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Since September 2020 the current global pandemic of COVID-19 caused by the SARS-CoV-2 coronavirus is characterized by a succession of waves of infection due to the emergence of new variants of the original virus, presenting various genomic mutations. Many mutations are present in the gene encoding the Spike protein, the main target of the nucleic acidbased vaccines. The Variants of Concern that have been reported since autumn 2020 include Alpha/ B.1.1.7 and sublineages, Beta/B.1.351, Gamma/P.1 and sublineages, Delta/B.1.617.2 and sublineages, Omicron/ B.1.1.529 and sublineages. The rapid and cheap variant monitoring in the population is pivotal for epidemiological studies and for the prompt detection of SARS-CoV-2 variants characterized by high transmissibility or reduced susceptibility to neutralizing antibodies induced by vaccination. Surveillance of genomic variants is currently based on viral whole genome sequencing (WGS) performed on a random fraction of samples positive to molecular tests. WGS involves high costs and extended analysis time compared to a PCR-based diagnostic test, as well as specialized staff and expensive instruments. To rapidly identify the variant in samples positive to SARS-CoV-2, different rapid tests based on real-time PCR and high-resolution melting (HRM) were designed and applied on 88 oropharyngeal swab samples collected from October 2020 to February 2022 (84 positive samples and 4 negative samples). The HRM results were confirmed by PCR product sequencing. Overall, the assays showed 100% specificity and sensitivity compared with commercial PCR assay for COVID-19 testing. Moreover, 83 samples out of 84 (98.8%) were correctly identified as follows: 8 Wuhan (wild type), 12 Alpha, 23 Delta, 37 Omicron BA.1, 1 Omicron BA.1.1, 2 Omicron BA.2. With our lab equipment, about 10 samples can be processed every 3 hours at the cost of 8.5 per sample, including RNA extraction. The identified variants overlapped with mutation and case prevalence over time in Italy (as reported in outbreak.info, which collects genomic data from the GISAID Initiative), accounting for the feasibility of this approach.
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Background: The prevalence of moderate or severe emotional distress in cancer patients ranges from 30 to 45%. There is evidence that distress and depression can impair the immune system's response to vaccines, and this effect may be greatest in vulnerable groups such as cancer patients. We have previously shown that chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1x109/L and increasing age predicted poor antibody response at 6 weeks (Buttiron Webber T. et al, Eur J Cancer. 2021). Here we assessed the effect of psychological distress on the antibody response at 6 months after two doses of vaccine. Material (patients) and methods: Before the first dose of vaccine, after 42 days and at six months the clinical research nurse administered the Distress Thermometer questionnaire to the participants. The main outcome measure was the antibody response at 6 months. Multivariable logistic and linear mixed-effects models for repeatedmeasures analysis were applied adjusting for possible confounding variables. Result(s): Between March and July 2021, 320 subjects were recruited, and 290 were assessable both for distress and antibody response at 6 months. Main patient characteristics were the following: median age 68.2, female 59%, stage IV 59%, no treatment 22%, chemo 39%, hormone 24%, target or immuno 15%. At baseline, high distress (5+) was present in 26% of subjects, with a higher rate in women vs men (34.4% vs 23.8%, p=0.08). Women with the highest educational level (degree) were significantly more distressed during time (p=0.04). Younger age predicted a higher risk of elevated distress in terms of personal relationships (p=0.004) and practical problems (p=0.01). The percentage of non-responders at 6 months was 10.1% in patients with low distress vs 20.6% in those with high distress (Odds Ratio [OR]=2.5;95% Confidence Interval [CI] 1.1-5.8, p=0.04). Also advanced stage and increasing age significantly predicted a poor seroconversion. High distress at baseline was also associated with lower CRP response, a marker of vaccine response (p=0.003). Depression was also associated with lower antibody response at 6 months (p=0.003). Conclusion(s): Distress and depression are important predictor of poor seroconversion to SARS-CoV-2 vaccine. These findings indicate the need for a multidisciplinary approach with the contribution of a psycho-oncologist to manage psychological disorders in cancer patients and further studies by the clinical research nurse.
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Background: The COVID-19 pandemic shifted most healthcare to remote delivery methods (telehealth technologies including clinical video televisit) to protect patients, clinicians, and hospital staff. Telerheumatology visits were found to be noninferior to in-person visits and are often more time and cost effective for patients.1 Objectives: Description of an initial integration of video televisit in regular follow-up. Methods: In cooperation with the ALTEMS Operational Telemedicine Observatory, we built a procedural manual for televisit, whose phases were as much as possible similar to the usual visit scenario. Patients in remission or in mild disease activity at the time of enrolling visit were involved. Clinical characteristics, treatments and televisits' features were considered for all patients (Table 1). Patient overall satisfaction was evaluated (rating 1 to 5). Results: 86 televisits were performed in 74 consecutive patients, with a mean age of 46.2 ± 13.5 years, diagnosed with the most common rheumatic diseases and on chronic immunosuppressive therapy (c-b-ts DMARDs mono or combination therapy). In 5 cases, in-person visit after televisit was required. the average duration of the televisit was 17 ± 3.5 minutes and the average overall satisfaction was 4.68/5. The average distance saved (round trip) was 77,5 km, equal to an avoided travel time of 66 minutes and with a total reduction in CO2 production of approximately 866 kg. 5 patients performed video visit from workplace, de facto inventing the 'working visit'. Conclusion: Telemedicine is going to become an essential element of clinical practice in rheumatology,2 especially for active, young, and working patients, helping to minimize the overall impact of the disease on QoL, as far as they are properly selected for clinical characteristics and informatic skills. The possibility to attend to televisit from the workplace will reduce the lost working-hours and the need of travel, thus acquiring undoubted social utility. In the near future, the use of televisit should be also extended to vulnerable patients lacking basic infor-matic resources, with the help of care-givers or dedicated territorial services.
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This manuscript presents a novel approach to the study of contemporary material culture using digital data. Scholars interested in the materiality of past and contemporary societies have been limited to information derived from assemblages of excavated, collected, or physically observed materials;they have yet to take full advantage of large or complex digital datasets afforded by the internet. To demonstrate the power of this approach and its potential to disrupt our understanding of the material world, we present a study of an ongoing global health crisis, the COVID-19 pandemic. In particular, we focus on face-mask production during the pandemic across the United States in 2020 and 2021. Scraping information on homemade face-mask characteristics at multimonth intervals-including location and materials-we analyze the production of masks and their change over time. We demonstrate that this new methodology, coupled with a sociopolitical examination of mask use according to state policies and politicization, provides an unprecedented avenue to understand the changing distributions and social significances of material culture. Our study of mask making elucidates a clear linkage between partisan politics and decreasing disease mitigation effectiveness. We further reveal how time-averaged asssemblages drown out the political meanings of artifacts otherwise visible with finer temporal resolution.
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The outbreak of SARS-CoV-2 pandemic highlighted the worldwide lack of surgical masks and personal protective equipment, which represent the main defense available against respiratory diseases as COVID-19. At the time, masks shortage was dramatic in Italy, the first European country seriously hit by the pandemic: aiming to address the emergency and to support the Italian industrial reconversion to the production of surgical masks, a multidisciplinary team of the University of Bologna organized a laboratory to test surgical masks according to European regulations. The group, driven by the expertise of chemical engineers, microbiologists, and occupational physicians, set-up the test lines to perform all the functional tests required. The laboratory started its activity on late March 2020, and as of the end of December of the same year 435 surgical mask prototypes were tested, with only 42 masks compliant to the European standard. From the analysis of the materials used, as well as of the production methods, it was found that a compliant surgical mask is most likely composed of three layers, a central meltblown filtration layer and two external spunbond comfort layers. An increase in the material thickness (grammage), or in the number of layers, does not improve the filtration efficiency, but leads to poor breathability, indicating that filtration depends not only on pure size exclusion, but other mechanisms are taking place (driven by electrostatic charge). The study critically reviewed the European standard procedures, identifying the weak aspects; among the others, the control of aerosol droplet size during the bacterial filtration test results to be crucial, since it can change the classification of a mask when its performance lies near to the limiting values of 95 or 98%.
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The current global pandemic (COVID-19) caused by the new Betacoronavirus SARS-CoV-2 is characterized by successive waves of infection due to new variants that include mutations in the gene encoding the Spike protein, the main target of the nucleic acidbased vaccines. In fact, as of autumn 2020, several countries have reported the detection of SARS-CoV-2 variants that have spread more efficiently (referred to as variants of concern by WHO). Such variants include the Alpha variant (English variant, B.1.1.7), the Beta variant (South African variant, B.1.351), the Gamma variant (Brazilian variant, P.1), and the more recent Delta variant (Indian variant, B.1.617. 2). Therefore, it is pivotal to monitor the virus and the onset of SARSCoV-2 variants characterized by high transmissibility or reduced susceptibility to neutralizing antibodies induced by vaccination.Surveillance of genomic variants is currently based on sequencing of viral genomes performed on a random fraction of samples positive by molecular test. The sequencing of 228 SARS-CoV-2 positive samples by ASUR Marche Area Vasta 1 (Fano-Pesaro-Urbino) from February to June 2021 highlighted the progressive increase of variants (mainly B.1.1.7 and to a lesser extent P.1) from early February until March 18th. From March 18th onwards, only variants B.1.1.7 and P.1 were detected. DNA sequencing involves high costs and extended analysis time compared to a PCR-based diagnostic test. To rapidly identify the samples containing virus variants to be sequenced for complete characterization, in synergy with the University of Urbino, five rapid tests based on real-time PCR and high-resolution melting (HRM) were designed on the gene encoding the Spike protein. Preliminary results indicated that the sensitivity of the assays was not significantly different from that of commercial molecular tests. Furthermore, through HRM analysis, it was possible to discriminate amplicons with mutation 1709 C > A causing the amino acid substitution A570D, specific for the alpha variant.
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Background: mRNA-based vaccines have shown 95% protection from SARS-COV-2 disease in healthy populations. Initial findings in cancer patients suggest a lower seroconversion and greater toxicity possibly related to myelo-immunosuppressive therapies. Material and methods: We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunization (AEFI) to the BNT162b2 vaccine in cancer patients on active treatment. Blood samples were collected by the research nurse for serum IgG, C-Reactive Protein (CRP), blood cell count, D-dimer and cytokine panel measurement at baseline first dose (visit 1), second dose at 21 days (visit 2), after 42 days (visit 3) and after 6 months (visit 4). At visit 1, 3 and 4 all participants will receive questionnaires about their psychological status: Hospital Anxiety and Depression Scale (HADS) and Distress Thermometer. The primary endpoint was poor seroconversion (IgG<25 AU/mL) after 21 days from second dose. Patients who ended treatment >6 months on active surveillance served as controls. Multivariable logistic model and mixed effect models for repeated measures investigated independent factors associated with poor seroconversion and AEFI, adjusting for confounders. Results: Between March 15 and July 21, 2021, 320 subjects were recruited and 291 were assessable for IgG response. The lack of seroconversion at 42 days was 1.6% (95% CI, 0.4-8.7) on active surveillance, 13.9% (8.2-21.6) on chemotherapy, 1.4% (5.1-21.3) on hormone therapy, 21.7% (7.5-43.7) on biological therapy and 4.8% (0.12- 23.8) on immunotherapy. Compared to controls, risk of no IgG response was greater for chemotherapy (P=0.023), biological therapy (0.009) and hormonotherapy (P=0.052). Older age and advanced stage also predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (P=0.001) and younger patients (P=0.009). There was a trend to a D-dimer increase in IgG responders (p=0.01). Conclusions: Except for immunotherapy, chemotherapy, biological therapy and hormone therapy as well as increasing age and advanced stage predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a booster dose and long-term serological testing in vaccine non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications.
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This article shows how to record current events from an archaeological perspective. With a case study from the COVID-19 pandemic in Norway, we provide accessible tools to document broad spatial and behavioral patterns through material culture as they emerge. Stressing the importance of ethical engagement with contemporary subjects, we adapt archaeological field methods-including geolocation, photography, and three-dimensional modeling-to analyze the changing relationships between materiality and human sociality through the crisis. Integrating data from four contributors, we suggest that this workflow may engage broader publics as anthropological data collectors to describe unexpected social phenomena. Contemporary archaeological perspectives, deployed in rapid response, provide alternative readings on the development of current events. In the presented case, we suggest that local ways of coping with the pandemic may be overshadowed by the materiality of large-scale corporate and state response. Copyright © The Author(s), 2021. Published by Cambridge University Press on behalf of Society for American Archaeology.
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Background: Recent studies show that patients with cancer are more exposed to a greater risk of Covid-19 infection, developing more severe symptoms and higher risk of death. The fear and risks include a source of stress for patients who have to go to the hospital for treatment. To meet their needs, we designed the Home Se-Cure project which aims to guarantee patients the continuity of oral, intramuscular and subcutaneous cancer therapies, delivering treatment at home. Materials and methods: The project will include patients aged> 65 years, fragile patients with ECOG 2-3-4, living in the neighboring areas of the hospital. We hypothesized to perform about 8 intervention per day. The interventions will include blood sampling, oral, intramuscular and subcutaneous therapies. The activity will be carried out during working hours, from 7.30 to 11 for two days a week. Nurses and oncologists will select the patients who will be contacted by phone to schedule the appointment. The oncologist prescribes and documents the blood tests and / or home cancer therapy to be delivered to the patient. The nurse picks up the drugs at the hospital pharmacy and goes to the patient's home equipped with the required PPE. Therapy can only be taken after confirmation by telephone from the nurse and doctor based on the result of the blood tests. A customer satisfaction questionnaire will be administered to patients and will be compared with those who refuse this service or cannot access it because of geographical reasons. Results: We expect our results to bring: reduce patient travel, ensure continuity of therapy, avoid gatherings at the day hospital. Guarantee the safety of fragile patients by respecting the ministerial recommendations. Avoid the stress related to the dilemma to perform the therapies Vs risk of contagion. Reduce access to the Emergency Room through early recognition of toxicity and non-compliant blood values. Conclusions: By accomplishing these results we would should achieve a better organization of the work, a reduction of the clinical risk, an improvement of the quality of care and a greater working well-being of the staff.
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Background: The coronavirus disease of 2019 (Covid-19) represents an unprecedented threat for human health worldwide that may have profound stress effects. Pregnancy is a sensitive period for adverse parenting effects on infants’ development and epigenetic mechanisms (DNA methylation) may play a pivotal role. Here we present the study protocol of the MOM-COPE project. Methods: Mothers and infants will be enrolled in twelve neonatal units in Northern Italy, a dramatic hotspot for Covid-19 contagion in Europe. Maternal covid-related stress will be assessed with an ad-hoc questionnaire. At birth, newborns and mothers’ salivary samples will be obtained to estimate target genes’ methylation (BDNF, FKBP5, NR3C1, SLC6A4, and OXTR). Post-natal bonding and infants’ temperament will be assessed through maternal reports at 3, 6 and 12 months. Maternal sensitivity and infants’ emotional regulation will be assessed during remote videotaped mother-infant interaction at 12 months. Results: The study has obtained approval of the Ethics Committee and is going to start by May 15th. Hypotheses and anticipated results will be discussed according to the available behavioral epigenetic literature on parenting, pregnancy and large-scale disasters. Discussion: This multi-centric study will provide evidence about the effect of pandemic-related prenatal stress exposure on the health and well-being of mothers and infants from birth to 12 months of age. Moreover, the longitudinal nature of the study will allow to assess the relative role of epigenetic regulation of specific target genes in mediating the effect of this precocious adverse exposure on short- and long-term outcomes.