Tobacco packaging design for preventing tobacco uptake (Protocol)

Transcription

1 Tobacco packaging design for preventing tobacco uptake (Protocol) McNeill A, Bauld L, Birken M, Hammond D, Moodie C, Stead M, Hitchman S, Hartmann- Boyce J This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2014, Issue 8

2 T A B L E O F C O N T E N T S HEADER ABSTRACT BACKGROUND OBJECTIVES METHODS REFERENCES APPENDICES DECLARATIONS OF INTEREST i

3 [Intervention Protocol] Tobacco packaging design for preventing tobacco uptake Ann McNeill 1, Linda Bauld 2, Mary Birken 3, David Hammond 4, Crawford Moodie 2, Martine Stead 2, Sara Hitchman 3, Jamie Hartmann-Boyce 5 1 UK Centre for Tobacco and Alcohol Studies, National Addiction Centre, Institute of Psychiatry, King s College London, London, UK. 2 Institute for Social Marketing, University of Stirling and UK Centre for Tobacco and Alcohol Control Studies, Stirling, UK. 3 King s College London, London, UK. 4 School of Public Health and Health Systems, University of Waterloo, Waterloo, Canada. 5 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK Contact address: Ann McNeill, UK Centre for Tobacco and Alcohol Studies, National Addiction Centre, Institute of Psychiatry, King s College London, London, UK. ann.mcneill@kcl.ac.uk. annmcneill9@gmail.com. Editorial group: Cochrane Tobacco Addiction Group. Publication status and date: New, published in Issue 8, Citation: McNeill A, Bauld L, Birken M, Hammond D, Moodie C, Stead M, Hitchman S, Hartmann-Boyce J. Tobacco packaging design for preventing tobacco uptake. Cochrane Database of Systematic Reviews 2014, Issue 8. Art. No.: CD DOI: / CD A B S T R A C T This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effectiveness of standardised tobacco packaging in preventing initiation into, or regular use of, tobacco. B A C K G R O U N D Description of the condition Tobacco use is the largest single preventable cause of disease and premature death worldwide, being a key causal factor in heart disease, stroke, chronic lung disease and cancers, among many other diseases. The vast majority of adult smokers took up the addiction during adolescence; each day globally over 80,000 young people start to smoke, many under the age of 10 and most now in lowor middle-income countries (Eriksen 2012). Hence, preventing young people from taking up tobacco use is a critically important health goal. A variety of interventions have been shown to reduce tobacco use, including prohibitions on tobacco promotion (World Bank 1999; World Health Organization 2013). Tobacco promotion has been defined as direct advertising (broadcast and print media, billboards/outdoor and point of sale) and indirect advertising in the form of cigarette-branded merchandise, free tobacco products and sponsorship (Henriksen 2012). Tobacco promotion has been demonstrated to increase the likelihood that children will take up smoking (Lovato 2011). Several industrialised countries have introduced comprehensive tobacco advertising and marketing bans (World Health Organization 2013). One channel of promotion remains however, in all countries except Australia. This is marketing through the tobacco pack itself. There is evidence that the tobacco industry has adapted to closure of other promotional channels by increasing their focus on tobacco packaging through design aspects, price-marketing and other innovations to promote tobacco use (Freeman 2008; Wakefield 2002). Australia is the first country to have introduced standardised packaging for cigarettes, doing so in December This review examines whether the introduction of standardised 1

4 tobacco packaging can prevent tobacco uptake in children and young people. A companion review will examine whether the introduction of standardised tobacco packaging can lead to cessation or reduction in tobacco use in current tobacco users. similar policy. The evidence base has increased markedly since the publication of the FCTC guidelines and the systematic review, and will expand further when more studies of the impact of Australia s introduction of standardised packaging become available. Description of the intervention Standardised packaging is an intervention aimed to replace the current packaging on tobacco packs. The exact description of standardised packaging can vary, but the World Health Organization s Framework Convention on Tobacco Control (FCTC) Article 13 guidelines (World Health Organization 2008) have suggested:..black and white or two other contrasting colours, as prescribed by national authorities; nothing other than a brand name, a product name and/or manufacturer s name, contact details and the quantity of product in the packaging, without any logos or other features apart from health warnings, tax stamps and other governmentmandated information or markings; prescribed font style and size; and standardized shape, size and materials. There should be no advertising or promotion inside or attached to the package or on individual cigarettes or other tobacco products. The only distinguishing feature of packs would then be the brand and product variant names and as stated above these would be in a uniform style, colour and position (Freeman 2008). As picture warnings covering 100% of packs would be another means of stripping packaging of any branding, the relationship between graphic health warnings covering 75% or more of packs is also being assessed as a component of standardised packaging. How the intervention might work Standardised packaging could work by replacing imagery/livery on the tobacco packs which is misleading, attractive or acting as a cue to tobacco use. Standardised packaging could also serve to increase the salience of health warnings. In all these cases standardised packaging could alter knowledge, attitudes and beliefs towards tobacco use among children, hence influencing their tobacco uptake. Why it is important to do this review The introduction of standardised packaging was recommended within the FCTC Article 11 guidelines (World Health Organization 2008), based on evidence around tobacco promotion in general and studies which have examined the impact of changes in packaging on knowledge, attitudes, beliefs and behaviour. A systematic review of the evidence of the literature (available up until August 2011) was published by some of the co-authors of this review (Stead 2013). In December 2012, standardised packaging was introduced across Australia, and several other countries have now indicated that they are interested in introducing a O B J E C T I V E S To assess the effectiveness of standardised tobacco packaging in preventing initiation into, or regular use of, tobacco. M E T H O D S Criteria for considering studies for this review Types of studies Given standardised tobacco packaging is a relatively new intervention, to date introduced only in one country (Australia in 2012), we will have broad criteria and include any relevant primary research studies in this review. Optimal designs include studies of impact in countries which have introduced standardised packaging, and experimental and intervention studies (randomised controlled trials (RCT)/quasi-RCTs). Other relevant designs include cross-sectional and cohort surveys, qualitative and mixed-method studies and physiological studies (such as eye tracking or neuroimaging studies).we will capture these other relevant designs in the initial iterations of the review. For this review, tobacco products include cigarettes, loose tobacco for hand-rolled cigarettes, cigars, cigarillos, pipe tobacco, kreteks, bidis (beedis), and also smokeless tobacco, which includes snuff and chewing tobacco. Packaging refers to the container (packet, pouch, tin) in which tobacco products are stored, but excludes the paper, leaves or other means of wrapping loose tobacco. Types of participants This review focuses on those aged under 18 years. We will include all other populations in this review, i.e. regardless of nationality, gender, socioeconomic status, ethnic group and tobacco use status. Types of interventions We will examine any studies that assess the impact of changes in tobacco packaging, such as changes in colour, design, size, and type of health warnings on the packs in relation to branded packaging. The control is likely to be current tobacco packaging but could also include variations of standardised packaging. 2

5 Types of outcome measures Primary outcomes The primary outcome will be the impact on tobacco use in young people assessed through the proportion reporting current tobacco use. Secondary outcomes We anticipate finding very few, if any, studies assessing the impacts on primary outcomes for inclusion in the first iteration of this review. Our list of secondary outcomes aims to cover all potential intermediate outcomes that can be measured and are relevant to tobacco uptake. These cover the following research questions: What is the effect of standardised tobacco packaging on tobacco use behaviour (cigarette consumption, foregoing cigarettes, choice of product, switching brands or within-brand families and type of tobacco used, covering the pack, smoking in front of others)? What is the effect of standardised tobacco packaging on susceptibility to tobacco use, attitudes, feelings and beliefs towards tobacco (including appeal, product attributes, risk perceptions)? How is the impact of warning labels (salience and visibility) influenced by standardised tobacco packaging? We will measure outcomes in a number of ways, from scale ratings to qualitative research themes. Given standardised packaging for tobacco packs have only recently been introduced in one country (Australia), most studies in this area have assessed changes in perceptions or behaviour amongst participants who have seen or used standardised packs over a relatively short period of time, so outcomes will be assessed over any measured time periods. We will assess all outcomes to investigate any differences based on demographics (gender, age, socioeconomic status, ethnicity) and tobacco use status wherever possible. Search methods for identification of studies We will compile the search strategy with combinations of tobaccorelated terms with packaging-related terms. We will adapt the terms used in the search in accordance with each database s search terminology. The terms will include (though will not be limited to) those listed in Appendix 1. We will include studies regardless of language or publication status. Electronic searches The search strategy will include searches for studies in the academic and grey (unpublished) literature from generic and topicspecific electronic databases from the fields of health and addiction, public policy, business and marketing, social sciences and psychology. We will search CENTRAL, the Cochrane Tobacco Addiction Group Specialized Register, MEDLINE/PubMed, EM- BASE, and PsycINFO. Additionally, we will search in the following bibliographic databases: ABI INFORM ASSIA Business Source Premier Conference Papers Index Conference Proceedings Citation Index- Social Science & Humanities EconLit HMIC Index to Theses (UK and Ireland) International Bibliography of the Social Sciences Social Policy and Practice Social Policy Digest Sociological Abstracts TROPHI (Trials Register of Public Health Interventions) Social Science Citation Index Zetoc Other catalogues and websites (see below): CDC Smoking and Health Resource Library Dart Europe (theses) Google Scholar Legacy Tobacco Documents Library Standardised Packaging Database OpenGrey (System for Information on Grey Literature in Europe) Social Science Research Network tobaccopapers.com WHO: World Health Organization World Advertising Research Centre World Cat Library Catalogue World Cat Dissertations Searching other resources Tobacco industry documents We will also search tobacco industry document repositories via the Legacy Tobacco Documents Library for relevant research studies on packaging. Handsearching We will check the bibliographies from included studies for further studies and citation trails, which check which papers have cited an included study. We will follow citation trails using Google Scholar and the Web of Knowledge cited reference search. Personal contact/grey literature We will contact key individuals and organisations, identified through the search process above, to identify further publications not retrieved in the searches. We will also contact researchers who 3

6 are known to have conducted relevant research to identify further studies and unpublished reports. We will also search for other grey literature including conference proceedings and unpublished reports via Google Scholar and dissertation abstracts. Data collection and analysis Selection of studies To be included in the review the studies should be: 1. from or after 1980 (the concept of plain packaging was introduced in 1986 and the first study published in 1987); 2. about human populations; 3. about tobacco; 4. about packaging; 5. primary research. There will be three phases of study selection. In the first phase, one review author will sift through the citations retrieved and exclude obviously irrelevant material (e.g. studies that are not about tobacco, packaging, or do not include human subjects). In the second stage of study selection, two review authors will independently screen the titles and abstracts of the studies against the inclusion criteria to identify potentially relevant studies. We will obtain fulltext copies of potentially relevant studies identified at this stage. A minimum of two review authors (content specialist and methodologist) will then independently screen the full-text studies for relevance, and eliminate any that do not meet the inclusion criteria. We will include studies remaining after the second screening stage in the review, and will link together reports or articles from the same studies. We will resolve any discrepancies in studies selected for inclusion by discussion between the review team. Data extraction and management We will develop a data extraction form and pilot and amend it as necessary. At least two review authors will independently extract data, resolving any errors or inconsistencies through discussion or by recourse to a third review author. One review author will enter the data into Review Manager 5 (RevMan 20140, with another review author checking the accuracy of the data entry. We will keep records of any amendments or corrections to the data extraction forms and will note details of discussions on inconsistencies. Data to be extracted Title/unique identifier Lead author Date of report/publication Version number of data extraction form ID of data extractor ID of study Aims, objectives Theoretical basis Study design (will trigger appropriate sub-fields e.g. if randomised controlled trial) Setting Participant details Sample size, attrition and follow-up Interventions Outcomes measured and when Results Assessment of risks of bias Sources of funding Potential conflicts of interest, declared or not We will note the source of each piece of data extracted and will make space for comments on the data extraction form throughout. Assessment of risk of bias in included studies We will assess risk of bias using the most recent Cochrane methodology. We will determine the selection of the appropriate tool for assessing risk of bias by the methods employed in the study. For randomised controlled trials, we will assess risk of selection bias (random sequence generation and allocation concealment), detection bias (blinding of outcome measurement), and attrition bias. We will assess non-randomised trials for bias through choosing relevant domains of the Cochrane Collaboration s Risk of bias tool for non-randomised studies, which is currently in development. Measures of treatment effect Where dichotomous data are presented in study reports, we will calculate treatment effects using odds ratios and report these in the text. Though the Cochrane Tobacco Addiction Group typically uses risk ratios to measure treatment effect, we anticipate data from included studies will be more amenable to measurement in odds ratios in this review. Dealing with missing data We will contact investigators or study sponsors in order to verify key study characteristics and obtain missing numerical outcome data where possible (e.g. when a study is reported as abstract only). Where this is not possible, and the missing data are thought to introduce serious bias, we will explore the impact of including such studies in the overall assessment of results by a sensitivity analysis. Data synthesis The methods of synthesis in a review of this type are likely to be comparatively complex. An earlier review completed by some of this review s author team (Moodie 2012) found considerable heterogeneity in terms of study design, context, participants, and 4

7 other study characteristics, and we expect that it will not be appropriate to combine study findings statistically in a meta-analysis (although meta-analysis may be appropriate to combine specific homogenous subgroups of studies). We will synthesise our findings according to the objectives outlined above. We will produce Summary of findings tables for all included outcomes. R E F E R E N C E S Additional references Eriksen 2012 Eriksen M, Mackay J, Ross H. The Tobacco Atlas, fourth edition. New York, NY and Atlanta, GA: American Cancer Society and World Lung Foundation, 2012, also available at Freeman 2008 Freeman B, Chapman S, Rimmer M. The case for the plain packaging of tobacco products. Addiction 2008;103(4): Henriksen 2012 Henrikson L. Comprehensive tobacco marketing restrictions : promotion, packaging, price and place. Tobacco Control 2012;21(2): Lovato 2011 Lovato C, Linn G, Stead LF, Best A. Impact of tobacco advertising and promotion on increasing adolescent smoking behaviours. Cochrane Database of Systematic Reviews 2011, Issue 10. [DOI: / CD pub2] Moodie 2012 Moodie C, Stead M, Bauld L, McNeill A, Angus K, Hinds K, et al.plain Tobacco Packaging: A Systematic Review. Public Health Research Consortium, UK Centre for Tobacco Control Studies (accessed at phrc.lshtm.ac.uk/ project_ _006.html) RevMan 2014 The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan) Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, Stead 2013 Stead M, Moodie C, Angus K, Bauld L, McNeill A, Thomas J, et al.is consumer response to plain/standardised tobacco packaging consistent with framework convention on tobacco control guidelines? A systematic review of quantitative studies. PLoS One 2013;8(10):e Wakefield 2002 Wakefield M, Morley C, Horan JK, Cummings KM. The cigarette pack as image: new evidence from tobacco industry documents. Tobacco Control 2002;11 Suppl 1:i73 i80. World Bank 1999 World Bank. Curbing the Epidemic, Governments and the Economics of Tobacco Control. Washington DC: World Bank Publications, World Health Organization 2008 World Health Organization. Guidelines for implementation of Article 13 of the WHO Framework Convention on Tobacco Control (decision FCTC/COP3 (12)). (Accessed at index.html). WHO Framework Convention on Tobacco Control, World Health Organization 2013 World Health Organization. Report on the Global Tobacco Epidemic 2013: enforcing bans on tobacco advertising, promotion and sponsorship. MPOWER report Indicates the major publication for the study 5

8 A P P E N D I C E S Appendix 1. Search Terms Tobacco concept AND plain packaging, where: 1. (Tobacco OR smoking OR smoker* or cigar* or cigarette*).ti, ab. 2. (Tobacco or Smoking or Smoking Cessation or Tobacco Industry or Tobacco Smoke Pollution).sh 3. (pack? or packet? or package* or packaging or plain pr warning or label$ or pictorial OR graphic).ti. 4. (Product labeling or Consumer Product Safety or Advertising as Topic).sh or or and 6 D E C L A R A T I O N S O F I N T E R E S T Ann McNeill is a trustee of, and receives grants from, various organisations whose goal is to reduce the mortality and morbidity caused by smoking and which support the implementation of a comprehensive tobacco control strategy including measures such as standardised packaging. However, the opinions of these organisations do not affect this review. Crawford Moodie has received consultancy fees from the European Commission for serving on the advisory panel for the development of pictorial health warnings and has received research grants from Cancer Research, UK, neither of which influence the submitted work. David Hammond has received research grants on studies of cigarette packaging. He has also served as a consultant, paid speaker and Advisor to a number of agencies involved in tobacco policy, including Health Canada, the European Commission, the UK Department of Health, and the US Centers for Disease Control and Prevention. He has served as an expert witness in several cases associated with the tobacco industry, including on behalf of the UK government in the Point of sale legal challenge, on behalf of the Government of Canada in health care cost recovery litigation, on behalf of the Commonwealth of Australia in plain packaging litigation, on behalf of the government of Uruguay and in the Craft vs. Philip Morris USA case. All other authors declare no known potential conflicts of interest. 6