Chrischilles, Elizabeth A.

Background: Nationally, many ASCVD patients fail to achieve an LDL-C <70 mg/dL, and uptake of both statin and non-statin therapies is low. The degree to which this varies across health systems is less clear. Methods: A cross sectional analysis was performed where lipid levels and lipid lowering therapies (LLT) were assessed using electronic health record data in patients with a previous diagnosis of ASCVD. The data was obtained across 14 US healthcare systems between 1/1/2021-12/31/2022. Proportions of patients with an active prescription of any statin, high intensity statin, ezetimibe, PCSK9i, and combination therapy (two or more agents) within 395 days of the most recent LDL-C value (index date) was evaluated overall and by participating site. Additionally, the proportion of patients with an LDL-C <70 mg/dL at the index date was also assessed. Results: Across 14 health systems, 1,118,623 patients with ASCVD were identified (median 61,840 per health system, range 8,161-182,315). Overall, 675,776 (60.4%) had an LDL-C level in the past year (range 39.1% - 70.8%). Of those with a lipid level, achievement of LDL-C <70 mg/dL ranged from 34.6-47.2%. In total, 42.6% were on any statin, 20.1% were on a high intensity statin, 4.3% on ezetimibe, and 1.2% on a PCSK9i. Only 2.9% were on combination therapy of a statin with ezetimibe or a PCSK9i. Variability was seen across health systems in utilization of each of these therapies, however even in the highest performing health systems, LLT uptake and achievement of LDL-C < 70mg/dL remained low ( Figure). Conclusion: Variability in utilization of LLT in ASCVD patients between health systems suggests that system-level factors may impact achieving guideline-based LDL-C goals. Despite the variability, the highest proportion of patients achieving an LDL-C <70mg/dL remained under 50% indicating the need for aggressive implementation efforts.

Abstract Purpose Sepsis disproportionately affects patients in rural and socially vulnerable communities. A promising strategy to address this disparity is provider‐to‐provider emergency department (ED)‐based telehealth consultation (tele‐ED). The objective of this study was to determine if county‐level social vulnerability index (SVI) was associated with tele‐ED use for sepsis and, if so, which SVI elements were most strongly associated. Methods We used data from the TELEmedicine as a Virtual Intervention for Sepsis in Rural Emergency Department study. The primary exposures were SVI aggregate and component scores. We used multivariable generalized estimating equations to model the association between SVI and tele‐ED use. Findings Our study cohort included 1191 patients treated in 23 Midwestern rural EDs between August 2016 and June 2019, of whom 326 (27.4%) were treated with tele‐ED. Providers in counties with a high SVI were less likely to use tele‐ED (adjusted odds ratio [aOR] = 0.51, 95% confidence interval [CI] 0.31‒0.87), an effect principally attributable to the housing type and transportation component of SVI (aOR = 0.44, 95% CI 0.22–0.89). Providers who treated fewer sepsis patients (1‒10 vs. 31+ over study period) and therefore may have been less experienced in sepsis care, were more likely to activate tele‐ED (aOR = 3.91, 95% CI 2.08‒7.38). Conclusions Tele‐ED use for sepsis was lower in socially vulnerable counties and higher among providers who treated fewer sepsis patients. These findings suggest that while tele‐ED increases access to specialized care, it may not completely ameliorate sepsis disparities due to its less frequent use in socially vulnerable communities.

Introduction: Guidelines are increasingly recommending a goal LDL-C <55 mg/dL in persons with atherosclerotic cardiovascular disease (ASCVD). The proportion and characteristics of US adults with ASCVD with an LDL-C <55 mg/dL remains unclear. Aims: To evaluate lipid management in ASCVD patients and factors associated with achieving an LDL-C <55mg/dL. Methods: Using electronic health record data from 8 US health systems, we evaluated LDL-C levels and treatment patterns in persons with prevalent ASCVD seen as outpatients between 1/1/2021-12/31/2021 with an LDL-C level within the prior year. Multivariable logistic regression modeling with generalized estimating equations was used to evaluate factors associated with an LDL-C <55 mg/dL. Results: Among 178,240 eligible ASCVD patients, 43.5% (77,472) had an LDL- C <70 mg/dL and 22.0% (39,270) had an LDL-C <55 mg/dL. Older age was associated with higher odds of LDL-C <55 mg/dL (OR 1.10 per 10 years, 95% CI 1.07-1.13), while female sex (OR 0.71, 95% CI 0.68-0.64) Black race (OR 0.77, 95% CI 0.70-0.86), and non-coronary artery disease forms of ASCVD including peripheral artery disease (PAD, OR 0.61, 95% CI 0.58-0.64) and cerebrovascular disease (CeVD, OR 0.72, 95% CI 0.66-0.79) were associated with lower odds of LDL-C <55 mg/dL in multivariable modeling. Overall, while 75.0% were on a statin, only 36.9% were on a high-intensity statin, 5.7% were on ezetimibe, and 1.7% were on a PCSK9i. Combination therapy was rare: only 4.2% were on a statin+ezetimibe, 0.5% on statin+PCSK9i, and 0.3% on all three. Conclusions: Less than a quarter of US patients with ASCVD achieve an LDL <55 mg/dL. Achieving this goal is even less common among younger adults, women, Black persons, and those with PAD and CeVD. Current therapeutic regimens often fail to use high-intensity statins, and markedly underutilize combinations of statins with ezetimibe and/or PCSK9 inhibitors.

Abstract Background Direct oral anticoagulation (DOACs) prevent stroke in patients with atrial fibrillation (AF) and have a superior safety profile compared with vitamin K antagonists (VKA). Yet, better definition of incidence and risk factors for major bleeding associated with DOACs in clinical practice may be important given emerging stroke prevention technologies, both pharmacologic and nonpharmacologic. Purpose To describe the incidence of and risk factors for major bleeding in individuals with AF on DOAC therapy. Methods We reviewed electronic health record data for two patient cohorts with AF prescribed DOACs: (1) Duke University Health System (DUHS) (2010–2018) and (2) Sites within the Patient-Centered Clinical Research Network (PCORnet) (2015–2019) which had ≥6 years assimilated data from both inpatient and outpatient encounters (7 sites). In each cohort, we assessed the 5-year incidence of major bleeding events defined as hospitalization for intracranial hemorrhage, or hospitalization for gastro-intestinal bleeding or procedure to control bleeding accompanied by transfusion within ±7 days or death within 30 days. Multivariable Fine-Gray proportional hazards modeling in each cohort was performed to evaluate independent risk factors for major bleeding on DOAC therapy. Results The cohorts included 10,625 patients (DUHS) and 58,321 patients (PCORnet) with AF. Major bleeding events occurred within 5 years of diagnosis in 639 (7.9%) of DUHS patients and 2568 (6.6%) of PCORnet patients (Table 1). The DUHS model predicted time to first major bleeding event with a C-index of 0.756 (95% CI 0.737, 0.775) and the PCORNet model had a c-index of 0.745 (0.736, 0.755) (Table 2). Independent factors associated with major bleeding consistent across both models (p&lt;0.001 in PCORnet for all unless noted) were higher CHA2DS2-VASc scores, lower eGFR, anemia (HR per 1-point increase in hemoglobin up to 12 g/dL 0.79 [0.76, 0.82]), prior major bleeding (HR 2.70 [2.22, 3.30]), cancer (HR 1.23 [1.12, 1.36]), recent cardiac surgery (HR 0.70 [0.51, 0.97]; p=0.030), alcohol use (HR 1.56 [1.29, 1.88]), aspirin use (HR 1.44 [1.32, 1.57]), and selective serotonin reuptake inhibitor use (HR 1.30 [1.19, 1.42]). Conclusions Across a large and geographically diverse contemporary population, risk of bleeding on DOAC for stroke prevention in AF remains a frequent and important clinical problem. There is an unmet need for stroke prevention therapies with improved safety profiles. We identified risk factors for major bleeding events on DOAC therapy, some of which are not represented in traditional risk scores, which may inform shared decision making for stroke prevention. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer Pharmaceuticals

e19065 Background: Treatment decisions for patients with advanced stage (stages IIIB and IV) non-small cell lung cancer (AS NSCLC) are influenced by comorbidity at time of diagnosis. We studied the effects of comorbidity on survival and whether effects differ for short-term (120 days) vs. for long-term (>120 days) survival. Methods: Data were from surveys and medical records of 1498 patients withnewly diagnosed AS NSCLC in the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS). Respiratory disease severity and comorbidities at diagnosis were measured from the Adult Comorbidity Evaluation (ACE-27) index and model fitting used the Akaike Information Criteria. The log-rank test was used for univariable survival models, and Cox proportional hazards regression for multivariable survival models. Results: Five comorbidities were significantly associated with survival and 437 (29.2%) patients had one or more of these. Survival to 120 days was significantly poorer for patients with a baseline diagnosis of stroke [hazard ratio (HR) 1.92; 95% confidence interval (CI) 1.26–2.93], diabetes (HR 1.33, 95% CI 1.08–1.65), or congestive heart failure (HR 1.45, 95% CI 1.07–1.96), controlling for age, gender, smoking status, stage, severe respiratory disease, and brain metastases. Given survival to 120 days (885 pts, 59%), survival beyond that was significantly poorer only for patients with baseline arrhythmia (HR 1.47, 95% CI 1.15–1.87) or end stage renal disease (HR 1.82, 95% CI 1.09–3.04), controlling for the covariates above. Adjustment for chemotherapy use had no effect on these associations. Conclusions: Several comorbidities present at diagnosis affected survival for AS NSCLC, with some comorbidities having a more immediate relationship to survival than others. Our finding provides information that could be used to tailor treatment decisions to patients’ comorbidities at diagnosis.

Abstract Background Most articles on hand hygiene report either overall compliance or compliance with specific hand hygiene moments. These moments vary in the level of risk to patients if healthcare workers (HCWs) are noncompliant. We assessed how task type affected HCWs’ hand hygiene compliance. Methods We linked consecutive tasks individual HCWs performed during the Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) study into care sequences and identified task pairs—2 consecutive tasks and the intervening hand hygiene opportunity. We defined tasks as critical and/or contaminating. We determined the odds of critical and contaminating tasks occurring, and the odds of hand hygiene compliance using logistic regression for transition with a random effect adjusting for isolation precautions, glove use, HCW type, and compliance at prior opportunities. Results Healthcare workers were less likely to do hand hygiene before critical tasks than before other tasks (adjusted odds ratio [aOR], 0.97 [95% confidence interval {CI}, .95–.98]) and more likely to do hand hygiene after contaminating tasks than after other tasks (aOR, 1.12 [95% CI, 1.10–1.13]). Nurses were more likely to perform both critical and contaminating tasks, but nurses’ hand hygiene compliance was better than physicians’ (aOR, 0.94 [95% CI, .91–.97]) and other HCWs’ compliance (aOR, 0.87 [95% CI, .87–.94]). Conclusions Healthcare workers were more likely to do hand hygiene after contaminating tasks than before critical tasks, suggesting that habits and a feeling of disgust may influence hand hygiene compliance. This information could be incorporated into interventions to improve hand hygiene practices, particularly before critical tasks and after contaminating tasks.

PURPOSE This pilot study examined the ability to operationalize the collection of real-world data to explore the potential use of real-world end points extracted from data from diverse health care data organizations and to assess how these relate to similar end points in clinical trials for immunotherapy-treated advanced non–small-cell lung cancer. PATIENTS AND METHODS Researchers from six organizations followed a common protocol using data from administrative claims and electronic health records to assess real-world end points, including overall survival (rwOS), time to next treatment, time to treatment discontinuation (rwTTD), time to progression, and progression-free survival, among patients with advanced non–small-cell lung cancer treated with programmed death 1/programmed death-ligand 1 inhibitors in real-world settings. Data sets included from 269 to 6,924 patients who were treated between January 2011 and October 2017. Results from contributors were anonymized. RESULTS Correlations between real-world intermediate end points (rwTTD and time to next treatment) and rwOS were moderate to high (range, 0.6 to 0.9). rwTTD was the most consistent end points as treatment detail was available in all data sets. rwOS at 1 year post–programmed death-ligand 1 initiation ranged from 40% to 57%. In addition, rwOS as assessed via electronic health records and claims data fell within the range of median OS values observed in relevant clinical trials. Data sources had been used extensively for research with ongoing data curation to assure accuracy and practical completeness before the initiation of this research. CONCLUSION These findings demonstrate that real-world end points are generally consistent with each other and with outcomes observed in randomized clinical trials, which substantiates the potential validity of real-world data to support regulatory and payer decision making. Differences observed likely reflect true differences between real-world and protocol-driven practices.