HIV rapid testing in community and outreach sites: results of a nationwide demonstration project in Italy.

BACKGROUND: Globally the access to HIV testing has greatly increased over the past 30 years. Nonetheless, a high proportion of people living with HIV remains undiagnosed, even in resource rich countries. To increase the proportion of people aware of their HIV serostatus and their access to medical care, several strategies have been proposed including HIV rapid test programs offered outside health facilities. The aim of this project was to evaluate the feasibility and efficacy of the HIV rapid testing offered in community and outreach settings in Italy. METHODS: We conducted a national demonstration project on HIV rapid tests offered in community and outreach settings, including nongovernmental organization (NGO) facilities, primary care services for migrants and low-threshold services or mobile units for drug users (DU services). HIV rapid test on oral fluid (OraQuick®; Orasure Technologies) was anonymously offered to eligible people who presented themselves at the selected sites. Those with reactive results were referred to a specialized outpatient unit for confirmatory testing and medical care. RESULTS: Over a period of six months a total of 2949 tests were performed and 45.2% of individuals tested had not been previously tested. Overall 0.9% (27/2949) of tested people had a preliminary positive test. In NGO facilities the positivity rate was 1%. All subjects who performed their confirmatory test were confirmed as positive. In services for migrants the positivity rate was 0.5 and 80% were referred to care (with 1 false positive test). In DU services we observed the highest positivity rate (1.4%) but the lowest linkage to care (67%), with 1 false positive test. CONCLUSION: Our project showed that the offering of an HIV rapid testing program in community and outreach settings in Italy is feasible and that it may reach people who have never been tested before, while having a significant yield in terms of new HIV diagnoses as well.

Glaucoma Drug Therapy in Pregnancy: Literature Review and Teratology Information Service (TIS) Case Series.

BACKGROUND: There are many contradictions about pregnancy and fetal/neonatal outcomes after topical use of timolol alone or timolol in combination with other antiglaucoma medications. METHODS: Seventy-five pregnant women exposed to antiglaucoma medications were followed prospectively by phone interviews. 27 women used timolol as monotherapy, 48 women used timolol as a part of multidrug therapy. We selected a control group of 187 healthy pregnant women. RESULTS: Topical use of timolol alone or timolol in combination with other antiglaucoma medications does not influence pregnancy or fetal/neonatal outcomes. CONCLUSION: Beta-blocker is the first choice treatment for glaucoma in pregnancy but, when necessary, multidrug therapy should not to be excluded.

The potential impact of routine testing of individuals with HIV indicator diseases in order to prevent late HIV diagnosis.

BACKGROUND: The aim of our work was to evaluate the potential impact of the European policy of testing for HIV all individuals presenting with an indicator disease, to prevent late diagnosis of HIV. We report on a retrospective analysis among individuals diagnosed with HIV to assess whether a history of certain diseases prior to HIV diagnosis was associated with the chance of presenting late for care, and to estimate the proportion of individuals presenting late who could have been diagnosed earlier if tested when the indicator disease was diagnosed. METHODS: We studied a large cohort of individuals newly diagnosed with HIV infection in 13 counselling and testing sites in the Lazio Region, Italy (01/01/2004-30/04/2009). Considered indicator diseases were: viral hepatitis infection (HBV/HCV), sexually transmitted infections, seborrhoeic dermatitis and tuberculosis. Logistic regression analysis was performed to estimate association of occurrence of at least one indicator disease with late HIV diagnosis. RESULTS: In our analysis, the prevalence of late HIV diagnosis was 51.3% (890/1735). Individuals reporting at least one indicator disease before HIV diagnosis (29% of the study population) had a lower risk of late diagnosis (OR = 0.7; 95%CI: 0.5-0.8) compared to those who did not report a previous indicator disease. 52/890 (5.8%) late presenters were probably already infected at the time the indicator disease was diagnosed, a median of 22.6 months before HIV diagnosis. CONCLUSIONS: Our data suggest that testing for HIV following diagnosis of an indicator disease significantly decreases the probability of late HIV diagnosis. Moreover, for 5.5% of late HIV presenters, diagnosis could have been anticipated if they had been tested when an HIV indicator disease was diagnosed.However, this strategy for enhancing early HIV diagnosis needs to be complemented by client-centred interventions that aim to increase awareness in people who do not perceive themselves as being at risk for HIV.

Folic acid use in planned pregnancy: an Italian survey.

It is well known that periconceptional folic acid supplementation decreases the risk of neural tube defects. The aim of this study was to evaluate the attitudes and practices of women with planned pregnancies regarding periconceptional folic acid intake and to identify factors associated with the use of this supplement. During 2 years of observation, we surveyed women with planned pregnancies who called our Teratology Information Service. A total of 500 women were surveyed: 217 (43.4%) took folic acid before becoming pregnant, and 283 (56.6%) did not take it. The women who took folic acid before becoming pregnant had a high education level and received preconception counselling. Our results suggest that less than half of Italian women took folic acid before they became pregnant although they were trying to conceive. Knowledge about the benefits of this vitamin is inadequate also among women who planned the pregnancy and the level of information received from their physicians.

[EpiInfo as a research and teaching tool in epidemiology and statistics: strengths and weaknesses]. / EpiInfo come strumento per la ricerca e per la didattica dell'epidemiologia e della statistica: punti di forza e di debolezza.

EpiInfo is a free software developed in 1988 by the Centers for Disease Control and Prevention (CDC) in Atlanta to facilitate field epidemiological investigations and statistical analysis. The aim of this study was to assess whether the software represents, in the Italian biomedical field, an effective analytical research tool and a practical and simple epidemiology and biostatistics teaching tool. A questionnaire consisting of 20 multiple-choice and open questions was administered to 300 healthcare workers, including doctors, biologists, nurses, medical students and interns, at the end of a CME course in epidemiology and biostatistics. Sixty-four percent of participants were aged between 26 and 45 years, 52% were women and 73% were unmarried. Results show that women are more likely to utilize EpiInfo in their research activities with respect to men (p = 0.023), as are individuals aged 26-45 years with respect to the older and younger age groups (p = 0.023) and unmarried participants with respect to those married (p = 0.010). Thirty-one percent of respondents consider EpiInfo to be more than adequate for analysis of their research data and 52% consider it to be sufficiently so. The inclusion of an EpiInfo course in statistics and epidemiology modules facilitates the understanding of theoretical concepts and allows researchers to more easily perform some of the clinical/epidemiological research activities.

Guidance for future HTA applications to vaccines: the HPV lesson.

The HTA is a multidisciplinary approach which is increasingly applied worldwide in order to support decision-makers in the introduction of health technologies. The application of HTA to vaccines is quite recent and linked to the increasing number of vaccines available or in development, especially to those intended to non pediatric immunization. In this article a description of the HTA approach used in the evaluation of the bivalent HPV vaccine in Italy is provided; moreover the reasons for keeping HTA process "alive" and identifying new or pending Public Health issues are discussed. In fact, the project raised questions and challenges about the standardization and sharing of HTA methods in Italy. Recently the need of updating the results is starting to be seen as urgent due to the evolution of scientific knowledge, the availability of the first results after technology introduction and the observed differences in vaccination strategies among Italian regions. Moreover in these last two years after the completion of the HTA project a number of new issues have risen in the Italian context as immunization rates, regional vaccination strategies, processes for vaccine selection and health economic issues.

The Health Technology Assessment of bivalent HPV vaccine Cervarix in Italy.

INTRODUCTION: Health Technology Assessment (HTA) approach was applied to Human Papilloma Virus (HPV) vaccine in the Italian context. METHODS: Epidemiology and costs of HPV infection and related diseases, vaccine efficacy, clinical and economic impact of the HPV vaccination and women's knowledge and attitudes towards vaccination were assessed. RESULTS: HPV infections pooled prevalence in Italy was 19% (95%CI: 10-30%) and cervical cancer incidence was 9.8/100,000 per year. The mean costs for in situ and invasive carcinoma hospitalisation were estimated respectively in euro1745.87 and euro2616.16. HPV vaccines have demonstrated high efficacy and good safety profile. The meta-analysis on efficacy results in preventing persistent cervical infections by HPV16 and 18 for both HPV vaccines resulted in 87% (95%CI: 80-91%) and 78% (95%CI: 62-87%). Modelling the impact of vaccination with bivalent vaccine, it would reduce cancer cases by 67% and be cost-effective, with a cost per Quality Adjusted Life Years (QALYs) gained of euro22,055. CONCLUSION: The thoroughness of the evaluation allowed us accounting for all the aspects of HPV infection/diseases. The HTA report on the HPV vaccine demonstrated to be a comprehensive tool for an informed decision making process.

Intrafamilial transmission of hepatitis C virus in Italy: a systematic review.

BACKGROUND: Hepatitis C virus (HCV) transmission is mainly due to parenteral exposure; however, in absence of such risk factor, there are reports of intrafamilial spread of HCV and observational studies suggest an increased risk for households of infected subjects. The aim of our study was to systematically review and meta-analyse studies about HCV prevalence among households of HCV patients in Italy. METHODS: PubMed and Embase were searched to identify Italian studies about HCV intrafamilial transmission. Keywords used were: 'HCV', 'Hepatitis C', 'intrafamilial', 'family' and 'Italy'. Selected studies were reviewed to assess the quality and meta-analysed using StatsDirect software. RESULTS: 25 studies were selected. The pooled overall prevalence was 9% (95% CI 7.1% to 11.1%). The highest pooled prevalence was found among sexual partners of index cases: 14.7% (95% CI 10.7% to 19.2%) globally and 9.9% (95% CI 3.6% to 18.8%) and 17.6% (95% CI 12.1% to 24%) in northern and central-southern regions, respectively. The meta-analysis of high-quality studies yielded the lowest HCV prevalence. CONCLUSION: To be a HCV patient household is a risk factor for HCV and counselling for these households should be provided.

Smoking status and gastric cancer risk: an updated meta-analysis of case-control studies published in the past ten years.

BACKGROUND: A meta-analysis of published studies was performed in order to clarify the risk of gastric cancer associated with cigarette smoking status. METHODS: Eligible studies were all the case-control studies investigating an association between smoking status and gastric cancer published from January 1, 1997, until June 30, 2006. In order to evaluate the quality of the published data, a qualitative scoring of papers was applied. The principal outcome measure was the odds ratio for the risk of gastric cancer associated with the smoking status using a random effects model. Cigarette smoking status was assessed in two ways: ever (current and ex) versus never smokers; current versus never smokers. RESULTS: We found a statistically significant result for the association between ever smoking status and gastric cancer risk (OR = 1.48; 95% CI, 1.28-1.71), considering 14,442 cases and 73,918 controls. Moreover, we found an odds ratio of 1.69 for current smoker status in comparison to never smokers (95% CI, 1.35-2.11). Considering only high quality studies, the odds ratio increased by 43% for gastric cancer risk in ever smokers (OR = 1.43; 95% CI, 1.24-1.66; Q = 378.60, P < 0.00001; 12 = 90%) and by 57% in current smokers (OR = 1.57; 95% CI, 1.24-2.01). We also considered separately Caucasians and Asian studies, finding for ever smokers an odds ratio of 1.46 (95% CI, 1.25-1.70; Q = 125.68, P < 0.00001; 12 = 82.5%) and of 1.47 (95% CI, 1.13-1.91; Q = 366.77, P < 0.00001; I2 = 94%), respectively. CONCLUSIONS: From the results of this quantitative meta-analysis, it appears that cigarette smoking has to be considered an important risk factor. The use of qualitative scoring decreases the magnitude of the relationship both for ever and current smoker exposure by 5-12%. Future studies on this topic need to clarify the biological interaction between environmental factors (such as cigarette smoking) and different polymorphisms on gastric cancer.

An assessment of the effect of hepatitis B vaccine in decreasing the amount of hepatitis B disease in Italy.

BACKGROUND: Hepatitis B (HBV) infection is an important cause of morbidity and mortality and it is associated to a higher risk of chronic evolution in infected children. In Italy the anti-HBV vaccination was introduced in 1991 for newborn and twelve years old children. Our study aims to evaluate time trends of HBV incidence rates in order to provide an assessment of compulsory vaccination health impact. METHOD: Data concerning HBV incidence rates coming from Acute Viral Hepatitis Integrated Epidemiological System (SEIEVA) were collected from 1985 to 2006. SEIEVA is the Italian surveillance national system that registers acute hepatitis cases. Time trends were analysed by joinpoint regression using Joinpoint Regression Program 3.3.1 according to Kim's method. A joinpoint represents the time point when a significant trend change is detected. Time changes are expressed in terms of the Expected Annual Percent Change (EAPC) with 95% confidence interval (95% CI). RESULTS: The joinpoint analysis showed statistically significant decreasing trends in all age groups. For the age group 0-14 EAPC was -39.0 (95% CI: -59.3; -8.4), in the period up to 1987, and -12.6 (95% CI: -16.0; -9.2) thereafter. EAPCs were -17.9 (95% CI: -18.7; -17.1) and -6.7 (95% CI: -8.0; -5.4) for 15-24 and > or =25 age groups, respectively. Nevertheless no joinpoints were found for age groups 15-24 and > or =25, whereas a joinpoint at year 1987, before compulsory vaccination, was highlighted in 0-14 age group. No joinpoint was observed after 1991. DISCUSSION: Our results suggest that the introduction of compulsory vaccination could have contribute partly in decreasing HBV incidence rates. Compulsory vaccination health impact should be better investigated in future studies to evaluate the need for changes in current vaccination strategy.

An evaluation of a new combined Spo2/PtcCO2 sensor in very low birth weight infants.

BACKGROUND: Recently, a new sensor for combined assessment of pulse oximetry oxygen saturation (Spo(2)) and transcutaneous monitoring of carbon dioxide partial pressure (PtcCO(2)) has been introduced (TOSCA 500, Radiometer basel AG, Switzerland) [corrected] We designed this study to evaluate the usability and reliability of TOSCA in neonates with birth weight

[Burnout in healthcare workers of a university teaching hospital in Rome, Italy: a cross-sectional study]. / Il burnout nel personale sanitario ospedaliero: risultati di uno studio trasversale condotto in un policlinico universitario a Roma.

A cross-sectional study was performed to assess the frequency of burnout in healthcare workers of a university teaching hospital in Rome (Italy), by means of the Maslach Burnout Inventory. In total 142 healthcare workers participated in the study. Average levels of emotional exhaustion and depersonalization were observed in the study population. Working in emergency care services was found to be correlated with lower levels of personal accomplishment with respect to working in other services. Monitoring burnout in social service and healthcare workers is an effective tool for identifying critical situations in the workplace.

The future of best investing in vaccines: the Health Technology Assessment approach.

Over the past two decades, scientific research has led to the development of a huge number of new health technologies, among which new vaccines. The decision process underlying the introduction of a new vaccine will be of particular concern in the future and a useful tool is needed to orientate decision makers towards better allocation of economic resources. Health Technology Assessment (HTA) is a multidisciplinary tool that aims to examine the clinical, economic, organizational, ethical, juridical, social and cultural implications of the introduction or the implementation of a specific technology; it could so represent an innovative and effective approach in order to support decision-making processes.

Socio-demographic determinants of coinfections by HIV, hepatitis B and hepatitis C viruses in central Italian prisoners.

BACKGROUND: The coinfections HIV/HCV/HBV are an important health issue in penitentiary communities. The aim of the study was to examine HIV, HBV and HCV coinfections determinants amongst prisoners in the jails of Southern Lazio (Central Italy), in the period 1995-2000. METHODS: Diagnosis of seropositivities for HIV, HBV and HCV was made using ELISA method. A multiple logistic regression analysis was conducted to verify the influence of socio-demographic factors on the HIV/HBV/HCV coinfections. RESULTS: HIV/HCV, HBV/HCV and HIV/HBV coinfections were detected in 42 (4%), 203 (17.9%) and 31 (2.9%) inmates, respectively. These coinfections are significantly associated with the status of drug addiction (OR = 16.02; p = 0.012; OR = 4.15; p < 0.001; OR = 23.57; p = 0.002), smoking habits (OR = 3.73; p = 0.033; OR = 1.42; p = 0.088; OR = 4.25; p = 0.053) and Italian nationality (OR = 7.05; p = 0.009; OR = 2.31; p < 0.001; OR = 4.61; p = 0.04). CONCLUSION: The prevalence of HIV, HBV and HCV seropositivity in jails suggests that information and education programs for inmates could be useful to reduce the spread of such infections.

Influence of reduced air pressure methods on dye penetration in standardized voids.

OBJECTIVE: The objective of this study was to evaluate the influence of the moment when reduced pressure is applied on dye penetration patterns. STUDY DESIGN: Nine hundred and sixty glass capillary tubes of different inner diameter (0.3 mm and 0.8 mm), divided into 48 groups, were submerged into dye in 3 different positions (horizontally, opening upwards, and opening downwards) under different vacuum conditions (passive, 5 kPa, 35 kPa, 70 kPa reduced pressure). When reduced pressure was applied half of the groups were submerged into dye before and half of the groups after the application of reduced pressure. Linear dye penetration was measured. Univariate analysis was performed with Mann-Whitney U test and Kruskal-Wallis test to select variables to be included in the regression model. A multiple logistic regression analysis with backward elimination was performed to assess the influence of different covariates on linear dye penetration. RESULTS: The multivariate linear regression showed that the moment of vacuuming had the greatest positive effect on linear dye penetration value (beta = 10.6, P < .0001). Also the level of pressure reduction had a positive effect on the outcome variable (beta = 0.2, P < .0001) while the vertical positioning of the tubes has negatively affected the outcome variable both for the open end upside (beta = -1.01, P = .024) and the open end downside (beta = -1.05, P = .019). Diameter of the tubes (P = .442) and immersion time (P = .727) had no effect on the outcome of linear dye penetration. CONCLUSIONS: Even minimum air pressure reduction applied before immersion of the specimens allowed the dye to extensively penetrate the voids.

Correlates of HCV seropositivity among familial contacts of HCV positive patients.

BACKGROUND: Determinants of intrafamilial HCV transmission are still being debated. The aim of this study is to investigate the correlates of HCV seropositivity among familial contacts of HCV positive patients in Italy. METHODS: A cross-sectional study was conducted with 175 HCV positive patients (index cases), recruited from Policlinico Gemelli in Rome as well as other hospitals in Central Italy between 1995 and 2000 (40% female, mean age 57 +/- 15.2 years), and 259 familial contacts. Differences in proportions of qualitative variables were tested with non-parametric tests (chi2, Yates correction, Fisher exact test), and a p value < 0.05 was considered significant. A multivariate analysis was conducted using logistic regression in order to verify which variables statistically have an influence on HCV positivity in contact individuals. RESULTS: Seropositivity for HCV was found in 8.9% of the contacts. From the univariate analysis, risk factors significantly associated to HCV positivity in the contacts were: intravenous drug addiction (p = 0.004) and intercourse with drug addicts (p = 0.005). The only variables associated significantly and independently to HCV seropositivity in patients' contacts were intercourse with drug addicts (OR = 19.28; 95% CI: 2.01 - 184.94), the retirement status from work (OR = 3.76; 95% CI: 1.17 - 11.98), the time of the relationship (OR = 1.06; 95% CI: 1.00 - 1.11) and tattoos (OR = 7.68; 95% CI: 1.00 - 60.20). CONCLUSION: The present study confirms that having intercourse with a drug addict is the most significant risk factor for intrafamilial HCV transmission. The association with retirement status from work could be related to both a long-term relationship with an index case and past exposure to common risk factors.