OBJECTIVES/GOALS: To evaluate the clarity of plain-language informed consent forms (ICF) created using a browser-based tool called the ICF Navigator, we solicited feedback from two community review boards (CRB) to ensure the resulting ICF met the informational needs of all potential participants, including those with limited health literacy skills. METHODS/STUDY POPULATION: Community-engaged research highlights the importance of involving community members in the planning and execution of translational research projects. Virtual discussions were held to elicit feedback from two separate CRBs on the understandability of an ICF that was generated using an online, browser-based tool that we designed to aid researchers in the creation of plain-language ICFs. CRBs included representation of diverse communities from across the state of Arkansas, including individuals who may have limited health literacy skills, those with and without prior experience participating in clinical research projects, members living in rural and urban settings, and those whose race or ethnicity have been traditionally underrepresented among clinical research participants. RESULTS/ANTICIPATED RESULTS: CRB feedback was used to inform actionable improvements to the tool, such as removing content redundancies and embedding tips to guide researchers on how best to optimize the clarity and understandability of resulting ICFs. Program refinements in response to the feedback have been implemented and will be evaluated in another round of CRB discussions in early 2023. Feedback from this follow-up CRB session will also be presented in addition to a discussion of how the feedback was used to improve the online tool, which will ultimately be available for free use by other institutions. DISCUSSION/SIGNIFICANCE: The use of community feedback to optimize the functionality of the ICF Navigator demonstrates the value of CRBs for ensuring that ICFs are culturally salient and readily understandable by all potential research participants, particularly those who may have limited health literacy skills, thereby promoting more equitable opportunities for all.

We studied 83 cardiac-surgery patients with nasal S. aureus carriage who received 4 intranasal administrations of XF-73 nasal gel or placebo <24 hours before surgery. One hour before surgery, patients exhibited a S. aureus nasal carriage reduction of 2.5 log10 with XF-73 compared to 0.4 log10 CFU/mL for those who received placebo (95% CI, −2.7 to −1.5; P < .0001).

Archaeological compliance is defined by state and federal legislation and the constrained, precise language in which it is written. Rules and policies operationalize the law but provide some flexibility in its interpretation and implementation. The pronounced use of “legal” and “scientific” language in archaeological compliance can be considered insensitive or offensive to some tribal members when discussing the disposition and care of the remains and belongings of their ancestors. The language we use constructs our reality and defines how we interpret our interactions of the lived experience. It is therefore necessary to revise the language employed in archaeological compliance to ensure that it reflects the values of the communities that these laws define to determine treatment and ultimate disposition of their ancestral remains and belongings. This article describes and encourages the use of a respectful terminology, developed in conjunction with compliance professionals and tribal representatives, to restructure the language we use and redefine our interactions as more considerate of tribal concerns for repatriation.

A high dose of whey protein hydrolysate fed with milk minerals rich in calcium (Capolac®) results in enhanced glucagon-like peptide-1 (GLP-1) concentrations in lean individuals; however, the effect of different calcium doses ingested alongside protein is unknown. The present study assessed the dose response of calcium fed alongside 25 g whey protein hydrolysate on GLP-1 concentrations in individuals with overweight/obesity. Eighteen adults (mean ± sd: 8M/10F, 34 ± 18 years, 28·2 ± 2·9 kgm−2) completed four trials in a randomised, double-blind, crossover design. Participants consumed test solutions consisting of 25 g whey protein hydrolysate (CON), supplemented with 3179 mg (LOW), 6363 mg (MED) or 9547 mg (HIGH) Capolac® on different occasions, separated by at least 48 h. The calcium content of test solutions equated to 65, 892, 1719 and 2547 mg, respectively. Arterialised-venous blood was sampled over 180 min to determine plasma concentrations of GLP-1TOTAL, GLP-17–36amide, insulin, glucose, NEFA, and serum concentrations of calcium and albumin. Ad libitum energy intake was measured at 180 min. Time–averaged incremental AUC (iAUC) for GLP-1TOTAL (pmol·l−1·min−1) did not differ between CON (23 ± 4), LOW (25 ± 6), MED (24 ± 5) and HIGH (24 ± 6). Energy intake (kcal) did not differ between CON (940 ± 387), LOW (884 ± 345), MED (920 ± 334) and HIGH (973 ± 390). Co-ingestion of whey protein hydrolysate with Capolac® does not potentiate GLP-1 release in comparison with whey protein hydrolysate alone. The study was registered at clinical trials (NCT03819972).

Group Name: Bright STAR Authorship Group

Background: Blood cultures are fundamental in the diagnosis and treatment of sepsis. Culture practices vary widely, and overuse can lead to false-positive results and unnecessary antibiotics. Our objective was to describe the implementation of a multisite quality improvement collaborative to reduce unnecessary blood cultures in pediatric intensive care unit (PICU) patients, and its 18-month impact on blood culture rates and safety metrics. Methods: In 2018, 14 PICUs joined the Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children (Bright STAR) Collaborative, designed to understand and improve blood culture practices in critically ill children. Guided by a centralized multidisciplinary study team, sites first reviewed existing evidence for safe reduction of unnecessary blood cultures and assessed local practices and barriers to change. Subsequently, local champions developed and implemented clinical decision-support tools informed by local patient needs to guide new blood-culture practices. The coordinating study team facilitated regular evaluations and discussions of project progress through monthly phone calls, site visits if requested by sites or the study team, and collaborative-wide teleconferences. The study team collected monthly blood culture rates and monitored for possible delays in obtaining blood cultures using a standardized review process as a safety balancing metric. We compared 24 months of baseline data to 18 months of postimplementation using a Poisson regression model accounting for the site-specific patient days and correlation of culture use within a site over time. Results: Across the 14 sites, before implementation, 41,768 blood cultures were collected over 259,701 PICU patient days. The mean preimplementation site-specific blood culture rate was 15.7 cultures per 100 patient days (rate range, 9.6–48.2 cultures per 100 patient days). After implementation, 22,397 blood cultures were collected over 208,171 PICU patient days. The mean postimplementation rate was 10.4 cultures per 100 patient days (rate range, 4.7–28.3 cultures per 100 patient days), which was 33.6% lower than the preimplementation (relative rate 0.66; 95% CI, 0.65–0.68 p <0.01). In 18 months post-implementation, sites reviewed 793 positive blood cultures, and identified only one suspected delay in culture collection possibly attributable to the site’s blood culture reduction program. Conclusions: Multidisciplinary quality improvement teams safely facilitated a 33.6% average reduction in blood culture use in critically ill children at 14 hospitals. Future collaborative work will determine the impact of blood culture diagnostic stewardship on antibiotic use and other important patient safety outcomes.

Funding: No

Disclosures: None

Figure 1.

Coronary artery aneurysms in children were observed as a rare complication associated with coronavirus disease 2019 (COVID-19). This case report describes the severe end of the spectrum of the new multisystem inflammatory syndrome in a 12-year-old child with coronary aneurysms, myocardial dysfunction, and shock, managed successfully with extracorporeal membrane oxygenation support and immunomodulation therapy. This report also highlights the additional benefits of cardiac CT in the diagnosis and follow-up of coronary aneurysms.

Background: Blood cultures are essential diagnostic tools used to identify bloodstream infections and to guide antimicrobial therapy. However, collecting cultures without clear indications or that do not inform management can lead to false-positive results and unnecessary use of antibiotics. Blood culture practices vary significantly in critically ill children. Our objective was to create a consensus guideline focusing on when to safely avoid blood cultures in pediatric intensive care unit (PICU) patients. Methods: A panel of multidisciplinary experts, many participating in the Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children (Bright STAR) Collaborative, engaged in a 2-part modified Delphi process. Round 1 consisted of a preparatory literature summary and an electronic survey sent to subject matter experts (SMEs). In the survey, SMEs rated a series of recommendations about when to avoid blood cultures on a 5-point Likert scale, 1 being the lowest score and 5 being the highest score. Consensus was achieved for each recommendation if 75% of respondents chose a score of 4 or 5, and these were included in the final guideline. Any recommendations that did not meet these a priori criteria for consensus were set aside for discussion during the in-person expert panel review (round 2). An outside expert in consensus methodology facilitated round 2. After a review of the survey results and comments from round 1 and group discussion, the SMEs voted on these recommendations in real time. Voting was blinded. Participants included Bright STAR site leads, national content experts, and representatives from relevant national societies. Results: We received 29 completed surveys from 34 invited participants for an 85% response rate. Of the 27 round 1 recommendations, 18 met predetermined criteria for consensus. Round 2 included 26 in-person voting participants who (1) discussed and modified the 9 recommendations that had not met round 1 consensus, and (2) modified for clarity or condensed from multiple into single recommendations the 18 recommendations that had met the round 1 consensus. The final document contains 19 recommendations that provide guidance on how to safely improve blood culture use in PICU patients (Table 1). Also, 8 recommendations discussed did not reach consensus for inclusion. Conclusions: Using a modified Delphi process, we created consensus recommendations on when to avoid blood cultures and prevent overuse in critically ill children. These guidelines are a critical step in disseminating diagnostic stewardship and reducing unnecessary testing on a wider scale.

Funding: Agency for Healthcare Research and Quality, R18 HS025642-01, 9/2017 – 9/2020 (Aaron Milstone, PI)

Disclosures: None

Case-Finding for Complex Chronic Conditions in Seniors 75+ (C5-75) is a systematic approach to identify frailty using gait speed and hand-grip strength and to screen for co-morbid conditions. We identified the C5-75 features offering the highest yield for identifying frailty and to streamline the screening program. Analyses included 1,948 C5-75 assessments completed from 2013 to 2018. Age 85 or older, less than regular physical activity, and more than two falls in the previous six months had the strongest associations with frailty. Exempting patients under 85 who reported regular physical activity and less than two falls excluded 39.1 per cent of the cohort while maintaining a sensitivity of 95.2 per cent and a negative predictive value of 99.4 per cent for frailty. These findings provide insight into optimizing screening for frailty, making it more feasible to implement and to identify co-existing conditions that may contribute to or be affected by frailty.

Hydrogen lithography has been used to template phosphine-based surface chemistry to fabricate atomic-scale devices, a process we abbreviate as atomic precision advanced manufacturing (APAM). Here, we use mid-infrared variable angle spectroscopic ellipsometry (IR-VASE) to characterize single-nanometer thickness phosphorus dopant layers (δ-layers) in silicon made using APAM compatible processes. A large Drude response is directly attributable to the δ-layer and can be used for nondestructive monitoring of the condition of the APAM layer when integrating additional processing steps. The carrier density and mobility extracted from our room temperature IR-VASE measurements are consistent with cryogenic magneto-transport measurements, showing that APAM δ-layers function at room temperature. Finally, the permittivity extracted from these measurements shows that the doping in the APAM δ-layers is so large that their low-frequency in-plane response is reminiscent of a silicide. However, there is no indication of a plasma resonance, likely due to reduced dimensionality and/or low scattering lifetime.

Morning coffee is a common remedy following disrupted sleep, yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults. Remarkably, the combined effects of sleep fragmentation and coffee on glucose control upon waking per se have never been investigated. In a randomised crossover design, twenty-nine adults (mean age: 21 (sd 1) years, BMI: 24·4 (sd 3·3) kg/m2) underwent three oral glucose tolerance tests (OGTT). One following a habitual night of sleep (Control; in bed, lights-off trying to sleep approximately 23.00–07.00 hours), the others following a night of sleep fragmentation (as Control but waking hourly for 5 min), with and without morning coffee approximately 1 h after waking (approximately 300 mg caffeine as black coffee 30 min prior to OGTT). Individualised peak plasma glucose and insulin concentrations were unaffected by sleep quality but were higher following coffee consumption (mean (normalised CI) for Control, Fragmented and Fragmented + Coffee, respectively; glucose: 8·20 (normalised CI 7·93, 8·47) mmol/l v. 8·23 (normalised CI 7·96, 8·50) mmol/l v. 8·96 (normalised CI 8·70, 9·22) mmol/l; insulin: 265 (normalised CI 247, 283) pmol/l; and 235 (normalised CI 218, 253) pmol/l; and 310 (normalised CI 284, 337) pmol/l). Likewise, incremental AUC for plasma glucose was higher in the Fragmented + Coffee trial compared with Fragmented. Whilst sleep fragmentation did not alter glycaemic or insulinaemic responses to morning glucose ingestion, if a strong caffeinated coffee is consumed, then a reduction in glucose tolerance can be expected.

This study investigated metabolic, endocrine, appetite and mood responses to a maximal eating occasion in fourteen men (mean: age 28 (sd 5) years, body mass 77·2 (sd 6·6) kg and BMI 24·2 (sd 2·2) kg/m2) who completed two trials in a randomised crossover design. On each occasion, participants ate a homogenous mixed-macronutrient meal (pizza). On one occasion, they ate until ‘comfortably full’ (ad libitum) and on the other, until they ‘could not eat another bite’ (maximal). Mean energy intake was double in the maximal (13 024 (95 % CI 10 964, 15 084) kJ; 3113 (95 % CI 2620, 3605) kcal) compared with the ad libitum trial (6627 (95 % CI 5708, 7547) kJ; 1584 (95 % CI 1364, 1804) kcal). Serum insulin incremental AUC (iAUC) increased approximately 1·5-fold in the maximal compared with ad libitum trial (mean: ad libitum 43·8 (95 % CI 28·3, 59·3) nmol/l × 240 min and maximal 67·7 (95 % CI 47·0, 88·5) nmol/l × 240 min, P < 0·01), but glucose iAUC did not differ between trials (ad libitum 94·3 (95 % CI 30·3, 158·2) mmol/l × 240 min and maximal 126·5 (95 % CI 76·9, 176·0) mmol/l × 240 min, P = 0·19). TAG iAUC was approximately 1·5-fold greater in the maximal v. ad libitum trial (ad libitum 98·6 (95 % CI 69·9, 127·2) mmol/l × 240 min and maximal 146·4 (95 % CI 88·6, 204·1) mmol/l × 240 min, P < 0·01). Total glucagon-like peptide-1, glucose-dependent insulinotropic peptide and peptide tyrosine–tyrosine iAUC were greater in the maximal compared with ad libitum trial (P < 0·05). Total ghrelin concentrations decreased to a similar extent, but AUC was slightly lower in the maximal v. ad libitum trial (P = 0·02). There were marked differences on appetite and mood between trials, most notably maximal eating caused a prolonged increase in lethargy. Healthy men have the capacity to eat twice the energy content required to achieve comfortable fullness at a single meal. Postprandial glycaemia is well regulated following initial overeating, with elevated postprandial insulinaemia probably contributing.

Mycoprotein is a food high in both dietary fibre and non-animal-derived protein. Global mycoprotein consumption is increasing, although its effect on human health has not yet been systematically reviewed. This study aims to systematically review the effects of mycoprotein on glycaemic control and energy intake in humans. A literature search of randomised controlled trials was performed in PubMed, Embase, Web of Science, Google Scholar and hand search. A total of twenty-one studies were identified of which only five studies, totalling 122 participants, met the inclusion criteria. All five studies were acute studies of which one reported outcomes on glycaemia and insulinaemia, two reported on energy intake and two reported on all of these outcomes. Data were extracted, and risk-of-bias assessment was then conducted. The results did not show a clear effect of acute mycoprotein on blood glucose levels, but it showed a decrease in insulin levels. Acute mycoprotein intake also showed to decrease energy intake at an ad libitum meal and post-24 h in healthy lean, overweight and obese humans. In conclusion, the acute ingestion of mycoprotein reduces energy intake and insulinaemia, whereas its impact on glycaemia is currently unclear. However, evidence comes from a very limited number of heterogeneous studies. Further well-controlled studies are needed to elucidate the short- and long-term effects of mycoprotein intake on glycaemic control and energy intake, as well as the mechanisms underpinning these effects.

Continued reliance on chemical methods for controlling annual bluegrass has resulted in many populations evolving resistance to PRE and POST herbicides, particularly in warm-season turfgrass species such as zoysiagrass. Soil seedbank management is critically important when managing herbicide-resistant weeds. Fraise mowing (also spelled fraze, frase, and fraize) is a new turfgrass cultivation practice designed to remove aboveground biomass while allowing turf to regrow vegetatively. We hypothesized that this process would remove annual bluegrass seed and therefore be a mechanical means of controlling annual bluegrass in turfgrass. Zoysiagrass field plots were fraise-mowed in June 2015 only, June 2016 only, June 2015 and June 2016, or left untreated. The fraise mower was configured to remove the uppermost 25 mm of plot surface (i.e., 15-mm verdure and 10-mm soil). Annual bluegrass infestation was quantified in April following fraise mowing via grid count. Soil cores (10.8 cm diameter) were extracted from each plot after grid count data were collected to assess effects of fraise mowing on the soil seedbank. Moreover, replicated subsamples (7.6 L) of debris generated during fraise mowing were collected to better understand weed seed content removed during the fraise mowing process. Fraise mowing in June offered a slight reduction (24%) in annual bluegrass cover the following April. Whereas 28% of the seed in fraise-mowing debris consisted of annual bluegrass, there was no difference in the quantity of annual bluegrass seed remaining in the soil seedbank among fraise-mowed and non–fraise-mowed plots. Although fraise mowing may help to temporarily reduce existing annual bluegrass infestations via mechanical removal, the frequency and depth we studied did not effectively reduce the seedbank. Fraise mowing is a useful tool for providing mechanical suppression of annual bluegrass but it is not a replacement for properly timed herbicide applications.