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1.
Journal of the American Association for Laboratory Animal Science ; JOUR:546, 61(5).
Article in English | EMBASE | ID: covidwho-2092148

ABSTRACT

FDA granted emergency use authorization (EUA) for the world's first mRNA vaccine, developed by Pfizer-BioNTech, in December 2020. As a result, many vaccinated people were protected from the fatality of COVID-19, but some people suffered from various side effects of the mRNA vaccine. The EUA was immediately decided to control COVID-19 pandemic and the deregulation of preclinical safety assessment for mRNA vaccine was inevitable. In preclinical phase, efficacy assessment of several mRNA vaccine candidates has been performed by using COVID-19 mouse infection model. However, the guideline of safety assessment for mRNA vaccine in mice has not yet been established. Therefore, it is necessary to identify mRNA vaccineinduced toxicity and clinical symptoms. In this study, we evaluated the clinical and serologic changes induced by the intramuscular injection of 4 types of mRNA vaccines (100 mug/head) with different compositions (C2/LNP90, C2LNP128, C3LNP90, and C3LNP128) in 6-wk-old male and female ICR mice. Five mice per group, a total of 25 male and female mice, respectively, were used in this study. mRNA vaccines were injected twice at an interval of 2 wk and necropsy was carried out 2 d after secondary injection. CBC, blood chemistry analysis, and visual evaluation of whole-body tissues were performed. The results showed that the body weight was decreased for 2 d after the first injection in C2/LNP128 and C3/LNP128- injected mice compared to vehicle-injected mice, but it was almost recovered at 14 d postinjection (dpi). The endpoint blood and serum analysis demonstrated that C2/LNP128 and C3/LNP128 decreased the number of lymphocyte, monocyte, and reticulocyte carrying the abnormal level of liver function indicator such as albumin, AST, ALT, and total protein. Additionally, C2/LNP128 decreased the number of platelets and C3LNP128 decreased the number of red blood cells, respectively. Spleen and inguinal lymph nodes were enlarged in all experimental groups compared to the control group. Notably, C2/ LNP128 and C3/LNP128 induced severe edema in the injection site, the femoral muscle, that was significantly enlarged. Although more detailed analyses should be carried out, these results suggest that the safety assessment of mRNA vaccines must be systematically established with multiple aspects of toxicology and laboratory animal medicine.

2.
Nursing Open ; 2022.
Article in English | Scopus | ID: covidwho-2013702

ABSTRACT

Aim: This study explored nursing students' eHealth literacy, lifestyle behaviours and COVID-19-related preventive behaviours and associated factors. Design: A cross-sectional comparative correlational study. Methods: Nursing students (n = 358) from a metropolitan area of South Korea were recruited for an online survey. The online questionnaire included: The eHealth Literacy Scale, the Health Promoting Lifestyle Profile-II and the COVID-19-related preventive behaviour scale. Results: COVID-19-related preventive behaviours correlated positively with satisfaction with one's major, time spent seeking health information online, eHealth literacy and lifestyle behaviours. Significant factors affecting COVID-19-related preventive behaviours were the following: being female (β = 0.194, p <.001), time spent seeking health information online (β = 0.114, p =.002), eHealth literacy (β = 0.167, p =.001) and lifestyle behaviours (β = 0.266, p <.001). Conclusions: Findings highlight the need to strengthen searching behaviours to access accurate health information online and reinforce eHealth literacy and health-promoting lifestyle behaviours to improve COVID-19 preventive behaviours among nursing students. © 2022 The Authors. Nursing Open published by John Wiley & Sons Ltd.

3.
Journal of Hospitality and Tourism Technology ; 2022.
Article in English | Web of Science | ID: covidwho-2005058

ABSTRACT

Purpose Existing service research has revealed that customers' perceived equity influences the sustainability of a business. Despite the importance of food service mobile applications during the COVID-19 pandemic, studies that have examined customers' loyalty toward mobile applications remain limited. Thus, this study aims to examine the impact of mobile application-related attributes on customers' behavior in the food delivery industry. Design/methodology/approach The authors collected data from 214 US customers to extend knowledge on perceived equity by examining the effect of multidimensional equity (i.e. value equity, brand equity and relationship equity) on loyalty in the mobile food service context. Findings Results of partial least square structural equation modeling suggest that three aspects of customers' perceived equity are positively related to customers' attitudinal loyalty, which is linked to behavioral loyalty. Moreover, the role of attitudinal loyalty and demographic characteristics (i.e. gender and age) is described. Originality/value This empirical research explores how food delivery brands can increase customers' positive behavior by investigating the role of multidimensional equity. Service providers must understand certain aspects of customers' perceived equity to increase food service brand sustainability.

4.
12th International Conference on ICT Convergence (ICTC) - Beyond the Pandemic Era with ICT Convergence Innovation ; : 1441-1443, 2021.
Article in English | Web of Science | ID: covidwho-1853463

ABSTRACT

This study aims to analyze the effects of Covid-19 on the floating population of Seoul, based on population influx/outflux data from January-June, 2019 and January- June, 2020. The datasets are partitioned into their respective administrative districts. Moreover, to understand the effects of Covid-19, the PageRank algorithm is employed to analyze and identify the districts with the most population influx as well as the changes in population movement in Seoul between 2019 to 2020.

5.
Journal of the American College of Cardiology ; 79(9):190-190, 2022.
Article in English | Web of Science | ID: covidwho-1848273
6.
Clinical Cancer Research ; 27(6 SUPPL 1), 2021.
Article in English | EMBASE | ID: covidwho-1816889

ABSTRACT

Coronavirus-19 outbreak caused concern of lowering performance of clinical trials, including delays in initiation, lower enrollment, or more frequent deviations related with visit schedule change. Korea, with the sixth largest number of industry-sponsored interventional drug trials in the world, has been controlling COVID-19 outbreak rather successfully and maintaining daily medical practice in most areas of the country. We investigated performance of oncology clinical trials before and after COVID-19 in Korea. We retrospectively identified and reviewed the files, notes, and source documents of ongoing breast cancer clinical trials during January to May 2019 and January to May 2020 in a single cancer center conducting oncology trials in Korea. Number of enrolled patients, drop-outs, protocol deviations including study visit delay or visit omission were measured. We investigated 77 ongoing studies from January to May 2020, and 67 from the same period in 2019. The numbers of newly initiated trials and new enrollment were not decreased during COVID-19 outbreak period. After outbreak of COVID-19, number of onsite monitoring was decreased, however total number of monitoring was maintained as remote monitoring was increased. Remote monitoring comprised 44% of all monitoring visit in 2020, and found 30%(15/50) of protocol deviations detected by all monitoring visit. Of the 26 study visit related protocol deviations during February to May 2020, 10(38%) cases were COVID-19 related. Thirteen percent(3/24) of study drop out cases were COVID-19 related, from subjects' demand due to fear of visiting hospital. Although monitoring access was limited, vigorous countermeasures successfully maintained performance of oncology clinical trials during COVID-19 outbreak in Korea. Remote monitoring visits successfully complemented restricted onsite monitoring. COVID-19 related protocol deviations and drop-out cases were noted, mostly from subjects' concerns about travel. Future regulations and guidelines should pursue developing alternatives of face-to-face contact visit as needed.

7.
Blood ; 138:2900, 2021.
Article in English | EMBASE | ID: covidwho-1736281

ABSTRACT

Introduction: Randomized trials demonstrated ~95% efficacy of SARS-CoV-2 spike messenger RNA (mRNA) vaccines. Patients (pts) after allogeneic hematopoietic cell transplant (HCT) have a variable period of immune deficiency and the impact of diagnosis, treatment regimens, GvHD, and immunosuppression on vaccine (vacc) immunogenicity is unknown. Methods: We performed a retrospective analysis of 149 consecutive pts (Table) who received a SARS-CoV-2 vacc between 12/17/2020, and 5/21/21, and were tested for anti-SARS-CoV-2 S1/S2 antibodies. Serology testing was performed with the Liaison® SARS-CoV-2 S1/S2 IgG assay (DiaSorin) with ≥15 AU/mL defined as a positive result. Pts with prior COVID-19 infection were excluded. Pts received mRNA-1273/Moderna (n= 46), BNT162b2/Pfizer-BioNTech (n= 100) or Jannsen vacc (n= 3). Reactogenicity was not investigated. Demographic and treatment variables were tested for prediction of vaccine response using Chi-square test or Fisher's exact test for categorical variables and two-sample t test for continuous variables. Univariate and multivariable logistic regression analyses with backward selection using Akaike information criterion (AIC) were used to examine interdependence of those variables and odds ratios (OR) with 95% confidence intervals (CI). Results: Pts underwent HCT from a related HLA matched sibling (n=36), related haploidentical (n= 23), or matched/mismatched unrelated donor (n= 89). 93% received fludarabine in the HCT conditioning regimen (data not shown). All pts received a calcineurin inhibitor (CNI) and 76 pts received ATG for GvHD prophylaxis. All pts achieved at least mixed donor lymphoid engraftment (data not shown). Median time from HCT to 1st vaccination was 26 months (range, 3-258 months). Median age at time of vaccination was 61 years (range, 24-78) and 75 (50%) were female. Serology was tested at a median of 37 days (range, 6-119 days) after the second vacc dose. Serology was tested <14 days in 3 pts;all were seropositive. No pt developed COVID-19 during the period of observation. 101 pts (67%) tested positive for anti-SARS-CoV-2 S1/S2 antibodies (vacc responders). Of the responders, the median time from HCT to 1st vacc was 45.5 months (range, 3-258, SD 39.78). Among the 23 pts between 3-9 months after HCT, 26% (n=6) had a positive antibody response, but all were receiving ongoing immunosuppression at time of vaccination. 29% (n=29) vacc responders were receiving prednisone (pred) in the management of cGvHD at the time of vaccination. 48 pts did not mount an antibody response (vacc non-responders). Of the non-responders, 30 pts were receiving cGvHD treatment at the time of vacc, 31 pts were taking pred, and 20 pts were taking CNIs. In univariate analysis, we found a history of prolonged use of pred (>8 weeks) and/or CNIs, on current treatment for cGvHD at time of vacc, and receipt of rituximab in the preceding 12 months predicted for lack of response (Table). Active use of pred and treatment with pred >8 weeks in the preceding 12 months prior to vacc predicted vacc non-response [OR 0.221;95% CI (0.106 - 0.456);p<0.001] and [OR 0.408;95% CI (0.197 - 0.844);p=0.016] in univariate analysis, respectively, however, active use of pred was predictive [OR 0.07;95% CI (0.016-0.304;p<0.001] while pred treatment >8 weeks was not [OR 2.00;95% CI (0.55-7.298;p=0.293] in multivariable analysis. Other significant predictors for non-response in the multivariable analysis include pt use of ruxolitinib [OR, 0.233, 95% CI, (0.067-0.808);p=0.022], and rituximab within 1 year [OR, 0.026, 95% CI, (0.007-0.099);p<0.001]. Discussion: In this study, we found that 67% allogeneic HCT pts developed anti-SARS-CoV-2 S1/S2 antibodies after SARS-CoV-2 vaccination. Predictors of non-response after adjustment for potential confounders, were factors that are expected to suppress immune response including active use of immunosuppressive medications. Consistent with prior studies, anti-CD20 therapy likely impairs humoral response to vaccination. Ruxolitinib also appears to impair response. owever, a proportion of pts being actively treated for cGvHD responded to vaccination and these pts should still be encouraged to receive vaccination in consideration of the COVID-19 mortality risk. Many questions remain including the protective benefit of immune response, the duration of response, and the potential value of booster vaccinations in non-responders. [Formula presented] Disclosures: Rowley: ReAlta Life Sciences: Consultancy.

8.
Chronobiology in Medicine ; 3(4):167-170, 2021.
Article in English | Scopus | ID: covidwho-1675634

ABSTRACT

A recently published study on coronavirus disease 2019 (COVID-19) and obstructive sleep apnea (OSA) suggested that there might be an association between certain risk factors and comorbidities associated with OSA, which are also associated with poor COVID-19 outcomes. However, it is unclear whether undiagnosed OSA correlates with COVID-19 severity in a South Korean population. We identified 7 patients who presented with nocturnal hypoxemia during hospitalization due to COVID-19. All patients underwent polysomnography 5-9 weeks after the infection. We retrospectively collected the patients' baseline characteristics, hospital admission data, and polysomnography findings. Of the 7 patients, all were diagnosed with OSA after COVID-19 infection. Their mean (±SD) age was 45.4±16.3 years, 57.1% were men, and their mean (±SD) body mass index was 33.4±6.0 kg/m2. Six patients presented with COVID-19-related pneumonia on chest X-rays, 3 of whom were admitted to the intensive care unit during the acute phase. The overnight polysomnography showed a mean AHI of 59.0±38.5/h and an oxygen desaturation index of 57.6±39.7/h. Undiagnosed OSA is a prevalent condition associated with moderate to severe COVID-19 infection. The study patients with sleep apnea and COVID-19 had obesity and severe oxygen desaturation but did not complain of daytime sleepiness. © This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/bync/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright © 2021 Korean Academy of Sleep Medicine

9.
12th International Conference on Information and Communication Technology Convergence, ICTC 2021 ; 2021-October:1441-1443, 2021.
Article in English | Scopus | ID: covidwho-1642556

ABSTRACT

This study aims to analyze the effects of Covid-19 on the floating population of Seoul, based on population influx/outflux data from January-June, 2019 and January-June, 2020. The datasets are partitioned into their respective administrative districts. Moreover, to understand the effects of Covid-19, the PageRank algorithm is employed to analyze and identify the districts with the most population influx as well as the changes in population movement in Seoul between 2019 to 2020. © 2021 IEEE.

10.
Respirology ; 26(SUPPL 3):23-24, 2021.
Article in English | EMBASE | ID: covidwho-1583451

ABSTRACT

Background: Although the use of remdesivir and systemic corticosteroids have reduced deaths from COVID-19, COVID-19 still has a high mortality rate. Aims: To know the effectiveness of the combined use of remdesivir and regdanvimab (CT-P59) in patients with severe COVID-19. Methods: From March to early May 2021, 124 severe COVID-19 patients were admitted to Ulsan University Hospital (Ulsan, Korea), and received oxygen therapy and remdesivir. Among them, 25 were administered regdanvimab before oxygen/remdesivir. We retrospectively compared the outcomes of the two groups: remdesivir alone group (n = 99 [79.8%]) vs. regdanvimab/remdesivir group (n = 25 [20.2%]). Results: The oxygen-free days at day 28 (primary outcome), defined as the number of days a patient was alive and oxygen-free for 28 days from oxygen/remdesivir start, were significantly higher in regdanvimab/remdesivir group (mean ± SD [standard deviation]: 19.36 ± 7.87 vs. 22.72 ± 3.66, P = 0.003). The association between the regdanvimab/ remdesivir group and the oxygen-free days was also significant in multivariate analysis (logistic regression), where the initial SpO2/FiO2 ratio (severity index) was adjusted. Further, in the regdanvimab/remdesivir group, the lowest SpO2/FiO2 ratio during treatment was significantly higher (mean ± SD: 237.05 ± 89.68 vs. 295.63 ± 72.74, P = 0.003), and the Kaplan-Meier Estimate of oxygen supplement days in surviving patients (at day 28) were significantly shorter (mean ± SD: 8.24 ± 7.43 vs. 5.28 ± 3.66, P (log-rank test) = 0.024). Conclusions: In severe COVID-19 patients, clinical outcomes could be improved by using regdanvimab in addition to remdesivir.

11.
Clinical Trials ; 18(SUPPL 5):79-80, 2021.
Article in English | EMBASE | ID: covidwho-1582532

ABSTRACT

Introduction: PREPARE is a pragmatic clusterrandomized crossover trial that compares the effectiveness of two common pre-operative antiseptic skin solutions to reduce the risk of surgical site infection after orthopedic fracture surgery. The trial compares 2% chlorhexidine in 70% isopropyl alcohol (ChloraPrep™) versus 0.7% iodine povacrylex in 74% isopropyl alcohol (DuraPrep™), and recruiting sites alternate study solutions every 2 months. Before the US national response to the COVID-19 pandemic, all PREPARE trial clinical sites obtained informed consent in person at the hospitals or fracture clinics. However, after 13 March 2020, the COVID-19 restrictions limited inperson consenting at some hospitals. Affected clinical sites were encouraged to transition to telephone consent, which was already included as a consent option in the PREPARE protocol. We aimed to determine how COVID-19 restrictions impacted the number of enrolling clinical sites and participant enrollment in the PREPARE trial. Methods: Prior to implementing telephone consent, clinical sites had to determine local logistics and obtain institutional review board approval for telephone consent scripts and procedures from the central or local institutional review boards. We descriptively evaluated the number of clinical sites that switched to telephone consent, the number of clinical sites that had to pause enrollment, and the length of the enrollment pauses. We evaluated monthly enrollment at the following time periods: (1) prior to the COVID-19 restrictions (1 July 2019 to 13 March 2020), (2) immediately after the COVID-19 restrictions in place (March, April, and May 2020), and (3) from 1 June 2020 to 30 November 2020. Results are stratified by open and closed fractures and are summarized using descriptive statistics. Results: At the time of the pandemic, 13 clinical sites were participating in the PREPARE trial. Eleven (84.6%) clinical sites paused enrollment due to COVID- 19 restrictions. The median length of enrollment pause was 44 days (range = 7-92 days;interquartile range = 54 days). By 16 June 2020, all clinical sites resumed enrollment. The average monthly enrollment before the COVID-19 restrictions was 198 closed fracture participants (SD = 22, range = 161-227) and 41 open fracture participants (SD = 16, range = 22-60). The enrollment rate was the lowest in April 2020, when 47 closed fracture participants and nine open fracture participants were enrolled. By June 2020, enrollment began increasing. From 1 June 2020 to 30 November 2020, the average monthly enrollment rate was 183 closed fracture participants (SD = 30, range = 129-206) and 44 open fracture participants (SD = 12, range = 24-61), which was close to pre-COVID enrollment. Monthly enrollment between 2019 and 2020 was similar, except for the months of March to May 2020 for closed fracture enrollment (p = 0.001) and March and April 2020 for open fracture enrollment (p = 0.04) cohorts. Conclusion: By pre-emptively including telephone consent in the PREPARE protocol, clinical sites were quickly and ethically adapting their procedures for obtaining informed consent via telephone. Although multiple sites paused enrollment, the enrollment pause was brief and had minimal impact on enrollment. A highly pragmatic design allowed for minimal interruptions to enrollment during the pandemic.

12.
Blood ; 138:1460, 2021.
Article in English | EMBASE | ID: covidwho-1582437

ABSTRACT

Introduction: Non-Hodgkin lymphoma (NHL) constitutes ~40% of hematologic malignancies and, in 2020, resulted in 19,940 deaths in the USA. The most common NHL subtypes are diffuse large B-cell lymphoma (DLBCL), including primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma (FL). Although a majority of patients respond to standard-of-care therapy, many patients with NHL eventually relapse, highlighting the need for additional treatments. Real-world data regarding the safety and efficacy of emerging therapies in the relapsed/refractory (R/R) population, and the association between treatment patterns and patient outcomes, are limited. These data could provide unique insights to clinical and health-related quality of life (HRQoL) outcomes in patients with DLBCL, FL, or PMBCL treated with emerging therapies, especially novel options such as chimeric antigen receptor (CAR) T cell therapies. Methods: The Connect ® Lymphoma Disease Registry (NCT04982471) is a US-based, multicenter, prospective observational cohort study of patients with R/R NHL (DLBCL, FL, and PMBCL). Approximately 2100 patients ≥ 18 years of age from ~200 community oncology (~80%) or academic (~20%) sites will be enrolled over a ~3-year period. Patients with histologically confirmed NHL subtypes will be enrolled into 1 of 4 cohorts: first R/R DLBCL, second R/R DLBCL, first R/R FL, or first R/R PMBCL (Figure). Patients will be required to have begun second- (first R/R) or third- (second R/R) line systemic treatment within 60 days prior to enrollment. Patients receiving treatment for any active malignancy other than DLBCL, FL, or PMBCL at the time of enrollment, or who are diagnosed with any other malignancy in the 6 months prior to enrollment, will be excluded. All treatment and management decisions will be determined by the practicing clinicians. Patients may undergo hematopoietic stem cell transplantation, CAR T cell therapy, or other treatments at other sites while participating in this study. Patients will be followed from enrollment for up to 5 years or until death, withdrawal of consent, loss to follow-up, or study termination, whichever occurs first. Data collection will occur at enrollment (baseline) and then every ~3 months. The main objectives of the Connect ® Registry are to describe patient characteristics, practice patterns, and factors associated with treatment choice, sequencing, and effectiveness in NHL subtypes. Secondary objectives include describing treatment regimen safety, patient-reported outcomes (PROs) including HRQoL, and healthcare resource utilization outcomes. Exploratory objectives include tumor and blood biomarker evaluation and understanding the availability of social support and its impact on long-term treatment decision-making. Case report forms will be used to collect clinical and treatment data, including baseline demographics, clinical characteristics, treatment details and response, and socioeconomic factors. Outcome measures for efficacy will be progression-free survival, event-free survival, objective response rate, time to next treatment, and overall survival. The availability of social support will be assessed via a specific questionnaire administered at baseline. General (EQ-5D-5L) and disease-specific (FACT-Lym) questionnaires will also be administered. Patients may also optionally agree to release tumor biopsies and blood samples for biomarker analysis. Clinicians will be required to report serious adverse events (AEs), secondary primary malignancies, and confirmed COVID-19 infections within 24 hours. Non-serious AEs of interest include grade 1-3 cytokine release syndrome, grade 1-3 neurotoxicity, grade 3 colitis, grade 3 arrhythmia, grade 3 hemorrhage. Other AEs of interest to be collected include grade 3 hypogammaglobulinemia, prolonged grade 3 cytopenia, and grade 3 infections. Data collected in the Connect ® Registry will increase understanding of the association between emerging therapies and patient outcomes for R/R DLBCL, FL, and PMBCL. Study support: Bristol Myers Squibb [Formula presented] Disclosures: Flowers: Amgen: Research Funding;Janssen: Research Funding;Biopharma: Consultancy;Ziopharm: Research Funding;Burroughs Wellcome Fund: Research Funding;Nektar: Research Funding;Karyopharm: Consultancy;Iovance: Research Funding;Allogene: Research Funding;AbbVie: Consultancy, Research Funding;Cellectis: Research Funding;Pfizer: Research Funding;Sanofi: Research Funding;BeiGene: Consultancy;Kite: Research Funding;EMD: Research Funding;Genentech/Roche: Consultancy, Research Funding;Morphosys: Research Funding;Adaptimmune: Research Funding;Novartis: Research Funding;Epizyme, Inc.: Consultancy;Spectrum: Consultancy;Pharmacyclics/Janssen: Consultancy;Acerta: Research Funding;4D: Research Funding;Denovo: Consultancy;Celgene: Consultancy, Research Funding;Guardant: Research Funding;Genmab: Consultancy;Gilead: Consultancy, Research Funding;Bayer: Consultancy, Research Funding;SeaGen: Consultancy;Cancer Prevention and Research Institute of Texas: CPRIT Scholar in Cancer Research: Research Funding;Takeda: Research Funding;National Cancer Institute: Research Funding;TG Therapeutics: Research Funding;Eastern Cooperative Oncology Group: Research Funding;Xencor: Research Funding;Pharmacyclics: Research Funding. Andorsky: Celgene/Bristol Myers Squibb: Research Funding;AbbVie: Consultancy;Celgene/Bristol Myers Squibb: Consultancy;AstraZeneca: Other: served on steering committees;Epizyme: Research Funding;AbbVie: Research Funding. Burke: SeaGen: Consultancy, Speakers Bureau;X4 Pharmaceuticals: Consultancy;Bristol Myers Squibb: Consultancy;Verastem: Consultancy;AstraZeneca: Consultancy;MorphoSys: Consultancy;Adaptive Biotechnologies: Consultancy;Roche/Genentech: Consultancy;Epizyme: Consultancy;Kura: Consultancy;AbbVie: Consultancy;Beigene: Consultancy, Speakers Bureau;Kymera: Consultancy. Cerhan: Genentech: Research Funding;NanoString: Research Funding;Celgene/BMS: Other: Connect Lymphoma Scientific Steering Committee, Research Funding;Regeneron Genetics Center: Other: Research Collaboration. Grinblatt: Astellas Pharma, Inc.: Consultancy;Bristol Myers Squibb: Consultancy;Astra Zeneca: Consultancy;AbbVie: Consultancy. Toomey: Bristol Myers Squibb: Consultancy. Zelenetz: Gilead: Honoraria, Research Funding;Verastem: Honoraria;Novartis: Honoraria;MEI Pharma: Honoraria, Research Funding;SecuraBio: Honoraria;Abbvie: Honoraria, Research Funding;MorphoSys: Honoraria;Pharmacyclics: Honoraria;AstraZeneca: Honoraria;LFR: Other;Genentech/Roche: Honoraria, Research Funding;NCCN: Other;MethylGene: Research Funding;Beigene: Honoraria, Other, Research Funding;BMS/Celgene/JUNO: Honoraria, Other;Amgen: Honoraria;Gilead: Honoraria;Janssen: Honoraria. Sullivan: Bristol Myers Squibb: Current Employment, Current holder of individual stocks in a privately-held company. Flick: Bristol Myers Squibb: Current Employment. Kiselev: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company, Current holder of individual stocks in a privately-held company. Kaplan: Bristol Myers Squibb: Current Employment. Ahn: Bristol Myers Squibb: Current Employment.

13.
Blood ; 138:1347, 2021.
Article in English | EMBASE | ID: covidwho-1582258

ABSTRACT

Background Patients with hematologic malignancies have poor outcomes from COVID infection with associated mortality of up to 30-40%. Studies have shown that these patients are less likely to mount an antibody response after COVID infection 1. The Pfizer-BioNTech and Moderna COVID mRNA vaccines have been shown to be 94% effective in preventing severe disease in the general population. There is limited data on the efficacy of these vaccines in lymphoma patients, and to suggest the optimal timing of vaccination to elicit immunity in patients receiving immunochemotherapy. Methods This is a retrospective study of adult lymphoma patients who received the COVID vaccine between 12/2020 and 04/2021. The primary endpoint was a positive anti-COVID spike protein antibody titer following 2 doses of the COVID mRNA vaccines or 1 dose of the COVID adenovirus vaccine. Additional outcomes of interest included key variables, such as lymphoma subtype and treatment with anti-CD20 monoclonal antibodies. Subgroups were compared using Fisher's exact test, and unadjusted and adjusted logistic regression models were used for univariate (UVA) and multivariate (MVA) analyses. Results One-hundred thirty-seven patients were identified with baseline characteristics as shown in Table 1. Overall, the study population was older at a median age of 69 (IQR 59-78) years old, 52% of patients were male, and 72% of patients were white. The most frequent comorbidities were cardiovascular disease (39%) and former smoking history (34%), and 45 (33%) patients were obese (BMI >= 30). Testing for anti-COVID spike protein antibodies occurred at a median 48 (IQR 25-62) days [range 6-120] after second vaccination. Lymphoma subtypes in our cohort were: indolent lymphomas (35%), CLL/SLL (20%), 27 (20%) patients with Burkitt's, DLBCL, PMBCL combined, and 25 (18%) patients with Hodgkin's and T-cell lymphomas (HL/TCL) combined. Majority of patients received COVID mRNA vaccines, and we were able to confirm the specific type in 71 (52%) patients. Only 1 person received the COVID adenovirus vaccine. Ninety-two patients (67.2%) developed anti-COVID spike protein antibodies after receiving a COVID vaccine. Of 27 patients who received an anti-CD20 monoclonal antibody-containing regimen in the last 12 months prior to vaccination, 14 (52%) patients produced antibodies. This rate was numerically lower than 72% (26/36) of those who developed antibodies and received an anti-CD20 antibody greater than 12 months prior to vaccination. There were differences observed in the ability to produce serology towards the COVID vaccine amongst lymphoma subtypes. Of 28 patients with CLL, 12 (43%) produced antibodies. There were 6 CLL patients receiving anticancer treatment at the time of vaccination, of which 2 patients produced antibodies. CLL/SLL patients were less likely to mount an antibody response to the COVID vaccine when compared to those with other types of lymphoma, and this difference was significant on UVA (OR 0.270, 95% CI 0.112-0.648), p=0.003) and MVA (OR 0.259, 95% CI 0.104-0.643, p=0.004). For patients with HL/TCL, 22 of 25 (88%) patients produced antibodies. Among the 3 HL/TCL patients that did not produce antibodies, 1 patient had HIV/AIDS post-transplant, 1 had relapsed AITL, and 1 received rituximab. All HL/TCL patients who received anticancer treatment in the last 6 months (10 of 10) produced antibodies at a median titer of 120 AU/mL (reference >=15 AU/mL), with 4 patients having a robust response of antibody titers >400 AU/mL. On statistical analysis, HL/TCL patients were more likely to elicit an antibody response to the COVID vaccine when compared to those with other types of lymphoma, and this response was significant on UVA (OR 4.084, 95% CI 1.149-14.515, p=0.03) and MVA (OR 4.442, 95% CI 1.219-16.191, p=0.024). Conclusion Lymphoma patients are capable of mounting a humoral response to the COVID mRNA vaccines. CLL/SLL appears predictive of a negative antibody response to the COVID vaccine, while HL/TCL histologies appeared to correlate to a positive antibody response even with treatment within 6 months of vaccination. Our study suggests anti-CD20 monoclonal antibody therapy in the last 12 months may affect the ability to produce serology towards a COVID vaccine. Further studies are required to confirm our findings, including whether T-cell immunity would be of clinical relevance in this patient population. 1. Passamonti et al, Br J Haematol 2021 [Formula presented] Disclosures: Leslie: Kite, a Gilead Company: Consultancy, Honoraria, Speakers Bureau;Abbvie: Consultancy, Honoraria;BeiGene: Consultancy, Honoraria, Speakers Bureau;PCYC/Janssen: Consultancy, Honoraria, Speakers Bureau;TG Therapeutics: Consultancy, Honoraria, Speakers Bureau;Janssen: Consultancy, Speakers Bureau;AstraZeneca: Consultancy, Honoraria, Speakers Bureau;Seagen: Consultancy, Honoraria, Speakers Bureau;Epizyme: Consultancy, Honoraria, Speakers Bureau;Karyopharm Therapeutics: Honoraria, Speakers Bureau;Celgene/BMS: Consultancy, Honoraria, Speakers Bureau;Merck: Consultancy;Pharmacyclics: Consultancy, Honoraria, Speakers Bureau;ADC Therapeutics: Consultancy. Goy: Acerta: Consultancy, Research Funding;Bristol Meyers Squibb: Membership on an entity's Board of Directors or advisory committees;AstraZeneca: Membership on an entity's Board of Directors or advisory committees;Genentech/Hoffman la Roche: Research Funding;AbbVie/Pharmacyclics: Membership on an entity's Board of Directors or advisory committees;Gilead: Membership on an entity's Board of Directors or advisory committees;Kite Pharma: Membership on an entity's Board of Directors or advisory committees;Janssen: Membership on an entity's Board of Directors or advisory committees;Vincerx pharma: Membership on an entity's Board of Directors or advisory committees;Rosewell Park: Consultancy;LLC(Targeted Oncology): Consultancy;Elsevier's Practice Update Oncology, Intellisphere, LLC(Targeted Oncology): Consultancy;Michael J Hennessey Associates INC: Consultancy;Hoffman la Roche: Consultancy;Xcenda: Consultancy;Medscape: Consultancy;Physicians' Education Resource: Consultancy, Other: Meeting/travel support;Vincerx: Honoraria, Membership on an entity's Board of Directors or advisory committees;AbbVie/Pharmacyclics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Bristol Meyers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Incyte: Honoraria;MorphoSys: Honoraria, Other;Novartis: Consultancy, Honoraria;OncLive Peer Exchange: Honoraria;Xcenda: Consultancy, Honoraria;AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Elsevier PracticeUpdate: Oncology: Consultancy, Honoraria;Celgene: Consultancy, Honoraria, Research Funding;Genomic Testing Cooperative: Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Other: Leadership role;COTA (Cancer Outcome Tracking Analysis): Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Other: Leadership role;Hackensack Meridian Health, Regional Cancer Care Associates/OMI: Current Employment;Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Kite, a Gilead Company: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Infinity/Verastem: Research Funding;Janssen: Research Funding;Karyopharm: Research Funding;Phamacyclics: Research Funding;Constellation: Research Funding. Feldman: Alexion, AstraZeneca Rare Disease: Honoraria, Other: Study investigator.

14.
Journal of Endourology ; 35(SUPPL 1):A179, 2021.
Article in English | EMBASE | ID: covidwho-1569557

ABSTRACT

Introduction & Objective: The COVID-19 pandemic has provided an impetus to reconsider traditional urologic practices and adapt to the unprecedented healthcare burden. Reducing length of stay after minimally invasive procedures is now more important than ever. Using percutaneous nephrolithotomy (PCNL) as a model, we sought to evaluate clinical barriers to same-day discharge in order to better understand the feasibility of outpatient surgery. Methods: Prospective data collected from 500 inpatient PCNLs performed at our institution between 2016 and 2020 was analyzed via the Registry for Surgery of the Kidney and Ureter (ReSKU). Preadmissions and aborted procedures were excluded. We analyzed issues and complications that warranted postoperative admission. Major categories included infection, bleeding, and excessive pain, which was defined as either a documented pain complication or administration of intravenous opioids within 24 hours after discharge from the recovery room. Multivariate statistics were used to assess risk factors for each outcome. Results: Excessive pain was the most common postoperative issue (40.9%). ASA score was inversely correlated with odds of having increased pain (OR 0.64, 95% CI 0.42-0.98) and was the only statistically significant predictor in our multivariate model that included dilated tract number, diameter, and location. The postoperative SIRS/sepsis rate within 7 days was 9.7%, and higher ASA score (OR 3.6, 95% CI 1.8-7.6) and incomplete stone clearance (OR 2.7, 95% CI 1.2-6.3) were significant predictors. Age, sex, body mass index (BMI), stone burden, and positive preoperative urine cultures were not associated with overall infection rate. In patients who had a postoperative infection, 34.1% of infections were detected intraoperatively or in the recovery room, and 48.8% were associated with the nephrostomy tube removal process on postoperative day 1. Patients who had a postoperative double-J stent rather than a nephrostomy tube had a lower overall infection rate (1.8%, p = 0.047). Finally, only 1.9% of patients had a bleeding complication, and 1.1% required a blood transfusion. Conclusions: Pain is the major barrier to same-day discharge after PCNL. Bleeding is infrequent and most infections can be recognized perioperatively or avoided with alternative tube management strategies. Rigorous patient selection for same-day discharge does not appear to be necessary. Optimizing pain control may be the key to performing outpatient surgery on a large scale.

15.
Journal of Endourology ; 35(SUPPL 1):A7-A8, 2021.
Article in English | EMBASE | ID: covidwho-1569538

ABSTRACT

Introduction & Objective: The global pandemic of COVID 19 necessitated limitations for in-person visits to stop the spread of the virus. At our institution, we sought to maintain patient access while delivering safe socially distanced care. We hypothesized that transitioning the clinics into a procedure-oriented center would create a safer, more efficient model for patient care delivery. Methods: Transitioning the clinic consisted of adopting Telehealth visits for the majority of patient's consultations while augmenting the use of physical space in the clinic to facilitate urological procedures. Multiple productivity, financial and patients experience metrics were collected between two periods of time defined as P1- Pre Covid (Feb-Jun 2019) and P2 Post-Covid (Feb-Jun 2020) and compared. Statistical analysis was performed using the Chi-Square test and the Z-test for two independent samples. Results: The percentage of performed procedures amongst all clinical visits increased in P2 (45% vs 29% p < 0.001). There was an increase in the percentage of new patients scheduled within 5- and 14-days during P2 (71 % vs 46%, p < 0.001, and 55 % vs 41%, p < 0.001) respectively. Total charges and RVUs decreased in P2 but the overall payments were higher compared to P1. This increase in revenue was due to a higher income generated by procedures. CGCAHPS and Press Ganey scores improved in P2 across all domains representing patient experience. This improvement was statistically significant for “Recommend this provider office” (90% vs 85.7% p = 0.01), “Access overall” (56% vs 49% p = 0.02), and “Moving through your visit overall” (59% vs 51% p = 0.007). Conclusions: Our data suggests that transitioning the urology clinics into a space that is mainly dedicated to outpatient procedures can represent a model that improves the patient's access to care and clinical experience, as well as strategically bolstering financial revenues. This is a more efficient care model that could replace current practice and represent the future of outpatient Urology. (Table Presented).

16.
Journal of Endourology ; 35(SUPPL 1):A135-A136, 2021.
Article in English | EMBASE | ID: covidwho-1569532

ABSTRACT

Introduction & Objective: The Coronavirus pandemic led to wide-spread reductions in surgical volume. Many patients were hesitant to undergo surgery, despite appropriate hospital precautions. Kidney stone patients pending surgical intervention have distinct risks associated with surgical delay including pain, infection, and loss of renal function. It is important to understand the risks of surgical delay during the pandemic and to better understand patient concerns and preferences for undergoing surgery. Methods: A prospective, multi-institutional patient survey during April and May 2020 was performed. Nephrolithiasis patients pending stone removal surgery including ureteroscopy, shockwave lithotripsy, percutaneous nephrolithotomy, and nephrectomy were interviewed at clinical encounters regarding their symptoms, unplanned clinical events, presence of nephrostomy tubes /double J stents, concerns and reassurances for coming to the hospital, and willingness to undergo surgery. The association of patient demographics, stone burden, renal function, stonerelated symptoms, and COVID risk factors with willingness to undergo surgery, and concerns for contracting COVID were examined. Results: 142 patients pending stone surgery completed surveys, with 66% willing to proceed with surgery, while 34% requested to delay. There was no statistical difference in patients willing versus unwilling to proceed with surgery, with regards to patient demographics, type of surgical procedure, stone burden, stonerelated symptoms, renal function compromise, presence of hydronephrosis, unplanned clinical events, or COVID risk factors. Those willing to proceed were more likely to have a ureteral stone (32% vs 15%, p = 0.03) or have a ureteral stent or nephrostomy tube in place (35% vs 6%, p < 0.01). Willingness to proceed with surgery was inversely correlated with COVID19 concerns. COVID19 concern was not impacted by age, sex, clinical site, distance to hospital, or COVID 19 risk factors. Conclusions: Kidney stone patients pending surgical treatment weremore willing to proceed with surgery based on the presence of a ureteral stone, upper urinary tract drainage tube, or low concern for COVID. Patient demographic, symptoms, kidney function, and other stone risk factors were not associated with willingness for surgery. Patients that are hesitant to proceed with surgery, despite appropriate hospital precautions should be educated appropriately regarding their risks with regards to COVID and nephrolithiasis.

17.
Journal of Urology ; 206(SUPPL 3):e1125, 2021.
Article in English | EMBASE | ID: covidwho-1483660

ABSTRACT

INTRODUCTION AND OBJECTIVE: The COVID-19 pandemic has provided an impetus to reconsider traditional urologic practices and adapt to the unprecedented healthcare burden. Reducing length of stay after minimally invasive procedures is now more important than ever. Using percutaneous nephrolithotomy (PCNL) as a model, we sought to evaluate clinical barriers to same-day discharge in order to better understand the feasibility of outpatient surgery. METHODS: Prospective data collected from 500 inpatient PCNLs performed at our institution between 2016 and 2020 was analyzed via the Registry for Surgery of the Kidney and Ureter (ReSKU). Preadmissions and aborted procedures were excluded. We analyzed clinical problems and complications that warranted postoperative admission. Major categories included infection, bleeding, and excessive pain, which was defined as either a documented pain complication or administration of intravenous opioids within 24 hours after discharge from the recovery room. Multivariate statistics were used to assess risk factors for each outcome. RESULTS: Excessive pain was the most common postoperative problem (40.9%). ASA score was inversely correlated with odds of having increased pain (OR 0.64, 95% CI 0.42-0.98) and was the only statistically significant predictor in our multivariate model that included dilated tract number, diameter, and location. The postoperative SIRS/sepsis rate within 7 days was 9.7%, and higher ASA score (OR 3.6, 95% CI 1.8-7.6) and incomplete stone clearance (OR 2.7, 95% CI 1.2-6.3) were significant predictors. Age, sex, body mass index (BMI), stone burden, and positive preoperative urine cultures were not associated with overall infection rate. In patients who had a postoperative infection, 34.1% of infections were detected intraoperatively or in the recovery room, and 48.8% were associated with the nephrostomy tube removal process on postoperative day 1. Patients who had a postoperative double-J stent rather than a nephrostomy tube had a lower overall infection rate (1.8%, p = 0.047). Finally, only 1.9% of patients had a bleeding complication, and 1.1% required a blood transfusion. CONCLUSIONS: Excessive pain is the most common clinical barrier to same-day discharge after PCNL and affects nearly half of all patients. Bleeding is infrequent, and most infections can be recognized perioperatively or avoided with alternative tube management strategies. Rigorous patient selection for same-day discharge does not appear to be necessary. Optimizing pain control may be the key to performing outpatient surgery on a large scale.

18.
Journal of Urology ; 206(SUPPL 3):e522, 2021.
Article in English | EMBASE | ID: covidwho-1483625

ABSTRACT

INTRODUCTION AND OBJECTIVE: Inadequate pain control is a major barrier to same-day discharge after percutaneous nephrolithotomy (PCNL). This study was designed to evaluate whether the novel thoracic erector spinae plane block (ESPB) can reduce postoperative breakthrough pain and eliminate the need for intravenous (IV) opioids after PCNL. METHODS: A prospective cohort study of adult patients undergoing percutaneous nephrolithotomy (PCNL) was conducted at our institution from May 2020 to January 2021. Patients with a history of chronic pain and opioid use were excluded from the study. Participants in the intervention group received an ultrasound-guided T11 erector spinae plane block prior to the start of the procedure. Patients were admitted postoperatively and prescribed an oral pain regimen;IV opioids were prescribed only upon request. Verbal pain score ≥7) and opioid administration within 24 hours were analyzed as the primary outcome. RESULTS: A total of 56 patients undergoing PCNL were included in our study, of whom 23 successfully received ESPB. We found that 78% of patients in the ESPB group compared to 47% in the control group were successfully managed with oral analgesics alone without IV opioids or breakthrough pain (p=0.03). Although no difference in total 24-hour opioid usage was detected, ESPB significantly lowered the odds of having breakthrough pain after adjusting for factors such as age, sex, dilated tract size, and tract location (OR 0.21, 95% CI 0.050-0.78). CONCLUSIONS: ESPB greatly reduces breakthrough pain and IV opioid use after PCNL, and most patients who receive an ESPB can be managed with oral analgesics alone. The ESPB can be performed by urologists or by the regional pain specialists as part of a routine perioperative workflow. This holds great promise in facilitating sameday discharge after PCNL, a benefit that is especially impactful in the COVID-19 era.

19.
4th International Workshop on Predictive Intelligence in Medicine, PRIME 2021, held in conjunction with 24th International Conference on Medical Image Computing and Computer Assisted Intervention, MICCAI 2021 ; 12928 LNCS:37-46, 2021.
Article in English | Scopus | ID: covidwho-1473938

ABSTRACT

Following the pandemic outbreak, several works have proposed to diagnose COVID-19 with deep learning in computed tomography (CT);reporting performance on-par with experts. However, models trained/tested on the same in-distribution data may rely on the inherent data biases for successful prediction, failing to generalize on out-of-distribution samples or CT with different scanning protocols. Early attempts have partly addressed bias-mitigation and generalization through augmentation or re-sampling, but are still limited by collection costs and the difficulty of quantifying bias in medical images. In this work, we propose Mixing-AdaSIN;a bias mitigation method that uses a generative model to generate de-biased images by mixing texture information between different labeled CT scans with semantically similar features. Here, we use Adaptive Structural Instance Normalization (AdaSIN) to enhance de-biasing generation quality and guarantee structural consistency. Following, a classifier trained with the generated images learns to correctly predict the label without bias and generalizes better. To demonstrate the efficacy of our method, we construct a biased COVID-19 vs. bacterial pneumonia dataset based on CT protocols and compare with existing state-of-the-art de-biasing methods. Our experiments show that classifiers trained with de-biased generated images report improved in-distribution performance and generalization on an external COVID-19 dataset. © 2021, Springer Nature Switzerland AG.

20.
Breast Cancer Res Treat ; 190(2): 287-293, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1404658

ABSTRACT

PURPOSE: Older cancer survivors required medical care during the COVID-19 pandemic, but there are limited data on medical care in this age group. METHODS: We evaluated care disruptions in a longitudinal cohort of non-metastatic breast cancer survivors aged 60-98 from five US regions (n = 321). Survivors completed a web-based or telephone survey from May 27, 2020 to September 11, 2020. Care disruptions included interruptions in seeing or speaking to doctors, receiving medical treatment or supportive therapies, or filling prescriptions since the pandemic began. Logistic regression models evaluated associations between care disruptions and education, medical, psychosocial, and COVID-19-related factors. Multivariate models included age, county COVID-19 death rates, comorbidity, and post-diagnosis time. RESULTS: There was a high response rate (n = 262, 81.6%). Survivors were 32.2 months post-diagnosis (SD 17.5, range 4-73). Nearly half (48%) reported a medical disruption. The unadjusted odds of care disruptions were higher with each year of education (OR 1.22, 95% CI 1.08-1.37, p = < 0.001) and increased depression by CES-D score (OR 1.04, CI 1.003-1.08, p = 0.033) while increased tangible support decreased the odds of disruptions (OR 0.99, 95% CI 0.97-0.99, p = 0.012). There was a trend between disruptions and comorbidities (unadjusted OR 1.13 per comorbidity, 95% CI 0.99-1.29, p = 0.07). Adjusting for covariates, higher education years (OR1.23, 95% CI 1.09-1.39, p = 0.001) and tangible social support (OR 0.98 95% CI 0.97-1.00, p = 0.006) remained significantly associated with having care disruptions. CONCLUSION: Older breast cancer survivors reported high rates of medical care disruptions during the COVID-19 pandemic and psychosocial factors were associated with care disruptions. CLINICALTRIALS. GOV IDENTIFIER: NCT03451383.


Subject(s)
Breast Neoplasms , COVID-19 , Cancer Survivors , Aged , Aged, 80 and over , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Female , Humans , Middle Aged , Pandemics , SARS-CoV-2
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