &amp;lt; 30 at the start of therapy, with 18% requiring dialysis, while the remaining 36% experienced progressive renal dysfunction during treatment. The oral BTK agents prescribed were ibrutinib ( n = 103), acalabrutinib ( n = 18), and zanubrutinib ( n = 3). Most BTK inhibitors (n = 94 of 124 lines, 76%) were initiated at the FDA-label dose. 46 (37%) later required dose reduction, primarily due to drug toxicity ( n = 37). The most common reasons for dose reduction were cytopenia ( n = 10), failure to thrive ( n = 6), bleeding ( n = 5), and worsening renal function ( n = 5). Discontinuation of therapy for toxicity occurred in 50% (ibrutinib), 39% (acalabrutinib), and 33% (zanubrutinib). The most common reasons for discontinuation were infection ( n = 15), bleeding ( n = 10), arrhythmia ( n = 9), and disease progression ( n = 9). Among patients who received ibrutinib ( n = 103), the median progression-free survival (PFS) and overall survival (OS) were 45 and 49 months, respectively. In multivariate Cox regression, covariates associated with shorter PFS included the baseline severity of renal failure (HR 1.85, 95% CI 1.21 - 2.88), cirrhosis (HR 6.36, 95% CI 1.45 - 19.76), and heart failure (HR 4.20, 95% CI 1.82 - 9.47). Younger age, dialysis, and absence of atrial fibrillation at the start of therapy were protective in univariate but not multivariate models. Heart failure and cirrhosis retained their prognostic impact on OS in multivariate modeling. Factors including race, rural residence, obesity, IGHV status, and TP53 deletion were not significantly associated with survival in this cohort. The median duration of therapy of ibrutinib was 33 months. Ibrutinib dose reductions at initiation or during treatment were associated with a longer duration of therapy (Figure 1). Of note, dose reductions did not significantly reduce the response rate to ibrutinib or worsen survival. Interestingly, 11 patients had CLL-related kidney dysfunction. However, kidney function did not improve after treatment with a BTK inhibitor in any of the 115 patients. Progression of renal impairment was observed in 51 patients (50%) on ibrutinib, 8 (44%) on acalabrutinib, and none on zanubrutinib. The etiology of worsening renal function was uncertain for the majority of patients. Conclusion: The clinical outcomes of BTK inhibitors in patients with CLL and severe renal dysfunction have not been well-described. In our real-world data analysis, these agents appear to be a reasonable therapeutic option in severe renal impairment, including in older adults and those on dialysis. Lab monitoring is needed, given the risk of worsening renal function. Dose modifications may help improve tolerability without reducing efficacy. Unfortunately, severe renal dysfunction is unlikely to improve with CLL treatment, even in CLL-related kidney failure.

Abstract 12799: Geographic Variation in Cardiac Amyloidosis in U.S. Veterans From 2012 to 2021

Background: Prior studies suggest variability in cardiac amyloidosis (CA) detection across the U.S. with underdiagnosis in some regions. Research Question: It is unknown whether geographic variation exists in the occurrence of CA amongst U.S. Veterans in a contemporary cohort. Method: This is a retrospective observational cohort study. CA was defined as ≥ 1 heart failure (ICD9/10) and ≥ 1 amyloidosis diagnosis. For geographic mapping the location was the state of the diagnosing Veterans Affairs (VA) facility. The population at risk was patients in each state with ≥1 VA encounter during the year. The outcomes were incidence and prevalence rates of CA at the state and U.S. Census regional level (per 100,000 patients). The data source was the VA Corporate Data Warehouse (MDClone ADAMS platform). Results: The incidence and prevalence rates of CA by region are shown in the Table, and by state in the Figure. There was an increase in incidence and prevalence in all regions in 2012 and 2021. In both years, incidence and prevalence were highest in the Northeast and lowest in the South. Conclusion: Despite increasing recognition of CA in the VA Health System, there is regional variation in incidence and prevalence in 2012 and 2021. VA facilities in the Midwest, West and especially the South may have differences in CA detection relative to those in the Northeast region. Further research into health system, provider, and patient factors leading to this variation is needed to ensure health equity and quality of care for patients with CA.

Incidence, Microbiological Studies, and Factors Associated With Prosthetic Joint Infection After Total Knee Arthroplasty

Despite the frequency of total knee arthroplasty (TKA) and clinical implications of prosthetic joint infections (PJIs), knowledge gaps remain concerning the incidence, microbiological study results, and factors associated with these infections. To identify the incidence rates, organisms isolated from microbiological studies, and patient and surgical factors of PJI occurring early, delayed, and late after primary TKA. This cohort study obtained data from the US Department of Veterans Affairs (VA) Corporate Data Warehouse on patients who underwent elective primary TKA in the VA system between October 1, 1999, and September 30, 2019, and had at least 1 year of care in the VA prior to TKA. Patients who met these criteria were included in the overall cohort, and patients with linked Veterans Affairs Surgical Quality Improvement Program (VASQIP) data composed the VASQIP cohort. Data were analyzed between December 9, 2021, and September 18, 2023. Primary TKA as well as demographic, clinical, and perioperative factors. Incident hospitalization with early, delayed, or late PJI. Incidence rate (events per 10 000 person-months) was measured in 3 postoperative periods: early (≤3 months), delayed (between >3 and ≤12 months), and late (>12 months). Unadjusted Poisson regression was used to estimate incidence rate ratios (IRRs) with 95% CIs of early and delayed PJI compared with late PJI. The frequency of organisms isolated from synovial or operative tissue culture results of PJIs during each postoperative period was identified. A piecewise exponential parametric survival model was used to estimate IRRs with 95% CIs associated with demographic and clinical factors in each postoperative period. The 79 367 patients (median (IQR) age of 65 (60-71) years) in the overall cohort who underwent primary TKA included 75 274 males (94.8%). A total of 1599 PJIs (2.0%) were identified. The incidence rate of PJI was higher in the early (26.8 [95% CI, 24.8-29.0] events per 10 000 person-months; IRR, 20.7 [95% CI, 18.5-23.1]) and delayed periods (5.4 [95% CI, 4.9-6.0] events per 10 000 person-months; IRR, 4.2 [95% CI, 3.7-4.8]) vs the late postoperative period (1.3 events per 10 000 person-months). Staphylococcus aureus was the most common organism isolated overall (489 [33.2%]); however, gram-negative infections were isolated in 15.4% (86) of early PJIs. In multivariable analyses, hepatitis C virus infection, peripheral artery disease, and autoimmune inflammatory arthritis were associated with PJI across all postoperative periods. Diabetes, chronic kidney disease, and obesity (body mass index of ≥30) were not associated factors. Other period-specific factors were identified. This cohort study found that incidence rates of PJIs were higher in the early and delayed vs late post-TKA period; there were differences in microbiological cultures and factors associated with each postoperative period. These findings have implications for postoperative antibiotic use, stratification of PJI risk according to postoperative time, and PJI risk factor modification.

Variation in telehealth use for endocrine care: Patterns and predictors under the "new normal".

Use of telehealth for outpatient endocrine care remains common since onset of the COVID-19 pandemic, though the context for its use has matured. We aimed to describe the variation in telehealth use for outpatient endocrine visits under these "new normal" conditions and examine the patient, clinician-, and organization-level factors predicting use. Retrospective cross-sectional study using data from the U.S. Department of Veterans Affairs (VA) Corporate Data Warehouse on 167,017 endocrine visits conducted between 3/9/21 and 3/8/22. We used mixed effects logistic regression models to examine 1) use of telehealth vs. in-person care among all visits and 2) use of telephone vs. video among the subsample of telehealth visits. Visits were in person (58%), by telephone (29%), or by video (13%). Unique variability in telehealth use at each level of the analysis was 56% patient visit, 24% clinician, 18% facility. The strongest predictors were visit type (first vs. follow up) and clinician and facility characteristics. Among telehealth visits, unique variability in telephone (vs. video) use at each level was 44% patient visit, 24% clinician, 26% facility. The strongest predictors of telephone vs. video were visit type, patient age, and percent of the facility's population that was rural. We found wide variation in use of telehealth for endocrinology under the "new normal". Future research should examine clinician and facility factors driving variation, as many may be amenable to influence by clinical leaders and leveraged to enhance the availability of telehealth for all clinically appropriate patients.

Case Sampling vs Universal Review for Evaluating Hospital Postoperative Mortality in US Surgical Quality Improvement Programs

Representative surgical case sampling, rather than universal review, is used by US Department of Veterans Affairs (VA) and private-sector national surgical quality improvement (QI) programs to assess program performance and to inform local QI and performance improvement efforts. However, it is unclear whether case sampling is robust for identifying hospitals with safety or quality concerns. To evaluate whether the sampling strategy used by several national surgical QI programs provides hospitals with data that are representative of their overall quality and safety, as measured by 30-day mortality. This comparative effectiveness study was a national, hospital-level analysis of data from adult patients (aged ≥18 years) who underwent noncardiac surgery at a VA hospital between January 1, 2016, and September 30, 2020. Data were obtained from the VA Surgical Quality Improvement Program (representative sample) and the VA Corporate Data Warehouse surgical domain (100% of surgical cases). Data analysis was performed from July 1 to December 21, 2022. The primary outcome was postoperative 30-day mortality. Quarterly, risk-adjusted, 30-day mortality observed-to-expected (O-E) ratios were calculated separately for each hospital using the sample and universal review cohorts. Outlier hospitals (ie, those with higher-than-expected mortality) were identified using an O-E ratio significantly greater than 1.0. In this study of data from 113 US Department of Veterans Affairs hospitals, the sample cohort comprised 502 953 surgical cases and the universal review cohort comprised 1 703 140. The majority of patients in both the representative sample and the universal sample were men (90.2% vs 91.1%) and were White (74.7% vs 74.5%). Overall, 30-day mortality was 0.8% and 0.6% for the sample and universal review cohorts, respectively (P < .001). Over 2145 quarters of data, hospitals were identified as an outlier in 11.7% of quarters with sampling and in 13.2% with universal review. Average hospital quarterly 30-day mortality rates were 0.4%, 0.8%, and 0.9% for outlier hospitals identified using the sample only, universal review only, and concurrent identification in both data sources, respectively. For nonsampled cases, average hospital quarterly 30-day mortality rates were 1.0% at outlier hospitals and 0.5% at nonoutliers. Among outlier hospital quarters in the sample, 47.4% were concurrently identified with universal review. For those identified with universal review, 42.1% were concurrently identified using the sample. In this national, hospital-level study, sampling strategies employed by national surgical QI programs identified less than half of hospitals with higher-than-expected perioperative mortality. These findings suggest that sampling may not adequately represent overall surgical program performance or provide stakeholders with the data necessary to inform QI efforts.

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices

The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues. To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system. This retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse. Implantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021. The primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed. In total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, -2.1% to 4.1%). The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

Towards shortening the Brief Addiction Monitor-Revised (BAM-R)

IntroductionThe Brief Addiction Monitor-Revised (BAM-R) is a widely used, 17-item assessment of substance use, risk, and protective factors associated with recovery from substance use disorders. Despite wide adoption in the U.S. Department of Veterans Affairs (VA) and recommendations for use in measurement-based care (MBC), administration may not be feasible in many MBC settings due to time constraints. The purpose of this study was to derive a shortened version of the BAM-R for use in fast-paced healthcare settings. MethodsBAM-R data from 32,002 Veterans were obtained through the VA's Corporate Data Warehouse. We used logistic regression models to identify items for removal based on prediction of two clinical outcomes (90-day substance use disorder (SUD) treatment retention and 12-month mortality) and item-level sensitivity to change during substance use treatment. ResultsAlthough no intake BAM-R items predicted SUD treatment retention or mortality, effect sizes for item-level sensitivity to change during substance use treatment varied from small to large. Seven items were judged as relevant for MBC of SUD. Among all BAM-R items, Heavy Alcohol Use, Self-Help, Drug Use, Craving, and Mood items demonstrated the greatest magnitude of sensitivity to change. ConclusionsAlthough additional research is recommended before a shortened BAM-R can be implemented in non-specialty MBC settings, we identified 5 BAM-R items with perceived clinical utility and scores that demonstrated evidence of sensitivity to change. Shortening the BAM-R increases feasibility of use, though more work is needed to optimize measurement for SUD MBC.

Use of a Medication Safety Audit and Feedback Tool in the Emergency Department Is Affected by Prescribing Characteristics.

The Enhancing Quality of Prescribing Practices for Older Veterans Discharged from the Emergency Department (EQUIPPED) program developed an audit and feedback health information technology (IT) solution with the intent to replace the in-person academic detailing service provided by the program. The EQUIPPED dashboard provides emergency department (ED) providers with a personalized view of their prescribing performance. Here, we analyze the association between ED provider characteristics and viewership of the EQUIPPED dashboard, adding insight into strategies for addressing barriers to initial use. We performed a retrospective analysis of EQUIPPED dashboard viewership among four Veterans Affairs (VA) EDs. We extracted quantitative data from user interaction logs to determine evidence of dashboard use. Provider characteristics and baseline potentially inappropriate medication (PIM) prescribing rate were extracted from the VA's Corporate Data Warehouse. Logistic regression was used to examine the association between dashboard use and provider characteristics. A total of 82 providers were invited to receive audit and feedback via the EQUIPPED dashboard. Among invited providers, 40 (48.7%) had evidence of at least 1 dashboard view during the 1-year feedback period. Adjusted analyses suggest that providers with a higher baseline PIM prescribing rate were more likely to use the dashboard (odds ratio [OR]: 1.22; 95% confidence interval [CI]: 1.01-1.47). Furthermore, providers at ED site D were more likely to use the dashboard in comparison to the other sites (OR: 9.99; 95% CI: 1.72-58.04) and reportedly had the highest site-level baseline PIM rate. Providers with lower PIM prescribing rates (i.e., <5%) receive communication from an integrated dashboard reminder system that they are "optimal prescribers" which may have discouraged initial attempts to view the dashboard. Site D had the highest baseline PIM rate, but further qualitative investigation is warranted to better understand why site D had the greatest users of the dashboard.

The risk of major adverse cardiovascular events associated with the use of hypnotics in patients with insomnia

ObjectivesTo examine whether hypnotic use in patients with insomnia reduces major adverse cardiovascular events, including all-cause mortality and nonfatal major adverse cardiovascular events. MethodsUsing the Veterans Affairs Corporate Data Warehouse, we conducted a retrospective cohort study of 16,064 patients who were newly diagnosed with insomnia between January 1, 2010, and December 31, 2019. A pair of 3912 hypnotic users and nonusers were selected based on a 1:1 propensity score methodology. The primary outcome was extended major adverse cardiovascular events, a composite of the first occurrence of all-cause mortality or nonfatal major adverse cardiovascular events. ResultsDuring the median follow-up of 4.8 years, a total of 2791 composite events occurred, including 2033 deaths and 762 nonfatal major adverse cardiovascular events. Although the incidence rates of major adverse cardiovascular events were comparable between hypnotic users and nonusers in the propensity-matched cohort, users of benzodiazepines and Z-drugs had a higher risk of all-cause mortality (hazard ratio 1.47 [95% CI, 1.17-1.88] and 1.20 [95% CI, 1.03-1.39], respectively), while serotonin antagonist and reuptake inhibitors users had a survival advantage (hazard ratio 0.79 [95% CI, 0.69-0.91]) compared with nonusers. There were no differences in the risk of nonfatal major adverse cardiovascular events between all classes of hypnotics. Male patients and those aged 60 years or younger who were using benzodiazepines or Z-drugs experienced higher major adverse cardiovascular events than their counterparts. ConclusionsIn patients with newly diagnosed insomnia, treatment with hypnotics resulted in higher extended major adverse cardiovascular events but not nonfatal major adverse cardiovascular events with benzodiazepine and Z-drug users compared with nonusers. The use of serotonin antagonist and reuptake inhibitors agents had a protective effect against major adverse cardiovascular events warranting further investigation.