Virtual Clinical Outcome Ascertainment in a Prostate Cancer Treatment Trial

Introduction/Objective: The COVID-19 pandemic stopped site visits for clinical outcome data collection in March 2020. We utilized several remote methods to collect data and assessed their relative effectiveness. Background(s): The ProtecT randomized trial (Prostate cancer testing and treatment trial) aimed to determine the effectiveness of active monitoring (surveillance), radiation and surgery for localized disease. The primary outcome is prostate cancer mortality with clinical secondary outcomes of disease progression and metastasis. There was no difference in the primary outcome at 10 years (published in 2016) between groups (differences in metastasis and functional problems) so followup was extended to 15 years (November 2020). Method(s): The 10-year analysis used annual paper case report forms (CRFs) completed by research nurses based at UK hospitals. In extended follow-up, it was intended that National Health Service routine data would identify participants with potential disease progression. Prior to the pandemic the research nurse reviewed electronic health records at eight English hospitals and completed an eCRF in REDCap software. It became unlikely that site visits were going to be possible in 2020. A shortened eCRF was created focussed on essential outcome data and site staff agreed to help collect clinical data in July 2020. Result(s): Ethical approval for extending the study end date and the sponsor updating GDPR terms of site agreements were delayed by COVID-19 research taking priority. This also prevented the research nurse updating their NHS Research Passport for Honorary Contracts to access sites. Approvals were gained in December 2020. At four sites, local staff completed REDCap eCRFs with support from the data manager and research nurse by email and virtual calls. The research nurse gained remote access to hospital electronic health records at three sites by April 2021, which required extensive research governance approvals, training on hospital IT systems and their software on multiple laptops. At one site, from December 2020, 2-h virtual calls were held with local staff who interrogated electronic medical records as trial staff completed REDCap eCRFs. On average, 15 note reviews were conducted each call which were planned around clinical commitments. Secondary clinical outcomes were collected remotely for 94% of participants in follow-up (1395/1474). There was no difference in the three methods: remote hospital record access 594/601 (98.8%);local staff completion 575/600 (95.8%);and online calls 215/221 (97.3%) although less data cleaning was required as data queries were resolved during calls. Benefits also included savings on time traveling to sites and accommodation and local clinical staff could access a wider range of health records and information outside their hospital. However, enabling remote data capture delayed data analysis by 6 months. Conclusion(s): In a prostate cancer treatment trial remote data capture of clinical outcomes was successful as site visits became impossible due to the pandemic. Online methods were tailored to sites requirements but required substantial preparation and governance approvals.

A RARE CASE OF ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)-ASSOCIATED VASCULITIS IN THE SETTING OF COVID-19 INFECTION

SESSION TITLE: Management of COVID-19-Induced Complications SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 1:45 pm INTRODUCTION: Anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-AV) is an autoimmune mediated inflammation of small and medium sized vessel walls. The occurrence of this autoimmune vasculitis is typically associated with underlying infection, medications, and genetic predisposition.(1) The objective of this case report is to describe a rare presentation of ANCA-AV in the setting of COVID-19 infection. CASE PRESENTATION: A 67-year-old male presented to the hospital with a three-week history of cough productive of brown sputum, epistaxis, fatigue, decreased appetite, and unintentional weight loss. During the previous week, he experienced worsening dyspnea and bilateral lower extremity swelling. On physical examination, he was hypoxic requiring 4L of supplemental oxygen to maintain saturations greater than 90%. Diffuse and bilateral wheezes were heard on auscultation of his lungs. A tender petechial rash was dispersed over his limbs, trunk, oropharynx, and nasopharynx. A basic metabolic panel revealed a mild, acute renal impairment. Urinalysis showed new onset proteinuria and hemoglobinuria. Nasopharyngeal swab was positive for SARS-COV-2. Contrast-enhanced computed tomography of the chest revealed diffuse, bilateral ground glass opacities and interstitial changes. Therapy with piperacillin-tazobactam was started for presumed superimposed bacterial community acquired pneumonia in the setting of COVID-19 infection. On day three of hospitalization, the petechial rash progressed to hemorrhagic blisters. His oral petechiae were now ulcerated. A punch biopsy of the affected skin showed leukocytoclastic vasculitis. Anti-Proteinase 3 (PR3) antibodies were positive. Subsequent renal biopsy showed pauci-immune focal necrotizing crescentic glomerulonephritis consistent with ANCA-AV. Therapy with intravenous pulse dose corticosteroids led to improvement in his rash and body aches, and he was discharged home on oral steroids ten days after admission. DISCUSSION: This report describes a rare case of ANCA-AV in the setting of recent COVID-19 infection. Differentiation of ANCA-AV, bacterial and COVID-19 pneumonia can be challenging on chest imaging alone.(1) New onset renal impairment, hematuria, proteinuria and the presence of the petechial rash were suspicious for co-existing ANCA-AV in this patient. COVID-19- associated cytokine storm and formation of neutrophil extracellular traps (NETs) is postulated to be the underlying cause.(1-3) NETs present myeloperoxidase (MPO) and PR3 antigens to the immune system. Formation of auto-antibodies to MPO and PR3 lead to the development of ANCA-AV. The findings of NETs on kidney biopsy specimens in patients with ANCA-AV supports this hypothesis.(1,2) CONCLUSIONS: To avoid the misdiagnosis of COVID-19-induced vasculitis, a low threshold to investigate co-existing vasculitis in patients with COVID-19 and associated clinical findings is highly recommended. Reference #1: Izci Duran T, Turkmen E, Dilek M, Sayarlioglu H, Arik N. ANCA-associated vasculitis after COVID-19. Rheumatol Int. 2021;41(8):1523-1529. Reference #2: Uppal NN, Kello N, Shah HH, et al. De Novo ANCA-Associated Vasculitis With Glomerulonephritis in COVID-19. Kidney Int Rep. 2020;5(11):2079-2083. Reference #3: Cobilinschi C, Cobilinschi C, Constantinescu A, Draniceanu I, Ionescu R. New-Onset ANCA-Associated Vasculitis in a Patient with SARS-COV2. Balkan Med J. 2021;38(5):318-320. DISCLOSURES: No relevant relationships by Andrei Hastings No relevant relationships by Jason Lane No relevant relationships by Tanya Marshall No relevant relationships by Palak Rath No relevant relationships by Sterling Shriber No relevant relationships by inderprit Singh No relevant relationships by Samuel Wiles

Digital Tools Adopted by Public Health Agencies to Support COVID-19 Case Investigation and Contact Tracing, United States, 2020-2021.

During the COVID-19 pandemic, public health agencies implemented an array of technologies and digital tools to support case investigation and contact tracing. Beginning in May 2020, the Association of State and Territorial Health Officials compiled information on digital tools used by its membership, which comprises 59 chief health officials from each of the 50 states, 5 US territories, 3 freely associated states, and the District of Columbia. This information was presented online through a publicly available technology and digital tools inventory. We describe the national landscape of digital tools implemented by public health agencies to support functions of the COVID-19 response from May 2020 through May 2021. We also discuss how public health officials and their informatics leadership referenced the information about the digital tools implemented by their peers to guide and refine their own implementation plans. We used a consensus-based approach through monthly discussions with partners to group digital tools into 5 categories: surveillance systems, case investigation, proximity technology/exposure notification, contact tracing, and symptom tracking/monitoring. The most commonly used tools included the National Electronic Disease Surveillance System Base System (NBS), Sara Alert, REDCap, and Maven. Some tools such as NBS, Sara Alert, REDCap, Salesforce, and Microsoft Dynamics were repurposed or adapted for >1 category. Having access to the publicly available technology and digital tools inventory provided public health officials and their informatics leadership with information on what tools other public health agencies were using and aided in decision making as they considered repurposing existing tools or adopting new ones.

Prostate cancer-Exercise and Metformin Trial (Pre-EMpT): study protocol for a feasibility factorial randomized controlled trial in men with localised or locally advanced prostate cancer.

BACKGROUND: Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life. METHODS: Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up. DISCUSSION: Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions. TRIAL REGISTRATION: Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667 . Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018.

Implementation of a Nationwide Knowledge-Based COVID-19 Contact Tracing Training Program, 2020.

In the United States, the public health response to control COVID-19 required rapid expansion of the contact tracing workforce from approximately 2200 personnel prepandemic to more than 100 000 during the pandemic. We describe the development and implementation of a free nationwide training course for COVID-19 contact tracers that launched April 28, 2020, and summarize participant characteristics and evaluation findings through December 31, 2020. Uptake of the online asynchronous training was substantial: 90 643 registrants completed the course during the first 8 months. In an analysis of a subset of course participants (n = 13 697), 7724 (56.4%) reported having no prepandemic public health experience and 7178 (52.4%) reported currently serving as case investigators, contact tracers, or both. Most participants who completed a course evaluation reported satisfaction with course utility (94.8%; 59 497 of 62 753) and improved understanding of contact tracing practice (93.0%; 66 107 of 71 048). These findings suggest that the course successfully reached the intended audience of new public health practitioners. Lessons learned from this implementation indicate that an introductory course level is appropriate for a national knowledge-based training that aims to complement jurisdiction-specific training. In addition, offering a range of implementation options can promote course uptake among public health agency staff. This course supported the emerging needs of the public health practice community by training a workforce to fill an important gap during the COVID-19 pandemic and could serve as a feasible model for enhancing workforce knowledge for future and ongoing public health threats.

Documenting Data Use in a Model of Pandemic “Emotional Contagion” Using the Rigour and Transparency Reporting Standard (RAT-RS)

This paper utilizes the recently developed Rigour and Transparency Reporting Standard as a framework for describing aspects of the use of data in an agent-based modelling (ABM) EmotiCon project studying emotional contagion during the COVID-19 pandemic. After briefly summarizing the role of the ABM in the wider EmotiCon project, we outline how we intend to utilize qualitative data from a natural language processing analysis of Twitter data and quantitative data from a nationally representative survey in model building. The presentation during the SSC 2021 will elaborate on the outcome of implementing the idea. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Panel on Ethical Constraints on Validation, Verification, and Application of Simulation

Today's challenges must be addressed as socio-technical systems, including insights from the social sciences and humanities to adequately represent the human components. As results of simulations are increasingly driving and justifying political and social decisions, it is important to validate and verify (VV) simulation and data. However, the understanding of what establishes truth and how these views impact validation differ between the social and technical partners. Therefore, we must expand our view of VV. The panel provides various use cases and derives ethical questions related to supporting universities during the COVID-19 pandemic, creating multi-disciplinary teams with diverse viewpoints, challenges of using validated insights without critical evaluation, and lack of broadly accepted scientific measures to connect social models and empirical data. We conclude that the role of VV must be reemphasized, that its social-theoretical implications must be better understood, and that it should be driven by an overarching metaethical framework. © 2021 IEEE.

The evaluation of a Peer Enhanced eLearning Placement (PEEP) in MSc Physiotherapy (pre-registration) education

Keywords: e-learning, Peer enhanced, Placement Purpose: COVID-19 has brought many challenges with the availability of practice placements a key issue in Physiotherapy education. The Peer Enhanced ePlacement (PEEP) model was therefore used to develop an alternative approach to the initial two-week placement in the first year of the MSc Physiotherapy (pre-registration) programme. The evaluation aimed to understand the student experience of undertaking an online PEEP placement and to help inform the development of future models of placement delivery. Methods: A online practice-based learning experience was developed, based on the PEEP model, which included the use of case histories and presentations delivered by practice-based educators and patient video diaries to follow a journey through a case. Individual learning activities, peer learning tasks, reflective blogs and simulation suite activities were all underpinned by completion of an interactive on-line workbook. The learning outcomes remained unchanged from the previously established initial placement. Two pre-placement tutorials were run to familiarise student with the PEEP model. Evaluation was completed via an online questionnaire and focused on pre-placement preparation, PEEP content, student learning, the placement experience, perceptions of student support and issues faced as a result of the PEEP model. Results: 93.9% of students felt expectations were clear and they were prepared for placement, with 81% reporting they met all the learning outcomes and 21% stating they met most of the learning outcomes. The students identified their top 3 learning activities as the simulation suite (56.4%), the patient journey (37.5%) and the case histories (31.3%). Reflective blogs were the least favourite activity (56.3%). Prior to the placement, there was some anxiety about the PEEP model with 12.1% reporting they were very anxious, 18.2% somewhat anxious and 45.5% a little anxious. This decreased to 18.2% having a little anxiety about the model post placement. Students reported the strengths of the model were the variety of teams the students met, the support of the small peer group in learning, the clear structure of the placement, following a patient journey and support from university staff. Barriers were described as internet stability, lack of hands-on learning, self-motivation when isolated at home, lack of one-to-one opportunities and feedback, as well as not seeing real time patient assessment. Conclusion(s): The PEEP model provided an effective alternative model for an initial placement experience. The information provided to students ahead of the placement was valuable in setting expectations although anxiety was still apparent. The students valued the range of experiences provided which was potentially an enhancement from a more traditional model of delivery. The barriers were similar to other digital learning experiences. The evaluation will allow specific issues raised to be addressed in further iterations of this model. Impact: The PEEP model has previously been used to deliver placements for AHP students who have already experienced traditional models of practice based learning. This evaluation demonstrates the model is effective in providing a first experience of practice-based learning to physiotherapy students. As we move forward, we must utilise a variety of placement models to embrace all practice-based learning opportunities Funding acknowledgements: This placement evaluation was funded by NHS Education Scotland (NES).

Applying Extensive Reading of British Literature in the ESP Context

The paper presents the advantages of the integration of extensive reading of contemporary British literature in the original and the graded texts based on British Literature into EFL (English as a Foreign Language) teaching non-linguist students of the Humanities and Sciences at Perm State University, Russia. This topic is among those burning issues of ESP teaching/learning discourse studies in Russia and abroad which are being intensively integrated into one interdisciplinary field. Literary texts in a classroom are targeted at increasing the students’ interest and intrinsic motivation, providing variety, encouraging cultural understanding, introducing social, political, emotional and economic issues and improving their foreign language in the professionally oriented field. The Extensive Reading technology proved to be a valuable digital tool in the Covid-19 and post Covid-19 educational environment. Three projects on ER for ESP classes are analyzed in the paper. The results of the ER integration in the ESP through the analyses of the students’ reflections are presented as well. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Innovative care model for vascular access strategy in AKI in critically ill patients

Background: Central venous catheter (CVC) is the preferred vascular access in critically-ill patients needing kidney replacement therapy (KRT). Non-tunneled CVC (NT-CVC) is frequently selected for bedside placement and provider familiarity. With hemodynamic instability, tunneled CVC (T-CVC), despite its known advantages of lower infection risk, lower mechanical complications, better blood flow rates and patient comfort, is infrequently considered due to competing demands for central vein access, and provider inexperience. We report our early experience of building a collaborative training program to improve vascular access approach in the critically-ill patients. Methods: A single center retrospective study of T-CVC placed in an adult medical ICU between March 1, 2020 and December 31, 2020 by a nephrologist or an intensivist. The T-CVCs were placed in hemodynamically unstable patients for KRT and other medical therapies. Statistical analysis was limited to assess feasibility and safety of implementing a collaborative procedural service in an academic medical ICU. Results: A total of 120 CVC related procedures were completed during the study period. 106 were T-CVC placements (68 for KRT, 38 small bore non-KRT), seven T-CVC removals, one difficult NT-CVC for KRT, one T-CVC exchange, one fluoroscopy guided repositioning of NT-CVC, four aborted for suspected central vein occlusion. Twentyseven T-CVC (23 in COVID-19 positive and 4 for other compelling reasons) were placed at bedside with ultrasound guidance and anatomical landmarks without fluoroscopy. A safety pre-procedure checklist was developed for eligibility based on this experience. A minimum of 48-hr sterile blood culture report was essential to proceed. Complex comorbidities included coagulopathic patients. A minimum training competency was established and 2 critical care staff physicians were credentialed during this period. No major complications were encountered. Conclusions: A collaborative care model between nephrology and medical ICU for T-CVC focused strategy is feasible. T-CVC can be placed safely in a carefully selected critically-ill patient population. Training intensivists with basic procedural skills for T-CVC procedure is achievable over a short period.

COVID-19 Case Investigation and Contact Tracing: Early Lessons Learned and Future Opportunities.

CONTEXT: Case investigation and contact tracing are fundamental public health strategies for controlling and preventing the spread of infectious diseases. Although the principles behind these strategies are not new, the capacity and operational requirements needed to support disease investigation during the SARS-CoV-2 (COVID-19) pandemic are unprecedented. This article analyzes the implementation of case investigation and contact tracing in controlling COVID-19 transmission during the early stages of the US pandemic response (January 20 through August 31, 2020). PROGRAM IMPLEMENTATION: Governmental public health agencies mobilized to expand case investigation and contact tracing programs in the early months of the pandemic. In doing so, they encountered a range of challenges that included rapidly scaling up the workforce; developing and subsequently revising guidance and protocols specific to COVID-19 as more was learned about the virus over time; defining job functions; encouraging public acceptance of and participation in case investigation and contact tracing; and assessing the utility of these activities during both the containment and mitigation phases of outbreak response. COVID-19 case investigation and contact tracing programs presented an array of opportunities for health departments to innovate, especially around technology to support public health efforts, as well as opportunities to address health equity and advance community resilience. CONCLUSION: Lessons learned from disease intervention specialists, guidance and resources from federal agencies and national partners, and peer-to-peer exchange of promising practices can support jurisdictions encountering early implementation challenges. Further research is needed to assess COVID-19 case investigation and contact tracing program models and innovations, as well as strategies for implementing these activities during containment and mitigation phases.

Issue Guide: COVID-19 Case Investigation and Contact Tracing

From the Executive Summary: As communities relax stay-at-home orders and ramp up testing, the public health system is seeing increases in COVID-19 [coronavirus disease 2019] cases. Until vaccines are broadly available, the primary ways of preventing transmission of COVID-19 include interventions such as case investigation, contact tracing, social distancing, and isolation and quarantine. [...] An extensive and swift expansion of the case investigation and contact tracing workforce--paired with continuous evaluation to ensure effectiveness--is needed to adequately respond to rising caseloads and rapid investigation cycles. To complement this time-tested, workforce-based solution, technology companies have been engaging with various public health experts to develop new tools that could aid in COVID-19 response efforts. [...] This guide aims to help health officials think through critical functionalities needed for case investigations and contact tracing, technological options, and issues of implementation in adopting these technologies. It also addresses the latest topic of focus: the Apple;Google exposure notification application programming interface. The background and key considerations included are intended to inform decision-making for technology-enabled enhancement of case investigation and contact tracing capacity.COVID-19 (Disease);Public health surveillance;Privacy, Right of