Publications by authors named "Lisa Bauleo"

25 Publications

  • Page 1 of 1

Blood SIRT1 Shows a Coherent Association with Leptin and Adiponectin in Relation to the Degree and Distribution of Adiposity: A Study in Obesity, Normal Weight and Anorexia Nervosa.

Nutrients 2020 Nov 14;12(11). Epub 2020 Nov 14.

Department of Experimental Medicine, Section of Medical Physiopathology, Food Science and Endocrinology, "Sapienza" University of Rome, Rome, Italy.

Sirtuin 1 (SIRT1) is a sensor of cell energy availability, and with leptin and adiponectin, it regulates metabolic homeostasis. Widely studied in tissues, SIRT1 is under evaluation as a plasmatic marker. We aimed at assessing whether circulating SIRT1 behaves consistently with leptin and adiponectin in conditions of deficiency, excess or normal fat content. Eighty subjects were evaluated: 27 with anorexia nervosa (AN), 26 normal-weight and 27 with obesity. Bloodstream SIRT1, leptin and adiponectin (ELISA), total and trunk fat mass (FM) %, abdominal visceral adipose tissue, liver steatosis and epicardial fat thickness (EFT) were assessed. For each fat store, the coefficient of determination (R) was used to evaluate the prediction capability of SIRT1, leptin and adiponectin. Plasma SIRT1 and adiponectin coherently decreased with the increase of FM, while the opposite occurred with leptin. Mean levels of each analyte were different between groups ( < 0.005). A significant association between plasma variables and FM depots was observed. SIRT1 showed a good predictive strength for FM, particularly in the obesity group, where the best R was recorded for EFT (R = 0.7). Blood SIRT1, adiponectin and leptin behave coherently with FM and there is synchrony between them. The association of SIRT1 with FM is substantially superimposable to that of adiponectin and leptin. Given its homeostatic roles, SIRT1 may deserve to be considered as a plasma clinical/biochemical parameter of adiposity and metabolic health.
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http://dx.doi.org/10.3390/nu12113506DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7696683PMC
November 2020

Italian pool of asbestos workers cohorts: asbestos related mortality by industrial sector and cumulative exposure.

Ann Ist Super Sanita 2020 Jul-Sep;56(3):292-302

Dipartimento di Biologia e Biotecnologie "Charles Darwin", La Sapienza Università di Roma, Rome, Italy.

Objective: Italy has been a large user of asbestos and asbestos containing materials until the 1992 ban. We present a pooled cohort study on long-term mortality in exposed workers.

Methods: Pool of 43 Italian asbestos cohorts (asbestos cement, rolling stock, shipbuilding, glasswork, harbors, insulation and other industries). SMRs were computed by industrial sector for the 1970-2010 period, for the major causes, using reference rates by age, sex, region and calendar period.

Results: The study included 51 801 subjects (5741 women): 55.9% alive, 42.6% died (cause known for 95%) and 1.5% lost to follow-up. Asbestos exposure was estimated at the plant and period levels. Asbestos related mortality was significantly increased. All industrial sectors showed increased mortality from pleural malignancies, and most also from peritoneal and lung cancer and asbestosis, with exposure related trend. Increased mortality was also observed for ovarian cancer and for bladder cancer.

Discussion: The study confirmed the increased risk for cancer of the lung, ovary, pleura and peritoneum but not of the larynx and the digestive tract. A large increase in mortality from asbestosis was observed.
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http://dx.doi.org/10.4415/ANN_20_03_07DOI Listing
September 2020

Industrial Air Pollution and Respiratory Health Status among Residents in an Industrial Area in Central Italy.

Int J Environ Res Public Health 2020 05 27;17(11). Epub 2020 May 27.

Department of Epidemiology, Lazio Regional Health Service, ASL Roma 1, 147 Rome, Italy.

The area of Civitavecchia (Lazio region, Central Italy) has been a reason of concern in the past because of environmental air contamination. The aim of this study was to evaluate the association between air pollution from different sources and respiratory symptoms and lung function in the population. A sample of 1177 residents underwent medical examination and lung function tests. Information on individual characteristics, histories of exposure and medical history were collected through a validated questionnaire. Long-term exposure to industrial, harbour, biomass combustion emissions (PM) and urban traffic (NO) at residential address was assessed using a Lagrangian dispersion model. The associations between exposure and wheezing and dyspnea were assessed using logistic regression models, while modified Poisson regression models were used to evaluate cough with phlegm. Relationships between exposure and lung function were analysed using linear mixed-effects models and cross-correlation. PM10 emissions from the harbour were associated with lower lung function parameters (FEV1: β = -0.12, 95% CI -0.21 -0.03; = 0.02; FEV1/FVC: β = -1.67, (-3.10 -0.23); = 0.02. This association was observed also in healthy subjects, but not in females. We found, even if at low exposure level, an effect of environmental PM exposure from harbour on lung function.
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http://dx.doi.org/10.3390/ijerph17113795DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7312516PMC
May 2020

[The Integrated Environmental Health Impact of emissions from a steel plant in Taranto and from a power plant in Brindisi, (Apulia Region, Southern Italy)].

Epidemiol Prev 2019 Sep-Dec;43(5-6):329-337

Agenzia regionale strategica per la salute e il sociale della Puglia, Bari.

Objectives: to estimate the environmental and health impact attributable to PM2.5 emissions from the ex-ILVA steel plant in Taranto and the ENEL power plant in Brindisi (Apulia Region, Southern Italy).

Design: a SPRAY Lagrangian dispersion model was used to estimate PM2.5 concentrations and population weighted exposures following the requirements of the Integrated Environmental Authorization (IEA) of the two plants under study. Available concentration-response functions (OMS/HRAPIE and updates) were used to estimate the number of attributable premature deaths.

Setting And Participants: residents in the 40 municipalities of the domains of the VDS (assessment of health damage, according to the Regional Law n. 21/2012) of Brindisi (source: Italian National Institute of Statistics 2011 Census) and residents in Taranto, Statte, and Massafra (source: cohort study).

Main Outcome Measures: mortality from natural causes, cardiovascular and respiratory diseases, and lung cancer attributable to PM2.5. Incremental lifetime cumulative risks (ILCRs) for lung cancer associated to PM2.5 exposure.

Results: there was a reduction of the estimated impacts from the pre to the post IEA-scenarios in both Taranto and Brindisi. In Taranto, ILCRs greater than 1x10; were estimated in 2010 and 2012; the ILCR was greater than 1x10; in the district of Tamburi (near the plant) also for the 2015 scenario. ILCRs estimated for Brindisi were between 1x10; and 4x10;.

Conclusions: the Integrated Environmental Health Impact Assessment confirmed the results of the VDS conducted according to the toxicological risk assessment approach. An unacceptable risk was estimated for Tamburi also for the 2015 scenario, characterized by a production of 4.7 million tons of steel, about half compared to one foreseen by the IEA (8 mt.).
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http://dx.doi.org/10.19191/EP19.5-6.P329.102DOI Listing
April 2020

[Exposure assessment to air pollutants: dispersion models versus human biomonitoring].

Epidemiol Prev 2019 Jul-Aug;43(4):260-269

Dipartimento di epidemiologia del Sistema sanitario regionale del Lazio, ASL RM1, Roma.

Background: the assessment of individual exposure to toxicants in industrially contaminated areas is difficult when multiple productions are actively close to residential areas. Two thermoelectric power plants (one recently converted to coal) and a large harbour have been operating since the Sixties in the area of Civitavecchia (North of Rome, Lazio Region, Central Italy). Detailed exposure assessment of pollutants from industrial sources, heating (biomass combustion), and urban traffic were not available.

Objectives: to assess the individual exposure of residents by using both dispersion models and human biomonitoring.

Design: cross-sectional study.

Setting And Participants: residents in the area of Civitavecchia since 2001 aged 35-69 years were enrolled and their addresses were geocoded. Exposure assessment to power plants emissions (PM10), traffic (NOx), harbour (PM10), and biomass burning (PM10) was performed at individual residential address using Lagrangian dispersion models. The "Ambiente e Biomarcatori a Civitavecchia" study (Environment and biomarkers in Civitavecchia - ABC study) made available urinary concentrations of metals (i.e., Cd, Pt, W, Pd, Hg, Tl, Cr, Pd, Ni, As) in a sample of residents, while information on personal characteristics, lifestyles, work history, clinical history, and use of drugs was collected by interview.

Main Outcome Measures: for each metal, a linear regression analysis was implemented to study the association between its log-transformed values (adjusted for urinary creatinine) and the linear terms of the estimated pollutants concentrations, adjusted for age, gender, period, and other risk factors (i.e., educational level, smoking habit, alcohol, BMI). Geometric Mean Ratios (GMR) and the corresponding confidence intervals (95%CI) were computed.

Results: in the ABC sample of 1,141 residents (42% male, mean age 53.5 years, SD 9.7), there was a positive association between PM10 from power plants and urinary cadmium (Cd) (GMR: 1.12; 95%CI 1.00-1.25), traffic pollution (NOx) and platinum (Pt) (GMR: 1.17; 95%CI 1.00-1.38), PM10 from biomass burning and Cd (GMR: 1.14; 95%CI 1.05-1.24), and tungsten (W) (GMR: 1.19; 95%CI 1.03-1.37) and palladium (Pd) (GMR: 1.11; 95%CI 1.00-1.23). Other associations observed did not reach statistical significance.

Conclusions: although it may not be said that dispersion models can replace biomonitoring studies, they certainly represent an excellent tool for exposure assessment and, therefore, they may be used for the estimation of the individual exposure of populations living in industrially contaminated areas.
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http://dx.doi.org/10.19191/EP19.4.P260.076DOI Listing
April 2020

Industrial contaminated sites and health: results of a European survey.

Epidemiol Prev 2019 Jul-Aug;43(4):238-248

Department of Environment and Health, Italian National Health Institute, Rome (Italy).

Background: industrially contaminated sites (ICSs) have been recognised as a major public health concern since they involve exposure to multiple environmental stressors, normally distributed unevenly within population. The COST Action on Industrially Contaminated Sites and Health Network (ICSHNet) comprises a European network of experts and institutions to clarify needs and priorities for better characterising the impact on environment and health of ICS.

Objectives: evaluate the availability of information and studies concerning selected ICSs in participating Countries within the ICSHNet, with particular consideration on the accessibility to environmental, health and demographic data, and research and assessment tools.

Methods: to evaluate the availability of data, an Action Questionnaire (AQ) was developed based on previous questionnaires used in different European projects and on expert consultation. The AQ, with 84 items organised in eight sections, was adapted to an on-line version using the software LimeSurvey. The survey was sent to 47 participants within the ICSHNet, to report over a list of 99 ICSs previously identified.

Results: information was gathered from 81 sites out of the initially selected 99, reported by 45 participants from 27 Countries (82% of Countries in the ICSHNet). The predominant polluting activities were waste disposal (46%) and chemical industries (37%), affecting all environmental media, but more extensively surface and groundwater (70%) and soil (68%). Main categories of contaminants affecting different media were heavy metals and chlorinated hydrocarbons, but also BTEX (benzene, toluene, ethylbenzene, and xylene) and ambient air pollutants (e.g., particulate matter, SOx). Human health risk assessment was the most prevalent methodological approach for characterising impacts on health (32%), followed by epidemiological studies (26%), and health impact assessment (12%). The low reporting, both referring to data availability or methodologies, could be due to absence of data, or to the fact that the reporting person (many of them from the public health sector) did not know how to reach the environmental information.

Conclusions: survey findings suggest that improving the collection and access to specific environmental, health and demographic data related to ICSs is crucial to meet the methodological requirement to better analyse the health impact of ICSs.
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http://dx.doi.org/10.19191/EP19.4.A02.069DOI Listing
April 2020

Levels of Urinary Biomarkers of Oxidatively Generated Damage to DNA and RNA in Different Groups of Workers Compared to General Population.

Int J Environ Res Public Health 2019 08 20;16(16). Epub 2019 Aug 20.

Department of Occupational Medicine, Epidemiology, Occupational and Environmental Hygiene, INAIL Research, via Fontana Candida 1, Monte Porzio Catone, 00078 Rome, Italy.

(1) : The products of guanine oxidation in DNA and RNA excreted in urine are 8-oxo-7,8-dihydroguanine (8-oxoGua), 8-oxo-7,8-dihydroguanosine (8-oxoGuo), and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodGuo). Despite intra and inter-individual variability, it is possible to identify situations that significantly increase the levels of these compounds when comparing urinary concentrations of some workers to those of the general population. (2) : urines from gasoline pump attendants (58 from Saudi Arabia and 102 from Italy), 24 workers of a fiberglass reinforced plastics plant, 17 painters and 6 divers were analyzed by HPLC/MS-MS. To test the individual variability, two subjects provided daily samples for one month, and 132 urine samples from the general population were analyzed. (3) : We summarized the results for each biomarker, and found the following were statistically higher than in the general population: 8-oxoGua in fiberglass and Italian gasoline workers; 8-oxodGuo in fiberglass and both Saudi Arabian and Italian gasoline workers; 8-oxoGuo in fiberglass workers, both Saudi Arabian and Italian gasoline workers, and painters after the working shift. (4) : these results confirm that both 8-oxodGuo and 8-oxoGuo are valuable biomarkers for occupational exposures to dangerous chemicals and seem to suggest that 8-oxoGuo, related to RNA oxidation, is a suitable biomarker to evaluate short term, reversible effects of occupational exposures even within the health-based limit values.
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http://dx.doi.org/10.3390/ijerph16162995DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6719150PMC
August 2019

[Validation of algorithms for the identification of subjects with chronic disease using health information systems].

Epidemiol Prev 2018 Sep-Dec;42(5-6):316-325

Dipartimento di epidemiologia, Servizio sanitario regionale del Lazio, ASL Roma1, Roma.

Objectives: to test the validity of algorithms to identify diabetes, chronic obstructive pulmonary disease (COPD), hypertension, and hypothyroidism from routinely collected health data using information from self-reported diagnosis and laboratory or functional test.

Setting And Participants: clinical or self-reported diagnosis from three surveys conducted in Lazio Region (Central Italy) between year 2010 and 2014 were assumed as gold standard and compared to the results of the algorithms application to administrative data.

Main Outcome Measures: prevalence resulted from administrative data and from information available in the surveys were compared. Sensitivity, specificity, positive predictive value, and positive likelihood ratio of algorithms with respect to self-reported diagnosis, laboratory or functional test, assumed as gold standards, were calculated.

Results: we analyzed data of 7,318 subjects (1,545 for diabetes, 1,783 for COPD, 2,448 for hypertension, and 1,542 for hypothyroidism). For hypertension and hypothyroidism, we observed a higher prevalence from laboratory or functional test compared to self-reported diagnosis (54.5% vs. 44.9% and 7.5% vs. 1.5%). Sensitivity of administrative data with respect to self-reported diagnosis resulted 90.9%, 38.5%, 88.3%, and 47.8%, respectively, for diabetes, COPD, hypertension, and hypothyroidism. Respectively, specificity was 97.4%, 91.7%, 84.8% and 91.8%; positive predictive value was 70,9%, 38.1%, 82.6% and 8.1%. All values of positive likelihood ratio resulted moderate (about 5), with exception of the diabetes algorithm and the disease-specific payment exemptions register for hypertension (respectively 35.5 and 17.4).

Conclusion: hypertension and hypothyroidism resulted markedly underdiagnosed from self-reported data. Case identification algorithms are highly specific, allowing their utilization for selection of cohort of subject affected by chronic diseases. The sub-optimal sensitivity observed for COPD and hypothyroidism could limit the utilization of the algorithms for prevalence estimation.
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http://dx.doi.org/10.19191/EP18.5-6.P316.100DOI Listing
June 2019

A scoping review of the epidemiological methods used to investigate the health effects of industrially contaminated sites.

Epidemiol Prev 2018 Sep-Dec;42(5-6S1):59-68

Department of Epidemiology, Lazio Regional Health Service, ASL Roma 1, Rome (Italy).

Background: this paper is based upon work from COST Action ICSHNet. Industrial contaminated sites (ICSs) are of high concern since industrial plants have produced widespread contamination potentially affecting the health of local population OBJECTIVES: to assess the types of epidemiological designs applied in studies of health effects related to ICSs according to time periods, type of ICS, and geography.

Methods: a literature search was conducted in Medline (OVID) through June 30th, 2018, using MeSH and customized terms, and no restrictions on publication year or language. We included all studies throughout the world where a potential contamination of industrial origin occurred, an epidemiological approach (including biomonitoring, HBM) was applied, and health outcomes or exposure biomarkers among residents were investigated. Data on publication year, geographical localization and ICS characterization, study design (systematic reviews, cohort, case-control, temporal changes, cross-sectional, ecological, descriptive - area-level, case-series, narrative reviews, and HBM), and health outcomes were extracted from the abstracts. To check the sensitivity of the main search strategy, a case-study on Italy was conducted applying an ad-hoc search.

Results: from a literature search capturing 5,485 studies, 655 studies on resident populations were identified. The review includes more than 376 different ICSs, 86% from Europe, North America, and Asia combined, mostly dealing with nuclear sites and mining industries, waste and petrochemical activities. Most of the studies were descriptive (32.5%), cross-sectional (16.3%), or narrative review (14.8%), while analytical studies - case-control and cohort studies (9.6% and 8.4%, respectively) - were rarer; HBM were only 6.9%. A total of 235 studies, conducted mostly in Asia (34.5%), Europe (25.5%), and North America (22.3%), included children. The most frequently studied outcome was cancer (33.7%), followed by respiratory diseases (11.4%), and reproductive health (11.4%). The ad-hoc strategy greatly increased the number of detected papers (+122%).

Conclusions: future research should adopt the most valid and suitable study design, according to the area-specific social and environmental context, also in areas of the world which are less studied, but with very high environmental worries of the resident population suffering the industrial contamination. Involvement of local experts on ICSs and local inventories are recommended to improve the coverage of the present inventory.
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http://dx.doi.org/10.19191/EP18.5-6.S1.P059.088DOI Listing
June 2019

Long-term exposure to air pollutants from multiple sources and mortality in an industrial area: a cohort study.

Occup Environ Med 2019 01 14;76(1):48-57. Epub 2018 Sep 14.

Department of Epidemiology, Lazio Regional Health Service, ASL Roma 1, Rome, Italy.

Background And Aims: Residents near industrial areas are exposed to several toxins from various sources and the assessment of the health effects is difficult. The area of Civitavecchia (Italy) has several sources of environmental contamination with potential health effects. We evaluated the association between exposure to pollutants from multiple sources and mortality in a cohort of people living in the area.

Methods: All residents of the area in 1996 were enrolled (from municipal registers) and followed until 2013. Long-term exposures to emissions from industrial sources (PM10) and traffic (NO) at the residential addresses were assessed using a dispersion model. Residence close to the harbour was also considered. Cox survival analysis was conducted including a linear term for industrial PM10 and NO exposure and a dichotomous variable to indicate residence within 500 m of the harbour. Age, sex, calendar period, occupation and area-based socioeconomic position (SEP) were considered (HRs, 95% CI).

Results: 71 362 people were enrolled (52% female, 43% low SEP) and 14 844 died during the follow-up. We found an association between industrial PM10 and mortality from non-accidental causes (HR=1.06, 95% CI 1.01 to 1.12), all cancers (HR=1.11, 95% CI 1.01 to 1.21) and cardiac diseases (HR=1.12, 95% CI 1.01 to 1.23). We also found an association between NO exposure from traffic and mortality from all cancers (HR=1.13, 95% CI 1.01 to 1.26) and neurological diseases (HR=1.50, 95% CI 1.01 to 2.20). Living near the harbour was associated with higher mortality from lung cancer (HR=1.31, 95% CI 1.04 to 1.66) and neurological diseases (HR=1.51, 95% CI 1.05 to 2.18).

Conclusions: Estimated exposures to different pollution sources in this area were independently associated with several mortality outcomes while adjusting for occupation and socioeconomic status.
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http://dx.doi.org/10.1136/oemed-2018-105059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6327870PMC
January 2019

Biomonitoring of Urinary Benzene Metabolite SPMA in the General Population in Central Italy.

Toxics 2018 Jul 11;6(3). Epub 2018 Jul 11.

Lazio Regional Health Service, Department of Epidemiology, Via Cristoforo Colombo, 112, 00147 Rome, Italy.

Background: Benzene is an important component of cigarette smoke and car exhaust. Products containing benzene in concentrations greater than 0.1% are prohibited in Europe, but 1% of benzene is still allowed in gasoline. The purpose of the study was to assess the levels of urine benzene biomarkers in a sample of the general population not occupationally exposed to benzene, resident in the period 2013⁻2014 in Central Italy, compared to other groups.

Methods: The urinary levels of the benzene metabolites S-phenyl-mercapturic acid (SPMA) and cotinine (nicotine metabolite) were determined by means of HPLC with mass spectrometric detection in 1076 subjects.

Results: The median SPMA value in smokers was 1.132 µg/g of creatinine while in non-smokers it was 0.097 µg/g of creatinine, and the 95th percentile results were seven times higher.

Conclusion: The main source of benzene exposure in the studied population was active smoking, however, non-smokers were also exposed to airborne benzene concentrations. The concentration ranges found in this study can be used as a background reference for occupational exposure assessment to benzene by means of SPMA biomonitoring.
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http://dx.doi.org/10.3390/toxics6030037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6161128PMC
July 2018

Urinary Cotinine Concentration and Self-Reported Smoking Status in 1075 Subjects Living in Central Italy.

Int J Environ Res Public Health 2018 04 19;15(4). Epub 2018 Apr 19.

INAIL, Department of Occupational and Environmental Medicine, Epidemiology and Hygiene, Via di Fontana Candida 1, Monteporzio Catone, 00078 Rome, Italy.

Urinary cotinine, a metabolite of nicotine, is a marker of tobacco smoke exposure. A cutoff value for cotinine concentration can be set to distinguish smokers from non-smokers, independently from self-declared status. Cotinine was determined by isotopic dilution High Performance Liquid Chromatography coupled to tandem mass spectrometry (HPLC-MS/MS) between 2013 and 2014 on urine samples of a population of 1075 subjects. : 296 subjects have a cotinine level higher than 100 μg/g of creatinine (cutoff), with a median cotinine concentration of 1504.70 μg/g of creatinine. The mean is 27.5% of smokers and 60.5% in this group are females. The median value for non-smokers is 5.6 μg/g of creatinine. Two hundred and seventy-five subjects declared to be smokers in the questionnaire, but 6 (2.2%) present urinary cotinine levels lower than cutoff; 800 subjects declared to be non-smokers, but 26 of them presented urinary cotinine levels that were higher than the cutoff (3.3%). Using the cutoff of 100 μg/g, the misclassification of smokers resulted to be 2.2%, indicating that the selected value is suitable for studying the human exposures to environmental and occupational pollutants, including those produced by smoking.
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http://dx.doi.org/10.3390/ijerph15040804DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5923846PMC
April 2018

Levels of urinary metabolites of four PAHs and cotinine determined in 1016 volunteers living in Central Italy.

Environ Sci Pollut Res Int 2018 Oct 8;25(29):28772-28779. Epub 2018 Mar 8.

Department of Epidemiology (RM), Lazio Regional Health Service, Rome, Italy.

Polycyclic aromatic hydrocarbons (PAH) are products of the incomplete combustion of organic materials, and exposure of the general population to PAH is ubiquitous. They are also present in tobacco smoke. Some PAH are classified as carcinogens. Urine samples from 747 non-smoking and 269 smoking subjects living in the same area of Central Italy were analyzed in order to determine reference values for PAHs exposure of a general population. The concentration of cotinine, urinary metabolite of nicotine was also measured in these samples in order to classify the subjects as smokers or not. The median concentration and 50th percentile in females was higher than in males for all metabolites; 1- and 2-hydroxynaphtalene (1-OHNAP and 2-OHNAP) and 1-hydroxypyrene (1-OHPy), are significantly higher in smokers; on the other side 3-hydroxybenzo[a]pyrene (3-OHBaPy) and 6-hydroxynitropyrene (6-OHNPy) do not correlate with the cotinine concentration.
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http://dx.doi.org/10.1007/s11356-018-1650-xDOI Listing
October 2018

[If I say John Snow, what do you think?]

Epidemiol Prev 2017 May-Aug;41(3-4):159-161

Unità di statistica medica, Università degli Studi della Campania, Napoli.

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http://dx.doi.org/10.19191/EP17.3-4.P159.044DOI Listing
February 2019

Inhaled Corticosteroid Use in Chronic Obstructive Pulmonary Disease and Risk of Pneumonia: A Nested Case-Control Population-based Study in Lazio (Italy)-The OUTPUL Study.

COPD 2017 Jun 13;14(3):311-317. Epub 2017 Apr 13.

a Department of Epidemiology , Lazio Regional Health Service , Rome , Italy.

Inhaled corticosteroid (ICS) use in chronic obstructive pulmonary disease (COPD) patients is associated with a reduction of exacerbations and a potential risk of pneumonia. The objective was to determine if ICS use, with or without long-acting β-agonist, increases pneumonia risk in COPD patients. A cohort study was performed using linked hospital and drug prescription databases in the Lazio region. Patients (45+) discharged with COPD in 2006-2009 were enrolled and followed from cohort entry until first admission for pneumonia, death or study end, 31 December, 2012. A nested case-control approach was used to estimate the rate ratio (RR) associated with current or past use of ICS adjusted for age, gender, number of exacerbations in the previous year and co-morbidities. Current users were defined as patients with their last ICS prescribed in the 60 days prior to the event. Past users were those with the last prescription between 61 and 365 days before the event. Current use was classified into three levels (high, medium, low) according to the medication possession ratio. Among the cohort of 19288 patients, 3141 had an event of pneumonia (incidence rate for current use 87/1000py, past use 32/1000py). After adjustment, patients with current use were 2.29 (95% confidence interval [CI]: 1.99-2.63) times more likely to be hospitalised for pneumonia with respect to no use; for past use RR was 1.23 (95% CI: 1.07-1.42). For older patients (80+), the rate was higher than that for younger patients. ICS use was associated with an excess risk of pneumonia. The effect was greatest for higher doses and in the very elderly.
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http://dx.doi.org/10.1080/15412555.2016.1254172DOI Listing
June 2017

A survey on lifestyle and level of biomarkers of environmental exposure in residents in Civitavecchia (Italy).

Ann Ist Super Sanita 2016 Oct-Dec;52(4):488-494

Dipartimento di Epidemiologia del Servizio Sanitario Regionale del Lazio, Rome, Italy.

Background: The assessment of individual exposure to toxicants in industrially contaminated areas is difficult when multiple productions are active close to residential areas. Two thermoelectric power plants and a large harbor have been operating since the '60s in the area of Civitavecchia (North of Rome).

Methods: The ABC (Ambiente e Biomonitoraggio nell'area di Civitavecchia, Environment and Biomonitoring in Civitavecchia) program involved, in the period 2013-2014, residents in Civitavecchia and in the nearby municipalities (Santa Marinella, Allumiere, Tolfa and Tarquinia). They were randomly selected from the Municipal Register's data and their residence addresses were geocoded using GIS techniques. Biomonitoring of the following urinary metals, Sb, Be, Mo, Cd, Sn, W, Ir, Pt, Hg, Tl, V, Cr, Mn, Co, Ni, Cu, Zn, Rh, Pd, As were performed. Glucose and lipid metabolism, liver, renal, and endocrine function were evaluated through blood laboratory tests. Tests of lung functionwere also carried out as well as saturometry (oxygen rate in the blood with an illuminated sensor placed on the fingertip), anthropometric and blood pressure measurements. Information on individual characteristics, histories of exposure, such as the consumption of local food, occupational history, lifestyle and medical history were collected through a validated questionnaire. Samples of nails and hair were also collected. The biological material (blood, urine, nails and hair) was stored in a biobank for future analysis related to the possible mechanisms of biological damage. The study protocol received the approval of the local ethics committee.

Results: A total of 1177 residents were enrolled (58% female, 60% with a secondary or graduate school degree). No particular differences in metal concentrations based on the municipality of residence were observed. For arsenic, mercury, lead, and tungsten some differences between the two geographical areas were observed, probably due to different diet, lifestyle (e.g., alcohol consumption, smoking, use of jewelry and piercings, tattoos, physical activity, hormonal and mineral supplements, and drugs), and occupational exposure.

Conclusions: The undergoing study on the association between biomarkers concentration and pollutants concentrations - estimated using a dispersion modeling approach, and adjusting for personal characteristics and concomitant other environmental exposure - could clarify the individual exposure of the residents in this industrial area.
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http://dx.doi.org/10.4415/ANN_16_04_05DOI Listing
April 2017

Quantification of 1-hydroxypyrene, 1- and 2-hydroxynaphthalene, 3-hydroxybenzo[a]pyrene and 6-hydroxynitropyrene by HPLC-MS/MS in human urine as exposure biomarkers for environmental and occupational surveys.

Biomarkers 2017 Sep 8;22(6):575-583. Epub 2016 Nov 8.

c INAIL Research, Department of Occupational and Environmental Medicine, Epidemiology and Hygiene , Monte Porzio Catone (RM) , Italy.

Context: Several urinary PAHs metabolites can be detected by HPLC-MS/MS for individual exposure assessment.

Objective: Quantitation of urinary metabolites of four PAHs, selected on the basis of their significance, with reduced costs and high sensitivity.

Materials And Methods: HPLC-MS/MS was used and pure standards and isotope-labeled internal analogs of the analytes. Two hundred samples were tested after enzymatic hydrolysis.

Results: Accuracy was higher than 90% and variability lower than 19%; LODs permit to measure 1-hydroxypyrene, 1 and 2-hydroxynaphthalene in all subjects, 6-hydroxynitropyrene in the 65% and 3-hydroxybenzo[a]pyrene in the 70%.

Discussion And Conclusion: The method is suitable both for occupational and for environmental studies. This is the first paper reporting urinary levels of 6-hydroxynitropyrene in European subjects, nonoccupationally exposed to nitro-PAHs.
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http://dx.doi.org/10.1080/1354750X.2016.1252959DOI Listing
September 2017

One-year mortality associated with COPD treatment: a comparison of tiotropium and long-acting beta2-agonists in three Italian regions: results from the OUTPUL study.

Pharmacoepidemiol Drug Saf 2016 05 29;25(5):578-89. Epub 2016 Jan 29.

Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.

Purpose: Long-acting bronchodilators, i.e. beta-2-agonists (LABA) and tiotropium are commonly used in COPD treatment. Choice of a specific agent is based on effectiveness and safety. Evidence yields controversial results with respect to mortality. The present study compared one-year mortality associated to treatment with tiotropium versus LABA.

Methods: A population-based cohort study using data from Italian health information systems was performed. Patients aged 45+ years, discharged with COPD diagnosis in 2006-2009 were identified. Through record linkage with drug claims, patients who received a first prescription of LABA or tiotropium within 6 months after discharge were enrolled. The main analysis was restricted to naïve users (no prior use of either LABA or tiotropium). We used 'intention to treat' (ITT) and 'as treated' (AT) approaches. We followed patients for a maximum of 12 months. Hazard ratios (HRs) were calculated by Cox regression including quintiles of propensity score. In sensitivity analysis patients receiving tiotropium + LABA combination were included in the tiotropium group.

Results: Among the 33 891 enrolees, 28% were exposed to Tio, 56% to LABA, 16% to both. Overall mean age was 74 years and the mortality rate was 122/1000 person-years (py) at the ITT analysis and 108/1000 py at the AT analysis. The adjusted HR for tiotropium only compared with LABA only was 1.06 (95%CI: 0.94-1.20) at the ITT analysis and 1.00 (95%CI: 0.93-1.08) at the AT analysis. Results were robust in sensitivity analysis.

Conclusions: In this real-world study use of tiotropium was not associated with an increased risk of one-year mortality compared with LABA. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
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http://dx.doi.org/10.1002/pds.3961DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066679PMC
May 2016

The Effect on Total Mortality of Adding Inhaled Corticosteroids to Long-Acting Bronchodilators for COPD: A Real Practice Analysis in Italy.

COPD 2016 06 29;13(3):293-302. Epub 2015 Oct 29.

a Department of Epidemiology , Lazio Regional Health Service , Roma , Italy.

Purpose: Chronic therapy with long-acting bronchodilators (LB) is recommended to treat moderate-to-severe COPD. Although the benefits of adding inhaled corticosteroid (ICS) to LB are still unclear, patients who experience repeated exacerbations are suggested to add ICS to their LB treatment. The objective of this study is to analyze whether adding ICS to LB therapy reduces mortality.

Methods: We identified a cohort of patients discharged from hospital with COPD diagnosis between 2006 and 2009. The first prescription for LB or ICS following discharge was defined as the index prescription. Only new users were included (no use of any study drug in the 6 months before treatment). A 4-day time window was used to classify patients into "LB alone" or "LB plus ICS" initiators. We used propensity score to balance the study groups. Sensitivity analyses were performed in patients with recent out-of-hospital exacerbations.

Results: Among the 18615 adults enrolled, 12207 initiated "LB plus ICS" therapy and 6408 "LB alone." Crude mortality rates were 110 and 143 cases per 1000 person-years in the "LB plus ICS" and "LB alone" groups, respectively. The adjusted hazard ratio (HR) was 0.83 (95% CI: 0.72-0.97; p-value: 0.024). When analyzing patients with recent out-of-hospital exacerbations, the benefit of the combination therapy was more pronounced, HR = 0.63 (95% CI: 0.44-0.90; p-value: 0.012).

Discussion: Our findings showed a beneficial effect on mortality of adding inhaled corticosteroids to long-acting bronchodilators. The advantage was much more pronounced in patients with frequent exacerbations.
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http://dx.doi.org/10.3109/15412555.2015.1044861DOI Listing
June 2016

The impact of time-window bias on the assessment of the long-term effect of medication adherence: the case of secondary prevention after myocardial infarction.

BMJ Open 2015 Jun 10;5(6):e007866. Epub 2015 Jun 10.

Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.

Objectives: Time-window bias was described in case-control studies and led to a biased estimate of drug effect. No studies have measured the impact of this bias on the assessment of the effect of medication adherence on health outcomes. Our goals were to estimate the association between adherence to drug therapies after myocardial infarction (MI) and the incidence of a new MI, and to quantify the error that would have been produced by a time-window bias.

Setting: This is a population-based study. Data were obtained from the Regional Health Information Systems of the Lazio Region in Central Italy (around 5 million inhabitants).

Participants: Patients discharged after MI in 2006-2007 were enrolled in the cohort and followed through 2009.

Outcome Measure: The study outcome was reinfarction: either mortality, or hospital admission for MI, whichever occurred first.

Design: A nested case-control study was performed. Controls were selected using both time-dependent and time-independent sampling. Adherence to antiplatelets, β-blockers, ACE inhibitors/angiotensin receptor blockers (ACEI/ARBs) and statins was calculated using the proportion of days covered (PDC).

Results: A total of 6880 patients were enrolled in the cohort. Using time-dependent sampling, a protective effect was detected for all study drugs. Conversely, using time-independent sampling, the beneficial effect was attenuated, as in the case of antiplatelet agents and statins, or completely masked, as in the case of ACEI/ARBs and β-blockers. For ACEI/ARBs, the time-dependent approach produced ORs of 0.83 (95% CI 0.57 to 1.21) and 0.72 (0.55 to 0.95), respectively, for '0.5 < PDC ≤ 0.75' and 'PDC>0.75' versus '0 ≤ PDC ≤ 0.5'. Using the time-independent approach, the ORs were 0.96 (0.65 to 1.43) and 1.00 (0.76 to 1.33), respectively.

Conclusions: A time-independent definition of a time-dependent exposure introduces a bias when the length of follow-up varies with the outcome. The persistence of time-related biases in peer-reviewed papers strongly suggests the need for increased awareness of this methodological pitfall.
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http://dx.doi.org/10.1136/bmjopen-2015-007866DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4466602PMC
June 2015

Idiopathic Pulmonary Fibrosis (IPF) incidence and prevalence in Italy.

Sarcoidosis Vasc Diffuse Lung Dis 2014 Oct 20;31(3):191-7. Epub 2014 Oct 20.

Departement of Epidemiology, Regional Health Service of Lazio, Rome.

Background: Studies of Idiopathic Pulmonary Fibrosis (IPF) epidemiology show regional variations of incidence and prevalence; no epidemiological studies have been carried out in Italy.

Objective: To determine incidence and prevalence rates of IPF in the population of a large Italian region.

Methods: in this cross-sectional study study data were collected on all patients of 18 years of age and older admitted as primary or secondary idiopathic fibrosing alveolitis (ICD9-CM 516.3) to Lazio hospitals, from 1/1/2005 to 31/12/2009, using regional hospital discharge, population and cause of death databases. Reporting accuracy was assessed on a random sample of hospital charts carrying the ICD9-CM 516.3, 516.8, 516.9 and 515 codes, by reviewing radiology and pathology findings to define cases as IPF "confident", "possible" or "inconsistent".

Results: Annual prevalence and incidence of IPF were estimated at 25.6 per 100,000 and 7.5 per 100,000 using the ICD9-CM code 516.3 without chart audit while they were estimated at 31.6 per 100,000 and at 9,3 per 100,000 for the IPF "confident" definition after hospital chart audit.

Conclusion: The data provide a first estimate of IPF incidence in Italy and indicate that incidence and prevalence in southern European regions may be similar to those observed in northern Europe and North America.
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October 2014

Adherence to antiplatelet therapy after percutaneous coronary intervention: a population study in a region of Italy.

J Cardiovasc Med (Hagerstown) 2015 Mar;16(3):230-7

aDepartment of Epidemiology, Lazio Regional Health Service bDivisione di Cardiologia, Università di Roma La Sapienza, Ospedale Sant'Andrea cDepartment of Cardiology, St Spirito Hospital dDepartment of Interventional Cardiology, Azienda Ospedaliera San Camillo Forlanini eNational Agency for Regional Health Services, Rome, Italy.

Aims: We evaluated adherence to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for patients in the Lazio region of Italy and the impact of discharge ward type on therapy discontinuation.

Methods: From the Hospital Information System, we selected patients who underwent PCI from 2006 to 2007 and obtained Regional Drug Dispense Registry data for antiplatelet drugs prescribed for 12 months after discharge. Appropriate therapy was defined as DAPT with prescribed daily doses for each drug covering at least 75% of each individual follow-up period. The association between discharge ward type and antiplatelet therapy adherence at 12 months post discharge was estimated using multilevel logistic regression analysis.

Results: A total of 11 186 patients with PCI were included, and fewer than half (4984; 44.56%) were on adequate DAPT. Only 2930 of 5390 patients (54.36%) with DAPT in the first 6 months post discharge continued DAPT in the second 6 months. Patients discharged from cardiology units or intensive coronary care units were more likely (odds ratio = 1.26; P = 0.003) to receive appropriate antiplatelet therapy, and elderly patients were less likely (odds ratio = 0.65; P < 0.001) to do so.

Conclusion: The proportion of PCI patients receiving appropriate DAPT after discharge is suboptimal in this region, and elderly patients are less likely to receive appropriate therapy. These findings could be important for improving patient management and ensuring adherence to clinical guidelines and indicate the need for a systematic evaluation of the appropriateness of postdischarge therapy.
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http://dx.doi.org/10.2459/JCM.0000000000000070DOI Listing
March 2015

Use patterns of long-acting bronchodilators in routine COPD care: the OUTPUL study.

COPD 2014 Aug 3;11(4):414-23. Epub 2013 Oct 3.

1Department of Epidemiology, Lazio Regional Health Service , Roma , Italy.

Background: COPD is the fourth leading cause of death in the world. In the case of exacerbations or persistent symptoms, regular treatment with long-acting bronchodilators is recommended to control the symptoms, reduce exacerbations and improve health status. Objectives. To describe patterns of drug utilization among patients diagnosed with COPD, to measure continuity with long-acting bronchodilators, to identify determinants of not receiving long-acting therapy continuously.

Methods: We identified a cohort of patients discharged from hospital with diagnosis of COPD between 2006 and 2008. Patients were observed for a two-year follow-up period, starting from the day of discharge. Follow-up was segmented in six-month periods, in order to dynamically evaluate prescription patterns of Long-Acting Beta-Agonists (LABA), tiotropium, and inhaled corticosteroids. Patients with prescriptions for LABA and/or tiotropium in each of the six-month periods were defined as "continuously treated with long-acting bronchodilators." The degree of drug treatment coverage was measured through the Medication Possession Ratio (MPR). Logistic regression was performed to identify determinants of not receiving long-acting bronchodilators continuously.

Results: A total of 11,452 patients diagnosed with COPD were enrolled. Only 34.8% received long-acting bronchodilators continuously. The MPR was greater than 75% in 19.6% of cases. Among the determinants of not receiving long-acting bronchodilators continuously, older age and co-morbidities played an important role.

Conclusions: In clinical practice, the COPD pharmacotherapy is not consistent with clinical guidelines. Medical education is needed to disseminate evidence-based prescribing patterns for COPD, and to raise awareness among physicians and patients on the health benefits of an appropriate pharmacological treatment.
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http://dx.doi.org/10.3109/15412555.2013.839646DOI Listing
August 2014

Effect of evidence-based drug therapy on long-term outcomes in patients discharged after myocardial infarction: a nested case–control study in Italy.

Pharmacoepidemiol Drug Saf 2013 Jun;22(6):649-57

Purpose: There are some methodological concerns regarding results from observational studies about the effectiveness of evidence-based (EB) drug therapy in secondary prevention after myocardial infarction. The present study used a nested case–control approach to address these major methodological limitations.

Methods: A cohort of 6880 patients discharged from hospital after acute myocardial infarction (AMI) in 2006–2007 was enrolled and followed-up throughout 2009. Exposure was defined as adherence to each drug in terms of the proportion of days covered (cutoff ≥ 75%). Composite treatment groups, that is, groups with no EB therapy or therapy with one, two, three, or four EB drugs), were analyzed. Outcomes were overall mortality and reinfarction. Nested case–control studies were performed for both outcomes, matching four controls to every case (841 deaths, 778 reinfarctions) by gender, age, and individual follow-up. The association between exposure to EB drug therapy and outcomes was analyzed using conditional logistic regression, adjusting for revascularization procedures, comorbidities, duration of index admission, and use of the study drugs prior to admission.

Results: Mortality and reinfarction risk decreased with the use of an increasing number of EB drugs. Combinations of two or more EB drugs were associated with a significant protective effect (p < 0.001) versus no EB drugs (mortality: 4 EB drugs: ORadj = 0.35; 95%CI: 0.21–0.59; reinfarction: 4 EB drugs: ORadj = 0.23; 95%CI: 0.15–0.37).

Conclusions: These findings of the beneficial effects of EB polytherapy on mortality and morbidity in a population-based setting using a nested case–control approach strengthen existing evidence from observational studies.
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http://dx.doi.org/10.1002/pds.3430DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3746119PMC
June 2013

[Definition and validation of a predictive model to identify patients with chronic obstructive pulmonary disease (COPD) from administrative databases].

Epidemiol Prev 2012 May-Aug;36(3-4):162-71

Dipartimento di Epidemiologia del Servizio Sanitario Regionale, Lazio.

Objective: To develop and validate a predictive model for the identification of patients with Chronic Obstructive Pulmonary Disease (COPD) among the resident population of the Lazio region, using information available in the regional administrative systems (SIS) as well as clinical data of a panel of COPD patients.

Setting And Participants: All residents in the Lazio region over 40 years of age in 2007 (2,625,102 inhabitants)

Main Outcome Measures: The predictive model was developed through record linkage of health care related consumption patterns among 428 panel patients with confirmed COPD diagnosis in 2006 and a control group of patients without COPD (selection from outpatients specialized health care registry, 1:4). Hospital admission for COPD was defined a priori to be sufficient to identify a COPD patient. For all other panel patients and controls, specific drug use (minimum 2 prescriptions during 12 months) and hospitalization for respiratory causes during the past 9 years were retrieved and compared between panel and control patients. COPD associated factors were selected through a Bootstrap- Stepwise (BS) procedure. The predictive model was validated through internal (cross-validation-bootstrap) and external validation (comparison with external COPD patients with confirmed diagnosis), and through comparison with other COPD identification approaches.

Results: The BS procedure identified the following predictors of COPD: consumption of beta 2 agonists, anticholinergics, corticosteroids, oxygen, and previous hospitalization for respiratory failure. For each patient, the expected probability of being affected by COPD was estimated. Depending on the cut-point of expected probability, sensibility ranged from 74.5% to 99.6% and specificity from 37.8% to 86.2%. Using the 0.30 cut-point, the model succeeded in identifying 67% of patients with diagnosis of COPD confirmed with spirometry. The predictive performance increased with increasing COPD severity. Prevalence of COPD turned out to be 7.8 %. The age-specific estimation was similar to results from other approaches.

Conclusion: The predictive model shows good performance to identify COPD patients, even if it does not allow to identify those patients who have not been registered in the regional health care service or do not request any public health care service.
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December 2013
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