Interventions for tobacco use prevention in Indigenous youth (Protocol)

Transcription

1 Interventions for tobacco use prevention in Indigenous youth (Protocol) Carson KV, Labiszewski NA, Brinn MP, Peters M, Chang AB, Veale A, Esterman AJ, Smith BJ This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 9

2 T A B L E O F C O N T E N T S HEADER ABSTRACT BACKGROUND OBJECTIVES METHODS ACKNOWLEDGEMENTS REFERENCES HISTORY CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT i

3 [Intervention Protocol] Interventions for tobacco use prevention in Indigenous youth Kristin V Carson 1, Nadina A Labiszewski 1, Malcolm P Brinn 1, Matthew Peters 2, Anne B Chang 3, Antony Veale 4, Adrian J Esterman 5, Brian J Smith 6 1 Clinical Practice Unit, The Queen Elizabeth Hospital, Adelaide, Australia. 2 Medicine, Concord Clinical School, The University of Sydney, Sydney, Australia. 3 Menzies School of Health Research, Charles Darwin University, Casuarina, Australia. 4 Respiratory Medicine, The Queen Elizabeth Hospital, Adelaide, Australia. 5 University of South Australia, Adelaide, Australia. 6 Department of Medicine, University of Adelaide, The Queen Elizabeth Hospital, Adelaide, Australia Contact address: Kristin V Carson, Clinical Practice Unit, The Queen Elizabeth Hospital, 4A Main Building, 28 Woodville Road Woodville South, Adelaide, South Australia, 5011, Australia. kristin.carson@health.sa.gov.au. Editorial group: Cochrane Tobacco Addiction Group. Publication status and date: New, published in Issue 9, Citation: Carson KV, Labiszewski NA, Brinn MP, Peters M, Chang AB, Veale A, Esterman AJ, Smith BJ. Interventions for tobacco use prevention in Indigenous youth. Cochrane Database of Systematic Reviews 2011, Issue 9. 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 evaluate the effectiveness of intervention programs to prevent tobacco use initiation or progression to regular smoking amongst young Indigenous populations and to summarise these approaches for future prevention programmes and research. 1

4 B A C K G R O U N D Throughout the world, Indigenous populations bear a disproportionate burden of substance-related morbidity and mortality when compared to non-indigenous populations. Prevalence for tobacco use amongst the Indigenous populace is often double that of the relevant non-indigenous population, with estimates of 51-59% in Canada (Health Canada 2003; CEITC 2005), 47-53% in Australia (CEITC 2005; ABS 2009), 45.4% in New Zealand ( Ministry of Health 2009) and 44% in the United States for Alaskan natives (First Nations Center 2005; Alaska Department of Health 2006). Addiction to nicotine usually begins during early adolescence, with only 10% of new smokers initiating the habit after the age of 18 years (US Dept Health and Human Services 1998). For Indigenous youth there is an added social context, which one Australian report suggests has resulted in almost half of Indigenous youth aged 14 years and older reporting smoking on a daily basis, compared to approximately 20% in non-indigenous Australians (AIWH 2002). In a similar perspective, a Canadian survey of Indigenous youth reports smoking initiation peaking at 13 years of age (First Nations Center 2005). An evaluation of British Columbian youth estimates the prevalence of smoking in their Indigenous population to be 41% for youth aged 12 to 18 years and 61% for youth aged 19 to 24 years, whilst non-indigenous youth have prevalence estimates of 18% and 31% respectively (Reading 1999). A more recent evaluation, the First Nations regional longitudinal health survey in 2002/03, found 37.8% of youth reporting current smoking, which is double that of the relevant non-indigenous population (Reading 2009). As such, a disproportionate burden of disease has been attributed to the normalisation of tobacco use and the key role that it appears to play in social interactions and relationship building amongst Indigenous youth. The primary social influences resulting in youth initiation of smoking are relevant for all youth, Indigenous and non-indigenous alike, and include peer group pressure, positive attitudes toward smoking and the observation of adult smoking. For Indigenous youth this is amplified by the increase in adult smoking prevalence and the normalisation of tobacco use as part of the usual Indigenous landscape (Lindorff 2002; Scollo 2008; Leavy 2010). Furthermore, reports suggest that substandard and overcrowding living conditions increase tobacco exposure in young people in indigenous Australian communities (Johnston 1997; Eades 1999; Ivers 2001; Penman 2006; Johnston 2008). A recent Australian survey of tobacco exposure in Aboriginal and Torres Strait Islander households reports that 21% of children aged 0 to14 years were exposed to indoor tobacco smoke in 2008, which is a decrease from reports of 29% in 2004 to 2005 (ABS 2011). For these reasons systematic consolidation of current prevention strategies in Indigenous youth are required to identify features of effective programs, which can be translated into policy to guide future prevention initiatives. Specific definitions for Indigenous vary between regions and populations. These terms remain highly contested and are not always accepted or used (Nettelton 2007). Such examples include Australian Aboriginal or Torres Strait Islanders for the Australian Indigenous, First Nations are sometimes used to describe the Indian populations indigenous to Canada. Native Hawaiians are used for Hawaii s Indigenous and Tangata Whenua or People of the land for the Maroi of New Zealand (Cunningham 2003). In an attempt to create consistency, though cognisant of the preferential syntax for populations, the term Indigenous has been chosen to encompass participants within this review as it reflects the experiences shared by a group of people who have inhabited a country for thousands of years, which often contrast with those of other groups of people who reside in the same country for a few hundred years (Cunningham 2003). No offence is meant to any group for whom their preferred descriptor is not used. O B J E C T I V E S To evaluate the effectiveness of intervention programs to prevent tobacco use initiation or progression to regular smoking amongst young Indigenous populations and to summarise these approaches for future prevention programmes and research. M E T H O D S Criteria for considering studies for this review Types of studies Randomised controlled trials (RCT) or quasi-randomised controlled trials (CCT). Types of participants Young people aged 25 years or less, of either gender, who are members of indigenous populations, using indigenous in the sense described above, and are participating in a study to prevent tobacco use initiation. Interventions may target groups of individuals (e.g. school classes), some of whom have already used tobacco. We will distinguish between studies that report outcomes only for participants with no experience of tobacco use at baseline and those which include participants who have already smoked at baseline. Trial participants are not required to be selected according to their susceptibility or suitability for particular interventions. No attempts will be made to re-define Indigenous status for the purpose of including a study in this review. If meaningful data is found which refers to an Indigenous subpopulation in a larger study, it will be considered for inclusion in this review. 2

5 Types of interventions We will include interventions to prevent tobacco use initiation or progression from experimentation to regular tobacco use. Interventions will be grouped by type and setting based on the following categories: 1) School only (including class lessons etc.), e.g. school-based curriculum delivered by classroom teachers. 2) Mass media (including television, radio, billboards, posters etc.), e.g. community- or nation-wide media campaign directed at adolescents through highlighting the health effects of tobacco use. 3) Multi-component (i.e. more than one) community based intervention targeting large areas (including school, specialised community groups, health care professionals, mass media etc.), e.g. combined tobacco use prevention campaigns involving peer role models, school curriculums, anti-smoking messages at local sporting or community events, combined into one intervention. 4) Family-based programs, e.g. anti-smoking messages involving parent and child communication and activities including games, workbooks, discussions or written information. 5) Public policy (including legislative interventions, retailer restrictions etc.), e.g. policy for smoking ban in public places or where children are present, which is enforced by the community. We will not exclude trials with high levels of attrition, however this will be documented within the Risk of Bias tables and discussed. Controls can be usual practice, no intervention, co-interventions or reduced intervention. Control participants receiving reduced interventions may be offered brief tobacco use prevention advice, but support must be of a lower intensity than that given to the intervention participants. Types of outcome measures Primary outcomes The primary outcome will be tobacco use status as defined by self-reported tobacco use behaviour or objectively through biochemical validation (e.g. saliva thiocyanate levels, alveolar carbon monoxide), at the longest follow-up point reported in the study (minimum of six months). We will record the definition of smoking or tobacco use used by each study. This may be reported as any smoking/tobacco use since interventions, or as use within a particular period. We will consider the sustainability of change (whether the effect at longest follow up is larger or smaller that at earlier follow ups) in tobacco use behaviour after the intervention (less than versus longer than one year). Studies reporting tobacco use prevention data which exclude baselinetobacco users will be reported separately from those including baseline smokers within the reported cohort. If outcomes are reported separately for different categories of baseline users we will extract data for all outcomes. Trials reporting less than six-month follow up will be excluded. Secondary outcomes Secondary outcomes that will be extracted if reported will include: 1) whether the intervention has had an affect on intentions to use tobacco, attitudes to tobacco use, knowledge about tobacco use, decision making, refusal skills, self-efficacy and tobacco use perception/norms; 2) levels of implementation for process measures (e.g. measuring the amount of exposure to the intervention that the participants actually received, including details of implementation) as given in each included study, for example: cigarette purchases by minors, membership of anti-smoking clubs for young people, media reach and level of exposure to each component of an intervention; 3) costs of interventions. Search methods for identification of studies Electronic searches We will identify potential studies from the Tobacco Addiction specialised Register. This is generated by regular searches of The Cochrane Library, EMBASE, MEDLINE, PsycINFO and Science Citation Index for trials of tobacco use prevention interventions. No language restrictions will be applied. The following free text search terms will be used to identify records relevant to the topic: aborig* OR Indig* OR inuit OR maori OR native american OR american indian OR tribe* OR tribal, AND young people OR teen* OR adolesce* OR juveniles OR child* OR boy* OR girl*, Since the Specialised Regsiter is limited to studies of smoking and other tobacco used behaviour no smoking related terms will be used. In addition we will search MEDLINE using the search strategy used for the specialised register which combines terms for smoking and terms for identify controlled trials, combined with MeSH terms for indigenous populations, and age related limits. Online clinical trial registers will be searched for ongoing and recently completed studies including, Controlled Clinical Trials ( the National Research Register ( government registries (clinicaltrials.gov), and WHO registries ( Searching other resources We will review reference lists of all included studies and of reviews to identify potentially relevant citations. In addition, we will make enquiries regarding other published or unpublished studies known to the authors of the included studies. Data collection and analysis 3

6 Selection of studies From the title, abstract, or descriptors, KC will independently review the literature searches to identify potentially relevant trials. All studies that clearly do not meet the inclusion criteria in terms of study design, population or interventions, will be excluded. KC will extract the data, which will be checked by a second reviewer (either NL or MB). Both KC and either NL or MB will independently extract data for risk of bias for all included studies. Data extraction and management KC will extract data for the trials using a standardised data extraction form prior to entry into The Cochrane Collaboration software program, Review Manager KC will also correspond with authors to obtain any missing or raw data as required. Risk of bias for each included study will be extracted by two independent authors (KC and either NL or MB). The following information will be extracted: Methods: country/setting of trial; design; objectives; study site; methods of participant recruitment; methods of analysis Participants: age; gender; ethnicity; socio-economic status; n-values for eligibility, recruitment and completion Interventions: descriptions of interventions and controls; duration; intervention delivery; type/duration of behavioural support and control group components Outcomes: method of outcome collection; pre-specified outcome data; validation; follow-up period; other follow ups and definitions of abstinence; outcome data as defined under Types of outcome measures in this protocol. Risk of bias: methods of sequence generation; allocation concealment; blinding; incomplete outcome data; selective outcome reporting, imbalance of outcome measures at baseline, comparability of intervention and control group characteristics at baseline, protection against contamination, selective recruitment of participants and other potential threats to validity. Assessment of risk of bias in included studies Risk of bias (ROB) will be evaluated by two independent reviewers, KC and either NL or MB, in line with recommendations made in the Cochrane Handbook of Systematic Review of Interventions (Higgins 2009) and additional criteria developed by the Cochrane EPOC Group (EPOC 2009). This will be on the basis of allocation sequence, allocation concealment, blinding for participants and outcome assessors, incomplete outcome data, selective outcome reporting and other potential threats to validity. The three additional domains recommended by the Cochrane EOPC group assess design-specific threats to validity including: imbalance of outcome measures at baseline; comparability of intervention and control group characteristics at baseline; and protection against contamination (EPOC 2009). Finally, for cluster study designs, we assessed the risk of bias associated with an additional domain; selective recruitment of participants. ROB for each domain will be assessed as Low risk of bias, High risk of bias, or Unclear risk of bias, as per the guidelines from table 8.5.c of the Cochrane Handbook (Higgins 2009). Conflicts in the assessments will be resolved either by consensus or by referring to a third party of either BS or AV. Measures of treatment effect If possible, a risk ratio (RR) will be provided for the primary outcome of each trial. The RR will be defined as (number of subjects using tobacco in the intervention group/ total number randomised to the intervention group) / (number of subjects using tobacco in the control group/ total number randomised to the control group). The RR will be less than 1 if the intervention is effective, and more subjects remain non-smokers in the intervention group than in the control group. An estimated pooled weight average for RRs will be calculated using the Mantel-Hetzel fixed-effect model, with 95% confidence intervals, providing a low level of heterogeneity (see Subgroup analysis and investigation of heterogeneity). Where data are presented as a combination of continuous and dichotomous data for the same outcome, we will combine them using the generic inverse variance (GIV) approach as per section of the Cochrane Handbook (Higgins 2009). We expect secondary outcomes to be presented in different formats, as such we will present data as either dichotomous, continuous or combine the two if data are presented in different ways for the same outcome, using GIV. We aim to conduct an intention-to-treat analysis, including participants enrolled at baseline whether or not they receive the intended intervention. Unit of analysis issues For cluster controlled trials, the analysis will be performed at the level of individual whilst accounting for the clustering in the data. For studies that did not include adjustments for clustering the size of the trial will be reduced to the effective sample size (Rao 1992) using the original sample size from each study, divided by a design effect of 1.2 which is consistent with other tobacco use intervention trials (Gail 1992) and as per recommendations in the Cochrane Handbook, section (Higgins 2009). Trials may use a variety of statistical methods to investigate or compensate for clustering; we will record whether studies used these and whether the significance of any effect was altered. In the case of multi-arm trials we will include each pair-wise comparison separately, but with shared intervention groups divided out approximately evenly among the comparators. However, if the intervention groups are deemed similar enough to be pooled, the groups will be combined using appropriate formulas in the Cochrane Handbook (table 7.7.a for continuous data and chapter for dichotomous data) (Higgins 2009). 4

7 Dealing with missing data Missing information regarding participants will be evaluated on an available case analysis basis as described in chapter of the Cochrane Handbook (Higgins 2009). Where statistics essential for analysis are missing (e.g. group means and standard deviations for both groups are not reported) and can not be calculated from other data, we will attempt to contact the authors to obtain data. Loss of participants that occur prior to performance of baseline measurements will be assumed to have no effect on the eventual outcome data of the study. Any losses after the baseline measurement are taken will be assessed and discussed. We will consider both differential losses between intervention and control conditions, and differential losses within conditions according to baseline characteristics, Assessment of reporting biases Providing the inclusion of greater than ten included studies, potential reporting biases will be assessed using a funnel plot. Asymmetry in the plot could be attributed to publication bias, but may well be due to true heterogeneity, poor methodological design or artefact. In case of asymmetry, we may include contour lines corresponding to perceived milestones of statistical significance (p= 0.01, 0.05, 0.1 etc.) in funnel plots, which may help to differentiate between asymmetry due to publication bias from that due to other factors (Higgins 2009). In instances of fewer than ten studies, the reporting biases will be extrapolated within the other bias section in the risk of bias tables. Subgroup analysis and investigation of heterogeneity We will attempt to categorise trials according to the subgroups listed in Types of interventions above. Consideration will be given to pooling trials within these subgroups, but we will not attempt to pool trials of different intensities of behavioural interventions, or different types of population based interventions. There may be further heterogeneity contributed by factors such as baseline tobacco use status, participant and community characteristics, (e.g. age, physical state, cultural and educational differences), time of measurement of results and varying measurement tools used to assess outcomes. The chi square and I² statistic, in addition to visual inspect of the data (Higgins 2009), will be used to quantify inconsistencies across studies. In groups of trials where metaanalysis is judged potentially appropriate, extracted data will be pooled using the fixed-effect model. In the presence of substantial heterogeneity (based on visual inspection of study data, I² statistic, and consideration of study design and methodology), the use of a random-effects model will be considered. However this will be performed with caution taking into account the possible influence of smaller studies which could over or under estimate the true treatment effect. In addition to meta-analysis (if judged appropriate) we will also report data through narrative synthesis, treating the studies individually with consideration of their confidence intervals or reporting the results restricted to the larger, more rigorous studies as suggested in section of the Cochrane Handbook (Higgins 2009). These data will all be analysed using Review Manager Ideally we will aim to conduct subgroup analyses for each population (e.g. Australian Aborigines, Alaskan native etc.). Also within each population, tobacco use prevalence may vary widely between dispersed community groups, further adding to potential heterogeneity of results. As each Indigenous population is unique and each has specific characteristics (such as remoteness) that could influence the effectiveness of tobacco use cessation interventions, subgroup analysis would give the most relevant results for a particular population. However it is not anticipated that sufficient studies will exist for all (or even any) populations to be analysed as subgroups. Subgroup analysis of remote versus urban dwelling and isolated versus integrated populations will also be considered if possible. In studies of long duration, results may be presented for several periods of follow up including short-term (< 26 weeks), mediumterm (27 to 52 weeks) and long-term (> 53 weeks). Data permitting, extended follow up will also be collated for studies presenting data over two years. For studies with more than one follow up, we will consider whether the effect at longest follow up is larger or smaller than at earlier follow ups. Sensitivity analysis Sensitivity analysis will be conducted on studies with a high risk of bias for sequence generation and allocation concealment. Indigenous engagement in the review process A recent short report by McDonald 2010, outlines the results of a taskforce conducted between the public health group within the Cochrane Collaboration and Indigenous health researches, to discuss the issues and challenges of systematic reviews in Indigenous health. It highlights the levels of complexities involved in the synthesis of evidence in such populations, for whom the social determinants of health are key factors underlying health inequalities. An important outcome of this project was to emphasize the need for engagement through Indigenous people, organisations and communities to ensure that the health research meets the needs of those that use them, including the Indigenous communities themselves. For this reason, the review will be examined by two independent Indigenous representatives for consideration of applicability and content. At least one of these reviewers will be an Indigenous researcher or health care worker. A C K N O W L E D G E M E N T S 5

8 We would like to thank the Tobacco Addiction Group s editorial team, in particular Monaz Mehta and Lindsay Stead. R E F E R E N C E S Additional references ABS 2009 Australian Bureau of Statistics National Aboriginal and Torres Strait Islander Social Survey, / Main%20Features72008?opendocument& tabname=summary&prodno=4714.0&issue=2008&num= &view= [accessed 17/07/2011] 2009; Vol ABS 2011 Australian Bureau of Statistics The Health and Welfare of Australia s Aboriginal and Torres Strait Islander Peoples, Oct abs@.nsf/lookup/4707.0chapter650oct+2010 [accessed 12/07/2011] 2011; Vol AIWH 2002 Australian Institute of Health and Welfare National Drug Strategy Household Survey: first results; Drug Statistics Series No. 9. AIWH; Canberra 2002; Vol. Cat no. PHE35. Alaska Department of Health 2006 Alaska Department of Health and Social Services. Alaska tobacco facts June chronic/tobacco/alaska_tobacco_facts.pdf 2006:accessed 06/07/2010. CEITC 2005 Centre for Excellence in Indigenous Tobacco Control. International Indigenous tobacco control. control cited 06/07/2010. Cunningham 2003 Cunningham C, Stanley F. Indigenous by definition, experience, or world view. BMJ 2003;327(7412): Eades 1999 Eades S, Read A. Infant care practices in a metropolitan aboriginal population Bibbulung Gnarneep Team. Journal of Paediatric Child Health 1999;35(6): EPOC 2009 Cochrane EPOC Group Cochrane EPOC Group. Cochrane Effective Practice and Organisation of Care Group.. Available from: (accessed 1 November 2009). First Nations Center 2005 First Nations Center. First Nations Regional Longitudinal Health Survey (RHS) 2002/2003. Results for adults, youth and children living in first nations communities.. First Nations Centre, Ottawa, Canada 2005: Gail 1992 Gail MH, Byar DP, Pechacek TF, Corle DK. Aspects of Statistical Design for the Community Intervention Trial for Smoking Cessation (COMMIT). Controlled Clinical Trials 1992;13:6 21. Health Canada 2003 Health Canada. Smoking in Canada: an overview, Canadian Tobacco Use Monitoring Survey Fact-sheets : accessed 06/07/2010. Higgins 2009 Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Vol , The Cochrane Collaboration, Ivers 2001 Ivers R. Indigenous Australians and Tobacco: a literature review. Cooperative Research Centre for Aboriginal and Tropical Health, Darwin Johnston 1997 Johnston F, Beecham R, Dalgleish P, Malpraburr T, Gamarania G. The Maningrida Be Smoke Free Project. Health Promotion Journal of Australia 1997;8(1):12 7. Johnston 2008 Johnston V, Thomas DP. Smoking behaviours in a remote Australian Indigenous community: The influence of family and other factors. Social Science & Medicine 2008;67: [DOI: /j.socscimed ] Leavy 2010 Leavy J, Wood L, Phillips F, Rosenberg M. Try and try again: Qualitative insights into adolescent smoking experimentation and notions of addiction. Health Promotion Journal of Australia 2010;21(3): Lindorff 2002 Lindorff K, Canberra: National Aboriginal Community Controlled Health Organisation NACCHO. Tobacco - time for action. National Aboriginal and Torres Strait Islander Tobacco Control Project. Final Report. / report.pdf [accessed 17/07/2011] McDonald 2010 McDonald E, Priest N, Doyle J, Bailie R, Anderson I, Waters E. Issues and challenges for systematic reviews in Indigenous health. Journal of Epidemiology and Community Health 2010;64: [DOI: /jech ] Ministry of Health 2009 Ministry of Health: Tobacco Control Team, Roberts F, Devlin M, Bhattacharya A. Tobacco Trends 2008: A brief update of tobacco use in New Zealand. [accessed 17/07/2011]. Wellington: Ministry of Health; Manatu Hauora, [: ISBN: ISBN (online)] 6

9 Nettelton 2007 Nettelton C, Napolitano D, Stephens C. Overview of Current Knowledge of the Social Determinants of Indigenous Health. A working paper commissioned by the Commision on Social Determinants of Health. World Health Organisation Penman 2006 Penman R, Australian Government, Department of Families, Community Services and Indigenous Affairs. The growing up of Aboriginal and Torres Strait Islander children: A literature review. about/publicationsarticles/research/occasional/documents/ op15/op15.pdf [accessed 17/07/2011] [: ISBN: ] Rao 1992 Rao JNK, Scott AJ. A simple method for the analysis of cluster binary data. Biometrics 1992;48: Reading 1999 Reading J, Allard Y. The Tobacco Report. In First Nations and Inuit Regional Health Survey National Report. Ottawa: First Nations and Inuit Regional Health Survey National Steering Committee. Reading 2009 Reading CL, Wien F. Health Inequalitiesand Social Determinantsof Aboriginal Peoples Health. National Collaborating Centre for Aboriginal Health; epub.sub.uni-hamburg.de/epub/volltexte/2009/3060/pdf/ NCCAH_Loppie_Wien_Report.pdf [accessed 17/07/2011] Scollo 2008 Scollo MM, Winstanley MH [editors]. Tobacco in Australia: Facts and Issues; Chapter 8: Tobacco use among Aboriginal peoples and Torres Strait Islanders. [accessed 17/07/2011] 2008; Vol. Third edition. [: ISBN: ] US Dept Health and Human Services 1998 US Department of Health and Human Services. Tobacco use among US Racial/Ethical minority groups - African Americans, American Indians and Alaska Natives, Asian Americans and Pacific Islanders, and Hispanics: A Report of the Surgeon General. Trends in Tobacco Use 1998; Vol. 1: Indicates the major publication for the study H I S T O R Y Protocol first published: Issue 9, 2011 C O N T R I B U T I O N S O F A U T H O R S Protocol conceived and prepared by Kristin V Carson, reviewed by Antony Veale, Adrian J Esterman and Brian J Smith D E C L A R A T I O N S O F No conflicts of interest to report. I N T E R E S T S O U R C E S O F S U P P O R T Internal sources None, Not specified. 7

10 External sources No sources of support supplied 8