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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.
Using National Healthcare Safety Network data, an interrupted time series of intravenous antimicrobial starts (IVAS) among hemodialysis patients was performed. Annual adjusted rates decreased by 6.64% (January 2012–March 2020) and then further decreased by 8.91% until December 2021. IVAS incidence trends have decreased since 2012, including during the early COVID-19 pandemic.
We examined the association between influenza vaccination policies at acute care hospitals and influenza vaccination coverage among healthcare personnel for the 2021–22 influenza season. Mandatory vaccination and masking for unvaccinated personnel were associated with increased odds of vaccination. Hospital employees had higher vaccination coverage than licensed independent practitioners.
Resilience of the healthcare system has been described as the ability to absorb, adapt, and respond to stress while maintaining the provision of safe patient care. We quantified the impact that stressors associated with the COVID-19 pandemic had on patient safety, as measured by central line-associated bloodstream infections (CLABSIs) reported to the Centers for Disease Control and Prevention’s National Healthcare Safety Network.
Design:
Acute care hospitals were mandated to report markers of resource availability (staffing and hospital occupancy with COVID-19 inpatients) to the federal government between July 2020 and June 2021. These data were used with community levels of COVID-19 to develop a statistical model to assess factors influencing rates of CLABSIs among inpatients during the pandemic.
Results:
After risk adjustment for hospital characteristics, measured stressors were associated with increased CLABSIs. Staff shortages for more than 10% of days per month were associated with a statistically significant increase of 2 CLABSIs per 10,000 central line days versus hospitals reporting staff shortages of less than 10% of days per month. CLABSIs increased with a higher inpatient COVID-19 occupancy rate; when COVID-19 occupancy was 20% or more, there were 5 more CLABSIs per 10,000 central line days versus the referent (less than 5%).
Conclusions:
Reporting of data pertaining to hospital operations during the COVID-19 pandemic afforded an opportunity to evaluate resilience of US hospitals. We demonstrate how the stressors of staffing shortages and high numbers of patients with COVID-19 negatively impacted patient safety, demonstrating poor resilience. Understanding stress in hospitals may allow for the development of policies that support resilience and drive safe care.
We present results of frequency tripling experiments performed at the Hilase facility on a cryogenically gas cooled multi-slab ytterbium-doped yttrium aluminum garnet laser system, Bivoj/DiPOLE. The laser produces high-energy ns pulses at 10 Hz repetition rate, which are frequency doubled using a type-I phase-matched lithium triborate (LBO) crystal and consequently frequency summed using a type-II phase-matched LBO crystal. We demonstrated a stable frequency conversion to 343 nm at 50 J energy and 10 Hz repetition rate with conversion efficiency of 53%.
In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.
Methods:
A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.
Results:
We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.
Conclusion:
The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.
Björn Heile's 3 × 10 Musical Actions for Three Socially Distanced Performers features frequent changes in musical material, playing style and instrumental combinations. Throughout a series of short sections, the performers play, sing, speak, conduct and move around, following instructions that appear on tablets. This article reflects on audiences’ experiences of the work and on musical actions more generally. We consider musical actions as short, coherent motion chunks and distinguish between several types of action that appear in the piece: gestures (communicative actions, with or without sound), reactions (where a player responds to another) and interactions (where players mutually coordinate). The musicians’ individual and collective actions create a sense of play: on the one hand, they seem free and depart from standard concert conventions; on the other hand, they seem to be following a set of rules, even if these rules are not explained to the audience. As such, we approach the piece via theories of play and relate it to earlier modernist musical games. Ultimately, 3 × 10 Musical Actions emphasises several aspects of musical actions, as social, functional, expressive, playful and embodied.
In this collaborative account of Iddon's Sapindales, the authors recount how their experiences of live and virtual clarinet sounds and environmental sounds combine in varied ways. By focusing on relationships among sonic layers, the authors emphasise the dynamic interplay of live and recorded performance, music and environment, the real and the virtual, the abstract and the concrete. Each relationship involves mediation and ambiguity, with elements that alternatively split apart or join together. The listening outcomes that we describe repeatedly highlight a positional swing between subject and object, as the authors reach across explanatory modes, drawing on phenomenology, musicology, psychoanalysis and ecological psychology, among others. We aim to capture the process of aesthetic listening, a process that is live, interactive, constructive, imaginative.
The field of healthcare epidemiology is increasingly focused on identifying, characterizing, and addressing social determinants of health (SDOH) to address inequities in healthcare quality. To identify evidence gaps, we examined recent systematic reviews examining the association of race, ethnicity, and SDOH with inpatient quality measures.
Methods:
We searched Medline via OVID for English language systematic reviews from 2010 to 2022 addressing race, ethnicity, or SDOH domains and inpatient quality measures in adults using specific topic questions. We imported all citations to Covidence (www.covidence.org, Veritas Health Innovation) and removed duplicates. Two blinded reviewers assessed all articles for inclusion in 2 phases: title/abstract, then full-text review. Discrepancies were resolved by a third reviewer.
Results:
Of 472 systematic reviews identified, 39 were included. Of these, 23 examined all-cause mortality; 6 examined 30-day readmission rates; 4 examined length of stay, 4 examined falls, 2 examined surgical site infections (SSIs) and one review examined risk of venous thromboembolism. The most evaluated SDOH measures were sex (n = 9), income and/or employment status (n = 9), age (n = 6), race and ethnicity (n = 6), and education (n = 5). No systematic reviews assessed medication use errors or healthcare-associated infections. We found very limited assessment of other SDOH measures such as economic stability, neighborhood, and health system access.
Conclusion:
A limited number of systematic reviews have examined the association of race, ethnicity and SDOH measures with inpatient quality measures, and existing reviews highlight wide variability in reporting. Future systematic evaluations of SDOH measures are needed to better understand the relationships with inpatient quality measures.
A healthy diet is at the forefront of measures to prevent type 2 diabetes. Certain vegetable and fish oils, such as pine nut oil (PNO), have been demonstrated to ameliorate the adverse metabolic effects of a high-fat diet. The present study investigates the involvement of the free fatty acid receptors 1 (FFAR1) and 4 (FFAR4) in the chronic activity of hydrolysed PNO (hPNO) on high-fat diet-induced obesity and insulin resistance. Male C57BL/6J wild-type, FFAR1 knockout (-/-) and FFAR4-/- mice were placed on 60 % high-fat diet for 3 months. Mice were then dosed hPNO for 24 d, during which time body composition, energy intake and expenditure, glucose tolerance and fasting plasma insulin, leptin and adiponectin were measured. hPNO improved glucose tolerance and decreased plasma insulin in the wild-type and FFAR1-/- mice, but not the FFAR4-/- mice. hPNO also decreased high-fat diet-induced body weight gain and fat mass, whilst increasing energy expenditure and plasma adiponectin. None of these effects on energy balance were statistically significant in FFAR4-/- mice, but it was not shown that they were significantly less than in wild-type mice. In conclusion, chronic hPNO supplementation reduces the metabolically detrimental effects of high-fat diet on obesity and insulin resistance in a manner that is dependent on the presence of FFAR4.