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

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

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

Potential effects of vaccinations on the prevention of COVID-19: rationale, clinical evidence, risks, and public health considerations

IntroductionCoronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), has quickly spread around the world. Areas coveredThis review will discuss the available immunologic and clinical evidence to support the benefit of the influenza, pneumococcal, and tuberculosis vaccines in the context of COVID-19 as well as to provide an overview on the COVID-19-specific vaccines that are in the development pipeline. In addition, implications for vaccination strategies from a public health perspective will be discussed. Expert opinionSome vaccines are being considered for their potentially beneficial role in preventing or improving the prognosis of COVID-19: influenza, pneumococcal and tuberculosis vaccines. These vaccines may have either direct effect on COVID-19 via different types of immune responses or indirect effects by reducing the burden of viral and bacterial respiratory diseases on individual patients and national healthcare system and by facilitating differential diagnoses with other viral/bacterial respiratory disease. On the other hand, a large number of candidate vaccines against SARS-CoV-2 are currently in the pipeline and undergoing phase I, II, and III clinical studies. As SARS-CoV-2 vaccines are expected to be marketed through accelerated regulatory pathways, vaccinovigilance as well as planning of a successful vaccination campaign will play a major role in protecting public health