In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19. Then, we discuss how informed consent processes were modified or changed to address the pandemic, consider what lessons were learned, and present research and policy steps to prepare for future research and public health crises. The experiences and challenges for CTSA institutions offer an important perspective for examining what we have learned about informed consent and determining the next steps for improving the consent process.

Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention. They rely on the complex integration of scientific need, regulatory oversight, quality control in collection, processing and tracking, and linkage to robust phenotype information. The COVID-19 pandemic amplified many of these considerations and illuminated new challenges, all while academic health centers were trying to adapt to unprecedented clinical demands and heightened research constraints not witnessed in over 100 years. The outbreak demanded rapid understanding of SARS-CoV-2 to develop diagnostics and therapeutics, prompting the immediate need for access to high quality, well-characterized COVID-19-associated biospecimens. We surveyed 60 Clinical and Translational Science Award (CTSA) hubs to better understand the strategies and barriers encountered in biobanking before and in response to the COVID-19 pandemic. Feedback revealed a major shift in biorepository model, specimen-acquisition and consent process from a combination of investigator-initiated and institutional protocols to an enterprise-serving strategy. CTSA hubs were well equipped to leverage established capacities and expertise to quickly respond to the scientific needs of this crisis through support of institutional approaches in biorepository management.

In the context of a stark discrepancy in the educational outcomes of Aboriginal Australians compared to non-Aboriginal Australians, this article aims to contribute the voices of rural Aboriginal high school students to the discourse. This article utilises an appreciative enquiry approach to analyse the opinions and aspirations of 12 Aboriginal high school students in a South Australian regional centre. Drawing on student perspectives from semi-structured interviews, this article contributes to and contextualises the growing body of literature regarding educational aspirations. It demonstrates how rurality influences a complex system of intrinsic attributes, relationship networks and contextual factors. It offers an important counterpoint to discourses surrounding academic disadvantage and highlights the lived experience of rural Aboriginal Australians.

Background: Hospitalized patients are at an increased risk of invasive infection with Staphylococcus aureus when colonized with the bacteria on admission. Rates of methicillin-resistant Staphylococcus aureus (MRSA) bacteremia are directly correlated with overall patient acuity, placing patients in intensive care areas at greatest risk. Universal decolonization with nasal antibiotic ointments has been shown to reduce the incidence of invasive MRSA in critically ill patients; however, debate remains regarding the long-term efficacy of this strategy and the possibility of developing antimicrobial resistance. An alcohol-based nasal antimicrobial may be an effective alternative. This study evaluated the effectiveness of a twice daily alcohol-based product in reducing the rate of MRSA bacteremia in an academic tertiary-care adult intensive care setting. Methods: Our study was an observational design with retrospective and prospective cohorts each consisting of 61 critical care beds. The baseline incidence of MRSA bacteremia was determined from a 7-month period preceding the implementation of the nasal antimicrobial. At implementation, each admission received an electronic order for an alcohol-based nasal antiseptic that was applied twice daily during the intensive care stay. The primary outcome was the incidence of MRSA bacteremia in each group. MRSA bacteremia was defined by the CDC NHSN criteria after review by an infection prevention nurse. The 2 test was used to compare the rates between the 2 groups, and P < .005 was considered significant. Results: The study periods contained similar patient days, with 12,475 in the retrospective group and 12,733 in the prospective group. The rate of MRSA bacteremia in the retrospective cohort was 0.2404 compared to 0 in the prospective cohort. This rate change was statistically significant, with P < .0001. Conclusions: The alcohol-based nasal antiseptic was effective in reducing healthcare-onset MRSA bacteremia in this intensive care population. This approach may be a safe and effective alternative to nasal antibiotic ointment that avoids antibiotic resistance risks.

Funding: None

Disclosures: None

Background: Central venous catheter (CVC) maintenance bundle elements, including labeling IV tubing and dressings, consistently changing them, intact dressings, and dry healthy insertion sites, together have been shown to reduce risks of developing central-line–associated bloodstream infections (CLABSIs).1,2 CLABSIs are a significant, but preventable, cause of mortality among critically ill patients.3 In the last 12 months, the 16-bed medical intensive care unit (MICU) at a large, urban, academic facility had 2,621 central-line days, presenting many opportunities for CLABSI prevention. During that time, weekly observations assessed compliance with CVC maintenance bundle elements. Interventions: Multidisciplinary rounds were conducted to monitor nursing staff adherence to CVC maintenance bundle elements. The following bundle elements observed during rounds: (1) Is central-line dressing occlusive/intact? (2) Is CVC insertion site healthy with no redness/drainage? (3) Is CVC dressing labeled with insertion date? (4) Date/time of last dressing change adheres to policy? (4) All CVC tubing is labeled with date/time? (5) All CVC tubing dates adhere to policy? (6) If stopcock is present, is cap present over unused port? “Just-in-time” staff coaching was employed when noncompliance was observed. Findings were sent to leadership for manager follow-up. Staff were informed about products available within the hospital, which can improve dressing adherence and mitigate insertion-site bleeding. Education was provided to staff defining exact requirements for CVC dressings. The acronym “IDOL” was used to help remind staff of these fundamentals: (1) Intact dressing borders are well adhered, with <50% of the white border detached. (2) Drainage should be within the chlorhexidine square. (3) Occlusive means no bubbles, kinks, or wrinkles in the dressing. (4) Labeling is required and must include insertion date, date/time of change, and initials. Results: In the first 2 months of rounds, overall compliance averaged 85%. Compliance increased to an average of 91% during the subsequent 10 months. Early on, most fallouts were found with dressings not occlusive or intact and excessive drainage from insertion sites. Initially, 71% of sites were without excess drainage, and 57% of dressings were occlusive or intact. These measures increased to 83% and 89%, respectively, after the interventions. A 50% decrease in the number of CLABSIs was observed during the observation period, compared to the previous 12-month period. Conclusions: Consistent use of bundles has been shown to significantly improve patient outcomes with regard to hospital-acquired infections (HAIs).3 Frequent observations, education to define staff expectations, and holding staff accountable have all helped improve compliance with maintenance bundle elements. Preventing CLABSIs is not only important for patient safety and quality of care. Regulatory and accrediting agencies are now increasing their focus on infections and are tying them to reimbursement.

Funding: None

Disclosures: None

Twin 5-month seasonal forecast experiments are performed to predict the September 2018 mean and minimum ice extent using the fully coupled Navy Earth System Prediction Capability (ESPC). In the control run, ensemble forecasts are initialized from the operational US Navy Global Ocean Forecasting System (GOFS) 3.1 but do not assimilate ice thickness data. Another set of forecasts are initialized from the same GOFS 3.1 fields but with sea ice thickness derived from CryoSat-2 (CS2). The Navy ESPC ensemble mean September 2018 minimum sea ice extent initialized with GOFS 3.1 ice thickness was over-predicted by 0.68 M km2 (5.27 M km2) vs the ensemble forecasts initialized with CS2 ice thickness that had an error of 0.40 M km2 (4.99 M km2), a 43% reduction in error. The September mean integrated ice edge error shows a 18% improvement for the Pan-Arctic with the CS2 data vs the control forecasts. Comparison against upward looking sonar ice thickness in the Beaufort Sea reveals a lower bias and RMSE with the CS2 forecasts at all three moorings. Ice concentration at these locations is also improved, but neither set of forecasts show ice free conditions as observed at moorings A and D.

A central area of current philosophical debate in the foundations of mathematics concerns whether or not there is a single, maximal, universe of set theory. Universists maintain that there is such a universe, while Multiversists argue that there are many universes, no one of which is ontologically privileged. Often model-theoretic constructions that add sets to models are cited as evidence in favor of the latter. This paper informs this debate by developing a way for a Universist to interpret talk that seems to necessitate the addition of sets to V. We argue that, despite the prima facie incoherence of such talk for the Universist, she nonetheless has reason to try and provide interpretation of this discourse. We present a method of interpreting extension-talk (V-logic), and show how it captures satisfaction in ‘ideal’ outer models and relates to impredicative class theories. We provide some reasons to regard the technique as philosophically virtuous, and argue that it opens new doors to philosophical and mathematical discussions for the Universist.