How Did Governments Address the Needs of People With Disabilities During the COVID-19 Pandemic? An Analysis of 14 Countries' Policies Based on the UN Convention on the Rights of Persons With Disabilities

Background: People with disabilities have experienced heightened social risks in the context of the pandemic, resulting in higher rates of infection and mortality. They have also borne elevated burdens associated with public health measures. The United Nations Convention on the Rights of Persons with Disabilities (UNCRPD) obliges its 184 state parties to eliminate discrimination and ensure equality and inclusion for persons with disabilities, including protection and safety in situations of emergency. It remains unclear to what extent national COVID-19 policies have aligned with these commitments under the UNCRPD. Our objective in this exploratory study was to assess alignment between the UNCRPD indicators and COVID-19 policies from 14 countries with the goal of informing policy development that is inclusive of persons with disabilities and responsive to rights under the UNCRPD. Methods: We identified COVID-19 policy documents from 14 purposively selected countries. Country selection considered diversity based on geographic regions and national income levels, with restriction to those countries that had ratified the UNCRPD and had English or French as an official language. We used a computational text mining approach and developed a complex multilevel dictionary or categorization model based on the UNCRPD Bridging the Gap indicators proposed by the Office of the High Commissioner on Human Rights (OHCHR). This dictionary was used to assess the extent to which indicators across the entirety of the UNCRPD were represented in the selected policies. We analyzed frequency of associations with UNCRPD, as well as conducting ‘key word in context' analyses to identify themes. Results: We identified 764 COVID-19 national policy documents from the period of January 2020 to June 2021. When analyzed in relation to the Articles of the UNCRPD, the most frequently identified were Articles 11 (risk and humanitarian emergencies), 23 (home and family), 24 (education), and 19 (community living). Six countries produced 27 policies that were specifically focused on disability. Common themes within these documents included continuation of services, intersectionality and equity, and disability considerations in regulations and public health measures. Conclusion: Analyzing country policies in light of the UNCRPD offers important insights about how these policies do and do not align with states' commitments. As new policies are developed and existing ones revised, more comprehensive approaches to addressing the rights of persons with disabilities are urgently needed. © 2023 The Author(s);Published by Kerman University of Medical Sciences.

Ecmo as a Bridge to Lung Transplantation for Covid-19 Respiratory Failure: Outcomes and Risk Factors for Early Mortality

Severe COVID-19 infection can cause advanced respiratory failure requiring ECMO. In some cases, lung transplantation (LT) is a last viable treatment option. This study aims to evaluate outcomes among COVID patients bridged to LT with ECMO and identify risk factors for early mortality post-LT. Using the UNOS database, we identified 442 patients who underwent LT for COVID-19 respiratory failure between August 2020 and September 2022. Outcomes of patients requiring preoperative ECMO (n=253) were compared to those who did not require ECMO pre-LT (n=189). Survival analyses were conducted using the Kaplan-Meier survival function and Cox proportional hazards models. Risk factors for post-LT mortality were analyzed using a multivariate logistic regression model. Out of 442 patients, 253 required preoperative ECMO support for a median of 73 days (IQR 40, 119). The most common ECMO platform was veno-venous (p=0.0008). Patients requiring ECMO were younger, more frequently in an ICU, had higher LAS scores, more likely to require bilateral LT, had higher rates of tracheostomy and pre-LT dialysis, and were more likely to have ARDS etiologies of respiratory failure (all p<0.0001). At 1 and 6 months post-LT, there was no difference in survival between ECMO and non-ECMO patients (95.5% vs 97.5% at 1 month, 92.7% vs 93.4% at 6 months) (Fig 1a). However, ECMO patients had higher rates of prolonged ventilation, post-operative ECMO, new dialysis, and increased length of stay (all p<0.0001) post-LT. Risk factors for mortality included BMI (p=0.007), pan-resistant bacterial infection (p=0.01), preoperative VA ECMO (p=0.0008), prior cardiac surgery (p=0.05), and single LT procedure (p<0.0001) (Fig 1b). Our findings suggest that ECMO can safely be used as a bridge to LT in well-selected patients with COVID-19 respiratory failure despite prolonged support. Here we identify possible risk factors associated with early mortality that may require further evaluation. [ FROM AUTHOR] Copyright of Journal of Heart & Lung Transplantation is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Minor Changes with Large Implications: Modeling Amino Acid Mutations in SARSCoV Monoclonal Antibodies (80R and 362) Towards the Design of More Universal Antibodies

The SARS-CoV-2 virus is responsible for the COVID-19 pandemic which continues to impact nearly every person on Earth, having caused over 1.8 million deaths. Two anti-SARS-CoV monoclonal antibodies (MAbs) 80R and 362 are known to bind to epitopes on the spike protein receptor-binding domain (RBD) and neutralize the virus. To investigate this further and hypothesize structures for potentially more effective antibodies, undergraduate students cooperated in teams as part of the CREST (Connecting Researchers, Educators, and STudents) Program with the Center for Biological Modeling. Working collaboratively, students from eight universities nationwide applied their knowledge to build 3-D printed models to explain a particular protein-based molecular story using crystal structures of proteins described in the literature. The Nova Southeastern University (NSU) CREST team modeled and compared the 80R antibody that binds to SARS-CoV-1 and the MAb362 antibody that can bind to both SARS-CoV-1 and SARS-CoV-2. Students developed skills with protein visualization software including Pymol and Jmol to design models which showed the 80R and 362 antibodies binding to the RBD of the corresponding proteins. By studying the point mutation differences between the two antibodies (80R and 362), a potentially more universal antibody (named NSU1 in this study) was modeled. This hypothesized antibody was expected to bind more effectively to future mutations in the SARS spike protein. At the binding interface between these antibodies and the SARS spike protein, MAb362 mutations trend smaller and less polar including: Arg149Ser, Asn151Ser, Asp170Gly, and Trp213Ser. Due to the trend of smaller amino acids appearing in the MAb362 binding interface, it was hypothesized that more space in this area could allow antibodies to be more resistant to future SARS-CoV spike protein structure variations. NSU1 was modeled based on MAb362 with the following four additional mutations: Asp103Gly, Trp104Leu, Gly170Ser, and Arg211Val. All of these except for Gly170 are mutations that decreased size and polarity of amino acid residues within the binding interface. Position 170 is Asp on the 80R structure and thus a mutation to Ser is still expected to maintain this trend of smaller residues in the antibody. Due to the additional space created due to these amino acid substitutions in the binding region between the antibody and RBD of the spike protein, NSU1 was predicted to be more resistant to spike protein mutations. These models allowed for deeper understanding of the impact that mutations in antibodies can have on binding interactions with viral proteins. Additionally, the modeling process also provided insight into the molecular structure of a potentially more universal antibody against variations in SARS-CoV.

POSA216 Biosimilar Assessment Frameworks and Policy Shifts in the EU in the Post-COVID Context

Objectives: Recent years have witnessed EU markets updating their biosimilar policies;however, there remain countries where the full cost-savings potential of biosimilars is yet to be realized. This research aims to review the current EU biosimilar landscape, and to investigate the most recent policy shifts as an indicator of expected evolution in the post-COVID environment, as payers express growing interest in healthcare savings. Methods: A qualitative assessment of current EU biosimilar policies was performed, followed by an investigation into emerging global policy shifts, to provide insight into the future direction in which the biosimilar landscape in the EU is shifting. Findings were used to identify trends and predict the changes we should expect in the post-COVID context. Results: The most sophisticated regulatory and pricing environments for biosimilars were identified in Germany and the UK, with policies including regional quotas and reference price groups, respectively. Conversely, markets where streamlined biosimilar access pathways remain lacking include Italy, Spain, Austria, Poland, Romania and Turkey, together with the markets in which there are no legislative measures or recommendations to support uptake at the prescriber-level, such as Bulgaria, Czech Republic, Estonia, Ireland and Slovakia. Investigation of the most recent policy updates highlighted a focus on eradicating barriers to market access. In Italy, a streamlined procedure for pricing and reimbursement of biosimilars was introduced in October 2020. The UK has followed suit and introduced a new licensing pathway specifically for biosimilars, which will not require comparative efficacy data. Beyond EU, Quebec represents one of the example markets that recently announced intention to enforce biosimilar switching, becoming the fourth Canadian province to do so. Conclusions: Emerging policies indicate that future shifts will tackle biosimilar uptake from multiple fronts, with market access policy updates likely to include introduction of abbreviated reimbursement pathways for biosimilars, while switching policies drive uptake at the prescriber-level.

THE FIRST AND SECOND WAVE OF COVID-19 IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A TEMPORAL TREND ANALYSIS

Background: Cases of Coronavirus disease 2019 (COVID-19) have emerged in discrete waves across different regions in the world. We explored temporal trends in the reporting of COVID-19 in patients with inflammatory bowel disease (IBD), in a large global database. Methods: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international registry to study the character-istics and outcomes of patients with IBD diagnosed with COVID-19. Joinpoint regression models calculated the average percent change (APC) with 95% confidence intervals (CI) in weekly reported cases of COVID-19 in patients in the registry stratified by geographic regions (Asia, Europe, Latin America, and North America) during two time periods: March 22 to September 12 and September 13 to November 14, 2020. We also determined the APC in US regions (Midwest, Northeast, South and West) during the two time periods. Results: Across 63 countries and dependencies, 3,195 cases of COVID-19 in people with IBD were reported over an 8-month period. Overall, COVID-19 reporting steadily decreased throughout the world by 4.5% per week (95% CI: −5.7, −3.2) from March 22 to September 12, 2020 but then steadily climbed by 12.4% per week (95% CI: 6.8, 18.3) from September 13 to November 14, 2020. After stratification by geographic region, weekly reporting declined before September 13 in North America (APC = −2.0%;95% CI: −3.7, −0.4), Asia (APC =− 4.4%;95% CI: −7.8, −0.9), and Europe (APC = −8.6%;95% CI: −10.6, −6.6), but escalated in Latin America (APC = 3.4%;95% CI: 0.7, 6.1) (Figure 1). After September 12, the rate of weekly cases decreased in Latin America (APC = −19.0%;95% CI: −33.3, −1.7) and Asia (APC = −19.3%;95% CI: −34.6, −0.5), while increased in North America (APC = 10.7%;95% CI: 4.3, 17.4) and Europe (APC = 28.0%;95% CI: 17.3, 39.6) (Figure 1). Within the US, temporal trends differed by region: Midwest (stable APC: −0.8%;95% CI: −3.5, 1.9 then increase APC: 27.3%;95%: 16.1, 39.6), Northeast (decrease APC: −9.1%;95% CI:− 11.8, −6.2 then stable APC: 2.4%;95% CI: −9.9, 16.5), South (increase APC: 5.3%;95%CI: 2.5, 8.3 then decrease APC: −12.0;95% CI: −18.4, −5.0), and West (stable APC: 0.2%;95% CI: −3.0, 3.5 then stable APC: 9.0%;95% CI: −13.8, 37.9) (Figure 2). Conclusion: COVID-19 reporting to SECURE-IBD declined steadily during the first wave of the pandemic throughout the world except Latin America. Starting in September, reports to SECURE-IBD rose in both Europe and North America, consistent with the second wave of the pandemic in these countries.(Figure presented)Figure 1. Global regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Asia, B. Europe, C. Latin America, and D. North America: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020(Figure presented)Figure 2. United States regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Midwest, B. Northeast, C. South, and D. West: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020

SKCC medical oncology telehealthexperience during Covid-19 pandemic: Lessons learnedand operational changes to leverage telehealth tomaintain patient access

The purpose of this report is to share lessons learned at the Sidney Kimmel Cancer Center (SKCC) in response tothe COVID-19 National Emergency, marked by expanding telehealth (TH) to decrease patient risk while maintainingaccess to care. TH utilization requires resources (smart phones/tablets, email, internet), and there are disparities indigital media access in our patient population. We learned from a digital literacy survey performed at the SKCC in2018 that 30% of our patients used Android phones and > 60% of patients accessed the internet from a PC. OurEHR was built to support a “nonpandemic” level of TH visits, which increased in a short span from 29 visits inJanuary 2020 to 1,700 visits in April 2020. Pre-COVID, the Jefferson TH office had 5 support employees to assistpatients with TH. Though some patients needed support, the TH team had a manageable caseload. During the firstweeks of the pandemic, the EHR TH software was updated to accommodate increased demand, requiringPC/mobile device upgrades/setting changes, which posed a potential barrier to care. In response to increased THdemand and need for support, the SKCC launched an oncology-dedicated Telehealth Task Force (TTF) to addressbarriers to TH access. Examples of TTF's targeted patient solutions include set-up and delivery of smartphones, creating email accounts, disseminating instructions for TH use, and real- time assistance during TH visits. Dailyprotocol for support staff across the SKCC adapted to accommodate the increase in TH visits. Phone room staffexperienced increased volume of scheduling requests to change in-person visits to TH, from 165 rescheduled inMarch 2020 to 431 in April 2020, and established new scripting and triage protocol. Administrative staff now followsup telephonically for TH visits. Providers noted challenges in completing TH visits within predetermined appointmentlength due to technical delays and increased time needed for novice users. The nurse's role in the care team wasvital in reinforcing to patients the availability of TTF supports prior to their TH visits and communicating appointmentdelays to improve patient experience. Providers noted the need to document at the point of care as support staff relyon this to schedule testing/follow-up visits. Supportive resources for TH were quickly appreciated, such as access toforms for timely documentation of treatment consent. The SKCC experienced an exponential rise in TH use andmade critical workflow adjustments as well as creating a dedicated TTF to maintain access to care for oncologypatients during an uncertain public health crisis.