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RESEARCH PAPER
This paper describes the conceptual model that underlies the International Tobacco Control Policy
Evaluation Project (ITC Project), whose mission is to measure the psychosocial and behavioural impact of
See end of article for
authors’ affiliations key policies of the Framework Convention on Tobacco Control (FCTC) among adult smokers, and in some
....................... countries, among adult non-smokers and among youth. The evaluation framework utilises multiple country
controls, a longitudinal design, and a pre-specified, theory-driven conceptual model to test hypotheses
Correspondence to:
Geoffrey T Fong, PhD, about the anticipated effects of specific policies. The ITC Project consists of parallel prospective cohort
Department of Psychology, surveys of representative samples of adult smokers currently in nine countries (inhabited by over 45% of the
University of Waterloo, world’s smokers), with other countries being added in the future. Collectively, the ITC Surveys constitute the
200 University Avenue first-ever international cohort study of tobacco use. The conceptual model of the ITC Project draws on the
West, Waterloo, Ontario
N2L 3G1, Canada; psychosocial and health communication literature and assumes that tobacco control policies influence
[email protected] tobacco related behaviours through a causal chain of psychological events, with some variables more
closely related to the policy itself (policy-specific variables) and other variables that are more downstream
Received 12 December
2005 from the policy, which have been identified by health behaviour and social psychological theories as being
Accepted 26 April 2006 important causal precursors of behaviour (psychosocial mediators). We discuss the objectives of the ITC
....................... Project and its potential for building the evidence base for the FCTC.
T
he global effort to reduce the burden of tobacco use, warning labels of 30% of the package versus the recom-
which is projected to result in the premature deaths of mended 50%, with graphic elements), and to identify areas
over one billion people in the 21st century, over 70% of where improvement in policy impact might be achieved.
which will occur in low and middle income countries, This article describes the International Tobacco Control
culminated in the creation and adoption of the Framework Policy Evaluation Project (the ITC Project). We describe the
Convention on Tobacco Control (FCTC).1 2 The FCTC is the challenges of evaluating the national-level policies of the
first-ever international public health treaty. It obligates FCTC, the design considerations we weighed in creating our
ratifying countries to broad, comprehensive tobacco control methods, and the conceptual model developed to guide our
policies.2 The main policies of the FCTC are presented in table 1. research on how and why different policies exert their effects
The progression of the FCTC has been rapid. One hundred on tobacco use behaviours. Other articles in this supplement
and sixty-eight countries signed the FCTC and the ratification illustrate the application of the conceptual model in measur-
process, which started in May 2003, required a mere 18 ing policy effects on tobacco use behaviours and the
months to meet the 40-country threshold for the treaty to psychosocial precursors of such behaviours.
come into force. As of April 2006, 126 countries have ratified
the FCTC.3 The process of setting the specific terms and the EXISTING EVALUATION STUDIES OF TOBACCO
governance of the FCTC began in February 2006 at the First CONTROL POLICIES
Conference of the Parties. Evaluation of tobacco control policies at the population level is
The FCTC has propelled tobacco control into a new era as in its early stages of development, and as such, studies on the
countries all over the world consider incorporating FCTC effectiveness of tobacco control policies suffer from design
policies and recommendations into their own laws. This is a limitations. Cross-sectional studies, for example, are low in
time of great promise and great challenge. As tobacco control internal validity—that is, they are generally weak in their
policies are formulated and implemented, it is important that ability to yield causal attributions.4 Longitudinal studies are, of
policies undergo rigorous evaluation. As intuitively appealing course, higher in internal validity, but the limited number of
as it may be to put graphic photographs on warning labels, or such studies in tobacco policy research often lack comparison
to restrict sponsorship activities of tobacco companies, these groups, and are thus unable to disentangle policy effects from
policies must be evaluated to provide concrete evidence of secular trends and historical event threats to internal validity.4–6
their effects. Such research both serves to evaluate existing Furthermore, the few longitudinal studies with comparison
policies, and to inform and support future policies. In the communities have focused on local and/or state policies, not
same way that evidence-based medicine has been built from national ones.7 8 For example, many US studies have examined
rigorous evaluation of treatment options, evidence-based differences in smoking behaviour by comparing states with
high levels of per capita spending on tobacco control
public health policy must begin with building a database
from rigorous evaluation of public health policies. Doing so
will provide policymakers with the evidence base necessary to Abbreviations: ETS, environmental tobacco smoke; FCTC, Framework
Convention on Tobacco Control; GYTS, Global Youth Tobacco Survey;
implement and defend effective policies, to choose which ITC, International Tobacco Control, NIH, US National Institutes of Health;
level of implementation of an FCTC policy may be most SES, socioeconomic status; TTURC, Transdisciplinary Tobacco Use
desirable (for example, the minimal implementation for Research Center
www.tobaccocontrol.com
iii4 Fong, Cummings, Borland, et al
Table 1 Key policy provisions of the Framework governments, not researchers, control policy implementa-
Convention on Tobacco Control (FCTC) tion.3 Furthermore, policy options are often interrelated, so it
is often impossible to consider policies in isolation of other
l Increase tobacco taxes events. However, in the absence of a randomised clinical trial,
l Protect citizens from exposure to tobacco smoke in workplaces, public
there are four strategies that researchers can employ for the
transport and indoor public places
l Enact comprehensive bans on tobacco advertising, promotion and
rigorous evaluation of the effects of policies. First is the use of
sponsorship a quasi-experimental design (the so-called ‘‘natural experi-
l Regulate the packaging and labelling of tobacco products to prevent ment’’) in which one group that is exposed to a policy is
the use of misleading and deceptive terms such as ‘‘light’’ and ‘‘mild’’ compared to a comparable group that is not exposed, as
l Regulate the packaging and labelling of tobacco products to ensure
discussed above. Second is the use of a longitudinal cohort
appropriate product warnings are communicated to consumers, for
example, obligate the placement of rotating health warnings on design in which individuals are measured on the same key
tobacco packaging that cover at least 30% (but ideally 50% or more) outcome variables at multiple times, preferably before and
of the principal display areas and can include pictures or pictograms after a policy is implemented. Combining these two strategies
l Regulate the testing and disclosure of the content and emissions of in a single study yields a two-group, pre-post design, which
tobacco products
l Promote public awareness of tobacco control issues by ensuring offers a higher degree of internal validity than either feature
broad access to effective comprehensive educational and public alone.3 The utility of longitudinal designs is strengthened if
awareness programmes on the health risks of tobacco and exposure there are multiple data collections before and/or after policy
to tobacco smoke implementation as it allows more precise specification of
l Promote and implement effective programmes aimed at promoting
the cessation of tobacco use
effects—for example, taking into account temporal trends
l Combat smuggling, including the placing of final destination that were occurring before the implementation of the policy.
markings on packs A third strategy is the measurement of policy-specific
l Implement legislation and programmes to prohibit the sale of tobacco variables that are theorised to be affected initially after the
products to minors
l Implement policies to support economically viable alternative sources
policy is implemented. For example, in evaluating the impact
of income for tobacco workers, growers, and individual sellers of a new warning label policy on behaviour, one might
reasonably predict that for the policy to exert its effect on
behaviour, the target population must first report noticing
the new warning labels.12 A fourth strategy is the measure-
ment of policy-specific variables for policies that have not
(COMMIT, California, Florida, Massachusetts) with other changed; such variables act as another form of control. For
states whose tobacco control programmes have not been so example, we would expect that in a country where labels
well-funded.9–11 Sub-national activity inevitably excludes many have been enhanced and where taxation has not, label
crucial policies: health warning labels (and other aspects of salience would be enhanced over time, but taxation-relevant
tobacco packaging), restrictions on ‘‘light’’ or ‘‘mild’’ descrip- variables (for example, perceived cost of cigarettes) would
tors, and advertising and marketing restrictions12 13 are not.
typically implemented at a national or international level. Combining these four strategies, accompanied by the
This greater reach increases the potential impact of the inclusion of other explanatory variables (covariates) that
policies.14 Whatever the value of subnational policies—and in might help explain differences between two jurisdictions,
many cases, this value has been substantial—the FCTC has creates a powerful research design allowing more confident
placed national-level policies on centre stage. inferences to be made about the causal effects of policies and/
It follows from first principles of evaluation design that or combinations of policies.3 The design and the survey
evaluation of a policy implemented in one country is most instruments used in the ITC Project together satisfy all of
rigorous if conducted with reference to one or more other these conditions.16 The ITC Project was established with the
countries in which that policy has not been implemented. In goal of measuring the psychosocial and behavioural impact of
other words, evaluation of FCTC policies is best conducted via the FCTC policies on (primarily) adult smoking behaviours.16
international studies. However, there are few international As smokers are most directly affected by tobacco control
studies of tobacco use. To our knowledge, the only existing policies, this understanding is crucial to assessing the extent
international research effort that has some potential in to which they meet their objectives and of desirable and
evaluating the impact of FCTC policies is the Global Youth undesirable collateral effects. The survey component of the
Tobacco Survey (GYTS), which involves school-based surveys ITC Project currently consists of a set of parallel prospective
of youth in over 150 countries.15 Despite its wide scope, cohort surveys of representative samples of adult smokers in
however, the GYTS is limited by its cross-sectional design nine countries—Canada, United States, United Kingdom,
(although the ongoing effort to repeat the GYTS in a large Australia, Ireland, Thailand, Malaysia, South Korea, and
number of countries will increase its value as an evaluation China. The ITC evaluation framework utilises multiple
tool), its exclusive focus on youth, and by the limited number country controls, a longitudinal design, and a pre-specified,
of survey items that directly relate to FCTC policies. theory-driven conceptual model to test hypotheses about the
Although there exist national surveillance surveys in a number anticipated effects of given policies.
of countries, differences across countries in research methods,
questions employed, and the frequency and timing of survey
CONCEPTUAL MODEL OF THE ITC PROJECT
waves reduce their utility for making comparisons. Furthermore,
In addition to designing the ITC Surveys to allow us to make
virtually all of the existing national surveillance efforts are cross-
strong inferences about the effectiveness of policies, we set
sectional, which limits the kinds of causal inferences that can be
out to determine how policies may achieve their desirable
made about the impact of policies on individuals, and thus
effects. For example, we asked whether graphic warning
precludes any specific tests concerning how a given policy
labels have their effect because they merely heighten the
operates to affect the behaviour of individuals.
attention that smokers pay to the warnings or whether they
have their effect because they increase the perceived
THE CHALLENGE OF EVALUATING TOBACCO susceptibility (perceived risk) of the health hazards of
CONTROL POLICIES smoking.
It is not possible to conduct randomised experimental studies We developed a conceptual model of how tobacco control
to evaluate the effects of tobacco control policies because policies might work based on a combination of existing
www.tobaccocontrol.com
ITC Project conceptual framework iii5
models from the psychosocial literature and from health The more downstream effects are on the non-specific
communication theories.17–20 The resulting conceptual model, psychosocial mediators, which are conceptually distant from the
which is presented in fig 1, guided the selection of questions policy and which are theorised to be affected by multiple
included in all ITC Surveys. means, not just policies. Among these are variables such as
Our conceptual model assumes that each policy ultimately self-efficacy and intentions, which come from well-known
has an influence on behaviour through a specific causal chain psychosocial models of health behaviour, including the
of psychological events. Our conceptual model is a general theory of planned behaviour,17 social cognitive theory,18 the
framework for thinking about policies and their effects on a Health Belief Model,19 and Protection Motivation Theory.20
broad array of important psychosocial and behavioural We believe that policies will affect these general mediating
variables, and for testing how policy distinctions relate to variables indirectly, through their prior effects on the policy-
their effectiveness.17–20 specific variables. As each policy has its own policy-specific
Several key characteristics of this conceptual model require variables, to the extent that these are independent, it will
further explanation. First, the model focuses on how policies allow us to estimate the relative contributions of various
affect the behaviour of individual smokers, and thus policies to the outcomes of interest.
circumvents the vexing problem of making inferences about Third, our model explicitly identifies the mediators of
individuals from aggregates (that is, policy studies in which policy and articulates the goal of understanding the
countries are the unit of analysis, or in individual-level psychosocial processes that explain how and why a given
studies that are repeat cross-sectional and for which analyses policy may lead to changes in smoking behaviour. Our
are conducted over time). longitudinal design allows us to test the causal chain of
Second, policies are seen as potentially affecting indivi- effects that is depicted in the model; a repeat cross-sectional
duals along a variety of psychosocial and behavioural design would not.
variables, of which there are two classes. The most immediate The policy-relevant outcomes that we are measuring include
effects are those on the policy-specific variables—that is, those those that confer public health benefits (for example,
variables that are proximal (conceptually closest), or most quitting) but also include important compensatory behaviours
specifically related to the policy itself. Thus, new graphic that the smoker may engage in that, although responsive to
warning labels should increase salience and noticeability of the policy, may not lead to the economic and public health
warnings; price should affect perceived costs of cigarettes (for benefits that are ultimately the goal of such policies. For
example, belief that cigarettes have become too expensive); example, smokers may switch to discount brands in response
and lifting of restrictions on alternative nicotine products to price increases, which would confer no public health
should lead to increased awareness of the availability of those benefit. The ITC Project thus attempts to provide a more
products. These effects may also increase the likelihood of complete picture of the effects that may result from the
discrete behaviours specifically linked to the manifestations implementation of a tobacco control policy, and this complete
of the policy such as smokers hesitating, or even forgoing or picture includes both the detection of desirable effects and of
stubbing out cigarettes because of the warning labels. unintended, undesirable side effects.
Examples of survey questions designed to measure policy- In summary, the general conceptual model is a causal
specific variables are presented in table 2. chain model, and as such, suggests that the policy-specific
Figure 1 Conceptual model illustrating the hypothesised causal chain of how tobacco control policies exert their influence on tobacco use behaviours.
CPD, cigarettes per day; SES, socioeconomic status.
www.tobaccocontrol.com
iii6 Fong, Cummings, Borland, et al
Table 2 Examples of questions designed to measure will be exposed to its consequences in the ways anticipated.
policy-specific variables in the International Tobacco Taking the example of warning labels again, some smokers
Control Surveys barely look at a pack when they are smoking and may rarely
or never notice the warnings. This, however, could be due to
Policy Examples of questions measuring motivated avoidance, and it is important to measure whether
domain policy-specific variables this has an impact on behaviour. In a longitudinal survey of
Product In the last month how often, if at all, have you noticed the Ontario smokers, Hammond et al21 found that avoidance of
warnings warning labels on cigarette packages? the graphic Canadian warning labels by means such as
In the last month, how often, if at all, have you read or covering them up or by putting them in a cigarette case was
looked closely at the warning labels on cigarette not associated at follow-up with a decreased likelihood of a
packages? quit attempt. Additional questions can be addressed. For
Smoke-free Which of the following best describes the rules about example, is it enough for someone merely to notice warnings,
legislation smoking in drinking establishments, bars, and pubs or does one need to read them or otherwise contemplate and
where you live?
l Smoking is not allowed in any indoor area;
accept them? What role do micro-behavioural reactions, such
l Smoking is allowed only in some indoor areas; or as foregoing a cigarette as a result of noticing/reading, play in
l No rules or restrictions determining longer-term outcomes, such as quitting? In
For each of the following public places, please tell me if order to address these and other conceptual questions about
you think smoking should be allowed in all indoor areas, the impact of warning labels, we have included multiple
in some indoor areas, or not allowed indoors at all: measures to determine, empirically, from our survey results
l Hospitals
l Workplaces
which measures may be important in understanding the
l Drinking establishments (e.g. pubs/bars) impact of warning labels. In this regard, we should note that
l Restaurants and cafés the ‘‘best’’ measure for understanding the impact of
Price/taxation Where did you last buy cigarettes for yourself? warnings may depend on whether the warning is text-based
How much did you pay for your cigarettes?
or whether it includes graphic images. We have recognised
the complexities of testing these possibilities at the same time as
The last time you bought cigarettes for yourself, did you
buy them by the carton, the pack, or as single cigarettes?
we recognise their importance and have built in these multiple
The last time you bought cigarettes or tobacco for
measures in each policy domain to test these more specific
yourself, did you use any coupons or discounts to get a hypotheses about the impact of tobacco control policies.
special price?
Pro- and In the last 6 months… how often have you noticed things MODERATOR VARIABLES
counter- that promote smoking? One of the most interesting lines of inquiry in the ITC Project
advertising In the last 6 months, have you noticed cigarettes or is to determine whether a given policy differs in its impact as
tobacco products being advertised in any of the following a function of country. In the near future, for example, we will
places: television, radio, at the cinema/movie theatre
before or after the film/movie, on posters or billboards,
be able to determine whether the impact of graphic warnings
in newspapers or magazines, on shop/store windows or differs across Thailand, Australia, and the UK, three ITC
inside shops/stores where you buy tobacco? countries that have either implemented graphic warnings
Now I would like you to think about advertising or (Thailand), announced that they will (Australia), or is
information that talks about the dangers of smoking, or currently considering implementation (UK). Thus country is
encourages quitting. In the last 6 months how often, if at an important moderator variable in our conceptual model.
all, have you have noticed such advertising or
information?
Further, within a country, we will be testing for differential
policy impact on subgroups of a population, and have thus
Product Do you agree with this statement about ‘‘light’’ cigarettes:
included variables to determine which subgroups are more
regulation ‘‘Light cigarettes are less harmful than regular
cigarettes’’? favourably (and less favourably) influenced by FCTC policies.
These moderators fall into five broad classes: sociodemo-
graphics (for example, age, sex, SES, ethnic background);
past behaviour (for example, smoking history, current
consumption (cigarettes per day), quit attempts); personality
variables play a critical mediating role because they reside characteristics (for example, time perspective, coping style,
between the policy and the outcome variables that are tendency to avoid or confront potential stressors); other
important in public health—for example, quitting behaviour. environmental effects (for example, stress levels); and
These causal paths from policy-specific variables to behaviour potential exposure to policy (for example, unemployed people
could be direct, but more typically, will be through the more will be less affected by workplace smoking policies). In the
general mediators, and indeed, in some cases there may be latter case, we sometimes restrict the analyses to the affected
pathways through several kinds of mediators, both policy- sector of the population. Dealing with hypothesised mod-
specific and non-policy specific. We theorise that policies vary erators is relatively straightforward when they are postulated
in the psychosocial ‘‘routes’’ that they take to affect merely to add predictive power to linear models. The issues
behaviour—that is, we have specified different mediational become more complex when different mediational pathways
models for each policy domain. For example, noticing are postulated for subpopulations. For example, warning
warnings may first increase perceived risk of the hazards of avoiders might change behaviour through more emotion-
smoking, which should affect overall attitudes and outcome related pathways, while those who take in the information,
expectancies, which affect intentions, which in turn affect might be influenced through more cognitive pathways. The
behaviour. The design of our study is guided by the possibility ITC Project has the capacity to build separate models for these
of disentangling the web of alternative explanations and different subpopulations and thus to test conceptual models of
competing forces through the careful selection of specific the health behaviour at the national and international level.
mediators.
Our conceptual model provides us with the opportunity to WHAT HAPPENS IF OUR THEORETICAL MODELS ARE
test how policies impact or fail to impact behaviour as WRONG?
anticipated. For example, the mere existence of a policy, even Our goals are to evaluate the impact of policy and to
if implemented properly, does not guarantee that smokers understand the mechanisms of impact. If our mediational
www.tobaccocontrol.com
ITC Project conceptual framework iii7
models are not confirmed in our analyses of policy impact, cross-sectional design. This dual design feature allows us to
this provides an opportunity to explore the reasons why and, measure the effects of attrition and time-in-sample.16
to the extent possible, to build alternative models that might In many areas, these four countries are at the cutting edge
help us understand why a policy had (or failed to have) its of tobacco control policies or initiatives, and since the survey
desired impact. One theoretical innovation we have made in began, and over the next few years, there will be a number of
the ITC Surveys is to include variables from a range of major national-level tobacco control policies implemented in
theoretical frameworks to enable us to test alternative at least one of them. And so, the ITC Four Country Survey
conceptions.17–20 For example, in several policy domains, we will allow us to evaluate the implementation of different
have included not only the standard strength of belief FCTC policies at multiple points in time within the same
measures, but also measures of frequency. Although these country, with multiple countries as control/comparison
measures are not conventional in public health, they are of groups.
importance in social psychological research, and will allow us Over time, we will also be able to test the effects of
to test fine-grained conceptualisations based on attitude implementations of the same tobacco control policy across
accessibility, rather than just the more conventional measure different countries. For example, in 2006, Australian warning
of attitude strength.22 labels will include graphic photographs. Similarly, following
the recent enabling Directive from the European
Commission, UK warning labels may also include graphic
WHAT POLICIES ARE WE ABLE TO EVALUATE images in the near future. We will thus be able to compare
THROUGH THE ITC SURVEYS? the impact of similar policies in different countries—and thus
ITC Surveys are designed to evaluate the effects of policies on to begin addressing issues of the homogeneity versus
smokers, and increasingly, as our cohorts mature, recent ex- heterogeneity of policy effects across different countries.
smokers.16 We are evaluating all of the demand reduction Our capacity to do so is enriched owing to the launch of the
provisions in the FCTC as implemented in the ITC countries: ITC Southeast Asia Survey in Thailand and Malaysia in
packaging and labelling (Article 11), including health January 2005, described below in more detail. Thailand
warnings and the elimination of potentially misleading introduced graphic warnings in March 2005, and Malaysia is
descriptors (for example, ‘‘light’’ or ‘‘mild), restrictions/bans currently considering doing the same in the future. Because
on advertising, promotion, and sponsorship (Article 13), all ITC surveys share identical/similar measures from the
protection from exposure to tobacco smoke (Article 8), price identical conceptual framework and analytic plan, we will be
and tax measures to reduce demand (Article 6), dependence able to compare the effectiveness of the graphic warnings in
and cessation (Article 14), and some aspects of education, Thailand, Australia, and the UK.
communication, training, and public awareness of the
dangers of tobacco use (Article 12).
THE UTILITY OF THE ITC CONCEPTUAL MODEL IN
We have recently started to assess changes in cigarette
THE ITC FOUR COUNTRY SURVEY
brands produced by manufacturers to assess more directly
Several of the papers in this supplement illustrate the utility
how they have altered their cigarette brands in response to
of the model to understanding how tobacco control policies
different policies, and to be able to factor these changes in to
affect distal mediating variables and smoking behaviour
our understanding of the determinants of changes in
indirectly, through their prior effects on the policy-specific
smoking patterns. In addition, with the formation of the
variables.12 24–26 28 Harris et al24 examined changes from Wave
Roswell Park Transdisciplinary Tobacco Use Research Center
1 and Wave 2 of the ITC Four Country Survey on the noticing
(TTURC) funded by the US National Institutes of Health
of advertising/promotion in three different channels: bill-
(NIH), we, in collaboration with the US Centers for Disease
boards/posters, newspapers and magazines, and sponsorship
Control and Prevention, are increasing our capacity to
of sports events. Between Wave 1 and Wave 2, the UK
understand cigarette engineering and how that might change implemented a comprehensive ban on advertising and
in response to policy initiatives, which is the focus of Articles promotion. Our theoretical model predicted that noticing
9 and 10 of the FCTC (see below). the presence of tobacco products, advertising, or sponsorship
would decline in the UK, relative to the other three countries.
THE ITC FOUR COUNTRY SURVEY Indeed, the findings from Harris et al24 shows precisely that
Based on the above principles, we created the International pattern as policy-relevant variables changed only in those
Tobacco Control Four Country Survey. Table 2 presents channels where the policy was changed over time and not in
examples of policy-relevant variables, psychosocial media- those channels where the policy was left unchanged among
tors, and behavioural variables that were included in the the same individuals in the same country. Moreover, whereas
ITC Four Country Survey, which is available at: http://www. Canadian smokers did not vary from the USA and Australia
itcproject.org/Research_Methods/research_methods.htm. in noticing the presence of tobacco messages in a number of
The specific details of our survey methods, along with key channels, they reported a significant decline in noticing
survey statistics, are presented in Thompson et al.16 The ITC tobacco sponsorships of sporting events, owing to Canada’s
Four Country Survey is a random digit dialled telephone own imminent ban on tobacco sponsorships coinciding in
survey of over 2000 randomly selected smokers in each of the time with the UK’s sponsorship ban. This kind of specifi-
four largest English-speaking countries: Canada (where we city—precisely as would be predicted by the pattern and
created a French version of the survey for the francophone timing of advertising/promotion/sponsorship policies—
regions), the United States, the United Kingdom, and demonstrates strong convergent and discriminant validity
Australia. Wave 1 was conducted during October-December of the ITC Survey.
2002, Wave 2 during May-August 2003, Wave 3 during June–
December 2004, and Wave 4 from September–December EVALUATION OF SUB-NATIONAL POLICIES
2005. Beginning in 2005 with Wave 4, these annual survey We recognise that important tobacco control policies are
waves will be conducted during the last quarter of the year, implemented not only at the national level, but also at sub-
through 2009. At each wave, cohort members lost to attrition national levels within a country. Sub-national policies are
are replaced by newly recruited respondents from the same most apparent in the USA and Canada, with variation in
sampling frame. Thus, at each wave, the ITC Four Country environmental tobacco smoke (ETS) restrictions, taxation,
Survey incorporates both a cohort design and a repeat and product regulation at the state and provincial level25–27
www.tobaccocontrol.com
iii8 Fong, Cummings, Borland, et al
which might be regulated nationally in other countries. The cohort was followed up during December 2004–January
Taxation is implemented at a national level in Australia and 2005, after the smoke-free law had been in place for about
the UK, as are most other policies in the UK, except ETS eight months. The ITC Ireland/UK Survey is the first quasi-
restrictions that are currently being developed separately in experimental evaluation study of the effects of the March
Scotland and England, and are state-based in Australia. 2004 comprehensive smoke-free law in Ireland, and demon-
Where the sample sizes are sufficiently high we will test for strated that the law led to a near-total reduction of tobacco
the effects of sub-national policies. smoke in key public venues such as in bars/pubs, where
We have demonstrated this capacity using Wave 1 data reported presence of smoking fell from 98% to 4% in Ireland
from the ITC Four Country Survey to explore how variation in in contrast to the UK, where exposure to tobacco smoke
tobacco taxes and strength of indoor smoking rules impact remained the same. This was accompanied by significant
smoking behaviour and relevant beliefs across different increases in support for the smoke-free law among our
regions of the USA.23 25 26 In New York State, where cigarette national representative sample of adult smokers in Ireland.
prices are among the highest in the USA, 25% of the New These results are presented by Fong et al in this supplement.28
York smokers in our survey reported buying most of their In January 2006, we launched an expansion of the ITC
cigarettes from a low or untaxed source such as the internet, Ireland/UK Survey over three years to evaluate the impact of
compared to less than 2% in the rest of the USA.23 25 Those Scotland’s smoke-free law (implementation date: 26 March
who resided in the seven states that increased cigarette excise 2006), using England as the control. And England will
taxes between Wave 1 and Wave 2 were more likely to report implement its own comprehensive smoke-free law in 2007,
making special efforts such as travelling to another state to which we will evaluate with this same ongoing cohort survey.
purchase cheaper cigarettes compared to those who lived in In addition to bolstering the size of the cohort in Scotland, we
states that did not increase excise taxes.23 25 A similar sub- also added a nationally representative cohort of non-smokers
national analysis of smokers revealed much stronger support in Scotland, England, and the other parts of the UK to enrich
for smoking bans in places like California that have already our evaluation of the impact of smoke-free policies over time.
enacted such rules, compared to localities not covered by a
ban on indoor smoking.26 These data have also provided
ITC Surveys in Asia: Thailand, Malaysia, South Korea,
utility for educating policymakers as they have been
and China
presented to help identify the benefits and potential pitfalls
A second important expansion of the ITC Project is in Asia,
of tax increases and clean indoor air policies. It is clear from
where over half of the world’s smokers live, and where
these two examples that although our focus is on national
consumption is expected to increase in the coming decades,
level policies, we do indeed have the ability to identify and
particularly among females, who currently are significantly
examine differences within-country and disseminate those
less likely to smoke. Our first expansion was in two middle-
data to key target audiences.
income, Southeast Asia countries—Thailand and Malaysia.
The ITC Southeast Asia Surveys are parallel cohort surveys of
CURRENT AND FUTURE DIRECTIONS FOR THE ITC 2000 adult smokers and 1000 youth in each country. We
PROJECT employed a multistage cluster sampling design, with face-to-
As the ITC Project has evolved and expanded, we have face interviews in the adult smoker sample and self-
endeavoured to establish a platform and infrastructure for a completed questionnaires in the youth sample. The ITC
sustained cooperative research effort with countries through- Southeast Asia Surveys were based on the original ITC Four
out the world to evaluate the psychosocial and behavioural Country Survey in that they included items from each of the
effects of tobacco control policies. The ITC Project began its demand reduction policy domains of the FCTC, and the
evaluation of FCTC policies in four high-income countries question wording was identical or very similar, changing only
that have been among the leading countries in tobacco in cases when pilot testing indicated that an item was not
control. We did so because of the need to first establish the easily understood. The initial wave of the ITC Southeast Asia
design and protocols of the overall evaluation effort in Survey was conducted January–March 2005, just before the
countries where the research capacity and resources were introduction of the graphic warning labels in Thailand in late
available to conduct large-scale national surveys. March 2005. Our current plan is to conduct yearly follow-up
Demonstrating the viability and power of the ITC Survey survey waves, and at each wave, to employ the same
design in the four countries has allowed us to move forward replenishment procedures as in the ITC Four Country
toward our goal of adding countries that would vary on Survey—recruitment of new respondents from the same
important dimensions, notably on economic development, sampling frame.
global region, and in countries where tobacco control policies Thailand and Malaysia serve as models for tobacco control
(notably of the FCTC) were likely to be implemented in the in developing countries within Asia and beyond as both
near future. Over the past three years, we have thus engaged countries have committed to a range of policy initiatives and
in strategic expansion so that the present set of ITC have an established network of tobacco control researchers
participating countries constitute a broader, more diverse and resources. Thailand and Malaysia also have important
set of countries within which to evaluate the policies of the similarities such as per capita gross domestic product and
FCTC. Our future plans for expansion will broaden the set of geographical proximity. There are also important differences
ITC countries to an even greater extent. between the two countries. Thailand has had a long history of
We now describe the expansion of the ITC Project beyond strong tobacco control policies and programmes whereas
the ITC Four Country Survey. Malaysia has only recently begun its commitment to strong
tobacco control. In addition, religious and cultural differences
ITC Ireland/UK Survey between the two countries will allow us to examine the
In December 2003, we launched the first wave of the ITC relation of these factors to tobacco control policy. In short,
Ireland/UK Survey to evaluate the March 2004 comprehen- Thailand and Malaysia meet both the conceptual and
sive workplace smoke-free law in Ireland.28 The survey pragmatic requirements for the ITC Project, and the inclusion
methods were virtually identical to the ITC Four Country of both countries will allow us to examine the impact of key
Survey, consisting of a random digit dialled telephone cohort tobacco control policies in social, political, and economic
survey, with 1000 adult smokers in Ireland, and a parallel environments that vary considerably from those in the
control/comparison survey of 600 adult smokers in the UK. original four countries. If we can demonstrate similar effects
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ITC Project conceptual framework iii9
of policies in these countries to those occurring in our original with additional efforts toward developing similar projects in
four (affluent, largely English speaking) countries, it will India and in other countries), we will begin to address the
help to demonstrate the generality of policy impact. However, important basic question of whether the effectiveness of a
differences in response to policies will allow us to understand given tobacco control policy is relatively consistent or
what kinds of policy differences are required (if any) in inconsistent in its effectiveness across income levels, across
particular cultures. cultures, and across geographical regions. If policy effective-
An important feature of the ITC Southeast Asia Project is ness varies across countries, we may be able to identify
the inclusion of the youth survey. As in Western countries, factors that may explain that variability. At a broader level,
the great majority of smoking initiation in Asia occurs in these questions about generality versus specificity of policy
adolescent populations. The inclusion of a youth cohort of the effects across countries is part of a broader set of important
ITC Southeast Asia Survey allows us to identify the questions about the extent to which one country’s experi-
determinants of uptake, the transition to adult smoking, ences with tobacco (or tobacco control, or other health
and impact of various policies on this process in Thailand and challenges) can generalise to those of another country.
Malaysia. In addition, it will provide us with the potential for An initial foray into addressing this broader issue of
examining similarities and differences in how youth and generality versus specificity was made by Fong et al,29 who
adults may respond to tobacco control policies in those two examined the level of regret among smokers in the ITC Four
countries. Country Survey. We found that the experience of regret about
In November 2005, we launched the ITC Korea Survey, a smoking (‘‘if you had to do it over again, you would not have
collaboration of the ITC research team and researchers at the started smoking’’) was nearly universal (about 90%) and no
National Cancer Center of South Korea. The ITC Korea different across the four countries. Moreover, the predictors
Survey is a random digit dialled telephone survey of 1000 of regret (a long and broad list, including demographic
adult smokers in South Korea. The survey instrument itself, variables, perceived addiction, perceived cost, anticipated
along with the sampling design and protocol, are identical or future health damage from smoking) did not vary in their
very similar to the ITC Four Country Survey and ITC Ireland/ predictive power across the four countries: the country 6
UK Survey, which will allow strong comparisons to be made. predictor interaction was not statistically significant, despite
In April 2006, we launched the first wave of the ITC China the very high statistical power available because of the very
Survey, a collaboration of the ITC research team and the large sample size. Whatever cultural differences may exist
China Centers for Disease Control and Prevention. China is across these four countries, the experience of regret and the
home to 30% of the world’s smokers—a total of about 350 factors that predict regret are no different. It remains to be
million—and in recognition of the ominous future that these seen whether the level of regret and the factors that predict
statistics portend, China ratified the FCTC in August 2005. regret varies across the broader range of countries that have
The ITC China Survey will be an annual prospective cohort joined the ITC Project. An initial investigation by Lee et al30 of
survey (face-to-face) of about 5600 adult smokers and 1400 ITC Southeast Asia Survey data has shown that the level of
adult non-smokers across seven cities in China: Beijing, regret in Thailand is similar to that of the original four
Shanghai, Guangzhou, Zhengzhou, Changsha, Yinchuan, and countries, but that the level of regret in Malaysia is
Shenyang. The multistage sampling design is similar to the significantly lower (about 80%). The difference may reflect
design used in the ITC Southeast Asia Surveys, and the the fact that Thailand has had a longer history of strong
survey instrument, as with all ITC Surveys, consists of core tobacco control policies and advocacy, with norms for tobacco
items evaluating all of the FCTC demand reduction policies, use being considerably more negative than in Malaysia,
with some China-specific measures added to the core survey which has only more recently made a strong commitment to
instrument. In our construction of the sampling frame, we tobacco control.
are enumerating 6000 households in each city, and because As the ITC Project goes forward in our expansion process,
we are recording smoking status of all household members, we will be able to address the question of generality versus
we will be able to generate very good estimates of smoking specificity, commonality versus uniqueness, in the experience
prevalence in each city. Indeed, the ITC China Survey is being of tobacco use, and, importantly for the trajectory of the
used by the China Office of Tobacco Control as a tool for FCTC, in the impact of FCTC policies.
China’s surveillance efforts in the context of the FCTC. Wave
1 of the ITC China Survey launched in April 2006. ITC PRODUCT TRACKING PROJECT
Conducting the ITC Survey in these four Asian countries It is becoming increasingly clear that the tobacco problem
will allow comparisons to be made within Asia along a requires a coherent and integrated systemic response that
number of important dimensions—for example, comparisons takes into account both the motivations and understandings
between high versus middle/low income countries (Korea of smokers, but also the motivations and actions of those
versus China, Thailand, Malaysia), and history of tobacco who market tobacco products.31–34 Evidence from internal
control policies (Thailand being the country with the longest industry documents reveals that cigarette manufacturers
history versus the other three countries, with more recent have been successful in large measure by their ability to adapt
commitments to tobacco control). All four countries have to a changing policy environment.31 For example, cigarette
ratified the FCTC, and will begin (or continue) to implement manufacturers changed their marketing strategies in
FCTC policies in the near future. With our multiple country response to government efforts to warn consumers about
design, within Asia, and in the other non-Asian countries, the health risks of smoking (for example, creation and
the ITC Project is positioned to identify the commonalities as increased promotion of low tar brand extensions) and restrict
well as the dissimilarities of the impact of FCTC policies in advertising (for example, event sponsorships, direct market-
this critical region of the world, and to make comparisons in ing through mailing lists). It is important for policy
policy impact between Asian and non-Asian countries of the researchers to not only study how policies impact consumers
ITC Project. but also to learn how the industry adapts its products and
marketing efforts to maximise sales or otherwise maintain
Further expansion and addressing the issue of their profitability.
generality versus specificity Towards this goal, the ITC Project has established the first
As our expansion continues (at this time, we are developing international repository of selected popular cigarette brands
ITC Surveys in New Zealand, France, Mexico, and Uruguay, as a way of monitoring and evaluating changes in cigarette
www.tobaccocontrol.com
iii10 Fong, Cummings, Borland, et al
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ITC Project conceptual framework iii11
and intentions, and on subsequent tobacco use behaviours. 5 Chaloupka FJ, Hu TW, Warner KE, et al. The taxation of tobacco products. In:
Jha P, Chaloupka F, eds. Tobacco control in developing countries. New York:
Identifying the mechanisms through which tobacco control Oxford University Press, Inc, 2001:237–72.
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7 Borland R, Hill D. Initial impact of the new Australian tobacco health warnings
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researchers, advocates, and governments toward meeting the 2005;29:85–90.
10 Wakefield M, Chaloupka F. Effectiveness of comprehensive tobacco control
threat. We hope that through the efforts of our ITC Project programmes in reducing teenage smoking in the USA. Tob Control
team and those of other tobacco control researchers 2000;9:177–86.
throughout the world, the FCTC process will fulfil its 11 Farrelly MC, Pechacek TF, Chaloupka FJ. The impact of tobacco control
program expenditures on aggregate cigarette sales: 1981–2000. J Health
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policies, informed by evidence from the best available 12 Hammond D, Fong GT, McNeill A, et al. Effectiveness of cigarette warning
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ACKNOWLEDGEMENTS 13 Fong GT. Evaluating the Effects of the September 2003 European Union Policy
We thank Craig Steger and Christian Boudreau for their comments Banning ‘‘Light/Mild’’ Cigarette Brand Descriptors: Findings from the
International Tobacco Control Policy Evaluation Survey. Report Submitted to
on preliminary versions of this article. We thank Taryn Sendzik, Tara
Health Canada, January 13, 2005 (Contract #, 4500095771).
Elton-Marshall, Alexandra Lin Marie Fong, Stacey Jahn, Carol 14 Velicer WF, DiClemente CC. Understanding and intervening with the total
Murray, Ruth Loewen, and Pete Driezen for their assistance. population of smokers. Tob Control 1993;2:95–6.
15 Warren CW, Riley L, Asma S, et al. Tobacco use by youth: a surveillance
..................... report from the Global Youth Tobacco Survey project. Bull Wrld Health Organ
2000;78:868–76.
Authors’ affiliations 16 Thompson ME, Fong GT, Hammond D, et al. Methods of the International
G T Fong, Department of Psychology, University of Waterloo, Waterloo, Tobacco Control (ITC) Four Country Survey. Tob Control 2006;15(suppl
Ontario, Canada III):iii12–18.
K M Cummings, A Hyland, G A Giovino, Department of Health 17 Ajzen I. The theory of planned behavior. Organizational Behavior and
Behavior, Roswell Park Cancer Institute, Buffalo, New York, USA Human Decision Processes 1991;50:179–211.
18 Bandura A. Social foundations of thought and action: a social-cognitive
R Borland, Cancer Control Research Institute, The Cancer Council theory. Englewood Cliffs, New Jersey: Prentice-Hall, 1986.
Victoria, Carlton, Victoria, Australia 19 Becker MH. The health belief model and personal health behavior. Thorofare,
G Hastings, Institute for Social Marketing and Centre for Tobacco New Jersey: Charles B Slack, 1974.
Control Research, University of Stirling and the Open University, Stirling, 20 Rogers R, Prentice-Dunn S. Protection motivation theory. In: Gochman D, eds.
UK Handbook of health behavior research: Vol. 1. Determinants of health
behavior: personal and social. New York: Plenum, 1997:113–32.
D Hammond, Department of Health Studies and Gerontology, University 21 Hammond D, Fong GT, McDonald PW, et al. Impact of the graphic Canadian
of Waterloo, Waterloo, Ontario, Canada warning labels on adult smoking behaviour. Tob Control 2003;12:391–5.
M E Thompson, Department of Statistics and Actuarial Sciences, 22 Fazio RH, Williams CJ. Attitude accessibility as a moderator of the attitude
University of Waterloo, Waterloo, Ontario, Canada perception and attitude-behavior relations: an investigation of the 1984
presidential election. J Personality and Soc Psych 1986;51:505–14.
The ITC Project is supported by grants R01 CA 100362 and P50 23 Cummings KM, Hyland A, Travers M, et al. Cigarette purchase patterns and
CA111236 (Roswell Park Transdisciplinary Tobacco Use Research cigarette prices: US Data from the International Tobacco Control Policy
Center) from the National Cancer Institute of the United States, Robert Evaluation Survey. Paper presented at the Society for Research on Nicotine
and Tobacco, Arizona, February, 2004.
Wood Johnson Foundation (045734), Canadian Institutes of Health 24 Harris F, Mackintosh AM, Anderson S, et al. Effects of the 2003 advertising/
Research (57897), National Health and Medical Research Council of promotion ban in the United Kingdom on awareness of tobacco marketing:
Australia (265903), Cancer Research UK (C312/A3726), Canadian findings from the International Tobacco Control (ITC) Four Country Survey.
Tobacco Control Research Initiative (014578); Centre for Behavioural Tob Control 2006;15(suppl III):iii26–33.
Research and Program Evaluation, National Cancer Institute of Canada/ 25 Hyland A, Laux FL, Higbee C, et al. Cigarette purchase patterns in four
Canadian Cancer Society. Role of the funding sources: The funding countries and the relationship with cessation: findings from the International
Tobacco Control (ITC) Four Country Survey. Tob Control 2006;15(suppl
sources had no role in the study design, in the collection, analysis, and III):iii59–64.
interpretation of data, in the writing of the report, and in the decision to 26 Borland R, Young H-H, Siahpush M, et al. Support for and reported
submit the paper for publication. compliance with smoke-free restaurants and bars by smokers in four countries:
findings from the International Tobacco Control (ITC) Four Country Survey.
Competing interest statement: All authors declare that the answer to the Tob Control 2006;15(suppl III):iii34–41.
questions on the competing interest form www.bmj.com/cgi/content/ 27 O’Connor RJ, Giovino GA, Fix BV, Hyland A, et al. Smokers’ reactions to
full/317/7154/291/DC1 are all ‘‘No’’ and therefore have nothing to reduced ignition propensity cigarettes. Tob Control 2006;15:45–9.
declare. 28 Fong GT, Hyland A, Borland R, et al. Reductions in tobacco smoke pollution
and increases in support for smoke-free public places following the
Ethics approval: This manuscript is a review and presentation of the implementation of comprehensive smoke-free workplace legislation in the
conceptual framework of the International Tobacco Control Policy Republic of Ireland: findings from the ITC Ireland/UK Survey. Tob Control
Evaluation Project and as such, there are no primary data presented 2006;15(suppl III):iii51–8.
29 Fong GT, Hammond D, Laux FL, et al. The near-universal experience of regret
in this manuscript. Hence, ethics approval is not relevant for this among smokers in four countries: findings from the International Tobacco
manuscript. Control Policy Evaluation Survey. Nic Tob Res 2004;6(suppl 3):S341–51.
30 Lee WB, Zanna MP, Fong GT, et al. Regret, rationalization, and intentions to
quit among smokers in Malaysia and Thailand: findings from the ITC
Southeast Asia survey. Paper to be presented at the 13th World Conference
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