ABSTRACT
Introduction: European pharmacovigilance legislation requires healthcare professionals and citizens to report any suspected adverse drug reaction (SADR). SADRs are uploaded into the National Pharmacovigilance Network (RNF) database by the local responsible of pharmacovigilance. This information feeds Eudravigilance, the European database appointed to collect spontaneous reports of adverse reactions [1]. In the Veneto Region the quality of data entered in the RNF database by the Local Health Authority (LHA) is monitored by the Regional Centre of Pharmacovigilance [2]. Given the central role of vaccines in tackling the pandemic, we focused our attention on SADRs reported for the Covid-19 vaccines. Objective(s): This analysis aims to evaluate the SADRs related to Covid-19 vaccines entered by the LHA of Verona into the RNF database. Number and type of SADRs for the different vaccines administered to people assisted in the LHA were analyzed. Method(s): The doses of Comirnaty-Pfizer/BioNTech, Vaxzevria- AstraZeneca, Spikevax-Moderna and Janssen-Janssen Cilag vaccines administered in the period 01.01.2021-31.12.2021 were considered suitable for the analysis and the SADRs were classified using Med- DRA terminology. Data related to the vaccines were analyzed using Microsoft Excel and were expressed in number and percentage. Result(s): The LHA recorded 3,595 signaling forms corresponding to 10,657 SADRs. 74.8% of the SADRs referred to females, mostly aged 40-59. 53.4% of the cases showed a complete symptom resolution;22.4% experienced an improvement or resolution of the symptoms with persisting side effects. 19.4% of the SADRs were not completely resolved at the reporting time. Death was reported in 0.3% of the cases, while in 4.5% the outcome was not available. Table 1 shows the number of administered doses for each vaccine and the related reporting rates (RRs) for all the SADRs. RR for Spikevax was the highest, regardless of the SADR seriousness. Regarding the SADRs specifically investigated by the regulatory agencies, our analysis highlighted the following figures: risk of pericarditis/myocarditis (5 vs. 2 vs. 1 reports with Spikevax, Comirnaty and Vaxzevria, respectively), vaccine-induced immune thrombotic thrombocytopenia (one report with Vaxzevria) and menstrual disorders (six reports with Comirnaty vs. one with Vaxzevria). Conclusion(s): The number of signaling forms received by the LHA of Verona highlights an increasing awareness on the importance of reporting to provide useful data for public safety. Our analysis confirms current available data regarding the most frequently SADRs experienced with Covid-19 vaccines [3-6]. However, our data are important to underline that SADRs of clinical interest related to each type of vaccine have a low incidence. (Table Presented).
ABSTRACT
Introduction: European pharmacovigilance legislation requires healthcare professionals and citizens to report any suspected adverse drug reaction (SADR). SADRs are uploaded into the National Pharmacovigilance Network (RNF) database by the local responsible of pharmacovigilance. This information feeds Eudravigilance, the European database appointed to collect spontaneous reports of adverse reactions [1]. In the Veneto Region the quality of data entered in the RNF database by the Local Health Authority (LHA) is monitored by the Regional Centre of Pharmacovigilance [2]. Given the central role of vaccines in tackling the pandemic, we focused our attention on SADRs reported for the Covid-19 vaccines. Objective: This analysis aims to evaluate the SADRs related to Covid-19 vaccines entered by the LHA of Verona into the RNF database. Number and type of SADRs for the different vaccines administered to people assisted in the LHA were analyzed. Methods: The doses of Comirnaty-Pfizer/BioNTech, VaxzevriaAstraZeneca, Spikevax-Moderna and Janssen-Janssen Cilag vaccines administered in the period 01.01.2021-31.12.2021 were considered suitable for the analysis and the SADRs were classified using MedDRA terminology. Data related to the vaccines were analyzed using Microsoft Excel® and were expressed in number and percentage. Results: The LHA recorded 3,595 signaling forms corresponding to 10,657 SADRs. 74.8% of the SADRs referred to females, mostly aged 40-59. 53.4% of the cases showed a complete symptom resolution;22.4% experienced an improvement or resolution of the symptoms with persisting side effects. 19.4% of the SADRs were not completely resolved at the reporting time. Death was reported in 0.3% of the cases, while in 4.5% the outcome was not available. Table 1 shows the number of administered doses for each vaccine and the related reporting rates (RRs) for all the SADRs. RR for Spikevax was the highest, regardless of the SADR seriousness. Regarding the SADRs specifically investigated by the regulatory agencies, our analysis highlighted the following figures: risk of pericarditis/myocarditis (5 vs. 2 vs. 1 reports with Spikevax, Comirnaty and Vaxzevria, respectively), vaccine-induced immune thrombotic thrombocytopenia (one report with Vaxzevria) and menstrual disorders (six reports with Comirnaty vs. one with Vaxzevria). Conclusion: The number of signaling forms received by the LHA of Verona highlights an increasing awareness on the importance of reporting to provide useful data for public safety. Our analysis confirms current available data regarding the most frequently SADRs experienced with Covid-19 vaccines [3-6]. However, our data are important to underline that SADRs of clinical interest related to each type of vaccine have a low incidence.
ABSTRACT
Background-Aim: While a frontal dysfunction is reported in post- SARS-CoV-2 with neurological symptoms (neuro-SARS-CoV-2), it is unclear whether this brain vulnerability is long lasting or reversible. The present study evaluated brain dysfunctions-as measured by FDG-PET-in neuro-SARS-CoV-2 over time to provide a better understanding of physiopathology underlying central nervous system involvement. Methods: 26 patients with neuro-SARS-CoV-2 were included. Seven patients were in the acute, the others in the sub-acute and chronic phase, namely, four at 1-month, four at 2-months, four at 3-months, four at 5 months and four at 7-9-months after onset. Patients underwent FDG-PET exams, clinical and cognitive evaluations. One patient was evaluated longitudinally, during the acute phase, and at a 5-months follow-up. Brain metabolism was analysed at the singlesubject and group levels by a comparisons with healthy controls. Correlations between severity/extent of hypometabolism and clinical variables of interest (global cognitive cognition, blood oxygen level saturation, and inflammatory status -C-reactive protein measurements) were also assessed. Results: Patients with acute neuro-SARS-CoV-2 showed the most severe and diffuse cortical hypometabolism, affecting almost all cortical areas. 2-months after the acute infection, a significant decrease in hypometabolism extension emerged, affecting mainly the frontal and temporal cortex. At 5-months after the acute phase, a recovery of cortical hypometabolism was evident, with limited residual clusters in frontal regions. At 7-9-months, no regions with brain hypometabolism were present. The only patient evaluated longitudinally showed a significant brain metabolic improvement from the acute phase (with diffuse cortical hypometabolism) to a 5-months follow-up (brain hypometabolism limited to frontal areas). Of note, the extent and severity of hypometabolism were associated with severe global cognitive dysfunctions, low blood oxygen level saturation, and high inflammatory status in all patients. Conclusions: These findings suggest that cortical functional impairment observed in patients with neuro-SARS-CoV-2 infection is likely to be transient and almost reversible, possibly due to synergistic effects of systemic virus-mediated inflammation sustained by systemic cytokine release and transient hypoxia inducing reversible neural dysfunction and local microglial activation.
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OBJECTIVE: To compare trends in and rates of elective egg freezing (EF) cycles before and during the COVID-19 pandemic. MATERIALS AND METHODS: We retrospectively identified all appointments for EF from June 2019-February 2020 (group 1, pre-pandemic) and June 2020-February 2021 (group 2, post-pandemic) for comparison. Total numbers of EF consultation appointments and retrievals, time to first EF cycle after initial consultation, as well as patient demographics were collected. Growth rates in EF cycles from pre- to post-pandemic were calculated as a whole, by time to first EF cycle from initial consultation, as well as by age group (<30, 30-34.9, 35-39.9, 40-44.9 and >45). RESULTS: Post-pandemic retrieval volume for EF increased by 39% compared to pre-pandemic despite only a 3% increase in new consultation appointments seen over the same timeframe. Demographics in patients pursuing EF between the two timeframes were similar (average age 36.8 years pre-pandemic vs 36.6 years post-pandemic). There was 44% growth in patients pursuing EF cycles in 90 days or less, primarily driven by increased numbers of EF cycles in the 30-34.9 year-old age group. CONCLUSIONS: Despite stable numbers of patients presenting for EF consultation pre- and post-pandemic, more EF retrieval cycles were observed post-pandemic, notably occurring at earlier timepoints from initial consultation and in patients <35. This may represent pandemic-related reevaluation of life goals, changes in financial status, and/or alterations in workplace flexibility. Qualitative survey data will provide further insight into the motivators and drivers of EF, particularly during a time of national crisis. Research focused on what factors were most responsible for the increase in EF cycles may enable providers and patients to make accommodations in the future. IMPACT STATEMENT: Following the COVID-19 pandemic, we observed growth in EF cycle volume and the rates at which EF cycles were initiated after EF consultation. (Table Presented).
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Introduction: Patients with severe COVID-19 admitted to ICU have an increased risk of bacterial and fungal superinfections [1,2]. Steroid therapy with dexamethasone is one of the recommended treatments for patients on oxygen therapy. The aim of this study is to evaluate the incidence of superinfections in patients treated with steroids. Methods: We performed an observational retrospective study, including patients with severe COVID-19 admitted to our ICU between March 2020 and February 2021. Data on bacterial and fungal superinfections and steroid therapy were collected. Results: Among the 152 patients enrolled, 82 (53.9%) received steroid therapy before admission to ICU, 50 (32.9%) did not receive steroids, for 20 (13.2%) the steroid treatment was not known. The clinical characteristics of the two groups of patients at admission are presented in Table 1. Comparing patients receiving steroids and those not receiving steroids, the incidence of superinfections due to fungi was respectively 29.6% vs 12.2% (RR 2.41, CI 95%: 1.06-5.50). The incidence of Gram- and Gram + superinfections was respectively 56% vs 55% (RR 1.03, CI 95%: 0.75-1.41) and 54% vs 38% (RR 1.40, CI 95% 0.93-2.09). Among Gram- superinfections, we observed a significant association between steroid therapy and Acinetobacter spp. superinfection (19.7% in patients on steroids and 6.1% in patients who did not receive steroids, p = 0.03). The duration of steroid therapy was directly correlated with the number of superinfections for each patient (Spearman's rho = 0.34, CI 95% 0.18-0.48, p < 0.001). Conclusions: In patients with severe COVID-19 admitted to ICU, steroid therapy seems to be a risk factor for fungal superinfections and associated with Acinetobacter spp. superinfections. The duration of the steroid therapy is directly correlated to the number of superinfections for each patient. (Table Presented).
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The article aims to consider the potentials of telemedicine in the Child Neuropsychiatry (NPI) area, by presenting the experience gained during the period of the lockdown due to the COVID-19 health emergency. The NPI Public Health out-patient service of Turin, North Zone (ASLTO4), has found itself facing the emergency with a considerable effort of creativity and flexibility and limited computer knowledges. The ASL TO4 NPI has promoted the use of information technology not only to support televisit/teleconsultation, but also in the field of telerehabilitation, a less obvious area for telemedicine and perhaps more innovative. Information technologies has been also used to enhance the network of operators and different services. The article illustrates the work done by ASLTO4 NPI, with specific attention to telerehabilitation with Autism Spectrum Disorders, and figures out the advantages and potentials of telemedicine resulted from this experience. The paper also suggests that, if telemedicine will further develop, Public Health Service should provide a Service Center or an information technology support structure focused to satisfy the needs of individual services by providing guidelines, platforms, data sharing and collection, with a specific attention to privacy and sensitive data management. (PsycInfo Database Record (c) 2022 APA, all rights reserved) (Italian) L'articolo vuole aprire una riflessione sulle potenzialita della telemedicina nell'ambito della NPI, prendendo spunto dall'esperienza maturata durante il periodo del lockdown a causa dell'emergenza sanitaria COVID-19. La Struttura Complessa di Neuropsichiatria Infantile dell'ASLTO4 ha cercato di affrontare l'emergenza con un notevole sforzo di creativita e di flessibilita e con delle limitate conoscenze informatiche. Si e promosso l'uso della tecnologia informatica non solo per la televisita, nelle sue varie declinazioni, ma anche nell'ambito della teleriabilitazione, un ambito meno scontato e forse piu innovativo. Si sono inoltre utilizzate le tecnologie informatiche per potenziare la rete tra gli operatori e tra i diversi servizi. L'articolo illustra il lavoro svolto soprattutto in teleriabilitazione nei Nuclei DPS (Disturbi Pervasivi dello Sviluppo) e sviluppa alcune conside- razioni sui vantaggi e sulle potenzialita della telemedicina in base a quanto emerso durante l'esperienza. Inoltre, suggerisce che, qualora la telemedicina dovesse ulteriormente svilupparsi, i Servizi sanitari dovrebbero prevedere la creazione di un Centro Servizi, ovvero di una struttura di supporto informatico che risponda in maniera sistematica alle esigenze dei singoli servizi, che predisponga delle linee guida/ indicazioni operative e che offra delle piattaforme, dei sistemi di raccolta e di condivisione dei dati, in maniera interoperabile e con attenzione alle problematiche legate al trattamento dei dati sensibili. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
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Introduction: Chronic pain patients who undergo to stressful events may experience worsening in pain, sleep, and quality of life (QoL). The primary objective of this observational study was to compare QoL and sleep parameters before and after the COVID-19 lockdown in patients with Fibromyalgia Syndrome (FMS). The psychological impact of lockdown was also assessed, as well as the emotional impact of the pandemic and its correlations with patient socio-demographics. Methods: Patients aged ≥18 years with FMS diagnosed according to ACR (American College of Rheumatology) 2016 Criteria with at least one pre-pandemic QoL and sleep evaluation were included. QoL and sleep disturbances were analyzed by comparing scores on the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), the 12-item Short Form Survey (SF-12), and the Pittsburgh Sleep Quality Index (PSQI) before and after the first lockdown in Italy (March to May 2020). Psychological impact was investigated via a 52-item survey of daily life changes in FMS management during the lockdown and emotional impact with the Impact Event Scale-Revised (IES-R) tool during the onset period after the lockdown. Questionnaire responses were correlated with patients’ sociodemographics. Results: Questionnaires were submitted via email to 54 patients; 37/54 patients (63.7%) returned them. QoL and sleep disturbances showed no statistically significant worsening. However, the psychological impact survey revealed that 3 out of 5 patients feared very much for their family members’ lives during lockdown. The emotional impact survey disclosed 72.7% of patients with psychological distress. Conclusions: While questionnaire responses showed no significant changes in QoL and sleep after the COVID-19 lockdown in this sample of FMS patients, the emotional investigation revealed moderate/severe psychological distress not detected by commonly used QoL tests in FMS.
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Background and Aim: The lasting effects of SARS-CoV-2 infection in survivors of severe CoViD-19 are largely unknown. Our aim is to describe a new model of care in the setting of an Internal Medicine outpatient clinic for survivors of severe CoViD-19, and to evaluate their long-term respiratory sequelae. Materials and Methods: Patients affected by severe CoViD-19 pneumonia were enrolled into a 2-step follow-up at 5 months. Patients with multiple comorbidities who are unable to walk were excluded. In the first step clinical evaluation, chest X ray (CXR), 6 minutes walking test (6MWT) and validated questionnaires (mMRC, BFI test) were assessed. The second step included chest computed tomography, pulmonary function tests, and echocardiography. A chest x-ray severity score (CXRSS) was used to compare CXR before and after the discharge. Results: Among 340 patients discharged for severe CoViD-19, 153 showed exclusion criteria, and 187 patients were eligible. Until now, the first evaluation has been done in 45 patients (mean age 67 yrs). When compared before and after discharge?, the CXRSS showed a significant improvement (p<0.001). The median 6MWT was 420 m (20-540), BFI was 10 (0-64), mMRC was 1 (0-4). Only 7 patients were planned to a second step evaluation. Conclusions: After 5 months from hospital discharge, the majority of severe CoViD-19 survivors showed a resolution of pulmonary CXR reports and a good functional status. A 2-step clinical evaluation strategy in an Internal Medicine setting helps in early identification of patients at risk of developing respiratory sequelae.
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Background and Aim: Information regarding the predictors of outcome in patients with CoViD-19 remains scarce. We aimed to analyze the clinical and biochemical characteristics and predictors of death in patients hospitalized for CoViD-19. Materials and Methods: We retrospectively analyzed163 patients consecutively admitted for severe CoViD-19 between 9/2020 and12/2020 in the CoViD area of the Internal Medicine Department, Ospedale dell'Angelo, Mestre. Survival was evaluated at 28 days from admission. Results: Forty-two over163 CoViD-symptomatic patients died because of complications of infection (25,7%). Patients who died were significantly older (82 [76-86] vs 71 [54-80] years, p<0.001), had more cardiovascular comorbidities (p<0.01), higher signs of inflammation at admission (PCR13 [6-17] vs 7 [3-15] mg/dL, p<0.01;IL-6 63 [20-137] vs 21 [10-51] ng/L, p=0.001;D-dimer1.0 [0.6- 1.7] vs 0.7 [0.4-1.3] ng/mL, p<0.05), worse respiratory function at admission (P/F179 [115-268] vs 271 [210-342], p<0.001) and on day three (P/F110 [92-167] vs 225 [145-285], p<0.001), and wider organ involvement (creatinine1.4 [0.8-2.0] vs1.0 [0.8- 1.2] mg/dL, p=0.001;hsTnI 33 [20-123] vs12 [6-24] pg/mL, p<0.001;BNP 270 [120-556] vs 77 [132-187] pg/mL, p<0.001). At multivariate logistic regression analysis BNP (OR:1.01, CI:1.003- 1.017) and P/F on day three (OR 0.969, CI: 0.948-0.991) were independently associated with an increased risk of death. Conclusions: Our analysis may help clinicians in identifying patients with higher risk of death who deserve further clinical and research efforts.
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Mobility-impaired persons, either very old or younger but suffering with systemic neuromuscular disorders or chronic organ failures, spend small amounts of time for daily physical activity, contributing to aggravate their poor mobility by resting muscle atrophy. Sooner or later the limitations to their mobility enforce them to bed and to more frequent hospitalizations. We include among these patients at risk those who are negative for the SARS-COV-2 infection, but suffering with COVID-19 pandemic syndrome. Beside managements of psychological symptoms, it is mandatory to offer to the last group physical rehabilitation approaches easy to learn and self-managed at home. Inspired by the proven capability to recover skeletal muscle contractility and strength by home-based volitional exercises and functional electrical stimulation, we suggest also for chronic COVID-19 pandemic syndrome a 10-20 min long daily routine of easy and safe physical exercises that can activate, and recover from weakness, the main 400 skeletal muscles used for every-day mobility activities. Persons can do many of them in bed (Full-Body in-Bed Gym), and hospitalized patients can learn this light training before leaving the hospital. It is, indeed, an extension of well-established cardiovascular-respiratory rehabilitation training performed after heavy surgical interventions. Blood pressure readings, monitored before and after daily routine, demonstrate a transient decrease in peripheral resistance due to increased blood flow of many muscles. Continued regularly, Full-Body in-Bed Gym may help maintaining independence of frail people, including those suffering with the COVID-19 pandemic syndrome.