Building evidence for effective and sustainable cigarette warning label policy

描述(由申请人提供)：美国食品和药物管理局(FDA)现在对烟草拥有监管权力，包括选择和更改卷烟包装上健康警告标签(HWL)的图片和文本内容。2012年9月，美国计划在HWL上实施9种不同的文本消息和图像，覆盖50%的香烟包装正面和背面。在首轮图片式HWL实施后，其效果将随着时间的推移而“磨损”。如果FDA有证据表明，改变HWL的内容将“……促进公众更好地了解与使用烟草产品相关的风险”，则FDA有责任改变HWL的内容。这项拟议的研究将解决以前研究方法上的不足，为研究人员和美国监管机构提供最先进的科学证据，说明HWL政策的关键图画特征对吸烟者了解吸烟相关风险和戒烟的影响。这一结果将为美国现行政策的实施提供法律挑战，并将为美国和世界各地未来图片式HWL政策的决策提供依据。我们建议在美国和三个可比较的国家对成年吸烟者进行研究，这些国家都将在2012年实施新的图片式HWL，但政策在重要方面有所不同：1.美国将实施第一轮图片式HWL，使用简短而简单的风险信息；2.墨西哥将以世界上最高的频率轮换新的HWL(即每三个月两个新的HWL)；2.加拿大将实施其第二轮图片式HWL，其中包括全面的风险和戒烟信息；4.澳大利亚将实施第二轮图片式HWL，同时还将实施禁止在香烟包装上使用品牌颜色和标志的创新政策，以提高HWL的效力。该项目将利用这一前所未有的机会，系统地研究美国监管机构在未来政策制定中应考虑的不同图片式HWL政策随时间的实际影响。拟议的项目将追求以下具体目标：具体目标1：我们将使用准实验设计，在四个国家(加拿大、澳大利亚、墨西哥、美国)的成年吸烟者小组中确定哪些图画上的HWL特征最有效地促进对吸烟相关风险的了解，并增加戒烟行为。具体目标2：我们将在同一四个国家的成年吸烟者中进行一系列受控随机实验，系统地改变他们对图画HWL特征的暴露，这些特征相对于现有的HWL是新的，以确定这些操作对认知和情感的影响。实现这些目标将产生美国监管机构需要的科学证据，以了解不同图片化的HWL政策选项对现实世界的影响。研究结果将被分发给研究人员和决策者，包括FDA，FDA可以修订美国的HWL，以提高消费者对吸烟相关危害的理解。 与公共健康相关：2012年，美国、墨西哥、加拿大和澳大利亚都将在香烟包装上实施新的图画健康警告标签(HWL)，以解决吸烟问题，吸烟仍然是美国可预防的死亡的主要原因。这项拟议的研究将利用这一非同寻常的机会，检查新的图片式HWL在那些与美国相当、但图片式HWL政策在重要方面与美国政策形成对比的国家的影响。我们的创新研究将解决之前研究的方法问题，以便为美国监管机构提供科学知识，即他们需要制定最有效地建立和维持消费者对吸烟相关风险的理解的健康保险政策。

DESCRIPTION (provided by applicant): The US Food and Drug Administration (FDA) now has regulatory authority over tobacco, including the selection and changing of pictorial and textual content for health warning labels (HWLs) on cigarette packaging. In September 2012, the US is scheduled to implement nine different text messages and images on HWLs that will cover 50% of the front and back of cigarette packs. After the first round of pictorial HWLs is implemented, its effects will "wear out" over time. The FDA is charged with changing the content of HWLs if they have evidence that changing them will "...promote greater public understanding of the risks associated with the use of tobacco products.'' The proposed study will address methodological shortfalls of previous studies to provide researchers and US regulators with state-of-the-art scientific evidence on the effects of key pictorial HWL policy characteristics on smokers' understanding of smoking-related risks and on smoking cessation. The results will inform legal challenges to implementation of current US policy, and they will provide the basis for decision-making about future pictorial HWL policy in the US and around the world. We propose to conduct studies of adult smokers in the US and in three comparable countries that will all implement new pictorial HWLs in 2012, but with policies that differ from one another in important ways: 1. the US will implement its 1st round of pictorial HWLs, using short and simple risk messages; 2. Mexico will rotate new HWLs at the highest frequency in the world (i.e., two new HWLs every three months); 2. Canada will implement its 2nd round of pictorial HWLs, which include comprehensive risk and quit messages; 4. Australia will implement its 2nd round of pictorial HWLs, while also implementing the innovative policy of prohibiting brand colors and logos from cigarette packages in order to enhance the efficacy of HWLs. This project will capitalize on the unprecedented opportunity to systematically examine the real world effects over time of different pictorial HWL policies that US regulators should consider for future policy development. The proposed project will pursue the following specific aims: Specific Aim 1: We will use a quasi-experimental design with panels of adult smokers in four countries (Canada, Australia, Mexico, United States) to determine which pictorial HWL characteristics most effectively promote understanding of smoking-related risks and increase cessation behavior. Specific Aim 2: We will conduct a series of controlled randomized experiments among adult smokers in the same four countries, systematically varying their exposure to pictorial HWL characteristics that are novel relative to existing HWLs, in order to determine the cognitive and affective impact of these manipulations. Meeting these aims will produce the scientific evidence that US regulators need on the real world impacts of different pictorial HWL policy options. Results will be disseminated to researchers and decision-makers, including the FDA, which can revise US HWLs to improve consumer understanding of smoking-related harms. PUBLIC HEALTH RELEVANCE: In 2012, the United States (US), Mexico, Canada, and Australia will all implement new pictorial health warning labels (HWLs) on cigarette packaging in order to address smoking, which remains the leading cause of preventable death in the US. The proposed study will take advantage of the extraordinary opportunity to examine the effects of new pictorial HWLs in countries that are comparable to the US but with pictorial HWL policies that contrast in important ways with US policy. Our innovative study will address methodological problems with previous research in order to provide US regulators with the scientific knowledge that they need to develop a HWL policy that most effectively builds and sustains consumer understanding of smoking-related risks.