Giulia Carreras

Is human papillomavirus screening preferable to current policies in vaccinated and unvaccinated women? A cost-effectiveness analysis

Objectives Italy was the first European nation to offer free vaccination against human papillomavirus (HPV) types 16 and 18. The vaccination is actively encouraged and is available free of charge to 11-year-old girls. The introduction of new technologies such as HPV DNA testing and HPV vaccination requires cost-effectiveness analysis of cervical cancer strategies in Italy for both vaccinated and unvaccinated women. Methods A calibrated Markov model was developed to describe the natural history of HPV infection and cervical carcinogenesis. We performed a microsimulation generating the life histories of 10 million women. Changes in these life histories occur as consequences of prevention strategies. We estimated costs of screening activities using an activity-based costing analysis. We assessed lifetime risk due to cervical cancer, lifetime costs and quality-adjusted life-expectancy (QALE) for 18 scenarios. Strategies varied by screening interval (three and five years), primary and triage test (Pap test and HPV DNA test), and HPV 16 and 18 vaccination. Results The current screening policy (Pap test every three years) is more costly and less effective than HPV DNA test and Pap test triage every five years. For unvaccinated women an HPV DNA test every five years with a Pap test triage was cost-effective (ICER €5753/QALE). Vaccination followed by the same screening strategy was cost-effective (ICER €23,951/QALE) for women who are eligible to be vaccinated. Conclusions Our findings strongly support changing the Pap screening policy to the use of HPV DNA as a primary test with Pap test triage for both vaccinated and unvaccinated women.

Italy SimSmoke: the effect of tobacco control policies on smoking prevalence and smoking attributable deaths in Italy

BackgroundWhile Italy has implemented some tobacco control policies over the last few decades, which resulted in a decreased smoking prevalence, there is still considerable scope to strengthen tobacco control policies consistent with the World Health Organization (WHO) policy guidelines. The present study aims to evaluate the effect of past and project the effect of future tobacco control policies on smoking prevalence and associated premature mortality in Italy.MethodsTo assess, individually and in combination, the effect of seven types of policies, we used the SimSmoke simulation model of tobacco control policy. The model uses population, smoking rates and tobacco control policy data for Italy.ResultsSignificant reductions of smoking prevalence and premature mortality can be achieved through tobacco price increases, high intensity media campaigns, comprehensive cessation treatment program, strong health warnings, stricter smoke-free air regulations and advertising bans, and youth access laws. With a comprehensive approach, the smoking prevalence can be decreased by as much as 12% soon after the policies are in place, increasing to a 30% reduction in the next twenty years and a 34% reduction by 30 years in 2040. Without effective tobacco control policies, a total of almost 300 thousand lives will be prematurely lost due to smoking by the year 2040.ConclusionBesides presenting the benefits of a comprehensive tobacco control strategy, the model helps identify information gaps in surveillance and evaluation schemes that will promote the effectiveness of future tobacco control policy in Italy.

Estimating the probabilities of making a smoking quit attempt in Italy: stall in smoking cessation levels, 1986-2009

BackgroundNo data on annual smoking cessation probability (i.e., the probability of successfully quit in a given year) are available for Italy at a population level. Mathematical models typically used to estimate smoking cessation probabilities do not account for smoking relapse. In this paper, we developed a mathematical model to estimate annual quitting probabilities, taking into account smoking relapse and time since cessation.MethodsWe developed a dynamic model describing the evolution of current, former, and never smokers. We estimated probabilities of smoking cessation by fitting the model with observed smoking prevalence in Italy, 1986-2009.ResultsAnnual cessation probabilities were higher than 5% only in elderly persons and in women aged < 30 years, while in adults aged 30-49 and 50-59 cessations were about 2% and 3-5%, respectively. Most of quit probabilities stalled from 1986 to 2009.ConclusionsOver the last 20 years, cessation probabilities among Italian smokers, particularly for those aged 30-59 years, have been very low and stalled. Quitting in Italy is considered as a practicable strategy only by women in the age of pregnancy and by elderly persons, when it’s likely that symptoms of tobacco-related diseases have already appeared. In order to increase cessation probabilities, smoking cessation treatment policies (introducing total reimbursement of cessation treatments, with a further development of quitlines and smoking cessation services) should be empowered and a country-wide mass media campaign targeting smokers aged 30-59 years and focusing on promotion of quitting should be implemented.

Time Trends of Italian Former Smokers 1980-2009 and 2010-2030 Projections Using a Bayesian Age Period Cohort Model

This study aimed to describe past time trends of the prevalence of former smokers in Italy and to estimate prevalence projections using a Bayesian approach. An age-period-cohort (APC) analysis has been carried out in order to investigate the effect of the age, period and birth cohort on the prevalence of former smokers during 1980–2009. A Bayesian APC model with an autoregressive structure for the age, period and cohort parameters has been used to estimate future trends. Results showed that awareness of harm from smoking occurred at younger ages with each advancing cohort, and that women were more likely to attempt to stop smoking during pregnancies and breastfeeding, whereas men attempted to quit only when smoking-related diseases became evident. Projections of future trend recorded a further increase in the number of former smokers in future decades, showing an estimate of the “end of smoking” around years 2060 and 2055 in men and women, respectively. The application of the APC analysis to study the prevalence of former smokers turned out to be a useful method for the evaluation of past smoking trends, reflecting the effects of tobacco control policies on time and generations, and to make projections of future trend.

The Pap smear screening as an occasion for smoking cessation and physical activity counselling: baseline characteristics of women involved in the SPRINT randomized controlled trial

BackgroundGender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population.Methods/DesignAmong women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants.DiscussionOut of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit.Trial registration numberISRCTN: ISRCTN52660565

The Pap smear screening as an occasion for smoking cessation and physical activity counselling: effectiveness of the SPRINT randomized controlled trial

BackgroundThe organized Cervical Cancer Screening Programme (CCSP) in Italy might represent an occasion to deliver smoking cessation (SC) counselling to women attending the Pap test examination. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to SC counselling is not strong.Objective of the SPRINT trial was to evaluate the effectiveness of a standard SC counselling intervention delivered by trained midwives in the CCSP, and whether the adjunct of a PA counselling to the SC counselling might increase quit rates.Methods/DesignWe undertook a randomized controlled trial of 1,100 women undergoing the Pap examination in the three study centres Florence, Turin, and Mantua: 363 were randomly assigned to the SC counselling arm, 366 to the SC + PA counselling arm, and 371 to the control group. The intervention was a standard brief SC counselling combined with a brief counselling on increasing PA, and was tailored according to the Di Clemente-Prochaska motivational stages of change for SC and/or PA. Primary outcomes were quit rates, improvement in the motivational stages of change for SC, and reduced daily cigarette consumption. Analysis was by intention to treat.ResultsParticipants randomized in both intervention arms and in the preparation stage of change for SC doubled their likelihood of quitting at 6-month follow-up in comparison to controls (odds ratio [OR]=2.1, 95% confidence interval [95% CI]:1.0-4.6). Moreover, participants in the intervention arms and in the contemplation stage were more likely to reduce their daily cigarette consumption after the intervention (OR=1.8, 95% CI:1.1-3.0). Our study did not show any effect of PA counselling on various outcomes.ConclusionsSmoking cessation counselling delivered by midwives to smokers in preparation and contemplation stages of change during the Pap-smear screening was effective and should be recommended, given the high number of women attending the cervical cancer screening programme in Italy. Moreover, the daily number of women invited for the Pap-smear examination should be slightly lowered, in order to let midwives deliver SC counselling to smokers.Trial registrationCurrent Controlled Trials ISRCTN52660565

Reduction of risk of dying from tobacco-related diseases after quitting smoking in Italy

Aims and Background The aims of this paper are to compute the risks of dying of ischemic heart disease (IHD), lung cancer (LC), stroke, and chronic obstructive pulmonary disease (COPD) for Italian smokers by gender, age and daily number of cigarettes smoked, and to estimate the benefit of stopping smoking in terms of risk reduction. Methods Life tables by sex and smoking status were computed for each smoking-related disease based on Italian smoking data, and risk charts with 10-year probabilities of death were computed for never, current and former smokers. Results Men aged 45-49 years, current smokers, have a 8, 10, 3 and 1 in 1,000 chance of dying of IHD, LC, stroke and COPD, respectively, whereas women with the same characteristics have a 2, 6, 3 and 1 in 1,000 chance, respectively, for all smokers combined, i.e., independent of the smoking intensity. The risk reduction rates from quitting smoking are remarkable: a man who quits smoking at 45-49 years can reduce the risk of dying of IHD, LC, stroke and COPD in the next 10 years by 43%, 53%, 57% and 55%, respectively; a woman by 49%, 49%, 59% and 57%, respectively. Conclusions Estimates of risk reduction by quitting smoking are useful to provide a sounder scientific basis for public health messages and clinical advice.

Analyzing and Comparing the Association Between Control Policy Measures and Alcohol Consumption in Europe

This paper focuses on the association between alcohol consumption and the introduction of control policy measures, within the AMPHORA 12 country European project. We estimated the “net” associations between intervention policies and total alcohol consumption, taking into account contextual socioeconomic factors and including all policies in the same regression model. The associations were estimated for each country, and the country-specific results were compared in a random-effects meta-analysis. The association between policy measures and total alcohol consumption was very heterogeneous among countries. Policies on restricting alcohol availability and on enhancing the minimum age for alcohol purchase appeared to be related to decreasing alcohol consumption. The evidence regarding the effect of the others kinds of interventions was more contradictory.

Bayesian probabilistic sensitivity analysis of Markov models for natural history of a disease: an application for cervical cancer

Background : parameter uncertainty in the Markov model’s description of a disease course was addressed. Probabilistic sensitivity analysis (PSA) is now considered the only tool that properly permits parameter uncertainty’s examination. This consists in sampling values from the parameter’s probability distributions. Methods : Markov models fitted with microsimulation were considered and methods for carrying out a PSA on transition probabilities were studied. Two Bayesian solutions were developed: for each row of the modeled transition matrix the prior distribution was assumed as a product of Beta or a Dirichlet. The two solutions differ in the source of information: several different sources for each transition in the Beta approach and a single source for each transition from a given health state in the Dirichlet. The two methods were applied to a simple cervical cancer’s model. Results : differences between posterior estimates from the two methods were negligible. Results showed that the prior variability highly influence the posterior distribution. Conclusions : the novelty of this work is the Bayesian approach that integrates the two distributions with a product of Binomial distributions likelihood. Such methods could be also applied to cohort data and their application to more complex models could be useful and unique in the cervical cancer context, as well as in other disease modeling.

Can a national lung cancer screening program in combination with smoking cessation policies cause an early decrease in tobacco deaths in Italy

Objective is to predict smoking attributable deaths (SAD) for lung cancer and all causes in Italy, 2015 to 2040, assuming a yet unimplemented tobacco control policies (TCP) and a national, low-dose, lung cancer, computed tomography (CT) annual screening program (CT screen). A dynamic model describing the evolution of smoking habits was developed to estimate quit rates, 1986 to 2009, and to predict SAD under different scenarios: keeping the status quo; raising cigarette taxes by 20%; implementing cessation treatment policies (funding treatment, setting up an active quitline, promoting counseling among health professionals); introducing a three-round annual CT screen for current and former heavy smokers aged 55 to 74, 70% compliance, 20% lung cancer mortality reduction; combining all the above-mentioned measures. The CT screen brought a 3.0% constant annual reduction in lung cancer SAD and decreased or postponed all-cause SAD by 1.7% annually (a half due to respiratory diseases), relative to the status quo scenario. The effect was noticeable after few years from its introduction. TCP showed a steadily strengthening effect starting from 5 to 10 years after implementation. The lung cancer and all-cause SAD under cessation treatment policies, for instance, were reduced by 8.4% and 12.0% in 2030, respectively, and by 16.1% and 20.0% in 2040. TCP gave a greater effect than CT screen in reducing all-cause SAD because cessation brought about a reduction in smoking-related SAD other than lung cancer and respiratory diseases. Combining TCP and CT screen could bring about an early decrease in lung cancer and respiratory disease SAD due to CT screen, followed by a more substantial drop in all-cause SAD in subsequent decades due to TCP. Cancer Prev Res; 5(6); 874–82. ©2012 AACR.