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5
Methods for Studying Risk Perception
and Risk Communication
According to the Family Smoking Prevention and Tobacco Control
Act of 2009 (FSPTCA),1 consumer perceptions of labels or marketing state-
ments for modified risk tobacco products (MRTPs) should be tested to
show that they will not mislead the consumer to believe that the product
is less harmful or demonstrates less risk than is actually true. As such, on
an annual basis, pre- and postmarket studies should be conducted to dem-
onstrate that current and potential consumers of each MRTP understand
the actual and relative risks of the product. As discussed in Chapter 1, the
FSPTCA articulates a public health standard whereby product sponsors
must conduct studies on the effect of the product on the population as a
whole. As outlined in the law, this evaluation of the health of the popu-
lation must include studies demonstrating that (1) perceptions of less
risk from the MRTP do not result in nontobacco users initiating tobacco
use, (2) existing tobacco users who would otherwise consider quitting
all tobacco products do not switch to this new MRTP, and (3) usage of
tobacco products does not increase as a result of this new product.
This chapter begins with a brief review of how users and nonusers
perceive tobacco-related outcomes, including perceptions of epidemio -
logic data, short- and long-term risks to the individual, addiction, and
potential benefits. Careful attention is given regarding perceptions of dif -
ferent types of tobacco products, as well as how perceptions of tobacco
1 Family Smoking Prevention and Tobacco Control Act of 2009, Public Law 111-31, 123 Stat.
1776 (June 22, 2009).
191
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192 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
use outcomes vary by age and demographics. Next, the chapter outlines
the standards for studies on risk perceptions, including the questions
that should be addressed through the studies, standards for the research
designs, participant recruitment, measurement, and analysis.
BACKGROUND AND RATIONALE:
IMPORTANCE OF RISK PERCEPTIONS
Judgments about risk, otherwise known as risk perceptions, are
viewed as a fundamental element of most theoretical models of health
behavior and behavioral decision making, including social cognitive
theory (Bandura, 2001), the health belief model (Rosenstock, 1974),
the theory of reasoned action (Fishbein and Ajzen, 1975), the theory of
planned behavior (Ajzen, 1985), self-regulation theory (Kanfer, 1970), and
subjective culture and interpersonal relations theory (Triandis, 1977). In
general, these models argue that individuals’ perceptions about the value
and likelihood of behavior-related positive and negative consequences
and their vulnerability to those consequences play a key role in behav -
ioral choices. As such, understanding individuals’ perceptions of tobacco-
related products, including MRTPs, whether such perceptions change
over time with the introduction of MRTPs, and whether such percep-
tions play a role in tobacco use behavior, is critical. The committee also
acknowledges, as the 2007 Institute of Medicine (IOM) report articulated,
that perceptions of risk (and benefit) may have differing implications for
product use among different consumers. It is important to understand
both the risk (and benefit) perceptions of the consumer and the value that
is placed upon these perceptions.
In the next few sections, the committee provides an overview of the
literature on tobacco-related perceptions, followed by methodological
considerations to design studies to determine perceptions and behavioral
implications of MRTPs.
PERCEPTIONS OF EPIDEMIOLOGIC DATA FOR TOBACCO USE
It is critical to first understand the extent to which both tobacco users
and nonusers understand the actual risks of tobacco use, compared to
epidemiologic data. Much of the literature comparing perceptions to actual
data suggests that, on average, smokers overestimate the risks of smok-
ing (Borland, 1997; Johnson et al., 2002; Kristiansen et al., 1983; Viscusi,
1990, 1991, 1992), while other studies show that smokers underestimate
them (Arnett, 2000; Hansen and Malotte, 1986; Leventhal et al., 1987;
Schoenbaum, 1997; Sutton, 1998; Virgili et al., 1991). Among adolescents
and young adults (ages 18–22), Jamieson and Romer (2001) found that
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METHODS FOR STUDYING RISK PERCEPTION
70 percent of smokers and 79 percent of nonsmokers overestimated the risk
of contracting lung cancer from smoking. Just over a third of the smokers
and more than 40 percent of nonsmokers overestimated the risk of death
from smoking, and 41 percent of smokers and 27 percent of nonsmokers
either underestimated or did not know this rate (Jamieson and Romer,
2001). About a quarter of the nonsmoking participants and 21 percent of
the smokers also underestimated the number of years of life that would be
lost due to smoking, and they inaccurately perceived more deaths caused
by gunshots, car accidents, alcohol, and other drug use than by smoking
cigarettes (Jamieson and Romer, 2001). Given people’s limited understand-
ing of tobacco-related risk, MRTP labels and advertisements should be
careful to convey information on tobacco-related risks accurately and in a
manner that can be fully comprehended by the general population.
PERCEPTIONS OF TOBACCO-RELATED RISKS
AND BENEFITS TO THE INDIVIDUAL
A great number of studies have examined both smokers’ and non-
smokers’ perceptions of tobacco-related outcomes, including perceived
short- and long-term health risks, social risks, risks of becoming addicted,
risks from secondhand smoke, and cumulative risks. Findings on these
tobacco-related perceptions as well as the important relationship between
perceptions and tobacco use are reviewed next.
Historically, studies of tobacco-related perceptions were largely
focused on perceptions of long-term health risks associated with smok-
ing, such as heart attack and lung cancer. More recently, there has been an
emphasis on short-term health and social risks that are more pertinent to
adolescents and even adults, such as the smell of cigarettes, the yellow -
ing of teeth, and the possibility of getting into trouble (Gritz et al., 2003;
Halpern-Felsher et al., 2004; IOM, 2007; Prokhorov et al., 2002).
Studies have also examined whether such tobacco-related perceptions
are related to actual tobacco use. There have been a number of studies
that have relied on cross-sectional data to test the relationship between
adolescents’ perceived tobacco risk and actual tobacco use. The bulk of
these findings indicate that adolescents who have smoked hold lower
perceptions of risk than adolescents who have not smoked (Jamieson and
Romer, 2001; Romer and Jamieson, 2001).
Using prospective, longitudinal data to examine whether perceptions
actually predict the initiation of tobacco use, Song and colleagues (2009b)
showed that, compared to adolescents with the highest perceptions of
tobacco-related risks, adolescents with the lowest perceptions of tobacco-
related long-term risks were 3.64 times more likely to initiate tobacco use.
The same relationship was observed with perceptions of short-term risks,
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194 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
whereby the adolescent participants who believed that tobacco-related
short-term risks were unlikely were 2.68 times more likely to initiate
smoking compared to adolescents with higher perceptions of short-term
risks (Song et al., 2009b).
In addition to understanding the extent to which adolescent and adult
smokers and nonsmokers perceive tobacco-related risks and whether
these risk perceptions deter tobacco use, it is critical to learn the extent
to which perceived tobacco-related benefits motivate individuals to use a
tobacco product. Indeed, studies provide support that perceived benefits
are an equally, if not more important, component of the decision equa-
tion. For example, Prokhorov and colleagues (2002) found that scores on a
smoking-related pros or benefits scale increased and con scores decreased
as adolescents became more susceptible to smoking. Pallonen et al. (1998)
showed that nonsmokers were more likely to initiate tobacco use if they
perceived more smoking benefits, whereas perceived smoking risks were
less related to smoking onset.
Halpern-Felsher et al. (2004), as well as Goldberg et al. (2002), found
that participants who have smoked perceive benefits more likely to occur,
and risks less likely to occur, compared to adolescents who have not
smoked. Results from more recent longitudinal studies have demonstrated
that adolescents who report the highest perceptions of smoking-related
benefits are as much as 3.3 times more likely to initiate smoking (Song
et al., 2009b), and that adolescents who have experimented with as little
as one puff of cigarette have greater perceptions of benefits compared to
those who have never smoked (Morrell et al., 2010).
In summary, adolescents’ perceptions of the risks and benefits of ciga-
rette smoking play an important role in adolescents’ decisions to smoke,
and adolescents with lower perceptions of tobacco risks are more likely to
initiate tobacco use. It is therefore essential that studies of consumer per-
ceptions examine whether the information about MRTPs that is provided
to consumers affects the perceived risks and benefits of the products, and
what implications these perceptions have for subsequent use of the MRTP
in relation to pre-existing tobacco products. Given that adolescence is a
period of heightened vulnerability for the initiation of tobacco use, it is
particularly important to evaluate whether adolescents accurately under-
stand the purported benefits of an MRTP. The ethical considerations for
studies involving populations at high risk for tobacco initiation, such as
adolescents, are discussed in Chapter 2 and Chapter 6.
Other aspects of tobacco-associated risks that are not fully understood
by many adolescents and young adults include misunderstandings about
nicotine addiction and the ability to quit using tobacco products. Studies
suggest that smokers and nonsmokers are not fully aware of the addictive
nature of smoking (Arnett, 2000; DiFranza et al., 2011; Halpern-Felsher et
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METHODS FOR STUDYING RISK PERCEPTION
al., 2004; Leventhal et al., 1987; Slovic, 1998, 2001). It is argued that adoles-
cent smokers may be less concerned about the long-term risks of smoking
partly because they believe that they can stop smoking easily and at any
time (Arnett, 2000; Halpern-Felsher et al., 2004; IOM, 2007; Slovic, 1998).
Perceptions of addiction go beyond the physical need to smoke, and
include fulfilling an emotional or social need, such as avoiding unpleas -
ant mood states or wanting to socially relate to others (Johnson et al.,
2003). Rugaska et al. (2001) concluded that youth perceive dependence
risks to be associated solely with adult smoking; the authors found that
adolescents believe their underage smoking for social settings was safe, in
contrast to adults who smoke to cope with everyday life stress.
Weinstein et al. (2004) examined smokers’ beliefs concerning the ease
of quitting and the nature of addiction. They found that more than 96
percent of the adolescents and adults in their study agreed with the state -
ment, “the longer you smoke, the harder it is to quit,” and most believed
that addiction develops quickly. Other analyses have found that smokers
are relatively optimistic about the idea of addiction, believing that smok-
ing cessation is not that difficult (Jamieson and Romer, 2001) and overes-
timating the ease with which a smoker can quit (Weinstein et al., 2004).
When inquired about the ease of quitting smoking, adolescents with
smoking experience believed they will find it easier to quit and will be
more likely to quit smoking compared to adolescents without smok-
ing experience (Halpern-Felsher et al., 2004). Arnett (2000) found that
60 percent of the adolescents and almost half of the adults in their study
endorsed the idea that they could smoke for a few years and then quit if
and when they wanted. Weinstein et al. (2005) found differences in per-
ceptions of risks between smokers who did and did not plan to quit smok-
ing, with those planning to quit recognizing higher risks of lung cancer.
In addition to examining perceptions of personal risk from smoking,
a few studies have examined perceptions of risk from secondhand smoke,
including risk to others if you smoke, and personal risk from others’
smoke. Glantz and Jamieson (2000) found that youth who smoked were
less likely than nonsmoking youth to believe that secondhand smoke
leads to thousands of deaths each year. They also showed that adoles -
cents who planned to quit smoking were more aware of the effects of
secondhand smoke than were smokers without quit intentions. Romer
and Jamieson (2001) found that knowledge of secondhand smoke harm
was indirectly related to intentions to quit because of its relationship with
perceived risk of smoking overall. Kurtz and colleagues (2001) showed
that elementary, middle, and high school students with smoking experi-
ence were less knowledgeable about and had less negative views of sec-
ondhand smoke compared to students without smoking experience. Simi-
larly, Halpern-Felsher and Rubinstein (2005) found that adolescents with
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196 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
smoking experience perceived less risk from secondhand smoke than did
adolescents without smoking experience. In a follow-up study, Song et
al. (2009a) showed that perceptions of risk from secondhand smoke pre -
dicted smoking initiation, with adolescents with the lowest perceived risk
of secondhand smoke being the most likely to subsequently try smoking.
Taken together, this set of literature demonstrates the need to under-
stand and describe perceptions of tobacco-related outcomes, including
perceptions of short- and long-term risks, addiction, and potential ben -
efits. It is also important to understand perceptions concerning second-
hand smoke as well as other tobacco products. These studies aid in iden -
tifying critical perceptions held by smokers and nonsmokers; perceptions
are also instrumental in predicting subsequent tobacco use and changes
in patterns of use that are important to capture. Data from these studies
should be included in the portfolio of evidence submitted to the Food and
Drug Administration (FDA) when applying for a modified risk claim on
a tobacco product.
Differences in Perceptions of Risks and
Benefits by Type of Tobacco Product
A small set of literature has examined whether perceptions of risks
and benefits vary by the type of tobacco product. Most of this research
has examined perceptions of so called “light,” “ultra light,” and “low-
tar” cigarettes. The studies show that adults have misperceptions about
the health risks associated with smoking light and ultra light cigarettes;
most adult smokers believe these cigarettes deliver less tar and nicotine,
produce milder sensations, and result in less health consequences (Etter
et al., 2003; Shiffman et al., 2001; Slovic, 2001). Studies have also shown
that smokers have switched to these so-called lighter cigarettes to reduce
the health risks of smoking (Slovic, 2001). Shiffman et al. (2001) examined
the perceptions of light, ultra light, and regular cigarettes among adult
daily smokers; participants believed that lights and ultra lights were less
risky compared to regular cigarettes and that the ultra light cigarettes
were the least harmful. Similarly, Etter et al. (2003) quantified the percep-
tions of smoking different cigarettes, showing that participants believed
they needed to smoke two light cigarettes or four ultra light cigarettes
to inhale the same amount of nicotine as one would inhale from a single
regular cigarette. Etter and colleagues (2003) also found that current adult
light cigarette smokers believed they were at less risk of developing lung
cancer than did smokers of regular cigarettes.
Kropp and Halpern-Felsher (2004) extended these studies to examine
adolescents’ perceptions of light cigarettes. In their study, adolescents
believed they were significantly less likely to have a heart attack, get lung
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METHODS FOR STUDYING RISK PERCEPTION
cancer, have trouble breathing, get a bad cough, and die from a smoking-
related disease if smoking light cigarettes compared with smoking regular
cigarettes. The participants also believed that light cigarettes have less tar
and nicotine than regular cigarettes and that it would be easier to quit
smoking light compared to regular cigarettes.
A study of Norwegian older adolescents and young adults (aged
16–20 years) examined perceptions of different tobacco products, includ -
ing roll-your-own tobacco, factory-made cigarettes, low-tar factory-made
cigarettes, pipe tobacco, cigars or cigarillos, loose snus, prepackaged snus,
and nicotine replacement therapies (NRTs). Participants rated roll-your-
own tobacco as most harmful and NRTs less harmful (Øverland et al.,
2008). In a direct comparison, snus was considered less harmful than ciga-
rettes on average, and participants who used snus rated it less harmful
than did nonusers of snus (Øverland et al., 2008). Callery and colleagues
(2011) examined the relative health risk beliefs among a group of adult
Canadian smokers (aged 18–30 years). They found that between 30 per-
cent and 47 percent of the participants wrongly believed that smokeless
tobacco and cigarettes are equally harmful, and some wrongly noted that
smokeless tobacco is more harmful than cigarettes (Callery et al., 2011).
Other studies have examined whether smokers believe there are dif-
ferences in harm based on type, brand, or color packaging of tobacco
products. Mutti and colleagues (2011) showed that adult smokers attrib -
uted differential risks based on cigarette brands and packaging color
(e.g., gold or silver compared to red or black). Smokers of light and mild
cigarettes perceived their cigarette brand to be less harmful compared to
others, as did smokers of cigarettes found in gold, silver, purple, or blue
packages. Similarly, Bansal-Travers et al. (2011) perceived differences in
risk based on color of the cigarette package, with white coloring denoting
less risk.
These studies confirm that adults and adolescents, as well as smokers
and nonsmokers, harbor misconceptions about tobacco products based on
the packaging coloring or descriptors. As noted by a previous IOM com-
mittee (2007), “such perceptions are likely the result, in part, of the tobacco
industry’s marketing of light cigarettes as the healthier smoking choice,
a safer alternative to cessation, and a first step toward quitting smoking
altogether.” More favorable perceptions of light, ultra light, and low-tar
cigarettes are important to note, since many smokers have made the choice
to smoke light cigarettes because they believe such cigarettes are less
addictive or safer than regular cigarettes (Etter et al., 2003). Further, adults
who smoke light or ultra light cigarettes might be less likely to attempt to
quit smoking, believing that their cigarette choices provide a safer alterna-
tive to regular cigarette smoking (Etter et al., 2003; Shiffman et al., 2001).
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198 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
Demographic Differences in Tobacco-Related Perceptions
With the exception of identifying age differences, there are surpris-
ingly few studies that have examined differences in tobacco-related per-
ceptions by other demographic variables, such as gender, race/ethnicity, or
socioeconomic status. The small literature on these topics is reviewed next.
Previous studies have found limited gender-specific differences among
smokers with regards to benefit perceptions of smoking. Among adults,
women are more likely than men to be concerned about post-cessation
weight gain, women are more likely to identify weight gain as the cause for
relapse to smoking, and women are less likely to be motivated to quit smok-
ing if they fear subsequent weight gain (Swan et al., 1993; Weekley, 1992).
McKee et al. (2005) showed that adult females perceived both greater risk
and greater benefits from smoking than did adult males. Others have found
that women are less likely to acknowledge the health benefits of smoking
cessation (Sorensen and Pechacek, 1987) and that men are more likely to
quit smoking in order to have better health (Curry et al., 1997). Adolescent
males report fewer health concerns than females, and they perceive fewer
risks and greater benefits associated with a variety of health-related risky
behaviors (Millstein and Halpern-Felsher, 2002). Taken together, these stud-
ies provide evidence to support the existence of gender-based differences
in perceptions of the risks and benefits of smoking. These differences may
also relate to why females have poorer smoking cessation outcomes as
compared to males (Perkins, 2001). Thus, consumer perceptions of tobacco
products applying for the modified risk claim should be explored sepa-
rately for males and females in adolescent and adult samples.
Surprisingly few studies have examined cultural variation (including
race, ethnicity, country of origin, acculturation, language usage, and social
class) in perceptions, especially related to tobacco use. As described in a
previous IOM report (2007),
it is possible that the level of perceived risk (and benefit) may differ
across groups of individuals, possibly as a factor of culture, socioeco-
nomic status, or differences in exposure to behavior-related outcomes,
for example. Alternatively, groups of adolescents or young adults might
perceive the same level of risk, but these perceptions might have differ-
ent implications for their smoking, in part due to differences in perceived
control, risk-reducing strategies used, or value placed on the negative
outcome (e.g., bad breath or trouble breathing) compared to the value
placed on the benefit (e.g., looking cool) of smoking.
Future studies are needed.
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METHODS FOR STUDYING RISK PERCEPTION
Adolescents’ Reasons for Smoking
Qualitative studies have used methods such as one-on-one interview -
ing or focus groups to understand the motivations for smoking (IOM,
2007). Based on these studies, the most commonly identified reasons for
smoking include: to satisfy curiosity, to fit in with peers, to relieve stress
and boredom, to decrease appetite, to increase the high from alcohol and
drugs, and because parents smoke (Clark et al., 2002; Dunn and Johnson,
2001; Gittelsohn et al., 2001; Kegler and Cleaver, 2000; Nichter et al., 1997;
Vuckovic et al., 2003). A previous IOM committee (2007) noted that “ado-
lescents form perceptions of smoking images, such as nonsmokers being
more mature (Lloyd et al., 1997), and adolescents recognize that different
types of smoking identities (beyond the usual categories of nonsmokers,
experimenters, and smokers) exist for adolescents (Johnson et al., 2003).”
A number of studies indicate that such images have an impact on ado -
lescents’ smoking. Gerrard and colleagues’ (2008) Prototype Willingness
Model of adolescent risk behavior postulates that an adolescent’s image
of a typical smoker or nonsmoker will influence his or her willingness
to smoke, and ultimately his or her actual smoking behavior. Research
confirms that adolescents who hold more favorable images of a typical
smoker are more willing to smoke and accept the consequences of smok -
ing (Gerrard et al., 2008).
Advertisements for tobacco products have targeted reasons for smok-
ing across a variety of groups defined by demographic characteristics
such as age (adolescents, young adults, and adults), gender, race, socio -
economic status, and psychosocial needs; they have also been directed at
creating favorable images of smokers in order to increase sales (Anderson
et al., 2005; Balbach et al., 2003; Carpenter et al., 2005; Cook et al., 2003;
Cummings et al., 2002; Landrine et al., 2005; Ling and Glantz, 2004;
Wakefield et al., 2002; Wayne and Connolly, 2002). Pre- and postmarket
studies should show that perceptions of MRTPs do not cause consumers
to increase use of harmful tobacco products or lead to dual use of MRTPs
and conventional tobacco products.
SCIENTIFIC STANDARDS FOR STUDIES ON RISK
PERCEPTION AND RISK COMMUNICATION
Study Questions to Address the Risk Perceptions
of Modified Risk Tobacco Products
With reference to each MRTP, it will be important to identify con-
sumers’ perceptions of disease risk, likelihood of addiction, likelihood
of reducing or increasing others’ exposure to potentially hazardous com-
pounds (e.g., secondhand smoke), and perceptions of risk compared to
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200 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
other products that are already on the market. Perceptions of general
harm, such as overall risk of harm or addiction, as well as perceptions
of specific harm, such as risk of lung cancer or heart disease, should be
studied. It is also important to establish consumers’ intentions of using
the product, both for consumers who do and do not currently use any
other tobacco product. Of particular importance are adolescents’ percep -
tions of the risks and benefits of using the product, and whether they
intend to initiate tobacco use with the MRTP rather than a traditional
tobacco product because they believe the latter is a “safe” alternative.
These issues should be addressed in both pre- and postmarket studies.
Studies of risk perception should also include comprehensive ques-
tions that address the many aspects of risk perceptions, including areas
which researchers may ordinarily regard as self-evident. For example, it
is important to include questions about perceived risks of secondhand
smoke to nonusers for all MRTPs, regardless if the product is inhaled
or non-inhaled. Such a comprehensive approach will allow researchers
and regulators to better understand all components of perceived risk
reduction. In addition, longitudinal postmarket studies should address
whether differences in perceptions and/or intentions among different
age, racial, socioeconomic status, or education groups predict later prod -
uct use, change in product use, or progression to dual use of MRTPs and
traditional tobacco products.
Research Designs
This section outlines the committee’s review of research designs for
use in pre- and postmarket studies of consumer perceptions of MRTPs.
The focus of the discussion is on specific issues related to ethical proce -
dures, target population selection and recruitment, construct measure -
ment, and analysis.
To determine perceptions of MRTPs, as well as whether such per-
ceptions influence tobacco use behavior, studies will need to occur both
pre- and postmarket for each MRTP. Premarket research will play an
essential role in developing the messages that the tobacco industry can
use to communicate information about the MRTPs to consumers. This
research will determine consumers’ ability to accurately understand
messages that communicate information about the risks, benefits, and
conditions of use pertaining to the MRTP itself and compared to existing
tobacco products. Studies should also test how these messages influence
consumers’ perceptions of the risks, benefits, and likelihood of addic -
tion related to the MRTP. Clearly, no message developed can result in
any significant misunderstanding, misinterpretation, or generalization
of what exactly the MRTP is supposedly modifying. For example, if the
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METHODS FOR STUDYING RISK PERCEPTION
tobacco company claims that the product contains less nicotine, then
the consumer or potential consumer cannot believe that the product also
reduces the risk of lung cancer. Thus, the perceived influence of the new
product on health and other outcomes should match the actual difference
in health effects.
The first stage of premarket research will involve formative work
using focus groups. Focus groups are useful for offering depth and insight
from similar groups of people, especially when the intent is to gather
general themes and ideas on topics not yet well studied. Focus groups
are particularly useful when no existing research can provide the infor-
mation, and they are an ideal way to generate new ideas that will be
relevant for subsequent larger-scale studies, surveys, and future research
(Krueger, 2000). These focus groups should consist of the target popula-
tions described below. The first phase of focus group research should
include discussions with various groups of individuals regarding the
best, most effective, and most comprehensible messaging that should be
used to market and to label the product if the product is later approved
as an MRTP. That is, what is the most accurate and easily comprehended
message? The second phase should include discussions with groups of
similar individuals to assess how the messages that were developed in
phase 1 are received by consumers. Specifically, do potential consumers
understand the messages correctly? Do the messages change intentions
to use this MRTP or any other tobacco product?
Once messages that communicate potential risks and benefits of use
are developed using the focus groups, the effects of these messages on
consumer perceptions should be tested. Statements to be tested should
include not only product labels or inserts intended to convey health infor-
mation about the product, but also marketing statements that will appear
on any form of advertisement of the MRTP. Nonverbal messages should
be tested as well. For example, when banned from using labels such as
“light” or “mild” on cigarette packages in countries other than the United
States, the industry switched to using lighter colors to indicate “lighter”
cigarettes. As a result, smokers perceived cigarettes in the lighter colored
packs to be less harmful and easier to quit (Hammond and Parkinson,
2009; Hammond et al., 2009); this phenomenon has been replicated in
a recent U.S. study as well (Bansal-Travers et al., 2011). Therefore, if the
industry decides to use imagery, color-coding, or any other visual (but
nonverbal) means of conveying information about the MRTP, then they
should also test the influence of this type of messaging on consumer per-
ceptions in pre- and postmarket studies, as well as its influence on use of
the MRTP in postmarket studies.
The minimum standards to test consumer perceptions and under-
standing of messages about MRTPs include showing these messages to
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210 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
BOX 5-3
Sample Questions for Measuring Intentions to Use an MRTP
• What is the chance that you will try [the MRTP] sometime in the next 6 months?
• What is the chance that you will try [the MRTP] in your life?
• What is the chance that you will ever use [the MRTP]?
• What is the chance that you will use [the MRTP] to help you quit smoking
cigarettes/chewing tobacco/etc.?
• What is the chance that you will use [the MRTP] in addition to other tobacco
products that you already use?
• If one of your best friends were to offer you [the MRTP] in the next 6 months,
would you use it? (for adolescents)
rette expectancies has been the Smoking Consequences Questionnaire
(Brandon and Baker, 1991) and its various derivatives for adults, ado-
lescents, and children (Copeland et al., 1995; Lewis-Esquerre et al., 2005;
Rash and Copeland, 2008). Broadly, expectancies can be divided into
positive outcomes (i.e., anticipated benefits) and negative outcomes (i.e.,
anticipated harms). Wetter and colleagues (1994) established that posi -
tive expectancies (positive reinforcement, negative reinforcement, and
appetite-weight control) predicted withdrawal severity while negative
expectancies predicted cessation success. Studies in adolescent popula -
tions have shown outcome expectancies (those relating to negative affect
relief in particular) are related to smoking uptake, behavior, and nicotine
dependence (Heinz et al., 2010; Wahl et al., 2005). One study that exam -
ined expectancies in relation to modified tobacco products showed that
positive expectancies predicted interest in trying both Quest and Eclipse,
regardless of level of smoking experience (O’Connor et al., 2007). The
committee suggests that studies of MRTP perceptions include a measure
of outcome expectancies.
Affective Responses
Evidence that has emerged over the past decade points to the impor-
tance of affect in shaping decisions about a wide array of health behaviors,
including tobacco use (Keer et al., 2010; Kiviniemi et al., 2007; Lawton
et al., 2009). While judgment and decision making have most widely
been regarded as rational processes, accumulating evidence suggests an
important role for affective processes and emotions in guiding decisions,
primarily through heuristics (Greifeneder et al., 2011; Slovic et al., 2005).
According to this model, affective reactions to stimuli, which are often
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METHODS FOR STUDYING RISK PERCEPTION
automatic, can become salient in guiding decisions based on individual
and situational conditions, particularly those requiring complex analysis
or under time pressure. Broadly speaking, activities viewed positively
are seen as low risk/high benefit, whereas those viewed negatively are
seen as high risk/low benefit. Other evidence suggests that messages that
evoke emotional responses are better remembered (Lang and Dhillon,
1995) and promote higher order cognitive processing (Donohew et al.,
1998; Keller and Block, 1996). Thus, affective heuristics, and emotional
factors more broadly, can be important to consider in user and nonuser
reactions to MRTPs. A number of measures have been developed to assess
affective reactions. Some measures are scales that ask participants to rate
their feelings by responding to descriptive statements or words along
unipolar or bipolar (semantic differential) axes, either numeric or visual-
analog. Validated clinical measures such as the Profile of Mood States
or Positive and Negative Affect Schedule can also be employed to mea-
sure current feelings among participants (McNair et al., 1971; Watson et
al., 1988). Affect can also be measured using pictograms to assess affect
valence, arousal, and dominance brought about by a particular stimulus
(Bradley and Lang, 1994). This measure has been validated against the
International Affective Picture System (IAPS) (Lang et al., 1997). The
IAPS images cover five domains: pleasant-aroused, pleasant-calm, neu -
tral, unpleasant-calm, and unpleasant-aroused. The committee suggests
that studies examining affective reactions to MRTP-related stimuli (e.g.,
advertising, packaging, marketing) include a set of IAPS images from
each domain for comparative purposes.
Consistent with the importance of affect and outcome expectancies,
Wakefield and colleagues have been working to evaluate youth reactions
to smoking messaging (Wakefield et al., 2003, 2005). They have noted five
key considerations to understand ad impact and facilitate comparison of
different ads: (1) previous exposure and reactions to general antismoking
information and to test ads, (2) comprehension, (3) specific ad appraisals,
(4) relative utility of target ad compared to generic antismoking informa -
tion, and (5) recall of the test ad within 1 week. The proposed metrics are
broadly applicable across media types (e.g., video, print, Internet) and
include both cognitive and emotional responses. A sample questionnaire
used by the Wakefield et al. research team to assess youth responses to
anti-smoking ads is provided in Figure 5-1.
Analyses
The industry should hire independent, professional biostatisticians
to aid in initial measurement design and all analyses following comple-
tion of data collection. The biostatisticians should conduct a priori power
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212 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
What is the MAIN point that this ad is trying to make?
What ELSE is it trying to say?
How well do the following phrases describe this ad? (Circle one number for each phrase)
Neither
Strongly Disagree Strongly
This ad…. Disagree Disagree nor Agree Agree Agree
…was clear 1 2 3 4 5
…had a message that is
1 2 3 4 5
important to me
…said things that were hard to
1 2 3 4 5
believe
…made me stop and think 1 2 3 4 5
…made me curious to know if
1 2 3 4 5
what the ad says is true
…is one that I would talk to
1 2 3 4 5
other people about
…told me something new 1 2 3 4 5
…talked down to me 1 2 3 4 5
This ad made me feel…
…sad 1 2 3 4 5
…angry 1 2 3 4 5
…happy 1 2 3 4 5
…scared 1 2 3 4 5
This ad was…
…funny 1 2 3 4 5
…powerful 1 2 3 4 5
…boring 1 2 3 4 5
…emotional 1 2 3 4 5
Overall, I thought this ad was a very good anti-smoking advertisement…
1 2 3 4 5
What makes it that way?
Have you seen this ad on TV before today?
Yes No Not Sure
FIGURE 5-1 Sample advertisement rating questions.
SOURCE: Wakefield et al., “Assessment of youth responses to anti-smoking ads:
Description of a research protocol,” Practice Ad Coding Scheme. Chicago: Im-
pacTeen, 2002. Reprinted with permission.
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213
METHODS FOR STUDYING RISK PERCEPTION
analyses for all studies in order to determine appropriate sample size and
level of acceptable power.
In general, the analysis of the focus group data should involve a
continuum from the raw data to descriptive statements to interpreta-
tion. Analysis of the data should occur in three steps: (1) identification
of participants’ concepts, (2) organization of participants’ concepts into
a hierarchy (a model), and (3) quantitative analysis of frequency of par-
ticipants’ concepts. Analyses should first identify concepts (e.g., health)
used by participants in the course of the interview using a variety of tech -
niques drawn from grounded theory (Strauss and Corbin, 1997). Next, the
identified concepts should be organized into a hierarchy, making use of
diagrams and other comparative analytic techniques. Once a hierarchy
of participants’ concepts is completed, the entire dataset should be coded
for participants’ concepts using an appropriate software package, such
as NVivo (NUD*IST). Participant concept data should then be exported
into a database, allowing for analyses of whether frequency of participant
concepts varies by individual-level characteristics, and so on.
The issues discussed in this chapter are relevant for the interpretation
of data generated from scientific studies and for the evaluation of prod-
uct applications at the FDA. The next chapter discusses the cross-cutting
issues presented in this chapter as well as earlier chapters. The next chap -
ter will also focus on methods to integrate information, and present the
committee’s findings and recommendations.
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