Product architecture decisions are made early in the product development process and have far-reaching effects. Unless anticipated through experience or intuition, many of these effects may not be apparent until much later in the development process, making changes to the architecture costly in time, effort and resources. Many researchers through the years have studied various elements of product architecture and their effects. By using a repeatable process for aggregating statements on the effects of architecture strategies from a selection of the literature on the topic and storing them in a systematic database, this information can then be recalled and presented in the form of a Product Architecture Strategy and Effect (PASE) matrix. PASE matrices allow for the identification, comparison, evaluation, and then selection of the most desirable product architecture strategies before expending resources along a specific development path. This paper introduces the PASE Database and matrix and describes their construction and use in guiding design decisions. This paper also provides metrics for understanding the robustness of this database.

Previous research has examined whether voters will punish candidates who engage in sexual harassment in national-level elections, revealing partisanship as a strong predictor of electoral punishment. Using original survey data, we evaluate whether the public supports a broader range of sanctions (e.g. apologies, training, and removal from office) that legislatures can impose upon politicians who perpetrate sexual harassment in Canada’s municipalities, a non-partisan context. In the absence of partisan-based motivated reasoning, we find that women are more likely than men to support the removal from office of a councillor who engages in sexual harassment. Respondents who do not believe that sexism is a problem and are skeptical about claims of gender-based violence are also less likely to support punishment in these cases. These findings have relevance for democratic institutions, revealing that sanctions imposed on politicians who perpetrate sexual harassment can help maintain political accountability and restore public trust.

From early on, infants show a preference for infant-directed speech (IDS) over adult-directed speech (ADS), and exposure to IDS has been correlated with language outcome measures such as vocabulary. The present multi-laboratory study explores this issue by investigating whether there is a link between early preference for IDS and later vocabulary size. Infants’ preference for IDS was tested as part of the ManyBabies 1 project, and follow-up CDI data were collected from a subsample of this dataset at 18 and 24 months. A total of 341 (18 months) and 327 (24 months) infants were tested across 21 laboratories. In neither preregistered analyses with North American and UK English, nor exploratory analyses with a larger sample did we find evidence for a relation between IDS preference and later vocabulary. We discuss implications of this finding in light of recent work suggesting that IDS preference measured in the laboratory has low test-retest reliability.

Background: Presenteeism when ill in healthcare personnel (HCP) can contribute to the spread of respiratory illness among HCP and patients. However, during the COVID-19 pandemic and now, there are substantial challenges preventing HCP from staying home when ill. We examined these challenges using the Systems Engineering Initiative for Patient Safety (SEIPS) framework. Method: As part of a larger anonymous electronic survey between 3/11/2022 and 4/12/2022 at an academic tertiary referral center, in inpatient and ambulatory settings where respondents were asked to describe factors impacting presenteeism when ill, we analyzed free-text responses using the SEIPS categories of tasks, tools/technology, person, organization, and physical environment. Result: 522 comments were received in response to the open-ended survey question asking individuals to describe any factors that would assist them in remaining home and/or help them get tested for COVID-19 when they have symptoms of a respiratory illness; 21 were excluded due to absent or incomplete response. Of the remaining responses (N = 501, Figure 1), 82% were associated with a single SEIPS component such as organization (N = 409), while other responses discussed factors that involved two SEIPS components, in no particular order (N = 92). A majority of the responses (N = 324, 55%) reported organizational barriers, frequently citing a strict sick call-in policy as well as a lack of protected time-off for COVID-19 testing or related absences. The next two most commonly identified components were physical environment (N= 88, 15%) and tasks (N = 72, 12%), mentioning barriers such as far distances to testing centers and prolonged waiting periods for testing Results: The person and tools/technology components were less commonly identified, with a frequency of 9% each. Conclusion: A number of systems level factors were identified that may impact the ability of HCP to stay home when ill. Interventions to help overcome HCP perceived barriers to staying home when experiencing respiratory symptoms should focus on the policies and practices within an organization. Communication from leadership should support staying home with respiratory symptoms by creating plans for coverage and back up consistently across all employee types in direct care.

Background: External comparisons of antimicrobial use (AU) may be more informative if adjusted for encounter characteristics. Optimal methods to define input variables for encounter-level risk-adjustment models of AU are not established. Methods: This retrospective analysis of electronic health record data included 50 US hospitals in 2020-2021. We used NHSN definitions for all antibacterials days of therapy (DOT), including adult and pediatric encounters with at least 1 day present in inpatient locations. We assessed 4 methods to define input variables: 1) diagnosis-related group (DRG) categories by Yu et al., 2) adjudicated Elixhauser comorbidity categories by Goodman et al., 3) all Clinical Classification Software Refined (CCSR) diagnosis and procedure categories, and 4) adjudicated CCSR categories where codes not appropriate for AU risk-adjustment were excluded by expert consensus, requiring review of 867 codes over 4 months to attain consensus. Data were split randomly, stratified by bed size as follows: 1) training dataset including two-thirds of encounters among two-thirds of hospitals; 2) internal testing set including one-third of encounters within training hospitals, and 3) external testing set including the remaining one-third of hospitals. We used a gradient-boosted machine (GBM) tree-based model and two-staged approach to first identify encounters with zero DOT, then estimate DOT among those with >0.5 probability of receiving antibiotics. Accuracy was assessed using mean absolute error (MAE) in testing datasets. Correlation plots compared model estimates and observed DOT among testing datasets. The top 20 most influential variables were defined using modeled variable importance. Results: Our datasets included 629,445 training, 314,971 internal testing, and 419,109 external testing encounters. Demographic data included 41% male, 59% non-Hispanic White, 25% non-Hispanic Black, 9% Hispanic, and 5% pediatric encounters. DRG was missing in 29% of encounters. MAE was lower in pediatrics as compared to adults, and lowest for models incorporating CCSR inputs (Figure 1). Performance in internal and external testing was similar, though Goodman/Elixhauser variable strategies were less accurate in external testing and underestimated long DOT outliers (Figure 2). Agnostic and adjudicated CCSR model estimates were highly correlated; their influential variables lists were similar (Figure 3). Conclusion: Larger numbers of CCSR diagnosis and procedure inputs improved risk-adjustment model accuracy compared with prior strategies. Variable importance and accuracy were similar for agnostic and adjudicated approaches. However, maintaining adjudications by experts would require significant time and potentially introduce personal bias. If findings are confirmed, the need for expert adjudication of input variables should be reconsidered.

Disclosure: Elizabeth Dodds Ashley: Advisor- HealthTrackRx. David J Weber: Consultant on vaccines: Pfizer; DSMB chair: GSK; Consultant on disinfection: BD, GAMA, PDI, Germitec

Substance use disorders among juveniles are a major public health concern and are often intertwined with other psychosocial risk factors including antisocial behavior. Identifying etiological risks and mechanisms promoting substance use disorders remains a high priority for informing more focused interventions in high-risk populations. The present study examined brain gray matter structure in relation to substance use severity among n = 152 high-risk, incarcerated boys (aged 14–20). Substance use severity was positively associated with gray matter volume across several frontal/striatal brain regions including amygdala, pallidum, putamen, insula, and orbitofrontal cortex. Effects were apparent when using voxel-based-morphometric analysis, as well as in whole-brain, data-driven, network-based approaches (source-based morphometry). These findings support the hypothesis that elevated gray matter volume in striatal reward circuits may be an endogenous marker for vulnerability to severe substance use behaviors among youth.

OBJECTIVES/GOALS: High serum copper (Cu) levels have previously been described in bariatric patients. The kidneys are a target organ for Cu toxic insult but the role of Cu on kidney function (eGFR) is uncertain. This study examines the association between Cu and eGFR in a bariatric population in Southeast Louisiana. METHODS/STUDY POPULATION: Seven hundred fifty patients will be recruited from the Bariatric Center of the University Medical Center in New Orleans. Inclusion criteria include: age ≥ 18 years, clinic visit between June 1, 2018 – May 31st 2024, and having a serum Cu test result. Covariables such as inflammatory markers and hormonal contraception use will be assessed as potential confounders. Blood pressure will be assessed as a potential effect modifier. Data will be obtained from electronic medical records. Two cohorts will be assembled, a pre-surgery cross-sectional cohort and another followed post-surgery. Separate models will be developed stratified by race-ethnicity. RESULTS/ANTICIPATED RESULTS: In a pilot study of bariatric patients 26% had elevated (>155 mcg/dl) serum Cu and pronounced racial differences were noted. Characteristics consisted of a mean BMI of approximately 50 kg/m2; 91% were female and 69% were Black. Black patients had approximately double the prevalence (OR 1.98; 95% CI: 1.15, 3.4) compared to white patients. Due to the dual nature of the kidneys’ involvement in metabolism via excretion and being the target organ for toxic insult, racial differences in exposure, coupled with the disproportionate rates of chronic kidney disease in Black adults, may be an explanation for the association between elevated Cu levels and eGFR in Black adults in this study. DISCUSSION/SIGNIFICANCE: Results from this study will provide insight into the prevalence of Cu and its association with kidney function in a bariatric population. Chronic kidney disease or other forms of renal impairment may result in the need for more conservative guidelines for dietary copper in bariatric medicine.

Dynamical and thermodynamic properties of water at room temperature in Ca- and hexade-cyltrimethylammonium- (HDTMA) exchanged bentonite were determined for 4 different water contents (~0.03–0.55 g water g-1 clay). Incoherent quasi-elastic neutron scattering (QENS) was used to measure the translational and rotational mobility of water in the clays, while chilled mirror dewpoint psychrometry measured water activity of the samples, differential scanning calorimetry (DSC) provided information about the temperature of dehydration and X-ray diffraction (XRD) quantified layer spacings for the clays. The neutron scattering data were fit to a jump diffusion model that yielded mean jump lengths, jump diffusion residence times and rotational relaxation times for water in the clays. Mean jump lengths were quite similar for the 2 different cation saturations at equivalent water contents, and decreased with increasing water content. The fitted jump lengths ranged from 0.27–0.5 nm and were 2–4 times larger than that found for bulk water (0.13 nm). Jump diffusion residence times were 3–30 times longer than that for bulk water (1.2 ps) and also decreased with increasing water content. The residence times were somewhat shorter for HDTMA-clay as compared with Ca-clay at equivalent water contents. Rotational motion was less strongly influenced than translational motion by the presence of the clay surface. The energy state of water in the 2 cation saturations were quite different; dehydration temperatures for the HDTMA-clay were approximately 30 °C lower than the Ca-clay at equal water contents, while water activities, as P/P0, were up to 0.6 units higher. A linear relationship was found between water activity and the translational diffusion coefficient, although at the highest water content, the diffusion coefficient of water for the HDTMA-clay was approximately 30% higher than that measured for bulk water.

Secondary surface layers form by replacement of almandine garnet during chemical weathering. This study tested the hypothesis that the kinetic role of almandine’s weathering products, and the consequent relationships of primary-mineral surface texture and specific assemblages of secondary minerals, both vary with the solid-solution-controlled variations in Fe and Al contents of the specific almandine experiencing weathering.

Surface layers are protective (PSL) when the volume of the products formed by replacement is greater than or equal to the volume of the reactants replaced. Under such circumstances, reaction kinetics at the interface between the garnet and the replacing mineral are transport controlled and either transport of solvents or other reactants to, or products from, the dissolving mineral is rate limiting. Beneath PSLs, almandine garnet surfaces are smooth, rounded, and featureless. Surface layers are unprotective (USL) when the volume of the products formed by replacement is less than the volume of the reactants replaced. Under such circumstances, reaction kinetics at the interface between the garnet and the replacing mineral are interface controlled and the detachment of ions or molecules from the mineral surface is rate limiting. Almandine garnet surfaces beneath USLs exhibit crystallographically oriented etch pits. However, contrary to expectations, etch pits occur on almandine garnet grains beneath some layers consisting of mineral assemblages consistent with PSLs.

Based on the Pilling-Bedworth criterion, surface layers are more likely to be protective over a broad range of reactant-mineral compositions when they contain goethite, kaolinite, and pyrolusite. However, this combination requires specific ranges of Fe and Al content of the natural reacting almandine garnet. To form a PSL of goethite and kaolinite, an almandine garnet must have a minimum Al stoichiometric coefficient of ~3.75 a.p.f.u., and a minimum Fe stoichiometric coefficient of ~2.7 a.p.f.u.

Product minerals also influence the mobility of the least-mobile major rock-forming elements. A PSL consisting of goethite, gibbsite, and kaolinite yields excess Al for export during almandine garnet weathering. As the quantity of kaolinite present in the PSL decreases, the amounts of Al available for export increases.

The reactivity of colloidal particles is regulated by their surface properties. These properties affect the wettability, flocculation-dispersion characteristics, ion exchange, sorption capacities and transport of inorganic colloids. Most studies have focused on hydrophilic, charged-particle surfaces, often ignoring the alterations in surface properties produced by the adsorption of natural organic matter, surfactants and other compounds. Adsorption of these substances can potentially render a surface substantially more hydrophobic. Nevertheless, comparatively little is known about changes in surface properties and reactivity of minerals upon sorption of hydrophobic organic compounds. In this study, the properties of four minerals (kaolinite, pyrophyllite, montmorillonite and Min-U-Sil®) and two inorganic materials (X-ray amorphous Al hydroxide and X-ray amorphous Si oxide) were compared before and after treatment with the common silylating agent, trimethylchlorosilane (TMCS). The samples were characterized by measurements of total carbon, cation exchange capacity (CEC), particle size, specific surface area (SSA), electrophoretic mobility, contact angle, particle aggregation, and by X-ray diffraction and diffuse reflectance infrared spectroscopy. For the layer silicates, surface coverage was limited to ∼2% trimethyl silane (TMSi). TMSi covered 7.5% of the Min-U-Sil® surface and 33% of the X-ray amorphous Si oxide. Treatment did not affect the structure of the minerals but reduced the CEC, SSA and electrophoretic mobilities. Water contact angles increased to between 18 and 114° with treatment. While the apolar characteristic of the surfaces decreased minimally with treatment, the Lewis acid/base properties were substantially reduced and interfacial free energy shifted from positive to negative values indicating a more hydrophobic surface character. For all the samples except kaolinite, these changes affected the stability of the colloids in suspension depending upon solution pH. Although the grafting of TMSi altered colloidal mineral surface properties and increased their hydrophobicity, these changes were not sufficient to predict colloid aggregation behavior.

Large research teams and consortia present challenges for authorship. The number of disciplines involved in the research can further complicate approaches to manuscript development and leadership. The CHARM team, representing a multi-disciplinary, multi-institutional genomics implementation study, participated in facilitated discussions inspired by team science methodologies. The discussions were centered on team members’ past experiences with authorship and perspectives on authorship in a large research team context. Team members identified challenges and opportunities that were used to create guidelines and administrative tools to support manuscript development. The guidelines were organized by the three values of equity, inclusion, and efficiency and included eight principles. A visual dashboard was created to allow all team members to see who was leading or involved in each paper. Additional tools to promote equity, inclusion, and efficiency included providing standardized project management for each manuscript and making “concept sheets” for each manuscript accessible to all team members. The process used in CHARM can be used by other large research teams and consortia to equitably distribute lead authorship opportunities, foster coauthor inclusion, and efficiently work with large authorship groups.

The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT’s are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide. The trial examined three medications (metformin, ivermectin, and fluvoxamine) as outpatient treatment of SARS-CoV-2 for their effectiveness in preventing severe or long COVID-19. Decentralized strategies included HIPAA-compliant electronic screening and consenting, prepacking investigational product to accelerate delivery after randomization, and remotely confirming participant-reported outcomes. Of the 1417 individuals with the intention-to-treat sample, the remote nature of the study caused an additional 94 participants to not take any doses of study drug. Therefore, 1323 participants were in the modified intention-to-treat sample, which was the a priori primary study sample. Only 1.4% of participants were lost to follow-up. Decentralized strategies facilitated the successful completion of the COVID-OUT trial without any in-person contact by expediting intervention delivery, expanding trial access geographically, limiting contagion exposure, and making it easy for participants to complete follow-up visits. Remotely completed consent and follow-up facilitated enrollment.