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Debate surrounds the early peopling of the Arabian Peninsula. The first evidence of the Levallois lithic technology in the Huqf area of south-eastern Arabia now extends the Middle Palaeolithic record of hominin activity into central Oman and helps to diversify the picture of Arabian prehistory.
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.
The purpose of this study is to investigate whether sex plays a role in donor-site dysfunction after head and neck reconstruction.
Methods
In this retrospective case series, 76 patients were assessed for donor-site morbidity using the Short Form 36, Short Musculoskeletal Function Assessment, disabilities of the arm, shoulder, and hand, and lower-limb core scale. Differences by sex were compared using t-tests. Multivariable linear regression analysis was conducted to adjust for potential confounders.
Results
Females observed significantly greater disability for the SF-36 mental component summary score with a mean of 45.9 (standard deviation 10.5) compared to males, with a mean of 51.8 (standard deviation 10.2), p = 0.02. Sex is significantly related to SF-36 mental component summary score after controlling for neuropsychiatric disease and tracheostomy status.
Conclusion
Females reported significantly worse mental component scores compared to males undergoing free flap reconstruction of the head and neck.
This paper discusses approaches for tradespace analysis, exploration, and visualization to address multi-objective decision-making. Next, computational tools for early-stage tradespace analysis to enhance programmatic decision-making are introduced via a vehicle design example to demonstrate the effectiveness and capability of the method. Using a smaller sample of technologies in this problem a synthetic tradespace spans the space of potential and available solutions and provides an opportunity for design engineers to develop an insight into possible technologies and solutions within the tradespace.
OBJECTIVES/GOALS: Under enrollment of trials is a continued challenge in clinical research. In response, the Oregon Clinical and Translational Research Institute (OCTRI), the CTSA at Oregon Health & Science University (OHSU), launched a central resource, OCTRI Recruitment, to equip researchers with the knowledge and tools needed for recruitment success. METHODS/STUDY POPULATION: OCTRI Recruitment focused programmatic development in response to the voice of OHSU researchers. In 2018, a qualitative assessment project, “Clinical Research Recruitment Methods at OHSU”, was launched, which included a survey (N=100) and optional interview (N=24), to determine recruitment method utilization and experience, along with opinions on the needs and culture of recruitment at OHSU. In 2022, as part of the same protocol project, a second survey was deployed (N=31), to determine changes in recruitment method use and to identify further recruitment challenges. OCTRI Recruitment also obtains continual informal input on perceived recruitment challenges and opportunities through engagement within the OHSU research team community. RESULTS/ANTICIPATED RESULTS: 2018 survey and interviews showed: many researchers relied on their clinic’s patient population for recruitment (74%); were unaware of available tools to recruit OHSU patients, especially informatics tools (5-22%); and were not aware of and minimally use methods to recruit outside OHSU (<40%). In response, OCTRI Recruitment developed and began recruitment consultations, guidance materials, and educational seminars. In 2022, survey results showed an increase in the use of informatics-based recruitment tools (2-14%+) and increased use of methods focused on individuals outside of OHSU (1-7%+). Additionally, a review of studies post OCTRI Recruitment consultation over three years (N=51) showed that of those studies, 40% increased enrollment numbers and 61% increased team’s confidence level post consult. DISCUSSION/SIGNIFICANCE: This approach to program creation allowed for a uniquely targeted development of services in response to the voice of OHSU researchers and recruitment challenges. Based on additional data, efforts have begun to address the recruitment challenges of a study opportunity website, participant compensation methods, and community-based recruitment.
The cost effectiveness of treating Bell’s palsy with prednisolone in children is unknown. This study aimed to assess the cost effectiveness of prednisolone, compared with placebo, in treating Bell’s Palsy in children from a healthcare sector perspective.
Methods
This economic evaluation was a prospectively planned secondary analysis of a triple-blind randomized superiority trial conducted from 2015 to 2020 that compared prednisolone with placebo. The time horizon was six months after randomization. The 180 participants were aged from six months to 17 years and presented within 72 hours of onset of clinician diagnosed Bell’s palsy. Interventions were oral prednisolone (1 mg per kg daily) or taste-matched placebo administered for ten days. Incremental cost-effectiveness ratios comparing prednisolone with placebo were estimated. Costs included medication costs, doctor visits, and medical tests over the six-month study period. Effectiveness was measured using quality-adjusted life-years (QALYs) derived from the Child Health Utility 9D instrument. Nonparametric bootstrapping was performed to capture uncertainties. Prespecified subgroup analyses by age (12 to 17 years versus <12 years) were performed.
Results
The mean cost per patient was USD188 in the prednisolone group and USD121 in the placebo group over the six-month period (difference USD66, 95% confidence interval [CI]: 47, 179). The mean QALYs gained over six months were 0.45 in the prednisolone group and 0.44 in the placebo group (difference 0.01, 95%CI: -0.01, 0.03). Prednisolone was very likely cost effective given a conventional willingness-to-pay threshold of USD 50,000 per QALY gained (the cost per additional QALY gained was USD6,625 using prednisolone compared with placebo). Subgroup analysis suggested that this was primarily driven by the high probability of prednisolone being cost effective in children aged 12 to 17 years (98%), compared with those younger than 12 years (51%).
Conclusions
This study provides new evidence to stakeholders and policy makers who are considering whether to make prednisolone available for treating Bell’s palsy in children aged 12 to 17 years.
Warfarin remains the preferred anticoagulant for many patients with CHD. The complexity of management led our centre to shift from a nurse-physician-managed model with many providers to a pharmacist-managed model with a centralized anticoagulation team. We aim to describe the patient cohort managed by our Anticoagulation Program and evaluate the impact of implementation of this consistent, pharmacist-managed model on time in therapeutic range, an evidence-based marker for clinical outcomes.
Methods:
A single-centre retrospective cohort study was conducted to evaluate the impact of the transition to a pharmacist-managed model to improve anticoagulation management at a tertiary pediatric heart centre. The percent time in therapeutic range for a cohort managed by both models was compared using a paired t-test. Patient characteristics and time in therapeutic range of the program were also described.
Results:
After implementing the pharmacist-managed model, the time in therapeutic range for a cohort of 58 patients increased from 65.7 to 80.2% (p < .001), and our Anticoagulation Program consistently maintained this improvement from 2013 to 2022. The cohort of patients managed by the Anticoagulation Program in 2022 included 119 patients with a median age of 24 years (range 19 months–69 years) with the most common indication for warfarin being mechanical valve replacement (n = 81, 68%).
Conclusions:
Through a practice change incorporating a collaborative, centralized, pharmacist-managed model, this cohort of CHD patients on warfarin had a fifteen percent increase in time in therapeutic range, which was sustained for nine years.
Selection of the anesthetic technique to be employed during a procedure begins during the preoperative evaluation with consideration of factors such as the patient’s comorbidities and preferences and the type of procedure to be performed. Oftentimes, general anesthesia is not necessary and the procedure can be performed under a lesser depth of sedation. Procedural sedation is a technique that allows the patient to tolerate the discomfort of a procedure while still maintaining cardiorespiratory function. In order to accomplish this, the anesthesia provider administers sedative, dissociative, and/or analgesic agents alone or in combination [1].
Preoperatively, the patient will transition from different depths of anesthesia, including the levels of sedation, to general anesthesia (GA). Sedation is a continuum of symptoms that range from minimal symptoms of anxiolysis to symptoms of moderate and deep sedation. Moderate sedation is defined by the patient remaining asleep, but being easily arousable. Deep sedation is achieved when the patient is only arousable to painful stimulation. GA refers to medically induced loss of consciousness with concurrent loss of protective reflexes and skeletal muscle relaxation. GA is most commonly achieved via induction with intravenous sedatives and analgesics, followed by maintenance of volatile anesthetics [1]. Table 9.1 lists the depths of anesthesia and associated characteristics.
We investigate differences in profitability of three Aberdeen-influenced breeds, Angus, Red Angus, and American Aberdeen. Using data from North Dakota, we measure differences in birth weights, calving intervals, weaning weights, cow weights, and profitability. Weaning weights differ between breeds, setting up a trade-off between lower feed costs for smaller cows and higher revenue for larger cows. American Aberdeen-influenced cows bred to Red Angus bulls have $1–$6 per acre higher returns than Angus or Red Angus-influenced cows. Aberdeen sires have the lowest returning calves.
Amiodarone may be considered for patients with junctional ectopic tachycardia refractory to treatment with sedation, analgesia, cooling, and electrolyte replacements. There are currently no published pediatric data regarding the hemodynamic effects of the newer amiodarone formulation, PM101, devoid of hypotensive agents used in the original amiodarone formulation. We performed a single-center, retrospective, descriptive study from January 2012 to December 2020 in a pediatric ICU. Thirty-three patients were included (22 male and 11 female) between the ages of 1.1 and 1,460 days who developed post-operative junctional ectopic tachycardia or other tachyarrhythmias requiring PM101. Data analysis was performed on hemodynamic parameters (mean arterial pressures and heart rate) and total PM101 (mg/kg) from hour 0 of amiodarone administration to hour 72. Adverse outcomes were defined as Vasoactive-Inotropic Score >20, patients requiring ECMO or CPR, or patient death. There was no statistically significant decrease in mean arterial pressures within the 6 hours of PM101 administration (p > 0.05), but there was a statistically significant therapeutic decrease in heart rate for resolution of tachyarrhythmia (p < 0.05). Patients received up to 25 mg/kg in an 8-hour time for rate control. Average rate control was achieved within 11.91 hours and average rhythm control within 62 hours. There were four adverse events around the time of PM101 administration, with three determined to not be associated with the medication. PM101 is safe and effective in the pediatric cardiac surgical population. Our study demonstrated that PM101 can be used in a more aggressive dosing regimen than previously reported in pediatric literature with the prior formulation.
A potential voter must incur a number of costs in order to successfully cast an in-person ballot, including the costs associated with identifying and traveling to a polling place. In order to investigate how these costs affect voter turnout, we introduce two quasi-experimental designs that can be used to study how the political participation of registered voters is affected by differences in the relative distance that registrants must travel to their assigned Election Day polling place and whether their polling place remains at the same location as in a previous election. Our designs make comparisons of registrants who live on the same residential block, but are assigned to vote at different polling places. We find that living farther from a polling place and being assigned to a new polling place reduce in-person Election Day voting, but that registrants largely offset for this by casting more early in-person and mail ballots.
Peer review is an essential quality assurance component of radiation therapy planning. A growing body of literature has demonstrated substantial rates of suggested plan changes resulting from peer review. There remains a paucity of data on the impact of peer review rounds for stereotactic body radiation therapy (SBRT). We therefore aim to evaluate the outcomes of peer review in this specific patient cohort.
Methods and materials:
We conducted a retrospective review of all SBRT cases that underwent peer review from July 2015 to June 2018 at a single institution. Weekly peer review rounds are grouped according to cancer subsite and attended by radiation oncologists, medical physicists and medical radiation technologists. We prospectively compiled ‘learning moments’, defined as cases with suggested changes or where an educational discussion occurred beyond routine management, and critical errors, defined as errors which could alter clinical outcomes, recorded prospectively during peer review. Plan changes implemented after peer review were documented.
Results:
Nine hundred thirty-four SBRT cases were included. The most common treatment sites were lung (518, 55%), liver (196, 21%) and spine (119, 13%). Learning moments were identified in 161 cases (17%) and translated into plan changes in 28 cases (3%). Two critical errors (0.2%) were identified: an inadequate planning target volume margin and an incorrect image set used for contouring. There was a statistically significantly higher rate of learning moments for lower-volume SBRT sites (defined as ≤30 cases/year) versus higher-volume SBRT sites (29% vs 16%, respectively; p = 0.001).
Conclusions:
Peer review for SBRT cases revealed a low rate of critical errors, but did result in implemented plan changes in 3% of cases, and either educational discussion or suggestions of plan changes in 17% of cases. All SBRT sites appear to benefit from peer review, though lower-volume sites may require particular attention.
Interactions with parents are integral in shaping the development of children’s emotional processes. Important aspects of these interactions are overall (mean level) affective experience and affective synchrony (linkages between parent and child affect across time). Respectively, mean-level affect and affective synchrony reflect aspects of the content and structure of dyadic interactions. Most research on parent–child affect during dyadic interactions has focused on infancy and early childhood; adolescence, however, is a key period for both normative emotional development and the emergence of emotional disorders. We examined affect in early to mid-adolescents (N = 55, Mage = 12.27) and their parents using a video-mediated recall task of 10-min conflict-topic discussions. Using multilevel modeling, we found evidence of significant level-2 effects (mean affect) and level-1 effects (affective synchrony) for parents and their adolescents. Level-2 and level-1 associations were differentially moderated by adolescent age and adolescent internalizing and externalizing symptoms. More specifically, parent–adolescent synchrony was stronger when adolescents were older and had more internalizing problems. Further, more positive adolescent mean affect was associated with more positive parent affect (and vice versa), but only for dyads with low adolescent externalizing problems. Results underscore the importance of additional research examining parent–child affect in adolescence.
Pompe disease results from lysosomal acid α-glucosidase deficiency, which leads to cardiomyopathy in all infantile-onset and occasional late-onset patients. Cardiac assessment is important for its diagnosis and management. This article presents unpublished cardiac findings, concomitant medications, and cardiac efficacy and safety outcomes from the ADVANCE study; trajectories of patients with abnormal left ventricular mass z score at enrolment; and post hoc analyses of on-treatment left ventricular mass and systolic blood pressure z scores by disease phenotype, GAA genotype, and “fraction of life” (defined as the fraction of life on pre-study 160 L production-scale alglucosidase alfa). ADVANCE evaluated 52 weeks’ treatment with 4000 L production-scale alglucosidase alfa in ≥1-year-old United States of America patients with Pompe disease previously receiving 160 L production-scale alglucosidase alfa. M-mode echocardiography and 12-lead electrocardiography were performed at enrolment and Week 52. Sixty-seven patients had complete left ventricular mass z scores, decreasing at Week 52 (infantile-onset patients, change −0.8 ± 1.83; 95% confidence interval −1.3 to −0.2; all patients, change −0.5 ± 1.71; 95% confidence interval −1.0 to −0.1). Patients with “fraction of life” <0.79 had left ventricular mass z score decreasing (enrolment: +0.1 ± 3.0; Week 52: −1.1 ± 2.0); those with “fraction of life” ≥0.79 remained stable (enrolment: −0.9 ± 1.5; Week 52: −0.9 ± 1.4). Systolic blood pressure z scores were stable from enrolment to Week 52, and no cohort developed systemic hypertension. Eight patients had Wolff–Parkinson–White syndrome. Cardiac hypertrophy and dysrhythmia in ADVANCE patients at or before enrolment were typical of Pompe disease. Four-thousand L alglucosidase alfa therapy maintained fractional shortening, left ventricular posterior and septal end-diastolic thicknesses, and improved left ventricular mass z score.
Social Media Statement: Post hoc analyses of the ADVANCE study cohort of 113 children support ongoing cardiac monitoring and concomitant management of children with Pompe disease on long-term alglucosidase alfa to functionally improve cardiomyopathy and/or dysrhythmia.
The earliest stage in the innovation lifecycle, problem formulation, is crucial for setting direction in an innovation effort. When faced with an interesting problem, engineers commonly assume the approximate solution area and focus on ideating innovative solutions. However, in this project, NASA and their contracted partner, Accenture, collaboratively conducted problem discovery to ensure that solutioning efforts were focused on the right problems, for the right users, and addressing the most critical needs—in this case, exploring weather tolerant operations (WTO) to further urban air mobility (UAM) – known as UAM WTO. The project team leveraged generative, qualitative methods to understand the ecosystem, players, and where challenges in the industry are inhibiting development. The complexity of the problem area required that the team constantly observe and iterate on problem discovery, effectively “designing the design process.” This paper discusses the approach, methodologies, and selected results, including significant insights on the application of early-stage design methodologies to a complex, system-level problem.
Geography and institutions both shaped Australia’s economic history. After 60,000 years continuous civilization, about 1 million people lived in all parts of the continent in 1700. Aridity, climatic unpredictability, and infertile soil influenced the development of a hunter-gatherer economy that was characterized by sophisticated technologies for food production, especially land management through fire, and kin-based distribution that ensured more than mere survival. Economic activity was governed by gender and age. There was considerable human and social capital in Aboriginal society. Competition for land arrived with British convicts in 1788 and accelerated with gold discovery in 1851 attracting more people, capital and impetus to self-government. A herding economy based on wool exports, food exports, and a busy coastal urban economy permitted a small European population very high real GDP per head from 1830, possibly the highest in the world. The absence of diseases dangerous to Europeans and low levels of income inequality underpinned their high average living standards. The impact of the European economy on the indigenous people caused a devastating depopulation of about two-thirds from starvation, European diseases, and settler violence, producing a stark contrast between the condition of the original population and the newcomers by 1870.
Patients with single-ventricle CHD undergo a series of palliative surgeries that culminate in the Fontan procedure. While the Fontan procedure allows most patients to survive to adulthood, the Fontan circulation can eventually lead to multiple cardiac complications and multi-organ dysfunction. Care for adolescents and adults with a Fontan circulation has begun to transition from a primarily cardiac-focused model to care models, which are designed to monitor multiple organ systems, and using clues from this screening, identify patients who are at risk for adverse outcomes. The complexity of care required for these patients led our centre to develop a multidisciplinary Fontan Management Programme with the primary goals of earlier detection and treatment of complications through the development of a cohesive network of diverse medical subspecialists with Fontan expertise.
ABSTRACT IMPACT: Congregations’ support for social, emotional, mental and spiritual wellness is foundational to human health and their community knowledge and presence can improve resilience and health in socially vulnerable neighborhoods. OBJECTIVES/GOALS: The Indiana CTSI Monon Collaborative is listening and understanding the most pressing health issues in the community and are working together to design and deliver community health solutions. We worked with our community ambassador to launch a health and wellness learning community for ten congregations seeking to build a health-connector network. METHODS/STUDY POPULATION: Study team used qualitative (interviews, focus groups, listening sessions, learning management system, participatory-design research) and quantitative (surveys) data collection methods in the development and ongoing implementation of the learning community. Study Population: Based on initial assessment of health and social vulnerability data within the Marion County neighborhoods in Indianapolis, community ambassador engaged congregations in more vulnerable neighborhoods to seek participation in learning community. Ten congregations signed a covenant of participation; learning community includes 10 clergy and 8 health advocates. RESULTS/ANTICIPATED RESULTS: Since the inception of the Learning Community in May 2020, we have developed a better understanding of the assets and barriers of LC participants around health and well-being. Through ongoing virtual gatherings (facilitated by community ambassador Good to the Soul), sharing of resources through our online modules on Canvas (LMS), and synthesis of data captured throughout our time together, LC participants have developed SMART goals which will inform priority setting for congregations to assist them in identifying the resources and connections necessary to drive forward solutions together as they seek out funding opportunities to support health improvement. DISCUSSION/SIGNIFICANCE OF FINDINGS: The learning community has provided a space and structure for congregations to align around a shared goal focused on health and wellness. Through regular gatherings we were able to connect people, organizations, and systems who were all eager to learn and work across boundaries leading to greater resilience in vulnerable communities.
Background: When control mechanisms such as water temperature and biocide level are insufficient, Legionella, the causative bacteria of Legionnaires’ disease, can proliferate in water distribution systems in buildings. Guidance and oversight bodies are increasingly prioritizing water safety programs in healthcare facilities to limit Legionella growth. However, ensuring optimal implementation in large buildings is challenging. Much is unknown, and sometimes assumed, about whether building and campus characteristics influence Legionella growth. We used an extensive real-world environmental Legionella data set in the Veterans Health Administration (VHA) healthcare system to examine infrastructure characteristics and Legionella positivity. Methods: VHA medical facilities across the country perform quarterly potable water sampling of healthcare buildings for Legionella detection as part of a comprehensive water safety program. Results are reported to a standardized national database. We did an exploratory univariate analysis of facility-reported Legionella data from routine potable water samples taken in 2015 to 2018, in conjunction with infrastructure characteristics available in a separate national data set. This review examined the following characteristics: building height (number of floors), building age (reported construction year), and campus acreage. Results: The final data set included 201,936 water samples from 819 buildings. Buildings with 1–5 floors (n = 634) had a Legionella positivity rate of 5.3%, 6–10 floors (n = 104) had a rate of 6.4%, 11–15 floors (n = 36) had a rate of 8.1%, and 16–22 floors (n = 9) had a rate of 8.8%. All rates were significantly different from each other except 11–15 floors and 16–22 floors (P < .05, χ2). The oldest buildings (1800s) had significantly less (P < .05, χ2) Legionella positivity than those built between 1900 and 1939 and between 1940 and 1979, but they were no different than the newest buildings (Fig. 1). In newer buildings (1980–2019), all decades had buildings with Legionella positivity (Fig. 1 inset). Campus acreage varied from ~3 acres to almost 500 acres. Although significant differences were found in Legionella positivity for different campus sizes, there was no clear trend and campus acreage may not be a suitable proxy for the extent or complexity of water systems feeding buildings. Conclusions: The analysis of this large, real-world data set supports an assumption that taller buildings are more likely to be associated with Legionella detection, perhaps a result of more extensive piping. In contrast, the assumption that newer buildings are less associated with Legionella was not fully supported. These results demonstrate the variability in Legionella positivity in buildings, and they also provide evidence that can inform implementation of water safety programs.
Funding: None
Disclosures: Chetan Jinadatha, principal Investigator/Co-I: Research: NIH/NINR, AHRQ, NSF principal investigator: Research: Xenex Healthcare Services. Funds provided to institution. Inventor: Methods for organizing the disinfection of one or more items contaminated with biological agents. Owner: Department of Veterans Affairs. Licensed to Xenex Disinfection System, San Antonio, TX.