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Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).
RESUMEN
Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).
RESUMEN
Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).
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Iodine-based disinfectants have recently been reported to inactivate severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Iodine exists in various forms and, the relative inactivation abilities of different iodine compounds remain unclear. In this study, we examined the inactivating effects of different forms of iodine used in iodine-based disinfectants (free iodine, iodide ions, and polyiodide ions such as triiodide ion and povidone-iodine). Although iodide ions were unable to inactivate SARS-CoV-2, free iodine, iodine complex, and polyiodide significantly inactivated the virus. Iodine complex and polyiodide were the main components responsible for disinfection activity.
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Rational: Corticosteroid therapy plays a key role in the treatment of COVID-19 patients with respiratory failure. However, a rebound phenomenon after steroid cessation rarely occurs. Here, we investigated the clinical features of patients with rebound after steroid therapy. Methods: In total, 84 patients with COVID-19 treated with corticosteroids were enrolled and analysed retrospectively. A rebound was defined as when a patient’s respiratory status deteriorated after the cessation of corticosteroid therapy, without secondary bacterial infection. Results: Subjects in the rebound group were more likely to having severe respiratory failure than those in the non-rebound group. While the duration of steroid therapy was longer in the rebound group (8 days vs 10 days, p=0.0009), the dosage of steroid and the timing of the start or termination of steroid therapy did not show any differences between the two groups (p=0.17 and 0.68, respectively). The values of soluble interleukin-2 receptor (sIL-2R) at the baseline and the values of C reactive protein (CRP) or lactate dehydrogenase (LDH) at the end of steroid therapy were significantly higher in the rebound group (937 vs 1336 U/mL;p=0.002, 0.63 vs 3.96 mg/dL;p=0.01 and 278 vs 451 IU/mL;p=0.01, respectively). No patient in the rebound group suffered from thromboses, and the causes of death were exacerbation of COVID-19, ventilator-associated pneumonia or sepsis. The prediction model using baseline features for the rebound phenomenon included four variables of age >68 years, required supplemental oxygen >5 L/min, lymphocyte counts <792 /µL and sIL-2R >1146 U/mL. The discrimination ability of this model was 0.906 (0.755–0.968). Conclusion: These findings suggest that severe respiratory failure has a higher risk for the rebound phenomenon after the cessation of corticosteroids, and the values of sIL-2R, LDH and CRP are useful to assess the probability of developing rebound. A multivariate model was developed to predict rebound risk, which showed acceptable discrimination ability.
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The emergency department (ED) is a safety-critical environment in which healthcare workers (HCWs) are overburdened, overworked, and have limited resources, especially during the COVID-19 pandemic. One way to address this problem is to explore the use of robots that can support clinical teams, e.g., to deliver materials or restock supplies. However, due to EDs being overcrowded, and the cognitive overload HCWs experience, robots need to understand various levels of patient acuity so they avoid disrupting care delivery. In this paper, we introduce the Safety-Critical Deep Q-Network (SafeDQN) system, a new acuity-aware navigation system for mobile robots. SafeDQN is based on two insights about care in EDs: high-acuity patients tend to have more HCWs in attendance and those HCWs tend to move more quickly. We compared SafeDQN to three classic navigation methods, and show that it generates the safest, quickest path for mobile robots when navigating in a simulated ED environment. We hope this work encourages future exploration of social robots that work in safety-critical, human-centered environments, and ultimately help to improve patient outcomes and save lives.
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The COVID-19 pandemic exacerbated problems of already overwhelmed healthcare ecosystems. The pandemic worsened long-standing health disparities and increased stress and risk of infection for frontline healthcare workers (HCWs). Telemedical robots offer great potential to both improve HCW safety and patient access to high-quality care, however, most of these systems are prohibitively expensive for under-resourced healthcare organizations, and difficult to use. In this paper, we introduce Iris, a low-cost, open hardware/open software telemedical robot platform. We co-designed Iris with front-line HCWs to be usable, accessible, robust, and well-situated within the emergency medicine (EM) ecosystem. We tested Iris with 15 EM physicians, who reported high usability, and provided detailed feedback critical to situating the robot within a range of EM care delivery contexts, including under-resourced ones. Based on these findings, we present a series of concrete design suggestions for those interested in building and deploying similar systems. We hope this will inspire future work both in the current pandemic and beyond. © 2022, ICST Institute for Computer Sciences, Social Informatics and Telecommunications Engineering.
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Studio is an active form of pedagogy that can help train collaborative, reflective engineers. However, traditional studio pedagogy is predicated on a shared physical space-it is not clear how to translate the benefits of the studio to a virtual environment. In this work we contrast and compare four studio classes at Olin College-transitioned to virtual studios in response to the COVID-19 pandemic-in terms of their design, implementation, and student responses. Through a mixed-methods approach we uncover trends in student agency and motivation, technology choices and their ramifications on collaboration, and social aspects of the virtual space. © American Society for Engineering Education, 2021
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COVID-19, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has become a global pandemic. Patients with hematological disorders are known to be at high risk of morbidity and mortality from COVID-19, and vaccines against SARS-CoV-2 have been rapidly developed. Although mRNA vaccines against SARS-CoV-2 are reported to be effective, efficacy in patients with hematological malignancies who have received anti-CD20 antibody treatment remains unclear. Here, we prospectively evaluated the efficacy of BNT162b2 mRNA COVID-19 vaccine in patients with B-cell malignancies treated with anti-CD20 antibody. We first evaluated antibody titers in 12 healthy volunteers (median age 75.5 years, range 57-82) and three lymphoma patients undergoing R-CHOP therapy (73, 81, and 81 years old) who had received 2 vaccine doses of BNT162b2 at pre-vaccination, 21 days after the first dose and 14 days after the second dose of vaccination. IgG antibody titers for S1 protein were measured in serum samples by ELISA. In healthy control subjects, titers were clearly increased. In contrast, no patient treated with R-CHOP developed antibodies even after the second vaccination (Figure A). To determine the SARS-CoV-2-specific T-cell reactivity in these three patients, we evaluated interferon (IFN)-γ response to the SARS-CoV-2 spike peptide before and after the second vaccination dose, and detected IFN-γ responses after vaccination in all three patients (Figure B). Next, to investigate the duration of the effect of anti-CD20 antibody on antibody production to BNT162b2, we enrolled 36 patients (median age 74 years, range 50-87) who had received the final dose of anti-CD20 antibody 48-1320 (median 571) days before vaccination. S1 antibody titers were measured 14 days after the second dose of vaccination. Diagnoses included diffuse large B-cell lymphoma (n = 21), follicular lymphoma (n = 9), lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (n = 3), and mantle cell lymphoma (n = 3). Thirty-four patients had received rituximab-based and 2 had received obinutuzumab-based therapy, with a median of 6 (range 3-20) courses. No patient had received any chemotherapy after the last anti-CD20 antibody dose. No patient vaccinated within close to one year or sooner after the last anti-CD20 antibody administration showed an increase in titers. Furthermore, titers in most patients were lower than in healthy volunteers even among those vaccinated more than three years after the last administration (Figure C). Finally, we investigated surrogate markers of antibody production ability. We found no relationship between the percent of B-cells (CD19-positive cells) and S1 antibody titers (Figure D), whereas all patients (n = 9) with total IgG level below lower normal limit (< 870 mg/dl) had low S1 antibody titers (< 0.16), below the lowest optical density (O.D.) value in healthy donors (Figure E). These findings indicate that the antibody-mediated response to vaccination in patients following treatment with anti-CD20 antibody was considerably impaired for an extended time. Alternative protection strategies for these patients are therefore warranted. Although T-cell responses were detected, we recommend that these patients continue to wear a face mask and wash their hands to prevent COVID-19 even after vaccination. [Formula presented] Disclosures: Yakushijin: Chugai pharmaceutical Co. Ltd.: Research Funding;Jazz pharmaceuticals: Research Funding;Nippon Shinyaku: Honoraria. Kiyota: Bristol-Myers Squibb: Honoraria, Research Funding;Ono Pharmaceutical: Honoraria, Research Funding;Astra-Zeneca: Honoraria, Research Funding;Roche Phamaceuticals: Research Funding;Merck Biopharma: Honoraria;Merck Sharp & Dohme: Honoraria;Eisai: Honoraria;Bayer: Honoraria. Matsuoka: Takeda Pharmaceutical Company: Research Funding;Sysmex: Research Funding. Minami: Behring: Research Funding;CSL: Research Funding;Yakult Honsha: Research Funding;Nippon Shinyaku: Research Funding;Astellas Pharma: Research Funding;Asahi-Kasei Pharma: Research Funding;Eli Lilly: H noraria, Research Funding;Taiho Pharmaceutical: Honoraria, Research Funding;Takeda Pharmaceutical: Honoraria, Research Funding;Sanofi: Honoraria, Research Funding;Pfizer: Honoraria, Research Funding;Ono Pharmaceutical: Honoraria, Research Funding;Novartis: Honoraria, Research Funding;MSD: Honoraria, Research Funding;Merck Serono: Honoraria, Research Funding;Kyowa-Kirin: Honoraria, Research Funding;Eisai: Honoraria, Research Funding;DaiichiSankyo: Honoraria, Research Funding;Chugai Pharmaceutical: Honoraria, Research Funding;Bristol-Myers Squibb: Honoraria, Research Funding;Boehringer Ingelheim: Honoraria, Research Funding;Bayer Yakuhin: Honoraria, Research Funding;Nippon Kayaku: Research Funding;Celgene: Honoraria;Ohtsuka Pharmaceutical: Honoraria;Shire Japan: Honoraria;Genomic Health: Honoraria;Abbvie: Honoraria.
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Recently, live video broadcasting is frequently used due to the COVID-19 pandemic. More realistic and comfortable experiments can be realized if multiple real-time videos from different places are displayed on a single screen. This paper calls such live broadcasting “same world broadcasting” as if all objects exist in the same space. In this paper, we propose a distributed system for the same world broadcasting. We evaluate the proposed system using the experimental implementation in a LAN environment and an open testbed environment. The experiment results show that the proposed system can reduce the processing time to collect and compose many real-time videos. © 2021 IEEE.
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A 79-year old Japanese woman was diagnosed with coronavirus disease (COVID-19), caused by SARS coronavirus 2 (SARS-CoV-2), based on a positive reverse transcription-PCR (RT-PCR) test result. Chest computed tomography revealed mild interstitial pneumonia. She had intermittent persistent inflammatory reactions with fever. Laboratory findings and RT-PCR test results showed SARS-CoV-2 positivity for more than 70 days. To the best of our knowledge, this relatively mild case has the longest duration of viral shedding recorded, as confirmed by RT-PCR analysis. This case demonstrates that the viral shedding in COVID-19 can be prolonged, even in mild disease, and highlights the difficulties in distinguishing viral shedding from SARS-CoV-2 infectivity.