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BACKGROUND: As a legacy of the large asbestos consumption until the definitive ban in 1992, Italy had to tackle a real epidemic of asbestos related diseases. The Italian National Registry of Malignant Mesotheliomas (ReNaM) is a permanent surveillance system of mesothelioma incidence, with a regional structure. Aims, assignments and territorial network of ReNaM are described, as well as data collection, recording and coding procedures. OBJECTIVES: To describe the Italian epidemiological surveillance system of mesothelioma incidence, to provide updated data about occurrence of malignant mesothelioma in Italy, and to discuss goals, attainments, and expectations of registering occupational cancer. DESIGN: Analysis of data by malignant mesothelioma incident cases surveillance system. SETTING AND PARTICIPANTS: Italy, network of regional sur-veillance system, all Italian regions. MAIN OUTCOME MEASURES: A Regional Operating Centre (COR) is currently established in all the Italian regions, actively searching incident malignant mesothelioma cases from health care institutions. Occupational history, lifestyle habits, and residential history are obtained using a standardized questionnaire, administered to the subject or to the next of kin by a trained interviewer. The extent of dataset, epide-miological parameters, and occupations involved are reported updated at 31.12.2016, and standardized incidence rates are calculated. RESULTS: At December 2016, ReNaM has collected 27,356 malignant mesothelioma cases, referring to the period of incidence between 1993 and 2015. The modalities of exposure to asbestos have been investigated for 21,387 (78%) and an occupational exposure has been defined for around 70% of defined cases (14,818). CONCLUSIONS: The Italian experience shows that epidemiological systematic surveillance of asbestos related diseases incidence has a key importance for assessing and monitoring the public health impact of occupational and/or environmental hazards, programming preventive interventions, including remediation plans and information campaigns, and supporting the efficiency of insurance and welfare system. Monitor-ing the incidence of malignant mesothelioma through a specialized cancer registry is essential to follow-up the health effects of changing modalities and extent of occupational exposures over years and of environmental contamination. Such consolidated surveillance system is recommended also for occupational cancers with low aetiological fraction.

Finkelstein1 invited physicians and researchers interested in mesothelioma to investigate on past usage of talcum powders by affected people. In Italy, asbestos contamination in talc for industrial use has been documented,2 and, as he underlines tremolite contamination at low levels of cosmetic and pharmaceutical talc has been reported in USA by Blount3 and Gordon and colleagues.4 In the Italian National Mesothelioma Register (ReNaM), the analysis of intensive exposure to talc has been evaluated with respect to occupational and environmental history. The catalogue of possible asbestos exposure circumstances (a tool for the interviewers) reports the potential presence of industrial talcs in quarries or mines working activities, in leather tanning and in rubber industries. The use of intensive cosmetic talc for personal use is evaluated by means of a structured questionnaire,5 as reported in the ReNaM guidelines (see https://www.inail.it/cs/internet/docs/all-linee-guida-renam.pdf%3Fsection=attivita, p82, p98, in Italian). In our paper regarding gender differences in mesothelioma epidemiology,6 we have presented figures referring to 21 463 MM cases detected by ReNaM with a diagnosis between 1993 and 2012. Among female case list (6087 cases), 4374 cases (71.9%) have been interviewed for defining exposure. During the interview, 30 MM female cases referred an intensive use of talc in the context of occupational or life habits. For five of them, the regional centre has identified an exposure to asbestos due to intensive talc use, classifying such modality of exposure as ‘leisure activities’ (see ReNaM guidelines5). For the remaining 25 cases, an occupational exposure to asbestos in other working (or familiar or environmental) circumstances has been identified and coded. Registry data such as those provided by ReNaM cannot provide estimates of the mesothelioma risk associated with any particular exposure circumstance. We plan to include talc exposure at work and cosmetic talc usage in the analyses of a case–control study on pleural mesothelioma currently under way. A specific survey to compare and discuss how the modalities of exposure to talc have been evaluated in patients with mesothelioma in countries where epidemiological surveillance systems are active could improve knowledge and support prevention policies.

Objectives The GIOVE Study was aimed to the achievement of allocative efficiency of the budget allocated to the prevention of human papillomavirus (HPV)-induced diseases. An ex-ante determination of the most efficient allocation of resources between screening and multicohort quadrivalent immunisation programmes was followed by the ex-post assessment of the allocative efficiency actually achieved after a 12-month period. Design A bound optimisation model was developed to determine the ex-ante allocative efficiency of resources. The alternatives compared were the screening programme alone and the quadrivalent immunisation with access to screening. A sensitivity analysis was carried out to assess the uncertainty associated with the main inputs of the model. Subsequently, a cohort of girls with a complete recorded vaccination history were enrolled in an observational retrospective study for 18 months to ensure full compliance with the recommended schedule of vaccination (0, 2, 6 months) within a 12-month time horizon. Setting Basilicata region, in the south of Italy. Participants 12 848 girls aged 12, 15, 18 or 25 years. Intervention Immunisation with quadrivalent anti-HPV vaccine. Outcome measures The vaccination coverage rate was considered to be the indicator of the best achievable benefit, given the budgetary constraints. Results Assuming a vaccine price of €100 per dose, a vaccination coverage rate of 59.6% was required for the most effective allocation of resources. The optimal rate of coverage was initially in favour of the multicohort strategy of vaccination against HPV (72.8%±2%). When the price paid for the quadrivalent vaccine dropped to €85 per dose, the most efficient coverage rate (69.5%) shifted closer to the immunisation rate actually achieved during the 12-month observation period. Conclusions The bound optimisation model demonstrated to be a useful approach to the ex-ante allocation and the ex-post assessment of the resources allocated to the implementation of a multicohort quadrivalent anti-HPV vaccination programme., Article summary Article focus At present, screening and immunisation are cost–effective strategies to reduce the death toll of cervical HPV-related malignancies, which in Italy alone amounts to 1200 women per year. While there are no evidences to reduce the coverage of screening in favour of a wider coverage of immunisation, the adoption of a multicohort strategy of vaccination would allow a larger proportion of the female population aged between 12 and 25 years to be immunised in a shorter period of time (6–8 years). A bound optimisation model was developed to determine the allocative efficiency of the resources used for the screening and the vaccination programmes. Subsequently, an observational retrospective study was carried out to verify the degree of allocation efficiency actually attained after implementation of the multicohort immunisation programme. Key messages Using a vaccine price of €100 per dose, a coverage rate of 59.6% was required for the most effective allocation of resources. A sensitivity analysis showed that when the price was reduced to €85 per dose, the most efficient coverage rate increased to 69.5%. A vaccination coverage rate of 72.8%±2.0% was observed. Although statistically significant, the observed inefficiency was progressively reducing from 21% in the July 2007 to August 2008 period to 5% after September 2008, when the vaccine price was reduced to €85 per dose. The bound optimisation model demonstrated to be a useful approach to assess the allocative efficiency of the resources budgeted to the implementation of a multicohort quadrivalent anti-HPV vaccination programme. Strengths and limitations of this study The relevance of this study is enhanced by its internal validity: the sample size was significant (over 12 000 girls enrolled) and coherent (all subjects enrolled were coming from the same region); the observation time allowed to cover the entire immunisation cycle; individual data related to vaccination (including all costs incurred) were complete and accurate (provided by the Regional Health Authority); the bound optimisation model adequately described the available competing choices: immunisation versus screening. The bound optimisation model is subject to the condition that the programmes evaluated are completely divisible, with constant return to scale and that every subject included receives a fraction of the total expected benefit. Nonetheless, these limitations do not seem to affect the generalisability of the research outcomes.

Background The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy. Methodology/Principal Findings The reference population comprises around 3 million infants vaccinated in Italy in the study period 1999–2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1–23 months were identified through the death certificates. Vaccination history was retrieved from immunisation registries. Association between immunisation and death was assessed adopting a case series design focusing on the risk periods 0–1, 0–7, and 0–14 days after immunisation. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR = 1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0–7 and 0–14 were 2.0 (95% CI 1.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR = 2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined. Conclusions The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates in Germany. The limited increase in RRs found in Italy appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age.