Cleveland Clinic Health System Research Articles

Proportion and predictors of FVC decline in patients with interstitial lung disease

RationaleThe proportion of patients who develop progressive pulmonary fibrosis (PPF), along with risk factors for progression remain poorly understood. ObjectivesTo examine factors associated with an increased risk of developing PPF among patients at a referral center. MethodsWe identified patients with a diagnosis of interstitial lung disease (ILD) seen within the Cleveland Clinic Health System. Utilizing a retrospective observational approach we estimated the risk of developing progression by diagnosis group and identified key clinical predictors using the FVC component of both the original progressive fibrotic interstitial lung disease (PFILD) and the proposed PPF (ATS) criteria. ResultsWe identified 5934 patients with a diagnosis of ILD. The cumulative incidence of progression over the 24 months was similar when assessed with the PFILD and PPF criteria (33.1 % and 37.9 % respectively). Of those who met the ATS criteria, 9.5 % did not meet the PFILD criteria. Conversely, 4.3 % of patients who met PFILD thresholds did not achieve the 5 % absolute FVC decline criteria. Significant differences in the rate of progression were seen based on underlying diagnosis. Steroid therapy (HR 1.46, CI 1.31–1.62) was associated with an increased risk of progressive fibrosis by both PFILD and PPF criteria. ConclusionRegardless of the definition used, the cumulative incidence of progressive disease is high in patients with ILD in the 24 months following diagnosis. Some differences are seen in the risk of progression when assessed by PFILD and PPF criteria. Further work is needed to identify modifiable risk factors for the development of progressive fibrosis.

Healthcare utilization and clinical characteristics of genetic epilepsy in electronic health records.

Understanding the clinical characteristics and medical treatment of individuals affected by genetic epilepsies is instrumental in guiding selection for genetic testing, defining the phenotype range of these rare disorders, optimizing patient care pathways and pinpointing unaddressed medical need by quantifying healthcare resource utilization. To date, a matched longitudinal cohort study encompassing the entire spectrum of clinical characteristics and medical treatment from childhood through adolescence has not been performed. We identified individuals with genetic and non-genetic epilepsies and onset at ages 0-5 years by linkage across the Cleveland Clinic Health System. We used natural language processing to extract medical terms and procedures from longitudinal electronic health records and tested for cross-sectional and temporal associations with genetic epilepsy. We implemented a two-stage design: in the discovery cohort, individuals were stratified as being 'likely genetic' or 'non-genetic' by a natural language processing algorithm, and controls did not receive genetic testing. The validation cohort consisted of cases with genetic epilepsy confirmed by manual chart review and an independent set of controls who received negative genetic testing. The discovery and validation cohorts consisted of 503 and 344 individuals with genetic epilepsy and matched controls, respectively. The median age at the first encounter was 0.1 years and 7.9 years at the last encounter, and the mean duration of follow-up was 8.2 years. We extracted 188,295 Unified Medical Language System annotations for statistical analysis across 9659 encounters. Individuals with genetic epilepsy received an earlier epilepsy diagnosis and had more frequent and complex encounters with the healthcare system. Notably, the highest enrichment of encounters compared with the non-genetic groups was found during the transition from paediatric to adult care. Our computational approach could validate established comorbidities of genetic epilepsies, such as behavioural abnormality and intellectual disability. We also revealed novel associations for genitourinary abnormalities (odds ratio 1.91, 95% confidence interval: 1.66-2.20, P = 6.16 × 10-19) linked to a spectrum of underrecognized epilepsy-associated genetic disorders. This case-control study leveraged real-world data to identify novel features associated with the likelihood of a genetic aetiology and quantified the healthcare utilization of genetic epilepsies compared with matched controls. Our results strongly recommend early genetic testing to stratify individuals into specialized care paths, thus improving the clinical management of people with genetic epilepsies.

Clinician use of the Statin Choice Shared Decision-making Encounter Tool in a Major Health System.

Effective shared decision-making (SDM) tools for use during clinical encounters are available, but, outside of study settings, little is known about clinician use of these tools in practice. To describe real-world use of an SDM encounter tool for statin prescribing, Statin Choice, embedded into the workflow of an electronic health record. Cross-sectional study. Clinicians and their statin-eligible patients who had outpatient encounters between January 2020 and June 2021 in Cleveland Clinic Health System. Clinician use of Statin Choice was recorded within the Epic record system. We categorized each patient's 10-year atherosclerotic cardiovascular disease risk into low (< 5%), borderline (5-7.5%), intermediate (7.5-20%), and high (≥ 20%). Other patient factors included age, sex, insurance, and race. We used mixed effects logistic regression to assess the odds of using Statin Choice for statin-eligible patients, accounting for clustering by clinician and site. We generated a residual intraclass correlation coefficient (ICC) to characterize the impact of the clinician on Statin Choice use. Statin Choice was used in 7% of 68,505 eligible patients. Of 1047 clinicians, 48% used Statin Choice with ≥ 1 patient, and these clinicians used it with a median 9% of their patients (interquartile range: 3-22%). In the mixed effects logistic regression model, patient age (adjusted OR per year: 1.04; 95%CI 1.03-1.04) and 10-year ASVCD risk (aOR for 5-7.5% versus < 5% risk: 1.28; 95%CI: 1.14-1.44) were associated with use of Statin Choice. Black versus White race was associated with a lower odds of Statin Choice use (aOR: 0.83; 95%CI: 0.73-0.95), as was female versus male sex (aOR: 0.83; 95%CI: 0.76-0.90). The model ICC demonstrated that 53% of the variation in use of Statin Choice was clinician-driven. Patient factors, including race and sex, were associated with clinician use of Statin Choice; half the variation in use was attributable to individual clinicians.

2740. Letermovir for the Prevention and Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients

Abstract Background Cytomegalovirus (CMV) is a common infection that can lead to end-organ damage and graft rejection in solid organ transplant (SOT) recipients. Due to the increase in drug-resistant CMV and unfavorable side effect profile of available CMV-active agents, there is a need for additional prophylactic and treatment strategies in this patient population. The goal of this study is to evaluate SOT recipients prescribed letermovir for prophylaxis and/or treatment of CMV. Methods This study was a retrospective review of adult SOT recipients in the Cleveland Clinic Health System prescribed letermovir from 11/8/2017 to 8/1/2022. The primary objective was to describe the utilization of letermovir in SOT recipients. Secondary objectives included: proportion of SOT recipients that experienced CMV breakthrough on letermovir prophylaxis, proportion of SOT recipients that experienced refractory CMV infection on letermovir treatment, prevalence of letermovir resistance, and letermovir-induced adverse effects. Results A total of 45 patients were included in the study, with 52 letermovir courses. Lung was the most commonly transplanted organ (35%), followed by kidney (22%). 78% of patients were high-risk CMV and the most common immunosuppression regimen consisted of a calcineurin inhibitor in combination with a corticosteroid (82%). 11 patients received letermovir for primary CMV prophylaxis, with only one patient experiencing new/worsening viremia while on the agent. Of the 34 patients who received letermovir for secondary CMV prophylaxis, 11 experienced new/worsening viremia. 7 patients received letermovir for CMV treatment, at a median viral load of 991 IU/mL (IQR 603-2,738) on initiation and peak viral load of 3,892 IU/mL (IQR 1,407-10,209) while on therapy. No patients in the treatment group experienced refractory infection. 7/52 (13.5%) letermovir courses were discontinued due to new/worsening viremia, with no letermovir resistance identified. No letermovir-related adverse effects were documented. Conclusion Our study shows that letermovir appears to be effective in suppressing CMV viremia. Letermovir may be an alternative option for SOT recipients who are unable to tolerate or have resistance to traditional CMV therapeutics. Disclosures All Authors: No reported disclosures

Reducing antimicrobial overuse through targeted therapy for patients with community-acquired pneumonia: a study protocol for a cluster-randomized factorial controlled trial (CARE-CAP)

BackgroundCommunity-acquired pneumonia (CAP) is a significant public health concern and a leading cause of hospitalization and inpatient antimicrobial use in the USA. However, determining the etiologic pathogen is challenging because traditional culture methods are slow and insensitive, leading to prolonged empiric therapy with extended-spectrum antibiotics (ESA) that contributes to increased hospital length of stay, and antimicrobial resistance. Two potential ways to reduce the exposure to ESA are (a) rapid diagnostic assays that can provide accurate results within hours, obviating the need for empiric therapy, and (b) de-escalation following negative bacterial cultures in clinically stable patients.MethodsWe will conduct a large pragmatic 2 × 2 factorial cluster-randomized controlled trial across 12 hospitals in the Cleveland Clinic Health System that will test these two approaches to reducing the use of ESA in adult patients (age ≥ 18 years) with CAP. We will enroll over 12,000 patients and evaluate the independent and combined effects of routine use of rapid diagnostic testing at admission and pharmacist-led de-escalation after 48 h for clinically stable patients with negative cultures vs usual care. We hypothesize that both approaches will reduce days on ESA. Our primary outcome is the duration of exposure to ESA therapy, a key driver of antimicrobial resistance. Secondary outcomes include detection of respiratory viruses, treatment with anti-viral medications, positive pneumococcal urinary antigen test, de-escalation by 72 h from admission, re-escalation to ESA after de-escalation, total duration of any antibiotic, 14-day in-hospital mortality, intensive care unit transfer after admission, healthcare-associated C. difficile infection, acute kidney injury, total inpatient cost, and hospital length-of-stay.DiscussionOur study aims to determine whether identifying an etiological agent early and pharmacist-led de-escalation (calling attention to negative cultures) can safely reduce the use of ESA in patients with CAP. If successful, our findings should lead to better antimicrobial stewardship, as well as improved patient outcomes and reduced healthcare costs. Our findings may also inform clinical guidelines on the optimal management of CAP.Trial registrationClinicalTrials.gov NCT05568654. Registered on October 4, 2022.

Predictors of Major Adverse Cardiovascular Events in Patients With Moderate Aortic Stenosis: Implications for Aortic Valve Replacement.

Although the prognosis and management of severe aortic stenosis has been extensively studied, the risk stratification and outcomes of patients with moderate aortic stenosis remain elusive. This study included 674 patients from the Cleveland Clinic Health System with moderate aortic stenosis (aortic valve area, 1-1.5 cm2; mean gradient, 20-40 mm Hg; and peak velocity <4 m/s) and an NT-proBNP (N-terminal pro-B-type natriuretic peptide) level within 3 months of index diagnosis. The primary outcome of major adverse cardiovascular events (defined as the composite outcome of progression to severe aortic stenosis requiring aortic valve replacement, heart failure hospitalization, or death) was extracted from the electronic medical record. The mean age was 75.3±12 years, and 57% were men. During a median follow-up of 316 days, the composite end point occurred in 305 patients. There were 132 (19.6%) deaths, 144 (21.4%) heart failure hospitalizations, and 114 (16.9%) patients underwent aortic valve replacement. Elevated NT-proBNP (1.41 [95% CI, 1.01-1.95]; P=0.048), diabetes (1.46 [95% CI, 1.08-1.96]; P=0.01), elevated averaged mitral valve E/e' ratio (hazard ratio, 1.57 [95% CI, 1.18-2.10]; P<0.01), and presence atrial fibrillation at the time of index echocardiogram (hazard ratio, 1.83 [95% CI, 1.15-2.91]; P=0.01) were each independently associated with an increased hazard for the composite outcome and when taken collectively, each of these factors incrementally increased risk. These results further elucidate the relatively poor short-medium term outcomes and risk stratification of patients with moderate aortic stenosis, supporting randomized trials assessing the efficacy of transcatheter aortic valve replacement in this population.

Emergency Department Co-testing for Human Immunodeficiency Virus When Testing for Gonorrhea and Chlamydia: A Readily Available, Missed Opportunity for Targeted HIV Testing in Emergency Departments.

Conducting human immunodeficiency virus (HIV) testing in emergency departments (EDs) can be an effective approach to testing and reaching populations at highest risk of contracting HIV. All gonorrhea and chlamydia (G/C) and HIV tests ordered in the Cleveland Clinic Health System's 14 EDs were included in the analysis. Data were collected from electronic health records. Descriptive statistics, with medians and means, were computed. From January 1, 2019, to December 31, 2021, we reviewed ED visits for the purpose of sexually transmitted infection (STI) screening, with an emphasis on G/C screening. In October 2019, both HIV rapid testing and G/C testing began across all 14 Cleveland Clinic EDs. The overall rate of co-testing for HIV when obtaining a G/C test for STI evaluation increased overall to around 30% for our health system EDs, with some individual EDs approaching 60%. The approach the Cleveland Clinic implemented is an effective way to test for HIV in the ED. Local health departments and stakeholders in HIV communities should support and collaborate with EDs in their jurisdictions to accelerate HIV testing initiatives by using an HIV plus G/C co-testing metric.

Patient, Operator, and Procedural Characteristics of Guidewire Retention as a Complication of Vascular Catheter Insertion.

Pre-specified observational analysis as part of a quality improvement study of consecutive guidewire retention events across a multihospital health system from August 2007 to October 2015. Ten hospitals within the Cleveland Clinic Health System in Ohio, United States. Consecutive all-comers who experienced guidewire retention after vascular catheter insertion. None. Data were manually obtained from the electronic medical records and reviewed for potential contributing factors for guidewire retention, stratified into patient, operator, and procedural characteristics. A total of 24 events were identified. Overall, the median age was 74 years, 58% were males, and the median body mass index was 26.5 kg/m2. A total of 12 (50%) individuals were sedated during the procedure. Most incidents (10 [42%]) occurred in internal jugular venous access sites. The majority of cases (13 [54%]) were performed or supervised by an attending. Among all cases, three (12%) were performed by first-year trainees, seven (29%) by residents, three (12%) by fellows, and four (17%) by certified nurse practitioners. Overall, 16 (67%) events occurred during regular working hours (8 amto 5 pm). In total, 22 (92%) guidewires were inserted nonemergently, with two (8%) during a cardiac arrest. Ultrasound guidance was used in all but one case. Guidewire retention can occur even in the presence of optimal patient, operator, and procedural circumstances, highlighting the need for constant awareness of this risk. Efforts to eliminate this important complication will require attention to issues surrounding the technical performance of the procedure.

Self-reported factors contributing to delay in ALS diagnosis among primary care providers in a large Ohio-based US healthcare network

ObjectiveThis study's primary objective is to identify self-reported factors that contribute to diagnostic delay in ALS among Primary Care Providers (PCPs). MethodsA de novo email-based survey was deployed to Ohio-based PCPs in the Cleveland Clinic Health System. ResultsOf the 77 PCP participants [including 30 Advance Practice Providers (APPs)] only: (a) 18% of physicians, and 3% of APPs were very confident or confident with recognizing signs and symptoms of ALS, (b) 13% of physicians, and 21% of APP s felt very confident or confident with distinguishing between a neurologic cause of dysfunction from other possible causes, and (c) 23% of physicians, and 11% of APPs felt very confident or confident with distinguishing between upper and lower motor neuron signs. If presented with a weak patient without a specific diagnosis, PCPs most frequently ordered electrodiagnostic testing, brain MRI, cervical or thoracic spine MRI, and serum creatine kinase. PCPs identified top reasons for delayed ALS diagnosis as: (a) patient's delay in seeking medical help, (b) diagnostic uncertainty (c) waiting time for neurology/neuromuscular medicine (NM) consultation. The most desired strategies to shorten diagnostic delay involved: (a) educating PCPs and other non-neurologist “gatekeeper” providers, (b) improving access to specialist neurology care, and (c) developing a reliable diagnostic test for ALS. DiscussionSelf-reported factors that increase ALS diagnostic delay among PCPs primarily comprise gaps in clinical knowledge and skills required to detect key symptoms and signs, and suboptimal referral access to a neurology/NM provider. These areas represent important opportunities for targeted improvement efforts.

Multidisciplinary Approach to Improve Human Immunodeficiency Virus and Syphilis Testing Rates in Emergency Departments.

Best practice guidelines recommend that patients at risk for sexually transmitted infections (STIs), such as gonorrhea (GC) and chlamydia, should also be tested for human immunodeficiency virus (HIV) and syphilis. This prospective quality assurance study aimed to increase HIV and syphilis testing rates in emergency departments (EDs) across the Cleveland Clinic Health System from January 1, 2020 through January 1, 2022. A multidisciplinary team of emergency medicine, infectious diseases, pharmacy, and microbiology personnel convened to identify barriers to HIV and syphilis testing during ED encounters at which GC/chlamydia were tested. The following interventions were implemented in response: rapid HIV testing with new a workflow for results follow-up, a standardized STI-screening order panel, and feedback to clinicians about ordering patterns. There were 57 797 ED visits with GC/chlamydia testing completed during the study period. Human immunodeficiency virus testing was ordered at 5% of these encounters before the interventions were implemented and increased to 8%, 23%, and 36% after each successive intervention. Syphilis testing increased from 9% before the interventions to 12%, 28%, and 39% after each successive intervention. In multivariable analyses adjusted for age, gender, and location, the odds ratio for HIV and syphilis testing after all interventions was 11.72 (95% confidence interval [CI], 10.82-12.71; P ≤.001) and 6.79 (95% CI, 6.34-7.27; P ≤.001), respectively. The multidisciplinary intervention resulted in improved testing rates for HIV and syphilis.

Sustained weight loss may reduce cancer risk.

Sustained weight loss may reduce cancer risk.

An age-friendly population health dashboard geolocating by clinical and social determinant needs.

An age-friendly population health dashboard geolocating by clinical and social determinant needs.

S658 Risk Factors Associated With Upper Gastrointestinal Bleeding in Cancer Patients Exposed to Immune Checkpoint Inhibitors

Introduction: Immune checkpoint inhibitors (ICIs) have emerged as effective treatment options for many advanced malignancies. These agents have been associated with several immune related adverse events (irAEs) that may lead to discontinuation of therapy. Gastrointestinal (GI) side effects are amongst the most commonly reported irAEs. Currently, limited data exists on upper GI bleed (UGIB) in patients exposed to ICIs. The aim of this study was to evaluate the characteristics and risk factors associated with UGIB among cancer patients treated with ICIs. Methods: We performed a retrospective study on all cancer patients from Cleveland Clinic health system who received treatment with ICI’s till June 2021. Only the patients with clinical and endoscopic evidence of upper GI bleed were included in the study. The study group (GI Bleed) was matched with control group (non-Bleeders) in 1:3. We compared characteristics of both groups (Bleeders and Non-Bleeders) using univariate and multivariate analysis. Results: Of the 6820 patients that received ICIs over the study period, 401 patients developed GI bleed. 30 patients had clinical and endoscopic evidence of upper GI Bleed. The most common endoscopic findings were gastric and duodenal ulcers (63%). Compared with the non-bleeding cohort, patients who developed UGIB bleeding had lower BMI (p= 0.0203). Non-small cell lung cancer was the most frequently treated malignancy in the bleeding group. Patients in the bleeding group had higher exposure to pembrolizumab compared to the non-bleeding group (80% vs. 45.6%, p= 0.001). The incidence of ICI induced colitis and hepatotoxicity were more frequent in the bleeding group compared to the non-bleeding cohort (53.5% vs. 27.8%, p= 0.0106). The presence of cirrhosis, diabetes and chronic kidney disease were similar in both groups. On the multivariant analysis, exposure to pembrolizumab (OR=3.62, p=0.0211), aspirin (OR= 10.55, p=0.0002) and with history of ICI induced colitis and hepatotoxicity (OR=3.66 p=0.0108) were predictive factors in development of bleeding. (Table) Conclusion: This is a novel study that evaluates the risk of UGIB in cancer patients treated with ICIs. In this univariate and multivariate analysis, exposure to aspirin, pembrolizumab and overall incidence of IrAEs were associated with increased risk of bleeding. Although UGIB is a relatively rare irAE, more studies are needed for risk stratification of patients exposed to ICIs. Table 1. - Baseline Clinical Characteristics Of Cancer Patients Exposed To ICIs Variable Non-Bleeding (n=90) Bleeding (n=30) p-value Age, mean ± SD 70.6 ± 11.0 69.6 ± 11.3 0.6854 Gender (Male), n (%) 56 (62.2) 19 (63.3) 0.9133 Race (White), n (%) 76 (84.4) 23 (76.7) 0.3316 Hispanic, n (%) 1 (1.1) 2 (6.7) 0.1539 Medication Type, n (%) PembrolizumabOther 41 (45.6)49 (54.4) 24 (80.0)6 (20.0) 0.0010 BMI, n (%)< 26≥ 26 38 (42.2)52 (57.8) 20 (66.7)10 (33.3) 0.0203 History of Upper GI Bleed, n (%) 7 (7.8) 0 (0.0) 0.1902 On Aspirin prior to procedure, n (%) 5 (5.6) 12 (40.0) < 0.0001 On Plavix prior to procedure, n (%) 1 (1.1) 1 (3.3) 0.4391 On Warfarin prior to procedure, n (%) 0 (0.0) 1 (3.3) 0.2500 Chronic kidney disease, n (%) 34 (37.8) 13 (43.3) 0.5893 Diabetes, n (%) 33 (36.7) 9 (30.0) 0.5073 Cirrhosis, n (%) 4 (4.4) 1 (3.3) 1.0000 Type of cancer treated, n (%)Non-small cell lung cancerOther 25 (27.8)65 (72.2) 15 (50.0)15 (50.0) 0.0253 Evidence of metastasis to the GI Tract, n (%) 4 (4.4) 0 (0.0) 0.5710 ICPI induced side effect, n (%) 25 (27.8) 16 (53.3) 0.0106 Treatment with steroids, n (%) 21 (23.3) 11 (36.7) 0.1527 Treatment with Infliximab or Entyvio, n (%) 1 (1.1) 1 (3.3) 0.4391 Current alive, n (%) 29 (32.2) 8 (26.7) 0.5682 PPI, n (%)NoYes 53 (58.9)37 (41.1) 17 (56.7)13 (43.3) 0.8307 Footnote: PPI (protein pump inhibitor).

A risk model to identify Legionella among patients admitted with community-acquired pneumonia: A retrospective cohort study.

Background:Guidelines recommend testing hospitalized patients with community-acquired pneumonia (CAP) for Legionella pneumophila only if the infection is severe or risk factors are present. There are no validated models for predicting Legionella.Objective:To derive and externally validate a model to predict a positive Legionella test.Design, Setting and Participants:Diagnostic study of adult inpatients with pneumonia using data from 177 US hospitals in the Premier Healthcare Database (training and hold-out validation sets) and 12 Cleveland Clinic Health System (CCHS) hospitals (external validation set). We used multiple logistic regression to predict positive Legionella tests in the training set, and evaluated performance in both validation sets.Main Outcome and Measures:The outcome was a positive Legionella test. Potential predictors included demographics and co-morbidities, disease severity indicators, season, region, and presence of a local outbreak.Results:Of 166,689 patients hospitalized for pneumonia, 43,070 were tested for Legionella and 642 (1.5%) tested positive. The strongest predictors of a positive test were a local outbreak (odds ratio [OR], 3.4), June–October occurrence (OR, 3.4), hyponatremia (OR, 3.3), smoking (OR, 2.4), and diarrhea (OR, 2.0); prior admission within 6 months (OR, 0.27) and chronic pulmonary disease (OR, 0.49) were associated with a negative test. Model c-statistics were 0.79 in the Premier and 0.77 in the CCHS validation samples. High-risk patients were only slightly more likely to have been tested than lower-risk patients. Compared to actual practice, the model-based testing strategy detected twice as many cases.Conclusions:Although Legionella is an uncommon cause of pneumonia, patient characteristics can identify individuals at high risk, allowing for more efficient testing.

Primary care physician referral practices regarding BRCA1/2 genetic counseling in a major health system.

The United States Preventive Services Task Force recommends primary care physicians refer patients at high risk for BRCA1/2 mutations to genetic testing when appropriate. The objective of our study was to describe referrals for BRCA1/2 testing in a large integrated health system and to assess factors associated with referral. This retrospective cohort study includes female patients between 18 and 50years who had a primary care visitin the Cleveland Clinic Health System between 2010 and 2019. We used multivariable logistic regression to estimate differences in the odds of a woman being referred for BRCA1/2 testing by patient factors and referring physician specialty. We also assessed variation in referrals by physicians. Among 279,568 women, 5% were high risk. Of those, 22% were referred for testing. Black patients were significantly less likely to be referred than white patients (aOR 0.87; 95% CI 0.77, 0.98) and Jewish patients were more likely to be referred than non-Jewish patients (aOR 2.13; 95% CI 1.68, 2.70). Patients primarily managed by OB/GYN were significantly more likely to be referred than those cared for via Internal/Family Medicine (aOR 1.45; 95% CI 1.30, 1.61). Less than a quarter of primary care physicians ever referred a patient for testing. The majority of primary care patients at high risk for a BRCA1/2 mutation were not referred for testing, and over a decade, most physicians never referred a single patient. Internal/Family Medicine physicians, in particular, need support in identifying and referring women who could benefit from testing.

Abstract 231: Patient, Operator, And Procedural Characteristics Of Guidewire Retention As A Complication Of Vascular Catheter Insertion

Introduction: Guidewire retention after intravascular catheter insertion is considered a “never event.” Prior reports attribute this complication to various characteristics including uncooperative patients, operator inexperience, off-hour or emergent insertion, and underutilization of ultrasound guidance. In this descriptive analysis of consecutive events, we assessed the frequency of patient, operator, and procedural factors in guidewire retention. Methods: All consecutive incidents of guidewire retention across 10 hospitals within the Cleveland Clinic Health System in Ohio from August 2007 to October 2015 were prospectively identified and retrospectively analyzed. Data were manually obtained from the electronic medical records and reviewed for potential contributing factors for guidewire retention including patient, operator, and procedural characteristics. Results: A total of 24 guidewire retention events were identified. Overall, the median age was 74 years, 58% were males, and the median body mass index was 26.5 kg/m 2 . A total of 12 (50%) individuals were sedated during the procedure. Most incidents (10 [42%]) occurred in internal jugular venous access sites. The majority of cases (13 [54%]) were performed or supervised by an attending. Among all cases, 3 (12%) were performed by first-year trainees, 7 (29%) by residents, 3 (12%) by fellows, and 4 (17%) by certified nurse practitioners. Overall, 16 (67%) events occurred during regular working hours (8AM - 5PM). In total, 22 (92%) guidewires were inserted non-emergently, with 2 (8%) during a cardiac arrest. Ultrasound guidance was used in all but 1 case. Conclusion: Guidewire retention can occur even in the presence of optimal patient, operator, and procedural circumstances, highlighting the need for constant awareness of this risk. Efforts to eliminate this important complication will require attention to issues surrounding the technical performance of the procedure.

Outcomes Associated with ICU Telemedicine and Other Risk Factors in a Multi-Hospital Critical Care System: A Retrospective, Cohort Study for 30-Day In-Hospital Mortality.

Introduction: Intensive care unit telemedicine (ICU-TM) is expanding due to increasing demands for critical care, but impact on outcomes remains controversial. This study evaluated the association of ICU-TM and other clinical factors with 30-day, in-hospital mortality. Methods: This retrospective, cohort study included 151,780 consecutive ICU patients admitted to nine hospitals in the Cleveland Clinic Health System from 2010 to 2020. Patients were identified from an institutional datamart and Acute Physiology and Chronic Health Evaluation IV (APACHE IV) registry. Primary outcome was 30-day in-hospital mortality. Analyses included multivariate logistic regression modeling, and survival analysis. Results: Overall, unadjusted 30-day, in-hospital mortality incidence was significantly different with (5.6%) or without ICU-TM (7.2%), and risk ratio was 0.78 (95% confidence interval [CI] 0.75-0.81) (p < 0.0001). Mortality rate for ICU-TM and no ICU-TM was 2.4/1,000 versus 3.2/1,000 patient days, respectively (p < 0.0001). Multivariate logistic regression showed that ICU-TM was associated with reduced 30-day mortality (odds ratio 0.78, 95% CI 0.72-0.83). Increased risk was seen with cardiac arrest admissions, males, acute stroke, weekend admission, emergency admission, race (non-white), sepsis, APACHE IV score, ICU length of stay (LOS), and the interaction term, emergency surgical admissions. Reduced risk was associated with hospital LOS, surgical admission, and the interaction terms (weekend admissions with ICU-TM and after-hour admissions with ICU-TM). The model c-statistic was 0.77. Median ICU and hospital lengths of stay were significantly reduced with ICU-TM, with no difference in 48-h mortality or 48-h mortality rate. Conclusion: ICU telemedicine exposure appears to be one of several operational and clinical factors associated with reduced 30-day, in-hospital mortality.

Implementation Experience with a 30-Day Hospital Readmission Risk Score in a Large, Integrated Health System: A Retrospective Study.

BackgroundDriven by quality outcomes and economic incentives, predicting 30-day hospital readmissions remains important for healthcare systems. The Cleveland Clinic Health System (CCHS) implemented an internally validated readmission risk score in the electronic medical record (EMR).ObjectiveWe evaluated the predictive accuracy of the readmission risk score across CCHS hospitals, across primary discharge diagnosis categories, between surgical/medical specialties, and by race and ethnicity.DesignRetrospective cohort study.ParticipantsAdult patients discharged from a CCHS hospital April 2017–September 2020.Main MeasuresData was obtained from the CCHS EMR and billing databases. All patients discharged from a CCHS hospital were included except those from Oncology and Labor/Delivery, patients with hospice orders, or patients who died during admission. Discharges were categorized as surgical if from a surgical department or surgery was performed. Primary discharge diagnoses were classified per Agency for Healthcare Research and Quality Clinical Classifications Software Level 1 categories. Discrimination performance predicting 30-day readmission is reported using the c-statistic.ResultsThe final cohort included 600,872 discharges from 11 Northeast Ohio and Florida CCHS hospitals. The readmission risk score for the cohort had a c-statistic of 0.6875 with consistent yearly performance. The c-statistic for hospital sites ranged from 0.6762, CI [0.6634, 0.6876], to 0.7023, CI [0.6903, 0.7132]. Medical and surgical discharges showed consistent performance with c-statistics of 0.6923, CI [0.6807, 0.7045], and 0.6802, CI [0.6681, 0.6925], respectively. Primary discharge diagnosis showed variation, with lower performance for congenital anomalies and neoplasms. COVID-19 had a c-statistic of 0.6387. Subgroup analyses showed c-statistics of > 0.65 across race and ethnicity categories.ConclusionsThe CCHS readmission risk score showed good performance across diverse hospitals, across diagnosis categories, between surgical/medical specialties, and by patient race and ethnicity categories for 3 years after implementation, including during COVID-19. Evaluating clinical decision-making tools post-implementation is crucial to determine their continued relevance, identify opportunities to improve performance, and guide their appropriate use.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-07277-4.

Association of Weight Loss Achieved Through Metabolic Surgery With Risk and Severity of COVID-19 Infection

Obesity is an established risk factor for severe COVID-19 infection. However, it is not known whether losing weight is associated with reduced adverse outcomes of COVID-19 infection. To investigate the association between a successful weight loss intervention and improved risk and severity of COVID-19 infection in patients with obesity. This cohort study involved adult patients with a body mass index of 35 or higher (calculated as weight in kilograms divided by height in meters squared) who underwent weight loss surgery between January 1, 2004, and December 31, 2017, at the Cleveland Clinic Health System (CCHS). Patients in the surgical group were matched 1:3 to patients who did not have surgical intervention for their obesity (control group). The source of data was the CCHS electronic health record. Follow-up was conducted through March 1, 2021. Weight loss surgery including Roux-en-Y gastric bypass and sleeve gastrectomy. Distinct outcomes were examined before and after COVID-19 outbreak on March 1, 2020. Weight loss and all-cause mortality were assessed between the enrollment date and March 1, 2020. Four COVID-19-related outcomes were analyzed in patients with COVID-19 diagnosis between March 1, 2020, and March 1, 2021: positive SARS-CoV-2 test result, hospitalization, need for supplemental oxygen, and severe COVID-19 infection (a composite of intensive care unit admission, need for mechanical ventilation, or death). A total of 20 212 patients (median [IQR] age, 46 [35-57] years; 77.6% female individuals [15 690]) with a median (IQR) body mass index of 45 (41-51) were enrolled. The overall median (IQR) follow-up duration was 6.1 (3.8-9.0) years. Before the COVID-19 outbreak, patients in the surgical group compared with control patients lost more weight (mean difference at 10 years from baseline: 18.6 [95% CI, 18.4-18.7] percentage points; P < .001) and had a 53% lower 10-year cumulative incidence of all-cause non-COVID-19 mortality (4.7% [95% CI, 3.7%-5.7%] vs 9.4% [95% CI, 8.7%-10.1%]; P < .001). Of the 20 212 enrolled patients, 11 809 were available on March 1, 2020, for an assessment of COVID-19-related outcomes. The rates of positive SARS-CoV-2 test results were comparable in the surgical and control groups (9.1% [95% CI, 7.9%-10.3%] vs 8.7% [95% CI, 8.0%-9.3%]; P = .71). However, undergoing weight loss surgery was associated with a lower risk of hospitalization (adjusted hazard ratio [HR], 0.51; 95% CI, 0.35-0.76; P < .001), need for supplemental oxygen (adjusted HR, 0.37; 95% CI, 0.23-0.61; P < .001), and severe COVID-19 infection (adjusted HR, 0.40; 95% CI, 0.18-0.86; P = .02). This cohort study found that, among patients with obesity, substantial weight loss achieved with surgery was associated with improved outcomes of COVID-19 infection. The findings suggest that obesity can be a modifiable risk factor for the severity of COVID-19 infection.

IsoPSA® Reduces Provider Recommendations for Biopsy and Magnetic Resonance Imaging in Men with Total Prostate Specific Antigen ≥4 ng/ml: A Real-World Observational Clinical Utility Study.

We assessed the impact of the IsoPSA® test for prostate cancer risk assessment on provider patient management decisions in a real-world clinical setting. A total of 38 providers, including advanced practice providers, fellowship trained oncologists and general urologists in the Cleveland Clinic health system including both community-based practices and academic locations, enrolled 900 men being evaluated for prostate cancer; 734 met inclusion criteria (age ≥50 years, total serum prostate specific antigen [PSA] ≥4 and <100 ng/ml and no history of prostate cancer) and IsoPSA indication for use. A standard template was used to document biopsy recommendation prior to and after receiving IsoPSA results. The primary outcome was the number of biopsy and magnetic resonance imaging recommendation changes occurring after IsoPSA testing. IsoPSA testing resulted in a 55% (284 vs 638) net reduction in recommendations for prostate biopsy for men with total PSA ≥4 ng/ml. Additionally, a 9% reduction in recommendations for magnetic resonance imaging was observed. There was strong concordance between IsoPSA results and provider recommendations for prostate biopsy, with 87% of patients with an IsoPSA index above the threshold recommended for biopsy and 92% of patients with an IsoPSA index below the threshold not recommended for biopsy. In a real-world clinical setting, providers from diverse training backgrounds and practice settings readily adopted IsoPSA with substantial reductions in the rate of recommended prostate biopsies in patients with elevated PSA values (≥4 ng/ml). There was a high concordance between recommendation for or against prostate biopsy and the IsoPSA result.