Epidemiological Unit

Le Grazie di Ancona, Italy

Epidemiological Unit

Le Grazie di Ancona, Italy

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Holzmann M.J.,Karolinska University Hospital | Holzmann M.J.,Institute of Environmental Medicine | Holzmann M.J.,Karolinska Institutet | Jungner I.,Epidemiological Unit | And 8 more authors.
Annals of Medicine | Year: 2012

Aim. To evaluate dyslipidemia as predictor of myocardial infarction (MI) in subjects with or without chronic kidney disease (CKD). Methods. In 142,394 middle-aged Swedes referred for laboratory evaluation, glomerular filtration rates (GFR) were estimated using the Modification of Diet in Renal Disease study equation. CKD was defined as GFR 1560 mL/min/1.73 m 2. Subjects were stratified into presence or absence of CKD, and lipid measures were related to MI using Cox's proportional hazards regression. Results. During 12 years of follow-up there were 5,466 MIs. The adjusted hazard ratio for MI for the highest versus the lowest quartile of the apolipoprotein (apo) B/apoA-1 ratio among individuals without CKD was 2.88 (95% confidence interval 2.543.26) and for those with CKD 3.35 (2.254.91). The corresponding estimates for the total cholesterol/high-density lipoprotein (HDL) cholesterol ratio were 3.13 (2.783.52) and 3.54 (2.435.17), respectively. Receiver operator characteristics analyses showed an advantage in the prediction of MI for the apoB/apoA-1 ratio as compared to conventional lipids (P < 0.0001). Conclusions. The ratio of apoB/apoA-1, the ratio of total cholesterol/HDL cholesterol, and non-HDL cholesterol were all strong predictors of myocardial infarction, both among subjects with and without renal dysfunction, with a possible advantage for the apoB/apoA-1 ratio. © 2012 Informa UK, Ltd.


Parente F.,Dell | Marino B.,Dell | Ardizzoia A.,Alessandro Manzoni Hospital | Ucci G.,Alessandro Manzoni Hospital | And 7 more authors.
American Journal of Gastroenterology | Year: 2011

Objectives: In 2005, the National Health Service recommended a population-based colorectal cancer (CRC) screening program using biennial fecal occult blood testing (FOBT), followed by total colonoscopy in positive patients. So far, no studies have been performed to evaluate the impact of a mass-screening CRC campaign on the health system services at the community level in Italy. We have therefore assessed the workload generated by the first two biennial rounds of screening program on the activity of hospital services involved in CRC diagnosis in the Lecco province. Methods: Routine data from all hospital services of our province were collected on activity levels related to CRC diagnosis from January 2003 to December 2009. This time span covered the 2 years prior to, as well as the two biennial rounds of the CRC screening program. In particular, we focused on the volume of outpatient FOBTs and colonoscopies (both diagnostic and interventional) performed among subjects outside the screening program. Joinpoint models were used to test whether an apparent change in trend of examination over time was statistically significant in different age cohorts of the population (<50 years, 50-69 years, and ≥70 years). Results: The volume of extra-screening per-patient/FOBTs and colonoscopies increased significantly over the evaluated periods in all ages, until year 2008, when a steady trend was beginning; the AAPCs (average of the annual percent changes) values were 5.7, 3.1, and 8.4 for FOBT and 14.6, 13.4, and 16.7 for colonoscopy in the three age cohorts, respectively. However, the increase in both FOBT and colonoscopy demand was maximal in the cohort ≥70 years, where three statistically significant annual percent changes (APCs) were identified (in 2003-2005, 2005-2006, and 2006-2007 APCs were 12.3, 14.9, and 15.9 for FOBT, and 18.7, 36.8, and 25.4 for colonoscopy, respectively). Conclusions: After the implementation of a FOBT-based mass-screening program for CRC, careful consideration must be given to the significant increase in the workload of hospital services involved in CRC diagnosis, outside the screening campaign. The extra-work mainly involves gastroenterologists performing colonoscopy, whose activity increased over the 5-year period by 118%, as well as laboratory services, where the demand of FOBTs rose by 40%. This phenomenon, mainly attributable to a profound change in the attitude toward CRC screening by those age cohorts outside the program, covers a time span of two full rounds of screening, whereupon a steady trend for colonoscopy is apparent. © 2011 by the American College of Gastroenterology.


Rastrelli G.,University of Florence | Corona G.,University of Florence | Corona G.,Maggiore Bellaria Hospital | Monami M.,University of Florence | And 6 more authors.
Journal of Sexual Medicine | Year: 2011

Introduction. Intracavernous alprostadil injection (ICI) test has been considered useless in assessing the vascular status of subjects with erectile dysfunction (ED). Aim. To analyze the clinical correlates of ICI test in patients with ED and to verify the value of this test in predicting major adverse cardiovascular events (MACE). Methods. A consecutive series of 2,396 men (mean age 55.9±11.9 years) attending our outpatient clinic for sexual dysfunction was retrospectively studied. A subset of this sample (N=1,687) was enrolled in a longitudinal study. Main Outcome Measures. Several clinical, biochemical, and instrumental (penile color Doppler ultrasound; PCDU) factors were evaluated. All patients underwent an ICI test, and responses were recorded on a four-point scale ranging from 1=no response to 4=full erection. Results. Among the patients studied, 16.4%, 41.2%, 40.2% and 2.2% showed grade 4, 3, 2, and 1 ICI test response, respectively. After adjusting for confounders, subjects with grade 1 ICI test response showed reduced perceived sleep-related, masturbation-related, and sexual-related erections when compared with the rest of the sample. In addition, a worse response to ICI test was associated with a higher prevalence of hypogonadism-related symptoms and signs along with lower testosterone levels. The prevalence of both diabetes mellitus and metabolic syndrome was inversely related to ICI test response. Accordingly, dynamic and basal peak systolic velocity (PSV), as well as acceleration at PCDU, decreased as a function of ICI test response. In the longitudinal study, after adjusting for confounders, grade 1 response was independently associated with a higher incidence of MACE (hazard ratio=2.745[1.200-6.277]; P<0.05). These data were confirmed even when only subjects with normal PSV (>25cm/s) were considered. Conclusions. Our results demonstrate that poor ICI test response is associated with several metabolic disturbances and higher incidence of MACE. We strongly recommend performing ICI test with alprostadil in all ED subjects. © 2011 International Society for Sexual Medicine.


Corona G.,University of Florence | Corona G.,Maggiore Bellaria Hospital | Monami M.,University of Florence | Boddi V.,University of Florence | And 9 more authors.
Journal of Sexual Medicine | Year: 2010

Introduction.: Although testosterone (T) has been suggested to play a protective role against the development of atherosclerosis, studies demonstrating an association between low T and incident major adverse cardiovascular events (MACE) are scanty in the general population and absent in subjects with erectile dysfunction (ED). Aim.: To investigate whether low T in subjects with ED predict incident fatal or nonfatal MACE. Methods.: This is an observational prospective cohort study evaluating a consecutive series of 1687 patients attending our andrological unit for ED. Patients were interviewed using the structured interview on erectile dysfunction (SIEDY) and ANDROTEST structured interviews measuring components relative to ED and hypogonadal-related symptoms, respectively. Main Outcome Measures.: Total T was evaluated at baseline. Information on MACE was obtained through the City of Florence Registry Office. Results.: Among the patients studied, 5.2, 13.8, and 22.4% were hypogonadal according to different thresholds (T < 8, 10.4 and 12 nmol/L or 230, 300 and 350 ng/dL, respectively). During a mean follow-up of 4.3 ± 2.6 years, 139 MACE, 15 of which were fatal, were observed. Unadjusted incidence of MACE was not associated with T levels. Conversely, the proportion of lethal events among MACE was significantly higher in hypogonadal patients, using either 10.4 nmol/L (300 ng/dL) or 8 nmol/L (230 ng/dL) thresholds. However, after adjustment for age and Chronic Diseases Score in a Cox regression model, only the association between incident fatal MACE and T < 8 nmol/L (230 ng/dL) was confirmed (HR = 7.1 [1.8-28.6]; P < 0.001). Interestingly, measuring hypogonadal-related symptoms and signs through ANDROTEST, only fatal MACE were also associated with a higher score (HR = 1.2 [1.0-1.5] for each ANDROTEST score increment; P = 0.05 after adjustment for age and Chronic Diseases Score). Conclusions.: T levels are associated with a higher mortality of MACE. The identification of low T levels should alert the clinician thus identifying subjects with an increased cardiovascular risk. Corona G, Monami M, Boddi V, Cameron-Smith M, Fisher A, de Vita G, Melani C, Balzi D, Sforza A, Forti G, Mannucci E, and Maggi M. Low testosterone is associated with an increased risk of MACE lethality in subjects with erectile dysfunction. © 2010 International Society for Sexual Medicine.


Corona G.,University of Florence | Monami M.,University of Florence | Boddi V.,University of Florence | Cameron-Smith M.,University of Florence | And 8 more authors.
Journal of Sexual Medicine | Year: 2010

Introduction. Although penile blood flow (PBF) has been recommended as an additional diagnostic test in identifying erectile dysfunction (ED) patients at risk for latent cardiovascular disease, no study has ever assessed the possible association of PBF and the relational component of sexual function with incident major cardiovascular events (MACE). Aim.: The aim of this study is to investigate whether severity of ED, PBF, and other factors related to a couple's relationship predict incident MACE. Methods.: A consecutive series of 1,687 patients was studied. Different clinical, biochemical, and instrumental (penile flow at color Doppler ultrasound) parameters were evaluated. Main Outcome Measures.: Information on MACE was obtained through the City of Florence Registry Office. Results.: During a mean follow-up of 4.3 ± 2.6 years, 139 MACE, 15 of which were fatal, were observed. Cox regression analysis, after adjustment for age and Chronic Disease Score, showed that severe ED predicted MACE (hazard ratio [HR] 1.75; 95% confidence interval 1.10-2.78; P < 0.05). In addition, lower PBF, evaluated both in flaccid (before) and dynamic (after prostaglandin-E1 stimulation) conditions, was associated with an increased risk of MACE (HR = 2.67 [1.42-5.04] and 1.57 [1.01-2.47], respectively, for flaccid [<13 cm/second] and dynamic [<25 cm/second] peak systolic velocity; both P < 0.05). Reported high sexual interest in the partner and low sexual interest in the patient proved to have a protective effect against MACE. Conclusions.: The investigation of male sexuality, and in particular PBF, and sexual desire, could provide insights not only into present cardiovascular status but also into prospective risk. © 2010 International Society for Sexual Medicine.


Fisher A.D.,University of Florence | Rastrelli G.,University of Florence | Bandini E.,University of Florence | Corona G.,University of Florence | And 7 more authors.
Journal of Sexual Medicine | Year: 2012

Introduction. Previous cross-sectional and longitudinal studies reported a negative correlation between fatherhood and testosterone (T) levels, likely due to a centrally mediated downregulation of the hypothalamic-pituitary-gonadal axis. Moreover, epidemiological data indicate that fatherhood might affect metabolic and cardiovascular outcomes, although different results have been reported. Up to now, no studies have evaluated these associations in a population of men seeking treatment for sexual dysfunction (SD). Aim. To explore biological and clinical correlates of number of children (NoC) and its possible associations with forthcoming major cardiovascular events (MACE) in a sample of men with SD. Methods. A consecutive series of 4,045 subjects (mean age 52±13.1 years old) attending the Outpatient Clinic for SD was retrospectively studied. A subset of the previous sample (N=1,687) was enrolled in a longitudinal study. Main Outcome Measures. Information on MACE was obtained through the City of Florence Registry Office. Results. Among patients studied, 31.6% had no children, while 26.3% reported having one child, 33.4% two, and 8.8% three or more children. Although fatherhood was negatively related with follicle-stimulating hormone levels and positively with testis volume, we found a NoC-dependent, stepwise decrease in T plasma levels, not compensated by a concomitant increase in luteinizing hormone. NoC was associated with a worse metabolic and cardiovascular profile, as well as worse penile blood flows and a higher prevalence of metabolic syndrome (MetS). In the longitudinal study, after adjusting for confounders, NoC was independently associated with a higher incidence of MACE. However, when the presence of MetS was introduced as a further covariate, the association was no longer significant. Conclusions. This study supports the hypothesis that bond maintenance contexts and fatherhood are associated with an adaptive downregulation of the gonadotropin-gonadal axis, even in a sample of men with SD. Moreover, our data suggest that NoC predicts MACE, most likely because of an unfavorable, lifestyle-dependent, parenthood-associated behavior. © 2012 International Society for Sexual Medicine.


Corona G.,University of Florence | Corona G.,Maggiore Bellaria Hospital | Rastrelli G.,University of Florence | Boddi V.,University of Florence | And 7 more authors.
International Journal of Andrology | Year: 2011

The physiological role of prolactin (PRL) in men is not completely clarified. We previously reported that in subjects consulting for sexual dysfunction, lower PRL plasma levels were associated with worse lipid and glycaemic profile, as well as with a higher prevalence of metabolic syndrome and arteriogenic erectile dysfunction (ED). The aim of this study was to assess possible associations between PRL levels and incident major cardiovascular events (MACE) in subjects with ED. When only subjects without pathological hyperprolactinaemia (PRL<735mU/L or 35ng/mL) and pituitary diseases were considered, both unadjusted and adjusted analyses showed a significantly lower incidence of MACE in subjects with PRL levels in the highest PRL quintile (246-735mU/L or 12-35ng/mL) when compared with the rest of the sample. In particular, the risk of MACE was reduced by 5% (1-9%; p=0.03) for each 10ng/mL increment of PRL. Conversely, comparing patients with hyperprolactinaemia with matched controls, no significant difference was detected between cases and controls in MACE. In subjects at high risk for cardiovascular diseases, such as those with ED, a relatively high PRL plasma level is associated with an overall decreased chance of MACE, independently from other known risk factors. © 2010 The Authors. International Journal of Andrology © 2011 European Academy of Andrology.


PubMed | Epidemiological Unit, University of Foggia, Local Health Unit of Alessandria Piemonte Region, Laziosanita Agency for Public Health of Lazio Region and 2 more.
Type: Journal Article | Journal: Vaccine | Year: 2015

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.


PubMed | PATH, Mahidol University, Chengdu Institute of Biological Products and Epidemiological Unit
Type: Journal Article | Journal: Vaccine | Year: 2016

The performance of live attenuated Japanese Encephalitis SA 14-14-2 vaccine (CD-JEV) among children previously given inactivated mouse brain-derived JE vaccine (IMBV) is unknown. We evaluated the safety and immunogenicity of CD-JEV administered to 2- and 5-year-old children in Sri Lanka.In this open-label, single arm trial in the Colombo District of Sri Lanka, generally healthy children 2 and 5years of age who had previously received two and three doses of IMBV, respectively, were administered one dose of CD-JEV subcutaneously. Participants were monitored for adverse events for one year post-vaccination. Serum neutralizing antibody responses were evaluated pre and 28 and 365days post-vaccination using JE plaque reduction neutralization test and characterized as the proportion of participants seroconverting. Seroconversion was defined as either reaching a titer considered seroprotective (1:10) among participants with a baseline titer <1:10 or achieving at least a 4-fold rise in titer among participants with a baseline titer 1:10.Of 305 children given CD-JEV, 294 were included in the primary analysis of immunogenicity. Prior to vaccination, 144/147 (98.0%) 2-year-olds and 146/147 (99.3%) 5-year-olds had seroprotective levels. 28days post-vaccination, 79/147 [53.7% (95% CI, 45.3-62.0)] 2-year olds and of 60/147 [40.8% (95% CI, 32.8-49.2)] 5-year olds achieved seroconversion. Among 2-year-olds, geometric mean titers (GMTs) rose from 697 to 3175 28days post-vaccination. Among 5-year-olds, GMTs rose from 926 to 2776. Most adverse reactions were mild, and no serious adverse events were related to study vaccination.Administration of CD-JEV to these children with pre-existing neutralizing JE antibody titers was safe and resulted in substantial boosting of antibody levels. These results may inform other countries in Asia considering switching from IMBV to now WHO-prequalified CD-JEV vaccine to combat this disease of public health importance.


PubMed | University of Padua, Out of Hour Service, Epidemiological Unit, Catholic University of the Sacred Heart and Health Director
Type: Journal Article | Journal: BMJ open | Year: 2016

A growing presence of inappropriate patients has been recognised as one of the main factors influencing emergency department (ED) overcrowding, which is a very widespread problem all over the world. On the other hand, out-of-hours (OOH) physicians must avoid delaying the diagnostic and therapeutic course of patients with urgent medical conditions. The aim of this study was to analyse the appropriateness of patient management by OOH services, in terms of their potentially inappropriate referral or non-referral of non-emergency cases to the ED.This was an observational retrospective cohort study based on data collected in 2011 by the local health authority No. 4 in the Veneto Region (Italy). After distinguishing between patients contacting the OOH service who were or were not referred to the ED, and checking for patients actually presenting to the ED within 24hours thereafter, these patients medical management was judged as potentially appropriate or inappropriate.The analysis considered 22662 OOH service contacts recorded in 2011. The cases of potentially inappropriate non-referral to the ED were 392 (1.7% of all contacts), as opposed to 1207 potentially inappropriate referrals (5.3% of all contacts). Age, nationality, type of disease and type of intervention by the OOH service were the main variables associated with the appropriateness of patient management.These findings may be useful for pinpointing the factors associated with a potentially inappropriate patient management by OOH services and thus contribute to improving the deployment of healthcare and the quality of care delivered by OOH services.

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