SAFETY INCIDENTS CLASSIFIED AS CLINICAL PROCESS/ PROCEDURE IN HOSPITALIZED PATIENTS DURING THE COVID-19 PANDEMIC

Objective: Compare reported patient safety incidents related to a clinical process/ procedure among patients with laboratory-confirmed COVID-19 diagnosis and with Severe Acute Respiratory Syndrome (SARS) caused by another infectious or undetermined agent and the other patients. Results and discussion: retrospective, documentary study approved by the ethics committee in a public teaching hospital in southern Brazil. In the study, 2,191 notifications and records of COVID-19 between March and September 2020 were used. The data were submitted to descriptive analysis with frequencies of the variables in the data set, Fisher's test to determine the associations between outcomes (classification/process/ problem) and calculation of relative risk to measure its strength. The incidence of pressure ulcers was almost 3.7 times higher in patients with SARS. In the others, various tube-related incidents and events associated to the surgical process predominated. Conclusion: Intensive nursing care for patients with SARS, risk management and strengthening of good practices for the safety of all patients were relevant. © 2023, Universidade Federal do Parana. All rights reserved.

Leisure or work? Shopping behavior in neighborhood stores in a pandemic context

Purpose: This study aims to understand customer's assessments of neighborhood stores during the COVID-19 pandemic through the influence of in-store environmental factors on patronage intention. Design/methodology/approach: Online survey with 528 participants about the last shopping trip in neighborhood retail. The authors performed data analysis using structural equation modeling techniques. Findings: High-perceived spatial crowding negatively influences shopping experience value perceptions, while human crowding influences patronage intentions through increased perceived hedonic value. Research limitations/implications: Results suggest that purchase experience at well-known neighborhood stores during a sanitary crisis is becoming less convenience-oriented and a substitute for leisure activities due to social distancing. Practical implications: The findings elucidate the social function of neighborhood convenience retailing during the COVID-19 pandemic. The results emphasize that a pleasant shopping experience arising from a good relationship with shopkeepers and other customers is more influential on patronage intention than a good product assortment and store layout. Social implications: This paper contributes to the survival of small neighborhood businesses during the financial crisis installed due to Covid-19 by helping businesses become more attractive to their consumers and competitive in the new context. Originality/value: The combined context of the health crisis due to COVID-19 and neighborhood retail of an emerging country raises the need for tests to better understand established marketing theories. Based on this rationale, this work intends to replicate and extend selected previous findings to the new environment dictated by the pandemic. © 2023, Marcelo Moll Brandão, Arthur França Sarcinelli, Ananda Bisi Barcelos and Luiza Postay Cordeiro.

Changes in anticancer treatment plans in patients with solid cancer hospitalized with COVID-19: analysis of the nationwide BSMO-COVID registry providing lessons for the future.

BACKGROUND: Solid cancer is an independent prognostic factor for poor outcome with COVID-19. As guidelines for patient management in that setting depend on retrospective efforts, we here present the first analyses of a nationwide database of patients with cancer hospitalized with COVID-19 in Belgium, with a focus on changes in anticancer treatment plans at the time of SARS-CoV-2 infection. METHODS: Nineteen Belgian hospitals identified all patients with a history of solid cancer hospitalized with COVID-19 between March 2020 and February 2021. Demographic, cancer-specific and COVID-specific data were pseudonymously entered into a central Belgian Society of Medical Oncology (BSMO)-COVID database. The association between survival and primary cancer type was analyzed through multivariate multinomial logistic regression. Group comparisons for categorical variables were carried out through a Chi-square test. RESULTS: A total of 928 patients were registered in the database; most of them were aged ≥70 years (61.0%) and with poor performance scores [57.2% Eastern Cooperative Oncology Group (ECOG) ≥2]. Thirty-day COVID-related mortality was 19.8%. In multivariate analysis, a trend was seen for higher mortality in patients with lung cancer (27.6% versus 20.8%, P = 0.062) and lower mortality for patients with breast cancer (13.0% versus 23.3%, P = 0.052) compared with other tumour types. Non-curative treatment was associated with higher 30-day COVID-related mortality rates compared with curative or no active treatment (25.8% versus 14.3% versus 21.9%, respectively, P < 0.001). In 33% of patients under active treatment, the therapeutic plan was changed due to COVID-19 diagnosis, most frequently involving delays/interruptions in systemic treatments (18.6%). Thirty-day COVID-related mortality was not significantly different between patients with and without treatment modifications (21.4% versus 20.5%). CONCLUSION: Interruption in anticancer treatments at the time of SARS-CoV-2 infection was not associated with a reduction in COVID-related mortality in our cohort of patients with solid cancer, highlighting that treatment continuation should be strived for, especially in the curative setting.

Efficacy of hydrogen peroxide wipes for decontamination of AZD1222 adenovirus COVID-19 vaccine strain on pharmaceutical industry materials.

This study aimed to evaluate the performance of accelerated hydrogen peroxide® wipes (HPW) for decontamination of the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine in a pharmaceutical industry. Two matrices were tested on stainless-steel (SS) and low-density-polyethylene (LDP) surfaces: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were spiked, dried and the initial inoculum, possible residue effect (RE) and titre reduction after disinfection with HPW were determined. No RE was observed. The disinfection procedure with HPW resulted in complete decontamination the of AZD1222 adenovirus strain in FCV (≥7·46 and ≥7·49 log10 infectious unit [IFU] ml-1 for SS and LDP carriers respectively) and API (≥8·79 and ≥8·78 log10 IFU ml-1 for SS and LDP carriers respectively). In conclusion, virucidal activity of HPW was satisfactory against the AZD1222 adenovirus strain and can be a good option for disinfection processes of SS and LPD surfaces in pharmaceutical industry facilities during recombinant COVID-19 vaccine production. This procedure is simple and can be also applied on safety unit cabins and sampling bags made of LDP as well.

Short and medium-term outcomes of patients with solid cancer hospitalized with COVID-19 in Belgium according to cancer diagnosis and treatment characteristics

Background: Solid cancer is an independent prognostic factor for COVID-19 related mortality. Adverse prognostic factors in these patients include low performance status, lung cancer, advanced cancer stage and recent diagnosis. In this study, we further evaluated prognostic effects of cancer diagnosis and treatment variables and characterized changes in anticancer treatment plans due to COVID-19 diagnosis in a nation-wide cohort study. Methods: Patients with a history of solid cancer hospitalized with COVID-19 between March 2020 and February 2021 in one of the 20 participating institutions in Belgium were included. Patient demographics, comorbidities, COVID-19 hospitalization course and treatment, cancer and anticancer treatment characteristics, treatment changes due to COVID-19 and clinical outcomes in-hospital and during follow-up were retrospectively registered in a central database. The primary objective was to evaluate potential differences in 30-day and 3-month COVID-19-related mortality according to cancer and anticancer treatment characteristics. Results: A total of 946 patients (median age 73y, interquartile range 64-81y) were included. Pre-existing comorbidities were present in 90.1% of patients, and 21.9% had a history of > 1 malignancy. Half of the patients (n = 463, 49.3%) had received anticancer treatment ≤3 months before COVID-19 diagnosis (“active cancer”), of whom 286 (63.1%) in the non-curative setting. The overall 30-day and 3-month COVID-19- related mortality rates in this cohort were 21.4% (n = 178) and 24.1% (n = 194), respectively. COVID- related 3-month mortality was comparable in patients with active cancer (n = 96, 24.3%) and in patients with non-active cancer (n = 97, 24.0%), but within the first group COVID-related mortality was higher in those receiving systemic treatment in the non-curative (28.3%) versus the curative setting (15.2%). A change in the anticancer treatment plan due to COVID-19 was recorded in 148/463 patients with active cancer (32.0%). In patients with changes in systemic treatment plans (n = 146), treatment was delayed in 94 patients (in half of cases for > 1 month) and cancelled in 42 patients. The main reason for modifications in anti-cancer treatment was COVID-19 related complications (79.6%), followed by fear for/existence of anticancer treatment related toxicity (14.8%). Conclusions: Our nation-wide analysis in patients with solid cancer hospitalized with COVID-19 shows comparable 3-month mortality among patients who did and who did not receive anticancer treatment in the three months before COVID-19 diagnosis. Changes in anticancer treatment were very frequent in patients hospitalized with COVID-19. Further monitoring of the long-term impact of COVID-19-related changes to anticancer treatment plans is warranted.

Demographic and laboratory determinants of humoral immune responses and impact of different anti-SARS-CoV-2 vaccine platforms in patients with cancer: A systematic review and meta-analysis

Background: Patients (pts) with cancer have increased mortality from COVID-19 and their vaccination is crucial to prevent severe infection. We aimed to identify demographic and laboratory determinants of humoral immune responses to COVID-19 vaccination in pts with cancer and investigate differences in responses based on the vaccine platform. Methods: We searched for records in PubMed, Embase, and CENTRAL up to 28/09/21, as well as conference proceedings from ASCO and ESMO 2021. We included studies of pts ≥16 yr with a cancer diagnosis, who were vaccinated against SARS-CoV-2. Studies were excluded if ≥10% of the participants had other causes of immunosuppression or baseline anti- SARS-CoV-2 spike protein antibodies (Ab)/previous COVID-19 (PROSPERO ID: CRD42021282338). For this subgroup analysis of studies that reported a proportion of pts with cancer and positive Ab titers at any timepoint following complete vaccination, a random-effects model was used to estimate the humoral response rate (HRR) with 95% confidence intervals (CI). Results: We included 64 records, reporting data from 10,511 cancer pts. The HRR in the overall population and by subgroup are shown in Table. Elder patients with hematologic cancers (59%, CI 47-70%,N= 667) and patients with lymphopenia (50%, CI 25-75%, N = 111) or hypogammaglobulinemia (36%, CI 19-57%, N=226) were the subgroups with lower HRR. Male (77%, CI 69-84%, N = 2,659) and Asian (84%, CI 54-96%, N = 37) pts showed a trend to lower HRR when compared with females and other races, respectively. Pts vaccinated with mRNA vaccine platforms (79%, CI 74-83%, N = 9,404) had numerically higher HRR than those receiving the adenovirus vaccines (28%, CI 19-40%, N = 74). Conclusions: This study highlights demographic and laboratory determinants of weaker immune responses to SARS-CoV-2 vaccination, permitting better identification of more vulnerable pts. Despite the small number of pts included receiving adenovirus vaccines, these data also suggest prioritizing mRNA platform vaccination in pts with cancer.

Impact of cancer diagnosis, stage, and systemic therapies on immunogenicity after COVID-19 vaccination in patients with cancer: A systematic review and metaanalysis

Background: Patients (pts) with cancer are at increased risk of severe COVID-19. Both underlying malignancy and anti-cancer treatments influence the immune system, potentially impacting the level of vaccine protection achieved. Methods: A systematic literature search of PubMed, Embase, CENTRAL and conference proceedings (ASCO annual meetings and ESMO congress) up to 28/09/21, was conducted to identify studies reporting anti-SARS-CoV-2 spike protein immunoglobulin G seroconversion rates (SR) at any time point after complete COVID-19 immunization (mRNA- or adenoviral-based vaccines) in cancer pts. Complete immunization was defined as 1 dose of JNJ-78436735 vaccine or 2 doses of BNT162b2, mRNA-1273 or ChAdOx1 nCoV-19 vaccines. Subgroup analyses were performed to examine the impact of cancer diagnosis, disease stage, and anticancer therapies on the SR. Overall effects were pooled using random-effects models and reported as pooled SR with 95% confidence intervals (CI). Results: Of 1,548 identified records, 64 studies were included in this analysis reporting data from 10,511 subjects. The Table shows the SR in the overall population and specific subgroups. In pts with solid malignancies (SM), disease stage and primary site did not significantly impact the SR. In pts with hematologic malignancies (HM), SR were significantly lower in pts with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) compared to acute lymphoblastic leukemia (ALL), Hodgkin lymphoma (HL), and multiple myeloma (MM). Concerning the impact of cancer therapies on SR, pts with SM undergoing chemotherapy had numerically lower SR (N = 1,234, SR 87%, CI 81-92) compared to those treated with immune checkpoint inhibitors (N = 574, SR 94%, CI 88-97) or endocrine therapy (N = 326, SR 94%, CI 86-97) with or without another targeted therapy. Pts with HM treated with anti-CD20 therapy (within the last 12 months: N = 360, SR 7%, CI 2-20;or more than 12m: N = 175, SR 59%, CI 35-80), immune-modulating agents (BTK or BCL2 inhibitors) (N = 462, SR 47%, CI 32-64%) or other immunotherapies (anti-CD19/CART or anti-CD38) (N = 293, SR 37%, CI 23-53) had lower SR compared to pts treated with autologous (N = 353, SR 77%, CI 67- 85) or allogenic stem cell transplantation (N = 509, SR 77%, CI 68-84). Conclusions: SR varies between cancer types and anticancer therapies with some cancer pts having low protection against COVID- 19 even after complete vaccination.

Case report of Curtobacterium isolated from a catheter tip sample misidentified as Cronobacter.

The Curtobacterium genus is a member of the family Microbacteriaceae, and Curtobacterium species are recognized as plant pathogens. The aim of this study was to investigate a dubious result of species identification for an infection located on a catheter tip of a patient with Covid-19. A strain isolated from a catheter tip sample, identified by VITEK® 2 as Cronobacter spp., was submitted to polyphasic analysis: Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) using VITEK® MS, real-time polymerase chain reaction targeting dnaG gene, and 16S rRNA full gene Sanger sequencing analysis for confirmation. The strain presented negative result using qPCR and could not identified by MALDI-TOF MS. 16S rRNA full gene Sanger sequencing analysis identified the strain as Curtobacterium spp. The Gram-variable characteristic (Gram-negative instead of Gram-positive) of the isolated strain was the responsible for the misidentification by VITEK® 2 and VITEK® MS did not identify the strain. 16S rRNA full gene sequencing analysis identified the strain as Curtobacterium genus, but other complementary techniques are necessary to identify at species level.

Spread of Gamma (P.1) Sub-Lineages Carrying Spike Mutations Close to the Furin Cleavage Site and Deletions in the N-Terminal Domain Drives Ongoing Transmission of SARS-CoV-2 in Amazonas, Brazil

The Amazonas was one of the most heavily affected Brazilian states by the COVID-19 epidemic. Despite a large number of infected people, particularly during the second wave associated with the spread of the Variant of Concern (VOC) Gamma (lineage P.1), SARS-CoV-2 continues to circulate in the Amazonas. To understand how SARS-CoV-2 persisted in a human population with a high immunity barrier, we generated 1,188 SARS-CoV-2 whole-genome sequences from individuals diagnosed in the Amazonas state from 1st January to 6th July 2021, of which 38 were vaccine breakthrough infections. Our study reveals a sharp increase in the relative prevalence of Gamma plus (P.1+) variants, designated Pango Lineages P.1.3 to P.1.6, harboring two types of additional Spike changes: deletions in the N-terminal (NTD) domain (particularly Delta 144 or Delta 41-144) associated with resistance to anti-NTD neutralizing antibodies or mutations at the S1/S2 junction (N679K or P681H) that probably enhance the binding affinity to the furin cleavage site, as suggested by our molecular dynamics simulations. As lineages P.1.4 (S:N679K) and P.1.6 (S:P681H) expanded (Re > 1) from March to July 2021, the lineage P.1 declined (Re < 1) and the median Ct value of SARS-CoV-2 positive cases in Amazonas significantly decreases. Still, we did not find an increased incidence of P.1 variants among breakthrough cases of fully vaccinated patients (71%) in comparison to unvaccinated individuals (93%). This evidence supports that the ongoing endemic transmission of SARS-CoV-2 in the Amazonas is driven by the spread of new local Gamma/P.1 sublineages that are more transmissible, although not more efficient to evade vaccine-elicited immunity than the parental VOC. Finally, as SARS-CoV-2 continues to spread in human populations with a declining density of susceptible hosts, the risk of selecting more infectious variants or antibody evasion mutations is expected to increase. IMPORTANCE The continuous evolution of SARS-CoV-2 is an expected phenomenon that will continue to happen due to the high number of cases worldwide. The present study analyzed how a Variant of Concern (VOC) could still circulate in a population hardly affected by two COVID-19 waves and with vaccination in progress. Our results showed that the answer behind that was a new generation of Gamma-like viruses, which emerged locally carrying mutations that made it more transmissible and more capable of spreading, partially evading prior immunity triggered by natural infections or vaccines. With thousands of new cases daily, the current pandemics scenario suggests that SARS-CoV-2 will continue to evolve and efforts to reduce the number of infected subjects, including global equitable access to COVID-19 vaccines, are mandatory. Thus, until the end of pandemics, the SARS-CoV-2 genomic surveillance will be an essential tool to better understand the drivers of the viral evolutionary process.

Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID-19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry.

This study aimed to evaluate the performance of hydrogen peroxide vapour (HPV) to inactivate the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine for application in cleaning validation in pharmaceutical industries production areas. Two matrixes were tested: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to HPV in an isolator. One biological indicator with population >106 Geobacillus stearothermophilus spores was used to validate the HPV decontamination cycle as standard. HPV exposure resulted in complete virus inactivation in FVC (≥5·03 log10 ) and API (≥6·40 log10 ), showing HPV efficacy for reducing chimpanzee adenovirus AZD1222 vaccine strain. However, the optimum concentration and contact time will vary depending on the type of application. Future decontamination studies scaling up the process to the recombinant COVID-19 vaccine manufacturing areas are necessary to evaluate if the HPV will have the same or better virucidal effectivity in each specific production area. In conclusion, HPV showed efficacy for reducing AZD1222 chimpanzee adenovirus strain and can be a good choice for pharmaceutical industries facilities disinfection during recombinant COVID-19 vaccine production.

On the use of telemedicine in the context of COVID-19: legal aspects and a systematic review of technology

Purpose: The aim of this study was to carry out a systematic review of telemedicine technology and to discuss the role of legislation in the application of telemedicine technology within the scope of COVID-19. Methods: The search for papers was conducted in the databases Cochrane Central, MEDLINE, and Embase. The keywords considered for this systematic review were (coronavirus OR “2019-nCoV” OR 2019nCoV OR nCoV2019 OR “nCoV-2019” OR “COVID-19” OR COVID19 OR “HCoV-19” OR HCoV19 OR CoV OR “2019 novel*” OR Ncov OR “n-cov” OR “SARS-CoV-2” OR “SARSCoV-2” OR “SARSCoV2” OR “SARSCoV2” OR SARSCov19 OR “SARS-Cov19” OR “SARS-Cov-19” OR “severe acute respiratory syndrome*” OR ((corona* OR corono*) AND (virus* OR viral* OR virinae*))) AND ((telemedicine OR telehealth OR “remote assessment” OR telemonitoring)). The review process was carried out by six independent reviewers, using the PRISMA-P method. Results: As a result, a total of 34 papers were selected, which addressed the study of telemedicine technologies used in times of endemics, epidemics, and pandemics, focusing on COVID-19. Conclusion: Telemedicine allows for care in remote areas and at a lower cost to the patient and, in the current situation, it can reduce the number of contagions as well as the occupation of beds in health facilities. Telemedicine may suffer from limitations, mainly due to current legislation, but in this pandemic era of COVID-19, several countries around the world have made their laws more flexible to allow more widespread use of telemedicine. © 2021, Sociedade Brasileira de Engenharia Biomedica.

A Two-Stream Model Based on 3D Convolutional Neural Networks for the Recognition of Brazilian Sign Language in the Health Context

Deaf people are a considerable part of the world population and communicate naturally using sign languages. However, although many countries adopt their sign language as an official language, there are linguistics barriers to accessing fundamental rights, especially access to health services, even more critical situation in the midst of the COVID-19 crisis. This situation has been the focus of some government policies that oblige essential service providers to provide sign language interpreters to assist Deaf people. However, this type of solution has high operating costs, mainly to serve the entire Deaf community in all environments. These setbacks motivate the investigation of methodologies and automated tools to support this type of problem. In this paper, we address this problem by proposing two-stream model for the recognition of the Brazilian Sign Language (Libras) in the health context. The proposed solution does not use any additional capture sensor or hardware, being entirely base on images or sequences of images (videos). The results show that the solution is able to recognize the Libras signs in the test dataset reasonably well, achieved an average accuracy of approximately 96,12% considering a scenario where the interpreter used in the test set was not used in the training set, which shows that there are good evidence that it can assist in the communication process with Deaf people. Besides, an additional contribution of this paper is the introduction of a new dataset in the Brazilian sign language (Libras) containing 5000 videos of 50 signs in the health context, which may assist the development and research of other solutions. © 2020 ACM.

Home fall of elderly people: implications of stressors and representations in the COVID-19 context

OBJECTIVES: To describe personal conditions and home structure that predisposes the elderly to the risk of falling, in the perspective of Neuman's stressors;to describe the content, structure and origin of social representations about falling at home by elderly people;and conjecture the implications of this empirical evidence on the daily lives of the elderly in the context of the pandemic caused by COVID-19. METHOD: Mixed method with concomitant triangulation (January-July/2017), qualitative design (structural and procedural approaches to the Social Representations Theory) and quantitative (sectional) approaching elderly people >=65 years. RESULTS: Environmental factors were identified for falling at home, fear of activities of daily living and loss of visual acuity. Feelings and behaviors mentioned in the possible central nucleus justified the modulation of behaviors. Analysis categories: 1) Representation of the (in)adaptability of the home environment;2) Representation and overcoming limitations arising from weaknesses. CONCLUSION: It was possible to produce conjectures based on empirical evidence in the current situation in the pandemic's dynamics.

Safe practices in airway management of patients with Covid-19: Integrative review

Introduction: The pandemic caused by the SARS-CoV-2 virus in early 2020 changed the practices of health professionals in order to mitigate the risks of contamination of health care frontline workers, mainly activities related to the management of the airways of patients with Covid-19. Objective: to identify the practices necessary to ensure the safety of health professionals in managing the airway of patients suspected or diagnosed with Covid-19. Materials and methods: an integrative review carried out in ten relevant databases in the health area, with the sample consisting of 17 surveys. The practices identified were listed according to the four procedures punctuated by the literature: endotracheal intubation, extubation, bronchoscopy and tracheostomy. Results: the main recommendations mentioned were: endotracheal intubation: performed by an experienced, trained, minimal team and professionals from risk groups for covid-19 should not be part of this team;extubation: do not use a high flow nasal catheter after the procedure;bronchoscopy: perform in an isolated room with negative pressure;tracheostomy: may be considered early, but the risk-benefit must be assessed. Conclusion: the practices identified may direct the management of airways and guide the construction of assistive, educational or managerial technologies. Copyright © 2021 by author(s) and Mykolas Romeris University.