bluuebunny/crossref_metadata_2025_split huggingface dataset:
532. Establishing a SARS-CoV-2 Monoclonal Antibody Infusion Clinic: Early Trends in Outcomes and Disparities
Authors: Hare Allison J , Rivera McPhaul Judith M , Cargan Patrick , Tebas Pablo , Degnan Kathleen , Baron Jillian T , Hamilton Keith W 
Published: December 2021

Abstract

Background
SARS-CoV-2 monoclonal antibodies (SMA) have demonstrated efficacy in treatment of early, mild to moderate COVID-19 in patients at high risk for progression to severe COVID-19. We created an SMA infusion clinic at a large, urban academic medical center using both internal and community-based referral mechanisms to promote the equitable distribution of treatment.

Methods
Data were analyzed from clinic referrals from December 13, 2020 through April 20, 2021. Patient demographics, census-based area deprivation index (ADI) scores (scale of 1-10, with 1 representing least socioeconomic deprivation and 10 representing most), and relevant comorbidities were collected. Outcomes included days of symptoms until referral, patient receipt of SMA therapy after referral, adverse events, and ER visits and hospitalizations within 14 days of SMA administration. Association between demographic factors and relevant outcomes were determined using chi-square or Wilcoxon rank-sum tests as appropriate.

Results
47/433 (11%) referred patients were ineligible based on inclusion and exclusion criteria. Of eligible patients, 310/386 (80%) received treatment; patients who did not receive treatment either declined (93%), could not be contacted (5%), no-showed (1%), or were admitted for hypoxia (1%). Of treated patients, only 3 (1%) had adverse reactions. Within 14 days of SMA administration, 28 (9%) patients visited the ER or were admitted for COVID-19. Black patients had a longer median duration of symptoms prior to referral compared to White patients (5 vs. 3 days, p &lt; 0.01) (Figure 1). White patients were more likely to receive SMA after referral compared to Black patients (88% vs. 64%, p &lt; 0.01), as were patients with ADI score 1-5 compared to those with ADI score 6-10 (88% vs. 70%, p &lt; 0.01) (Figures 2 and 3). Black patients who received SMA had a higher rate of ER visits or admissions than White patients, although the difference was not statistically significant (14% vs. 7%, p = 0.10).

Figure 1. Bar graph displaying number of patients per race (White, Black, or Other) by duration of symptoms prior to referral.

Figure 2. Bar graph displaying number of patients who did and did not receive SMA by race

Figure 3. Bar graph displaying number of patients who did and did not receive SMA by ADI.

Conclusion
Rate of adverse reactions and COVID-related ER visits or admissions were low in patients who received SMA. Despite efforts to promote the equitable distribution of treatment through multiple referral mechanisms, racial and socioeconomic disparities still exist.

Disclosures
All Authors: No reported disclosures
538. The Role of N-acetylcysteine on Post Covid-19 Pulmonary Fibrosis
Authors: Demot Bernard , Hizon Kristin Ivan Mark 
Published: December 2021

Abstract

Background
Covid 19 have long lasting complications, from myalgia, body weakness to life debilitating strokes, and pulmonary fibrosis. Several mechanisms had been described but mostly viral or autoimmune which causes damages which leads to Acute respiratory distress syndrome. There is no approved treatment as of this time. Antifibrotic drugs use had been limited due to hepatoxicity, on top of Covid 19 hepatopathy. This study aims to describe the role of N-acetylcysteine on Post COVID 19 pulmonary fibrosis as an alternative treatment.

Methods
Patients are admitted at Baguio General Hospital and Medical Center at the COVID wards. Patients are COVID confirmed by RT PCR nasopharyngeal swab. Patient who are classified as severe were given Dexamethasone, Enoxaparin and Remdesivir for 5-10 days. Patients who are not weaned off from O2 support underwent Chest CT scan. Patients with Extensive Fibrosis were then consented to undergo High Dose IV Infusion of N-acetylcysteine. (150mg/kg in 1st hour, 50mg/kg next 4 hours and 100mg/kg last 20 hours). Repeat Chest CT Scan was done.

Results
Peripheral Bilateral Ground Glass Opacities and Pulmonary Consolidation was seen on pre-treatment CT Scans. Repeat CT scans showed significant regression of Ground Glass Opacities and Pulmonary Consolidation.
CT SCAN pre and post treatment

Conclusion
High dose N-acetylcysteine showed promising results on Post COVID 19 Pulmonary Fibrosis.

Disclosures
All Authors: No reported disclosures
566. Impact of a Culturally Sensitive Multilingual Community Outreach Model on COVID-19 Vaccinations at an Urban Safety-net Community Hospital
Authors: Mena Lora Alfredo J , Echeverria Stephanie L , Li Ella , Morales Miguel , Esquiliano Rita , Schultz Genessa , Sifuentes James , Spencer Sherrie , Takhsh Eden , Lavani Romeen 
Published: December 2021

Abstract

Background
The United States (US) is one of the most affected countries by the COVID-19 pandemic. A disproportionate burden of COVID-19 deaths is seen in Black, Asian, and Latinx groups. COVID-19 vaccines are the primary mitigation strategy to reduce morbidity and mortality. However, vaccine hesitancy is high in these communities due to factors such as low health literacy, language barriers, and other health inequities. Our objective was to implement a culturally sensitive, multi-lingual, community outreach model to promote vaccine education and facilitate vaccine administration.

Methods
Community healthcare workers or “promotoras” were deployed to high traffic areas such as supermarkets, laundromats, churches, and commercial hubs from February-May 2021. The promotoras provided culturally sensitive vaccine counseling to individuals in their preferred language and facilitated vaccine appointments at our hospital. Our data was compared with publicly available data from other facilities organized by ZIP codes defined by the Department of Public Health as low, medium, or high-vulnerability to COVID-19.

Results
A total of 109 outreach workers were hired, of which 67% (73) were Latinx, 27% (29) Black and 6% (7) Asian. Overall, 8,806 individual encounters led to 6,149 scheduled appointments and 3,192 completed first doses (Figure 1). A total of 14,636 individuals were vaccinated. Average age was 45.5 (range 12-98). Preferred language was 54% Spanish, 38% English, and 8% Chinese. Ethnicity was mostly Hispanic (66%) with race mostly white (54%) (Figure 2). High and medium-risk ZIP codes represented 69.4% of vaccinations at our facility (Figure 3).

Figure 1. Education encounters and appointments made by community outreach workers and associated vaccinations.

Figure 2. Racial distribution of vaccinated individuals at our facility

Figure 3. Comparative vaccinations by zip codes from hospitals in our area.

Conclusion
We successfully implemented a culturally sensitive community outreach model which resulted in higher vaccination rates from at risk ZIP codes when compared to other hospitals. Promotoras encouraged vaccination in native languages, thereby increasing vaccine awareness and appointment faciliation. Barriers to vaccine access remain in these vulnerable communities. This model educated the community via its own members and may help reduce barriers, increase vaccine awareness and vaccination rates.

Disclosures
All Authors: No reported disclosures
605. Rates of Patient Satisfaction with Home-Based Outpatient Antimicrobial Therapy (OPAT)
Authors: Garst Ryan , Haines Danell J , Sullivan Connie 
Published: December 2021

Abstract

Background
The use of home-based outpatient parenteral antimicrobial therapy (OPAT) is well established. Studies by the National Home Infusion Foundation (NHIF) show that 1.4 million patients receive OPAT each year.1 With patient satisfaction a priority, NHIF developed, validated, and reliability tested the Uniform Patient Satisfaction Survey for Home Infusion Providers in 2017.2 Medicare patients are the fasting growing segment in the US and account for a disproportionate share of health care usage. Determining older patient satisfaction is imperative because patients who are more satisfied are more compliant with treatment3 and tend to return for continued care.4 Accordingly, the purpose of this study was to determine the level of home-based OPAT patient satisfaction and if a significant difference (p = ≤ .05) exists between the 0-64 and 65+ age groups.

Methods
2019 and 2020 OPAT survey data (n=5,559) was used in this study. Top box percent, typically used in health care patient satisfaction, was calculated for each survey question. Data was summarized using 7 composite categories formed from the 22 survey questions. Differences (p = ≤ .05) between the age groups was also calculated.

Results
Mean patient age was 64.31 (SD=14.78), 54.99% were 65+ years old, and 58.85% were male. OPAT patients gave high marks to their home infusion service (Table 1). The highest top box % for the composite scores was “Patient instructions” which averaged 98.91%. The most common healthcare satisfaction question “I was satisfied with the overall quality of the services provided” showed significant difference between the age groups (p = .002) with the 0-64 groups being more satisfied than the 65+ (Exhibit 1).
Table 1. OPAT Patient Satisfaction Survey Composite Scores: Percent of Patients Selecting Top-Box Score (n= 5,559)

Exhibit 1. Level (%) of Agreement to “I was satisfied with the overall quality of the services provided” by Age Group (n = 5,559)

Conclusion
Analysis of each survey question shows the 65+ patients are less satisfied than younger patients on the following: being informed of side effects, explanation of financial responsibilities, and the helpfulness of the billing staff. Even though the scores are high for both age groups, additional research needs to be conducted to determine why scores for the 65+ age group are lower, and changes needed for improvement. Knowing the level of OPAT patient satisfaction will benefit infectious disease physicians, providers, prescribers, payers, and regulators as they evaluate how to expand home-based services.

Disclosures
All Authors: No reported disclosures
616. Predicting Misdiagnoses of Infectious Disease in Emergency Department Visits
Authors: Chapman Alec B , Peterson Kelly , Widanagamaachchi Wathsala , Jones Makoto M 
Published: December 2021

Abstract

Background
Diagnostic error leads to delays of care and mistaken therapeutic decisions that can cascade in a downward spiral. Thus, it is important to make accurate diagnostic decisions early on in the clinical care process, such as in the emergency department (ED). Clinical data from the Electronic Health Record (EHR) could identify cases where an initial diagnosis appears unusual in context. This capability could be developed into a quality measure for feedback. To that end, we trained a multiclass machine learning classifier to predict infectious disease diagnoses following an ED visit.

Methods
To train and evaluate our classifier, we sampled ED visits between December 31, 2016, and December 31, 2019, from Veterans Affairs (VA) Corporate Data Warehouse (CDW). Data elements used for prediction included lab orders and results, medication orders, radiology procedures, and vital signs. A multiclass XGBoost classifier was trained to predict one of five infectious disease classes for each ED visit based on the clinical variables extracted from CDW. Our model was trained on an enriched sample of 916,562 ED visits and evaluated on a non-enriched blind testing set of 356,549 visits. We compared our model against an ensemble of univariate Logistic Regression models as a baseline. Our model was trained to predict for an ED visit one of five infectious disease classes or “No Infection”. Labels were assigned to each ED visit based on ICD-9/10-CM diagnosis codes used elsewhere and other structured EHR data associated with a patient between 24 hours prior to an ED visit and 48 hours after.

Results
Classifier performance varied across each of the five disease classes (Table 1). The classifier achieved the highest F1 and AUC for UTI, the lowest F1 for Sepsis, and the lowest AUC for URI. We compared the average precision, recall and F1 scores of the multiclass XGBoost with the ensemble of Logistic Regression models (Table 2). XGBoost achieved higher scores in all three metrics.
Table 1. Classification performance

XGBoost testing set performance in each disease class, visits with no labels, and macro average. The infectious disease classes with the highest score in each metric are shown in bold.
Table 2. Baseline comparison

Macro average scores for XGBoost and baseline classifiers.

Conclusion
We trained a model to predict infectious disease diagnoses in the Emergency Department setting. Future work will further explore this technique and combine our supervised classifier with additional signs of medical error such as increased mortality or anomalous treatment patterns in order to study medical misdiagnosis.

Disclosures
All Authors: No reported disclosures
627. CURE ID as a Tool for Curating and Analyzing Drugs Used in COVID-19 Clinical Trials
Authors: Charles Reema , Paul Parvesh , Stone Heather , Gorobet Serghei , Nhundu Belinda , Borkowski Katarzyna M , Duggal Mili , Tirupathi Raghavendra 
Published: December 2021

Abstract

Background
CURE ID is an internet-based data repository (https://cure.ncats.io/explore) developed collaboratively by FDA and NCATS/NIH. It is designed to capture real-world clinical outcome data to advance drug repurposing and to inform future clinical trials for infectious diseases with high unmet medical need. It also serves as a repository of clinical trials automatically pulled from https://www.clinicaltrials.gov into the CURE ID platform, where they were then manually curated, with the intention of keeping the infectious diseases community updated on the various clinical trials underway. The current study is a descriptive analysis of various therapeutics in clinical trials against COVID-19 on the CURE ID platform.

Methods
Using clinicaltrials.gov we selected those trials addressing therapeutics for COVID-19 and reviewed the drugs used, the current status of the trials, and the phases of development.

Results
As of May 2021, we identified 2,154 clinical trials and 933 drugs from clinicaltrials.gov that met the inclusion criteria. Hydroxychloroquine (n=251) was the most commonly investigated agent, followed by convalescent plasma (n=147), azithromycin (n=98), ivermectin (n=68), mesenchymal Stem Cells (n=63), tocilizumab (n=58), remdesivir (n=53) and favipiravir (n=51). At the time of our analysis, the majority (45%) of the clinical trials were in the recruiting phase, 12% were in the active phase, and 13% of the studies were completed. The majority (31%) of trials were in phase two, followed by phase three (21%) and phase one (10%). The vast majority of the agents were repurposed (92%), while only 8% of the agents were new molecular entities. Remdesivir was the only drug approved for marketing for treatment of certain patients with COVID-19 at the time of our analysis.

Conclusion
Several repurposed and novel drugs are being investigated to treat COVID-19 in clinical trials. CURE ID provides a broad view of the various drugs being researched and serves to keep the scientific community informed. Such a platform may help prevent duplication of efforts and help the scientific community with more coordinated research efforts and larger platform trials that can robustly answer scientific questions during a pandemic.

Disclosures
All Authors: No reported disclosures
631. Economic Analysis of Imipenem/Cilastatin/Relebactam Compared to Piperacillin/Tazobactam for Treating Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
Authors: Naik Jaesh , Massello Matthew , Ralph Lewis , Dillon Ryan J , Yang Joe 
Published: December 2021

Abstract

Background
Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) is associated with high rates of morbidity and mortality; this is often worse among patients who experience a delay in receiving appropriate therapy. Initial treatment choice and early adjustment occurs prior to pathogen susceptibility results and may be based on suspicion of a resistant infection and/or clinical deterioration. This study assesses the cost effectiveness of Imipenem/cilastatin/relebactam (IMI/REL) in an early adjustment prescribing scenario compared to PIP/TAZ for patients with high risk of resistant infection from a US perspective.

Methods
Although early adjustment data was not directly available, pathogen susceptibility data derived from 2017-19 Study for Monitoring Antimicrobial Resistance Trends (SMART) surveillance program was applied to estimate patients who may have clinical worsening, likely due to a resistant infection. The efficacy and safety data for IMI/REL and PIP/TAZ were informed by the modified intent-to-treat population of a phase III trial (RESTORE-IMI 2). Our analysis comprised a decision tree (reflecting hospitalization period) followed by a yearly Markov model (capturing lifetime impact). The decision tree captured short-term outcomes (clinical cure, all-cause mortality, and hospital resource use). The Markov model translated short term outcomes into quality-adjusted life years (QALYs). Results were expressed as an incremental cost-effectiveness ratio (ICER). Sensitivity analyses were conducted to test the robustness of model results.

Results
Compared with PIP/TAZ, IMI/REL in the early adjustment setting was associated with increased costs (&10,087 per patient) but a higher cure (+7%) and lower mortality (-3%) rate. The resulting ICER (&12,173/QALY) falls well below typical US willingness to pay thresholds. Model drivers were the SMART-based susceptibility profiles and RESTORE-IMI 2 response and mortality rates.

Conclusion
Our results suggest that IMI/REL, used as an early adjustment option, could be considered cost effective for patients with worsening HABP/VABP in a US setting, when compared against PIP/TAZ.

Disclosures
Jaesh Naik, MSc, BresMed Health Solutions (Employee) Lewis Ralph, MSc, Bresmed (Employee) Ryan J. Dillon, MSc, Merck & Co. Inc., (Employee, Shareholder) Joe Yang, Ph.D., Merck & Co (Employee)
640. Development of a Laboratory Verification Protocol for Concurrent Detection of Bacterial, Fungal, and Antimicrobial Resistance Genes in a Multiplex Syndromic Joint Infection Panel
Authors: Cronin Monica , Fadgen Taylor K , Ogden Lisa , Green Jeremy P , Thatcher Stephanie A , Young Rebecca C , Hoelcle Brandon 
Published: December 2021

Abstract

Background
Verification is a critical component of implementing a diagnostic test in a clinical lab and can be time consuming and costly. A verification protocol and organism panel were developed in collaboration with ZeptoMetrix®, LLC to verify all analyte detections for the BioFire® Joint Infection (JI) Panel*. The BioFire JI Panel detects 31 pathogens and 8 antimicrobial resistance (AMR) genes associated with joint infections from synovial fluid specimens.

Methods
A protocol was developed using prototype NATtrol™ controls from ZeptoMetrix®, synovial fluid, and the BioFire® FilmArray® 2.0 and the BioFire® FilmArray® Torch Systems. Control materials were tested in the presence of synovial fluid from pooled human donors. The 32 targets required for all analyte detections were divided into 5 pools of 6-7 analytes and then tested over multiple days on several systems.

Results
Preliminary outcomes were good with a cumulative positive detection rate of 100% (310/310) and expected negative detections of 99.3% (1182/1190) from 50 prototype BioFire JI Panel test runs. AMRs were correctly identified in 50/50 (100%) replicates when a correlated bacterium was present. Unexpected detections of Streptococcus spp. (7/50) and Staphylococcus lugdunensis (1/50) were likely due to contaminants in the synovial fluid; Streptococcus spp. was confirmed by testing the synovial fluid in isolation.

Conclusion
Efficient performance verification may be achieved by combining 32 organisms/8 AMR into 5 pools and can be completed with 20 test runs in 4 days. The pooling scheme provides multiple positive/negative detections per analyte and accurately detects AMR. The protocol and controls serve as a useful tool for providing reliable detections of targets over multiple days, operators and systems and offers a flexible solution for supporting verification needs.
*The BioFire® Joint Infection Panel is currently pending US FDA De Novo review. This product has not been evaluated by other global regulatory agencies for in vitro diagnostic use.
Not available for sale. Panel menu subject to change.

Disclosures
Monica Cronin, MS, BioFire Diagnostics, LLC (Employee) Taylor K. Fadgen, Bachelor of Science, BioFire Diagnostics, LLC (Employee) Lisa Ogden, BS, BioFire Diagnostics, LLC (Employee) Jeremy P. Green, BS, BioFire Diagnostics, LLC (Employee, Shareholder) Stephanie A. Thatcher, MS, BioFire Diagnostics (Employee) Rebecca C. Young, MS, BioFire Diagnostics, LLC (Employee) Brandon Hoelcle, BS, ZeptoMetrix, LLC (Employee)
648. Rapid, Non-invasive Detection of Cryptic Tularemia Using a Plasma-Based Microbial Cell-Free DNA Next-Generation Sequencing Test
Authors: Malik Salma , Paul Vishesh , Damodaran Thara , Prabakhar Deepa , Khan Amir , Ahmad Sharjeel 
Published: December 2021

Abstract

Background
Francisella tularensis causes severe infections and is a Category A potential bioterrorism agent but its microbiological diagnosis can be challenging. The diagnosis of tularemia is limited by non-specific protean clinical symptoms that overlap with other infectious syndromes, the fastidious nature of Francisella tularensis, along with insensitivity and poor specificity of serology. Rapid, non-invasive diagnosis of tularemia by microbial cell-free DNA (mcfDNA) next-generation sequencing (NGS) of plasma offers a means to overcome these limitations.

Methods
The Karius Test™ (KT) detects and quantifies mcfDNA in molecules/µL (MPM) from &gt;1400 organisms in plasma (performed at the CLIA certified/CAP accredited Karius laboratory). KT detections of Francisella tularensis were compiled from three medical centers with clinical review by healthcare providers.

Results
KT detected Francisella tularensis in four patients. All were adult males in whom the diagnosis was unexpected. The most common symptoms were fever and chest pain. White blood cell count neutrophilic predominance and abnormal chest X-ray findings were found in three cases. A broad infectious disease work-up was performed with the initiation of broad spectrum empiric antibiotics in all cases. KT was the first test to identify Francisella tularensis as the microbiological diagnosis with a time to diagnosis of 2.25 days (avg) +/- 0.5 from sample collection (one day from sample receipt in all cases), enabling narrowed, targeted antibiotic treatment. Francisella tularensis mcfDNA concentration was 1772 MPM (avg) +/- 1914. KT was the only test to establish the diagnosis in two cases; tularemia serologies were confirmatory in two cases, one of which had confirmatory culture from lymph node biopsy. Three patients were diagnosed with the pneumonic form of the illness and one with a visceral glandular form. Possible epidemiological exposures were identified in all cases.

Conclusion
KT enabled rapid, non-invasive, plasma-based diagnosis of diverse clinical manifestations of invasive tularemia against a competing broad infectious and non-infectious differential diagnosis. Timely diagnosis enabled targeted narrowing of antibiotic therapy and successful treatment of pneumonic and glandular forms of the infection.

Disclosures
All Authors: No reported disclosures