Legal and regulatory primer for the practice of telemedicine in the United States

After two years of the COVID-19 pandemic, telemedicine has become a critical and permanent component of the global healthcare spectrum. With the rising acceptance of telemedicine globally and the importance of providing patients with high-quality care via virtual technology, this chapter aims to educate the reader on the significant and emerging legal and regulatory issues related to the practice of telemedicine. The chapter provides a step-by-step summary of the primary legal and regulatory considerations that must be addressed in order to advance and maintain an effective and high-quality telemedicine platform. As explained herein, the current legal and regulatory landscape remains fluid and challenging. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2022. All rights reserved.

Sequential Immunization of Updated Covid-19 DNA and Rna Vaccines in Nonhuman Primates

Background: COVID-19 vaccines that expand immunity against emerging variants of concern (VOC) are needed to protect against ongoing viral evolution. We investigated the impact of boosting nonhuman primates pre-immune to the original WA-1 strain with updated VOC vaccines on the breadth and magnitude of mucosal and systemic antibody (Ab) and T cell (Tc) responses. Method(s): Cynomolgus macaques were primed with 2 doses of WA-1 Spike protein encoded by either an IL-12 adjuvanted DNA vaccine administered by gene gun (GG) or a self-amplifying RNA vaccine (repRNA) delivered intramuscularly (IM) with a cationic nanocarrier (LIONTM/IM, HDT Bio) or by GG (FIG 1). A booster dose was administered at week 17 with DNA or repRNA vaccines expressing B.1.351 (Beta) and B.1.617 (Delta) Spike receptor-binding domains (RBDs) fused to influenza HA2 stem domain (SHARP, designed by AIR/ JP) followed by a final Beta + Delta + WA-1 SHARP boost at week 34. Blood and bronchoalveolar lavages (BAL) were collected before and after each dose. Binding and neutralizing Ab to VOCs, including Omicron strains, were measured by ELISA and pseudovirus neutralization assays. Tc responses to Spike protein (WA-1 peptides) were measured by ELISpot. Immune responses were compared between groups and between blood vs lung using non-parametric statistical tests. Result(s): Two doses of WA-1 DNA or repRNA vaccines induced broad Ab against all VOC with the repRNA vaccine inducing the highest titers. Boosting with VOC SHARP significantly increased mucosal and systemic Ab responses against all VOCs tested including Omicron. After final boost, all groups had comparable binding and neutralization Ab titers and Tc responses regardless of method of delivery (GG or LIONTM/IM) or formulation (DNA or repRNA). Tc responses were significantly higher in the BAL vs PBMC after WA-1 Spike doses (p=0.0420) and VOC SHARP boosters (p=0.0009). Conclusion(s): The WA-1 strain primed for broad responses against VOCs that were significantly boosted with updated SHARP vaccines including responses against Omicron, even though this strain was not included in any dose. This suggests that sequential immunization with updated vaccines may broaden mucosal and systemic immunity against future VOCs. The repRNA vaccine initially induced the strongest responses, but there were no differences between RNA and DNA following additional booster doses, a result that supports development of a more cost-effective, room temperature stable DNA vaccine for worldwide boosters. (Figure Presented).

Pay per View: Cost and Satisfaction of Virtual Video Clinics

Aims: The COVID-19 pandemic necessitated use of video consultations to provide continued patient care. It is not clear if video clinics are well received by patients, or if they are cost efficient. We evaluate The benefits of video consultation and review The impact on waiting times and cost implications to a trust. Method(s): 100 patients referred between January-December 2021 with gallstones were invited to complete a patient satisfaction questionnaire after initial clinic consultation. Patients were divided into three groups based on consultation type;face-to-face, telephone and video consultation (via The Attend Anywhere platform). Secondary outcome measures included time from referral to appointment, time to final outcome and cost implications. Result(s): 93 patients responded;33 video, 30 face-to-face and 30 telephone consultations. Of these patients 62% were female and 38% male with an average age of 51 (25-84). Average time from referral was 22 days in The video cohort, 22 in The telephone cohort and 32 for face-to-face appointments. Of The video cohort, 44% were booked for cholecystectomy from initial consultation and 56% sent for further investigation. The conversion rate from video to face-to-face consultation was zero. 50% of respondents stated face-to-face consultations as their preferred method of future consultation, 49% of patients opted for video and 1% preferred telephone consultation. 79% reported increased satisfaction due to convenience of consultation. Conclusion(s): This study demonstrates video consultations decrease costs and waiting times. Patient satisfaction is comparable to inperson visit. Specific referral criteria and patient selection is essential to maximise The benefits of video consultations.

The impact of diversity, equity, and inclusion training in an independent community oncology practice

Background: Historically, Diversity, Equity, and Inclusion (DEI) efforts have largely been left out of private practice medical facilities - mainly present in large academic hospital centers. Virginia Oncology Associates (VOA), a member of The US Oncology Network, is an independent community oncology and hematology practice specializing in the diagnosis and treatment of cancer and blood disorders. VOA has approximately 600 total employees consisting of physicians and clinical and non-clinical staff. In August of 2020, VOA launched an initiative to foster a culture of inclusion with the creation of its Inclusion Council (IC). Sixteen employees', both clinical (3 physicians) and non-clinical, were chosen to participate. The council reports to VOA's joint policy board. Methods: The council partnered with an outside organization, Virginia's Center for Inclusive Communities, to launch a practice-wide DEI training program focusing on unconscious bias and microaggression. The training was initially planned to be in person, but due to the constraints of the COVID pandemic, the training was performed using a virtual platform. The members of IC attended three two-hour sessions while other staff members and physicians were mandated to participate in at least one training session. After completion of the sessions, a survey was sent to all employees and physicians to measure the impact of DEI training. All employees were also given the opportunity to provide additional, anonymous, written feedback. Results: Table. A total of 169 employees responded. 72% of respondents agreed or strongly agreed that the program increased awareness of unconscious bias and microaggression, 67% felt that the program helps foster a culture of inclusion in the workplace, and 66% of respondents felt that the program met expectations. Conclusions: DEI efforts are vital in all aspects of health care delivery and oncology settings. DEI training met staff expectations and positively fostered a culture of inclusion by bringing attention to unconscious bias and microaggression in a community oncology practice.

The introduction of the trauma triage clinic at a district general hospital: safety and efficacy during the first year of implementation.

INTRODUCTION: Previously published work has shown that there are no missed injuries following the introduction of a trauma triage clinic (TTC). This study aimed to assess both the safety and efficacy of the TTC model in a district general hospital in the United Kingdom. We aimed to assess the rate of missed 'high-risk' injuries, including posterior shoulder dislocations, talar injuries, Lisfranc injuries and complex carpal instability. METHODS: Data were collected retrospectively between November 2017 and October 2018 (inclusive). During this time, 3,721 patients were reviewed (mean age 38 years, SD 25.5, range 1-103 years). Case notes and x-rays were reviewed for all patients. Compliance was assessed against British Orthopaedic Association Standards for Trauma (BOAST 7) guidelines for fracture clinic services. The standard for adherence to guidelines was 100%. RESULTS: Thirty-two of 3,721 patients had a missed injury during the study period, and 66% of these injuries were high risk. TTC was effective in reducing the number of patients seen in the fracture clinic, with 23% of patients discharged directly from the TTC. Eighty-nine per cent of patients were reviewed in clinic within 72 hours of presentation, with a median time to review of 2 days. CONCLUSION: This study has shown that TTC is efficient in reducing the burden of patients seen in the fracture clinic, but it is not as safe as reported previously. Although the prevalence of missed injuries is low, hospitals introducing a TTC model should consider departmental processes to help accurately identify and triage high-risk injuries.

People in intensive care with COVID-19: demographic and clinical features during the first, second, and third pandemic waves in Australia.

OBJECTIVE: To compare the demographic and clinical features, management, and outcomes for patients admitted with COVID-19 to intensive care units (ICUs) during the first, second, and third waves of the pandemic in Australia. DESIGN, SETTING, AND PARTICIPANTS: People aged 16 years or more admitted with polymerase chain reaction-confirmed COVID-19 to the 78 Australian ICUs participating in the Short Period Incidence Study of Severe Acute Respiratory Infection (SPRINT-SARI) Australia project during the first (27 February - 30 June 2020), second (1 July 2020 - 25 June 2021), and third COVID-19 waves (26 June - 1 November 2021). MAIN OUTCOME MEASURES: Primary outcome: in-hospital mortality. SECONDARY OUTCOMES: ICU mortality; ICU and hospital lengths of stay; supportive and disease-specific therapies. RESULTS: 2493 people (1535 men, 62%) were admitted to 59 ICUs: 214 during the first (9%), 296 during the second (12%), and 1983 during the third wave (80%). The median age was 64 (IQR, 54-72) years during the first wave, 58 (IQR, 49-68) years during the second, and 54 (IQR, 41-65) years during the third. The proportion without co-existing illnesses was largest during the third wave (41%; first wave, 32%; second wave, 29%). The proportion of ICU beds occupied by patients with COVID-19 was 2.8% (95% CI, 2.7-2.9%) during the first, 4.6% (95% CI, 4.3-5.1%) during the second, and 19.1% (95% CI, 17.9-20.2%) during the third wave. Non-invasive (42% v 15%) and prone ventilation strategies (63% v 15%) were used more frequently during the third wave than during the first two waves. Thirty patients (14%) died in hospital during the first wave, 35 (12%) during the second, and 281 (17%) during the third. After adjusting for age, illness severity, and other covariates, the risk of in-hospital mortality was similar for the first and second waves, but 9.60 (95% CI, 3.52-16.7) percentage points higher during the third than the first wave. CONCLUSION: The demographic characteristics of patients in intensive care with COVID-19 and the treatments they received during the third pandemic wave differed from those of the first two waves. Adjusted in-hospital mortality was highest during the third wave.

IS IT TIME FOR PATIENT-INITIATED METHOTREXATE MONITORING?

Background/Aims Regular blood monitoring is recommended to ensure safety in patients on methotrexate (MTX). During the COVID pandemic, British Society of Rheumatology (BSR) sanctioned a reduction in monitoring for patients stable on MTX for 12 months. In accordance Devon CCG approved changing local Shared Care Guidelines (SCG), reducing the frequency to six monthly in stable MTX patients. Our aim was to assess whether monitoring frequency changed during the pandemic, and if so whether any patients came to harm. Methods Patients stable on MTX monotherapy for at least a year to 31.3.2020 were identified via hospital pathology. 854 patients identified;the mean number of days between monitoring requests was calculated for the year to April 2020, and year to April 2021, respectively. A subanalysis of 229 patients who had reduced from monthly to three monthly blood tests at similar time points was undertaken. Tests included: platelets (PLT), mean cell volume (MCV), neutrophils (NEUT), estimated glomerular filtration rate (eGFR), and alanine aminotransferase (ALT). Confidence intervals evaluated any differences in the results between monthly and three-monthly frequencies, in terms of overall distribution as well as at an individual patient level. Additionally, the numbers of 'catastrophic' test results, as defined by the Royal College of Pathologists, were calculated for the higher frequency and reduced frequency years. Results Testing frequency in the year to April 2020 approximated to monthly, and three-monthly in the year to April 2021. Sub-analysis in 229 patients showed the overall distributions of PLT, MCV, NEUT, eGFR and ALT results were no more likely to be outside normal laboratory parameters when tested less frequently. Furthermore, individual patients were no more likely to have results outside normal laboratory parameters with less frequent testing. Overall, our analysis indicated that reduced monitoring did not lead to more abnormal results. Additionally, 'catastrophic' results were extremely uncommon, and did not increase with reduced testing. Routine MTX monitoring revealed no catastrophic results, these only occurred in patients being managed for co-existing morbidities. Conclusion MTX monitoring reduced during the pandemic but not in adherence to updated SCG. We evidence that reducing frequency of routine blood monitoring did not increase abnormal results or cause harm in stable MTX patients. Significant blood abnormalities were rare and universally occurred only with co-existing morbidities. Across primary and secondary care workloads are increasing, resources are limited, and cost efficiencies needed. These findings support a review of the frequency of routine blood monitoring;is now the time to shift to patient-initiated testing in those stable on MTX monotherapy.

Inexpensive Multipatient Respiratory Monitoring System for Helmet Ventilation During COVID-19 Pandemic

Helmet continuous positive applied pressure is a form of noninvasive ventilation (NIV) that has been used to provide respiratory support to COVID-19 patients. Helmet NIV is low-cost, readily available, provides viral filters between the patient and clinician, and may reduce the need for invasive ventilation. Its widespread adoption has been limited, however, by the lack of a respiratory monitoring system needed to address known safety vulnerabilities and to monitor patients. To address these safety and clinical needs, we developed an inexpensive respiratory monitoring system based on readily available components suitable for local manufacture. Open-source design and manufacturing documents are provided. The monitoring system comprises flow, pressure, and CO2 sensors on the expiratory path of the helmet circuit and a central remote station to monitor up to 20 patients. The system is validated in bench tests, in human-subject tests on healthy volunteers, and in experiments that compare respiratory features obtained at the expiratory path to simultaneous ground-truth measurements from proximal sensors. Measurements of flow and pressure at the expiratory path are shown to deviate at high flow rates, and the tidal volumes reported via the expiratory path are systematically underestimated. Helmet monitoring systems exhibit high-flow rate, nonlinear effects from flow and helmet dynamics. These deviations are found to be within a reasonable margin and should, in principle, allow for calibration, correction, and deployment of clinically accurate derived quantities. Copyright © 2022 by ASME.

Ecological analysis of the temporal trends in the association of social vulnerability and race/ethnicity with county-level covid-19 incidence and outcomes in the United States

Background: The COVID-19 pandemic adversely affected socially vulnerable and minority communities in the US initially, but the temporal trends during the year-long pandemic remain unknown. Objective: We examined temporal association between county-level Social Vulnerability Index (SVI), a percentile-based measure of social vulnerability to disasters, its subcomponents and race/ethnic composition with COVID-19 incidence and mortality in US in the year starting in March 2020. Methods: Counties (n=3091) with > 50 COVID-19 cases by March 6th, 2021 were included. Associations between SVI (and its subcomponents) and county level racial composition with incidence and death per capita were assessed using a negative-binomial mixed-effects model. This model was used to examine potential time varying associations between weekly number of cases/deaths and SVI or racial composition. Data was adjusted for percentage of population aged ≥65 years, state level testing rate, county-level comorbidities, and environmental factors. Results: Higher SVI, indicative of greater social vulnerability, was independently associated with higher COVID-19 incidence (adjusted incidence rate ratio [IRR] per-10 percentile increase:1.02, (95% CI 1.02, 1.03, p<0.001), and death per capita (1.04, (95% CI 1.04, 1.05, p<0.001). SVI became an independent predictor of incidence starting from March 2020, but this association became weak or insignificant by winter, a period that coincided with sharp increase in infection rates and mortality, and when counties with higher proportion of White residents were disproportionately represented (“third wave”). By Spring 2021, SVI was again a predictor of COVID-19 outcomes. Counties with greater proportion of Blacks also observed similar temporal trends in COVID-19-related adverse outcomes. Counties with greater proportion of Hispanics had worse outcomes throughout the duration of the analysis. Conclusion: Except for winter “third wave” when majority White communities had highest incidence of cases, counties with greater social vulnerability and higher minority populations, experienced worse COVID-19 outcomes.

Expected impacts of the wets deployment of the oe35 oscillating water column

To bring the wave energy sector to full commercialisation, the laboratory and small-scale testing, TRL 3 – TRL 6, must progress to full scale, long-term testing, TRL 7 – TRL9. The cost of testing at full-scale grows exponentially in early stages of scale-up. The high costs make gathering as much knowledge as possible from each test vital. The TRL 6 deployment of the Ocean Energy OE35 buoy, with the Siemens HydroAir Turbine at the US Navy Wave Energy Test Site (WETS) in Kāne‘ohe Bay, O’ahu, Hawai’i is the largest floating oscillating water columns (OWC) deployment to date. The buoy has been fabricated and delivered to O’ahu for deployment, but final deployment, like so many aspects of life, has been delayed due to the COVID-19 pandemic. This paper aims detail the some of the expected important outcomes from the 12-month deployment at WETS, and the learning from the project so far. © European Wave and Tidal Energy Conference 2021.

Undergraduate Biology Students Received Higher Grades During COVID-19 but Perceived Negative Effects on Learning

Institutions across the world transitioned abruptly to remote learning in 2020 due to the COVID-19 pandemic. This rapid transition to remote learning has generally been predicted to negatively affect students, particularly those marginalized due to their race, socioeconomic class, or gender identity. In this study, we examined the impact of this transition in the Spring 2020 semester on the grades of students enrolled in the in-person biology program at a large university in Southwestern United States as compared to the grades earned by students in the fully online biology program at the same institution. We also surveyed in-person instructors to understand changes in assessment practices as a result of the transition to remote learning during the pandemic. Finally, we surveyed students in the in-person program to learn about their perceptions of the impacts of this transition. We found that both online and in-person students received a similar small increase in grades in Spring 2020 compared to Spring 2018 and 2019. We also found no evidence of disproportionately negative impacts on grades received by students marginalized due to their race, socioeconomic class, or gender in either modality. Focusing on in-person courses, we documented that instructors made changes to their courses when they transitioned to remote learning, which may have offset some of the potential negative impacts on course grades. However, despite receiving higher grades, in-person students reported negative impacts on their learning, interactions with peers and instructors, feeling part of the campus community, and career preparation. Women reported a more negative impact on their learning and career preparation compared to men. This work provides insights into students’ perceptions of how they were disadvantaged as a result of the transition to remote instruction and illuminates potential actions that instructors can take to create more inclusive education moving forward. © Copyright © 2021 Supriya, Mead, Anbar, Caulkins, Collins, Cooper, LePore, Lewis, Pate, Scott and Brownell.

Impact of induction immunosuppression selection on clinical outcomes in kidney transplant recipients during the COVID-19 pandemic in New York City

Purpose: As an early epicenter in the coronavirus pandemic, our center modified induction immunosuppression strategies for transplantation. We sought to determine if changes in induction immunosuppression secondary to the COVID-19 pandemic impacted the incidence of acute rejection. Methods: Adult kidney transplant recipients at NYU Langone Health between 09/2019 and 08/2020 were retrospectively identified. Patients who received a multiorgan transplant or whose induction regimen was changed due to clinical course were excluded. Patients transplanted before and after 3/17/2020 were grouped as pre-pandemic (PRE) and post-pandemic (POST), respectively, based on temporary interruption of transplantation. Induction immunosuppression discordance was identified by blind adjudication from a standard protocol. Reduced induction agent use (basiliximab given when pre-pandemic protocol indicated rabbit anti-thymocyte globulin (rATG)) was compared between groups using a Chi-square test. Biopsyproven acute rejection (BPAR) and the incidence of rejection was compared using a Poisson regression model. Results: 203 kidney transplant recipients were retrospectively identified. 38 patients were excluded, leaving 165 patients for analysis. Median patient age was 57 years, 67% were male, and diabetes mellitus (35%) was the most common cause of renal disease. Discordance from protocol induction agent was 16% in the PRE group and 28% in the POST group (p=0.06). More patients received reduced induction with basiliximab in lieu of rATG in the POST group than the PRE group (26% vs. 7%, p=0.001). BPAR occurred in 5 PRE (5%) and 6 POST (11%) patients (p=0.19). The incidence of rejection was 0.13 and 0.75 rejection episodes/1,000-patient days for the PRE and POST groups, respectively;this was significantly different between the 2 time periods (unadjusted IRR 5.69, 95% CI 1.74-18.6, p=0.004). Conclusions: More patients received reduced induction immunosuppression driven by the COVID-19 pandemic concerns. These COVID-related changes in immunosuppression may have contributed to a trend in increased acute rejection in a preliminary analysis.

Grand rounds via videoconferencing: A suitable option in a post-COVID-19 era?

AIMS & OBJECTIVES: This study aimed to gain feedback from the clinical team to establish positive and negative aspects of conducting Grand Rounds via video conferencing and the barriers to adopting this technology. METHODS: Following ten Grand Rounds conducted via video conferencing, an online survey was created using Microsoft Forms. It comprised of Likert scale, multiple choice and free text questions, addressing the following themes: comfort, participation, teaching, technology, organisation, accessibility and social contact. It was distributed to members of the critical care team, including consultants, registrars, advanced nurse practitioners, allied health professionals and band 7 nurses. The replies were collated using Microsoft Excel. Likert scales responses were displayed in a bar chart and a 66% majority was felt to be significant. Following a thematic analysis by the author, free text responses were divided into positive and negative themes and displayed in a word cloud. RESULTS: 30 surveys were distributed with 19 (63%) responses. Overall 11 (58%) respondents preferred Grand Rounds via video conferencing. The majority felt video conferencing improved comfort, efficiency and organisation of Grand Rounds. The majority felt the technology did not detract from the discussion, but enhanced it. Three (15%) had recurrent issues with connectivity. There was no significant majority missing the social aspects of Grand Rounds. Some expressed concern of the exclusion of nurses caring for the patients. CONCLUSIONS: Video conferencing improved the efficiency, learning and accessibility of Grand Rounds. With better connectivity and involvement of nursing staff, video conferencing will become a viable and preferred method for conducting Grand Rounds.

Predicting the Size and Duration of the COVID-19 Pandemic

This article explores the ongoing COVID-19 pandemic, asking how long it might last. Focusing on Bahrain, which has a finite population of 1.7M, it aimed to predict the size and duration of the pandemic, which is key information for administering public health policy. We compare the predictions made by numerical solutions of variations of the Kermack-McKendrick SIR epidemic model and Tsallis-Tirnakli model with the curve-fitting solution of the Bass model of product adoption. The results reiterate the complex and difficult nature of estimating parameters, and how this can lead to initial predictions that are far from reality. The Tsallis-Tirnakli and Bass models yield more realistic results using data-driven approaches but greatly differ in their predictions. The study discusses possible sources for predictive inaccuracies, as identified during our predictions for Bahrain, the United States, and the world. We conclude that additional factors such as variations in social network structure, public health policy, and differences in population and population density are major sources of inaccuracies in estimating size and duration. © Copyright © 2021 Lewis and Al Mannai.

COVID-19 Impact on Heart Organ Transplantation - New Insights from a Single-Center Experience

Purpose During the COVID 19- pandemic, there is no consensus on management strategies for treating infected heart transplant patients. The outcomes of these patients vary by institution. We report our center experience and management strategies to date. Methods All patients who received heart transplantation, from January 4th 2018 to September 25th 2020 and were diagnosed with SARS-CoV-2 were included and full chart review was performed. Results There were 113 heart transplants at our institution by September 2020. A total of 13 (12%) patients were infected with SARS-CoV-2: 9 (69%) isolated heart, 3 heart -kidney (23%) and 1 heat- lung (8%). The median (IQR) time from transplant to diagnosis was 10 (5-16) months. The mean age was 57 years and 50% were male;50% were of Hispanic ethnicity. The main presenting symptoms were fever (43%), cough (86%) and SOB (43%). Chest x-ray was abnormal in all patients. We evaluated all patients and 79% were hospitalized and 21% were closely monitored as outpatients. None of our patients were hospitalized at outside institutions. Two (14%) required intubation and none required V-V ECMO support. The immunotherapy was modified in all patients: MMF and prednisone were discontinued, tacrolimus dose was reduced. COVID19 treatment was: 71% received hydroxychloroquine, 50% azithromycin, 15% remdesevir, 7% convalescent plasma. All hospitalized patients received anticoagulation. One patient had 2R/3A rejection within 30 days prior to diagnosis. Graft function was maintained in all patients with median LVEF% 65 (59-65%) except one patient who had received thymoglobulin 2 weeks prior to COVID 19 infection (LVEF 30%). The patient had a prolonged intubation but ultimately recovered and was discharged from the hospital. The one death (7.1%) was a heart - kidney recipient who concomitantly presented with pseudomonas sepsis and severe neutropenia. The remaining patients have all been discharged home. Conclusion We present our single center experience in managing COVID 19 infected heart transplant patients. We implemented uniform management strategies by incorporating aggressive reduction of immunosuppression, frequent scheduled contacts with infected outpatients and making sure all infected patients requiring hospitalization were treated at a transplant center.