bluuebunny/crossref_metadata_2025_split huggingface dataset:
51. Patient Reported Outcomes Collection: A Mixed Methods Study at an urban HIV Clinic associated with a Historically Black Medical College in the Southern United States
Authors: Parisot Paul , Wheeler Facerlyn , Bonnet Kemberlee , Rebeiro Peter F , McCainster Korlu , Cooper Robert , Berthaud Vladimir , Schlundt David , Pettit April 
Published: December 2021

Abstract

Background
Black Americans, particularly in the South, are disproportionately affected by the US HIV epidemic. We piloted the use of an electronic tablet to collect patient reported outcomes (PRO) data on social and behavioral determinants of health among people with HIV (PWH) at the Meharry Community Wellness Center (MCWC), an HIV clinic affiliated with a Historically Black Medical College in Nashville, Tennessee. Studies have shown PRO collection can improve patient outcomes and provide oft-overlooked data on mental health, substance use, and patient adherence to ART.

Methods
We enrolled 100 PWH in care at the MCWC consecutively to complete validated PRO tools (Table 1) using the Research Electronic Data Capture (REDCap) platform on a hand-held tablet. Using a purposive sampling strategy, we enrolled 20 of the 100 participants in an in-depth interview (IDI). Interview guide development was grounded in the Cognitive Behavioral Model in which thoughts, feelings, and behaviors are inter-related. IDIs were audio recorded, transcribed, de-identified, and formatted for coding. A hierarchical coding system was developed and refined using an inductive-deductive approach.

Results
Among 100 PWH enrolled, median age was 50 years, 89% were Black, 60% were male, and 82% were living below 100% of the Federal Poverty Level. IDI participants felt the tablet was easy to use and the question content was meaningful. Question content related to trauma, sexual and drug use behaviors, mental health, stigma, and discrimination elicited uncomfortable or distressing feelings in some participants. Patients expressed a strong desire to be truthful and most would complete these surveys without compensation at future visits if offered.

Conclusion
The use of an electronic tablet to complete PRO data collection was feasible and well received by this cohort of vulnerable persons in HIV care in the US South. Despite some discomfort, our cohort overwhelmingly believed this was a valuable part of their medical experience. Real-time PRO data collection allows providers to screen for and act on social and behavioral determinants of health. Future research will focus on scaling up the implementation and evaluation of PRO data collection in a contextually appropriate manner.

Disclosures
Peter F. Rebeiro, PhD, MHS, Gilead (Other Financial or Material Support, Single Honorarium for an Expert Panel)
52. PrEP Adherence and Discontinuation at a Pharmacy-Supported PrEP Program in Atlanta, GA
Authors: Yacout Hiba , Smith Bradley L , Foster Shelbie , Lora Meredith , Niles-Carnes Laris , Zheng Ziduo , Kundu Suprateek , Gruen Judah K , Cantos Valeria D 
Published: December 2021

Abstract

Background
Pre-exposure prophylaxis (PrEP) is a highly effective biomedical strategy to decrease Human Immunodeficiency Virus (HIV) acquisition. Effectiveness of oral PrEP is linked to medication adherence. In 2018, Grady Health System (GHS) launched a PrEP program to increase PrEP access among un- and underinsured individuals living in metro Atlanta, Georgia. The purpose of this study is to determine PrEP medication adherence, PrEP discontinuation rates, and associated individual factors of patients enrolled during the first 18 months of the program’s implementation.

Methods
A single-center, retrospective chart review was conducted on patients enrolled in the GHS PrEP program between June 1, 2018 and February 29, 2020 who received more than one monthly PrEP prescription. Adherence was estimated using the medication possession ratio (MPR). The primary outcome was mean adherence to PrEP. Secondary outcomes include rate of high percent adherence (MPR &gt; 80%), median time of engagement in care, PrEP discontinuation rates, rates of PrEP re-engagement, and individual factors associated with PrEP discontinuation and low adherence.

Results
This study included 154 patients, 70.8% of them were Black, 62.3% were cisgender men, 59.1% were uninsured, and the mean age was 34. The majority of patients identified as men who have sex with men (51.9%). Mean PrEP adherence was 89.2%; 77.3% of patients demonstrated a high rate of adherence. No individual or social factors were associated with low adherence, but younger age was associated with higher rates of PrEP discontinuation (p&lt; 0.0061). At the end of the follow up period on October 30, 2020, 53.8% of patients were active in the program and 12.7% of those who discontinued had re-engaged with the program. The average length of program engagement was 9.8 months.
Table 1. Baseline socio-demographic characteristics (N=154)

Table 2. PrEP Adherence and Discontinuation at the GHS PrEP Program from 2018 to 2020 (N=154)

Table 4. Multivariate analysis of individual factors associated with PrEP discontinuation and low adherence

Conclusion
Mean PrEP adherence at a safety net PrEP program in Atlanta was high and PrEP discontinuation rates were comparable to other PrEP clinics nationwide. We found no association with individual factors previously linked to lower adherence, including Black race, younger age, and insurance status. Program-related factors that may have impacted these findings need to be investigated. Other future areas of research include strategies to optimize engagement in care in younger patients.

Disclosures
Bradley L. Smith, Pharm.D., AAHIVP, Gilead Sciences, Inc (Advisor or Review Panel member)
54. Self-Perception of Risk for HIV Acquisition and Calculated Risk for HIV Acquisition Among Active Duty Air Force Members with Newly Diagnosed HIV Infection
Authors: Schmid Audie B , Okulicz Jason , Hakre Shilpa , Yabes Joseph , Mika Walter V 
Published: December 2021

Abstract

Background
Persons may underestimate their risk of HIV infection despite presence of risk factors. Accurate appraisal of HIV risk may assist both patients and providers in preventing HIV acquisition. We evaluated self-perceived risk (SPR) versus calculated risk (CR) of HIV infection in active duty US Air Force (USAF) members with incident HIV infection.

Methods
USAF members with new HIV diagnosis evaluated at a specialty care military medical center between January 2015-March 2020 with available case report forms were included (n=142). Chart reviews were performed and demographic, social, and clinical characteristics were collected from initial Infectious Disease specialty encounters and case report forms. SPR was characterized as Low or High and compared to CR derived by the Denver HIV Risk Score (DHRS) by points based on patient demographic and risk exposure characteristics.

Results
Overall, patients were predominantly male (98%), with a median age of 26 years (IQR 22-30), and the majority (85%) reported same-sex partners (Table 1). Patients more commonly characterized themselves as Low SPR (n=78; 55%) than High SPR (n=64; 45%). Demographic characteristics were similar except a higher proportion of Low SPR patients (29%) were married or partnered compared to High SPR patients (14%; p=0.04). There was no difference in self-reported condom use (≥50% of the time) between Low (63%) and High (72%) SPR patients (p=0.28) and documented history of sexually transmitted infections was similarly high in both groups ( &gt;70%; p=0.85). Previous HIV pre-exposure prophylaxis (PrEP) use was uncommon in both Low SPR (8%) and High SPR (6%) groups. For the evaluation of CR by DHRS (Table 2), both Low and High SPR groups had median scores in the very high risk category (≥50 points) with similar results by test component.

Conclusion
USAF members with incident HIV infection more commonly identified with low SPR despite similar risk behaviors and CRs as high SPR patients. The development of patient education programs and promotion of HIV prevention services including PrEP are needed to reduce incident HIV cases in the USAF. Validated HIV risk calculators like the DHRS may also assist medical providers in identifying candidates for HIV prevention services.

Disclosures
All Authors: No reported disclosures
55. Infective Endocarditis After Surgical or Transcatheter Aortic Valve Replacement
Authors: Papamanoli Aikaterini , Muncan Brandon , Parikh Puja , Skopicki Hal A , Kalogeropoulos Andreas 
Published: December 2021

Abstract

Background
Infective endocarditis (IE) can complicate both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) with significant morbidity and mortality despite differing pathogenesis. In the presence of limited data from direct comparison studies and recent expansion of TAVI to younger and lower- risk patients, we compared the incidence and timing of IE in TAVI versus SAVR.

Methods
Using data from the TriNetX electronic health records network, we identified (1) a cohort of patients who underwent TAVI between January 2016 and December 2020 (CPT procedure code 1021150) and (2) a propensity score-matched cohort of patients who underwent SAVR (CPT procedure codes 1035167 or 1029693, without any associated transcatheter procedure). We examined the incidence of IE (captured with ICD-10 codes I33, I38, or I39) over a 5-year follow up period and matched the cohorts for demographic data and clinically relevant background history. We used Kaplan-Meier estimates and Cox proportional hazards models to compare incidence between matched cohorts.

Results
We identified 6,302 patients with TAVI and 6,302 matched patients with SAVR. The baseline characteristics of the cohorts were well balanced, Table 1. All standardized mean differences were &lt; 0.05, indicating adequate matching between cohorts. The Kaplan-Meier mortality at 5 years was 38.0% in the TAVI vs. 22.0% in the SAVR cohort (log-rank P &lt; 0.001). There were 290 cases with IE in the TAVI and 604 cases in the SAVR cohort. The corresponding 5-year event rates were 10.0% vs. 16.9% (log-rank P &lt; 0.001), respectively, Figure 1. The risk ratio of TAVI vs. SAVR related IE over the entire 5-year period was 0.48 (95%CI 0.42 — 0.55; P &lt; 0.001). However, the relative risk for IE was non-proportional between groups over the 5-year period, with an early pronounced incidence among SAVR relative to TAVI patients and gradual convergence of the hazard rates over time, Figure 2.

Figure 1. Cumulative 5-Year Incidence (Kaplan-Meier Estimates) of Infective Endocarditis Among Matched Transcatheter Aortic Valve Implantation (TAVI) vs. Surgical Aortic Valve Replacement (SAVR) Recipients

Figure 2. Risk of Infective Endocarditis in SAVR vs. TAVI Recipients Over Time

Conclusion
In this comparative study, the risk for IE was lower among TAVI vs. SAVR recipients, primarily due to the higher risk of IE during the early post-SAVR period. With increasing uptake of TAVI procedures, a better understanding of the temporal occurrence and pathophysiology of IE and application of effective treatment strategies in these patients is required.

Disclosures
All Authors: No reported disclosures
56. Long-Term Cardiovascular Outcomes After Drug-Related vs Non-Drug-Related Infective Endocarditis
Authors: Muncan Brandon , Papamanoli Aikaterini , Skopicki Hal A , Kalogeropoulos Andreas 
Published: December 2021

Abstract

Background
Drug use-related infective endocarditis (IE) has nearly doubled in the past two decades in the United States, largely due to the current opioid crisis. Although there are robust data on surgical outcomes for people who use drugs (PWUD) vs. non-PWUD patients after an initial encounter for IE, long-term comparative data on post-IE outcomes are relatively sparse.

Methods
Using data from the TriNetX electronic health records network, we identified (1) a cohort of patients 16 to 64 years old who had a first encounter for IE (captured with ICD-10 codes I33, I38, or I39) and history of drug use (captured with ICD-10 codes F11, F13-F16, F18, F19, O99.32, or T40) preceding the IE episode and (2) a propensity score-matched cohort of patients age 16-64 who had a first episode of IE and no documented drug use. We compared the post-IE incidence of (1) mortality; (2) ischemic stroke; (3) intracranial hemorrhage; (4) myocardial infarction; (5) heart failure; and (6) sudden cardiac death (cardiac arrest or ventricular fibrillation or tachycardia) between the 2 cohorts over a 5-year follow up period. We matched the cohorts for demographic data and clinically relevant medical history. We used Kaplan-Meier estimates and Cox models to compare incidence.

Results
We identified 6,578 PWUD patients and 6,578 matched non-PWUD patients 16-64 years old with a first episode of IE. The baseline characteristics are summarized in Table 1. Standardized mean differences of characteristics were generally &lt; 0.1, indicating adequate matching. The 5-year Kaplan-Meier rates of outcomes of interest are summarized in Table 2. Mortality did not differ between cohorts. However, the incidence of ischemic stroke and intracranial hemorrhage was consistently higher among PWUD throughout the 5-year follow-up. Rates of myocardial infarction were also higher among PWUD; however, the difference was more pronounced later during follow-up. Rates of heart failure and sudden cardiac death did not differ.

Conclusion
Cardiovascular events after IE were common among both PWUD and non-PWUD patients over a 5-year follow-up period. However, rates of ischemic and hemorrhagic stroke were consistently higher among PWUD. Further investigation is needed to elucidate the sources of elevated stroke risk among PWUD and identify targets for intervention.

Disclosures
All Authors: No reported disclosures
57. Evaluation of the 2019 European Heart Rhythm Association International Consensus Document in Patients with Cardiovascular Implantable Electronic Devices Who Develop Staphylococcus aureus Bacteremia
Authors: Chesdachai Supavit , Baddour Larry M , Sohail Muhammad R , Palraj Raj , Madhavan Malini , Tabaja Hussam , Fida Madiha , DeSimone Daniel 
Published: December 2021

Abstract

Background
Cardiovascular implantable electronic device (CIED) implantation has markedly increased over the past two decades. Staphylococcus aureus bacteremia (SAB) occurs in patients with CIED and determination of device infection among patients without clinical findings of pocket site infection is often difficult. Our study examines the characteristics, management, and outcomes of SAB in patients living with CIED using 2019 international criteria to define CIED infection.

Methods
We conducted a retrospective study of patients with CIED who were hospitalized at Mayo Clinic, Rochester, with SAB from January 1, 2012 to December 31, 2019. Patients who met CIED infection criteria following SAB based on the 2019 European Heart Rhythm Association International Concensus Document were identified. A time-to-event analysis was used to determine the impact, if any, of complete device extraction on outcomes.

Results
Overall, 110 patients with CIED developed SAB and 92 (83.6%) of them underwent transesophageal echocardiogram (TEE). Eighty-eight (80%) had CIED infection with 57 (51.8%) and 31 (28.2%) patients meeeting criteria for definite and possible CIED infections, respectively. Forty-three (75.4%) patients with definite CIED infection underwent complete device extraction. For possible and rejected CIED infection, the rates of complete device extraction were 35.5% and 27.3%, respectively (p&lt; .001 for each). The primary endpoint of a composite of one-year mortality and SAB relapse had a rate that was significantly lower in patients with CIED infection who underwent complete device extraction as compared to that of patients who did not undergo device extraction (25.9% vs. 76.5%, p&lt; .001). No significant difference in outcomes was seen in the rejected CIED infection group (33.3% vs. 62.5%, p =.27).

Conclusion
The rate of CIED infections following SAB was higher than that reported previously. Increased use of TEE and a novel case definition with broader diagnostic criteria were likely operative, in part, in accounting for the the higher rate of CIED infections complicating SAB. Complete device removal is critical in patients with either definite or possible CIED infection as defined by the 2019 consensus document to improve one-year mortality and SAB relapse rates.

Disclosures
Larry M. Baddour, MD, Boston Scientific (Individual(s) Involved: Self): Consultant; Botanix Pharmaceuticals (Individual(s) Involved: Self): Consultant; Roivant Sciences (Individual(s) Involved: Self): Consultant Muhammad R. Sohail, MD, Medtronic (Consultant)Philips (Consultant)
61. Short- versus prolonged-courses of antimicrobial therapy for patients with uncomplicated Pseudomonas aeruginosa bloodstream infection
Authors: Bae Moonsuk , Jeong Yun-Seo , Bae Seongman , Kim Min Jae , Chong Yong Pil , Kim Sung-Han , Lee Sang-Oh , Choi Sang-Ho , Kim Yang Soo , Jung Jiwon 
Published: December 2021

Abstract

Background
The optimal duration of antimicrobial therapy for uncomplicated Pseudomonas aeruginosa bloodstream infection (BSI) is unknown. We compared the outcomes of short and prolonged courses of antimicrobial therapy in adults with uncomplicated pseudomonal BSI.

Methods
All patients with uncomplicated P. aeruginosa BSI admitted at a tertiary-care hospital from May 2016 to September 2020 were included. We compared the rate of recurrent P. aeruginosa infection and 30-day mortality among patients who underwent short (7‒11 days) and prolonged (12‒21 days) courses of antimicrobial therapy using propensity score analysis with the inverse probability of treatment weighting (IPTW) method.

Results
We evaluated 1,477 patients with uncomplicated P. aeruginosa BSI; of them, 290 met the eligibility criteria, including 97 (33%) who underwent short-course therapy (9 [interquartile range (IQR), 8‒11] days) and 193 (67%) who underwent prolonged-course therapy (15 [IQR, 14‒18] days). We found no significant difference in the risk of recurrence or 30-day mortality between the prolonged-course and short-course groups (n=10, 11% vs. n=32, 16%; IPTW-adjusted hazard ratio (HR) 0.61; 95% confidence interval (CI) 0.30−1.24; p=0.17). The recurrence of P. aeruginosa infection at any site within 180 days of completing therapy occurred significantly more in the prolonged-course group (n=10, 10% vs. n=38, 20%; IPTW-adjusted HR 0.48; 95% CI 0.24−0.96, p=0.04). The resistance acquisition in subsequent P. aeruginosa isolates was more frequent in the prolonged-course group, although the difference was not statistically significant (n=2, 20% vs. n=12, 32%; p=0.70).

Conclusion
Short-course antimicrobial therapy could be as effective as prolonged-course therapy for uncomplicated P. aeruginosa bloodstream infection.

Disclosures
All Authors: No reported disclosures
64. Novel Biomarkers Improve Estimation of Vancomycin Clearance in Critically Ill Children
Authors: Downes Kevin J , Zuppa Athena F , Sharova Anna , Gianchetti Lauren , Duffey Emily , Goldstein Stuart L , Neely Michael 
Published: December 2021

Abstract

Background
There are a paucity of robust population PK (popPK) models to inform vancomycin (VAN) dosing in critically ill children. The majority of published models incorporate peak/trough data and rely on flawed estimates of renal function. We sought to develop a popPK model for IV VAN in critically ill children utilizing novel plasma and urinary biomarkers.

Methods
We conducted a prospective observational study of critically ill children prescribed VAN for a suspected infection in the CHOP pediatric ICU. Children &lt; 1 year of age and those receiving ECMO or CRRT were excluded. Five VAN samples were collected from a single dosing interval for each subject. Plasma biomarkers (creatinine [Cr], cystatin C [CysC], NGAL) and urinary biomarkers (CysC, NGAL, KIM-1, osteopontin) were collected the morning of PK sampling; urinary biomarkers were corrected for urine creatinine. Nonparametric popPK modeling was performed using Pmetrics. The impact of renal function (GFR) on VAN clearance (CL) was estimated first, comparing model performance with each biomarker (Cr and plasma CysC). The influence of age, sex, additional biomarkers, PIM3 score, and receipt of vasopressors as covariates was then assessed for relevant PK parameters.

Results
30 subjects completed the study. Median age was 10 years (range 1-17); 76% were male. The majority (90%) of children received VAN for suspected sepsis. PK sampling occurred at a median of 37.7 hours (range 24.6-94.8) into VAN treatment; 136 VAN samples were included. A 2-compartment model with fixed allometric scaling of 0.75 on clearances and 1 on volumes best described the data. CysC-based GFR as a covariate on VAN CL using the HOEK formula (GFR = -4.32 + (80.35/CysC)) resulted in the best model fit. Age and plasma NGAL were also informative on VAN CL in the final model (Figure 1). During model building, urinary NGAL was also associated with VAN CL (comparable to plasma NGAL) and outperformed Cr, although it was not retained in the final model.
Figure 1. Final population PK model and parameter estimates.

Conclusion
Plasma CysC is a better renal function estimate than Cr to inform VAN clearance in critically ill children. Urinary and plasma NGAL also improved estimation of VAN CL during popPK modeling. Novel biomarkers can better describe VAN exposures in critically ill children than reliance on Cr alone.

Disclosures
Kevin J. Downes, MD, Merck (Individual(s) Involved: Self): Grant/Research Support Stuart L. Goldstein, MD, Bioporto (Consultant, Grant/Research Support)