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Cesaroni G.,Lazio Regional Health Service | Badaloni C.,Lazio Regional Health Service | Gariazzo C.,Italian Workers Compensation Authority INAIL | Stafoggia M.,Lazio Regional Health Service | And 3 more authors.
Environmental Health Perspectives | Year: 2013

Background: Few European studies have investigated the effects of long-term exposure to both fine particulate matter (≤ 2.5 μm; PM2.5) and nitrogen dioxide (NO2) on mortality. Objectives: We studied the association of exposure to NO2, PM2.5), and traffic indicators on cause-specific mortality to evaluate the form of the concentration-response relationship. Methods: We analyzed a population-based cohort enrolled at the 2001 Italian census with 9 years of follow-up. We selected all 1,265,058 subjects ≥ 30 years of age who had been living in Rome for at least 5 years at baseline. Residential exposures included annual NO2 (from a land use regression model) and annual PM2.5) (from a Eulerian dispersion model), as well as distance to roads with > 10,000 vehicles/day and traffic intensity. We used Cox regression models to estimate associations with cause-specific mortality adjusted for individual (sex, age, place of birth, residential history, marital status, education, occupation) and area (socioeconomic status, clustering) characteristics. Results: Long-term exposures to both NO2 and PM2.5) were associated with an increase in nonaccidental mortality [hazard ratio (HR) = 1.03 (95% CI: 1.02, 1.03) per 10-μg/m3 NO2; HR = 1.04 (95% CI: 1.03, 1.05) per 10-μg/m3 PM2.5)]. The strongest association was found for ischemic heart diseases (IHD) [HR = 1.10 (95% CI: 1.06, 1.13) per 10-μg/m3 PM2.5)], followed by cardiovascular diseases and lung cancer. The only association showing some deviation from linearity was that between NO2 and IHD. In a bi-pollutant model, the estimated effect of NO2 on mortality was independent of PM2.5). Conclusions: This large study strongly supports an effect of long-term exposure to NO2 and PM2.5) on mortality, especially from cardiovascular causes. The results are relevant for the next European policy decisions regarding air quality.


De Sario M.,Lazio Regional Health Service | Katsouyanni K.,National and Kapodistrian University of Athens | Michelozzi P.,Lazio Regional Health Service
European Respiratory Journal | Year: 2013

Due to climate change and other factors, air pollution patterns are changing in several urbanised areas of the world, with a significant effect on respiratory health both independently and synergistically with weather conditions; climate scenarios show Europe as one of the most vulnerable regions. European studies on heatwave episodes have consistently shown a synergistic effect of air pollution and high temperatures, while the potential weather-air pollution interaction during wildfires and dust storms is unknown. Allergen patterns are also changing in response to climate change, and air pollution can modify the allergenic potential of pollens, especially in the presence of specific weather conditions. The underlying mechanisms of all these interactions are not well known; the health consequences vary from decreases in lung function to allergic diseases, new onset of diseases, exacerbation of chronic respiratory diseases, and premature death. These multidimensional climate-pollution-allergen effects need to be taken into account in estimating both climate and air pollution-related respiratory effects, in order to set up adequate policy and public health actions to face both the current and future climate and pollution challenges. Copyright ©ERS 2013.


Mallone S.,Institute for Cancer Prevention | Stafoggia M.,Lazio Regional Health Service | Faustini A.,Lazio Regional Health Service | Paolo Gobbi G.,National Research Council Italy | And 2 more authors.
Environmental Health Perspectives | Year: 2011

Background: Outbreaks of Saharan-Sahel dust over Euro-Mediterranean areas frequently induce exceedances of the Europen Union's 24-hr standard of 50 μg/m 3 for particulate matter (PM) with aerodynamic diameter ≤ than 10 μm (PM 10). Objectives: We evaluated the effect of Saharan dust on the association between different PM fractions and daily mortality in Rome, Italy. Methods: In a study of 80,423 adult residents who died in Rome between 2001 and 2004, we performed a time-series analysis to explore the effects of PM2.5, PM 2.5-10, and PM10 on natural, cardiac, cerebrovascular, and respiratory mortality. We defined Saharan dust days by combining light detection and ranging (LIDAR) observations and analyses from operational models. We tested a Saharan dust-PM interaction term to evaluate the hypothesis that the effects of PM, especially coarse PM (PM 2.5-10), on mortality would be enhanced on dust days. Results: Interquartile range increases in PM 2.5-10 (10.8 μg/m 3) and PM10 (19.8 μg/m 3) were associated with increased mortality due to natural, cardiac, cerebrovascular, and respiratory causes, with estimated effects ranging from 2.64% to 12.65% [95% confidence interval (CI), 1.18-25.42%] for the association between PM 2.5-10 and respiratory mortality (0- to 5-day lag). Associations of PM 2.5-10 with cardiac mortality were stronger on Saharan dust days (9.73%; 95% CI, 4.25-15.49%) than on dust-free days (0.86%; 95% CI, -2.47% to 4.31%; p = 0.005). Saharan dust days also modified associations between PM10 and cardiac mortality (9.55% increase; 95% CI, 3.81-15.61%; vs. dust-free days: 2.09%; 95% CI, -0.76% to 5.02%; p = 0.02). Conclusions: We found evidence of effects of PM 2.5-10 and PM 10 on natural and cause-specific mortality, with stronger estimated effects on cardiac mortality during Saharan dust outbreaks. Toxicological and biological effects of particles from desert sources need to be further investigated and taken into account in air quality standards.


Gasparrini A.,London School of Hygiene and Tropical Medicine | Guo Y.,University of Queensland | Hashizume M.,Nagasaki University | Lavigne E.,University of Ottawa | And 20 more authors.
The Lancet | Year: 2015

Background Although studies have provided estimates of premature deaths attributable to either heat or cold in selected countries, none has so far offered a systematic assessment across the whole temperature range in populations exposed to different climates. We aimed to quantify the total mortality burden attributable to non-optimum ambient temperature, and the relative contributions from heat and cold and from moderate and extreme temperatures. Methods We collected data for 384 locations in Australia, Brazil, Canada, China, Italy, Japan, South Korea, Spain, Sweden, Taiwan, Thailand, UK, and USA. We fitted a standard time-series Poisson model for each location, controlling for trends and day of the week. We estimated temperature-mortality associations with a distributed lag non-linear model with 21 days of lag, and then pooled them in a multivariate metaregression that included country indicators and temperature average and range. We calculated attributable deaths for heat and cold, defined as temperatures above and below the optimum temperature, which corresponded to the point of minimum mortality, and for moderate and extreme temperatures, defined using cutoffs at the 2·5th and 97·5th temperature percentiles. Findings We analysed 74 225 200 deaths in various periods between 1985 and 2012. In total, 7·71% (95% empirical CI 7·43-7·91) of mortality was attributable to non-optimum temperature in the selected countries within the study period, with substantial differences between countries, ranging from 3·37% (3·06 to 3·63) in Thailand to 11·00% (9·29 to 12·47) in China. The temperature percentile of minimum mortality varied from roughly the 60th percentile in tropical areas to about the 80-90th percentile in temperate regions. More temperature-attributable deaths were caused by cold (7·29%, 7·02-7·49) than by heat (0·42%, 0·39-0·44). Extreme cold and hot temperatures were responsible for 0·86% (0·84-0·87) of total mortality. Interpretation Most of the temperature-related mortality burden was attributable to the contribution of cold. The effect of days of extreme temperature was substantially less than that attributable to milder but non-optimum weather. This evidence has important implications for the planning of public-health interventions to minimise the health consequences of adverse temperatures, and for predictions of future effect in climate-change scenarios. Funding UK Medical Research Council. © 2015 Gasparrini et al. Open Access article distributed under the terms of CC BY.


Gasparrini A.,London School of Hygiene and Tropical Medicine | Leone M.,Lazio Regional Health Service
BMC Medical Research Methodology | Year: 2014

Background: Measures of attributable risk are an integral part of epidemiological analyses, particularly when aimed at the planning and evaluation of public health interventions. However, the current definition of such measures does not consider any temporal relationships between exposure and risk. In this contribution, we propose extended definitions of attributable risk within the framework of distributed lag non-linear models, an approach recently proposed for modelling delayed associations in either linear or non-linear exposure-response associations. Methods. We classify versions of attributable number and fraction expressed using either a forward or backward perspective. The former specifies the future burden due to a given exposure event, while the latter summarizes the current burden due to the set of exposure events experienced in the past. In addition, we illustrate how the components related to sub-ranges of the exposure can be separated. Results: We apply these methods for estimating the mortality risk attributable to outdoor temperature in two cities, London and Rome, using time series data for the periods 1993-2006 and 1992-2010, respectively. The analysis provides estimates of the overall mortality burden attributable to temperature, and then computes the components attributable to cold and heat and then mild and extreme temperatures. Conclusions: These extended definitions of attributable risk account for the additional temporal dimension which characterizes exposure-response associations, providing more appropriate attributable measures in the presence of dependencies characterized by potentially complex temporal patterns. © 2014 Gasparrini and Leone; licensee BioMed Central Ltd.


Alessandrini E.R.,Lazio Regional Health Service | Stafoggia M.,Lazio Regional Health Service | Faustini A.,Lazio Regional Health Service | Gobbi G.P.,CNR Institute of Neuroscience | Forastiere F.,Lazio Regional Health Service
Occupational and Environmental Medicine | Year: 2013

Introduction Outbreaks of Saharan dust have been shown to exacerbate the effect of particulate matter (PM) on mortality. Their role on PM-morbidity association is less clear. This study aims to evaluate the effect of Saharan dust on the PM-hospitalisations association in Rome, Italy. Methods We studied residents hospitalised in Rome between 2001 and 2004 and performed a time-series analysis to explore the effects of PM2.5, PM2.5-10 and PM10 on cardiac, cerebrovascular and respiratory emergency hospitalisations, respectively. Saharan dust days were identified by combining Light Detection and Ranging observations and analyses from operational models. We tested a dust-PM interaction to evaluate the hypothesis that the PM effect on hospitalisations would be enhanced on dust days. Results We studied 77 354, 26 557 and 31 620 hospitalisations for cardiac, cerebrovascular and respiratory diseases, respectively, providing effect estimates per IQR. PM2.5-10 was associated with cardiac diseases (3.93%; 95% CI 1.58 to 6.34). PM 10 was associated with cardiac (3.37%; 95% CI 1.11 to 5.68), cerebrovascular (2.64%; 95% CI 0.06 to 5.29) and respiratory diseases (3.59%: 95% CI 0.18 to 7.12). No effect of PM2.5 was detected. Saharan dust modified the effect of the PM2.5-10 on respiratory hospitalisations, higher during dust days compared with dust-free days (14.63% vs -0.32%; p value of interaction=0.006). Saharan dust also increased the effect of PM10 on cerebrovascular diseases (5.04% vs 0.90%, p value of interaction=0.143). Discussion A clear enhanced effect of PM2.5-10 on respiratory diseases and of PM10 on cerebrovascular diseases emerged during Saharan dust outbreaks.


Amato L.,Lazio Regional Health Service
Cochrane database of systematic reviews (Online) | Year: 2013

The evidence of tapered methadone's efficacy in managing opioid withdrawal has been systematically evaluated in the previous version of this review that needs to be updated To evaluate the effectiveness of tapered methadone compared with other detoxification treatments and placebo in managing opioid withdrawal on completion of detoxification and relapse rate. We searched: Cochrane Central Register of Controlled Trials (The Cochrane Library 2012, Issue 4), PubMed (January 1966 to May 2012), EMBASE (January 1988 to May 2012), CINAHL (2003- December 2007), PsycINFO (January 1985 to December 2004), reference lists of articles. All randomised controlled trials that focused on the use of tapered methadone versus all other pharmacological detoxification treatments or placebo for the treatment of opiate withdrawal. Two review authors assessed the included studies. Any doubts about how to rate the studies were resolved by discussion with a third review author. Study quality was assessed according to the criteria indicated in the Cochrane Handbook for Systematic Reviews of Interventions. Twenty-three trials involving 2467 people were included. Comparing methadone versus any other pharmacological treatment, we observed no clinical difference between the two treatments in terms of completion of treatment, 16 studies 1381 participants, risk ratio (RR) 1.08 (95% confidence interval (CI) 0.97 to 1.21); number of participants abstinent at follow-up, three studies, 386 participants RR 0.98 (95% CI 0.70 to 1.37); degree of discomfort for withdrawal symptoms and adverse events, although it was impossible to pool data for the last two outcomes. These results were confirmed also when we considered the single comparisons: methadone with: adrenergic agonists (11 studies), other opioid agonists (eight studies), anxiolytic (two studies), paiduyangsheng (one study). Comparing methadone with placebo (two studies) more severe withdrawal and more drop-outs were found in the placebo group. The results indicate that the medications used in the included studies are similar in terms of overall effectiveness, although symptoms experienced by participants differed according to the medication used and the program adopted. Data from literature are hardly comparable; programs vary widely with regard to the assessment of outcome measures, impairing the application of meta-analysis. The studies included in this review confirm that slow tapering with temporary substitution of long- acting opioids, can reduce withdrawal severity. Nevertheless, the majority of patients relapsed to heroin use.


Minozzi S.,Lazio Regional Health Service
The Cochrane database of systematic reviews | Year: 2013

The prevalence of opiate use among pregnant women can range from 1% to 2% to as high as 21%. Heroin crosses the placenta and pregnant, opiate-dependent women experience a six-fold increase in maternal obstetric complications such as low birth weight, toxaemia, third trimester bleeding, malpresentation, puerperal morbidity, fetal distress and meconium aspiration. Neonatal complications include narcotic withdrawal, postnatal growth deficiency, microcephaly, neuro-behavioural problems, increased neonatal mortality and a 74-fold increase in sudden infant death syndrome. To assess the effectiveness of any maintenance treatment alone or in combination with psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions for child health status, neonatal mortality, retaining pregnant women in treatment and reducing the use of substances. We searched the Cochrane Drugs and Alcohol Group Trials Register (September 2013), PubMed (1966 to September 2013), CINAHL (1982 to September 2013), reference lists of relevant papers, sources of ongoing trials, conference proceedings and national focal points for drug research. We contacted authors of included studies and experts in the field. Randomised controlled trials assessing the efficacy of any maintenance pharmacological treatment for opiate-dependent pregnant women. We used the standard methodological procedures expected by The Cochrane Collaboration. We found four trials with 271 pregnant women. Three compared methadone with buprenorphine and one methadone with oral slow-release morphine. Three out of four studies had adequate allocation concealment and were double-blind. The major flaw in the included studies was attrition bias: three out of four had a high drop-out rate (30% to 40%) and this was unbalanced between groups.Methadone versus buprenorphine: the drop-out rate from treatment was lower in the methadone group (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.41 to 1.01, three studies, 223 participants). There was no statistically significant difference in the use of primary substance between methadone and buprenorphine (RR 1.81, 95% CI 0.70 to 4.69, two studies, 151 participants). For both, we judged the quality of evidence as low. Birth weight was higher in the buprenorphine group in the two trials that could be pooled (mean difference (MD) -365.45 g (95% CI -673.84 to -57.07), two studies, 150 participants). The third study reported that there was no statistically significant difference. For APGAR score neither of the studies which compared methadone with buprenorphine found a significant difference. For both, we judged the quality of evidence as low. Many measures were used in the studies to assess neonatal abstinence syndrome. The number of newborns treated for neonatal abstinence syndrome, which is the most critical outcome, did not differ significantly between groups. We judged the quality of evidence as very low.Methadone versus slow-release morphine: there was no drop-out in either treatment group. Oral slow-release morphine seemed superior to methadone for abstinence from heroin use during pregnancy (RR 2.40, 95% CI 1.00 to 5.77, one study, 48 participants). We judged the quality of evidence as moderate.Only one study which compared methadone with buprenorphine reported side effects. For the mother there was no statistically significant difference; for the newborns in the buprenorphine group there were significantly fewer serious side effects.In the comparison between methadone and slow-release morphine no side effects were reported for the mother, whereas one child in the methadone group had central apnoea and one child in the morphine group had obstructive apnoea. We did not find sufficient significant differences between methadone and buprenorphine or slow-release morphineto allow us to conclude that one treatment is superior to another for all relevant outcomes. While methadone seems superior in terms of retaining patients in treatment, buprenorphine seems to lead to less severe neonatal abstinence syndrome. Additionally, even though a multi-centre, international trial with 175 pregnant women has recently been completed and its results published and included in this review, the body of evidence is still too small to draw firm conclusions about the equivalence of the treatments compared. There is still a need for randomised controlled trials of adequate sample size comparing different maintenance treatments.


Tamburino C.,University of Catania | Tamburino C.,ETNA Foundation | Barbanti M.,University of Catania | Barbanti M.,ETNA Foundation | And 10 more authors.
Journal of the American College of Cardiology | Year: 2015

Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials. © 2015 American College of Cardiology Foundation.


Cesaroni G.,Lazio Regional Health Service | Porta D.,Lazio Regional Health Service | Badaloni C.,Lazio Regional Health Service | Stafoggia M.,Lazio Regional Health Service | And 3 more authors.
Environmental Health: A Global Access Science Source | Year: 2012

Background: Land Use Regression models (LUR) are useful to estimate the spatial variability of air pollution in urban areas. Few studies have evaluated the stability of spatial contrasts in outdoor nitrogen dioxide (NO2) concentration over several years. We aimed to compare measured and estimated NO2 levels 12 years apart, the stability of the exposure estimates for members of a large cohort study, and the association of the exposure estimates with natural mortality within the cohort. Methods: We measured NO 2 at 67 locations in Rome in 1995/96 and 78 sites in 2007, over three one-week-long periods. To develop LUR models, several land-use and traffic variables were used. NO2 concentration at each residential address was estimated for a cohort of 684,000 adults. We used Cox regression to analyze the association between the two estimated exposures and mortality. Results: The mean NO2 measured concentrations were 45.4 μg/m3 (SD 6.9) in 1995/96 and 44.6 μg/m3 (SD 11.0) in 2007, respectively. The correlation of the two measurements was 0.79. The LUR models resulted in adjusted R2 of 0.737 and 0.704, respectively. The correlation of the predicted exposure values for cohort members was 0.96. The association of each 10 μg/m3 increase in NO2 with mortality was 6 % for 1995/96 and 4 % for 2007 LUR models. The increased risk per an inter-quartile range change was identical (4 %, 95 % CI:36 %) for both estimates of NO2. Conclusions: Measured and predicted NO2 values from LUR models, from samples collected 12 years apart, had good agreement, and the exposure estimates were similarly associated with mortality in a large cohort study. © 2012 Cesaroni et al.; licensee BioMed Central Ltd.

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