InterventionDoes the effect go up in smoke? A randomized controlled trial of pictorial warnings on cigarette packaging
Introduction
This randomized controlled trial is focusing on one of the WHO Framework Convention on Tobacco Control's (FCTC) most discussed recommendation: Article 11.1.b.V of the FCTC recommends the use of pictures to emphasize warnings on cigarette packaging [1]. Despite the fact that the FCTC was signed and ratified by more than 150 countries, only a few have made the effort to actually introduce and enforce the use of images [2], [3]. Canada (2001), Brazil (2002), and Singapore (2004) were the first countries to make the combination of written warnings and graphic images on cigarette packaging (so called “pictorial warnings”) a legal requirement [3], [4], [5]. The European Union has urged all EU member states to introduce and enforce similar measures (2003/641/EG). Therefore, the European Commission recently developed a collection of images to be printed on cigarette packaging in combination with the written warnings already in use and made this image catalogue available to the EU member states [3], [6]. The discussion within and among EU nations regarding the introduction of these measures is still ongoing. Among the EU states actively involved in these discussions is the one with by far the largest number of smokers, namely Germany.
The concept of printing warnings on cigarette packaging appears to be enticingly smart; such warnings are cheap, appeal to a broad audience among smokers and non-smokers, and they restrict and counterbalance the advertising and brand label space of tobacco companies. Last but not least, they appeal to a smoker at an ideal point in time, i.e. the moment she/he feels the desire to smoke [7]. Thus, a smoker who consumes approximately one pack of cigarettes per day will be confronted with the warning images at least 7000–8000 times a year [5], [8].
The pictorial and written warnings suggested by the EU represent classic fear appeals. From the many experimental studies into fear appeals, two main theoretical frameworks have been derived: The Protection Motivation Theory [9] and the Extended Parallel Process Model [10], [11], [12]. Both models define relevant components of effective fear appeals: the Extended Parallel Process Model (EPPM) states that an effective fear appeal causes a consecutive, cognitive response to fear reaction, awareness of one's own vulnerability, as well as of the severity of the presented threat, along with an estimation of response efficacy and feasible self efficacy. This model further asserts that this cognitive process results in an increase in the motivation to quit, which, in the ideal case, in turn leads to the actual cessation of smoking. In this way, the components of this model can, on the one hand, be seen as the cognitive consequences of a fear appeal. On the other hand, these constructs can, according to the two aforementioned theories, be interpreted as determinants of a consecutive motivation. Since the EPPM has more often been implemented in tobacco prevention programs than Protection Motivation Theory, we chose the former for our theoretical rationale [8], [13]. Therefore our study includes the model's central constructs as outcome measures (fear intensity, vulnerability, severity, self and response efficacy). Another aspect discussed in the prevention research field examines the effect of health warnings dependent on an individual's self-perception. In order to reinforce their positive perception of themselves, those affected (e.g. patients, HIV-risk groups, alcohol consumers, drug consumers) could react defensively to such emotive and fear-inducing appeals by means of avoidance strategies, according to Steele's Theory of Self Affirmation [14]. Therefore, we took into account the role of the smokers’ self-perception (via the construct of self-affirmation) in our study.
Although these theoretical models exist, up until now they have barely been investigated regarding explaining the possible effects of warnings on cigarette packaging: a systematic review published by the German Cancer Research Center in May 2009 as well as our own investigations show that some population-based surveys seem to support the positive impact of warnings on cigarette packaging in general [5]. But, most studies investigate only written warnings [15], [16], [17] or only pictorial warnings [18], [19], respectively. Only few studies compare the effects of a combination of pictorial and written warnings by for example comparing their effects in different countries or for various survey years [20], [21], [22], [23]. To date, especially randomized controlled trials regarding this topic are rare.
Typical methodological limitations of survey data were criticized and it was suggested to carry out additional experimental studies [4], [24]. The German Cancer Research Center's review of literature shows that so far only two randomized controlled trials comparing the impact of both types of warning exist. Neither of these studies investigates the impact on the “motivation to quit” which is a central and crucial variable. Peters and colleagues studied affective reactions [25] whereas Thrasher et al. [26] took a closer look on the impact of warnings on the price of cigarette packs in a very special context (in an auction). Therefore our study aims at filling the gap in research that exists with regard to randomized controlled trials.
It focuses on the following research questions:
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Do pictorial warnings on cigarette packaging lead to a stronger motivation to quit than written warning information?
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Are factors preceding the motivation to quit (fear intensity, vulnerability, severity, self and response efficacy) more strongly influenced by pictorial warnings than by those containing only text?
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Does previous self-affirmation play a significant role for these primary and secondary outcomes by reducing defensive reactions?
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Do these warnings have the same effects on addicted smokers as they do on non-addicted smokers?
Section snippets
Eligibility criteria for participants
Ninety-five students were recruited from October 22nd to 23rd, 2007 in front of the central canteen and the cafeteria of Mannheim University, Germany. Participants were admitted to this convenience sample if they fulfilled the following criteria: at the time of the study (1) current smoker (according to their own rating), (2) aged between 18 and 30, (3) student and (4) fully informed and consented to participating in the study. On returning the questionnaire each student received one Euro and a
Results
Eighty-eight out of ninety-five volunteers fulfilled the inclusion criteria and delivered complete questionnaires (Fig. 2). The collective consisted of 39 males and 49 females aged between 18 and 30 (Mean age 22.0 ± 2.40). All of the participants were students from various faculties (business administration, economics, social sciences, law, humanities and economic education). The CONSORT flow diagram indicates that all 2 × 44 = 88 participants were randomly assigned for the successful allocation
Comparison with findings of other studies
On the one hand, our findings are consistent with some findings of former studies on this topic, but on the other hand, they reveal general questions about the effect of pictorial warnings.
The fact that pictorial warnings produce a stronger motivation to quit and more intense levels of fear was also demonstrated by Gierl and Koncz [6], Hammond et al. [21], Hammond et al. [19], Kees et al. [4] and Thrasher et al. [22] with the exception of Petersen and Lieder [8]. Recent survey data from
Conflict of interest
All authors disclose any actual or potential conflict of interest including any financial, personal or other relationships with other people or organizations that could inappropriately influence, or be perceived to influence, the work.
Acknowledgments
The team of authors wishes to thank the following colleagues for their valuable advice and support of this article: Darcey Terris, Ursula Goldberger, Bastian Specht, Silke Röhrig, Max Zalewski, Hanna-Marei Steininger and Tatiana Yarmoliuk.
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These authors contributed to this paper equally.