Exploring the psychological impact of contact tracing work on staff during the COVID-19 pandemic.

BACKGROUND: Contact tracing is a key control measure in the response to the COVID-19 pandemic. While quantitative research has been conducted on the psychological impact of the pandemic on other frontline healthcare workers, none has explored the impact on contact tracing staff. METHODS: A longitudinal study was conducted using two repeated measures with contact tracing staff employed in Ireland during the COVID-19 pandemic using two-tailed independent samples t tests and exploratory linear mixed models. RESULTS: The study sample included 137 contact tracers in March 2021 (T1) and 218 in September 2021 (T3). There was an increase from T1 to T3 in burnout related exhaustion (p < 0·001), post-traumatic stress disorder (PTSD) symptom scores (p < 0·001), mental distress (p < 0·01), perceived stress (p < 0·001) and tension and pressure (p < 0·001). In those aged 18-30, there was an increase in exhaustion related burnout (p < 0·01), PTSD symptoms (p < 0·05), and tension and pressure scores (p < 0·05). Additionally, participants with a background in healthcare showed an increase in PTSD symptom scores by T3 (p < 0·001), reaching mean scores equivalent to those of participants who did not have a background in healthcare. CONCLUSIONS: Contact tracing staff working during the COVID-19 pandemic experienced an increase in adverse psychological outcomes. These findings highlight a need for further research on psychological supports required by contact tracing staff with differing demographic profiles.

Emergency use authorization medication distribution, utilization, and monitoring in a national integrated healthcare system.

PURPOSE: The purpose of this project was to develop and optimize a dashboard and registry to manage the distribution, utilization, and monitoring of coronavirus disease 2019 (COVID-19) emergency use-authorized medications (CEUAMs). SUMMARY: CEUAMs have specific requirements that must be met for prescribing, monitoring, and compliance. When remdesivir, the first COVID-19 medication with emergency use authorization (EUA), was approved, it immediately became necessary for the Veterans Health Administration, a national integrated health system, to describe the requirements for EUA, to distribute the medication in a fair and equitable manner, and to ensure compliance with all EUA requirements. A dashboard was developed and iteratively updated as additional CEUAMs were approved. The dashboard tracked CEUAM distribution and monitoring at the national, regional, facility, and patient level. Par stock levels were initially determined at the national level. Facilities were also able to request an additional allotment of medication based on demand and allocated supplies from the Department of Health and Human Services. Providers completed a questionnaire for the CEUAM for each patient to ensure all requirements for the medication were met. If there were data integrity concerns, the entry was flagged for review at the facility level and, upon evaluation, corrections were made. CONCLUSION: Development of the dashboard was resource intensive but provided an excellent mechanism to share information among facilities and national offices. Other healthcare systems can develop similar dashboards to ensure appropriate use of CEUAMs for their patients while meeting all CEUAM requirements.

In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic.

STUDY OBJECTIVES: Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. The goal of this study was to evaluate clinical benefits of CBT-I to veterans with insomnia disorder during the early months of the COVID-19 pandemic using an uncontrolled observational design. METHODS: A cohort of 63 Veterans Affairs (VA) mental health providers delivered CBT-I to 180 veterans as part of an evidence-based psychotherapy training program and captured de-identified treatment outcome data through a data portal. The main patient outcomes were change in the Insomnia Severity Index (ISI) total score from the initial clinical assessment session to the last treatment session, response rate (% with ISI change > 7 from assessment to last session), and remission rate (% with ISI < 8 at the last session). We tested the noninferiority of telehealth only compared with at least 1 in-person session. RESULTS: Fifty-six percent of veterans seen for an evaluation completed CBT-I treatment during the structured training program phase and completed an initial and final ISI. Among these veterans, ISI scores decreased by an average of 9.9 points from before to after treatment (P < .001), 66% experienced a clinically meaningful treatment response, and 43% experienced insomnia symptom remission. Benefits were similar whether the veteran received some in-person care or received CBT-I entirely via telehealth. CONCLUSIONS: Findings suggest, regardless of treatment modality, CBT-I remained highly effective during the early months of the pandemic, which was a challenging time for both clinical providers and veterans in need of insomnia treatment. CITATION: Martin JL, DeViva J, McCarthy E, et al. In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. J Clin Sleep Med. 2023;19(7):1211-1217.

Evidence Based Funding in Illinois: A Discussion of Equity in Urban Education

In this pilot study, we examine the realities of differential funding structures across the US, which disproportionately disadvantage historically marginalized communities (Black and Brown students) and students living in poverty, contributing to an intractable opportunity gap. Prior research indicates that equitable funding can, in fact, decrease the opportunity gap between dominant and non-dominant-culture students. We use the new funding structure in Illinois as a case study in funding equity that should be applied nationally. We critique the current funding structure of public schools in general, which has defamed the public sector in favor of school choice, vouchers, and charter schools--all with less oversight than public schools and structured to profit from public monies. Finally, we address the impact of COVID19 on existing funding inequities.

Identifying SARS-CoV-2 regional introductions and transmission clusters in real time.

The unprecedented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) global sequencing effort has suffered from an analytical bottleneck. Many existing methods for phylogenetic analysis are designed for sparse, static datasets and are too computationally expensive to apply to densely sampled, rapidly expanding datasets when results are needed immediately to inform public health action. For example, public health is often concerned with identifying clusters of closely related samples, but the sheer scale of the data prevents manual inspection and the current computational models are often too expensive in time and resources. Even when results are available, intuitive data exploration tools are of critical importance to effective public health interpretation and action. To help address this need, we present a phylogenetic heuristic that quickly and efficiently identifies newly introduced strains in a region, resulting in clusters of infected individuals, and their putative geographic origins. We show that this approach performs well on simulated data and yields results largely congruent with more sophisticated Bayesian phylogeographic modeling approaches. We also introduce Cluster-Tracker (https://clustertracker.gi.ucsc.edu/), a novel interactive web-based tool to facilitate effective and intuitive SARS-CoV-2 geographic data exploration and visualization across the USA. Cluster-Tracker is updated daily and automatically identifies and highlights groups of closely related SARS-CoV-2 infections resulting from the transmission of the virus between two geographic areas by travelers, streamlining public health tracking of local viral diversity and emerging infection clusters. The site is open-source and designed to be easily configured to analyze any chosen region, making it a useful resource globally. The combination of these open-source tools will empower detailed investigations of the geographic origins and spread of SARS-CoV-2 and other densely sampled pathogens.

Automated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis (gameChange): a multicentre, parallel-group, single-blind, randomised, controlled trial in England with mediation and moderation analyses.

BACKGROUND: Automated delivery of psychological therapy using immersive technologies such as virtual reality (VR) might greatly increase the availability of effective help for patients. We aimed to evaluate the efficacy of an automated VR cognitive therapy (gameChange) to treat avoidance and distress in patients with psychosis, and to analyse how and in whom it might work. METHODS: We did a parallel-group, single-blind, randomised, controlled trial across nine National Health Service trusts in England. Eligible patients were aged 16 years or older, with a clinical diagnosis of a schizophrenia spectrum disorder or an affective diagnosis with psychotic symptoms, and had self-reported difficulties going outside due to anxiety. Patients were randomly assigned (1:1) to either gameChange VR therapy plus usual care or usual care alone, using a permuted blocks algorithm with randomly varying block size, stratified by study site and service type. gameChange VR therapy was provided in approximately six sessions over 6 weeks. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 6 (primary endpoint), and 26 weeks after randomisation. The primary outcome was avoidance of, and distress in, everyday situations, assessed using the self-reported Oxford Agoraphobic Avoidance Scale (O-AS). Outcome analyses were done in the intention-to-treat population (ie, all participants who were assigned to a study group for whom data were available). We performed planned mediation and moderation analyses to test the effects of gameChange VR therapy when added to usual care. This trial is registered with the ISRCTN registry, 17308399. FINDINGS: Between July 25, 2019, and May 7, 2021 (with a pause in recruitment from March 16, 2020, to Sept 14, 2020, due to COVID-19 pandemic restrictions), 551 patients were assessed for eligibility and 346 were enrolled. 231 (67%) patients were men and 111 (32%) were women, 294 (85%) were White, and the mean age was 37·2 years (SD 12·5). 174 patients were randomly assigned to the gameChange VR therapy group and 172 to the usual care alone group. Compared with the usual care alone group, the gameChange VR therapy group had significant reductions in agoraphobic avoidance (O-AS adjusted mean difference -0·47, 95% CI -0·88 to -0·06; n=320; Cohen's d -0·18; p=0·026) and distress (-4·33, -7·78 to -0·87; n=322; -0·26; p=0·014) at 6 weeks. Reductions in threat cognitions and within-situation defence behaviours mediated treatment outcomes. The greater the severity of anxious fears and avoidance, the greater the treatment benefits. There was no significant difference in the occurrence of serious adverse events between the gameChange VR therapy group (12 events in nine patients) and the usual care alone group (eight events in seven patients; p=0·37). INTERPRETATION: Automated VR therapy led to significant reductions in anxious avoidance of, and distress in, everyday situations compared with usual care alone. The mediation analysis indicated that the VR therapy worked in accordance with the cognitive model by reducing anxious thoughts and associated protective behaviours. The moderation analysis indicated that the VR therapy particularly benefited patients with severe agoraphobic avoidance, such as not being able to leave the home unaccompanied. gameChange VR therapy has the potential to increase the provision of effective psychological therapy for psychosis, particularly for patients who find it difficult to leave their home, visit local amenities, or use public transport. FUNDING: National Institute of Health Research Invention for Innovation programme, National Institute of Health Research Oxford Health Biomedical Research Centre.

Experiences of Sleep Problems Among Older Korean Immigrants

Despite poor sleep among older adults, little is known about the sleep habits of older immigrants living in the United States. The current pragmatic qualitative descriptive study explored sleep among older Korean immigrants, using a focus group with six participants and individual phone interviews with 22 Korean immigrants aged ≥60 years. Transcripts were coded to identify underlying themes. Several thematic categories were identified under six domains: daytime function, getting ready for bed, falling asleep, awakenings during sleep, going back to sleep, and seeking advice from peers. Unhealthy sleep behaviors were found during daytime and bedtime, particularly among those who were retired/unemployed or living alone. Seeking advice from peers was common but none of the advice helped participants sleep. Sleep education programs in Korean-speaking communities can be used to target those who are socially isolated and may benefit older Korean immigrants with sleep difficulties. [Research in Gerontological Nursing, xx(x), xx–xx.]

Systems analysis shows that thermodynamic physiological and pharmacological fundamentals drive COVID-19 and response to treatment.

Why a systems analysis view of this pandemic? The current pandemic has inflicted almost unimaginable grief, sorrow, loss, and terror at a global scale. One of the great ironies with the COVID-19 pandemic, particularly early on, is counter intuitive. The speed at which specialized basic and clinical sciences described the details of the damage to humans in COVID-19 disease has been impressive. Equally, the development of vaccines in an amazingly short time interval has been extraordinary. However, what has been less well understood has been the fundamental elements that underpin the progression of COVID-19 in an individual and in populations. We have used systems analysis approaches with human physiology and pharmacology to explore the fundamental underpinnings of COVID-19 disease. Pharmacology powerfully captures the thermodynamic characteristics of molecular binding with an exogenous entity such as a virus and its consequences on the living processes well described by human physiology. Thus, we have documented the passage of SARS-CoV-2 from infection of a single cell to species jump, to tropism, variant emergence and widespread population infection. During the course of this review, the recurrent observation was the efficiency and simplicity of one critical function of this virus. The lethality of SARS-CoV-2 is due primarily to its ability to possess and use a variable surface for binding to a specific human target with high affinity. This binding liberates Gibbs free energy (GFE) such that it satisfies the criteria for thermodynamic spontaneity. Its binding is the prelude to human host cellular entry and replication by the appropriation of host cell constituent molecules that have been produced with a prior energy investment by the host cell. It is also a binding that permits viral tropism to lead to high levels of distribution across populations with newly formed virions. This thermodynamic spontaneity is repeated endlessly as infection of a single host cell spreads to bystander cells, to tissues, to humans in close proximity and then to global populations. The principal antagonism of this process comes from SARS-CoV-2 itself, with its relentless changing of its viral surface configuration, associated with the inevitable emergence of variants better configured to resist immune sequestration and importantly with a greater affinity for the host target and higher infectivity. The great value of this physiological and pharmacological perspective is that it reveals the fundamental thermodynamic underpinnings of SARS-CoV-2 infection.

The interacting physiology of COVID-19 and the renin-angiotensin-aldosterone system: Key agents for treatment.

SARS-CoV-2 interacting with its receptor, angiotensin-converting enzyme 2 (ACE2), turns the host response to viral infection into a dysregulated uncontrolled inflammatory response. This is because ACE2 limits the production of the peptide angiotensin II (Ang II) and SARS-CoV-2, through the destruction of ACE2, allows the uncontrolled production of Ang II. Recovery from trauma requires activation of both a tissue response to injury and activation of a whole-body response to maintain tissue perfusion. Tissue and circulating renin-angiotensin systems (RASs) play an essential role in the host response to infection and injury because of the actions of Ang II, mediated via its AT1 receptor. Both tissue and circulating arms of the renin angiotensin aldosterone system's (RAAS) response to injury need to be regulated. The effects of Ang II and the steroid hormone, aldosterone, on fluid and electrolyte homeostasis and on the circulation are controlled by elaborate feedback networks that respond to alterations in the composition and volume of fluids within the circulatory system. The role of Ang II in the tissue response to injury is however, controlled mainly by its metabolism and conversion to Ang-(1-7) by the enzyme ACE2. Ang-(1-7) has effects that are contrary to Ang II-AT1 R mediated effects. Thus, destruction of ACE2 by SARS-CoV-2 results in loss of control of the pro-inflammatory actions of Ang II and tissue destruction. Therefore, it is the response of the host to SARS-CoV-2 that is responsible for the pathogenesis of COVID-19.

Effectiveness, User Engagement and Experience, and Safety of a Mobile App (Lumi Nova) Delivering Exposure-Based Cognitive Behavioral Therapy Strategies to Manage Anxiety in Children via Immersive Gaming Technology: Preliminary Evaluation Study.

BACKGROUND: Childhood anxiety disorders are a prevalent mental health problem that can be treated effectively with cognitive behavioral therapy, in which exposure is a key component; however, access to treatment is poor. Mobile-based apps on smartphones or tablets may facilitate the delivery of evidence-based therapy for child anxiety, thereby overcoming the access and engagement barriers of traditional treatment. Apps that deliver therapeutic content via immersive gaming technology could offer an effective, highly engaging, and flexible treatment proposition. OBJECTIVE: In this paper, we aim to describe a preliminary multi-method evaluation of Lumi Nova, a mobile app intervention targeting mild to moderate anxiety problems in children aged 7-12 years using exposure therapy delivered via an immersive game. The primary objective is to evaluate the effectiveness, user engagement and experience, and safety of the beta version of Lumi Nova. METHODS: Lumi Nova was co-designed with children, parents, teachers, clinicians, game industry experts, and academic partnerships. In total, 120 community-based children with mild to moderate anxiety and their guardians were enrolled to participate in an 8-week pilot study. The outcome measures captured the app's effectiveness (anxiety symptoms, child-identified goal-based outcomes, and functional impairment), user engagement (game play data and ease-of-use ratings), and safety (mood ratings and adverse events). The outcome measures before and after the intervention were available for 30 children (age: mean 9.8, SD 1.7 years; girls: 18/30, 60%; White: 24/30, 80%). Additional game play data were automatically generated for 67 children (age: mean 9.6, SD 1.53 years; girls: 35/67, 52%; White: 42/67, 63%). Postintervention open-response data from 53% (16/30) of guardians relating to the primary objectives were also examined. RESULTS: Playing Lumi Nova was effective in reducing anxiety symptom severity over the 8-week period of game play (t29=2.79; P=.009; Cohen d=0.35) and making progress toward treatment goals (z=2.43; P=.02), but there were no improvements in relation to functional impairment. Children found it easy to play the game and engaged safely with therapeutic content. However, the positive effects were small, and there were limitations to the game play data. CONCLUSIONS: This preliminary study provides initial evidence that an immersive mobile game app may safely benefit children experiencing mild to moderate anxiety. It also demonstrates the value of the rigorous evaluation of digital interventions during the development process to rapidly improve readiness for full market launch.

"LONG COVID"-A hypothesis for understanding the biological basis and pharmacological treatment strategy.

Infection of humans with SARS-CoV-2 virus causes a disease known colloquially as "COVID-19" with symptoms ranging from asymptomatic to severe pneumonia. Initial pathology is due to the virus binding to the ACE-2 protein on endothelial cells lining blood vessels and entering these cells in order to replicate. Viral replication causes oxidative stress due to elevated levels of reactive oxygen species. Many (~60%) of the infected people appear to have eliminated the virus from their body after 28 days and resume normal activity. However, a significant proportion (~40%) experience a variety of symptoms (loss of smell and/or taste, fatigue, cough, aching pain, "brain fog," insomnia, shortness of breath, and tachycardia) after 12 weeks and are diagnosed with a syndrome named "LONG COVID." Longitudinal clinical studies in a group of subjects who were infected with SARS-CoV-2 have been compared to a non-infected matched group of subjects. A cohort of infected subjects can be identified by a battery of cytokine markers to have persistent, low level grade of inflammation and often self-report two or more troubling symptoms. There is no drug that will relieve their symptoms effectively. It is hypothesized that drugs that activate the intracellular transcription factor, nuclear factor erythroid-derived 2-like 2 (NRF2) may increase the expression of enzymes to synthesize the intracellular antioxidant, glutathione that will quench free radicals causing oxidative stress. The hormone melatonin has been identified as an activator of NRF2 and a relatively safe chemical for most people to ingest chronically. Thus, it is an option for consideration of re-purposing studies in "LONG COVID" subjects experiencing insomnia, depression, fatigue, and "brain fog" but not tachycardia. Appropriately designed clinical trials are required to evaluate melatonin.

Numbers of close contacts of individuals infected with SARS-CoV-2 and their association with government intervention strategies.

BACKGROUND: Contact tracing is conducted with the primary purpose of interrupting transmission from individuals who are likely to be infectious to others. Secondary analyses of data on the numbers of close contacts of confirmed cases could also: provide an early signal of increases in contact patterns that might precede larger than expected case numbers; evaluate the impact of government interventions on the number of contacts of confirmed cases; or provide data information on contact rates between age cohorts for the purpose of epidemiological modelling. We analysed data from 140,204 close contacts of 39,861 cases in Ireland from 1st May to 1st December 2020. RESULTS: Negative binomial regression models highlighted greater numbers of contacts within specific population demographics, after correcting for temporal associations. Separate segmented regression models of the number of cases over time and the average number of contacts per case indicated that a breakpoint indicating a rapid decrease in the number of contacts per case in October 2020 preceded a breakpoint indicating a reduction in the number of cases by 11 days. CONCLUSIONS: We found that the number of contacts per infected case was overdispersed, the mean varied considerable over time and was temporally associated with government interventions. Analysis of the reported number of contacts per individual in contact tracing data may be a useful early indicator of changes in behaviour in response to, or indeed despite, government restrictions. This study provides useful information for triangulating assumptions regarding the contact mixing rates between different age cohorts for epidemiological modelling.

Invaluable role of histopathology in the diagnosis of cutaneous leiomyosarcoma in insulin injection site reaction.

Soft tissue sarcomas (STSs) are rare and may often be misdiagnosed, resulting in delays in treatment. A 67-year-old cisgender woman with type 2 diabetes mellitus and obesity presented to her primary care physician with a mass on her left proximal arm. The clinical opinion of the attending physician was that of an insulin injection site reaction. After further evaluation from the physician, the patient was diagnosed with a lipoma without confirmatory histology. The patient continued to present with an enlarging mass, decline in health status and continued with local wound care. The patient underwent a confirmatory biopsy following which, the patient was diagnosed with leiomyosarcoma. This case report highlights the case of a person with a low or moderate income with a self-reported low health literacy living in a rural community and how STS may be misdiagnosed in medically underserved. The patient's primary or oncology care team are not involved in the production or review of this case report.

Contact tracing during the COVID-19 outbreak: a protocol for enabling rapid learning from experiences and exploring the psychological impact on contact tracers.

Background: Given the unprecedented nature of the COVID-19 pandemic, the Irish health system required the redeployment of public sector staff and the recruitment of dedicated contact tracing staff in the effort to contain the spread of the virus. Contact tracing is crucial for effective disease control and is normally carried out by public health teams. Contact tracing staff are provided with rapid intensive training but are operating in a dynamic environment where processes and advice are adapting continuously. Real-time data is essential to inform strategy, coordinate interconnected processes, and respond to needs . Given that many contact tracers have been newly recruited or redeployed, they may not have significant experience in healthcare and may experience difficulties in managing the anxieties and emotional distress of the public. Aim: (i) identify emerging needs and issues and feed this information back to the Health Service Executive for updates to the COVID-19 Contact Management Programme (CMP); (ii) understand the psychological impact on contact tracers and inform the development of appropriate supports. Methods: We will use a mixed-methods approach. A brief online survey will be administered at up to three time points during 2021 to measure emotional exhaustion, anxiety, general health, and stress of contact tracing staff, identify tracing systems or processes issues, as well as issues of concern and confusion among the public. Interviews will also be conducted with a subset of participants to achieve a more in-depth understanding of these experiences. Observations may be conducted in contact tracing centres to document processes, practices, and explore any local contextual issues. Impact: Regular briefs arising from this research with data, analysis, and recommendations will aim to support the work of the CMP to identify problems and implement solutions. We will deliver regular feedback on systems issues; challenges; and the psychological well-being of contact tracing staff.

Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.

With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency provided the agencies' perspectives on the challenges in ensuring data quality in novel clinical trial designs and the importance of the management and documentation of protocol deviations, sponsor oversight of clinical trials, and use of electronic source data, including electronic health records. This paper summarizes considerations of both agencies on these topics, along with case examples. This paper touches upon considerations when using real-world data to support regulatory decisions. It also discusses the impact of the coronavirus disease 2019 (COVID-19) pandemic on clinical trial conduct and underscores the importance of well-designed, resilient, and adaptable systems for GCP compliance and data integrity.