Population model

The population evolves over time due to deaths and births. Sex and age-specific population data for the year 1999 were available from the Italian Institute of Statistics (http://www.istat.it). Since the data were presented by age group, the data were smoothed to obtain individual ages. Mortality by age and gender and fertility rates by age come from ISTAT for the year 2005. Projections from the model keep population roughly constant, consistent with data and projected population increases from ISTAT.

Smoking model

Within the smoking model, individuals are classified as never smokers from birth until they initiate smoking or die. They may evolve from current to former smokers through cessation or may return to current smokers through relapse. The extent of relapse depends on the number of years since quitting.

Smoking prevalence data for the period 1999–2009 were available from the Multipurpose Surveys “Aspects of daily living”, carried out from 1993 onwards by the Institute of Health Information and Statistics of Italy (ISTAT) [20]. These surveys were carried out almost every year on representative samples of the Italian population (about 24,000 families and 54,000 persons distributed in about 850 Italian municipalities of different population sizes). Smoking status was based on participant self-report as never, former, or current smoker [20]. Smoking prevalence and initiation rate data were linearly interpolated to obtain data for the missing years. Figures on the subdivision of former smokers by duration since quitting were derived from the ISTAT Multipurpose Surveys “Aspects of daily living” [20]. Because former-smokers were not distinguished by years-quit data after the first year, we used data from the Netherlands to estimate the proportions in the years-quit categories of 1year or more.

Due to empirical challenges in measuring initiation and cessation and in order to ensure stability and internal consistency of the model, initiation rates at each age were measured as the difference between the smoking rate at that age year and the rate at the previous age year. We examined data from ISTAT regarding when smokers and former smokers stated that they first started smoking. Based on that information, we allowed initiation up through age 30.

To measure the annual cessation rate, we used data available for those who quit in the last year. Using the baseline smoking prevalence data, we constructed a cessation rate by age and gender, measured as those who quit in the last year as percent of “those currently smoking plus those who quit in the last year”. Since that rate does not allow for relapse of those who quit less than one year ago, we applied a 50% relapse rate to that measure. These rates are consistent with estimates suggested by West [21,22] and those found in studies of quitting behaviors in the Netherlands [23-25]. Since data were not available for Italy, we used U.S. relapse rates [8,26-29], but we compared ex-smoker rates and made adjustments accordingly to calibrate the model. After calibrating the model, we increased the relapse rate to 75% for ages 30–34, 70% for ages 35–44, 65% for ages 45–54, and 60% for ages 55–64years.

Smoking-Attributable Deaths

SADs are based on the excess risks of current and former smokers relative to never smokers. Death rates by age, gender and smoking status were calculated from death rates, smoking rates, and relative risks. The number of current and former smokers at each age was multiplied by their respective excess risk and summed to obtain total SADs.

Large scale studies of the relative risk of smoking are not available for Italy. Since Italy has a similar smoking history to the United States and is a high income country, we used relative risk estimates from the U.S. Cancer Prevention Study (CPS) II [28,30,31]. We note that Doll and Peto [32,33] found similar relative risks in prospective studies conducted in the UK. For ex-smokers, we allow relative risks to decline at the rate observed in U.S. studies [34], similar to those found in the British studies [32,33]. Moreover, CPS II relative risk estimates were in agreement with those found in Italian epidemiological studies for several mortality causes [35].

Policy effects

SimSmoke includes a separate policy module for each of the major policies. Policy effect sizes are in terms of percentage reductions applied to smoking prevalence in the year when the policy was implemented, and, unless otherwise specified, applied to initiation and cessation rates in future years. Policies and effect sizes are summarized in Table2. The effect of implementing a policy depends on the prior level of that policy (e.g., the incremental effect of a complete work site ban is less when a country already has a partial worksite ban than if no smoking ban is implemented). We input data on policy levels for each year from the baseline year through 2009, based on the WHO MPOWER reports [1,2] and on data provided by tobacco control staff in Italy.

Table 2

Policies, description and effect sizes of the SimSmoke model

Policy	Description	Potential percentage effect*
		Through price elasticity:
Tax Policy	Cigarette price index	−0.3 ages 15–24
		−0.2 ages 25–34
		−0.1 ages 35 and above
Clean Air Policies
Worksite total Ban	Ban in all areas	6% with variations by age and gender
Worksite ban except ventilated areas	Smoking restricted to ventilated areas in all indoor workplaces	4% with variations by age and gender
Worksite ban limited to common area	Smoking limited to non ventilated common area	2% with variations by age and gender
Restaurant total ban	Ban in all indoor restaurants in all areas	1% effect
Restaurant ban except separate areas	Ban in all restaurants except in designated areas	0.5% effect
Other places total ban	Ban in 3 of 4 (malls, retail stores, public transportation and elevators)	1% effect
Enforcement and publicity	Government agency is designated to enforce and publicize the laws	Effects reduced by as much as 50% if 0 enforcement
Mass Media Campaigns
Highly publicized campaign	Campaign publicized heavily on TV (at least two months of the year) and at least some other media	3.25% effect (doubled when accompanied by local programs)
Moderately publicized campaign	Campaign publicized sporadically on TV and in at least some other media, and a local program	1.8% effect (doubled when accompanied by local programs)
Low publicity campaign	Campaign publicized only sporadically in newspaper, billboard or some other media.	0.5% effect (doubled when accompanied by local programs)
Marketing Ban
Comprehensive marketing ban	Ban is applied television, radio, print, billboard, in-store displays, sponsorships and free samples	5% reduction in prevalence,
		6% reduction in initiation,
		3% increase in cessation rates
Total Advertising Ban	Ban is applied all media television, radio, print, billboard	3% reduction in prevalence,
		4% reduction in initiation,
		2% increase in cessation rates
Weak advertising ban	Ban is applied some of television, radio, print, billboard	1% reduction in prevalence and initiation only
Enforcement and publicity	Government agency is designated to enforce the laws	Effects reduced by as much as 50% if 0 enforcement
Warning Labels
Strong	Labels are large, bold and graphic	2% reduction in prevalence
		2% reduction in initiation
		4% increase in cessation rate
Weak	Laws cover less than 1/3 of package, not bold or graphic	1% reduction in prevalence & initiation rates, 2% increase in cessation rates
Publicity	Health information is well publicized	1% additional effect on prevalence and initiation rates
Cessation Treatment Policy	Complete availability and reimbursement of pharmaco- and behavioral treatments, quitlines, and brief interventions	4.75% reduction in prevalence, 39% increase in cessation rate
Youth Access Restrictions
Strongly enforced & publicized	Compliance checks are conducted regularly, penalties are heavy, and with publicity is strong, vending machine and self-service bans	30% reduction for age<16 in prevalence and initiation only,
		20% reduction for ages 16–17 in prevalence and initiation only
Well enforced	Compliance checks are conducted sporadically, penalties are potent, and little publicity	15% reduction for age<16 in prevalence and initiation only,
		10% reduction for ages 16–17 in prevalence and initiation only
Low enforcement	Compliance checks are not conducted, penalties are weak, and no publicity	3% reduction for age<16 in prevalence and initiation only,
		2% reduction for ages 16–17 in prevalence and initiation only

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* Unless otherwise specified, the same percentage effect is applied as a percentage reduction in the prevalence and initiation rate and a percentage increase in the cessation rate, and is applied to all ages and both genders. The effect sizes are shown relative to the absence of any policy. They are based on literature reviews, advice of an expert panel and model validation.

Tax policy in SimSmoke uses cigarette prices adjusted for inflation as the policy input through 2010, which changes in price are translated into changes in smoking prevalence through elasticities (i.e., the percent change in smoking prevalence for a one percent change in price). The model uses the total cigarette excise tax (including ad valorem and specific) to adjust future prices. Gallus and colleagues [36] obtained price elasticities for Italy comparable to those in the U.S., with minimal tendencies for smokers to substitute to smuggled cigarettes and hand rolled cigarettes [37]. The price effects are assumed to be the same as in U.S. model, where the elasticity for smoking prevalence is −0.3 for those through age 24, -0.2 for those aged 25–34, and −0.1 for those aged 35 and above. Since the vast majority of tobacco users smoke tobacco, the price was based on the tobacco price index deflated by the consumer price index from 1999 through 2009 (stats.oecd.org/index.aspx? querytype=view&queryname=221). We examine the effect of an increase in future tobacco prices by 25% in the first year (i.e. 2011), an additional 20% the second (relative to the preceding year), 15% the third, 10% the fourth and 5% the fifth year. This would imply a total 99.3% price increase over the next 5years, which would be similar to increasing the current ad valorem and specific excise taxes from its current level by around 20%.

Smoke-free air policy considers smoking restrictions in: 1) worksites, 2) restaurants and bars, and 3) other places, with their effect dependent on enforcement and publicity (based on the level of tobacco control campaigns). With strong enforcement and publicity, the effect of a ban in restaurants is 2%, in pubs and bars is 1%, in worksites is 6%, and in other public places is 1%, with the full effects dependent on full enforcement, based on recent reviews [4,38] and studies from Italy [37,39-41]. Italy now has strong smoke-free air laws. Dating back to 1975, there were bans on smoking in many public places, including hospital wards, in all the school classes, libraries, cinemas and museums, and in public transport (http://www.salute.gov.it/stiliVita/paginaInternaMenuStiliVitaFaq.jsp?id=44&menu=strumentieservizi&label=faq), which is designated as a full ban in other public places. A ban was not implemented until 2005 for all worksites, bars and restaurants. While there is an exclusion for ventilated areas, it is very costly to comply with this regulation. Italy is considered to have weak worksite laws (ban in government and health facilities), and no ban in restaurant or pubs and bars through 2005, and then complete smoke-free air laws (worksites, bars and restaurants), and other public places since 2005. Based on information in the MPOWER Report [1] for 2007, the enforcement level is set to 8 out of 10.

MPOWER [1] distinguishes enforcement and 4 levels of direct (advertising and point of sale) and indirect (sponsorships, branding, or promotional discounts) marketing as: 1) none, 2) minimal (up to 3 direct or 1 indirect ban), 3) moderate (4–6 direct or 1 indirect), and 4) complete (direct and indirect). With a complete direct and indirect ban, prevalence is reduced by 5% and initiation by 6%, and cessation is increased by 3% [4,42,43]. Since 1983, there was a ban on direct advertising in newspapers, radio, and television. In 1991, the ban was extended to cover most indirect advertising, with some minor changes in 2004 related to Formula One racing sponsorship and free distribution practices. According to the MPOWER Reports, there is a ban on all types of indirect advertising. On that basis, we categorize Italy as having a complete (level 4) marketing ban from the baseline year to the present. Based on the 2009 MPOWER report [2], however, enforcement is 10 for direct and 3 for indirect, which were averaged to set enforcement to 7 out of 10 for all years.

MPOWER provides 4 levels for health warnings on cigarette packs: none, minimal (< 30% of the principal display area), moderate (covering at least 30% of the display area and includes seven pack warning criteria) and complete (covers at least 50% of the display area and includes all seven warning criteria and a ban on deceitful terms). Based on Levy et al. [4] and more recent studies [44-46] strong health warnings reduce prevalence by 2% and initiation by 1%, and increase cessation by 5%. When warning labels are moderate (low), prevalence is reduced by 0.75% (0.5%), cessation is increased by 2.5% (1.0%) and initiation is reduced by 0.5% (0.5%). When warning labels are moderate or high, a synergy from publicity through tobacco control campaigns reduces prevalence by an additional 1% and increases cessation by an additional 2% if tobacco control funding is high and half of that amount if it is medium. Health warnings were minimal in Italy until 2003. Following EU directives, warnings were increased to cover at least 30% of both sides of the pack in 2003, but have not included pictorial images. Thus, we assigned a moderate warning from 2003 to 2010.

SimSmoke specifies three levels for tobacco control campaigns: 1) low: a national agency and minimal funding or employees, 2) medium: a national agency plus 10+ employees or per capita expenditures over $0.10 (USD) per capita, and 3) high: a national agency and expenditures over $0.50 per capita, and incorporates synergies arising from publicity surrounding other tobacco control policies. Based on reviews [4,47-49] and several recent studies [50-53], a well-funded tobacco control campaign in conjunction with other policies yields an effect size of 6.5%. A low campaign yields an effect size of 1%. Without other policies in place, the effects are reduced by half. Anti-tobacco media campaigns have been implemented in Italy in 2002–2003, 2004, 2005, 2009, and 2010 (http://www.salute.gov.it/servizio/campagna.jsp). The 2010 media campaign was a 35second television spot delivered on 15days in summer, and cinema and radio spots delivered from November 15 to December 15, 2010. The MPOWER Report [1,2] indicates health expenditures of less than $1 USD per person. Because of the sporadic and generally low level of he campaign, we assign a low intensity media campaign to Italy since 1999.

A strongly enforced policy restricting the purchase of cigarettes by youth and with bans on self-service and vending machines reduces smoking prevalence by those under the age of 18 by as much as 25% [54]. While retailers have a duty to ensure tobacco products are not sold to anyone under the age of 16, youth are rarely denied purchase of cigarettes in Italy [55]. Enforcement is set to a zero level since the baseline year of the model, with no bans on vending machines or self-service displays.

Cessation treatment includes four sub-policies. Treatment coverage is based on the places providing cessation treatments (physician offices, hospitals, community centres, provider offices and other). With a high-level media campaign, prevalence is reduced by 2.25%, and the cessation rate is increased by 12% in future years [48,56]. The effect of a quitline also depends on publicity, with prevalence reduced by 0.5% and cessation increased by 5% in all future years [56]. An index for pharmacotherapy availability was developed, which was given full weight if: i) both nicotine replacement therapy (NRT) and buproprion were available, and ii) NRT is available in a pharmacy without prescription or general store. When fully implemented, prevalence is reduced by 1.0%, and the cessation rate is increased by 6% in all future years [57,58]. Brief interventions would involve at minimum that health care providers advise and assist in cessation. When fully implemented, prevalence is reduced by 0.5% in the first year, and the cessation rate is increased by 10%, based on evidence provided in Levy et al. [4]. When all sub-policies are implemented (from a scenario of no policy), smoking prevalence is reduced by 4.75% and the cessation rate is increased by 39.3%.

Since 2003, NRT has been available OTC in pharmacies, and was only provided by prescription in previous years. Buproprion is available with a prescription for all years. The National Health Service provides no reimbursement to smokers for pharmacotherapy or behavioral treatments [59] and there is little use, although heavy smokers are more frequent compared with other high income nations [60,61]. Several Smoking Cessation Services are not adequately funded and their activities are only periodically implemented [62]. According to the MPOWER Report [2] and based on the characteristics described above, financial coverage of treatments is provided only in some places for primary care facilities, hospitals, and offices of health professionals, and we assume those values for all years. MPOWER [2] indicates that there is a quitline, which Italian sources indicate has been in existence since 1999, but is available for limited hours and serves only about 0.6-0.7% of smokers [61], and is considered to be passive. A recent survey found that only 22% of smokers reported having only received advice to quit by their general practitioners [63], but another recent survey (PASSI; see http://www.epicentro.iss.it/passi/english.asp) found that health professionals delivered smoking cessation counseling to 60% of smokers. We set brief interventions at a level of 30% for all years.