Nurse-Supported Self-Directed Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial.

Importance: Cognitive behavioral therapy for insomnia (CBTi) is the standard of care for treating insomnia disorder, but access is limited. Alternative approaches are needed to expand access to the standard of care. Objective: To examine the effectiveness of a nurse-supported, self-directed behavioral insomnia intervention for decreasing insomnia severity and improving sleep outcomes among veterans, a population with considerable mental health comorbidity. Design, Setting, and Participants: This randomized clinical trial included 178 patients with insomnia disorder who were recruited from a Veterans Affairs hospital (Durham VA Healthcare System) from September 2019 to April 2022 and randomized following baseline assessment; follow-ups were conducted at 8 weeks (primary end point) and 6 months. Data analysis was primarily conducted during the summer of 2023 and concluded in May 2024. Intervention: Six weekly phone calls from a nurse interventionist plus assigned treatment manual readings covering CBTi treatment components. The health education manual focused on health topics but not sleep. Main Outcomes and Measures: The primary outcome was the Insomnia Severity Index (score range, 0-28; remission <8; differential improvement of 3 points targeted) score assessed at 8 weeks postrandomization. Secondary outcomes were sleep outcomes, depression, fatigue, treatment response, and remission. Results: Of 178 study participants, the mean (SD) age was 55.1 (13.2) years, and 128 (71.9%) identified as men. At 8 weeks, Insomnia Severity Index scores decreased by an estimated mean (SE) of 5.7 (0.51) points in the intervention group and 2.0 (0.47) points in the control group, a differential mean improvement of 3.7 points (95% CI, -5.0 to -2.4; P < .001). Differences were sustained at 6 months (mean, -2.8; 95% CI, -4.4 to -1.3; P < .001). The intervention also resulted in greater improvements at 8 weeks postrandomization in diary sleep onset latency, wake after sleep onset, and sleep efficiency and actigraphy sleep efficiency; these differences were sustained at 6 months. At 8 weeks, depression and fatigue were significantly reduced, and the odds of treatment response and remission were greater in the intervention group compared with controls. Conclusions and Relevance: This randomized clinical trial found that despite greater prevalence of mental health conditions and sleep difficulties among veterans, a nurse-supported self-directed CBTi was more effective than health education control for reducing insomnia severity and improving sleep outcomes. Although less effective than therapist-delivered CBTi, findings were comparable with other trials using modified CBTi protocols. Trial Registration: ClinicalTrials.gov Identifier: NCT03727438.

Improving Cancer Care for Women Seeking Services in the Veterans Health Administration Through the Breast and Gynecological Oncology System of Excellence.

Women are the fastest growing population among Veterans and have substantial risk factors that increase their likelihood for developing cancer. To ensure that the Department of Veterans Affairs Veterans Health Administration (VHA) offers the best possible cancer care to women Veterans, it established the Breast and Gynecologic Oncology System of Excellence (BGSoE) in 2021. The BGSoE offers telehealth oncology services and a comprehensive cancer navigation program. Veterans are identified through physician referral or through the BGSoE dashboard which integrates ICD-10 codes and text mining from VA electronic health records to identify eligible Veterans with breast or gynecological cancers. Descriptive statistics, including Veteran demographics and geographical location, were derived from BGSoE dashboard data. From January 1, 2021 to March 15, 2024, the BGSoE identified a total of 7,187 incident cases of breast or gynecological cancer among living Veterans. Most cancers were breast (78%) versus gynecological cancers (22%) and 10% of Veterans with breast cancer were identified as male. The average age at diagnosis was 59 for Veterans with breast cancer and 56 for those Veterans with gynecological cancers. Among Veterans in the BGSoE, 28% identified as Black and 6% identified as Hispanic. As the prevalence of women Veterans requiring cancer-related care continues to rise, it will be essential for VHA to evaluate the equitable reach, quality, and acceptability of women-focused cancer health services. The BGSoE focuses on providing high-quality and coordinated clinical cancer care. Veterans Health Administration also established the Center for Oncology Outcomes Review and Gender (COURAGE) to evaluate the BGSoE and continue to strengthen cancer care services in VHA. Initial evaluation objectives include establishing an evidence base regarding Veterans with breast and gynecological cancers, including their experiences with cancer care in the VHA. Eventually, COURAGE will provide ongoing monitoring and evaluation to continue to grow and improve cancer care in the VHA.

Feasibility of a family-involved intervention to increase engagement in evidenced-based psychotherapies for posttraumatic stress disorder: A pilot study.

OBJECTIVE: To assess the feasibility of a family-involved intervention, family support in mental health recovery (FAMILIAR), for veterans with posttraumatic stress disorder (PTSD) seeking psychotherapy at a single Veterans Administration Health System. METHOD: This mixed-methods study reports qualitative and quantitative findings from a single-group pilot of 24 veterans and their support partners (SPs) about experiences with the intervention and interviews with eight VA mental health clinicians and leaders and the study interventionist to explore intervention feasibility. Findings across data sources were merged within domains of Bowen and colleagues' pilot study feasibility framework. RESULTS: Out of 24 dyads, 16 veterans and 15 associated SPs completed the intervention. Participants viewed the intervention to be valuable and feasible. Veterans and SPs reported that they enrolled in the study to develop a shared understanding of PTSD and treatment. While participants identified few logistical barriers, finding a time for conjoint sessions could be a challenge. Veterans, SPs, and providers discussed benefits of the intervention, including that it facilitated conversation between the veteran and SP about PTSD and mental health care and helped to prepare the dyad for treatment. Providers noted potential challenges integrating family-involved interventions into clinical workflow in VA and suggested the need for additional training and standardized procedures for family-centered care. CONCLUSIONS: Our study identified potential implementation facilitators (e.g., standard operating procedures about session documentation, confidentiality, and family ethics) and challenges (e.g., clinical workflow integration) that require further study to bring FAMILIAR into routine clinical care. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Postpartum Treatment for Chronic Hepatitis C Virus Among People With Opioid Use Disorder: A Prospective Pilot Clinical Trial.

OBJECTIVE: The objective of this study was to evaluate the feasibility and acceptability of postpartum hepatitis C virus (HCV) treatment integrated within a substance use treatment program for pregnant and postpartum people with opioid use disorder (OUD). METHODS: We conducted a prospective pilot clinical trial of sofosbuvir/velpatasvir (SOF/VEL) treatment among postpartum people with OUD and HCV. Feasibility outcomes included rates of HCV treatment utilization and completion, medication adherence, and sustained virologic response 12 weeks after treatment completion (SVR12). Acceptability was measured through self-reported adverse effects and medication adherence. RESULTS: From January 2018 to August 2021, 164 pregnant people received care for OUD at the study site. Among those, 64 (39.0%) were HCV antibody positive and 45 (27.4%) had active HCV infection. Among 45 eligible patients, 32 (71.1%) enrolled and 21 (46.7%) initiated HCV treatment. Of 21 participants who initiated treatment, 16 (76.2%) completed the SOF/VEL treatment, and 11 (52.4%) completed the SVR12. All participants who completed treatment were cured. Common reasons for dropout during the HCV clinical care cascade were OUD treatment discontinuation, illicit substance use recurrence, and lost to follow-up. Participants reported high satisfaction with HCV treatment, including minimal adverse effects, and no HCV treatment concerns. CONCLUSIONS: Nearly half of pregnant people with HCV initiated postpartum treatment within an integrated care model of HCV treatment within a substance use treatment program. Postpartum SOF/VEL was efficacious, tolerable, and acceptable. Despite this, postpartum HCV treatment among people with OUD remains challenging, and many barriers remain.

Rolling out PRIDE in All Who Served: Barriers and Facilitators for Sites Implementing an LGBTQ+ Health Education Group for Military Veterans.

BACKGROUND/OBJECTIVE: The Veterans Health Administration (VHA) PRIDE in All Who Served health education group (PRIDE) was developed to improve health equity and access to care for military veterans who are lesbian, gay, bisexual, transgender, queer, and/or other sexual/gender-diverse identities (LGBTQ+). This 10-week program rapidly spread to over 30 VHA facilities in 4 years. Veterans receiving PRIDE experience improved LGBTQ+ identity-related resilience and reductions in suicide attempt likelihood. Despite PRIDE's rapid spread across facilities, information is lacking on implementation determinants. The current study's goal was to clarify determinants of PRIDE group implementation and sustainment. METHODS: A purposive sample of VHA staff (N = 19) with experience delivering or implementing PRIDE completed teleconference interviews January-April 2021. The interview guide was informed by the Consolidated Framework for Implementation Research. Rapid qualitative matrix analysis was completed with methods to ensure rigor (e.g., triangulation and investigator reflexivity). RESULTS: Key barriers and facilitators of PRIDE implementation were heavily related to facility inner setting (what is happening inside the facility), including implementation readiness (e.g., leadership support for LGBTQ+-affirming programming, access to LGBTQ+-affirming care training) and facility culture (e.g., systemic anti-LGBTQ+ stigma). Several implementation process facilitators enhanced engagement at sites, such as a centrally facilitated PRIDE learning collaborative and a formal process of contracting/training for new PRIDE sites. DISCUSSION/CONCLUSION: Although aspects of the outer setting and larger societal influences were mentioned, the majority of factors impacting implementation success were at the VHA facility level and therefore may be more readily addressable through tailored implementation support. The importance of LGBTQ+ equity at the facility level indicates that implementation facilitation should ideally address institutional equity in addition to implementation logistics. Combining effective interventions with attention to local implementation needs will be required before LGBTQ+ veterans in all areas will benefit from PRIDE and other health equity-focused interventions.

Exploring the importance of predisposing, enabling, and need factors for promoting Veteran engagement in mental health therapy for post-traumatic stress: a multiple methods study.

PURPOSE: This study explored Veteran and family member perspectives on factors that drive post-traumatic stress disorder (PTSD) therapy engagement within constructs of the Andersen model of behavioral health service utilization. Despite efforts by the Department of Veterans Affairs (VA) to increase mental health care access, the proportion of Veterans with PTSD who engage in PTSD therapy remains low. Support for therapy from family members and friends could improve Veteran therapy use. METHODS: We applied a multiple methods approach using data from VA administrative data and semi-structured individual interviews with Veterans and their support partners who applied to the VA Caregiver Support Program. We integrated findings from a machine learning analysis of quantitative data with findings from a qualitative analysis of the semi-structured interviews. RESULTS: In quantitative models, Veteran medical need for health care use most influenced treatment initiation and retention. However, qualitative data suggested mental health symptoms combined with positive Veteran and support partner treatment attitudes motivated treatment engagement. Veterans indicated their motivation to seek treatment increased when family members perceived treatment to be of high value. Veterans who experienced poor continuity of VA care, group, and virtual treatment modalities expressed less care satisfaction. Prior marital therapy use emerged as a potentially new facilitator of PTSD treatment engagement that warrants more exploration. CONCLUSIONS: Our multiple methods findings represent Veteran and support partner perspectives and show that amid Veteran and organizational barriers to care, attitudes and support of family members and friends still matter. Family-oriented services and intervention could be a gateway to increase Veteran PTSD therapy engagement.

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.

BACKGROUND: Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. METHODS: In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. CONCLUSION: Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. GOV IDENTIFIER: NCT03727438.

Adapting a family-involved intervention to increase initiation and completion of evidenced-based psychotherapy for posttraumatic stress disorder.

Posttraumatic stress disorder (PTSD) is disabling condition among United States Veterans. Training programs for evidenced-based therapies have been rolled out nationally in the Veterans Health Administration (VHA), but provider adoption of these treatments is limited and rates of Veteran dropout are high. Increasing support for mental health therapy within the Veteran's social network would improve treatment engagement. We discuss the adaptation of Recovery-Oriented Decisions for Relatives' Support (REORDER)-a family-based intervention for individuals with serious mental illness- to create Family Support in Mental Health Recovery (FAMILIAR), an intervention that seeks to strengthen support partners' abilities to help Veterans engage in therapy. Our goal was to apply modifications to meet the needs of Veterans with PTSD and their support partners. We used input from Veterans, support partners, clinicians and VA system leaders to inform the modifications. Then, a multi-disciplinary intervention development team met to determine which modifications would be applied and how. We used the domains from the Framework for Adaptations and Modification (FRAME) to systematically track and describe modifications. Adaptations made to REORDER included changes in content, structure, and delivery format. The resulting intervention, FAMILIAR, was a 3-4 session intervention beginning prior to EBP initiation and continuing through sessions 3, 4 or 5 of the EBP. Sessions were designed for maximum flexibility and could be offered either in-person or virtually, and sessions involve interactions between the interventionist with the Veteran and support partner alone and together. We learned the importance of including diverse stakeholder perspectives to develop a comprehensive understanding of the needs of the target population and the health system. While feasibility and effectiveness testing is needed, we applied a proactive adaptation approach that we anticipate will make FAMILIAR successful in addressing patient, clinical, and system considerations of a family approach to increase Veteran engagement in PTSD treatment.

Characterization of Serum Samples With Discordant Results in 2 Herpes Simplex Virus Type 2 IgG Assays.

BACKGROUND: Our laboratory system tests sera for herpes simplex virus type 2 (HSV-2) IgG using the DiaSorin Liaison chemiluminescent immunoassay (CIA), with the option to confirm positive samples by a laboratory-developed HerpeSelect inhibition assay. As part of the confirmation process, the HerpeSelect HSV-2 IgG enzyme immunoassay (EIA) is performed. This study investigated the relationship between DiaSorin HSV-2 IgG CIA-positive indices and HerpeSelect HSV-2 IgG EIA results. METHODS: HerpeSelect HSV-2 IgG EIA results were compiled for a cohort of consecutive DiaSorin HSV-2 IgG CIA-positive (index ≥1.10) samples. To further characterize DiaSorin CIA-positive samples that were positive (concordant) or negative (discordant) by the HerpeSelect EIA, a separate composite reference study panel was constructed and also tested using the Biokit HSV-2 IgG assay and an HSV-2 IgG inhibition assay developed for the DiaSorin instrument. Samples were classified as DiaSorin HSV-2 IgG true positive or false positive based on a composite reference using HerpeSelect EIA, Biokit, and DiaSorin inhibition results. RESULTS: Of 2305 consecutive DiaSorin HSV-2 IgG CIA-positive samples, 411 (17.8%) were HerpeSelect HSV-2 IgG EIA negative; 343 of 411 (83%) had DiaSorin indices of 1.10 to 3.00. For the composite reference study panel (N = 120), 59 of 60 discordant samples were classified as DiaSorin HSV-2 IgG false positive based on the composite reference, whereas 58 of 60 concordant samples were classified as true positive. CONCLUSIONS: Nearly all DiaSorin HSV-2 IgG CIA-positive but HerpeSelect HSV-2 IgG EIA-negative sera are falsely positive in the DiaSorin CIA. Furthermore, most DiaSorin false-positive samples exhibit low-positive indices, suggesting that guidelines for confirmatory testing should include low-positive samples by CIA and EIA.

Transience of interference in an immunoassay measuring serum levels of beta-D-glucan.

Some sera tested for 1-3-beta-D-glucan to identify invasive fungal infections exhibit interference. To assess interference transience, we evaluated results for 426 patients with an interference sample followed by a later sample. Interference was transient for 73% of patients (later sample negative or positive); median time between samples was 8 days.

The association of alcohol use with all-cause and cardiovascular disease-related hospitalizations or death in older, high-risk Veterans.

BACKGROUND: The prevalence of alcohol misuse among older adults has grown dramatically in the past decade, yet little is known about the association of alcohol misuse with hospitalization and death in this patient population. METHODS: We examined the association between alcohol use (measured by a screening instrument in primary care) and rates of all-cause and cardiovascular disease (CVD)-related 6-month hospitalization or death via electronic health records (EHRs) in a nationally representative sample of older, high-risk Veterans. Models were adjusted for sociodemographic and clinical characteristics, including frailty and comorbid conditions. RESULTS: The all-cause hospitalization or death rate at 6 months was 14.9%, and the CVD-related hospitalization or death rate was 1.8%. In adjusted analyses, all-cause hospitalization or death was higher in older Veterans who were nondrinkers or harmful use drinkers compared to moderate use drinkers, but CVD-related hospitalization or death was similar in all categories of drinking. CONCLUSIONS: These findings suggest that the complex association between alcohol and all-cause acute healthcare utilization found in the broader population is similar in older, high-risk Veteran patients. These findings do not support an association between alcohol consumption and CVD-specific hospitalizations.

Subgroups of High-Risk Veterans Affairs Patients Based on Social Determinants of Health Predict Risk of Future Hospitalization.

OBJECTIVE: Population segmentation has been recognized as a foundational step to help tailor interventions. Prior studies have predominantly identified subgroups based on diagnoses. In this study, we identify clinically coherent subgroups using social determinants of health (SDH) measures collected from Veterans at high risk of hospitalization or death. STUDY DESIGN AND SETTING: SDH measures were obtained for 4684 Veterans at high risk of hospitalization through mail survey. Eleven self-report measures known to impact hospitalization and amenable to intervention were chosen a priori by the study team to identify subgroups through latent class analysis. Associations between subgroups and demographic and comorbidity characteristics were calculated through multinomial logistic regression. Odds of 180-day hospitalization were compared across subgroups through logistic regression. RESULTS: Five subgroups of high-risk patients emerged-those with: minimal SDH vulnerabilities (8% hospitalized), poor/fair health with few SDH vulnerabilities (12% hospitalized), social isolation (10% hospitalized), multiple SDH vulnerabilities (12% hospitalized), and multiple SDH vulnerabilities without food or medication insecurity (10% hospitalized). In logistic regression, the "multiple SDH vulnerabilities" subgroup had greater odds of 180-day hospitalization than did the "minimal SDH vulnerabilities" reference subgroup (odds ratio: 1.53, 95% confidence interval: 1.09-2.14). CONCLUSION: Self-reported SDH measures can identify meaningful subgroups that may be used to offer tailored interventions to reduce their risk of hospitalization and other adverse events.

Widespread reworking of Hadean-to-Eoarchean continents during Earth's thermal peak.

The nature and evolution of Earth's crust during the Hadean and Eoarchean is largely unknown owing to a paucity of material preserved from this period. However, clues may be found in the chemical composition of refractory minerals that initially grew in primordial material but were subsequently incorporated into younger rocks and sediment during lithospheric reworking. Here we report Hf isotopic data in 3.9 to 1.8 billion year old detrital zircon from modern stream sediment samples from West Greenland, which document successive reworking of felsic Hadean-to-Eoarchean crust during subsequent periods of magmatism. Combined with global zircon Hf data, we show a planetary shift towards, on average, more juvenile Hf values 3.2 to 3.0 billion years ago. This crustal rejuvenation was coincident with peak mantle potential temperatures that imply greater degrees of mantle melting and injection of hot mafic-ultramafic magmas into older Hadean-to-Eoarchean felsic crust at this time. Given the repeated recognition of felsic Hadean-to-Eoarchean diluted signatures, ancient crust appears to have acted as buoyant life-rafts with enhanced preservation-potential that facilitated later rapid crustal growth during the Meso-and-Neoarchean.

Sleep-disordered breathing in severe mental illness: clinical evaluation of oximetry diagnosis and management limitations.

BACKGROUND: To describe the diagnosis and management pathway of sleep-disordered breathing (SDB) in a sample of patients with severe mental illness (SMI), and to assess the feasibility and patient acceptability of overnight oximetry as a first-step screening method for detecting severe SDB in this population. METHODS: The study was a retrospective audit of patients with SMI seen at a Collaborative Centre for Cardiometabolic Health in Psychosis service who were invited for overnight oximetry between November 2015 and May 2018. The adjusted oxygen desaturation index (ODI) was calculated using 4% desaturation criteria. Results were discussed with a sleep specialist and categorized into a 4-level risk probability tool for SDB. RESULTS: Of 91 adults consenting for overnight oximetry, 90 collected some oximetry data, though 11 of these 90 patients collected technically unsatisfactory oximetry. Thus 79/90 patients (88%) collected adequate oximetry data for at least one night. The oximetry traces suggested likely minimal obstructive sleep apnea (OSA) in 41 cases, moderate to severe OSA in 25 patients, severe OSA in 9 patients and possible obesity hypoventilation syndrome (OHS) in 4 cases. Full polysomnography was recommended for 39 patients but only one-third underwent testing. Nineteen patients were reviewed by a sleep specialist. Of the 10 patients who initiated CPAP, four were considered adherent to treatment. CONCLUSION: Home oximetry may be a pragmatic option for SDB screening in patients with SMI but reliable full diagnostic and management pathways need to be developed.

Patient-Reported Social and Behavioral Determinants of Health and Estimated Risk of Hospitalization in High-Risk Veterans Affairs Patients.

Importance: Despite recognition of the association between individual social and behavioral determinants of health (SDH) and patient outcomes, little is known regarding the value of SDH in explaining variation in outcomes for high-risk patients. Objective: To describe SDH factors among veterans who are at high risk for hospitalization, and to determine whether adding patient-reported SDH measures to electronic health record (EHR) measures improves estimation of 90-day and 180-day all-cause hospital admission. Design, Setting, and Participants: A survey was mailed between April 16 and June 29, 2018, to a nationally representative sample of 10 000 Veterans Affairs (VA) patients whose 1-year risk of hospitalization or death was in the 75th percentile or higher based on a VA EHR-derived risk score. The survey included multiple SDH measures, such as resilience, social support, health literacy, smoking status, transportation barriers, and recent life stressors. Main Outcomes and Measures: The EHR-based characteristics of survey respondents and nonrespondents were compared using standardized differences. Estimation of 90-day and 180-day hospital admission risk was assessed for 3 logistic regression models: (1) a base model of all prespecified EHR-based covariates, (2) a restricted model of EHR-based covariates chosen via forward selection based on minimizing Akaike information criterion (AIC), and (3) a model of EHR- and survey-based covariates chosen via forward selection based on AIC minimization. Results: In total, 4685 individuals (response rate 46.9%) responded to the survey. Respondents were comparable to nonrespondents in most characteristics, but survey respondents were older (eg, >80 years old, 881 [18.8%] vs 800 [15.1%]), comprised a higher percentage of men (4391 [93.7%] vs 4794 [90.2%]), and were composed of more White non-Hispanic individuals (3366 [71.8%] vs 3259 [61.3%]). Based on AIC, the regression model with survey-based covariates and EHR-based covariates better estimated hospital admission at 90 days (AIC, 1947.7) and 180 days (AIC, 2951.9) than restricted models with only EHR-based covariates (AIC, 1980.2 at 90 days; AIC, 2981.9 at 180 days). This result was due to inclusion of self-reported measures such as marital or partner status, health-related locus of control, resilience, smoking status, health literacy, and medication insecurity. Conclusions and Relevance: Augmenting EHR data with patient-reported social information improved estimation of 90-day and 180-day hospitalization risk, highlighting specific SDH factors that might identify individuals who are at high risk for hospitalization.

Detection of SARS-CoV-2 IgG Targeting Nucleocapsid or Spike Protein by Four High-Throughput Immunoassays Authorized for Emergency Use.

A total of 1,200 serum samples that were tested for SARS-CoV-2 IgG antibody using the Abbott Architect immunoassay targeting the nucleocapsid protein were run in 3 SARS-CoV-2 IgG immunoassays targeting spike proteins (DiaSorin Liaison, Ortho Vitros, and Euroimmun). Consensus-positive and consensus-negative interpretations were defined as qualitative agreement in at least 3 of the 4 assays. Agreement of the 4 individual assays with a consensus-negative interpretation (n = 610) ranged from 96.7% to 100%, and agreement with a consensus-positive interpretation (n = 584) ranged from 94.3% to 100%. Laboratory-developed inhibition assays were utilized to evaluate 49 consensus-negative samples that were positive in only one assay; true-positive reactivity was confirmed in only 2 of these 49 (4%) samples. These findings demonstrate very high levels of agreement among 4 SARS-CoV-2 IgG assays authorized for emergency use, regardless of antigen target or assay format. Although false-positive reactivity was identified, its occurrence was rare (no more than 1.7% of samples for a given assay).

Evaluation of Transport Media and Specimen Transport Conditions for the Detection of SARS-CoV-2 by Use of Real-Time Reverse Transcription-PCR.

The global coronavirus (CoV) disease 2019 (COVID-19) pandemic has resulted in a worldwide shortage of viral transport media and raised questions about specimen stability. The objective of this study was to determine the stability of severe acute respiratory syndrome CoV 2 (SARS-CoV-2) RNA in specimen transport media under various storage conditions. Transport media tested included UTM, UTM-RT, ESwab, M4, and saline (0.9% NaCl). Specimen types tested included nasopharyngeal/oropharyngeal swabs in the above-named transport media, bronchoalveolar lavage (BAL) fluid, and sputum. A high-titer SARS-CoV-2 remnant patient specimen was spiked into pooled SARS-CoV-2 RNA-negative specimen remnants for the various medium types. Aliquots of samples were stored at 18°C to 26°C, 2°C to 8°C, and -10°C to -30°C and then tested at time points up to 14 days. Specimens consistently yielded amplifiable RNA with mean cycle threshold differences of <3 over the various conditions assayed, thus supporting the use and transport of alternative collection media and specimen types under a variety of temperature storage conditions.

Feasibility and acceptability of using a web-based contraceptive support tool in a university health clinic.

Objective: To evaluate feasibility of integrating Bedsider.org, a web-based contraceptive decision support tool, at a university health clinic (UHC). Participants: Female students (ages 18-29) seeking contraceptive care at the UHC were enrolled in September 2015 (n = 46). Methods: Providers recruited eligible patients during reproductive healthcare visits and introduced Bedsider. Surveys were administered immediately following the visit and a follow-up 2-4 weeks later. Electronic health records through 6 weeks post-enrollment were extracted. Results: Most patients had positive views toward Bedsider and appreciated receiving information during their UHC encounters. None were using long-acting reversible contraceptives (LARC) at enrollment. At follow-up, two patients self-reported IUD use. Among those recently sexually active, use of more effective contraceptive methods increased from 65% to 74%; 11% had initiated or were scheduled to receive a LARC. Conclusion: Bedsider can be feasibly integrated into UHC visits and may support women's selection of more effective contraceptive methods, including LARCs.

Association Between Bariatric Surgery and Long-term Health Care Expenditures Among Veterans With Severe Obesity.

Importance: Bariatric surgery has been associated with improvements in health in patients with severe obesity; however, it is unclear whether these health benefits translate into lower health care expenditures. Objective: To examine 10-year health care expenditures in a large, multisite retrospective cohort study of veterans with severe obesity who did and did not undergo bariatric surgery. Design, Setting, and Participants: A total of 9954 veterans with severe obesity between January 1, 2000, and September 30, 2011, were identified from veterans affairs (VA) electronic health records. Of those, 2498 veterans who underwent bariatric surgery were allocated to the surgery cohort. Sequential stratification was used to match each patient in the surgery cohort with up to 3 patients who had not undergone bariatric surgery but were of the same sex, race/ethnicity, diabetes status, and VA regional network and were closest in age, body mass index (calculated as weight in kilograms divided by height in meters squared), and comorbidities. A total of 7456 patients were identified and allocated to the nonsurgery (control) cohort. The VA health care expenditures among the surgery and nonsurgery cohorts were estimated using regression models. Data were analyzed from July to August 2018 and in April 2019. Interventions: The bariatric surgical procedures (n = 2498) included in this study were Roux-en-Y gastric bypass (1842 [73.7%]), sleeve gastrectomy (381 [15.3%]), adjustable gastric banding (249 [10.0%]), and other procedures (26 [1.0%]). Main Outcomes and Measures: The study measured total, outpatient, inpatient, and outpatient pharmacy expenditures from 3 years before surgery to 10 years after surgery, excluding expenditures associated with the initial bariatric surgical procedure. Results: Among 9954 veterans with severe obesity, 7387 (74.2%) were men; the mean (SD) age was 52.3 (8.8) years for the surgery cohort and 52.5 (8.7) years for the nonsurgery cohort. Mean total expenditures for the surgery cohort were $5093 (95% CI, $4811-$5391) at 7 to 12 months before surgery, which increased to $7448 (95% CI, $6989-$7936) at 6 months after surgery. Postsurgical expenditures decreased to $6692 (95% CI, $6197-$7226) at 5 years after surgery, followed by a gradual increase to $8495 (95% CI, $7609-$9484) at 10 years after surgery. Total expenditures were higher in the surgery cohort than in the nonsurgery cohort during the 3 years before surgery and in the first 2 years after surgery. The expenditures of the 2 cohorts converged 5 to 10 years after surgery. Outpatient pharmacy expenditures were significantly lower among the surgery cohort in all years of follow-up ($509 lower at 3 years before surgery and $461 lower at 7 to 12 months before surgery), but these cost reductions were offset by higher inpatient and outpatient (nonpharmacy) expenditures. Conclusions and Relevance: In this cohort study of 9954 predominantly older male veterans with severe obesity, total health care expenditures increased immediately after patients underwent bariatric surgery but converged with those of patients who had not undergone surgery at 10 years after surgery. This finding suggests that the value of bariatric surgery lies primarily in its associations with improvements in health and not in its potential to decrease health care costs.

Herpes simplex virus type 2 (HSV-2) IgG index values in two immunoassays in relation to HSV-2 IgG inhibition assay results.

CDC guidelines recommend confirmatory testing of sera with low-positive indices (1.10-3.50) in the HerpeSelect® (HSLT) HSV-2 IgG screening assay. To determine if this recommendation is adequate for our patient population, we reviewed HSLT HSV-2 IgG screening indices for 262 screen-positive sera (index >1.10) tested in our confirmatory assay, which assesses inhibition of binding to recombinant gG2 by HSV-1- and HSV-2-infected cell lysates. To determine how the recommendation affects other screening assays, we tested these samples in the Liaison® HSV-2 IgG assay. Of 124 false-positive sera, 20% and 39% had an index >3.50 in the HSLT and Liaison screening assays, respectively. In both assays, 51% of 63 indeterminate sera (inhibition by HSV-1 lysate) had indices >3.50. Similarly, ≥75% of 75 true-positive samples exhibited indices >3.50 in both assays. Thus, confirmatory testing only of sera with low-positive HSV-2 IgG indices misses some false-positive and indeterminate samples, leading to misdiagnosis of HSV-2 infection.