Multicenter Diagnostic Evaluation of OnSite COVID-19 Rapid Test (CTK Biotech) among Symptomatic Individuals in Brazil and the United Kingdom.

The COVID-19 pandemic has given rise to numerous commercially available antigen rapid diagnostic tests (Ag-RDTs). To generate and to share accurate and independent data with the global community requires multisite prospective diagnostic evaluations of Ag-RDTs. This report describes the clinical evaluation of the OnSite COVID-19 rapid test (CTK Biotech, CA, USA) in Brazil and the United Kingdom. A total of 496 paired nasopharyngeal (NP) swabs were collected from symptomatic health care workers at Hospital das Clínicas in São Paulo, Brazil, and 211 NP swabs were collected from symptomatic participants at a COVID-19 drive-through testing site in Liverpool, United Kingdom. Swabs were analyzed by Ag-RDT, and results were compared to quantitative reverse transcriptase PCR (RT-qPCR). The clinical sensitivity of the OnSite COVID-19 rapid test in Brazil was 90.3% (95% confidence interval [CI], 75.1 to 96.7%) and in the United Kingdom was 75.3% (95% CI, 64.6 to 83.6%). The clinical specificity in Brazil was 99.4% (95% CI, 98.1 to 99.8%) and in the United Kingdom was 95.5% (95% CI, 90.6 to 97.9%). Concurrently, analytical evaluation of the Ag-RDT was assessed using direct culture supernatant of SARS-CoV-2 strains from wild-type (WT), Alpha, Delta, Gamma, and Omicron lineages. This study provides comparative performance of an Ag-RDT across two different settings, geographical areas, and populations. Overall, the OnSite Ag-RDT demonstrated a lower clinical sensitivity than claimed by the manufacturer. The sensitivity and specificity from the Brazil study fulfilled the performance criteria determined by the World Health Organization, but the performance obtained from the UK study failed to do. Further evaluation of Ag-RDTs should include harmonized protocols between laboratories to facilitate comparison between settings. IMPORTANCE Evaluating rapid diagnostic tests in diverse populations is essential to improving diagnostic responses as it gives an indication of the accuracy in real-world scenarios. In the case of rapid diagnostic testing within this pandemic, lateral flow tests that meet the minimum requirements for sensitivity and specificity can play a key role in increasing testing capacity, allowing timely clinical management of those infected, and protecting health care systems. This is particularly valuable in settings where access to the test gold standard is often restricted.

Effect of 2018 American College of Cardiology/American Heart Association Guideline Change on Statin Prescription for People Living with HIV.

The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines were updated in 2018 to explicitly recommend statin use for primary cardiovascular disease prevention among people living with HIV (PLWH), but little is known about the effect of this guideline change. We aimed to assess the effect of the 2018 ACC/AHA guideline change on statin prescription among PLWH. We used data from an institutional HIV registry to identify PLWH aged 40-75 years, engaged in HIV care between June 2016 and May 2021, had a LDL cholesterol between 70 and 189 mg/dl, 10-year atherosclerotic cardiovascular disease (ASCVD) risk score ≥7.5%, no prior statin prescription, and no history of diabetes or ASCVD. Our outcome of interest was a new statin prescription within 12 months of eligibility. We estimated standardized risk difference (RD) with 95% confidence limits (CL) by comparing prescription probabilities before and after guideline change. Our study population comprised 251 PLWH (171 before, 80 after the guideline change), of whom 57% were aged <55 years, 82% were male, and 45% were non-Hispanic black. The standardized 12-month statin prescription risk was 43% (95% CL: 31%, 60%) after the guideline change and 19% (95% CL: 13%, 26%) before the guideline change (RD = 25%, 95% CL: 9.1%, 40%). Our results suggest that the 2018 ACC/AHA guideline change increased statin prescription among PLWH, but a sizable proportion of eligible PLWH were not prescribed statin. Future studies are needed to identify strategies to enhance implementation of statin prescription guidelines among PLWH.

Evaluation of eight lateral flow tests for the detection of anti-SARS-CoV-2 antibodies in a vaccinated population.

BACKGROUND: Rapid determination of an individual's antibody status can be beneficial in understanding an individual's immune response to SARS-CoV-2 and for initiation of therapies that are only deemed effective in sero-negative individuals. Antibody lateral flow tests (LFTs) have potential to address this need as a rapid, point of care test. METHODS: Here we present a proof-of-concept evaluation of eight LFT brands using sera from 95 vaccinated individuals to determine sensitivity for detecting vaccination generated antibodies. Samples were analysed on eight different brands of antibody LFT and an automated chemiluminescent microparticle immunoassay (CMIA) that identifies anti-spike antibodies which was used as our reference standard. RESULTS: All 95 (100%) participants tested positive for anti-spike antibodies by the chemiluminescent microparticle immunoassay (CMIA) reference standard post-dose two of their SARS-CoV-2 vaccine: BNT162b2 (Pfizer/BioNTech, n = 60), AZD1222 (AstraZeneca, n = 31), mRNA-1273 (Moderna, n = 2) and Undeclared Vaccine Brand (n = 2). Sensitivity increased from dose one to dose two in six out of eight LFTs with three tests achieving 100% sensitivity at dose two in detecting anti-spike antibodies. CONCLUSIONS: These tests are demonstrated to be highly sensitive to detect raised antibody levels in vaccinated individuals. RDTs are low cost and rapid alternatives to ELISA based systems.

Pain Catastrophizing and Functional Disability in Youth with Chronic Pain: An Examination of Indirect Effects.

Pediatric pain conditions are not uncommon and may lead to functional disability. The purpose of this study is to examine indirect effects of pain catastrophizing on functional disability through anxiety, depression, and pain in youth with chronic pain. Participants included 197 youth (144 females, Mage = 14.67 years) with chronic pain conditions. Youth completed self-report measures of pain catastrophizing, depression, anxiety, pain intensity, and functional disability. Caregivers also completed a measure of youth functional disability. Using a cross-sectional design, a multiple mediator model was estimated with pain catastrophizing as the predictor, functional disability as the outcome, and depression, anxiety, and pain intensity as mediators. Results supported a mediation model in which depression (B = 0.1145, SE = 0.0528, Z = 2.1686; B = 0.1512, SE = 0.0585, Z = 2.5846) and pain intensity (B = 0.1015, SE = 0.0422, Z = 2.4052; B = 0.0634, SE = 0.0343, Z = 1.8484) significantly mediated the effects of catastrophizing on child self-report and parent-report functional disability, respectively, while anxiety (B = - 0.0260, SE = 0.0439501, Z = - 0.5923; B = - 0.0637, SE = 0.0552, Z = - 1.1540) did not. Theoretical and clinical applications are discussed.

Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2.

In the context of the coronavirus disease 2019 (COVID-19) pandemic there has been an increase of the use of antigen-detection rapid diagnostic tests (Ag-RDT). The performance of Ag-RDT vary greatly between manufacturers and evaluating their analytical limit of detection (LOD) has become high priority. Here we describe a manufacturer-independent evaluation of the LOD of 19 marketed Ag-RDT using live SARS-CoV-2 spiked in different matrices: direct culture supernatant, a dry swab, and a swab in Amies. Additionally, the LOD using dry swab was investigated after 7 days' storage at - 80 °C of the SARS-CoV-2 serial dilutions. An LOD of ≈ 5.0 × 102 pfu/ml (1.0 × 106 genome copies/ml) in culture media is defined as acceptable by the World Health Organization. Fourteen of 19 Ag-RDTs (ActiveXpress, Espline, Excalibur, Innova, Joysbio, Mologic, NowCheck, Orient, PanBio, RespiStrip, Roche, Standard-F, Standard-Q and Sure-Status) exceeded this performance criteria using direct culture supernatant applied to the Ag-RDT. Six Ag-RDT were not compatible with Amies media and a decreased sensitivity of 2 to 20-fold was observed for eleven tests on the stored dilutions at - 80 °C for 7 days. Here, we provide analytical sensitivity data to guide appropriate test and sample type selection for use and for future Ag-RDT evaluations.

Psychedelics as a novel approach to treating autoimmune conditions.

With a rise in the incidence of autoimmune diseases (AiD), health care providers continue to seek out more efficacious treatment approaches for the AiD patient population. Classic serotonergic psychedelics have recently been gaining public and professional interest as novel interventions to a number of mental health afflictions. Psychedelics have also been shown to be able to modulate immune functions, however, while there has been great interest to researching into their psychotherapeutic applications, there has so far been very little exploration into the potential to treat inflammatory and immune-related diseases with these compounds. A handful of studies from a variety of fields suggest that psychedelics do indeed have effects in the body that may attenuate the outcome of AiD. This literature review explores existing evidence that psychedelic compounds may offer a potential novel application in the treatment of pathologies related to autoimmunity. We propose that psychedelics hold the potential to attenuate or even resolve autoimmunity by targeting psychosomatic origins, maladaptive chronic stress responses, inflammatory pathways, immune modulation and enteric microbiome populations.

Developing a practical suicide risk prediction model for targeting high-risk patients in the Veterans health Administration.

OBJECTIVES: The US Veterans Health Administration (VHA) has begun using predictive modeling to identify Veterans at high suicide risk to target care. Initial analyses are reported here. METHODS: A penalized logistic regression model was compared with an earlier proof-of-concept logistic model. Exploratory analyses then considered commonly-used machine learning algorithms. Analyses were based on electronic medical records for all 6,360 individuals classified in the National Death Index as having died by suicide in fiscal years 2009-2011 who used VHA services the year of their death or prior year and a 1% probability sample of time-matched VHA service users alive at the index date (n = 2,112,008). RESULTS: A penalized logistic model with 61 predictors had sensitivity comparable to the proof-of-concept model (which had 381 predictors) at target thresholds. The machine learning algorithms had relatively similar sensitivities, the highest being for Bayesian additive regression trees, with 10.7% of suicides occurred among the 1.0% of Veterans with highest predicted risk and 28.1% among the 5.0% of with highest predicted risk. CONCLUSIONS: Based on these results, VHA is using penalized logistic regression in initial intervention implementation. The paper concludes with a discussion of other practical issues that might be explored to increase model performance.

Barriers, facilitators, and benefits of implementation of dialectical behavior therapy in routine care: results from a national program evaluation survey in the Veterans Health Administration.

National implementation of evidence-based psychotherapies (EBPs) in the Veterans Health Administration (VHA) provides important lessons on the barriers and facilitators to implementation in a large healthcare system. Little is known about barriers and facilitators to the implementation of a complex EBP for emotional and behavioral dysregulation-dialectical behavioral therapy (DBT). The purpose of this study was to understand VHA clinicians' experiences with barriers, facilitators, and benefits from implementing DBT into routine care. This national program evaluation survey measured site characteristics of VHA sites (N = 59) that had implemented DBT. DBT was most often implemented in general mental health outpatient clinics. While 42% of sites offered all four modes of DBT, skills group was the most frequently implemented mode. Fifty-nine percent of sites offered phone coaching in any form, yet only 11% of those offered it all the time. Providers were often provided little to no time to support implementation of DBT. Barriers that were difficult to overcome were related to phone coaching outside of business hours. Facilitators to implementation included staff interest and expertise. Perceived benefits included increased hope and functioning for clients, greater self-efficacy and compassion for providers, and ability to treat unique symptoms for clinics. There was considerable variability in the capacity to address implementation barriers among sites implementing DBT in VHA routine care. Mental health policy makers should note the barriers and facilitators reported here, with specific attention to phone coaching barriers.

Promoting Help Seeking to Veterans.

BACKGROUND: Few studies have considered different messaging strategies that may augment campaign efficacy to generate help-seeking behaviors among populations at increased risk for suicide, mainly US military veterans. AIMS: Findings are presented from the pilot evaluation of the It's Your Call campaign implemented by the Department of Veterans Affairs (VA). Three messaging strategies (with varying intensity and mix of messages) were compared to explore which best promote use of the Veterans Crisis Line (VCL) among veteran populations. METHOD: Daily VCL call data were obtained for 10 US cities during 2011-2012 where the campaign was active, and modeled using Poisson regression to identify changes in utilization patterns associated with the implementation of different messaging strategies. RESULTS: Significant increases in call rates were only evident during the campaign in communities where mixed messages were disseminated. Further, use of mixed messages yielded greater increases in call rates when compared with the other tested strategies. This was an observational study where identification of causal relationships between variables was limited. CONCLUSION: Findings are encouraging as messaging was associated with help seeking, and they provide insights into strategies that may rapidly promote crisis line use. Results also underscore the need for further research on suicide prevention campaigns and dissemination practices.

Dialectical Behavior Therapy Training and Desired Resources for Implementation: Results From a National Program Evaluation in the Veterans Health Administration.

CONTEXT: Little is known about nonresearch training experiences of providers who implement evidence-based psychotherapies for suicidal behaviors among veterans. EVIDENCE ACQUISITION: This national program evaluation identified the history of training, training needs, and desired resources of clinicians who work with at-risk veterans in a national health care system. This sequential mixed methods national program evaluation used a post-only survey design to obtain needs assessment data from clinical sites (N = 59) within Veterans Health Administration (VHA) facilities that implemented dialectical behavior therapy (DBT). Data were also collected on resources preferred to support ongoing use of DBT. RESULTS: While only 33% of clinical sites within VHA facilities reported that staff attended a formal DBT intensive training workshop, nearly 97% of participating sites reported having staff who completed self-study using DBT manuals. Mobile apps for therapists and clients and templates for documentation in the electronic health records to support measurement-based care were desired clinical resources. CONCLUSION: Results indicate that less-intensive training models can aid staff in implementing DBT in real-world health care settings. While more training is requested, a number of VHA facilities have successfully implemented DBT into the continuum of care for veterans at risk for suicide.

Measuring Associations of the Department of Veterans Affairs' Suicide Prevention Campaign on the Use of Crisis Support Services.

Campaigns have become popular in public health approaches to suicide prevention; however, limited empirical investigation of their impact on behavior has been conducted. To address this gap, utilization patterns of crisis support services associated with the Department of Veterans Affairs' Veterans Crisis Line (VCL) suicide prevention campaign were examined. Daily call data for the National Suicide Prevention Lifeline, VCL, and 1-800-SUICIDE were modeled using a novel semi-varying coefficient method. Analyses reveal significant increases in call volume to both targeted and broad resources during the campaign. Findings underscore the need for further research to refine measurement of the effects of these suicide prevention efforts.

VA Suicide Prevention Applications Network: A National Health Care System-Based Suicide Event Tracking System.

OBJECTIVES: The US Department of Veterans Affairs' Suicide Prevention Applications Network (SPAN) is a national system for suicide event tracking and case management. The objective of this study was to assess data on suicide attempts among people using Veterans Health Administration (VHA) services. METHODS: We assessed the degree of data overlap on suicide attempters reported in SPAN and the VHA's medical records from October 1, 2010, to September 30, 2014-overall, by year, and by region. Data on suicide attempters in the VHA's medical records consisted of diagnoses documented with E95 codes from the International Classification of Diseases, Ninth Revision. RESULTS: Of 50 518 VHA patients who attempted suicide during the 4-year study period, data on fewer than half (41%) were reported in both SPAN and the medical records; nearly 65% of patients whose suicide attempt was recorded in SPAN had no data on attempted suicide in the VHA's medical records. CONCLUSION: Evaluation of administrative data suggests that use of SPAN substantially increases the collection of data on suicide attempters as compared with the use of medical records alone, but neither SPAN nor the VHA's medical records identify all suicide attempters. Further research is needed to better understand the strengths and limitations of both systems and how to best combine information across systems.

Predictive Modeling and Concentration of the Risk of Suicide: Implications for Preventive Interventions in the US Department of Veterans Affairs.

OBJECTIVES: The Veterans Health Administration (VHA) evaluated the use of predictive modeling to identify patients at risk for suicide and to supplement ongoing care with risk-stratified interventions. METHODS: Suicide data came from the National Death Index. Predictors were measures from VHA clinical records incorporating patient-months from October 1, 2008, to September 30, 2011, for all suicide decedents and 1% of living patients, divided randomly into development and validation samples. We used data on all patients alive on September 30, 2010, to evaluate predictions of suicide risk over 1 year. RESULTS: Modeling demonstrated that suicide rates were 82 and 60 times greater than the rate in the overall sample in the highest 0.01% stratum for calculated risk for the development and validation samples, respectively; 39 and 30 times greater in the highest 0.10%; 14 and 12 times greater in the highest 1.00%; and 6.3 and 5.7 times greater in the highest 5.00%. CONCLUSIONS: Predictive modeling can identify high-risk patients who were not identified on clinical grounds. VHA is developing modeling to enhance clinical care and to guide the delivery of preventive interventions.

Parenting and independent problem-solving in preschool children with food allergy.

OBJECTIVE: To examine autonomy-promoting parenting and independent problem-solving in children with food allergy. METHODS: 66 children with food allergy, aged 3-6 years, and 67 age-matched healthy peers and their mothers were videotaped while completing easy and difficult puzzles. Coders recorded time to puzzle completion, children's direct and indirect requests for help, and maternal help-giving behaviors. RESULTS: Compared with healthy peers, younger (3- to 4-year-old) children with food allergy made more indirect requests for help during the easy puzzle, and their mothers were more likely to provide unnecessary help (i.e., explain where to place a puzzle piece). Differences were not found for older children. CONCLUSIONS: The results suggest that highly involved parenting practices that are medically necessary to manage food allergy may spill over into settings where high levels of involvement are not needed, and that young children with food allergy may be at increased risk for difficulties in autonomy development.

Age-related concerns of male veteran callers to a suicide crisis line.

In July 2007, the United States Department of Veterans Affairs (VA) partnered with the Department of Health and Human Services' Substance Abuse and Mental Health Service Administration (SAMHSA) to create the Veterans Crisis Line (VCL) in order to meet the unique needs of Veterans in distress. The current study utilized a mixed methods design to examine characteristics of male callers to the VCL. Results from qualitative analyses demonstrated that the majority of callers between April 1 and August 31, 2008 contacted the VCL with concerns related to mental health issues, suicide ideation, and substance abuse issues. Quantitative analyses demonstrated age differences associated with concerns presented by callers such that middle-aged and older callers were more likely to present with loneliness and younger callers were more likely to present with mental health concerns. The results of this study will help to inform future research designed to optimize the effectiveness of the VCL for suicide prevention in Veterans.

Suicide prevention and postvention resources: what psychiatry residencies can learn from the Veteran's Administration experience.

Suicide risk assessment and coping with the loss of a patient through suicide are two of the more challenging aspects of psychiatry residency. Over the last decade, the Department of Veterans Affairs has focused on a significant effort into the development of a comprehensive suicide prevention. This article aims to describe the initiatives and resources in place at the VHA to help address the issue of suicidal behavior in veterans and how residency programs can use this to enhance teaching of suicide prevention and postvention.

The effects of coping style on virtual reality enhanced videogame distraction in children undergoing cold pressor pain.

This study sought to evaluate the effectiveness of virtual reality (VR) enhanced interactive videogame distraction for children undergoing experimentally induced cold pressor pain and examined the role of avoidant and approach coping style as a moderator of VR distraction effectiveness. Sixty-two children (6-13 years old) underwent a baseline cold pressor trial followed by two cold pressor trials in which interactive videogame distraction was delivered both with and without a VR helmet in counterbalanced order. As predicted, children demonstrated significant improvement in pain tolerance during both interactive videogame distraction conditions. However, a differential response to videogame distraction with or without the enhancement of VR technology was not found. Children's coping style did not moderate their response to distraction. Rather, interactive videogame distraction with and without VR technology was equally effective for children who utilized avoidant or approach coping styles.