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 statements 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 demonstrate 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 population 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 epidemiologic data, short- and long-term risks to the individual, addiction, and potential benefits. Careful attention is given regarding perceptions of different types of tobacco products, as well as how perceptions of tobacco

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1 Family Smoking Prevention and Tobacco Control Act of 2009, Public Law 111-31, 123 Stat. 1776 (June 22, 2009)



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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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193 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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195 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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197 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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199 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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201 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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211 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. REFERENCES Abrams, D. B., R. Niaura, R. A. Brown, K. M. Emmons, M. G. Goldstein, P. M. Monti, and L. A. Linnan. 2003. The tobacco dependence treatment handbook: A guide to best practices . New York, NY: The Guilford Press. Ajzen, I. 1985. From intentions to actions: A theory of planned behavior. In Action control, from cognition to behavior, edited by J. Kuhl, and J. Beckmann. Berlin: Springer-Verlag. American Psychiatric Association. 2000. Diagnostic and statistical manual of mental disorders: DSM-IV-TR. 4th ed. Washington, DC: American Psychiatric Publishing, Inc. Anderson, S. J., S. A. Glantz, and P. Ling. 2005. Emotions for sale: Cigarette advertising and women’s psychosocial needs. Tobacco Control 14(2):127. Arnett, J. J. 2000. Optimistic bias in adolescent and adult smokers and nonsmokers. Addictive Behaviors 25(4):625-632. Balbach, E. D., R. J. Gasior, and E. M. Barbeau. 2003. R. J. Reynolds’ targeting of African Americans: 1988-2000. American Journal of Public Health 93(5):822-827. Bandura, A. 2001. Social cognitive theory of mass communication. Media Psychology 3(3):265-299. Bansal-Travers, M., R. O’Connor, B. V. Fix, and K. M. Cummings. 2011. What do cigarette pack colors communicate to smokers in the U.S.? American Journal of Preventive Medicine 40(6):683-689. Biehl, M., and B. L. Halpern-Felsher. 2001. Adolescents’ and adults’ understanding of prob - ability expressions. Journal of Adolescent Health 28(1):30-35.

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