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DOE OSTI2021

Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective

Pediatric patient-reported outcome (PRO) data can help inform the US Food and Drug Administration’s (FDA’s) benefit-risk assessment of cancer therapeutics by quantifying symptom and functional outcomes from the patient’s perspective. This study assessed use of PROs in commercial pediatric oncology trials submitted to the FDA for regulatory review. FDA databases were searched to identify pediatric oncology product applications approved between 1997 and 2020. Sponsor-submitted documents were reviewed to determine whether PRO data were collected, which instruments were used, and the quality of collected data (ie, sample size, completion rates, and use of fit-for-purpose instruments). The role of PROs in each trial (endpoint hierarchy) was also recorded in addition to whether any PRO endpoints were included in product labeling. We reviewed 17 pediatric oncology applications, 4 of which included PRO data: denosumab, tisagenlecleucel, larotrectinib, and selumetinib. In these 4 instances, PROs served as exploratory endpoints and were not incorporated in product labeling. Trials that collected PRO data were phase II or phase I/II single-arm studies with sample sizes of 28 to 88 patients. Symptomatic adverse events (AEs) were characterized using clinician-reported Common Terminology Criteria for Adverse Events (CTCAE) without additional patient self-report. PROs were infrequently used in pediatric cancer registration trials. When PROs were used, PRO data were limited by lack of a clear research objective and corresponding prospective statistical analysis plan. Contemporary PRO symptom libraries, such as the National Cancer Institute’s Pediatric PRO-CTCAE, may provide an opportunity to better evaluate the occurrence and impact of symptomatic AEs, from the patient’s perspective, in pediatric oncology trials.

Oncology↗

DOE OSTI2020

Development and validation of a 30-day mortality index based on pre-existing medical administrative data from 13,323 COVID-19 patients: The Veterans Health Administration COVID-19 (VACO) Index

Background Available COVID-19 mortality indices are limited to acute inpatient data. Using nationwide medical administrative data available prior to SARS-CoV-2 infection from the US Veterans Health Administration (VA), we developed the VA COVID-19 (VACO) 30-day mortality index and validated the index in two independent, prospective samples. Methods and findings We reviewed SARS-CoV-2 testing results within the VA between February 8 and August 18, 2020. The sample was split into a development cohort (test positive between March 2 and April 15, 2020), an early validation cohort (test positive between April 16 and May 18, 2020), and a late validation cohort (test positive between May 19 and July 19, 2020). Our logistic regression model in the development cohort considered demographics (age, sex, race/ethnicity), and pre-existing medical conditions and the Charlson Comorbidity Index (CCI) derived from ICD-10 diagnosis codes. Weights were fixed to create the VACO Index that was then validated by comparing area under receiver operating characteristic curves (AUC) in the early and late validation cohorts and among important validation cohort subgroups defined by sex, race/ethnicity, and geographic region. We also evaluated calibration curves and the range of predictions generated within age categories. 13,323 individuals tested positive for SARS-CoV-2 (median age: 63 years; 91% male; 42% non-Hispanic Black). We observed 480/3,681 (13%) deaths in development, 253/2,151 (12%) deaths in the early validation cohort, and 403/7,491 (5%) deaths in the late validation cohort. Age, multimorbidity described with CCI, and a history of myocardial infarction or peripheral vascular disease were independently associated with mortality–no other individual comorbid diagnosis provided additional information. The VACO Index discriminated mortality in development (AUC = 0.79, 95% CI: 0.77–0.81), and in early (AUC = 0.81 95% CI: 0.78–0.83) and late (AUC = 0.84, 95% CI: 0.78–0.86) validation. The VACO Index allows personalized estimates of 30-day mortality after COVID-19 infection. For example, among those aged 60–64 years, overall mortality was estimated at 9% (95% CI: 6–11%). The Index further discriminated risk in this age stratum from 4% (95% CI: 3–7%) to 21% (95% CI: 12–31%), depending on sex and comorbid disease. Conclusion Prior to infection, demographics and comorbid conditions can discriminate COVID-19 mortality risk overall and within age strata. The VACO Index reproducibly identified individuals at substantial risk of COVID-19 mortality who might consider continuing social distancing, despite relaxed state and local guidelines.

60 APPLIED LIFE SCIENCES↗

DOE OSTI2021

Universal Utility Data Exchange (UUDEX) – Security and Administration: Cybersecurity of Energy Delivery Systems (CEDS) Research and Development

A critical component of the Universal Utility Data Exchange (UUDEX) approach is the integrated security contained within its processing. This document describes how that security is designed and expected to be implemented by UUDEX Implementations (U-Implementations), including the UUDEX Server (U-Server) and UUDEX Clients (U-Clients). The UUDEX security hierarchy consists of three levels: 1. The UUDEX Instance (U-Instance) itself, which sits at the top of the hierarchy and contains the U-Server, the UUDEX Identity Authority (U-Identity Authority), and the UUDEX Administrator (U-Administrator) functions; 2. A group of one or more UUDEX Participants (U-Participants) that present “organizations” that participate in the U-Instance and contains the UUDEX Administrator Participant (U-U-Administrator Participant) function; 3. A group of one or more UUDEX Endpoints (U-Endpoints) that represent the individual UUDEX Publish Clients (U-Publish Client) responsible for supplying data to the U-Instance that is consumed by UUDEX Subscriber Clients (U-Subscriber Clients). U-Endpoints can be either autonomous devices that publish and subscribe data such as data exchange servers found in supervisory control and data acquisition and energy management systems, or they can be tied to users of applications that, for example, submit DOE OE-417 disturbance reports. U-Participants and U-Endpoints can be organized into UUDEX Groups (U-Groups). Any number of U-Participants or U-Endpoints can be members of a U-Group. A given U-Participant or U-Endpoint can be a member of multiple U-Groups, but a U-Group cannot contain other U-Groups. For example, a U-Group could be created to contain all U-Participant Transmission Operators within the purview of a Reliability Coordinator, and another U-Group could be created to contain all U-Participant Generator Operators within the purview of a Reliability Coordinator. U-Participants that are both Transmission Operators and Generator Operators would be members of both U-Groups. U-Participants, U-Endpoints, and U-Groups are used in the access control structures to provide access to individual UUDEX Subjects (U-Subjects). U-Groups are created by the U-Administrator and are managed by the U-Administrator or the designated U-Group Managers. U-Endpoints can be assigned UUDEX Roles (U-Roles) that can be used to further restrict access. U-Roles are assigned to individual U-Endpoints. For example, a U-Role of “Security Analyst” could be used to restrict which U-Endpoints can publish or subscribe security incident reports and vulnerability notifications, while a U-Role of “Transmission Planner” can be used to restrict which U-Endpoints can publish power system model updates. U-Role definitions are created by the U-Administrator, but the U-Roles are assigned to U-Endpoints by their respective UUDEX Participant Administrators (U-Participant Administrator). Because all information required to make security decisions is either included within the U-Endpoint’s X.509 digital certificate or stored in a datastore on the U-Server, all security decisions are performed and enforced within the U-Server. This reduces the complexity of the U-Client code and minimizes the chance for compromise of the integrity of the UUDEX security features.

97 MATHEMATICS AND COMPUTING↗

DOE OSTI2024

Trends in the administration of COVID-19 vaccines with other vaccines in the United States reported to V-safe during December 14, 2020—May 19, 2023

Introduction COVID-19 vaccines may be administered with other vaccines during the same healthcare visit. COVID-19 monovalent (Fall 2021) and bivalent (Fall 2022) vaccine recommendations coincided with annual seasonal influenza vaccination. Data describing the frequency of the co-administration of COVID-19 vaccines with other vaccines are limited. Methods We used V-safe, a voluntary smartphone-based U.S. safety surveillance system established by the CDC, to describe trends in the administration of COVID-19 vaccines with other vaccines reported to V-safe during December 14, 2020 – May 19, 2023. Results Of the 21 million COVID-19 vaccinations reported to V-safe, 2.2% (459,817) were administered with at least 1 other vaccine. Co-administration most frequently occurred during the first week of October 2023 (27,092; 44.1%). Most reports of co-administration included influenza vaccine (393,003; 85.5%). Co-administration was most frequently reported for registrants aged 6 months-6 years (4,872; 4.4%). Conclusion Reports of co-administration to V-safe peaked during October 2023, when influenza vaccination most often occurs, possibly reflecting increased opportunities for multiple vaccinations and greater acceptability of the co-administration of COVID-19 vaccine with other vaccines, especially influenza vaccine.

60 APPLIED LIFE SCIENCES↗

DOE OSTI2020

Development of a High Performance Computing Accounts Administration Web Application

INL's High Performance Computing (HPC) accounts administration tool is a web application that that allows an administrator to change user information, create an HPC account, create or modify an LDAP group or project, and modify the members in a group. An administrator can search for a user, obtain the relevant information about the user, and update their account information. To create or modify an LDAP group or project, the administrator can filter a list of groups or projects according to the name, owner, or administrator that created the project or group, choose a name accordingly, and specify the group or project owner.

97 MATHEMATICS AND COMPUTING↗

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 OSTI2022

The Chilling Effects of Administrative Burden on Efficiency Policy Uptake: Examining the Case of Federal ESAs

Utilizing policies and programs which incentivize energy efficiency or on-site renewables is difficult. The challenges and costs associated with researching these policies, interacting with their providers, and ensuring regulatory compliance can be collectively referred to as administrative burden. To better understand the impact of administrative burden on energy efficiency policies, we investigated the administrative burden associated with energy sales arrangements (ESA). ESAs are a contracting vehicle related to energy savings performance contracts where an energy services company designs and constructs a renewable energy system at a federal site, transferring ownership of those generating assets to the site after a 20-year term. We conducted a series of in-depth interviews with a variety of relevant ESA stakeholders, including federal project managers, subject matter experts, and energy service companies. We then augmented these interviews with a review of the relevant literature. This research indicated that the current level of administrative burden decreases the adoption of renewable energy through ESAs by the federal government by raising upfront costs, depressing project attempts due to complexity, and introducing delays and challenges in successfully implemented projects. This chilling effect is especially pronounced in new policy vehicles and with inexperienced implementers. Findings from the specific case of ESAs can be generalized to other types of energy policy including efficiency programs. Policy makers decrease the efficacy of initiatives through increased administrative burden, and these effects will be most pronounced in programs with novel design or targeted at unfamiliar audiences.

Newkirk, Alex↗

DOE OSTI2023

Finding of No Adverse Effect for the Façade Alteration of Building 23-117, Administration Building, Mercury, Area 23, Nevada National Security Site, Nye County, Nevada

The U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Field Office (NNSA/NFO) plans to update the façade of Building 23-117 in the town of Mercury (Nevada State Historic Preservation Office [SHPO] Resource No. B15256), which is on the Nevada National Security Site (NNSS) in Nye County, Nevada. The purpose of the undertaking is to incorporate Building 23-117 into the new Mercury campus in accordance with the master plan for the modernization of Mercury. The NNSA/NFO will implement this undertaking in accordance with the Programmatic Agreement between the National Nuclear Security Administration Nevada Field Office and the Nevada State Historic Preservation Officer Regarding Modernization and Operational Maintenance of the Nevada National Security Site, at Mercury in Nye County, Nevada, hereafter referred to as the Mercury PA. Building 23-117 was built in 1982 as the architect-engineer Administration Building1 for Holmes & Narver, a government contractor who helped design and engineer the town of Mercury and other areas on the NNSS from its inception until the termination of their contract in 1990. The building continued to be used by subsequent government contractors and is currently still in use by MSTS. The town of Mercury and the immediate surrounding area have been formally determined eligible for listing in the National Register of Historic Places (National Register, NRHP) as the Mercury Historic District (MHD, SHPO Resource No. D230) under Criteria A and C for its importance in supporting nuclear testing and scientific research from 1951 through 1992. Building 23-117 was identified as a contributing element to the MHD in a 2018 architectural survey of the district (Reno et al.) and recorded on a Nevada Architectural Resource Assessment (ARA) form (Reno et al. 2017). It is a historic property for the purposes of compliance with Section 106 of the National Historic Preservation Act (NHPA) and is subject to the stipulations of the Mercury PA. The NNSA/NFO requested that Desert Research Institute (DRI), cultural resource subject matter experts, analyze the effects of the proposed project on historic properties in the Area of Potential Effect (APE) and make a recommended finding for the undertaking in accordance with Section 106 of the NHPA and the Mercury PA. The purpose of this letter report is to submit documentation related to the mitigation of the façade alteration of Building 23-117 (Nevada State Historic Preservation Office [SHPO] Resource No. B15256) in the Mercury Historic District (MHD, SHPO Resource No. D230). This submission is intended to comply with the stipulations in the Programmatic Agreement between the National Nuclear Security Administration Nevada Field Office and the Nevada State Historic Preservation Officer Regarding Modernization and Operational Maintenance of the Nevada National Security Site at Mercury in Nye County, Nevada, hereafter referred to as the Mercury PA.

54 ENVIRONMENTAL SCIENCES↗

DOE OSTI2020

Developing Subgrantee Administrative Training for the Weatherization Assistance Program

During Fiscal Years (FY) 2019 and 2020, the National Renewable Energy Laboratory (NREL) developed a series of online trainings for the U.S. Department of Energy (DOE) Weatherization Assistance Program (WAP) to support Subgrantee administrative professionals. NREL and its subcontractor developed a series of online administrative trainings for WAP Subgrantees. In total, 29 administrative training courses were developed for WAP Subgrantees, focused on the following job roles: Weatherization Director, Fiscal Manage, Quality Assurance Manager. As of September 8, 2020, 2,840 users in nearly all WAP Grantee jurisdictions had registered with the learning management system and completed over 23,000 courses. This report provides a summary of the development process, rollout, and outreach to the WAP network, user response, and lessons learned.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

DOE OSTI2023

San Xavier District Solar Energy Project for Administration Building and Education Center

The San Xavier District of the Tohono O’odham Nation (District) developed grid-tied solar photovoltaic (PV) systems for two tribal buildings: the San Xavier District Administration Building and Education Center. For the Administration Building, an approximately 182-kilowatt (kW) solar PV system is projected to produce roughly 310,000 kilowatt-hours (kWh) per year and displace about 80% of the energy use of the building. For the Education Center, an approximately 73.5-kw system is projected to produce roughly 130,000 kWh per year and displace about 95% of the building’s energy use. The anticipated 25-year cost savings from the combined 255-kW systems are estimated to be approximately $1,750,000 and $820,000 for the Administration Building and the Education Center, respectively.

14 SOLAR ENERGY↗

DOE OSTI2021

Protective effects of intravitreal administration of mesenchymal stem cell-derived exosomes in an experimental model of optic nerve injury

Traumatic optic neuropathy results in the loss of retinal ganglion cells (RGCs), leading to unavoidable visual impairment. However, there is no effective therapy by far. Accumulated studies support the perception that mesenchymal stem cells (MSCs) secrete exosomes that serve as a protective paracrine factor. The study aimed to explore and evaluate the potential therapeutic effects of intravitreal transplantation of MSC-derived exosomes (MSC-exos) in an experimental model of optic nerve crush (ONC). Exosomes were isolated from rat MSCs and characterized by transmission electron microscope and western blotting. At the onset of ONC, a single intravitreal injection of exosomes or PBS was administered to the rats. At day 30, hematoxylin and eosin staining, immunohistochemistry, and βIII-tubulin staining were performed to evaluate the survival of RGCs. Moreover, TUNEL assay was used to examine the apoptosis of RGCs. Inflammation-relevant factors were identified via quantitative polymerase chain reaction. The expression levels of cell apoptosis-related molecules and key members of the PI3K/AKT signaling pathway were determined via western blot analysis. We found that MSC-exos exhibited typical characteristic morphologies (cup-shaped) and sizes (peak size of 93 nm). Furthermore, they exhibited substantial expression of the exosome markers CD63 and TSG101, but lacked the expression of the cellular marker GM130. Treatment with intravitreal MSC-exos notably promoted the survival of RGCs in ONC rats. The level of pro-inflammatory cytokines, including TNF-α, IL-1β, IL-6, IL-8, and MCP-1, were reduced, whereas those of the anti-inflammatory factor IL-10 were increased. Moreover, the apoptosis induced by ONC was decreased by the administration of MSC-exos via upregulation of the Bcl-2/Bax ratio and downregulation of caspase-3 activity. Furthermore, MSC-exos significantly stimulated AKT phosphorylation, whereas LY294002 restored the apoptosis-preventing effects of MSC-exos. The results of our results demonstrated that intravitreal administration of MSC-exos ameliorates ONC-induced injury in a rat model. These findings might aid in the development of effective exosome-based therapeutic strategies for the treatment of optic nerve degeneration.

60 APPLIED LIFE SCIENCES↗

DOE OSTI2020

Machine learning prediction of incidence of Alzheimer’s disease using large-scale administrative health data

Nationwide population-based cohort provides a new opportunity to build an automated risk prediction model based on individuals’ history of health and healthcare beyond existing risk prediction models. We tested the possibility of machine learning models to predict future incidence of Alzheimer’s disease (AD) using large-scale administrative health data. From the Korean National Health Insurance Service database between 2002 and 2010, we obtained de-identified health data in elders above 65 years (N = 40,736) containing 4,894 unique clinical features including ICD-10 codes, medication codes, laboratory values, history of personal and family illness and socio-demographics. To define incident AD we considered two operational definitions: “definite AD” with diagnostic codes and dementia medication (n = 614) and “probable AD” with only diagnosis (n = 2026). We trained and validated random forest, support vector machine and logistic regression to predict incident AD in 1, 2, 3, and 4 subsequent years. For predicting future incidence of AD in balanced samples (bootstrapping), the machine learning models showed reasonable performance in 1-year prediction with AUC of 0.775 and 0.759, based on “definite AD” and “probable AD” outcomes, respectively; in 2-year, 0.730 and 0.693; in 3-year, 0.677 and 0.644; in 4-year, 0.725 and 0.683. The results were similar when the entire (unbalanced) samples were used. Important clinical features selected in logistic regression included hemoglobin level, age and urine protein level. This study may shed a light on the utility of the data-driven machine learning model based on large-scale administrative health data in AD risk prediction, which may enable better selection of individuals at risk for AD in clinical trials or early detection in clinical settings.

97 MATHEMATICS AND COMPUTING↗

DOE OSTI2021

URINARY EXCRETION OF PLUTONIUM IN MAYAK WORKERS DURING AND AFTER CA-DTPA ADMINISTRATION

Chelation therapy is sometimes used after potential exposures to plutonium to increase urinary excretion of the radionuclide to improve the accuracy of bioassay measurements. The purpose of this report is to describe the enhancement of urinary excretion of plutonium during and after the administration of the trisodium salt of calcium diethylenetriaminepentaacetate (Ca-DTPA) daily for 3 d to a group of male and female plutonium workers from the Mayak Production Association in Ozyorsk, Russia. One-hundred and two cases (18 females and 84 males) were selected where urinary contents of plutonium, prior to chelation, exceeded the detection threshold. Daily urine collections were obtained during the 3 d of Ca-DTPA treatments. In addition, 58 of these cases had urine bioassays at 1–45 d after chelation. The daily enhancement over baseline values excretion of plutonium was found to be 50.4×/1.4 (geometric mean and geometric standard deviation); 58.9×/1.2; 72.9×/1.4 in the first, second and third days of Ca-DTPA administration. The mean enhancement for the 3-d period was 60.1×/1.7. The rate of plutonium excretion from 1 to 45 d after chelation decreased with a half-period of 3.9 d and the chelation enhancement factor (Кenh-i) is described by the function Кenh-i = (0.79 ± 0.24) + (42.9 ± 1.2) × e-(0.18 ± 0.01) × day.

Environmental Sciences & Ecology↗

DOE OSTI2021

Effect of dehydroepiandrosterone administration before in vitro fertilization on the live birth rate in poor ovarian responders according to the Bologna criteria: A randomised controlled trial

Abstract Objective To evaluate the effect of dehydroepiandrosterone (DHEA) pre‐treatment before in vitro fertilization and embryo transfer (IVF‐ET) on the live birth rate in infertile women with poor ovarian response (POR) defined according to the Bologna criteria. Design A randomized, double‐blind, placebo‐controlled trial. Setting Nine reproductive medical centers in China. Population A total of 821 participants with POR defined according to the Bologna criteria were enrolled in the study between April 2016 and December 2018. Methods Eligible participants were randomly assigned to receive either DHEA ( n = 410) or placebo ( n = 411) treatments for 4–12 weeks prior to IVF‐ET, in a 1:1 ratio. Main outcome measures Live birth rate after the first embryo transfer. Results Thirty‐six (8.8%) of 410 women in the DHEA group and 37 (9.0%) of 411 women in the placebo group had a live birth, with no significant difference observed between groups (relative risk, 0.98, 95% CI, 0.63–1.51; p = 0.911). There were no significant differences in the number of retrieved oocytes, and the rates of clinical pregnancy, pregnancy loss, and cumulative live births between the two groups. Conclusions DHEA administration prior to IVF‐ET had no beneficial effect on the live birth rate relative to placebo in women with POR defined according to the Bologna criteria. Tweetable Abstract No benefit was found in poor ovarian responders who received DHEA administration prior to IVF.

Wang, Ze↗

DOE OSTI2022

Effects of exogenous GnRH administration on lambing performance of oestrus‐synchronized Kazak ewes during the breeding season

Abstract The objective of this study was to investigate the effects of GnRH at insemination on lambing performance of Kazak ewes. Oestrus was synchronized in 774 adult Kazak ewes using an intravaginal sponge impregnated with flurogestone acetate. The sponge was left in the vagina for 12 days followed with an injection of 330 IU of eCG at sponge removal. Each ewe was inseminated twice at 48 h and 60 h after sponge removal. The treatment group ( n = 387) was intramuscularly injected at the first insemination with a dose of 25 μg GnRH and the control group ( n = 387) with saline solution. The results showed that GnRH administration significantly decreased the fertility rate. In addition, significant differences were observed between the two groups in terms of the twin birth rate, the abortion rate and the litter size. In conclusion, GnRH administration at insemination was not recommended in Kazak ewes undergoing the fixed time artificial insemination during the breeding season. The breed may be a critical determinant of the potential for the exploitation of GnRH application in sheep breeding programmes.

Zhang, Jing↗

DOE OSTI2023

Characteristics of Veterans With Depression Who Use the Veterans Choice Program of the Veterans Health Administration

Objective: The Veterans Choice Program (VCP) of the Veterans Health Administration (VHA) allowed eligible veterans to use their benefits with participating providers outside the VHA. The authors aimed to identify characteristics of veterans with depression who used or did not use mental health care through the VCP. Methods: In this cross-sectional study, the authors analyzed secondary data from the national VHA Corporate Data Warehouse. VHA administrative data were linked with VCP claims to examine characteristics of VCP-eligible veterans with depression. Further, the study sample included 595,943 unique veterans who were enrolled in the VHA before 2013, were eligible for the VCP in 2016, were alive in 2018, and had an assessed Patient Health Questionnaire–9 (PHQ-9) score or depressive disorder diagnosis documented in the VHA between 2016 and 2018. Results: Veterans who used the VCP had lower medical comorbidity scores and lived in less socioeconomically disadvantaged counties, compared with veterans who received only VHA care. VCP veterans were also more likely to have a PHQ-9 score assessment and to have higher mean depression scores. Mean counts of annual mental health visits per 1,000 veterans were markedly higher for direct VHA care than for care provided via the VCP. As a percentage of the total counts of visits per 1,000 veterans across the VCP and VHA, residential programs and outpatient procedures were the services that were most frequently delivered through the VCP. Conclusions: Between 2016 and 2018, the VCP was used primarily to augment mental health care provided by the VHA, rather than to fill a gap in care.

60 APPLIED LIFE SCIENCES↗

DOE OSTI2020

UTrain Manual for Training Administrators

This Institutional Training Administrative Procedure provides the business rules that must be followed when working in UTrain. As commercial off-the-shelf software with customizations, UTrain cannot address all the implementation business requirements, and thus, administrative business rules and processes were defined and documented. Many business rules were incorporated into the UTrain training materials. UTrain is the Laboratory’s official learning management system. UTrain is the system of record for all Laboratory training, qualification, certification, and worker authorization. All training at LANL must be documented in UTrain. The detailed steps of how to operate UTrain are contained in the UTrain courses and training manuals and in the UTrain job aids, not in this document.

96 KNOWLEDGE MANAGEMENT AND PRESERVATION↗

DOE OSTI2022

Evaluation of Building 23-117, Administration Building, Nevada National Security Site, Nye County, Nevada

The U.S. Department of Energy (DOE) National Nuclear Security Administration Nevada Field Office (NNSA/NFO) plans to update the façade of Building 23-117, Administration Building (Nevada State Historic Preservation Office [SHPO] Resource No. B15256), at the Nevada National Security Site (NNSS) in Nye County, Nevada. The NNSA/NFO is implementing a long-term project to modernize the town of Mercury for future mission needs. The project is considered an undertaking subject to review under Title 54 of United States Code (USC) § 306108, commonly known as Section 106 of the National Historic Preservation Act, Title 54 USC § 300101, et seq., and its implementing regulations, Title 36 of the Code of Federal Regulations (36 CFR) Part 800.

54 ENVIRONMENTAL SCIENCES↗