bluuebunny/crossref_metadata_2025_split huggingface dataset:
350. Unnecessary viral blood tests reduction and costs saving by using an automated test request blocking system
Authors: Rahamim-Cohen Daniella , Valinsky Lea , Beit Or Anat , Shamai-Lubovitz Orna , Fisher Moshe , Azuri Josef , Ben David Shirley Shapiro 
Published: November 2023

Abstract

Background
As demands and costs rise across all aspects of healthcare, blood tests form a significant part of existing health expenses. Laboratory analysis provides a vital tool for the evaluation and monitoring of patients with suspected infectious diseases in the community, but are occasionally ordered without accurate clinical indications, resulting in unnecessary expense, workload and patient distress. Here we examined the economic utility of integrating a rule engine system, used in this context to block unnecessary infectious disease laboratory tests.

Methods
An automated blocking system for blood tests, including tests for viral diseases, was designed and implemented within the electronic medical record (EMR) by Maccabi Healthcare Services, a health maintenance organization in Israel, serving over 2.5 million members, nationwide. The system blocks requests for tests identified as unnecessary, usually based on a previous result. Specifically, the system blocks blood tests for the following viral diseases: Hepatitis C viral load and serology for: EBV, CMV, Rubella, Varicella Zoster and Hepatitis B. Upon provider request, a non- authorized test can be re-evaluated by an infectious diseases specialist (Figure 1). Test costs were assessed using the standard Israel Ministry of Health price list in Israeli currency (New Israeli Shekel-NIS) and are expressed in 2023 USD (1$=3.62 NIS, according to the currency exchange rate on May 2, 2023).Figure 1:Automated test request blocking system workflow. EMR Electronic Medical Record, ID Infectious Disease

Results
During 2022, 407,403 requested viral blood tests were recoded (Table 1). Of them, 302,322 (74.2%) were automatically approved. Of those blocked, only a small proportion were requested for further authorization (between 0.15-1.1%). The calculated savings for declined tests is approximately 5.8 million USD.

Conclusion
This automated authorization system for certain viral blood tests resulted in an improved clinical decision process by blocking unnecessary tests and led to substantial monetary saving without sacrificing physician autonomy.

Disclosures
All Authors: No reported disclosures
353. Outpatient parenteral antimicrobial therapy (OPAT) in managing vertebral osteomyelitis
Authors: Villacorta Cari Evelyn , Young Michael , Clemons Alisha , Logan Ashley , Mynatt Ryan , Soria Jaime 
Published: November 2023

Abstract

Background
The outpatient parenteral antimicrobial therapy (OPAT) program was formally established at the University of Kentucky in 2019 to coordinate and monitor home-delivered antimicrobial treatment. This analysis describes the epidemiologic, microbiologic features, and outcomes of subjects diagnosed with vertebral osteomyelitis referred to the OPAT program.

Methods
A cross-sectional study was conducted; we analyzed the data collected during the OPAT program evaluation from July 2019 to October 2022. The data were collected and managed using REDCap electronic data capture tools hosted at the University of Kentucky.

Results
The analysis included 411 subjects diagnosed with vertebral osteomyelitis. referred to the OPAT program. The median age was 51 years old (range: 22-91), and 254 (61.8%) were male. Active or previous history of intravenous drug use (IVDU) was reported in 193 (47.1%), being the most recent use within the last 30 days reported in 142 (74.0%). Admission to the intensive care unit (ICU) was documented in 110 (27.0%) subjects; mainly due to infection related to the OPAT indication; the median Charlson Comorbidity Index score was 2 (IQR: 0-4). The median duration in the OPAT program was 18 (IQR: 11-34) days. The distribution by spinal segment was as follows 115 (28.0%) in the lumbar spine, 75 (18.2%) in the thoracic spine, 58 (14.1%) in the cervical spine, 57 (13.9%) in the sacral and sacrococcygeal spine, more than two segments in 12 (2.0%) subjects, and unspecified in 94 (22.9%) subjects. The most common pathogen isolated was Staphylococcus aureus in 182 (44.3%) subjects, followed by Streptococcus spp in 19 (4.6%). Among gram-negative bacterium, Serratia spp and Pseudomonas aeruginosa were the more prevalent pathogens, 18 (4.4%) and 15 (3.6%), respectively, mainly when the sacrococcygeal spinal segment was compromised. Fungal infection was documented in 13 (3.1%) subjects. The most common antimicrobial used was daptomycin, followed by vancomycin in 97 (23.6%) and 78 (19.0%) subjects, respectively. In this cohort, , the overall mortality rate was 2.2%.

Conclusion
The OPAT program is a convenient and safe alternative for treating vertebral osteomyelitis that requires a prolonged course of intravenous antimicrobial treatment.

Disclosures
All Authors: No reported disclosures
354. A Comparison of Different Strategies for Optimizing the Selection of Empiric Antibiotic Therapy for Hospital-Acquired Pneumonia (HAP) and Ventilator-Associated Pneumonia (VAP) Caused by Gram-Negative Bacteria in Intensive Care Units (ICU)
Authors: Wangchinda Walaiporn , Aitken Samuel L , Lephart Paul , Pogue jason M 
Published: November 2023

Abstract

Background
Guidelines for HAP/VAP recommend considering local susceptibility data and patient specific risk factors for empiric therapy. However, data are lacking assessing whether a unit-specific combination antibiogram or a patient-specific factor-based approach will better drive appropriate empiric treatment. This study aims to hypothetically compare the two methods.

Methods
This retrospective study was conducted at Michigan Medicine between 2021-2022. Microbiological data of 221 non-duplicated, first Gram-negative respiratory isolates obtained from 190 patients in the MICU and SICU in 2021 were used to develop unit-specific combination antibiograms (Table 1) and individual patient charts were accessed to identify the impact of the presence/absence of various risk factors on antimicrobial susceptibility to define optimal regimens. Selected empiric regimens based on each approach are shown in Table 2. These two approaches were then hypothetically applied to 129 patients with positive respiratory cultures in 2022. The appropriateness, defined by having at least one in vitro active agent, and the overuse of antibiotics in empiric regimens by the two approaches were then assessed and compared.

Results
The breakdown of different empiric regimens selected based on the two approaches are shown in Table 3. Cefepime was the backbone β-lactam in regimens for both MICU and SICU by unit-specific combination antibiograms and in 83.7% of regimens based on patient-specific risk factors. Empiric regimens based on patient-specific risk factor had a higher rate of appropriateness than those based on antibiograms (89.1% vs 83.7%), with a 33.1% reduction in the rate of inappropriate empiric therapy. Additionally, using combination antibiograms resulted in a higher prevalence of antibiotic overuse than using patient-specific risk factors (72.9% vs. 40.3%), with most inappropriate use due to unnecessary aminoglycoside use. The overuse of other agents was comparable between approaches.

Conclusion
Both approaches were useful and can be applied in empiric antibiotic selection. However, the patient-specific risk factor-based approach offers advantages in reducing rates of inappropriate therapy and decreasing the overuse of combination agents.

Disclosures
jason M. Pogue, PharmD, AbbVie: Advisor/Consultant|Entasis: Advisor/Consultant|Ferring: Advisor/Consultant|GSK: Advisor/Consultant|Merck: Advisor/Consultant|Merck: Grant/Research Support|Qpex: Advisor/Consultant|Shionogi: Advisor/Consultant
355. Stratification of Patient-Specific Risk Factors for Multidrug-Resistant Gram-Negative Respiratory Pathogens in Intensive Care Units (ICU)
Authors: Wangchinda Walaiporn , Aitken Samuel L , Lephart Paul , Pogue jason M 
Published: November 2023

Abstract

Background
Guidelines for nosocomial pneumonia recommend empiric combination therapy for patients with a risk of infection due to multidrug-resistant Gram-negative pathogens in ICUs. Common risk factors cited include ≥ 5-day duration in the ICU, transfer from other healthcare facilities, recent antibiotic use, and history of a resistant Gram-negative pathogen. However, the interrelation of these factors and which are key drivers remain ill-defined. This study is designed to stratify risk factors to further optimize empiric regimens.

Methods
A total of 190 patients who had a positive Gram-negative respiratory culture obtained from the MICU/SICU of Michigan Medicine in 2021 were included. Patients were classified into subgroups based on the presence/absence of each aforementioned risk factor. Cumulative susceptibility percentages of isolates in each risk group were examined and compared.

Results
Cumulative susceptibility percentages of Gram-negative respiratory isolates from patients with/without each risk factor are shown in Figure 1. Patients with recent antibiotic use or history of a resistant Gram-negative pathogen had noticeably lower susceptibility rates than those without those risk factors, whereas the presence/absence of prolonged ICU stay and/or admission from another facility had minimal impact on susceptibility rates. In patients without recent antibiotic exposure or history of a resistant pathogen, 90% had pathogens that demonstrated in vitro susceptibility to cefepime monotherapy. (Figure 2) In contrast, the susceptibility percentages of any β-lactam monotherapy were &lt; 75% in patients with one or more of these factors and remained &lt; 85% when adding an aminoglycoside or fluoroquinolone. More stratified analyses demonstrated that patients with previous positive carbapenem-resistant P. aeruginosa or Enterobacterales should receive a novel agent. Proposed stratified empiric regimens are summarized in Figure 3.

Conclusion
Recent antibiotic use and previous positive resistant Gram-negative cultures were significant factors for determining antibiotic resistance in Gram-negative respiratory pathogens. Risk stratification based on these two factors can help further optimize empiric antibiotic therapy.

Disclosures
jason M. Pogue, PharmD, AbbVie: Advisor/Consultant|Entasis: Advisor/Consultant|Ferring: Advisor/Consultant|GSK: Advisor/Consultant|Merck: Advisor/Consultant|Merck: Grant/Research Support|Qpex: Advisor/Consultant|Shionogi: Advisor/Consultant
356. Impact of CLSI Breakpoint Changes on Unit-Specific Combination Antibiograms for Gram-Negative Respiratory Isolates
Authors: Wangchinda Walaiporn , Aitken Samuel L , Pierce Virginia M , Lephart Paul , Pogue jason M 
Published: November 2023

Abstract

Background
In 2023, the CLSI updated aminoglycoside breakpoints for P. aeruginosa and Enterobacterales. The anticipated decrease in aminoglycoside susceptibility rates resulting from these revised breakpoints will impact empiric antibiotic selection for nosocomial pneumonia. This study aims to evaluate the impact of the new breakpoints on the susceptibility rates of various combination antibiotic regimens for Gram-negative pneumonia at Michigan Medicine.

Methods
The susceptibility rates of single and combination antibiotic regimens were determined by applying the CLSI breakpoints to 221 non-duplicated, first Gram-negative respiratory isolates obtained from patients in the MICU and SICU of Michigan Medicine in 2021. Combination antibiograms were developed to compare susceptibility rates of various potential empiric regimens based on the 2022 vs. 2023 aminoglycoside breakpoints. Subgroup analyses for P. aeruginosa vs. non-P. aeruginosa were performed.

Results
Comparisons of unit-specific combination antibiograms against all Gram-negative respiratory isolates using 2022 vs. 2023 breakpoints are shown in Table 1. Based on the 2022 breakpoints, overall susceptibility rates for aminoglycosides were higher than those of anti-pseudomonal β-lactams. The addition of an aminoglycoside improved the susceptibility percentages of a β-lactam up to 23%, allowing similar activity with amikacin-based combination therapy to levofloxacin-based. In contrast, based on 2023 breakpoints, the susceptibility rates of amikacin and gentamicin dropped significantly (85.1 to 58.8% and 81.0 to 56.6%, respectively) and combination with these two agents did not provide additional benefit to the β-lactam backbone. The tobramycin susceptibility rate was minimally affected by the breakpoint changes (82.8% vs. 79.2%). Subgroup analyses demonstrated that the decrease in susceptibility percentages for aminoglycosides was largely driven by the breakpoint changes for P. aeruginosa (Table 1).

Conclusion
The updated 2023 CLSI breakpoints resulted in a substantial decrease in the susceptibility percentages of amikacin and gentamicin which clinicians need to be aware of when choosing empiric antibiotic treatment.

Disclosures
Virginia M. Pierce, MD, FIDSA, UpToDate, Inc.: Authorship royalties jason M. Pogue, PharmD, AbbVie: Advisor/Consultant|Entasis: Advisor/Consultant|Ferring: Advisor/Consultant|GSK: Advisor/Consultant|Merck: Advisor/Consultant|Merck: Grant/Research Support|Qpex: Advisor/Consultant|Shionogi: Advisor/Consultant
369. The DOOR is open: A Web-based Application for Analyzing the Desirability of Outcome Ranking
Authors: Hamasaki Toshimitsu , He Yijie , Evans Scott R 
Published: November 2023

Abstract

Background
The Antibacterial Resistance Leadership Group (ARLG) has developed the Desirability of Outcome Ranking (DOOR) methodology, a novel paradigm for the design, conduct, analysis and interpretation of clinical trials. The DOOR methodology enables clinicians to effectively evaluate and select treatment strategies by providing an informative way to compare the patient-centered risks and benefits of intervention alternatives. There are two complementary approaches to DOOR analysis. The first approach summarizes DOOR responses between treatments by the probability of a more desirable outcome in one treatment relative to another (DOOR probability) using the concept of pairwise comparisons, The second, “partial credit” analyses, involves grading the DOOR levels on a scale from 0 (least desirable) to 100 (most desirable), allowing for strategic scoring, preferential assignment of relative importance to DOOR levels for personalized analyses, and evaluation of robustness through analysis of different scoring keys.

Methods
The Statistical and Data Management Center of the ARLG is developing interactive web-based applications (apps) with downloadable data presentations, to help clinical researchers conduct DOOR analyses.

Results
Two editions of the apps are available. The Standard Edition (Std) requires entry of summary level data of the DOOR outcome by intervention group. The app generates ARLG-recommended components of comprehensive DOOR analyses, including summary tables and figures of DOOR distributions, forest plot displays of DOOR probability estimates for the DOOR and its components, and partial credit analysis. The Professional Edition (Pro) reads patient-level data. In addition to the analyses provided in the Std, the Pro includes additional functionality and informed visualizations, i.e., inverse probability weighting (IPW)-based analyses, tie-breaker analyses, and the Anthology of Patient Stories plot.
Data Entry Panel of the Application (Standard Edition)
DOOR Frorst Plot Output (Standard Edition)
DOOR Forest Plot Output from DORI-05 study of comparing IV doripenem (DOR) to IV levofloxacin (LVX), with a step-down option of oral levofloxacin in both groups after 3 days of IV therapy (Standard Edition)
Partial credit analysis output from DORI-05 study of comparing IV doripenem (DOR) to IV levofloxacin (LVX), with a step-down option of oral levofloxacin in both groups after 3 days of IV therapy (Standard Edition)

Conclusion
The DOOR apps provide comprehensive tools for researchers to implement the DOOR methodology. The apps are freely available online at https://methods.bsc.gwu.edu/.

Disclosures
All Authors: No reported disclosures
376. Long Term Outcomes of a Pilot Single-Blinded, Randomized Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as the Third Dose after Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients
Authors: Natori Yoichiro , Martin Eric F , Mattiazzi Adela , Sota Katherine Alexandra , Viotti Julia Bini , Anjan Shweta , Guerra Giselle 
Published: November 2023

Abstract

Background
Due to immunosuppressive medication, the immunogenicity after COVID-19 vaccination is suboptimal and durability in Solid Organ Transplant (SOT) recipients is still questionable. Thus, booster dose has been studied to improve not only the short but also long-term immunogenicity. However, mix and match method for this purpose was not well studied.

Methods
This was a post hoc analysis of a patient-blinded, single center, randomized controlled trial comparing BNT162b2 vs JNJ-78436735 vaccine as the third dose after two doses of BNT162b2 vaccine. We included adult SOT recipients with functional graft who had received two doses of BNT162b2 vaccine and were randomly assigned to receive either vaccine. The outcome included SARS-CoV-2 IgG positivity at six months after the third dose and geometric mean titer.

Results
4 SOT recipients, including 39 kidney, 3 liver, 1 lung, and 1 heart transplants, were analyzed per protocol. Only 1 recipient did not develop IgG after 6 months. Median IgG levels at 6 months were 5893 and 65584 for BNT162b2 vs JNJ-78436735, respectively(p&lt; 0.01). For geometric mean titer from prior to third dose and 6 months after was 4.1 and 62.0 for BNT162b2 vs JNJ-78436735, respectively(p&lt; 0.01).

Conclusion
After 6 months post third dose, BNT162b2 showed significant higher immunogenicity in SOT recipients. BNT162b2 provided a higher IgG titer, and durability. To continue BNT162b2 vaccine boosters should be beneficial in SOT recipients but further study should be required.

Disclosures
Adela Mattiazzi, MD, Care Dx: Advisor/Consultant|Care Dx: Speaker|Kaneka: Advisor/Consultant|Kaneka: Speaker
380. The first two years of the European VACCELERATE volunteer registry
Authors: Salmanton-Garcia Jon , Stewart Fiona A , Heringer Sarah , Leckler Janina , Cornely Oliver A , Pana Zoi Dorothea 
Published: November 2023

Abstract

Background
The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in clinical trial participation. It has received funding from the European Union’s Horizon 2020 research and innovation programme (grant agreement 101037867), and the German Federal Ministry of Education and Research (grant BMBF01KX2040). As of today, the VACCELERATE Volunteer Registry is active in 17 countries, and associated to two national registries (France, The Netherlands), with 106,869 registered volunteers overall. Participants provide their contact information, including first and last name and e-mail address, age, gender, pre-existing comorbidities, vaccination status for SARS-CoV-2, COVID-19 history, and maximum distance willing to travel to a clinical trial site, if needed. The registry is open to both adults and children, complying with legal consent requirements. The VACCELERATE Volunteer Registry is active since October 2020.

Methods
Once volunteers sign in on www.vaccelerate.eu/volunteer-registry, data are stored until a request is received from entities managing or
performing clinical trials or epidemiological studies. Based on the inclusion criteria of the respective study, number of volunteers
needed, potential delivery of invitation reminders, and turnaround time is set. Afterwards, matching notifications are delivered.
Eventually, if volunteers autonomously decide to participate in the study, they may contact via email the promoters.

Results
So far, the VACCELERATE Volunteer Registry has been approached to match clinical trials and epidemiological studies with volunteers 28 times. Of those, 17 (61%) studies have been focused on different aspects of SARS-CoV-2, such as finding of the best vaccination scheme, new vaccine testing, or infection point-prevalence. Additionally, new vaccinations against Streptococcus pneumoniae have been the research topic of 6 (21%) studies. Overall, 71,758 study participations have been offered to VACCELERATE volunteers of all ages.

Conclusion
After 2 years since its activation, the VACCELERATE Volunteer Registry has become a reference for study sponsors and clinical trial units to speed up volunteer enrolment in trials. We expect a further increase in volunteer registration, and study requests.

Disclosures
Oliver A. Cornely, MD PhD, DZIF: Advisor/Consultant|DZIF: Board Member|DZIF: Grant/Research Support|DZIF: Honoraria|DZIF: Stocks/Bonds
382. A Multifaceted Intervention to Reduce Blood Culture Contamination in Medical and Surgical Wards: A Cluster Randomized Controlled Trial
Authors: Sayabovorn Naruemit , Chongtrakool Piriyaporn , Rachakhom Siriporn , Kaewsomnuck Supaporn , Wejsuwanmanee Rakkan , Khamphimabood Chuthaphorn , Jitmuang Anupop 
Published: November 2023

Abstract

Background
Blood culture (BC) is a standard diagnostic testing of bloodstream infection. Inappropriate blood sampling may lead to BC contamination causing antimicrobial overuse and adverse outcomes. Several individualized interventions during blood sampling are applied to reduce BC contamination. However, the efficacy of a multifaceted intervention applied to nursing staff for reducing the contamination rate has yet to be thoroughly studied.

Methods
From August 2020–January 2021, we conducted a 1:1 cluster-randomized controlled trial in 6 medical and 6 surgery wards. Six wards (3 medical, 3 surgery) as the intervention arm received the multifaceted intervention comprising a multimodal educational program, regular surveillance, and feedback. The other six wards (3 medical, 3 surgery) as the control arm received standard care. Participant nurses responsible for BC collection had to answer the pre- and post-study questionnaires to score their background knowledge on appropriate BC sampling. Clinical data and microbiological results were also collected.

Results
Of 3,630 blood culture bottles, 304 (8.4%) were culture positive, with an equal number of true bacteremia and contaminated bottles in both arms. The pre-study contamination rate was 2.2-2.5%. After applying the interventions, the contamination rate was 2.3% in the intervention arm and 3.2% in the control arm (p=0.535). Coagulase-negative staphylococci were the most common contaminants (12.8%). Factors associated with contaminated BC included pulmonary diseases (p=0.006), length of hospital stay (p=0.004), blood sampling at 7:00-15:00 (p=0.001), and delayed time to positivity (23.49 h, p&lt; 0.001). In addition, nurses who received the interventions achieved overall scores in post-study questionnaires significantly more than nurses who did not (p&lt; 0.001).

Conclusion
The multifaceted intervention can maintain a lower contamination rate throughout the study period. It may be a strategy to improve knowledge of an appropriate BC collection for medical staff. This study demonstrated that comorbidity, length of hospitalization, time of blood sampling, and time to culture positivity likely influenced BC contamination.

Disclosures
All Authors: No reported disclosures