The TackSHS Survey: a Cross-sectional Study on Secondhand Smoke in 12 European Countries
Conditions: Second Hand Tobacco Smoke
Sponsor: Mario Negri Institute for Pharmacological Research

Study Protocol – The TackSHS survey – Version: 1, date: 3 May 2016  
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The TackSHS survey: 
a cross-sectional study on secondhand smoke in 12 European countries 
 
 
 
NCT number: NCT02928536 
 
Date: 3 May 2016 
 
 
 

 
Study Protocol – The TackSHS survey – Version: 1, date: 3 May 2016  
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BACKGROUND AND RATIONALE 
Secondhand tobacco smoke (SHS) is a complex mixture of thousands of compounds, including 
particulate matter emitted by the combustion of tobacco products and from smoke exhaled by 
smokers [1]. It contains about 70 chemicals recognized as known or probable human carcinogens, 
other animal carcinogens, and many toxic and irritant agents [2]. Over the past two decades, SHS 
has been shown to cause adverse health effects on adults and children, including heart diseases, 
cardiovascular and respiratory disorders, lung cancer and other selected neoplasms [1, 2]. Of the 
5.7 million deaths attributable each year to tobacco smoking, more than 600,000 (i.e., around 1% 
of all deaths worldwide) refer to subjects who never smoked and that prematurely die due to their 
lifetime exposure to SHS [3, 4]. Consequently, the World Health Organization (WHO) in its 
Framework Convention for Tobacco Control (FCTC) states the need to develop smoke-free 
policies to protect non-smokers from the consequences of SHS [5]. According to various 
population-based cross-sectional surveys, it has been estimated that between 20% and 60% of 
European non-smokers are exposed to SHS [6-11]. However, important reductions in SHS 
exposure have been found in selected indoor settings, including workplaces and hospitality venues 
such as bars and restaurants [12], after the implementation of smoke-free legislations. 
 
Electronic cigarettes (e-cigarettes), the most common “electronic nicotine delivery systems”, have 
irrupted in the market over the last 5 years, and their sales and popularity have rapidly and 
considerably grown worldwide and across the European Union (EU). 
In Europe, there is certain variability in the prevalence of e-cigarette use among studies, depending 
on the population and the questions used in the surveys [13-16]. According to the 2012 
Eurobarometer survey, 7% of the European citizens, in particular current smokers, have tried e-
cigarettes [17, 18]. In Italy, a survey conducted in 2013 showed that awareness of e-cigarettes was 
91.1%, lowest among some vulnerable populations such as women, the elderly, and less educated 
subjects [19]. In Italy, ever e-cigarette use was 6.8% overall, and was inversely related to age, 
whereas no difference was observed according to sex [19]. In Spain, awareness of e-cigarettes 
was lower than in Italy (82.3%), but a similar prevalence of ever e-cigarette use (6.5%) was 
observed (1.6% current use, 2.2% past use and 2.7% e-cigarette experimentation). Moreover, 90% 
and 75% of ever e-cigarette users were current smokers respectively in Italy [19] and Spain [16, 
20]. E-cigarettes have been presented as a “safe” alternative for smokers by some behavioural and 
individual-risk scientists, while others, in view of the lack of sound evidence on their health effects, 
recommend a more cautious approach to their use and regulation. 
 
In 2015, the TackSHS Project (“Tackling secondhand tobacco smoke and e-cigarette emissions: 
exposure assessment, novel interventions, impact on lung diseases and economic burden in 
diverse European populations”; www.tackshs.eu), coordinated by the Institut Català d’Oncologia 
(Spain), has been funded by the European Commission (EC) within the Horizon 2020 research 
grants (grant agreement number: 681040). This 4-year project will try to elucidate the 
comprehensive impact that SHS and e-cigarette aerosol have on the respiratory health of the 
European population, and how health impacts vary according to socio-economic parameters, with 
particular emphasis on specific vulnerable groups. The TackSHS Project will put together for the 
first time various research teams, and, by means of an integrated series of work packages (WP), 
will result in a step forward to tackle exposure to SHS and e-cigarette emissions. Within the 
TackSHS Project, selected WPs (i.e., WP3, WP9 and WP10) involve the conduction of a survey in 
12 EU countries: the TackSHS survey. 
 
 

 
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OBJECTIVES 
The TackSHS Project includes three WPs involving the collection of cross-sectional individual-level 
data in 12 EU countries (the TackSHS survey). The three WPs are: 
 
WP3, coordinated by “Mario Negri” Institute (Milan, Italy): Survey on secondhand smoke and 
electronic cigarettes in Europe; 
 
WP9, coordinated by ISPO (Florence, Italy): Attributable mortality and morbidity to 
secondhand smoke in Europe; 
 
WP10, coordinated by Universidad Politécnica de Cartagena (Cartagena, Spain): Economic 
impact of secondhand tobacco smoke on morbidity and mortality and Return on Investment 
of Intervention. 
 
Objectives of this cross-sectional study are: 
 
to estimate prevalence of current smokers, electronic cigarette users (and, for Italy, heat-
not-burn cigarette users), and exposure to SHS and passive exposure to emissions from 
electronic cigarettes in selected European countries (WP3); 
 
to investigate the determinants of SHS exposure in those countries (WP3); 
 
to analyze the attitudes and perceptions of the adult European population towards policies 
to control tobacco and to limit SHS exposure (WP3); 
 
to study knowledge and believes of current smokers and the general adult population on the 
harmful effects of SHS (WP3); 
 
to compare smoking patterns, electronic cigarette use, and, particularly, SHS exposure 
between selected middle- and high-income countries in Europe (WP3); 
 
to compare smoking patterns, voluntary home smoking ban, and perception on the efficacy 
of smoking ban as a tobacco control policy between the new data in the selected European 
countries, and data from a companion pan-European survey conducted in 2010 (WP3); 
 
to assess: i) mortality attributable to SHS for lung cancer and ischaemic heart diseases 
among non-smoking adults; ii) morbidity (e.g., induction of asthma) attributable to SHS in 
non-smoking adults; iii) mortality attributable to SHS in children (e.g., Sudden Infant Death 
Syndrome [SIDS]); iv) morbidity (e.g., lower respiratory infections; asthma onset; acute otitis 
media) attributable to SHS in children (WP9); 
 
to quantify the economic burden associated to the exposure to SHS and e-cigarette aerosol 
in Europe (WP10). 
 
 
METHODS 
Study design 
To achieve the aims of this study, we will conduct a face-to-face population-based cross-sectional 
survey in 12 strategically selected European countries (Bulgaria, England, France, Germany, 
Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, and Spain). 
The study methodology will be similar to a previous companion pan-European survey, conducted 
in 18 European countries in 2010 within an EU Seventh Framework Programme (FP7) Project, 
entitled “Pricing Policies And Control of Tobacco in Europe” (PPACTE; Grant Agreement HEALTH-
F2-2009-223323) [21]. Briefly, in each country, the study sample will be representative of the 
general population aged 15 years and over in terms of age, sex, geographic area, and socio-
economic characteristics. The multi-stage methodology will be used as the preferred sampling 
methodology. In the first stage, the primary unit of selection will be geographic area or voting 
centre. In the second stage, households or municipalities will be selected. In the last stage, 

 
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respondents will be chosen randomly, in order to be representative of the population. In those 
countries where adult respondents will be selected from electoral rolls, the quota method will be 
used to select minors (i.e., aged 15 to 17). Other methods, including stratified or simple sampling 
or quota methods, will also be accepted wherever it is not possible to conduct a multistage random 
sampling. 
 
Selection of countries 
For the present study, an appropriate sample of 12 European countries – all EU Member States 
(MS) – representing geographical, legislative and cultural variations across the EU, has been 
selected. 
The selected European countries are the following: Bulgaria (BG), England (UK), France (FR), 
Germany (DE), Greece (GR), Ireland (IE), Italy (IT), Latvia (LV), Poland (PL), Portugal (PT), 
Romania (RO), and Spain (ES). 
These countries were selected after taking into account several aspects, including: i) different 
geographical distribution; ii) different level of per capita income; iii) different national smoking 
prevalence [21]; iv) different adoption of tobacco control strategies at a national level (i.e., Tobacco 
Control Scale, TCS) [22]; v) different tobacco ban legislations [22]; vi) high population size; vii) 
inclusion in a previous PPACTE survey [21]. 
According to geographic area, we considered countries from northern (IE, UK), central/western 
(DE, FR), central/eastern (BG, LV, PL, RO), and southern Europe (ES, IT, GR, PT). Moreover, the 
selection includes the 7 most populated EU MS (DE, ES, FR, IT, UK, PL, RO), and, among less 
populated countries, we prioritized middle-income countries (BG, RO). Finally, besides Germany, 
all the other countries were included in the 2010 PPACTE survey. Overall, the 12 selected EU MS 
represent 78.8% of the EU28 overall population. 
 
Study population 
In each of the 12 selected European countries, approximately 1000 individuals, representative of 
the general population aged 15 years and over in terms of age, sex, geographic area, and socio-
economic characteristics, will be enrolled in this cross-sectional study. The final sample will 
therefore include a total of approximately 12,000 subjects. 
Inclusion criteria  
 
individuals aged 15 years and over; 
 
individuals resident of the 12 selected countries; 
 
individuals able to understand and answer the questions of the questionnaire of the study in 
the country-specific language; 
 
individuals who formally accept to participate in the study. 
Exclusion criteria 
No specific exclusion criteria are considered. 
Sample size computation 
The sample size in each specific country will allow us to obtain prevalence estimates with a 
maximum standard error (SE) lower than ± 1.6%. Therefore, with such a sample size we will be 
able to provide stable prevalence estimates (with a relatively small 95% confidence interval), 
overall but also in each specific country. 
 
Data collection 
In each country, individuals will be surveyed by trained interviewers through face-to-face interviews 
using a structured standardized questionnaire. Data collection will be coordinated by DOXA, a 
leading market research organization and Italian branch of the Worldwide Independent 
Network/Gallup International Association (WIN/GIA), and performed in collaboration with its 

 
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European partners (see “Selection of the subcontractor performing data collection” paragraph). 
Whenever possible, data will be collected within computer assisted personal interviews (CAPI). 
Alternatively, paper and pencil (P&P) interviews will be accepted. Data collection will start once 
obtained the approval from the Ethics Committee of the 12 European countries involved in the 
study. The fieldworks will last two to three months in each country. 
The English version of the questionnaire (Annex 4) has been developed through the collaboration 
with the partners of the TackSHS consortium. Before fieldwork, DOXA and its European partners 
will translate the questionnaire, under the supervision of the TackSHS consortium, in various 
country-specific languages. Some questions are identical to those formulated in a previously 
conducted pan-European survey (the PPACTE survey), in order to allow comparisons in time. 
The first part of the questionnaire includes country-specific data to be provided by DOXA and its 
European partners for each European country. These data include i) information on sampling 
methodology (e.g., sampling method used, response rate, fieldwork dates, age range), and ii) 
country-specific information (e.g., country population size, price of cigarette packs, gross domestic 
product, structure of the school system, and current policies regulating tobacco smoking and 
electronic cigarette use implemented at a national level, with a focus on indoor public/private 
places and transports, and outdoor public places). 
The second part of the questionnaire is designed to collect individual-level information for each 
survey participant, and is divided in four sections: 
A. socio-economic and demographic characteristics (e.g., sex, age, level of education, and 
profession); 
B. cigarette smoking habit and e-cigarette use (e.g., smoking status, use of e-cigarette –and, in 
Italy, use of heat-not-burn tobacco cigarette-, smoking/vaping intensity and duration, and 
consequences of e-cigarette use on smoking behaviour); 
C. cigarette smoking, e-cigarette consumption, and SHS and e-cigarette aerosol exposures in 
different sites (e.g., exposure to SHS in indoor public places, workplaces, private venues, 
also in presence of minors, homes, transports, and selected outdoor places); 
D. attitudes and perceptions on smoke-free regulations and awareness of SHS harmful effects. 
 
Statistical analysis plan 
Creation of the survey dataset 
This task is included in the WP3 of the TackSHS Project. Once the fieldwork is completed, DOXA 
will collect data from its European partners, and, after internal checks, will provide to “Mario Negri” 
Institute, the 12 anonymous data files in text format, with the corresponding codebook in English 
language. The 12 data files will be managed by the expert biostatisticians at the Department of 
Epidemiology of “Mario Negri” Institute. Through the use of the statistical package SAS, version 9.4 
(SAS Institute, Cary, NC, USA), they will perform the input of the 12 textual data file into 12 
corresponding SAS datasets, and then create a unique final dataset SAS. This dataset will be 
checked for coherence and for the presence of possible errors, cleaned, and finalized through the 
generation of queries which will be addressed by DOXA and its European partners. 
 
Statistical analyses for WP3 
Statistical analyses required to achieve objectives related to WP3 will be conducted by expert 
biostatisticians at the Department of Epidemiology of “Mario Negri” Institute, using SAS statistical 
package. 
Prevalence of current smokers and e-cigarette users, and prevalence of exposure to SHS and e-
cigarette aerosol, will be estimated through univariate statistical analyses (i.e., descriptive statistics 
for categorical data, including absolute or relative frequencies), overall, by country, and in strata of 
selected demographic and socio-economic (individual and country-specific) characteristics. 

 
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Continuous variables (e.g., age at starting or quitting smoking, number of cigarettes smoked per 
day, number of e-cigarette puffs per day) will be summarized through the use of means and 
standard deviations. Alternatively, they will be categorized, and thus described through absolute or 
relative frequencies.  
Multivariate analyses will also be considered to identify sub-groups of the population (e.g., young 
vs. other age groups, unemployed vs. other working status, low vs. high educated subjects) or 
clusters of countries (e.g., middle vs. high income countries, low vs. high TCS, low vs. high 
smoking prevalence) more frequently adopting selected tobacco-related behaviours or more 
frequently exposed to SHS. Thus, odds ratios (OR), and the corresponding 95% confidence 
intervals (CI), will be estimated through logistic regression models after adjustment for age, sex, 
socio-economic status, and other selected individual-level characteristics. Multi-level procedures 
will also be considered. 
The aforementioned statistical approaches will be used also to describe: i) the attitudes and 
perceptions of the adult European population towards policies to control tobacco and to limit SHS 
exposure; and ii) the knowledge and believes of current smokers and the general adult population 
on the harmful effects of SHS. 
To evaluate the changes in time of selected smoking-related aspects, including smoking 
prevalence and patterns, voluntary home smoking ban, and perceptions on the efficacy of smoking 
bans as tobacco control policies, TackSHS data will be compared with data from a previous 
companion European survey (the PPACTE survey). A unique SAS dataset including common 
variables will be created for the 11 European countries considered in both surveys (i.e., BG, UK, 
FR, GR, IE, IT, LV, PL, PT, RO, and ES). Significance of differences between the two survey 
periods will be performed both through univariate (χ2 test for categorical variables and t-test for 
continuous ones) and multivariate analysis (regression models). 
 
Statistical analyses for WP9 
The statistical analyses needed to achieve objectives related to WP9 will be conducted at ISPO. 
To achieve WP9 aims, researchers at ISPO will conduct a review of the scientific literature on the 
methods to estimate attributable mortality and morbidity (AMM) to SHS, using various research 
engines, including PubMed. Moreover, they will update the list of health effects and their 
corresponding relative risks (RR) in terms of mortality and morbidity causally linked to SHS 
included in the IARC Monograph on involuntary smoking [1]. Within WP9 we will assess mortality 
attributable to SHS for lung cancer, ischaemic heart diseases, and morbidity attributable to SHS 
(e.g., induction of asthma) in non-smoking adults. Moreover, among children we will assess 
mortality attributable to SHS (e.g., Sudden Infant Death Syndrome, SIDS, in children aged <1 year) 
and morbidity attributable to SHS (lower respiratory infections in children aged <3 years; asthma 
onset in children aged <14 years; acute otitis media in children aged <14 years). In order to 
estimate AMM to SHS, ISPO researchers will use: i) mortality and morbidity figures of SHS-related 
diseases in Europe, and ii) prevalence of exposure to SHS of the European population. Mortality 
and morbidity figures of SHS-related diseases in EU-28 will be obtained through the collaboration 
with the World Health Organization-Global Burden of Disease (WHO-GBD) algorithm. Prevalence 
of SHS exposure will be derived from data collected within the TackSHS survey in the 12 
European countries considered. Eurobarometer surveys will be used to obtain prevalence of SHS 
exposure in the remaining EU-28 countries and to validate estimates from the TackSHS survey. 
Moreover, sensitivity analyses of AMM to SHS will be conducted varying different assumptions 
(e.g., using upper and lower 95% confidence limit of RRs or ORs from meta-analyses, using 
different hypotheses of susceptibility of current and ex-smokers to SHS, changing other 
assumptions). 
 

 
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Statistical analyses for WP10 
The statistical analyses needed to achieve objectives related to WP10 will be conducted at the 
University of Cartagena. To accomplish WP10 objectives, researchers will evaluate policies aimed 
at reducing exposure to SHS across European countries, through the development of a model 
(Return On Investment – ROI – model) able to assess the cost-effectiveness, budget impact and a 
wider set of social return on investment metrics of these policies. 
The choice of policies and interventions to be considered will be guided by the work developed in 
other WPs of the TackSHS Project, as well as by the review of the scientific literature. The choice 
of diseases, as well as the corresponding AMM parameters, will be guided by the results of WP9. 
The outcomes of the model will comprise not only standard cost-effectiveness and cost-utility ratios 
over these horizons but also a fully disaggregated list of health outcomes and resource use 
consequences over shorter time horizons. 
Country-specific versions of the model will be also constructed. The initial core of countries will be 
Germany, Spain and UK. This core is composed by the intersection of countries covered by the 
TackSHS survey and the countries for which there exist a high quality data set on the health and 
economic consequences of smoking related diseases resulting from the EU FP7 EQUIPT project 
[23] or the NICE ROI model. Evidence on exposure to SHS for these three core countries will be 
obtained from the TackSHS survey. Moreover, since this survey covers other additional EU MS, 
including two middle-income countries (Bulgaria and Romania), the initial core will be extended to 
include a selection of these countries. The criteria for inclusion will be based primarily on the 
availability of good quality data on costs of interventions, as well as prevalence and incidence of 
smoking-related diseases. Data requirements will consist of point estimates for the model 
parameters plus their confidence intervals in order to enable both deterministic and probabilistic 
sensitivity analyses. 
Smoke-free policies, comprising one or several interventions will be evaluated accounting for cost 
and health consequences. The results will be expressed in terms of several metrics of interest for 
stakeholders and decision makers (i.e., budget impact, incremental cost-benefit ratios, incremental 
cost-effectiveness ratios, averted mortality and morbidity, gains in life years and quality adjusted 
life years). 
 
 
ETHICAL AND ADMINISTRATIVE ASPECTS 
Informed consent 
At recruitment, information on survey characteristics will be given to all participants by suitably 
qualified professionals, who will be able to provide answers to any possible questions and to 
eliminate any concern respondents may have. This information will be provided through the 
Information Sheet (Annex 5 for adults and Annex 5bis for minors), and will be translated in various 
languages and provided to survey participants in a clear, jargon free way, using fully 
understandable terms and language. This document includes: 
 
the purpose of the information to be collected, including aims, methods and implications of 
the research; 
 
the extent to which personal data is used and accessed by various partners; 
 
the participant right to withdraw from participation in the study. 
Although in EU countries, according to their current legislation, written consent is not mandatory for 
this type of study, following the request of the EC all participants will be asked to sign the informed 
consent form for participation in the study. Written informed consent will thus be obtained from 
each adult participant, and, in case of minors, representing approximately 5% of the survey 
sample, from one of their parents or legal tutors. In countries collecting data with CAPI method 

 
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(using computer or tablet), participants will have the possibility to tick an electronic document in 
order to express their willingness to participate in the study. No written signature will therefore be 
required. In those countries using P&P interviews, participants will be asked to sign the Consent 
Form (Annex 6 for adults and Annex 6bis for minors), containing personal details of participants. 
Wherever obtained, the signed document will be sent to the “Mario Negri” Institute by those DOXA 
partners using P&P interviews, and will be stored in “Mario Negri” Institute in archives with the 
access allowed only to part of the staff involved in the survey. 
 
Privacy observance procedures 
Survey data will be in electronic format. Only a selected number of pre-designated members of the 
data collection team will have access to the laptops protected password. Once data collection is 
complete, all data will be uploaded into a single database and reliably and completely deleted from 
the laptops. 
Selected personal data, including the names of respondents, will be collected to enable quality 
assurance procedures and to allow participants willing to withdraw from participation in the survey 
to have their records deleted from the database. Once quality assurance procedures are complete 
(within 4 months of the completion of data collection), names and other unique personal identifiers 
(such as full address) will be reliably and completely deleted. 
During the quality assurance procedures, “Mario Negri” Institute will obtain an anonymous copy of 
the analysis database, i.e., without names of participants but with encrypted (not personally 
identifiable) codes. The encryption key is kept by DOXA and its European partners in a place 
separated from the research group. All access to the encryption key will be logged. This encryption 
key will be destroyed once quality assurance procedures are complete. After this procedure, there 
will not be anymore the possibility to identify the participant record and consequently to delete it 
from the database. 
The analysis database will be held securely on a password protected file server at the “Mario 
Negri” Institute, and only a limited number of researchers from its team or the consortium will have 
the possibility to access this analysis database. 
All data will be managed anonymously, in respect of the privacy regulations in force, only for 
scientific purposes, without any lucrative aim. Moreover, results of the study will not consist in 
individual-level data, but aggregated data, and summary results will be disseminated, thus not 
allowing to identify the survey participants. 
These and other measures are in agreement with national and current or forthcoming EU (i.e., 
Directive 95/46/EC) regulations. After evaluation of the Italian Ethics Committee (i.e., the Ethics 
Committee of the study coordinator), the study protocol will be submitted for evaluation to the 
Ethics Committees of the other 11 countries where data will be collected. In addition, the study 
protocol will be approved by the Data Monitoring Board and an External Ethics Advisor of the 
TackSHS team. 
 
Access to personal data and withdrawal from the study 
In the survey no sensitive personal data (e.g., health, sexual lifestyle, ethnicity, political opinion, 
religious or philosophical conviction), genetic information, or data involving tracking or observation 
of participants will be collected. According to other personal data, in the Information Sheet it has 
been made clear that subjects are completely free to withdraw their records from participation in 
the survey, and that the consent given by participants in the project can be withdrawn, without any 
explanation or justification. In this case, all data pertaining to the subjects in question will be 
destroyed. 
 
Selection of the subcontractor performing data collection  

 
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The development of the questionnaire and the data managing, analysis and interpretation will be 
carried out by the Department of Epidemiology of “Mario Negri” Institute, in collaboration with other 
TackSHS Project partners. However, the TackSHS consortium is not able to carry out the 
fieldwork, particularly in a cost-effectiveness manner and/or in a satisfactorily short period of time. 
Therefore, data collection of the European cross-sectional survey will be performed with the 
support of a leading market research organization, which will be involved as a subcontractor of 
“Mario Negri” Institute. 
“Mario Negri” Institute, a non-for-profit private institute, had no obligation at a national or EU level, 
to launch a call for tender to select the most suitable market research organization, since “Mario 
Negri” Institute is not a contracting authority/contracting entity. However, in respect of the current 
practice at EU level, “Mario Negri” Institute requested a series of quotations from selected research 
market institute before the project submission. The 6th of February 2015, formal quotes have been 
required by e-mail four leading research market institutes offering a network of representatives 
throughout Europe with trained surveyors (i.e., DOXA, GfK-Eurisko, IPSOS and TNS). For a 
scenario of a face-to-face survey with 1000 participants in each of 12 countries, 12-14 minutes of 
interview, DOXA quoted € 225,000 + VAT for completion of this work, GfK-Eurisko requested € 
315,000 + VAT, IPSOS requested € 325,680 + VAT and TNS requested € 421,000 + VAT. 
Therefore, DOXA provided by far the lowest quotation. Moreover, “Mario Negri” Institute has been 
collaborating with DOXA for several years to carry out annual national surveys on smoking since 
2001. Therefore, the collaboration has been established before the beginning of the project. More 
importantly, in 2010, within the PPACTE project, “Mario Negri” Institute, in collaboration with DOXA 
and its European partners, already conducted a face-to-face representative survey on economic 
aspects of smoking in 18 European countries, using the same sample size, sampling methodology, 
and population proposed for the present investigation. A specific objective of the TackSHS survey 
refers to the comparison between data provided by the new survey and PPACTE data. Having 
DOXA as a subcontractor assures the identical country-specific sampling methodology. This allows 
us to obtain a more accurate comparison of selected smoking characteristics. 
On the basis of the quotes received, the “best value for money” principle, and the long lasting 
collaboration with the Department of Epidemiology of “Mario Negri” Institute, DOXA has been 
identified as the best provider for the service. 
 
Secondary used database 
For comparison purposes, a previously collected personal dataset will be analysed. These data 
come from a companion pan-European face-to-face survey, conducted in 2010 within the PPACTE 
Project, financially supported by the EC FP7. That survey was conducted in 18 European countries 
(Albania, Austria, Bulgaria, Czech Republic, Croatia, England, Finland, France, Greece, Hungary, 
Ireland, Italy, Latvia, Poland, Portugal, Romania, Spain and Sweden), on a total of 18,056 
participants, representative for each country of the population aged ≥15 years. The study protocol 
was approved by the Institutional Review Board of the “Mario Negri” Institute. The procedures for 
recruitment of subjects, informed consent, data collection, storage and protection (based on 
anonymous identification code) were in accordance with the country specific legislation. This was 
ratified and signed by DOXA (the market research organization in charge of data collection) and 
each of its European partners. “Mario Negri” Institute was the owner/manager of the dataset, and 
therefore permission to use those data is not required. 
 
Ownership of the data 
Individual-level anonymous data sent from DOXA and its European partners, and stored at the 
“Mario Negri” Institute, will be the property of the study coordinator. Selected data will be made 
available to other TackSHS partners in order to pursue the aims of other WPs. 

 
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RELEVANCE AND IMPLICATIONS 
One of the expected outcomes of the TackSHS European survey is the characterization of 
exposure to SHS and to e-cigarette aerosol in populations with different socioeconomic level and 
from various European countries. These results will have important implications on multiple 
aspects of public health and prevention for the European population and, when appropriate, will be 
disseminated in order to guide the development or the improvement of current smoke-free laws to 
protect the health of non-smokers. 
Moreover, through the collaboration with other WPs of the TackSHS Project, we will also provide 
the first estimates of morbidity and mortality due to SHS exposure at the European level, and the 
cost impact of interventions to control SHS exposure through purpose-built economic models. This 
information will be country-specific and will allow the evaluation of the cost-effectiveness of 
interventions, as well as their budgetary impact and return on investment at different scales of 
implementation. At the societal level, we aim to focus on the hazards derived from SHS, and 
possibly from e-cigarettes aerosol, by strengthening our efforts to disseminate the results of the 
TackSHS Project, not only for policy makers and stakeholders, but also among patients and 
consumers organizations, both at the national and European level. 
 
 
DISSEMINATION 
The main channels of dissemination of the results of the TackSHS survey will be international 
peer-reviewed open-access journals. Open access journals will allow the free dissemination of the 
project’s results among the scientific community. The dissemination will be followed critically and 
professionally, to maximize the project’s impact on both scientific knowledge and on public health. 
A final report will also summarize the main findings of various WPs. All these documents will be 
also made available on the TackSHS Project website (www.tackshs.eu). The webpage will be 
constantly updated to include the publications, with direct links to the PubMed abstract and to the 
full text of the paper (when available). Main results regarding the economic evaluations of policies 
aimed at reducing exposure to SHS across European countries (WP10) will be also used, in 
conjunction with the results from the rest of WPs, to formulate policy proposals. Finally, key 
findings from the WPs will be presented in tobacco control or public health conferences, and we 
will likely produce other written and audio-visual materials (like “video capsules“ of 1-2 minutes with 
key information of the project for patients, scientists, and the public, or fact sheets) and use other 
varied forms of communications to promote awareness of the project results to organizations 
involved in the field of tobacco control, health promotion, and public health. 
 
 

 
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REFERENCES 
1. 
IARC. IARC monograph on the evaluation of carcinogenic risks to humans. Volume 83. 
Tobacco Smoke and Involuntary Smoking. Available online at: 
http://monographs.iarc.fr/ENG/Monographs/vol83/. Lyon, France: 2004. 
2. 
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