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DOE OSTI2025

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

Background/aims Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research over the past decade and characterized key regulatory and trial design elements with a focus on the primary efficacy endpoint utilized as the basis of approval. Methods Using the Food and Drug Administration’s Data Analysis Search Host database, we identified novel new drug applications and biologics license applications with orphan drug designation that were approved between 2013 and 2022 for non-oncologic indications. From Food and Drug Administration review documents and other external databases, we examined characteristics of pivotal trials for the included drugs, such as therapeutic area, trial design, and type of primary efficacy endpoints. Differences in trial design elements associated with primary efficacy endpoint type were assessed such as randomization and blinding. Then, we summarized the primary efficacy endpoint types utilized in pivotal trials by therapeutic area, approval pathway, and whether the disease etiology is well defined. Results One hundred and seven drugs that met our inclusion criteria were approved between 2013 and 2022. Assessment of the 107 drug development programs identified 150 pivotal trials that were subsequently analyzed. The pivotal trials were mostly randomized (80%) and blinded (69.3%). Biomarkers (41.1%) and clinical outcomes (42.1%) were commonly utilized as primary efficacy endpoints. Analysis of the use of clinical trial design elements across trials that utilized biomarkers, clinical outcomes, or composite endpoints did not reveal statistically significant differences. The choice of primary efficacy endpoint varied by the drug’s therapeutic area, approval pathway, and whether the indicated disease etiology was well defined. For example, biomarkers were commonly selected as primary efficacy endpoints in hematology drug approvals (70.6%), whereas clinical outcomes were commonly selected in neurology drug approvals (69.6%). Further, if the disease etiology was well defined, biomarkers were more commonly used as primary efficacy endpoints in pivotal trials (44.7%) than if the disease etiology was not well defined (27.3%). Discussion In the past 10 years, numerous novel drugs have been approved to treat non-oncologic rare diseases in various therapeutic areas. To demonstrate their efficacy for regulatory approval, biomarkers and clinical outcomes were commonly utilized as primary efficacy endpoints. Biomarkers were not only frequently used as surrogate efficacy endpoints in accelerated approvals, but also in traditionally approved rare disease drugs. The choice of primary efficacy endpoints varied by therapeutic area, approval pathway, and understanding of disease etiology.

Hong, Kyungwan [Rare Diseases Team, Office of New ↗

DOE OSTI2023

LANSCE Facility Longevity Assessment

This LANSCE Facility Longevity Assessment examined 34 total systems critical to the operation of the LANSCE accelerator complex. These systems are primarily owned, operated, and maintained by AOT Division. Based on the criteria used in this assessment, there are 12 AOT Division systems that are potential high risk as related to longterm LANSCE operations. These systems may also impact the success of LAMP. Also summarized in this report are the facility activities planned over the next decade. These include general facility maintenance and infrastructure upgrades, as well as planned electrical system upgrades. The LANSCE Facility Operations (LFO) Division is responsible for this activity scope and budget planning. Most of the planned activities are general in nature and should have little impact on accelerator operations or LAMP activities as currently envisioned. However, close coordination with between AOT, LFO, and LAMP would be prudent. A next step should be to develop an actionable plan to address the high-risk systems. Potential criteria for developing such a plan could include: (1) Evaluating the global impact of the system (operations, program, safety, etc.), (2) Ranking by impact (ranked now by risk), (3) Estimating cost to implement the corrective actions (Is there already a plan or not?), and (4) Estimating the time required for corrective actions. An alternative could include integration of the assessment data into both the Asset Management System and the Maintenance Analytics Risk Register.

43 PARTICLE ACCELERATORS↗

DOE OSTI2022

The Feasibility and the Benefits of the Advanced Nuclear Fuel Pellet Designs with Radially Varying Fuel Zoning and Burnable Poison Concentration (Final Summary Report)

As part of the work supported by the US Department of Energy (DOE) Office of Nuclear Energy (NE) Gateway for Accelerated Innovation in Nuclear (GAIN) FY 2021 Voucher, Exelon Generation, now Constellation, and Oak Ridge National Laboratory (ORNL) entered into a cooperative research and development agreement (CRADA) to evaluate and assess the feasibility and impact of various conceptual advanced nuclear fuel pellet designs (ANFPDs). The objective of this project was to perform modeling and simulation and analyses using the advanced modeling and simulation capabilities of VERA/BISON, developed by DOE, to determine the viability and benefits of numerous advanced nuclear fuel pellet design concepts in terms of fuel cycle costs, operational safety, and margin improvement. Whereas the detailed coupled neutronic and thermal hydraulic analyses performed using VERA provided in-depth knowledge in terms of fuel cycle performance, the detailed VERA results were used in subsequent fuel performance analyses using BISON. These subsequent analyses focused on several key fuel performance criteria, such as peak fuel centerline temperature (FCT), fission gas release (FGR), gap closure, plenum pressure, and cladding hoop stress. These key fuel performance criteria were analyzed for some of the conceptual fuel designs and were compared with the results obtained for UO 2 fuel. The results provided detailed information to enable better understanding of the performance of the fuel types analyzed. Understanding the advantage of loading these conceptual fuel designs into the core is important not only to Constellation but also to the entire light-water reactor (LWR) fleet in the United States.

11 NUCLEAR FUEL CYCLE AND FUEL MATERIALS↗

DOE OSTI2023

Performance Comparison of Helium and sCO 2 as Coolants for Modular Finger-Type Divertors

Several studies at the Georgia Institute of Technology have evaluated the thermal and fluids performance of the helium-cooled modular divertor with multiple jets (HEMJ) over the past decade. This finger-type divertor was studied both experimentally at nearly prototypical conditions and numerically at fully prototypical operating conditions using experimentally validated simulations. Recently, supercritical carbon dioxide (sCO 2 ) has been studied as the primary coolant in power cycles and other applications in various systems, in part because CO 2 achieves the high densities typical of supercritical fluids at relatively low temperatures and pressures, with a critical point of (7.38 MPa, 31°C). This density makes it possible to realize very compact and efficient sCO 2 power cycles. The feasibility of sCO 2 as a coolant for plasma-facing components, specifically the divertor, was therefore evaluated as part of the Fusion Energy System Studies design study activities. This work compares the thermal-fluid performance of helium and sCO 2 in the HEMJ divertor geometry using numerical simulations at prototypical conditions: inlet temperatures T i = 600°C to 700°C, pressures p ≈ 10 MPa, and steady-state incident heat fluxes on the tile q″ < 17 MW/m 2 . The performance is quantified here as the maximum heat flux that can be accommodated by the plasma-facing tile, the pumping power fraction, defined as the ratio of the coolant pumping power to the incident thermal power, and the operating stress limits based on ASME pressure vessel criteria. As expected, helium requires lower mass flow rates and pumping power fractions within imposed maximum temperature limits for the HEMJ pressure boundary. However, it also appears that neither helium nor sCO 2 can remove 10 MW/m 2 of incident heat flux while meeting ASME pressure vessel criteria. Finally, the numerical modeling reveals that sCO 2 may remove slightly higher incident heat fluxes than helium due to the imposed stress limits due to the sCO 2 coolant resulting in smaller local temperature gradients, albeit at a considerably higher pumping power fraction.

70 PLASMA PHYSICS AND FUSION TECHNOLOGY↗

DOE OSTI2023

Performance Assessment for the Environmental Restoration Disposal Facility (Annual Status Report FY 2022)

DOE O 435.1 and DOE M 435.1-1 require that a determination of continued adequacy of the performance assessment (PA) (CP-60089), composite analysis (CA), and disposal authorization statement (DAS) be made on an annual basis, and that the determination must consider the results of data collection and analysis from research, field studies, and monitoring as well as the need to update any Radioactive Waste Management Basis (RWMB) documents. Beginning in 1996, the Environmental Restoration Disposal Facility (ERDF) started accepting low-level radioactive, hazardous, and mixed wastes that were generated during cleanup activities at the Hanford Site. ERDF is composed of a series of cells or disposal areas and can accommodate future design expansions as needed. Currently, there are eight cells and two supercells in ERDF. Each supercell is the equivalent of two cells. During this reporting period (fiscal year 2022, extending from October 1, 2021, through September 30, 2022), approximately 8.52E+04 metric tons (9.39E+04 U.S. tons) of waste was disposed at ERDF. From ERDF inception through September 30, 2022, approximately 17.0 million metric tons (18.7 million U.S. tons) of waste has been disposed at ERDF, which equates to consumption of approximately 89.1% of the currently constructed disposal volume. According to the design of ERDF, the facility has the ability to be expanded as needed. As a condition of the DAS, disposal operations within ERDF must be in accordance with the waste acceptance criteria (ERDF-00011) that provide specific radionuclide disposal limits, waste form restrictions, and descriptions of acceptable waste packages in compliance with the requirements of DOE M 435-1.1. The ERDF waste acceptance criteria stipulate that waste destined for disposal at ERDF be controlled based on source, physical form, and contaminant concentration and activity levels. There have been no changes to the physical configuration of ERDF or to the waste forms (source, physical form, etc.). No new unreviewed disposal question screenings or evaluations have been generated in this reporting period. Therefore, there are no noted impacts to the PA, CA, DAS, or RWMB resulting from the evaluations and screenings. Sum-of-fractions analysis shows that the disposed inventory meets both the concentration and inventory threshold requirements. A sum-of-fractions value is computed for ERDF sensitive radionuclides contributing to the groundwater pathways and the air pathway inventory limits. Computed values were 5.50E-04 and 3.30E-03, respectively. The disposed waste inventory remained well under the PA imposed limits, as shown in Table 4 and Table 5 in the main text of this report. Required monitoring was satisfactorily completed during the fiscal year reporting period. Compliance with performance objectives were met as each of the reported values were well below the established limit. Overall, there are no substantive changes to primary PA assumptions or changes to the PA analysis conclusion; therefore, compliance with DOE O 435.1 and the DAS is maintained.

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

DOE OSTI2022

Performance Assessment for the Environmental Restoration Disposal Facility (Annual Status Report FY 2021)

DOE O 435.1 and DOE M 435.1-1 require that a determination of continued adequacy of the performance assessment (PA) (CP-60089), composite analysis (CA), and disposal authorization statement (DAS) be made on an annual basis, and that the determination must consider the results of data collection and analysis from research, field studies, and monitoring as well as the need to update any Radioactive Waste Management Basis (RWMB) documents. Beginning in 1996, the Environmental Disposal Facility (ERDF) started accepting low-level radioactive, hazardous, and mixed wastes that were generated during cleanup activities at the Hanford Site. ERDF is composed of a series of cells or disposal areas and can accommodate future design expansions as needed. Currently, there are eight cells and two supercells in ERDF. Each supercell is the equivalent of two cells. During this reporting period (fiscal year 2021, extending from October 1, 2020, through September 30, 2021), approximately 9.14E+04 metric tons (1.01E+05 U.S. tons) of waste was disposed at ERDF. From ERDF inception through September 30, 2021, approximately 16.9 million metric tons (18.9 U.S. tons) of waste has been disposed of at ERDF, which equates to consumption of approximately 88.7% of the currently constructed disposal volume. According to the design of ERDF, the facility has the ability to be expanded as needed. As a condition of the DAS, disposal operation within ERDF must be in accordance with the waste acceptance criteria (ERDF-00011) that provide specific radionuclide disposal limits, waste form restrictions, and descriptions of acceptable waste packages in compliance with the requirements of DOE M 435-1.1. The ERDF waste acceptance criteria stipulate that waste destined for disposal at ERDF be controlled based on source, physical form, and contaminant concentration and activity levels. There have been no changes to the physical configuration of ERDF or to the waste forms (source, physical form, etc.). No new unreviewed disposal question screenings or evaluations have been generated in this reporting period. Therefore, there are no noted impacts to the PA, CA, DAS, or RWMB resulting from the evaluations and screenings. Sum-of-fractions analysis shows that the disposed inventory meets both the concentration and inventory threshold requirements. A sum-of-fractions value is computed for ERDF sensitive radionuclides contributing to the all pathways and the air pathway inventory limits. Computed values were 7.63E-03 and 1.49E-03, respectively. The disposed waste inventory remained well under the PA imposed limits, as shown in Table 4 and Table 5 in the main text of this report. Required monitoring was satisfactorily completed during the fiscal year reporting period. Compliance with performance objectives were met as each of the reported values were well below the established limit. Overall, there are no substantive changes to primary PA assumptions or changes to the PA analysis conclusion; therefore, compliance with DOE O 435.1 and the DAS is maintained.

12 MANAGEMENT OF RADIOACTIVE AND NON-RADIOACTIVE W↗

DOE OSTI2025

CLEAP Project: OR-SAGE Analysis for MT, UT, and CO States

The OR-SAGE tool is designed to use industry-accepted practices in screening sites and then employ the proper array of data sources through the considerable computational capabilities of GIS technology available at ORNL. The tool was developed to screen the potential for NPP siting on a national and regional basis. However, because of the tool granularity, it is often focused specifically on the immediate area around user sites of interest. If data center siting parameters can be added to OR-SAGE, the ability to evaluate data center siting on a localized scale will be beneficial.1 More than 60 data sets have been collected and processed by ORNL to develop exclusionary, avoidance, and suitability criteria for screening sites for a variety of power generation types, including nuclear power plants. Available site evaluation parameters include population density, slope, seismic activity, proximity to cooling-water sources, proximity to hazard facilities, avoidance of protected lands and floodplains, susceptibility to landslide hazards, and many others. All siting parameters should be considered as flags to inform siting decisions and should not be used to rule in or rule out any NPP site. Once data center siting parameters are identified, appropriate data sets will be collected and processed. The OR-SAGE process is very versatile. Essentially, OR-SAGE is a visual, relational database. The database partitions the contiguous United States, a total of 720 million hectares (~1.8 billion acres), into 100-m by 100-m (1 hectare or ~2.5 acre) cells. The database is tracking just under 700 million individual land cells. Successive suitability criterion is applied to each cell in the database. User-specified thresholds can be applied to each siting parameter data layer. In this manner, a variety of scenarios can be quickly and thoroughly evaluated. Data can be added and/or revised within OR-SAGE to address user interests. Siting security assessment capability is currently being added to OR-SAGE. Security is expected to be of concern at data centers whether it is collocated with a nuclear power generating technology or not. If data center is collocated with a nuclear power generating source, the security threat attractiveness level of both will likely increase. It will be of additional benefit if a potential data center site is also assessed for security vulnerability.

97 MATHEMATICS AND COMPUTING↗

DOE OSTI2020

Evaluation of ASCE 4-16 and AISC 43-18 (Draft) for use in the Risk-Informed Performance-Based Seismic Design of Nuclear Power Plant Structures, Systems, and Components

This report describes the assessment of ASCE Standards 4-16 and 43-18 (Draft) for use in the Risk-Informed Performance-Based (RIPB) seismic design of structures, systems, and components (SSCs) at nuclear power plants. This work was performed for the U.S. Nuclear Regulatory Commission (NRC) Office of Regulatory Research (RES), to support potential endorsement of these industry standards for the design of nuclear power plants based on the RIPB approach. Currently, the NRC endorses a deterministic design approach for demonstrating the design adequacy of SSCs based on the Standard Review Plan (NUREG-0800) and NRC Regulatory Guides. In the RIPB approach, the design criteria are developed to achieve a target performance goal, which is defined by the annual frequency of occurrence of the design basis earthquake (i.e., Seismic Design Category) and the acceptable level of structural performance (i.e., Limit State) for the SSCs. ASCE 4-16 provides methods for performing a seismic analysis of structures to obtain the seismic response of these structures (e.g., building displacements, accelerations, in-structure response spectra) which are used in the design of the SSCs. It also provides methods for performing seismic analysis of SSCs to determine the seismic demands (e.g. member forces and displacements) needed to design individual SSCs. ASCE 43-18 (Draft) provides the criteria for the seismic design of SSCs using the seismic demands developed in ASCE 4-16. The use of ASCE Standard 43-18 (Draft), along with ASCE 4-16, provides the criteria for the seismic design of the SSCs. ASCE 43-18 (DRAFT) relies on other consensus codes and standards such as ACI 349 for reinforced concrete, AISC/N690 for steel structures, ASME Section III for pressure-retaining mechanical components and Containments, and IEEE-344 for Class 1E equipment. The goal of this technical review was to assess the adequacy of the provisions in these standards for use by the NRC in developing regulatory guidance for design of SSCs in nuclear power plants, based on the RIPB approach. The research reported herein describes the basis for acceptance of the new standards and identifies areas where additional staff guidance is needed for the seismic design of SSCs at nuclear power plants. This technical review has determined that ASCE 4-16 and ASCE 43-18 (Draft) provide an appropriate framework for the seismic design of SSCs at nuclear power plants using a Risk-Informed Performance-Based approach. However, some of the criteria therein warrant exceptions, qualifications, and/or clarifications.

42 ENGINEERING↗

DOE OSTI2024

Reduction of Methane Leaks through Corrosion Mitigation Pre-treatments for Pipelines with Field Applied Coatings

Corrosion of buried, coated steel pipelines transporting natural gas is a significant source of methane emissions, from pipeline venting required for maintenance and repairs and from pipeline leaks and incidents. Corrosion of steel under field applied coatings is an important safety concern for the pipeline industry. This project investigates the application of a field applied alloy over girth welds to mitigate external corrosion of buried coated steel pipelines. Various metallic coating options were considered, which were required to meet several criteria: (1) it must resist corrosion under open-circuit or mild cathodic protection conditions, (2) it must protect the substrate steel, and (3) it must not negatively affect the adhesion of the field coating. Finite element models and lab testing were performed of alloy coating compositions to identify promising alloy types underneath disbonded coatings. Polarization curves of coating alloys were generated to provide the boundary conditions for the COMSOL model to compute potential and current distributions around coated areas. Sacrificial and corrosion-resistant metal alloy coatings were evaluated and optimized using corrosion modeling and laboratory electrochemical testing, where aluminum alloy 5356 (5% Mg) and steel alloy B9 (9% Cr) were selected. Corrosion test coupons were designed and fabricated using thermal spray aluminum 5356 and welded B9 steel overlays on API 5L grade X42 line pipe steel. The corrosion test coupons, with simulated pipe coating damage, were tested in a laboratory soil box and a field pipeline site in Texas for 3-months. Corrosion test coupons were then tested for 6-months at field pipeline sites in Texas and Tennessee to quantify corrosion rates and performance of the aluminum and steel alloys under polyethylene tape and 2-part epoxy coatings, various coating holidays, and with and without cathodic protection.

03 NATURAL GAS↗

DOE OSTI2025

Including frameworks of public health ethics in computational modelling of infectious disease interventions

Decisions on public health interventions to control infectious diseases are often informed by computational models. Interpreting the predicted outcomes of a public health decision requires not only high-quality modelling but also an ethical framework for assessing the benefits and harms associated with different options. The design and specification of ethical frameworks matured independently of computational modelling, so many values recognized as important for ethical decision-making are missing from computational models. We demonstrate a proof-of-concept approach to incorporate multiple public health values into the evaluation of a simple computational model for vaccination against a pathogen such as SARS-CoV-2. By examining a bounded space of alternative prioritizations of three values relevant to public health ethics (aggregate clinical burden, equity in clinical burden, equity in adverse effects from vaccination), we identify value trade-offs, where the outcomes of optimal strategies differ depending on the ethical framework. This work demonstrates an approach to incorporating diverse values into decision criteria used to evaluate outcomes of models of infectious disease interventions.

"Mathematical Biology"↗

DOE OSTI2020

Communication-Constrained Expansion Planning for Resilient Distribution Systems

Distributed generation and remotely controlled switches have emerged as important technologies to improve the resiliency of distribution grids against extreme weather-related disturbances. Therefore it becomes important to study how best to place them on the grid in order to meet a resiliency criteria, while minimizing costs and capturing their dependencies on the associated communication systems that sustain their distributed operations. This paper introduces the Optimal Resilient Design Problem for Distribution and Communication Systems (ORDPDC) to address this need. The ORDPDC is formulated as a two-stage stochastic mixed-integer program that captures the physical laws of distribution systems, the communication connectivity of the smart grid components, and a set of scenarios that specifies which components are affected by potential disasters. The paper proposes an exact branch-and-price algorithm for the ORDPDC that features a strong lower bound and a variety of acceleration schemes to address degeneracy. The ORDPDC model and branch-and-price algorithm were evaluated on a variety of test cases with varying disaster intensities and network topologies. The results demonstrate the significant impact of the network topologies on the expansion plans and costs, as well as the computational benefits of the proposed approach.

97 MATHEMATICS AND COMPUTING↗

DOE OSTI2025

Understanding the Quadrupole Mass Filter and Testing a High-Resolution QMS RGA for ITER

A common type of residual gas analyzer is the quadrupole mass spectrometer. One of the main components within this instrument is a mass filter known as the quadrupole. It is responsible for the selective throughput of the ionized gas particles - by ascending mass number - prior to ion impacts on the analyzer (or detector) surface from which the ion current signal is generated for processing. However, the quadrupole is not fully described in relation to the electric field characteristics and the function as an ion mass separator. This paper describes the basic origins of the electrical design, the intricate assembly criteria, and performance of the quadrupole within the spectrometer. A specialized quadrupole mass spectrometer is part of a configuration for a diagnostic gas analyzer system planned for ITER, a fusion research machine. It has a verified capability, essential as a diagnostic criterion for this reactor project, to successfully deconvolute the mass signals of Helium-4 and deuterium (reactor fuel exhaust gases, separated by only 0.026 atomic mass units), down to a relative three-percent concentration of the former gas. The associated preliminary testing, performed at the Oak Ridge National Laboratory, is also addressed. Finally, one of the key parameters used to express gas concentration, the relative sensitivity factor, will be explained, including an evaluation of dependency on other variables.

Marcus, Chris [ORNL] (ORCID:0000000190139636)↗

DOE OSTI2022

Techno‐economic, environmental, and social measurement of clean energy technology supply chains

Abstract In addition to the criteria of reliability and cost, clean energy technologies, such as wind, solar, and batteries, need to strive to a higher standard of environmental and societal benefit along their entire supply chain. This means additional performance metrics for these technologies should be considered, such as embodied energy, embodied carbon, recycled content and recyclability, environmental impact of material sourcing, impact on land and ecosystems, materials recovery at end of life, and production through quality nonexploitive jobs with community benefit. Many commercial and emerging energy technologies have not yet been explicitly evaluated based on these environmental and social performance metrics, which presents multiple opportunities for researchers and analysts. In this paper, we review the importance and current limitations of techno‐economic and life‐cycle assessment models for research design and manufacturing decisions. We explore emerging manufacturing modeling options that could improve environmental and social performance and how they could be used to help guide research. Even with the deployment of low‐carbon energy‐generation technologies, the future of a successful clean energy transition requires collaboration between researchers, advanced manufacturers, independent standards and tracking organizations, local communities, and national governments, to ensure the financial, environmental, and social sustainability of the entire supply and manufacturing process of energy technologies.

29 ENERGY PLANNING, POLICY, AND ECONOMY↗

DOE OSTI2023

A meta-evaluation of the quality of reporting and execution in ecological meta-analyses

Quantitatively summarizing results from a collection of primary studies with meta-analysis can help answer ecological questions and identify knowledge gaps. The accuracy of the answers depends on the quality of the meta-analysis. We reviewed the literature assessing the quality of ecological meta-analyses to evaluate current practices and highlight areas that need improvement. From each of the 18 review papers that evaluated the quality of meta-analyses, we calculated the percentage of meta-analyses that met criteria related to specific steps taken in the meta-analysis process (i.e., execution) and the clarity with which those steps were articulated (i.e., reporting). We also re-evaluated all the meta-analyses available from Pappalardo et al. to extract new information on ten additional criteria and to assess how the meta-analyses recognized and addressed non-independence. In general, we observed better performance for criteria related to reporting than for criteria related to execution; however, there was a wide variation among criteria and meta-analyses. Meta-analyses had low compliance with regard to correcting for phylogenetic non-independence, exploring temporal trends in effect sizes, and conducting a multifactorial analysis of moderators (i.e., explanatory variables). In addition, although most meta-analyses included multiple effect sizes per study, only 66% acknowledged some type of non-independence. The types of non-independence reported were most often related to the design of the original experiment (e.g., the use of a shared control) than to other sources (e.g., phylogeny). We suggest that providing specific training and encouraging authors to follow the PRISMA EcoEvo checklist recently developed by O’Dea et al. can improve the quality of ecological meta-analyses.

59 BASIC BIOLOGICAL SCIENCES↗

DOE OSTI2025

Computational Modeling of Water Infiltration From Ditches Into Roadway Embankments

Ditches are built along roadways to convey the stormwater runoff. They collect the runoff from the pavement and adjacent drainage areas. Water can move freely in a ditch away from the road surface, thus making it safer for the vehicular traffic. South Carolina DOT expressed interest in studying infiltration of water from ditches into roadway embankments. As part of the current design criteria, it is recommended that the road subgrades be 1.0 foot above the design event water surface elevation in the ditch. The distance between the water surface and bottom of the subbase is referred to as “freeboard”. The purpose of this requirement is to lower the risk of pavement damage by moving the flow away from the pavement, containing the captured flow, and conveying flow received from adjacent properties to outfalls. With changes in roadway design standards, larger shoulders and flatter cross-slopes have moved ditches further away from the pavement and the subbase. These changes could allow for a lower freeboard standard without reducing safety margins due to the increased lateral distance from the subbase to the ditch. The objective of this study is to evaluate whether the current SCDOT criterion requiring the roadway subgrade to be 1 ft above the design-event ditch water surface can be relaxed under selected geometric and soil conditions, particularly where larger shoulder widths and flatter side slopes increase horizontal separation between ditch water and pavement structure.

42 ENGINEERING↗

DOE OSTI2024

Performance evaluation of finned tube heat exchanger using curved wavy delta winglet vortex generators with circular perforations

Vortex generation is recognized as an effective passive approach to improve the heat transfer rate in fin and tube heat exchangers (FTHEs). The current study proposed innovative designs of curved wavy delta winglet vortex generators (CWDWVGs), both without and with circular perforations, to improve the heat transfer efficiency of FTHEs. There is potential to increase heat transfer performance further through various CWDWVG designs. Here, this study explores seven unique CWDWVG configurations, from 1-wave to 7-wave. A 3-D computational numerical model is utilized to evaluate the Thermo-hydraulic performance of FTHEs fitted with these different CWDWVG configurations across Reynolds numbers from 400 to 2000. This comparative analysis of the Thermo-hydraulic performance of FTHEs featuring four parallel circular tube layouts assesses configurations both with and without vortex generators (VGs) and various hole configurations. The evaluation of Thermo-hydraulic performance involves different parameters, including the London area goodness factor (LAGF), Colburn factor (j), friction factor (f), pressure drop (?P), and Nusselt number (Nu). Results demonstrate that the various CWDWVG configurations and the number of holes in them substantially affect the efficiency, as evaluated by the dimensionless Performance Evaluation Criteria (PEC). Notably, the 7-wave CWDWVGs surpassed other configurations, and integrating circular punched perforations further improved the thermal-hydraulic performance of FTHE. Specifically, the 7-wave CWDWVGs without holes demonstrated superior performance over other configurations, showing a significant increase in Nusselt number by 75.18% and 85.16% at Reynolds numbers of 2000 and 400, respectively, alongside an increase in pressure drop by 216.38% to 224.96%. Meanwhile, the 7-wave CWDWVGs with eight holes, in comparison to those without holes, exhibited a Nusselt number increase of 0.85%, a pressure drop decrease of 7.31%, and a reduction in the friction factor by 5.82%.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

DOE OSTI2024

Comparative Performance of Three Eye-Tracking Devices in Detection of Mild Traumatic Brain Injury in Acute Versus Chronic Subject Populations

ABSTRACT Introduction Presently, traumatic brain injury (TBI) triage in field settings relies on symptom-based screening tools such as the updated Military Acute Concussion Evaluation. Objective eye-tracking may provide an alternative means of neurotrauma screening due to sensitivity to neurotrauma brain-health changes. Previously, the US Army Medical Research and Development Command Non-Invasive NeuroAssessment Devices (NINAD) Integrated Product Team identified 3 commercially available eye-tracking devices (SyncThink EYE-SYNC, Oculogica EyeBOX, NeuroKinetics IPAS) as meeting criteria toward being operationally effective in the detection of TBI in service members. We compared these devices to assess their relative performance in the classification of mild traumatic brain injury (mTBI) subjects versus normal healthy controls. Materials and Methods Participants 18 to 45 years of age were assigned to Acute mTBI, Chronic mTBI, or Control group per study criteria. Each completed a TBI assessment protocol with all 3 devices counterbalanced across participants. Acute mTBI participants were tested within 72 hours following injury whereas time since last injury for the Chronic mTBI group ranged from months to years. Discriminant analysis was undertaken to determine device classification performance in separating TBI subjects from controls. Area Under the Curves (AUCs) were calculated and used to compare the accuracy of device performance. Device-related factors including data quality, the need to repeat tests, and technical issues experienced were aggregated for reporting. Results A total of 63 participants were recruited as Acute mTBI subjects, 34 as Chronic mTBI subjects, and 119 participants without history of TBI as controls. To maximize outcomes, poorer quality data were excluded from analysis using specific criteria where possible. Final analysis utilized 49 (43 male/6 female, mean [x̅] age = 24.3 years, SD [s] = 5.1) Acute mTBI subjects, and 34 (33 male/1 female, x̅ age = 38.8 years, s = 3.9) Chronic mTBI subjects were age- and gender-matched as closely as possible with Control subjects. AUCs obtained with 80% of total dataset ranged from 0.690 to 0.950 for the Acute Group and from 0.753 to 0.811 for the Chronic mTBI group. Validation with the remaining 20% of dataset produced AUCs ranging from 0.600 to 0.750 for Acute mTBI group and 0.490 to 0.571 for the Chronic mTBI group. Conclusions Potential eye-tracking detection of mTBI, per training model outcomes, ranged from acceptable to excellent for the Acute mTBI group; however, it was less consistent for the Chronic mTBI group. The self-imposed targeted performance (AUC of 0.850) appears achievable, but further device improvements and research are necessary. Discriminant analysis models differed for the Acute versus Chronic mTBI groups, suggesting performance differences in eye-tracking. Although eye-tracking demonstrated sensitivity in the Chronic group, a more rigorous and/or longitudinal study design is required to evaluate this observation. mTBI injuries were not controlled for this study, potentially reducing eye-tracking assessment sensitivity. Overall, these findings indicate that while eye-tracking remains a viable means of mTBI screening, device-specific variability in data quality, length of testing, and ease of use must be addressed to achieve NINAD objectives and DoD implementation.

General & Internal Medicine↗

DOE OSTI2025

Machine Learning-Driven Optimization of Building Enclosures for Moisture Durability and Thermal Performance

The design of moisture-durable building enclosures with low embodied carbon often involves an iterative process of selecting the materials for the specific exposure conditions to meet the performance requirements. While hygrothermal simulations are commonly used to evaluate moisture durability, they often require advanced expertise for proper implementation. Machine learning (ML) provides a promising alternative by streamlining the design process and minimizing the reliance on complex simulations. This study presents a machine learning-based approach for predicting moisture durability in residential wall assemblies. The ML model was trained to estimate the mold index and maximum moisture content of various layers under typical exposure conditions. The model achieved a high predictive accuracy, with a coefficient of determination (R²) exceeding 0.90 when compared to traditional hygrothermal simulations on materials that were not part of training the ML model. Building on these results, the ML model was developed into a practical tool for optimizing wall assembly designs. This tool allows users to automatically optimize material selections based on energy, moisture, and carbon performance criteria. By incorporating multi-objective optimization, the tool identifies configurations that minimize embodied carbon while maintaining moisture safety and code-compliant thermal performance. Additionally, it provides insights into how material choices influence assembly durability, energy efficiency, and carbon reduction. The tool will be implemented in the Building Science Advisor (BSA) to enhance its performance and provide more granularity on the results. This research highlights the potential for ML-driven tools to simplify the design of high-performance building enclosures, offering architects and engineers a faster, more efficient way to balance critical performance factors.

Salonvaara, Mikael [ORNL] (ORCID:0000000318991554)↗