Development of a weighted scale to assess the quality of cost-effectiveness studies and an application to the economic evaluations of tetravalent HPV vaccine

Aim: Interest in the quality of economic analyses is increasing in the field of decision-making. Drummond's checklist is a useful tool. This study aimed to use a weighted version of Drummond’s checklist together with a consensus of experts to derive a new scoring system to improve the evaluation of economic analyses of tetravalent human papillomavirus (HPV) vaccine as a case study. Methods: Drummond's checklist is composed of 35 items divided into 3 sections: study design, data collection and analysis and interpretation of results. To weight the items, a group of experts was asked to attribute a score according to their importance. A bibliographic search of economic evaluations of tetravalent HPV vaccine was performed. Two researchers assessed the quality of selected studies according to the original and weighted checklist. Results: The weighted scores assigned by the consensus to study design, data collection and analysis and interpretation of results were 26, 45 and 48, respectively. Thirteen papers were included in the review of economic evaluations of tetravalent HPV vaccine. According to the weighted Drummond's checklist, their median quality score was 74 with a maximum of 119. The highest score was reached in the study design section. Conclusion: According to the weighted Drummond's checklist, studies were judged to be of medium quality. The main pitfalls were found in issues assigned the highest scores by the consensus, underlying the utility of weighting available checklists to improve the estimate of the quality of economic analyses. The weighted checklist could be thus proposed as a scoring tool to assess the quality

Cost-effectiveness analysis of different seasonal influenza vaccines in the elderly Italian population

In the perspective of reaching at least 75% influenza vaccination coverage in the elderly and substantial budget constraints, Italian decision makers are facing important challenges in determining an optimal immunization strategy for this growing and particularly vulnerable population. Four different influenza vaccines are currently available for Italian older adults aged 65 years or above, namely trivalent inactivated vaccines (TIVs), MF59-adjuvanted TIV (MF59-TIV), intradermal TIV (ID-TIV) and quadrivalent inactivated vaccines (QIVs). The present study is the first to compare the cost-effectiveness profiles of virtually all possible public health strategies, including the aforementioned four vaccine formulations as well non-vaccination. For this purpose, a decision tree model was built ex novo; the analysis was conducted from the third-payer perspective in the timeframe of one year. All available vaccines were cost-effective compared with non-vaccination. However, MF59-TIV had the most favorable economic profile in the Italian elderly population. Indeed, compared with non-vaccination, it was deemed highly cost-effective with an incremental cost-effectiveness ratio (ICER) of \u20ac10,750 per quality-adjusted life year (QALY). The ICER was much lower (\u20ac4,527/QALY) when MF59-TIV was directly compared with TIV. ID-TIV and QIV were dominated by MF59-TIV as the former comparators were associated with greater total costs and lower health benefits. Both deterministic and probabilistic sensitivity analyses confirmed robustness of the base case results. From the economic perspective, MF59-TIV should be considered as a preferential choice for Italian older adults aged 65 years or above

EBPH is Back for a Global Audience

We are proud to announce the re-starting of the Journal Epidemiology Biostatistics and Public Health (EBPH), made possible thanks to the Milano University Press (MUP), the new publisher of the journal

Prevalence, socio-economic predictors and health correlates of food insecurity among Italian children- findings from a cross-sectional study

AbstractConsidering food insecurity is a problem, even in developed countries, and the evidence gap regarding this issue in Italy, we aimed to assess the prevalence of food insecurity in a sample of Italian children and examine socio-economic and health correlates. This cross-sectional study was conducted in paediatric practices. Parents answered to the 18-items of the Household Food Security Module, 8 of which concern children. Paediatricians answered a questionnaire on children's health. Socio-economic and health correlates of food insecurity in children were assessed using univariable and multivariable logistic regression. Among 573 households with children, 15·4% were food insecure, while 9·1% of children were food insecure. Socio-economic factors associated to food insecurity were living in south Italy, households with three or more children, lower household yearly income, worse economic situation description and younger parents. Food insecure children were less likely to have a normal relational [ aOR 0.31 (CI 0.11-0.85)] and physical development [aOR 0.32(CI 0.15-0.65) and had more school difficulties [aOR 3.1(CI 1.33-7.24)] compared to their food secure peers. Food insecure children had higher odds of a deterioration in their health since birth and of a worse perceived health status, as reported by their parents. Considering the results in this sample and the lack of research regarding this issues in Italy and Europe more broadly, we call for consistent, national monitoring to determine the magnitude of the problem of food insecurity in households with children in Italy and to examine the socio-economic variables and health implications in different contexts

Does the use of dietary supplements enhance athletes’ sport performances? A systematic review and a meta-analysis

Background: The consumption of dietary supplements has increased in recent years. Despite their widespread use, there is confusion about effects on sport performances. The aim of this study was to investigate association between use of supplements and enhance of athletes’ sports performance. Methods: A review and a meta-analysis of studies conducted on Dietary Supplements and Sports between 2003 and 2013 were performed. Enhancement on sport performances was considered as outcome. The following aspects related to enhancement were considered: ergogenic effect (EE), time to exhaustion (TTE), muscular endurance (ME), post-exercise recovery (PER) and body mass (BM). With respect to meta-analysis, data on level of post Exercise Glucose (GpE [mg/dL]) and level of post exercise Lactate (LpE [mmol/L]) were considered as  indicators of TTE, PER and EE. Similarly, Change in Body Mass (CBM) [kg] was used as indicator of BM. Results: The most investigated dietary supplements were: Creatine, Carbohydrates, Beta-alanine, Proteins. The qualitative analysis evaluating the effect of supplements on sports listed by the International Olympic Committee has achieved interesting results: supplements didn’t show statistically significant effects when compared to placebo in more than 48% of papers. For the quantitative analysis, 15 studies were considered. The meta-analysis showed that there was no significant effect of Beta-alanine, Creatine and Carbohydrates on LpE and GpE. Furthermore, a non-significant increase in BM was observed in athletes undergoing Creatine compared to placebo. Conclusion: Considering the increasing attention to this topic, it would be interesting to investigate the existing awareness about effectiveness and possible risks of supplements

23-valent pneumococcal polysaccharide vaccine (PPV23) for the prevention of invasive pneumococcal diseases (IPDs) in the elderly: is it really effective?

Introduction. Incidence of invasive pneumococcal diseases (IPDs) in Italy is constantly increasing and that is particularly true among the elderly. 23-valent polysaccharide pneumococcal vac- cine (PPV23) is recommended to this age group and offered in all Italian regions. However, efficacy of PPV23 on preventing IPDs is debated. We therefore performed a review of the most recent avail- able meta-analyses in order to assess the efficacy of PPVs. Methods. The literature search was conducted using PubMed and Scopus search engines. We used the following keywords: ?pneu- mococcal?, ?polysaccharide?, ?vaccine?, ?efficacy?, ?elderly?, ?meta analysis?. Only meta-analyses published in the last 7 years were selected. We examined the results of the selected meta-anal- yses and assessed their quality according to the PRISMA recom- mendations. Results. The search returned 16 results in PubMed and 12 in Scopus: among them we selected 3 meta-analyses. According to our quality assessment, all meta-analyses showed generally posi- tive results and almost all items of the PRISMA checklist were respected. However, the research protocol and the registration number were absent in all the 3 revisions and the flow-chart was not shown in Moberley?s and Melegaro?s works. In the study by Huss et al. the relative risk of developing IPDs among vaccinated subjects was 0.90 (95%CI: 0.46-1.77, I2 4.9%), indicating a very slight benefit after vaccination. This contrasts with the results of the Cochrane Review by Moberley et al., in which the PPVs showed a protective efficacy in reducing the risk of IPDs of 74% (OR 0.26, 95%CI: 0.15-0.46) with no statistical heterogeneity (I2 0%). Melegaro et al. found a reduction not statistically signifi- cant of the incidence of IPD of 65% (OR 0.35; 95%CI 0.08-1.49) among healthy elderly, while the global estimate of vaccine efficacy among high risk elderly was minimal (OR 0.80; 95%CI 0.22-2.88). Conclusions. Most of the studies suggest that the PPVs confer low protection against IPDs. Anyhow, their methodological het- erogeneity does not allow definitive conclusions. While waiting to see the results of new trials about the efficacy of PPVs, in particular of PPV23, and the extension of the use of conjugate vaccine among the population over 65, stakeholders should be aware of the results of the meta-analyses discussed in this paper during the implementation of the vaccination programs for the elderly in Public Health. The full article is free available on www.jpmh.or

Human Papilloma Virus (HPV) vaccination in Italy: towards new perspectives and new challenges

Human Papilloma virus (HPV) is the cause of a sexually transmitted infection which can lead to the development of genital warts, anogenital and oropharyngeal cancers. In Europe, about 90% of HPV-related cancers and 90% of genital warts are estimated to be vaccine preventable each year. In Italy, around 5,000 cases of cancers are due to HPV infections each year. This explains why HPV infection control is considered a public health priority

Strategies to achieve HPV-related disease control in Italy: results from an integrative approach

Background: achieving Human Papilloma Virus (HPV) - related diseases control is an important challenge in public health. In Italy HPV vaccination uptake does not rise a sufficient level. The aim of this project is to identify strategies to promote HPV vaccination in Italy.  Methods: an integrated approach consisting of a systematic review and a two-step panel consultation was used to identify strategies to increase vaccination uptake among adolescents, population target of the national vaccination program, and to promote vaccination in additional targets. Overall, ten experts in the fields of Gynecology, Public Health, General Practice and Pediatrics were involved along with Patients representatives. Recommendations were elaborated according to a set of criteria drawn from the Evidence to Decision (EtD) framework.  Results: the systematic review led to the identification of three categories of strategies: reminds, education and multicomponent approaches respectively. A strong recommendation was formulated to use reminds tailored to vaccine recipients or their parents, and a moderate recommendation to use reminds directed to health professionals. A moderate recommendation was developed on the implementation of multicomponent interventions. A strong recommendation was yielded with respect to the promotion of HPV vaccination among women already treated for HPV-related diseases, fertile women not previously vaccinated and 25 year-old women undergoing cervical cancer screening. Lastly, a strong recommendation was formulated for catch-up initiatives targeted to women and men turning 18 years of age.  Conclusion: this project led to the identification of several valuable strategies to improve HPV vaccination and strengthen HPV-related diseases control at national level.&nbsp

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

Abstract 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 ≥25 age groups, respectively. Nevertheless no joinpoints were found for age groups 15–24 and ≥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.</p