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Introduction: The spread of SARS-CoV-2 pandemia in Europe has been socially counteracted with the aid of nonpharmaceutical interventions (NPIs). This rapidly changed the epidemiology of viral respiratory diseases other than the COVID-19. Thus a sharp decrease in bronchiolitis patients has been recorded all over Europe since 2020. Aims and Objectives: Due to the looser NPIs and to the increased accesses to hospitals than the year before we chose to analyze the series of admissions to our Unit either for bronchiolitis or for COVID-19, from 2021 October, 1st to 2022 January, 31st. Method(s): Data were obtained from the hospital database. Overall 2582 patients accessed the Pediatric Emergency Room (PER). Of them 228 (8.8%) were admitted to the Pediatric Unit (PU). All admissions were tested for SARSCoV-2 by nasopharyngeal molecular swab. Result(s): Overall we recorded 71 bronchiolitis and 26 COVID-19. Data are reported in the table herein. View inline In January 2022 the COVID-19 impacted overall admissions more significantly than did the bronchiolitis in November plus December 2021 (chi2, p<0.01). Conclusion(s): By our limited experience we tried to describe the relationships that seemingly regulate the epidemiology of respiratory viruses. As a matter of fact, when one virus promptly emerged the other seemed to find no space in the ecosystem despite the rules for NPIs did not change meanwhile. Epidemiology of viruses looking for the same habitat maybe needs furher evaluations.
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The COVID-19 pandemic is a microcosm for future challenges and crises. The greatest of these challenges is the climate crisis and the potential collapse of our Earth system. However, crises may also provide opportunities to transition to more sustainable futures. In our study, we qualitatively analyze statements of a heterogeneous group of 46 experts from academia, industry, government, and organized civil society to explore inasmuch experts perceived the pandemic as a window of opportunity for more sustainable supply chains (SCs) and what they consider opportunities, challenges, and necessary actions for more sustainable circular SCs. Our study contributes to current and future studies on the opportunities in times of crisis and the actions needed to overcome SCs vulnerabilities, thereby increasing the resiliency, circularity, and sustainability of SCs. © 2023 The Authors
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In recent years, the changing market needs due to the dramatic increase of e-commerce and the effects of Covid-19 pandemic have caused a growing demand for supply chain operations. This dynamic business context is also associated with relevant technological and innovative modifications. In the logistics sector, automated warehouses play a crucial role in dealing more effectively with this development trend. For this reason, they are a relevant topic in universities and engineering faculties. Nevertheless, these systems mostly find application and implementation in the industrial sector, determining a significant detachment from the academic sphere. This usually results in a not complete awareness of university students related to the development and operations of such structures. Therefore, an automated warehouse made up by an innovative Automated Storage and Retrieval System and a Mobile Industrial Robot fleet recently installed in a university laboratory was showed to a group composed of 62 engineering students with different academic background. Moreover, a simulation was carried out, physically reproducing the main operations of a distribution centre, namely receiving, kitting, picking, and shipping processes. The students perception related to the automated warehouses was then evaluated through a questionnaire submitted at the end of the experience. The survey demonstrated that most of the students was interested in topics related to the industrial logistics, despite many of them never saw an automated warehouse before the laboratory test. Furthermore, the large majority of the students evaluated positively the simulation and they affirmed that the proposed experience significantly enriched their knowledge about logistics automation. Finally, many students declared that thanks to the test, the interest towards the automated warehouses increased and more than 50% started considering the idea of working in the logistics sector. © 2022, AIDI - Italian Association of Industrial Operations Professors. All rights reserved.
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Background: The role and the durability of immunogenicity of the 3rd dose of vaccine against COVID-19 variants of concern (VOCs) in cancer patients remains to be elucidated. The aim of this study is to evaluate the immunogenicity of the 3rd dose of the SARS-CoV-2 BNT162b2 mRNA vaccine in triggering both the humoral and the cell-mediated immune response in the patients with solid tumors undergoing active treatment 6 months after booster Methods: We have prospectively evaluated kinetics of humoral and cellular immune response elicited by booster BNT162b2 anti-SARS-CoV-2 vaccine dose up to 6 months. Samples were collected at the enrollment (T0), 21 days after the booster (T1) and 6 months after (T2). Sera were tested for Spike trimeric IgG (cut off 33.8 BAU/mL) and SARS-CoV-2 neutralizing antibodies (NT Abs;cut off 1:10), T-cell response against Spike protein was detected by IFNgamma release assay (IGRA from Euroimmun). Result(s): One-hundred patients (36F/50M;median age 65, range 26-89) were included in the study. In 9 subjects, a COVID-19 infection was reported before the administration of the 1st dose of vaccine. Preliminary analyses were performed in a cohort of 79 previously unexposed subjects. The 3rd dose was administered at median 176 days (range 91-281) after the 1st dose. At T0 anti-S IgG response was median 170 (IQR 67.8-421.4) BAU/mL and it increased to median 2080 (IQR 2080-2080) BAU/mL at T1;a decrease of response was observed at T2 (median 1605 IQR 822-2080 BAU/mL). Overall, 11/79 (13.9%) patients were negative at baseline and 10/11 reached positive level of response at T1. Only 2 subjects were negative for serological response at T2. A similar trend was observed for SARS-CoV-2 NTAbs. In 65 patients we compared NT Abs levels reached against wild type (WT) strain, Delta and Omicron variants at T2. Median response against WT strain was 1:320 (IQR 1:40-1:640) while it decreased to 1:80 (IQR 1:20-1:320) and 1:10 (IQR <1:10-1:40) against Delta and Omicron variants (p value 0.08 and <0.001, respectively). Overall, 4/65 (6.2%) patients were negative for WT SARS-CoV-2 NT Abs while 6/65 (9.2%) and 17/65 (26.2%) were negative for Delta and Omicron SARSCoV- 2 NT Abs, respectively. Conclusion(s): Preliminary data suggest an enhanced immunogenicity elicited by booster in cancer patients, also against variant strains, even if a decrease NT Abs level was observed against Omicron. T-cellular response and multivariable analysis on demographic/clinical data will be presented at the meeting.
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Background Due to SARS-CoV-2 rapid mutations, the ending of the pandemic is still proceeding at a slow pace and there is the need to strengthen and invest in health systems that avoid hospital overload and its consequences on patients’ health. Most symptomatic infections have mild to moderate respiratory symptoms and patients are managed in the context of primary care. In Italy, literature on COVID-19 outpatients management by general practitioners (GPs) is scarce. This study explores the effect of GP active care and monitoring on COVID-19-related hospitalization in patients in the province of Modena (Italy) and investigates the possible determinants of GP's management. Methods This is a retrospective cohort study of SARS-CoV-2 infected adult outpatients managed by their GPs from March 2020 to April 2021 in the province of Modena (Italy). Data on GPs’ characteristics, management strategies (visits and remote monitoring), patients’ socio-demographic characteristics, and hospitalization were extracted from the GP's electronic medical records and were analyzed using descriptive statistics and multiple logistic regression. Results 46 GPs agreed to participate, and 5340 patients were included in the analyses. 3014 (56%) patients received active daily remote monitoring and 840 (16%) were visited at home. Remote monitoring and home visits were both associated with a reduction of the probability of hospitalization rate of approximately 50% (respectively OR:0.52, 95%CI:0.33, 0.80 and OR:0.50, 95%CI;0.33, 0.78). Preliminary analysis of determinants showed that GPs’ patient load, setting, age, and sex were significantly associated with management strategies. Conclusions Active monitoring performed by GPs was effective in reducing the probability of hospitalization. Primary and hospital care integration can be effective for COVID-19 management. Studies on GPs’ characteristics and patient load and their effect on their ability to care for patients are needed. Key messages • Active remote monitoring and visits performed by Italian general practitioners effectively reduced hospitalization for COVID-19. • Primary and hospital care integration can be effective for COVID-19 management.
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To assess how SARS-CoV-2 has changed the demand for in-person health care, we retrospectively analyzed data on access to the emergency department (ED) of San Martino Hospital, the referral acute-care center in the Liguria region (Northwest Italy). 181,699 records of patients diagnosed with an ICD-9 code between 2019 and 2021 were considered. In comparison to pre-pandemic levels, following the introduction of social distancing measures, the median number of ED visits declined by 41.4% in 2020 and by 28.1% in 2021. The period of maximum drop in access (-58.6%) corresponded to the 2020 11-12th calendar weeks and coincided with the highest rates of COVID-like illness - defined as either ILI or LRTI cases - identified through an operator-dependent syndromic surveillance system (+340%;19.5% of total ED attendances). In terms of relative impact, in 2020 and 2021 non-urgent ED codes decreased (by 6.7% and 7.3%) and both urgent and emergency ED codes increased (by 4.8% and 3.8% the former;5.5% and 8.8% the latter), even so, the absolute number of ED access fell drastically for all codes. Urgent codes, in particular, experienced the most severe decrease, shifting from a pre-pandemic value of 25,009 to 18,826 in 2020 and 19,528 in 2021. With regards to diagnosis, in 2020, respiratory infections saw the highest increase (+3.3%) while traumas and eye diseases saw the highest decrease (-1.1% and -3.8%, respectively). This trend reversed in 2021 during which respiratory infections decreased (-2.2%) and traumas increased (+2.2%). Despite the admissions of males and the elderly being routinely lower, these categories experienced the greatest increase in access for respiratory infections: +3.9% and +10.1% in 2020;+2.8% and +7.4% in 2021. While reduction of non-urgent ED visits indicates that the high pre-pandemic access levels may have been avoidable, the significant decline in non-COVID-19 urgent accesses potentially points to an increase in delayed and missed care. Key messages • During the COVID-19 pandemic – possibly due to fear and underestimation of symptoms – there was an overall reduction in ED accesses that potentially points to an increase in delayed or missed care. • The reduction in non-urgent attendances indicates that high pre-pandemic accesses may have been avoidable and that a reduction in unnecessary ED visits is an attainable goal for healthcare systems.
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Introduction: European legislation on pharmacovigilance was amended with the adoption of EU Regulation 2010/1235 [1], which introduced significant changes in the active participation of patients and healthcare professionals to the Adverse Drug Reaction (ADR) reporting process. In recent years a new trend has established worldwide, allowing patients to directly report ADRs to national pharmacovigilance authorities [2]. A consumer, defined as a nonhealthcare professional, is now also considered as a source of information on the safety of a medicinal product [3]. Objective(s): To identify numerosity and level of the involvement of citizens in ADR reporting in Sardinia. Method(s): We extracted data using Vigisegn platform from the Sardinian Region, from 2013 to 2021, for ADRs, stratified by year and qualification of the signaler. ADRs were also analyzed by severity, outcome, SOC (System Organ Classification) and ATC2 (Anatomical Therapeutic Chemical Classification System, level 2). Result(s): In Sardinia, from 2013 to 2021, 6.591 ADR reports were recorded, 1093 (17%) of which were by citizens. Among those reports, 75% were classified as "not serious" and 37% had resolved completely. From 2013 to 2021, citizen participation in ADR reporting changed significantly, from 1 to 26% (Table). In this period, most SOCs reported by citizens were "General pathologies and conditions related to site of administration" (596), "Pathologies of nervous system" (421), "Pathologies of musculoskeletal system and connective tissue" (328). As for SOC "Pathologies of reproductive system and breast", a significant increase in reporting was recorded: from 0% in 2013 to 73% in 2021. In this period, citizen reporting of pathologies of reproductive system and breast constituted 49% of the total reports. In absolute terms, the ATC J07 Vaccine was the most reported by citizens with 799 reports (2737 in 2021). Reports by citizens for homeostatic calcium drugs (H05) account for 81% (48 ADRs) of the total reports for this ATC. Conclusion(s): Increase in citizen reporting in 2017 and 2021 can be traced back to the information activities of the Regional Center following the introduction of mandatory vaccination and the awareness campaign for Covid-19 vaccines. Such increase reflects the growing importance of pharmacovigilance among citizens, meaning that an increasing number of citizens have now acquired the necessary tools to ADR reporting, thus becoming a significant source of information on the safety of drugs and vaccines. (Table Presented).
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Introduction: The anti-Covid vaccines approved in Italy are: Comirnaty, Spikevax, Vaxzevria, Janssen, Nuvaxovid. As of March 26th, 2022, 134,361 adverse events following immunization have been collected in the National Pharmacovigilance Database, 69% of them concern women [1]. Regarding the Sardinian region, as of May 12th, 2022, there are 3043 total reports, 63.4% involve women. In July 2021, the French Drug Agency issued an alert about reports concerning menstrual alterations [2]. PRAC, since new studies have been published, recently decided to further investigate [3]. A cohort study conducted in the US comparing cycle length in a vaccinated cohort vs. an unvaccinated cohort, showed a statistically significant difference [4]. A British case-control study found that 20% of the population included reported menstrual changes, with a higher incidence in individuals with a history of Covid infection [5]. A Norwegian study showed similar results [6]. Objective(s): To describe the adverse events regarding menstrual disorders in the Sardinian population vaccinated against Covid-19. Method(s): We analyzed reports of suspected adverse reactions in the National Pharmacovigilance Database regarding the region of Sardinia, from December 27th, 2020 to April 30th, 2022, we extracted those concerning menstrual cycle alterations after Covid-19 vaccine administration. Result(s): A total of 78 reports referring to all three scheduled administrations were collected. The majority concerned Comirnaty, with 56 reports: 51 were non-serious, concerning abnormal menstrual cycles in lenght and flow, amenorrhea, dysmenorrhea;five cases were considered serious, but there were other adverse events associated (hypersensitivity reactions, autoimmune disorders, myocarditis in one case). Six reports were related to Vaxevria, with similar manifestations as for Comirnaty;in one case the patient was treated with Tamoxifen. Sixteen cases were reported for Spikevax, with one reporting an episode of bleeding in a three-year menopausal patient. In one case, the patient (IUD carrier) reported menstrual disturbances following all three vaccine administrations (two Comirnaty, one Spikevax). Conclusion(s): The different distribution of reports among the vaccines can be explained by the increased administration of Comirnaty in the general population and the phasing out of Vaxzevria. Menstrual disorders are common and can be related to several conditions, although a link with Covid vaccines is plausible, as highlighted by recent studies [4-6] and as already observed for other vaccines. In particular, the strong immune system response created by mRNA vaccines may affect the hypothalamic-pituitary-ovarian axis, which regulate the menstrual cycle.
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To contribute to the study of the disease, data were recorded from all hospitalized patients in the Clinical Medicine room of Hospital Municipal Dr. Raúl Caccavo, Coronel Suárez, Buenos Aires province, diagnosed with COVID-19 in the first year of the pandemia (March 2020 to March 2021), the only health institution where patients were hospitalized in our city. A descriptive and retrospective transversal cut study was carried out with 178 patients (average age: 61 years old, range: 9 months -96 years), 90% of them hospitalized for a respiratory cause. The most prevalent co-morbilities were arterial hypertension (40%), diabetes (17%), obesity (16%), cardiovascular pathology (8%), COPD (8%), and cancer (5%). The average number of hospitalization days was 10. Out of the 178 COVID-19 diagnosed patients, 154 (86%) presented pneumonia and 14% required intensive care. Of the patients in the ICU, 94% needed MVA and 46% died. The overall number of deceased patients was 15%. The general lethality in the city of Coronel Suárez until 03/31/2021 was 0.9%. All patients hospitalized for respiratory causes were subjected to a thorax tomography, and 69% of them presented bilateral infiltration in ground glass. The laboratory tests revealed leucopenia in 15% of the patients and thrombocytopenia in 3% of them. These data could be an input for the development of COVID-19 clinical prediction models, although more evidence will be needed for that end.
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Introduction: European legislation on pharmacovigilance was amended with the adoption of EU Regulation 2010/1235 [1], which introduced significant changes in the active participation of patients and healthcare professionals to the Adverse Drug Reaction (ADR) reporting process. In recent years a new trend has established worldwide, allowing patients to directly report ADRs to national pharmacovigilance authorities [2]. A consumer, defined as a nonhealthcare professional, is now also considered as a source of information on the safety of a medicinal product [3]. Objective: To identify numerosity and level of the involvement of citizens in ADR reporting in Sardinia. Methods: We extracted data using Vigisegn platform from the Sardinian Region, from 2013 to 2021, for ADRs, stratified by year and qualification of the signaler. ADRs were also analyzed by severity, outcome, SOC (System Organ Classification) and ATC2 (Anatomical Therapeutic Chemical Classification System, level 2). Results: In Sardinia, from 2013 to 2021, 6.591 ADR reports were recorded, 1093 (17%) of which were by citizens. Among those reports, 75% were classified as "not serious" and 37% had resolved completely. From 2013 to 2021, citizen participation in ADR reporting changed significantly, from 1 to 26% (Table). In this period, most SOCs reported by citizens were "General pathologies and conditions related to site of administration" (596), "Pathologies of nervous system" (421), "Pathologies of musculoskeletal system and connective tissue" (328). As for SOC "Pathologies of reproductive system and breast", a significant increase in reporting was recorded: from 0% in 2013 to 73% in 2021. In this period, citizen reporting of pathologies of reproductive system and breast constituted 49% of the total reports. In absolute terms, the ATC J07 Vaccine was the most reported by citizens with 799 reports (2737 in 2021). Reports by citizens for homeostatic calcium drugs (H05) account for 81% (48 ADRs) of the total reports for this ATC. Conclusion: Increase in citizen reporting in 2017 and 2021 can be traced back to the information activities of the Regional Center following the introduction of mandatory vaccination and the awareness campaign for Covid-19 vaccines. Such increase reflects the growing importance of pharmacovigilance among citizens, meaning that an increasing number of citizens have now acquired the necessary tools to ADR reporting, thus becoming a significant source of information on the safety of drugs and vaccines.
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Introduction: The anti-Covid vaccines approved in Italy are: Comirnaty, Spikevax, Vaxzevria, Janssen, Nuvaxovid. As of March 26th, 2022, 134,361 adverse events following immunization have been collected in the National Pharmacovigilance Database, 69% of them concern women [1]. Regarding the Sardinian region, as of May 12th, 2022, there are 3043 total reports, 63.4% involve women. In July 2021, the French Drug Agency issued an alert about reports concerning menstrual alterations [2]. PRAC, since new studies have been published, recently decided to further investigate [3]. A cohort study conducted in the US comparing cycle length in a vaccinated cohort vs. an unvaccinated cohort, showed a statistically significant difference [4]. A British case-control study found that 20% of the population included reported menstrual changes, with a higher incidence in individuals with a history of Covid infection [5]. A Norwegian study showed similar results [6]. Objective: To describe the adverse events regarding menstrual disorders in the Sardinian population vaccinated against Covid-19. Methods: We analyzed reports of suspected adverse reactions in the National Pharmacovigilance Database regarding the region of Sardinia, from December 27th, 2020 to April 30th, 2022, we extracted those concerning menstrual cycle alterations after Covid-19 vaccine administration. Results: A total of 78 reports referring to all three scheduled administrations were collected. The majority concerned Comirnaty, with 56 reports: 51 were non-serious, concerning abnormal menstrual cycles in lenght and flow, amenorrhea, dysmenorrhea;five cases were considered serious, but there were other adverse events associated (hypersensitivity reactions, autoimmune disorders, myocarditis in one case). Six reports were related to Vaxevria, with similar manifestations as for Comirnaty;in one case the patient was treated with Tamoxifen. Sixteen cases were reported for Spikevax, with one reporting an episode of bleeding in a three-year menopausal patient. In one case, the patient (IUD carrier) reported menstrual disturbances following all three vaccine administrations (two Comirnaty, one Spikevax). Conclusion: The different distribution of reports among the vaccines can be explained by the increased administration of Comirnaty in the general population and the phasing out of Vaxzevria. Menstrual disorders are common and can be related to several conditions, although a link with Covid vaccines is plausible, as highlighted by recent studies [4-6] and as already observed for other vaccines. In particular, the strong immune system response created by mRNA vaccines may affect the hypothalamic-pituitary-ovarian axis, which regulate the menstrual cycle.
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BACKGROUND: The role and the durability of the immunogenicity of the third dose of vaccine against COVID-19 variants of concern in cancer patients have to be elucidated. PATIENTS AND METHODS: We have prospectively evaluated the immunogenicity of the third dose of the SARS-CoV-2 BNT162b2 messenger RNA vaccine in triggering both humoral and cell-mediated immune response in patients with solid tumors undergoing active treatment 6 months after the booster. Neutralizing antibody (NT Ab) titers and total anti-spike immunoglobulin G concentrations were measured in serum. Heparinized whole blood samples were used for the SARS-CoV-2 interferon-γ release assay (IGRA). RESULTS: Six months after the third dose only two patients (2.4%) showed negative spike-specific immunoglobulin G antibody levels (<33.8 BAU/ml). The median level of SARS-CoV-2 NT Abs decreased and only 39/83 (47%) subjects showed maximum levels of NT Abs. T-cellular positive response was observed in 38/61 (62.3%) patients; the highest median level of response was observed 21 days after the third dose (354 mIU/ml, interquartile range 83.3-846.3 mIU/ml). The lowest median level of NT Ab response was observed against the Omicron variant (1 : 10, interquartile range 1 : 10-1 : 40) with a significant reduced rate of responder subjects with respect to the wild-type strain (77.5% versus 95%; P = 0.0022) and Delta variant (77.5% versus 93.7%; P = 0.0053). During the follow-up period, seven patients (8%) had a confirmed post-vaccination infection, but none of them required hospitalization or oxygen therapy. CONCLUSIONS: Our work highlights a significant humoral and cellular immune response among patients with solid tumors 6 months after the third BNT162b2 vaccine dose, although a reduction in neutralizing activity against Omicron was observed.
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COVID-19 , Neoplasias , Vacunas Virales , Humanos , Vacunas contra la COVID-19/farmacología , Vacuna BNT162 , Estudios Longitudinales , Anticuerpos Antivirales , Vacunas Virales/genética , SARS-CoV-2 , COVID-19/prevención & control , Anticuerpos Neutralizantes , Inmunoglobulina G , Inmunidad Celular , Neoplasias/tratamiento farmacológico , OxígenoRESUMEN
Background: Although a full course of COVID-19 vaccine is effective in cancer patients, the duration of the protection and the efficacy of a booster dose against the new variants remain unknown. We prospectively evaluated the immunogenicity of the third dose of the SARS-CoV-2 BNT162b2 mRNA vaccine in cancer patients undergoing active treatment. Methods: Patients with solid cancer, vaccinated with a booster dose during active treatment, were prospectively enrolled in this study. Patients were classified in SARS-CoV-2 naïve (without previous COVID-19 infection) and SARS-CoV-2 experienced (with previous COVID-19 infection). Neutralizing antibody (NT Abs) titer and total anti-Spike IgG concentration were quantified in serum. Heparinized whole blood samples were used for SARS-CoV-2 Interferon Gamma Release Assay (IGRA). The primary endpoint was to assess the increase of IgG antibody level between baseline (T0) and 3 weeks after the booster (T1). Results: 142 consecutive patients were recruited. In SARS-CoV-2 naïve subjects, median level of IgG was 157 BAU/mL (interquartile range (IQR) 62-423) at T0 and reached median of 2080 (IQR 2080-2080) at three weeks after booster administration (T1;p < 0.0001). A median 16-fold increase of SARS-CoV-2 NT Abs titre (IQR 4-32) was observed in naïve subjects (from median 20 IQR 10-40 to median 640 IQR 160-640;p < 0.0001). Median IFN-γ level at T1 was significantly higher than that measured at T0 in SARS-CoV- 2 naïve subjects (p = 0.0049) but not in SARS-CoV-2 experienced patients. No difference was observed in terms of median response between patients treated with immunotherapy and chemotherapy (p > 0.05). A stronger correlation between SARS-CoV-2 NT Abs and total IgG level was observed at T0 (r = 0.76;p < 0.0001) compared to T1 (r = 0.27, p = 0.0081). No correlation as regards the number of days was observed from the first to the third vaccination and SARS-CoV-2 NT Abs/total IgG. The median level of SARS-CoV-2 NT Abs was 32-fold lower against Omicron compared to wild type strain (p = 0.0004) and 12-fold lower compared to Delta strain (p = 0.0110). Conclusions: The third dose is able to trigger both the humoral and the cell-mediated immune response in cancer patients on active treatment. Our preliminary data about the neutralization of the SARS-CoV-2 vaccine against variants of concern (VOCs) seem to confirm the vaccine lower activity. (Table Presented).