Antonio Boccia

The efficacy of influenza vaccine for healthy children: a meta-analysis evaluating potential sources of variation in efficacy estimates including study quality.

Background: Two systematic reviews evaluating influenza vaccine efficacy in healthy children have recently been published. Although quantitative summary estimates were similar, authors’ conclusions were quite contrasting. We carried out another meta-analysis reevaluating study inclusion criteria and using metaregression techniques in addition to sensitivity and subgroups analyses to evaluate potential sources of heterogeneity of efficacy estimates, including methodologic quality of studies. Methods: Only randomized clinical studies assessing the efficacy of influenza vaccine in healthy children/adolescents (age ≤18 years) for preventing naturally occurring influenza and/or acute otitis media cases were included. Summary estimates of effect were obtained using a random effects model. The methodologic quality of each study was assessed using 3 systems: Chalmers scale, Jadad scale and Schulz components (randomization, allocation concealment and double-blinding). Results: The overall vaccination efficacy was 36% (95% confidence interval: 31–40%) against clinically diagnosed illnesses (evaluated by 19 randomized clinical studies for a total of 247,517 children); 67% (51–78%) against laboratory-confirmed cases (18 trials, n = 8574); and 51% (21–70%) against acute otitis media (11 trials, n = 11,349). Significant sources of between-study heterogeneity were participants’ age and study quality both directly correlated with the efficacy. When the analysis was performed excluding USSR studies, the overall efficacy of the vaccine in preventing clinical cases substantially increased (from 36% to 61%). Conclusions: These findings may indicate that the vaccine efficacy might be greater than the overall estimates. Although no safety and cost considerations are addressed in this analysis, the present findings support vaccination as a possible option for the prevention of influenza in healthy children and adolescents.

Oral contraceptives and venous thromboembolism: a systematic review and meta-analysis.

AbstractBackground: An association between oral contraceptive (OC) use and venous thromboembolism (VTE) has long been recognized. However, no summary estimates of the increase in VTE risk associated with OC use have been available since 1995, and no meta-analyses have evaluated the VTE risk of new preparations containing drospirenone. Objective: The aim of the study was to carry out a meta-analysis to summarize existing evidence on the association between venous VTE and OC use, and to investigate how such an association may vary according to the type of OC, OC user characteristics, study characteristics and biases. Methods: Relevant cohort or case-control studies were searched in MEDLINE and other electronic databases up to May 2010, with no language restriction. Data were combined using a generic inverse-variance approach. Meta-regression in addition to stratification was used to explore potential predictors of the summary estimate of risk. Results: Sixteen cohort and 39 case-control studies were included in at least one comparison. Overall, the odds ratio (OR) of OC users versus non-users was 3.41 (95% CI 2.98, 3.92). This estimate was based upon nine cohort studies evaluating approximately 12 000 000 person-years, and 23 case-control studies including approximately 45 000 women. VTE risk for OC users was significantly lower in studies evaluating ‘all VTE cases’ than in those evaluating ‘idiopathic VTE only’ (OR 3.09 and 4.94, respectively). Among the carriers of genetic mutations G20210A and Factor V Leiden (FVL), OC users showed a significantly increased VTE risk compared with non-users (OR 1.63; 95% CI 1.01, 2.65, and OR 1.80; 95% CI 1.20, 2.71, respectively). When the newest OCs containing drospirenone were compared with non-drospirenone-containing OCs (except those containing levonorgestrel only), VTE risk did not significantly increase (OR 1.13; 95% CI 0.94, 1.35). Conclusions: This meta-analysis confirms that OC use significantly increases VTE risk. The strength of this association, however, varies according to the generation of OC, type of outcome and presence of a genetic mutation, with ORs ranging from 3 to 5.

The evaluation of the microbial safety of fresh ready-to-eat vegetables produced by different technologies in Italy

Aims:  The study was performed to evaluate the safety of whole and RTE vegetables and to investigate the effectiveness of different preventive strategies for the quality assurance of RTE vegetables collected from three Italian production systems. Producer 1, applied a strict system in compliance with GAP‐ GMP – HACCP, Producer 2 used chlorine disinfection at a second washing step, and Producer 3 using a physical microbial stabilization.

Immunogenicity and adverse events of avian influenza A H5N1 vaccine in healthy adults: multiple-treatments meta-analysis.

Influenza H5N1 is thought to be a likely causative agent for a future human influenza pandemic. Several types of H5N1 vaccine have been tested, including different doses and adjuvants, and a meta-analysis is needed to identify the best formulation. We searched Medline, Embase, the Cochrane Library, and other online databases to February, 2009, in any language for randomised trials comparing different H5N1 vaccines with or without placebo in healthy adults. Primary outcomes were seroconversion, seroresponse, or both according to haemagglutination-inhibition and microneutralisation. Secondary outcomes were adverse events. Because of the large number of compared formulations, multiple-treatments meta-analysis was used for primary outcomes. Direct-comparison meta-analyses were also done. We included 13 trials, which assessed 58 groups. With non-aluminium adjuvant, sufficiently high immunogenicity (greater than 70%) was achieved even at 12 microg or less (given as two doses of 6 microg or less), and higher doses did not provide major improvements. Immunogenicity for non-adjuvanted and aluminium-adjuvanted formulations increased with increasing dose, but was not sufficiently high. No serious vaccine-related adverse events were reported across 9600 participants. Currently, H5N1 influenza vaccines with non-aluminium adjuvants might represent the best available option in a pandemic. Large-scale studies are needed to verify the high immunogenicity of non-aluminium-adjuvanted vaccines that use very low doses of antigen.

Economic evaluation of Varicella vaccination: results of a systematic review

Introduction: The aim of the present study is to review the economic burden of varicella disease and the benefit of universal varicella vaccination in different settings pending its implementation in all Italian regions. Materials and Methods: Research was conducted using PubMed, Scopus and ISI databases. Score quality and data extraction were performed for all included studies. Results: Twenty-three articles met the criteria: 15 cost-effectiveness, 8 cost-benefit and one cost-utility analysis. Varicella vaccination could save the society from €637,762 (infant strategy) to 53 million annually (combined infant and adolescent strategy). The median and the mean quality scores resulted in 91.8% and 85.4% respectively; 11 studies were considered of high quality and 12 of low quality. Discussion: The studies are favorable to the introduction of universal varicella vaccination in Italy, being cost saving and having a positive impact on morbidity. The quality score of the studies varied greatly: recent analyses were of comparable quality to older studies.

Prevalence of influenza vaccination among nurses and ancillary workers in Italy: Systematic review and meta analysis

Introduction: Italian Ministry of Health, recommends vaccination for seasonal influenza to all healthcare workers (HCW), particularly to nurses who have an important interaction with patients. The aim of this study is to conduct a systematic review in order to estimate the pooled prevalence of influenza vaccinations among nurses and ancillary workers in Italy and analyse the enhancing and hindering factors. Results: The review was performed using 15 articles, six containing the prevalence of vaccination for nurses and ancillary workers, while the others qualitative analysis. In all the selected articles the score calculation has been carried out by using a protocol for observational studies. The nurses and ancillary workers pooled proportion of influenza vaccination was respectively 13,47% (95%CI 9,58-17,90%) and 12,52% (95%CI 9,97-15,31%). Discussion: The Italian mean of influenza vaccination prevalence appear low if compared to other European countries, ranging from 15% to 29% in Countries such as UK, Germany, France. This situation of weakness should be seen as an opportunity to improve the vaccination rate for seasonal influenza significantly This should be done by intervening on the category which affirms caring less. In fact, this category has a priority to receive vaccination, due to their numbers and closer contact to patients. Methods: Research was conducted using medical database Scopus, PubMed, the search engine Google Scholar and ISI web of knowledge, and was concluded February 1st 2011.

Hepatitis C Virus Infection Trends in Italy, 1996-2006

Background The World Health Organization (WHO) estimates that about 180 million people, 3% of the world population, are infected with the hepatitis C virus (HCV). In Italy, the prevalence in the general population is reported to be greater than 5% and 9% among households of HCV-positive patients. Objectives The aim of this study was to estimate the trends of HCV infection in Italy in the period 1996–2006. Materials and Methods The formula ln (rate) = b × years was applied for logarithmic transformation of the incidence rates to obtain time trends of HCV infection, using the join-point regression program software version 3.3.1. Linear graphs representing trends and the annual percentage change (APC) were considered for each joinpoint. Time changes are expressed as expected annual percentage change (EAPC) with the respective 95% confidence intervals (CIs); significance levels of time trends are also reported. The null hypothesis was tested using a maximum of 3 changes in slope with an overall significance level of 0.05 divided by the number of joinpoints in the final model. Results Considering all age groups, the incidence rate decreased from 2.02 to 0.55 per 100,000. The join-point analysis showed a statistically significant decrease in the incidence rates of HCV infection. No join-points were found in any age groups. Our data show that the incidence rates of HCV infections have considerably decreased in each age group throughout the studied period (1996–2006). Conclusions This decreasing trend in HCV infections is, in part, attributable to behavioral and social changes. Improved hygiene, use of precautions in medical settings, blood screening, and sexual educational campaigns seem to have contributed to reduce the transmission of infection during the last 10 years.

Routine Preoperative Investigation: Results of a Multicenter Survey in Italy

We conducted a study to acquire information on the current behavior of a sample of Italian surgeons and anesthesiologists about prescribing, interpreting, and using routine preoperative investigations. Consultants in surgery and anesthesiology in 60 hospitals in northern, central, and southern Italy were interviewed. Prescription of these procedures by doctors were driven more by personal experience than by updated scientific knowledge. This practice often led to ineffective and inefficient clinical practice, with healthy patients undergoing useless, time-consuming, costly, and sometimes harmful procedures.

Knowledge, Attitudes, and Smoking Behaviours among Physicians Specializing in Public Health: A Multicentre Study

Background. Healthcare professionals have an important role to play both as advisers—influencing smoking cessation—and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS) approach. Materials and Methods. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance), therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors). The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P ≤ 0.05. Results. A total of 388 answered the questionnaire on the website (85%), of which 81 (20.9%) declared to be smokers, 309 (79.6%) considered health professionals as behavioural models for patients, and 375 (96.6%) affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7%) heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. Conclusions. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

Quality of life among healthcare workers: a multicentre cross-sectional study in Italy.

OBJECTIVE To evaluate the quality of life among doctors, nurses, and occupational safety and health technologists (OSHT). STUDY DESIGN Cross-sectional study was undertaken in a population of healthcare workers in 10 Italian regions. METHODS The Italian version of short form-36 (SF-36) was anonymously and voluntarily self-administered by participants to assess the perceived health-related quality of life (HRQOL). The HRQOL scores for the sample and the Italian population were compared. A multiple linear regression was performed to assess the influence of age, gender, role, socializing time, working time, years spent in healthcare and years spent in the specific department on the SF-36 score. RESULTS The sample included 324 healthcare workers [57.1% women, mean age 39.0 (standard deviation 10.2) years]: 52.6% were medical doctors, 36.8% were nurses and 10.5% were OSHTs. Workers with a career of >15 years achieved a general health score lower than that of workers with a shorter career, while those who spent more time in socializing activities achieved a higher mental health score. The multivariate analysis showed that increasing age is positively related to role emotional levels (β = 0.243; P = 0.002), while it appears to be inversely related to general health (β = -0.218; P = 0.007) and physical function (β = -0.246; P = 0.001). Nurses had lower scores for bodily pain (β = -0.214; P < 0.001), social function (β = -0.242; P = 0.001) and role emotional (β = -0.211; P = 0.006) compared with doctors. Compared with the general Italian population, healthcare workers had higher scores for general health, physical function, role physical, bodily pain and mental health, and lower scores for vitality, social function and role emotional. CONCLUSIONS Healthcare workers have different levels of HRQOL related to their professional role. In particular, nurses have lower quality of life. These results may help to identify the main roles and attitudes that could cause frustration, dissatisfaction and emotional stress in healthcare workers.