Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This ...study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy. We conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases. The outcome was the first diagnosis of myocarditis/pericarditis between 27 December 2020 and 30 September 2021. Exposure risk period (0 to 21 days from the vaccination day, subdivided in 3 equal intervals) for first and second dose was compared with baseline period. The SCCS model, adapted to event-dependent exposures, was fitted using unbiased estimating equations to estimate relative incidences (RIs) and excess of cases (EC) per 100,000 vaccinated by dose, age, sex, and vaccine product. Calendar period was included as time-varying confounder in the model. During the study period 2,861,809 persons aged 12 to 39 years received mRNA vaccines (2,405,759 BNT162b2; 456,050 mRNA-1273); 441 participants developed myocarditis/pericarditis (346 BNT162b2; 95 mRNA-1273). Within the 21-day risk interval, 114 myocarditis/pericarditis events occurred, the RI was 1.99 (1.30 to 3.05) after second dose of BNT162b2 and 2.22 (1.00 to 4.91) and 2.63 (1.21 to 5.71) after first and second dose of mRNA-1273. During the 0 to 7) days risk period, an increased risk of myocarditis/pericarditis was observed after first dose of mRNA-1273, with RI of 6.55 (2.73 to 15.72), and after second dose of BNT162b2 and mRNA-1273, with RIs of 3.39 (2.02 to 5.68) and 7.59 (3.26 to 17.65). The number of EC for second dose of mRNA-1273 was 5.5 per 100,000 vaccinated (3.0 to 7.9). The highest risk was observed in males, at 0 to 7) days after first and second dose of mRNA-1273 with RI of 12.28 (4.09 to 36.83) and RI of 11.91 (3.88 to 36.53); the number of EC after the second dose of mRNA-1273 was 8.8 (4.9 to 12.9). Among those aged 12 to 17 years, the RI was of 5.74 (1.52 to 21.72) after second dose of BNT162b2; for this age group, the number of events was insufficient for estimating RIs after mRNA-1273. Among those aged 18 to 29 years, the RIs were 7.58 (2.62 to 21.94) after first dose of mRNA-1273 and 4.02 (1.81 to 8.91) and 9.58 (3.32 to 27.58) after second dose of BNT162b2 and mRNA-1273; the numbers of EC were 3.4 (1.1 to 6.0) and 8.6 (4.4 to 12.6) after first and second dose of mRNA-1273. The main study limitations were that the outcome was not validated through review of clinical records, and there was an absence of information on the length of hospitalization and, thus, the severity of the outcome. This population-based study of about 3 millions of residents in Italy suggested that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years. According to our results, increased risk of myocarditis/pericarditis was associated with the second dose of BNT162b2 and both doses of mRNA-1273. The highest risks were observed in males of 12 to 39 years and in males and females 18 to 29 years vaccinated with mRNA-1273. The public health implication of these findings should be considered in the light of the proven mRNA vaccine effectiveness in preventing serious COVID-19 disease and death.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Recently published studies have reported association of COVID-19 vaccine ChAdOx1-S (Vaxzevria) with Guillain Barré Syndrome (GBS). Less is known about the safety of other COVID-19 vaccines with ...respect to GBS outcome. This study investigated the association of COVID-19 vaccines with GBS in more than 15 million persons aged ≥12 years in Italy.
Study population was all individuals aged ≥12 years who received at least one dose of COVID-19 vaccines, admitted to emergency care/hospital for GBS from 27 December 2020-30 September 2021 in Italy. Identification of GBS cases and receipt of at least one dose of mRNA-1273 (Elasomeran), BNT162b2 (Tozinameran), ChAdOx1-S (Vaxzevria) and Ad26.COV2.S (Janssen) through record linkage between regional health care and vaccination registries. Relative Incidence (RI) was estimated Self-controlled case series method adapted to event-dependent exposure using in the 42-day exposure risk period after each dose compared with other observation periods.
Increased risk of GBS was found after first (RI = 6.83; 95% CI 2.14-21.85) and second dose (RI = 7.41; 2.35-23.38) of mRNA-1273 and first dose of ChAdOx1-S (RI = 6.52; 2.88-14.77). Analysis by age found an increased risk among those aged≥60 years after first (RI = 8.03; 2.08-31.03) and second dose (RI = 7.71; 2.38-24.97) of mRNA-1273. The first dose of ChAdOx1-S was associated with GBS in those aged 40-59 (RI = 4.50; 1.37-14.79) and in those aged ≥ 60 years (RI = 6.84; 2.56-18.28).
mRNA-1273 and ChAdOx1-S vaccines were associated with an increased risk of GBS however this risk resulted in a small number of excess cases. Limitations were loss of GBS outpatient cases and imprecision of the estimates in the subgroup analysis due to a low number of events.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
It is well established that cancer patients infected with SARS‐CoV‐2 are at particularly elevated risk of adverse outcomes, but the comparison of SARS‐CoV‐2 infection risk between cancer ...patients and cancer‐free individuals has been poorly investigated on a population‐basis.
Methods
A population‐based study was thus conducted in Friuli Venezia Giulia region, northeastern Italy, to estimate prevalence and determinants of SARS‐CoV‐2 infection among cancer patients, as compared to cancer‐free individuals, and to evaluate adverse outcomes of SARS‐CoV‐2 infection. The study included 263,042 individuals tested for SARS‐CoV‐2 in February–December 2020 with cancer history retrieved through the regional cancer registry. Odds ratios (ORs) of SARS‐CoV‐2 positivity, with corresponding 95% confidence intervals (CIs), were calculated using multivariable logistic regression models, adjusted for sex and age. Hazard ratios (HRs) adjusted for sex and age for intensive care unit (ICU) admission and all‐cause death were estimated using Cox models.
Results
Among 26,394 cancer patients tested for SARS‐CoV‐2, the prevalence of infection was 11.7% versus 16.2% among 236,648 cancer‐free individuals, with a corresponding OR = 0.59 (95% CI: 0.57–0.62). The prevalence was much higher (29% in both groups) during the second pandemic wave (October–December 2020). Among cancer patients, age ≥80 years and cancer diagnosis ≥13 months before SARS‐CoV‐2 testing were the major risk factors of infection. Among 3098 infected cancer patients, the fatality rate was 17.4% versus 15.8% among 23,296 negative ones (HR = 1.63, 95% CI: 1.49–1.78), and versus 5.0% among 38,268 infected cancer‐free individuals (HR = 1.23, 95% CI: 1.12–1.36). No significant differences emerged when considering ICU admission risk.
Conclusion
Albeit cancer patients reported reduced SARS‐CoV‐2 infection risk, those infected showed higher mortality than uninfected ones and infected cancer‐free population. Study findings claim for continuing to protect cancer patients from SARS‐CoV‐2, without reducing the level of oncologic care.
SARS‐CoV‐2 infection risk among cancer patients as compared to cancer‐free individuals has been poorly investigated on a population‐basis. This population‐based study found 40% lower odd of SARS‐CoV‐2 positivity among tested cancer patients than cancer‐free individuals. Nonetheless, SARS‐CoV‐2‐positive cancer patients reported higher risk of death, both as compared to negative ones or to positive cancer‐free population. Study findings claim for continuing to protect cancer patients from SARS‐CoV‐2 infection, without reducing the level of oncologic care.
In many countries, including Italy, there are few national data on pre-pregnancy Body Mass Index (BMI) and gestational weight gain (GWG), despite these being important predictors of maternal and ...neonatal health outcomes. This dearth of information makes it difficult to develop and monitor intervention policies to reduce the burden of disease linked to inadequate BMI status and/or GWG in pregnant women. This study describes the setting up and initial implementation of a regional surveillance system on pre-pregnancy BMI and GWG.
Between 1 January 2017 and 31 December 2018, anthropometric data were collected from all pregnant women accessing public health services in the Friuli Venezia Giulia region (Italy) for first ultrasound check (T1) and at delivery (T2). Anthropometric data collected at T1 (self-reported pre-pregnancy weight and measured weight and height) and T2 (measured weight and self-reported pre-pregnancy weight and height) were compared.
The system was able to reach 43.8% of all the women who gave birth in the region, and provided complete data for 6400 women of the 7188 who accessed the services at T1. At the beginning of pregnancy 447 (7.0%) women were underweight, 4297 (67.1%) had normal weight, 1131 (17.7%) were overweight and 525 (8.2%) had obesity. At delivery, 2306 (36.0%) women were within the appropriate weight gain range, while for 2021 (31.6%) weight gain was insufficient and for 2073 (32.4%) excessive. Only minor differences were observed between measured and self-reported anthropometric data.
The surveillance system offers an overview of the weight status of women during pregnancy. About 1/3 of women entered pregnancy with unsatisfactory BMI and 2/3 did not achieve the recommended weight gain. This surveillance system can be an effective tool to guide public health interventions.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
People with a history of cancer have a higher risk of death when infected with SARS-CoV-2. COVID-19 vaccines in cancer patients proved safe and effective, even if efficacy may be lower than in the ...general population. In this population-based study, we compare the risk of dying of cancer patients diagnosed with COVID-19 in 2021, vaccinated or non-vaccinated against SARS-CoV-2 and residing in Friuli Venezia Giulia or in the province of Reggio Emilia. An amount of 800 deaths occurred among 6583 patients; the risk of death was more than three times higher among unvaccinated compared to vaccinated ones HR 3.4; 95% CI 2.9–4.1. The excess risk of death was stronger in those aged 70–79 years HR 4.6; 95% CI 3.2–6.8, in patients with diagnosis made <1 year HR 8.5; 95% CI 7.3–10.5 and in all cancer sites, including hematological malignancies. The study results indicate that vaccination against SARS-CoV-2 infection is a necessary tool to be included in the complex of oncological therapies aimed at reducing the risk of death.
Influenza and its complications are an important public health concern, and vaccination remains the most effective prevention measure. However, the efficacy of vaccination depends on several ...variables, including the type of strategy adopted. The goal of this study was to assess the impact of different influenza vaccination strategies in preventing hospitalizations for influenza and its related respiratory complications. A retrospective cohort study was conducted on data routinely collected by the health services for six consecutive influenza seasons, considering the population aged 65 years or more at the time of their vaccination and living in northeastern Italy. Our analysis concerns 987,266 individuals vaccinated against influenza during the study period. The sample was a mean 78.0 ± 7.7 years old, and 5681 individuals (0.58%) were hospitalized for potentially influenza-related reasons. The hospitalization rate tended to increase over the years, not-significantly peaking in the 2016–2017 flu season (0.8%). Our main findings revealed that hospitalizations related to seasonal respiratory diseases were reduced as the use of the enhanced vaccine increased (R2 = 0.5234; p < 0.001). Multivariate analysis confirmed the significantly greater protective role of the enhanced vaccine over the conventional vaccination strategy, with adjusted Odds Ratio (adj OR) = 0.62 (95% CI: 0.59–0.66). A prior flu vaccination also had a protective role (adj OR: 0.752 (95% CI: 0.70–0.81)). Age, male sex, and H3N2 mismatch were directly associated with a higher risk of hospitalization for pneumonia. In the second part of our analysis, comparing MF59-adjuvanted trivalent inactivated vaccine (MF59-TIV) with conventional vaccines, we considered 479,397 individuals, of which 3176 (0.66%) were admitted to a hospital. The results show that using the former vaccine reduced the risk of hospitalization by 33% (adj OR: 0.67 (95% CI: 0.59–0.75)). This study contributes to the body of evidence of a greater efficacy of enhanced vaccines, and MF59-adjuvanted TIV in particular, over conventional vaccination strategies in the elderly.
The aim of the study is to validate at the biochemical level (presence of myocardial damage) the discharge diagnosis code ICD-9-CM 410.x1, and to compare the acute myocardial infarction (AMI) ...epidemiology based on pure administrative data with the epidemiology based on troponin and clinical data.
The health-related administrative databases of the Italian Region Friuli Venezia Giulia were used as the source of information. All the databases are anonymous and can be linked with each other at the individual patient level through a univocal stochastic key. Two methods were used to assess incidence in 2017: the first used the main hospital discharge diagnosis, validated by biochemical myocardial necrosis; the second identified from the cohort of all patients with any myocardial injury those with ischemic origin.
The positive-predictive value of the clinical diagnosis of AMI (410.x1), validated at the biochemical level, was 96.2%.About 40% of patients with a not trivial biochemical myocardial injury and an ischemic heart disease diagnosis (e.g. 411) were discharged without either ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) diagnosis, leading to a sensitivity of clinical discharge diagnosis of 47.6%.Thirty-day and 90-day mortality at multivariate analysis resulted respectively, 1.8 and 4.0% in NSTEMI, 6.6 and 9.8% in STEMI, 8.8 and 12.2% in patients with biochemical AMI and discharge diagnosis other than 410.x1.
Pure administrative data (clinical discharge diagnosis) are today insufficient to catch the whole hospital epidemiology of myocardial infarction missing an important proportion of AMI with an adverse prognosis comparable with STEMI.
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Background: Background: Hospital admission and death of infected cancer patients were investigated according to SARS-CoV-2 vaccination status. Methods: Population-based observational study on ...1874 SARS-CoV-2 infected patients with prostate (n=1276), kidney (n=327), and bladder (n=271) cancers. Hazard ratios (HR) and their 95% confidence intervals (CI), adjusted for sex and age, were computed to assess the risk of hospital admission and death of unvaccinated patients as compared to vaccinated ones. Results: 24.5% of patients with prostate, 26.9% with kidney and 29.5% with bladder cancer were unvaccinated. As compared to vaccinated ones, a statistically significant excess risk of hospital admission emerged for unvaccinated ones with prostate (HR=3.33, 95% CI: 2.50-4.55), and kidney (HR=4.35, 95% CI: 2.33-8.33) cancer. The 312 unvaccinated prostate cancer patients were also at a nearly 3-fold higher risk of death than vaccinated ones (HR=2.98, 95% CI:1.89-4.70). Conclusions: Study findings stress the importance of SARS-CoV-2 vaccines in reducing hospital admission and death in patients with urologic cancers, particularly prostate cancer.
Objective:
To describe the practice of prostate-specific antigen (PSA) testing over more than 20 years in Friuli Venezia Giulia (FVG), North-Eastern Italy.
Methods:
A population-based, ecological ...study was conducted using information derived from regional administrative health-related databases. Data on PSA and prostate biopsies performed on resident men aged ⩾45 years from 1998 to 2019 were retrieved. PSA and biopsy rates were calculated as the number of men who had at least one such procedure in each calendar year over the mean resident male population of the same year. Temporal trends were analyzed using joinpoint regression (annual percentage change –APC).
Results:
A total of 2,502,670 PSA were made between 1998 to 2019 in men aged ⩾45 years. The number of PSA steadily increased from 51,055 in 1998-1999 to 134,504 in 2010-2011, then dropped to 122,080 in 2018-2019. Significant changes in the slopes of PSA rates emerged in 2002 and 2009: the largest increase occurred during 1998-2002 (APC 18.4), followed by a smaller increase in 2002-2009 (APC 3.4) and a subsequent reduction (APC -2.5). Similar patterns emerged for all ages, but the decrease since 2009 was smaller for men aged ⩾65 years. An upward trend emerged in biopsy rate from 1998 to 2001 (APC 13.0), followed by a smaller increase until 2007 (APC 5.7) and a subsequent decrease. Biopsies as percentage of PSA decreased from 3.2% to 2.2%, particularly in those aged ⩾75 years.
Conclusions:
Although overall declining PSA rates have been observed in FVG since 2009, rates remained higher in the ⩾65-year-old group than in the 45-64–year-old group.
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