Post-marketing active surveillance of Guillain Barré Syndrome following COVID-19 vaccination in persons aged ≥12 years in Italy: A multi-database self-controlled case series study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

SARS-CoV-2 Infection, Vaccination and Risk of Death in People with An Oncological Disease in Northeast Italy.

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.

Monitoring gestational weight gain: setting up a regional surveillance system in Italy.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Vaccination against SARS-CoV-2 and risk of hospital admission and death among infected cancer patients: A population-based study in northern Italy.

BACKGROUND: The risks of hospital admission for COVID-19-related conditions and all-cause death of SARS-CoV-2 infected cancer patients were investigated according to vaccination status. METHODS: A population-based cohort study was carried out on 9754 infected cancer patients enrolled from January 1, 2021 to June 30, 2022. Subdistribution hazard ratio (SHRs) or hazard ratios (HRs) with 95 % confidence intervals (CI), adjusted for sex, age, comorbidity index, and time since cancer incidence, were computed to assess the risk of COVID-19 hospital admission or death of unvaccinated vs. patients with at least one dose of vaccine (i.e., vaccinated). RESULTS: 2485 unvaccinated patients (25.5 %) were at a 2.57 elevated risk of hospital admission (95 % CI: 2.13-2.87) and at a 3.50 elevated risk of death (95 % CI: 3.19-3.85), as compared to vaccinated patients. Significantly elevated hospitalizations and death risks emerged for both sexes, across all age groups and time elapsed since cancer diagnosis. For unvaccinated patients, SHRs for hospitalization were particularly elevated in those with solid tumors (SHR = 2.69 vs. 1.66 in patients with hematologic tumors) while HRs for the risk of death were homogeneously distributed. As compared to boosted patients, SHRs for hospitalization and HRs for death increased with decreasing number of doses. CONCLUSIONS: Study findings stress the importance of SARS-CoV-2 vaccines to reduce hospital admission and death risk in cancer patients.

The use of PSA testing over more than 20 years: A population-based study in North-Eastern Italy.

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.

Outcomes of SARS-CoV-2 infection in cancer versus non-cancer-patients: a population-based study in northeastern Italy.

INTRODUCTION: This study assesses the risk of infection and clinical outcomes in a large consecutive population of cancer and non-cancer patients tested for SARS-CoV-2 status. METHODS: Study patients underwent SARS-CoV-2 molecular-testing between 22 February 2020 and 31 July 2020, and were found infected (CoV2+ve) or uninfected. History of malignancy was obtained from regional population-based cancer registries. Cancer-patients were distinguished by time between cancer diagnosis and SARS-CoV-2 testing (<12/⩾12 months). Comorbidities, hospitalization, and death at 15 September 2020 were retrieved from regional population-based databases. The impact of cancer history on SARS-CoV-2 infection and clinical outcomes was calculated by fitting a multivariable logistic regression model, adjusting for sex, age, and comorbidities. RESULTS: Among 552,362 individuals tested for SARS-CoV-2, 55,206 (10.0%) were cancer-patients and 22,564 (4.1%) tested CoV2+ve. Irrespective of time since cancer diagnosis, SARS-CoV-2 infection was significantly lower among cancer patients (1,787; 3.2%) than non-cancer individuals (20,777; 4.2% - Odds Ratio (OR)=0.60; 0.57-0.63). CoV2+ve cancer-patients were older than non-cancer individuals (median age: 77 versus 57 years; p<0.0001), were more frequently men and with comorbidities. Hospitalizations (39.9% versus 22.5%; OR=1.61; 1.44-1.80) and deaths (24.3% versus 9.7%; OR=1.51; 1.32-1.72) were more frequent in cancer-patients. CoV2+ve cancer-patients were at higher risk of death (lung OR=2.90; 1.58-5.24, blood OR=2.73; 1.88-3.93, breast OR=1.77; 1.32-2.35). CONCLUSIONS: The risks of hospitalization and death are significantly higher in CoV2+ve individuals with past or present cancer (particularly malignancies of the lung, hematologic or breast) than in those with no history of cancer.

Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A multi-database, self-controlled case series study.

BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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.

Prevalence, determinants, and outcomes of SARS-COV-2 infection among cancer patients. A population-based study in northern Italy.

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.

Preventing the Risk of Hospitalization for Respiratory Complications of Influenza among the Elderly: Is There a Better Influenza Vaccination Strategy? A Retrospective Population Study.

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.

[Early effects of attendance to the Friuli Venezia Giulia (Northern Italy) mammography screening programme on the incidence of advanced-stage breast cancer: a cohort study]. / Effetti precoci dell'adesione al programma di screening mammografico della Regione Friuli Venezia Giulia sull'incidenza del cancro della mammella in stadio avanzato: uno studio di coorte.

OBJECTIVES: to evaluate the incidence of advanced-stage breast cancer (BC) - an early surrogate indicator of effectiveness of mammography screening - among women who attended the Friuli Venezia Giulia (FVG) Region (Northern Italy) screening programme compared to women who did not attend. DESIGN: retrospective cohort study. Women invited to the first screening round (2006-2007) were identified from the database of the programme. The cohort was record-linked to the archive of women invited to the second round (2008-2009). The definition of attendance to screening was based on attendance to at least one of the two rounds. The incidence of BC was assessed through record linkage with the FVG cancer registry using an anonymous univocal identifier (end of follow-up: 31st December 2013). Three distinct definitions of advanced stage were used: pT2 or greater (pT2+), positive lymph nodes (pN+), and TNM stage II or greater (stage II+). SETTING AND PARTICIPANTS: organized mammography screening programme for women aged 50-69 years in the five regional healthcare districts. MAIN OUTCOME MEASURES: incidence rate ratio (IRR) between attenders and non-attenders, adjusted for age and deprivation index, with 95% confidence interval (95%CI). RESULTS: the cohort included 104,488 attenders and 49,839 non-attenders. During follow-up (median duration 84 months), 2,717 invasive BCs were diagnosed among attenders and 1,149 among non-attenders. Total incidence rate was 13% higher among attenders (IRR 1.13; 95%CI 1.05-1.21). These, conversely, had a 36% lower rate of pT2+ BC (IRR 0.64; 95%CI 0.56-0.72), a 13% lower rate of pN+ BC (IRR 0.87; 95%CI 0.78-0.98), a 22% lower rate of stage II+ BC (IRR 0.78; 95%CI 0.70-0.87), and a 32% lower rate of mastectomy (IRR 0.68; 95%CI 0.60-0.78). CONCLUSIONS: attenders had lower incidence rates of advanced-stage BC. This early effect is suggestive of a future impact of the screening programme on BC mortality.

Measuring multimorbidity inequality across Italy through the multisource comorbidity score: a nationwide study.

BACKGROUND: Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. A simple multisource comorbidity score (MCS) has been recently developed and validated. A very large real-world investigation was conducted with the aim of measuring inequalities in the MCS distribution across Italy. METHODS: Beneficiaries of the Italian National Health Service aged 50-85 years who in 2018 were resident in one of the 10 participant regions formed the study population (15.7 million of the 24.9 million overall resident in Italy). MCS was assigned to each beneficiary by categorizing the individual sum of the comorbid values (i.e. the weights corresponding to the comorbid conditions of which the individual suffered) into one of the six categories denoting a progressive worsening comorbidity status. MCS distributions in women and men across geographic partitions were compared. RESULTS: Compared with beneficiaries from northern Italy, those from centre and south showed worse comorbidity profile for both women and men. MCS median age (i.e. the age above which half of the beneficiaries suffered at least one comorbidity) ranged from 60 (centre and south) to 68 years (north) in women and from 63 (centre and south) to 68 years (north) in men. The percentage of comorbid population was lower than 50% for northern population, whereas it was around 60% for central and southern ones. CONCLUSION: MCS allowed of capturing geographic variability of multimorbidity prevalence, thus showing up its value for addressing health policy in order to guide national health planning.

Clinical, demographical characteristics and hospitalisation of 3,010 patients with Covid-19 in Friuli Venezia Giulia Region (Northern Italy). A multivariate, population-based, statistical analysis.

OBJECTIVES: to describe the clinical and demographical characteristics of COVID-19 infected people in the Friuli Venezia Giulia Region (FVG, Northern Italy). DESIGN: retrospective cohort study with an individual level record linkage procedure of different administrative databases. SETTING AND PARTICIPANTS: the cohort included 3,010 patients residing in FVG who tested positive for COVID-19 between 1 March and 15 May 2020, 2020. Regional hospital admissions and deaths without hospital admissions up to June 1st, 2020 were analysed. Determinants of the probability of a highly severe illness were investigated in terms of hospitalisations or death without hospital admission. MAIN OUTCOME MEASURES: COVID-19 patients were identified from regional epidemiological data warehouse. Demographical and clinical variables such as gender, age, patient's comorbidities, vaccinations, ARBs/sartans prescriptions, and geographical residence variables were collected by linking different databases. Descriptive analyses were performed. Logistic multivariate regressions were used to estimate the probability of hospitalisation or death, whichever came first. Model coefficients and odds ratios (OR) were reported. RESULTS: COVID-19 population in FVG had a mean age of 60 years and 59% were females. The study found that 37% had hypertension while patients with cardiologic diseases, diabetes, and cancer were around 15%; 22% of the cases were residing in retirement homes. Approximately 30% received flu or pneumococcal vaccination and a similar proportion of patients had at least one prescription of ARBs /sartans in the previous 6 months. Statistical models showed a higher probability of a worst course of disease for males, elderly, highly complicated (in terms of resource use) subjects, in the presence of cardiologic diseases, diabetes, and pneumococcal vaccination. People living in retirement homes had a lower probability of hospitalisation/death without hospital admission. The cohort was divided into two groups: COVID-19 patients infected in the territory and infected in retirement homes. Among COVID-19 patients infected in the territory, the probability of hospitalisation/death was higher for males, for older individuals, and for those with comorbidities. Diabetes resulted to be a risk factor (OR 1.79; 95%CI 1.23-2.62), as well as pneumococcal vaccination (OR 1.64; 95%CI: 1.18-2.29), which is a likely proxy of fragile patients with pulmonary disease. The flu vaccination showed a potential protective effect with a 40% lower probability of hospitalisation or death (OR 0.62; 95%CI 0.44-0.85). Among the retirement homes cohort group, a higher probability of a bad course of disease emerged for males and for more complex patients. CONCLUSIONS: the greatest risk of hospitalisation/death as a measure of more severe illness was confirmed for males, elderly, and for individuals with comorbidities. Flu vaccination seemed to have had a protective effect while pneumococcal vaccination likely identified a group of high-risk patients to be actively monitored. For patients infected in the territory, different hospitalisation strategies were implemented by the regional health districts.

Epidemiology and mortality in an Italian region after the adoption of the universal definition of myocardial infarction.

AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Increased cancer risk in patients undergoing dialysis: a population-based cohort study in North-Eastern Italy.

BACKGROUND: In southern Europe, the risk of cancer in patients with end-stage kidney disease receiving dialysis has not been well quantified. The aim of this study was to assess the overall pattern of risk for de novo malignancies (DNMs) among dialysis patients in the Friuli Venezia Giulia region, north-eastern Italy. METHODS: A population-based cohort study among 3407 dialysis patients was conducted through a record linkage between local healthcare databases and the cancer registry (1998-2013). Person-years (PYs) were calculated from 30 days after the date of first dialysis to the date of DNM diagnosis, kidney transplant, death, last follow-up or December 31, 2013, whichever came first. The risk of DNM, as compared to the general population, was estimated using standardized incidence ratios (SIRs) and 95% confidence intervals (CIs). RESULTS: During 10,798 PYs, 357 DNMs were diagnosed in 330 dialysis patients. A higher than expected risk of 1.3-fold was found for all DNMs combined (95% CI: 1.15-1.43). The risk was particularly high in younger dialysis patients (SIR = 1.88, 95% CI: 1.42-2.45 for age 40-59 years), and it decreased with age. Moreover, significantly increased DNM risks emerged during the first 3 years since dialysis initiation, especially within the first year (SIR = 8.52, 95% CI: 6.89-10.41). Elevated excess risks were observed for kidney (SIR = 3.18; 95% CI: 2.06-4.69), skin non-melanoma (SIR = 1.81, 95% CI: 1.46-2.22), oral cavity (SIR = 2.42, 95% CI: 1.36-4.00), and Kaposi's sarcoma (SIR = 10.29, 95% CI: 1.25-37.16). CONCLUSIONS: The elevated risk for DNM herein documented suggest the need to implement a targeted approach to cancer prevention and control in dialysis patients.

Diagnoses and prescriptions of antidepressants in suicides: Register findings from the Friuli Venezia Giulia Region, Italy, 2002-2008.

OBJECTIVE: To explore to what extent and under which diagnoses individuals who committed suicide had received psychiatric in-patient care, and how many had previously committed non-lethal self-harm. To investigate the antidepressant treatment received by these individuals. METHODS: Case-control study based on a health register. RESULTS: Psychiatric hospitalisation was found in 31.2% of the cases and 2.3% of the controls, and was a strong predictor for suicide with an odds ratio (OR) = 19.5. This did not differ significantly between diagnostic categories (except anxiety disorders with OR = 5.3). Non-lethal self-harm in the study period was committed by 14.3% of the cases and 0.14% of the controls, and was twice as common in female cases than in male cases. Previous self-harm was a very strong independent predictor for suicide with OR = 53.1 when a single episode of self-harm had occurred, and OR = 98.0 for repeated episodes (adjusted for age, gender and hospitalisation). Only 16.1% of the cases were currently on antidepressant medication at the time of suicide. CONCLUSIONS: Few of the suicides had previously been psychiatric in-patients. Even fewer had current prescriptions for antidepressants. This suggests that better diagnosis and treatment of psychiatric patients is an important suicide preventive intervention.

Cancer among patients with type 2 diabetes mellitus: A population-based cohort study in northeastern Italy.

Diabetes mellitus (DM) is associated with an elevated risk of cancer. The aim of this study was to assess cancer risk and survival in individuals with type 2 DM (T2DM) in Friuli Venezia Giulia, Italy. A retrospective population-based cohort study of 32,247 T2DM patients aged 40-84 years was conducted through a record linkage of local healthcare databases and cancer registry for the period 2002-2009. Standardized incidence ratios (SIRs) with 95% confidence intervals (95%CIs) and 5-year survival probabilities after T2DM and cancer diagnosis were computed. The SIRs for all cancers (n=2069) was 1.28 (95%CI: 1.23-1.34). The highest SIRs were observed for cancers of the liver, female genital organs, small intestine, and pancreas. After 3 years from T2DM diagnosis, a reduced risk of prostate cancer (SIR=0.73, 95%CI: 0.54-0.96) was found in men aged 65-74 years, and a higher risk for breast cancer (SIR=1.24, 95%CI: 1.00-1.52) was found among T2DM female patients. The overall 5-year survival after T2DM was 88.7%. Furthermore, T2DM appeared to have a negative effect on survival of women with breast cancer. This population-based study confirmed that T2DM patients are at increased risk of several cancers, and of premature death in women with breast cancer.

Medication use during pregnancy, gestational age and date of delivery: agreement between maternal self-reports and health database information in a cohort.

BACKGROUND: Health databases are a promising resource for epidemiological studies on medications safety during pregnancy. The reliability of information on medications exposure and pregnancy timing is a key methodological issue. This study (a) compared maternal self-reports and database information on medication use, gestational age, date of delivery; (b) quantified the degree of agreement between sources; (c) assessed predictors of agreement. METHODS: Pregnant women recruited in a prenatal clinic in Friuli Venezia Giulia (FVG) region, Italy, from 2007 to 2009, completed a questionnaire inquiring on medication use during pregnancy, gestational age and date of delivery. Redeemed prescriptions and birth certificate records were extracted from regional databases through record linkage. Percent agreement, Kappa coefficient, prevalence and bias-adjusted Kappa (PABAK) were calculated. Odds Ratio (OR), with 95% confidence interval (95% CI), of ≥ 1 agreement was calculated through unconditional logistic regression. RESULTS: The cohort included 767 women, 39.8% reported medication use, and 70.5% were dispensed at least one medication. Kappa and PABAK indicated almost perfect to substantial agreement for antihypertensive medications (Kappa 0.86, PABAK 0.99), thyroid hormones (0.88, 0.98), antiepileptic medications (1.00, 1.00), antithrombotic agents (0.70, 0.96). PABAK value was greater than Kappa for medications such as insulin (Kappa 0.50, PABAK 0.99), antihistamines for systemic use (0.50, 0.99), progestogens (0.28, 0.79), and antibiotics (0.12, 0.63). Adjusted OR was 0.48 (95% CI 0.26; 0.90) in ex- vs. never smokers, 0.64 (0.38; 1.08) in < high school vs. university, 1.55 (1.01; 2.37) in women with comorbidities, 2.25 (1.19; 4.26) in those aged 40+ vs. 30-34 years. Gestational age matched exactly in 85.2% and date of delivery in 99.5%. CONCLUSIONS: For selected medications used for chronic conditions, the agreement between self-reports and dispensing data was high. For medications with low to very low prevalence of use, PABAK provides a more reliable measure of agreement. Maternal reports and dispensing data are complementary to each other to increase the reliability of information on the use of medications during pregnancy. Birth certificates provide reliable data on the timing of pregnancy. FVG health databases are a valuable source of data for pregnancy research.

Somatic disorders and antidepressant use in suicides: A population-based study from the Friuli Venezia Giulia region, Italy, 2003-2013.

BACKGROUND: Many somatic disorders are complicated by depression and increase the risk of suicide. Little is known about whether antidepressants might reduce the suicidal risk in patients with somatic disorders. METHODS: Data on diagnoses and antidepressant prescriptions were derived from the Social and Health Information System of the Friuli Venezia Giulia Region. Cases were all suicides that occurred in the region during the years 2003-2013 and were sex- and age-matched to controls from the general population. Conditional logistic regression analysis was used to assess the association between suicide and somatic disorders. RESULTS: The suicide rate in Friuli Venezia Giulia decreased from 11.3 to 10.7 per 100,000 inhabitants during the years 2003-2013, however patients with somatic disorder had a three times increased risk of suicide. Elderly somatic patients' suicide risk was twice as high as younger patients. The risk increased from 2.6 to 9.8 times as the number of comorbid disorders increased from 1 to 4 and over. Although no significant risk of suicide in patients with somatic disorders was found when patients were adherent to antidepressants, only 11.5% of the suicides was adherent in the year prior to death. CONCLUSIONS: Medical illnesses and underlying depressive symptoms may have a synergy effect on the risk of suicide, particularly in older patients and in patients with multiple morbidities. Since medically ill subjects adherent to antidepressants did not show a significant risk of suicide, early identification and adequate treatment of depression in somatic patients should be considered in order to prevent suicide.

A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy.

Although concerns about safety of influenza vaccination during pregnancy have been raised in the past, vaccination of pregnant women was recommended in many countries during the 2009 A/H1N1 pandemic influenza. A retrospective cohort study was conducted to evaluate the risk of adverse maternal, fetal and neonatal outcomes among pregnant women vaccinated with a MF59-adjuvanted A/H1N1 pandemic influenza vaccine. The study was carried out in four Italian regions (Piemonte, Friuli-Venezia-Giulia, Lazio, and Puglia) among 102,077 pregnant women potentially exposed during the second or third trimester of gestation to the vaccination campaign implemented in 2009/2010. Based on data retrieved from the regional administrative databases, the statistical analysis was performed using the Cox proportional-hazards model, adjusting for the propensity score to account for the potential confounding effect due to the socio-demographic characteristics and the clinical and reproductive history of women. A total of 100,332 pregnant women were eligible for the analysis. Of these, 2003 (2.0%) received the A/H1N1 pandemic influenza vaccination during the second or third trimester of gestation. We did not observe any statistically significant association between the A/H1N1 pandemic influenza vaccination and different maternal outcomes (hospital admissions for influenza, pneumonia, hypertension, eclampsia, diabetes, thyroid disease, and anaemia), fetal outcomes (fetal death after the 22nd gestational week) and neonatal outcomes (pre-term birth, low birth weight, low 5-min Apgar score, and congenital malformations). Pre-existing health-risk conditions (hospital admissions and drug prescriptions for specific diseases before the onset of pregnancy) were observed more frequently among vaccinated women, thus suggesting that concomitant chronic conditions increased vaccination uptake. The results of this study add some evidence on the safety of A/H1N1 pandemic influenza vaccination during pregnancy but, because of the reduced statistical power, meta-analyses and large multi-centres studies are needed in order to obtain more conclusive results, especially for rare outcomes.

[Naïve Bayes classification for classifying injury-cause groups from Emergency Room data in the Friuli Venezia Giulia region (Northern Italy)]. / Classificazione delle cause traumatiche di accesso al pronto soccorso in Friuli Venezia Giulia mediante Naïve Bayes Classification.

OBJECTIVES: to assess whether Naïve Bayes Classification could be used to classify injury causes from the Emergency Room (ER) database, because in the Friuli Venezia Giulia Region (Northern Italy) the electronic ER data have never been used to study the epidemiology of injuries, because the proportion of generic "accidental" causes is much higher than that of injuries with a specific cause. DESIGN: application of the Naïve Bayes Classification method to the regional ER database. MAIN OUTCOME MEASURES: sensitivity, specificity, positive and negative predictive values, agreement, and the kappa statistic were calculated for the train dataset and the distribution of causes of injury for the test dataset. RESULTS: on 22.248 records with known cause, the classifications assigned by the model agreed moderately (kappa =0.53) with those assigned by ER personnel. The model was then used on 76.660 unclassified cases. Although sensitivity and positive predictive value of the method were generally poor, mainly due to limitations in the ER data, it allowed to estimate for the first time the frequency of specific injury causes in the Region. CONCLUSION: the model was useful to provide the "big picture" of non-fatal injuries in the Region. To improve the collection of injury data at the ER, the options available for injury classification in the ER software are being revised to make categories exhaustive and mutually exclusive.