Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health’s National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial’s duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator’s institution. The Initial Consultation process focuses on the study’s scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.

Physician parents encounter unique challenges in balancing new parenthood with work responsibilities, especially upon their return from parental leave. We designed a pilot program that incorporated 1:1 parental coaching to expectant and new physician parents and provided stipends for lactation support and help at home. Additional initiatives included launching a virtual new parent group during the COVID-19 pandemic and starting an emergency backup pump supplies program. There was positive feedback for our Parental Wellness Program (PWP), which was used to secure expanded funding. Pilot results showed that our program had a meaningful impact on parental wellness, morale, productivity, and lactation efforts.

We characterized the patterns of agreement variation and consistency in three corpora of child and child-directed US English to better understand preschoolers’ input and to compare preschoolers’ own agreement production. We examined sentences with third-person subjects and tensed forms of be in two large single-family corpora and one cross-sectional corpus collected during a Search-and-Find activity. Caregivers’ agreement variation consistently reflected patterns previously found in adult-to-adult speech. Children's variation was conditioned by many of the same factors (e.g., sentence type, pronoun subject, and order of subject and verb) and clearly demonstrated acquisition of the categorical-variable split. However, some children showed substantially higher rates of nonagreeing forms (There's the cherries) than their caregivers and differed in their ranking of conditioning factors. We suggest that this reflects children's developing production processing abilities: shorter sentence-planning spans may make nonagreement a useful strategy for avoiding early number commitments in verb-first sentences.

Roughly 3% of the human genome consists of microsatellites or tracts of short tandem repeats (STRs). These STRs are often unstable, undergoing high-frequency expansions (increases) or contractions (decreases) in the number of repeat units. Some microsatellite instability (MSI) is seen at multiple STRs within a single cell and is associated with certain types of cancer. A second form of MSI is characterised by expansion of a single gene-specific STR and such expansions are responsible for a group of 40+ human genetic disorders known as the repeat expansion diseases (REDs). While the mismatch repair (MMR) pathway prevents genome-wide MSI, emerging evidence suggests that some MMR factors are directly involved in generating expansions in the REDs. Thus, MMR suppresses some forms of expansion while some MMR factors promote expansion in other contexts. This review will cover what is known about the paradoxical effect of MMR on microsatellite expansion in mammalian cells.

Background: The use of personal protective equipment (PPE) is a critical intervention in preventing the spread of transmission-based infections in healthcare settings. However, contamination of the skin and clothing of healthcare personnel (HCP) frequently occurs during the doffing of PPE. In fact, nearly 40% of HCP make errors while doffing their PPE, causing them to contaminate themselves. PPE monitors are staff that help to promote their colleagues’ safety by guiding them through the PPE donning and doffing processes. With the advent of the COVID-19 pandemic in early 2020, the UNC Medical Center chose to incorporate PPE monitors as part of its comprehensive COVID-19 prevention strategy, using them in inpatient areas (including COVID-19 containment units and all other units with known or suspected SARS-CoV-2–positive patients), procedural areas, and outpatient clinics. Methods: Infection prevention and nursing developed a PPE monitoring team using redeployed staff from outpatient clinics and inpatient areas temporarily closed because of the pandemic. Employee training took place online and included fundamentals of disease transmission, hand hygiene basics, COVID-19 policies and signage, and videos on proper donning and doffing, including coaching tips. The monitors’ first shifts were supervised by experienced monitors to continue in-place training. Employees had competency sheets signed off by a supervisor. Results: The Medical Center’s nursing house supervisors took over management and deployment of the PPE monitoring team, and infection prevention staff continued to train new members. Eventually, as closed clinics and areas reopened and these PPE monitors returned to their regular positions, areas used their own staff to perform the role of PPE monitor. In the fall of 2020, a facility-wide survey was sent to all inpatient staff to assess their perceptions of the Medical Center’s efforts to protect them from acquiring COVID-19. It included a question asking how much staff agreed or disagreed that PPE monitors “play an important role in keeping our staff who care for COVID-19 patients safe.” Of the 626 staff who answered this question, 67.6% agreed or strongly agreed that PPE monitors played an important role in keeping staff safe. Thus far, there has been no direct transmission or clusters of COVID-19 involving HCP in COVID-19 containment units with PPE monitors. Conclusions: PPE monitors are an important part of a comprehensive COVID-19 prevention strategy. In early 2021, the UNC Medical Center posted and hired paid PPE monitor positions to continue this critical work in a sustainable way.

Funding: No

Disclosures: None

In 2020 a group of U.S. healthcare leaders formed the National Organization to Prevent Hospital-Acquired Pneumonia (NOHAP) to issue a call to action to address non–ventilator-associated hospital-acquired pneumonia (NVHAP). NVHAP is one of the most common and morbid healthcare-associated infections, but it is not tracked, reported, or actively prevented by most hospitals. This national call to action includes (1) launching a national healthcare conversation about NVHAP prevention; (2) adding NVHAP prevention measures to education for patients, healthcare professionals, and students; (3) challenging healthcare systems and insurers to implement and support NVHAP prevention; and (4) encouraging researchers to develop new strategies for NVHAP surveillance and prevention. The purpose of this document is to outline research needs to support the NVHAP call to action. Primary needs include the development of better models to estimate the economic cost of NVHAP, to elucidate the pathophysiology of NVHAP and identify the most promising pathways for prevention, to develop objective and efficient surveillance methods to track NVHAP, to rigorously test the impact of prevention strategies proposed to prevent NVHAP, and to identify the policy levers that will best engage hospitals in NVHAP surveillance and prevention. A joint task force developed this document including stakeholders from the Veterans’ Health Administration (VHA), the U.S. Centers for Disease Control and Prevention (CDC), The Joint Commission, the American Dental Association, the Patient Safety Movement Foundation, Oral Health Nursing Education and Practice (OHNEP), Teaching Oral-Systemic Health (TOSH), industry partners and academia.

The article reports the perspectives of senior care staff as part of a study exploring personalisation in care homes. Behind the conceptual sword and shield of ‘choice and control’ associated with personalisation in the United Kingdom (UK) lie irreconcilable flaws, thrown into sharp relief in this context. Personalisation, which originated in community-based social services, has recently been extended into UK care homes. This service development has been stimulated by a desire to promote a humane response to caring for an ageing population, whilst containing costs. Seemingly promoting a relational approach, personalisation also entails consumerist underpinnings, with consequent tensions resulting in weakened policy mechanisms. Discussing findings pertaining to ‘food and eating’, the article illustrates the complex interplay between supporting resident capabilities with poor staff ratios; when choice is not really choice at all; balancing choice, risk and the duty of care; and responding to diverse perspectives about what matters. This complexity reflects the highly skilled nature of care work as promoted by care ethicists. The tensions permeated care home life and found parallels in the wider system of care. Honesty about the limitations of choice and control is essential to achieve ethical care in care homes. The care home constitutes fertile ground for exposing and exploring the shortcomings of the ‘logic of choice’ and for advancing a more relational, inclusive and sustainable conceptualisation of personalisation.

The archaeological assemblage recovered from the Middle Stone Age (MSA) levels in Blombos Cave, South Africa, is central to our understanding of the development of early modern humans. Here, we demonstrate that the cultural and technological innovations inferred from the Blombos Cave MSA record also correlate with significant shifts in site use and occupational intensity. Through a comprehensive geoarchaeological investigation of three MSA occupation phases, we identified distinct diachronic trends in the frequency of visits and the modes of occupation. During the earliest phases (ca. 88–82 ka), humans inhabited the cave for more extended periods, but cave visits were not frequent. During the later phases (ca. 77–72 ka), the cave was more regularly visited but for shorter periods each time. We argue that these changes in local occupational intensity, which also coincide with shifts in vegetation, sea levels, and subsistence, can best be explained by broader changes in hunter-gatherer mobility strategies and occupation patterns. Fundamental changes in regional settlement dynamics during Marine Oxygen Isotope Stages 5b-4 would have significantly affected the nature and frequency of social interaction within and between prehistoric populations living in the southern Cape, a scenario that ultimately may explain some of the social and technological advances that occurred there during this time frame.

Understanding the distribution, abundance and habitat preferences of species in the Southern Ocean provides a foundation for assessing the impacts of environmental change and anthropogenic disturbance on Antarctic ecosystems. In near-shore waters at Casey and Davis Stations, photoquadrat surveys were used to determine sea anemone distribution and abundance, habitat preferences, associations with other species and the impact of human disturbance on sea anemone distribution. Two distinct sea anemone morphotypes were found in this study: large sea anemones that require hard substrate for attachment and small, burrowing sea anemones found in muddy sediment. The large sea anemones were found in rocky habitats, with the exception of some sedimentary habitats where other biota were used as substrate. The large sea anemones were associated with a diverse community of epibenthic species found in rocky habitats. The burrowing sea anemones were associated with a less diverse assemblage of sediment-dwelling epibenthos. At Casey Station, sea anemones were more abundant in habitats adjacent to a former waste disposal site than at control sites. The reason for this is not yet known, but may be due to high organic matter inputs or, alternatively, a longer sea ice duration providing protection from ice scour.

OBJECTIVES/SPECIFIC AIMS: Characterize microbiome metadata describing specimens collected, genomic pipelines and microbiome results, and incorporate them into a data integration platform for enabling harmonization, integration and assimilation of microbial genomics with exposures as spatiotemporal events. METHODS/STUDY POPULATION: We followed similar methods utilized in previous efforts in charactering and developing metadata models for describing microbiome metadata. Due to the heterogeneity in microbiome and exposome data, we aligned them along a conceptual representation of different data used in translational research; microbiomes being biospecimen-derived, and exposomes being a combination of sensor measurements, surveys and computationally modelled data. We performed a review of literature describing microbiome data, metadata, and semantics [4–15], along with existing datasets [16] and developed an initial metadata model. We reviewed the model with microbiome domain experts for its accuracy and completeness, and with translational researchers for its utility in different studies, and iteratively refined it. We then incorporated the logical model into OpenFurther’s metadata repository MDR [17,18] for harmonization of different microbiome datasets, as well as integration and assimilation of microbiome-exposome events utilizing the UPIE. RESULTS/ANTICIPATED RESULTS: Our model for describing the microbiome currently includes three domains (1) the specimen collected for analysis, (2) the microbial genomics pipelines, and (3) details of the microbiome genomics. For (1), we utilized biospecimen data model that harmonizes the data structures of caTissue, OpenSpecimen and other commonly available specimen management platform. (3) includes details about the organisms, isolate, host specifics, sequencing methodology, genomic sequences and annotations, microbiome phenotype, genomic data and storage, genomic copies and associated times stamps. We then incorporated this logical model into the MDR as assets and associations that UPIE utilizes to harmonize different microbiome datasets, followed by integration and assimilation of microbiome-exposome events. Details of (2) are ongoing. DISCUSSION/SIGNIFICANCE OF IMPACT: The role of the microbiome and co-influences from environmental exposures in etio-pathology of various pulmonary conditions isn’t well understood [19–24]. This metadata model for the microbiome provides a systematic approach for integrating microbial genomics with sensor-based environmental and physiological data, and clinical data that are present in varying spatial and temporal granularities and require complex methods for integration, assimilation and analysis. Incorporation of this microbiome model will advance the performance of sensor-based exposure studies of the (UPIE) to support novel research paradigms that will improve our understanding of the role of microbiome in promoting and preventing airway inflammation by performing a range of hypothesis-driven microbiome-exposome pediatric asthma studies across the translational spectrum.

The construction of future technological systems in work domains that do not yet exist, known as the envisioned world problem, is an increasingly important topic for designers, particularly given the rapid rate of technological advancement in the modern era. This paper first discusses the theoretical underpinnings of using cognitive work analysis (CWA) for developing a decision support system (DSS) situated within the envisioned world problem and recasts the problem as pathway-dependent processes. Using this pathway-dependent framework, each stage of the envisioning process is described to reveal how human factors experts can link existing work domains to envisioned instances. Finally, a case study example of the envisioning process that incorporates CWA modelling is demonstrated as it pertains to the advancement of the human spaceflight domain. As a result, this paper provides a unified treatment of the envisioned world problem with an end-to-end example of one approach to designing future technologies for future work domains.