Prosjekt: Effekt av tobakksforebyggende tiltak i lav- og middelinntektsland

Kort beskrivelse/sammendrag
Forbruket av tobaksprodukter i lav- og mellominntektsland har økt med 5%  årlig fra 1970 til år 2000 (FAO, 2003). Hvis en tilsvarende utvikling får fortsette uhindret vil dette medføre en dramatisk økning i tobakksrelaterte helseskader om 20 til 30 år, som vil utgjøre en stor byrde for helsesystemet i disse landene. Det finnes god kunnskap om effektive intervensjoner mot røyking. Disse er imidlertid hovedsakelig utviklet og evaluert i høyinntektsland, og det er ikke klart hvorvidt intervensjonene kan overføres til lav- og mellominntektsland  med en forventning om tilsvarende effekt. Vi vil derfor søke og oppsummere resultatene fra studier som beskriver og dokumenterer effekten av intervensjoner for å redusere bruk av tobakk i lav- og mellominntektsland.

English:
General consumption of tobacco products increased at a rate of 5% from 1970 to the year 2000 in Low and middle income countries (LMIC) (FAO, 2003). If this continues unabated, the increase in burden of tobacco related chronic diseases 20 to 30 years later will create a large burden on the health systems in these countries.

At present, there is evidence of effective interventions for tobacco control but these are mainly developed and tested in high income settings and it is not clear if the findings can be applied to LMIC. We therefore will review the literature for studies done in LMIC to document the effect and characteristics of interventions for tobacco control in these settings.

Mandate
The Norwegian Cancer Society through its work with Norad and the Foreign department realises that tobacco use is a large problem that is gradually increasing in LMIC (countries with Gross National Income per capita of $11,455 or less, World Bank Website, accessed August 2009). Although some interventions have been effective in preventing further use of tobacco products in some settings, most of the evidence is from surveys and other studies with non rigorous designs.  A literature review of effectiveness studies will be helpful in mapping high quality studies and will guide priority setting for Norwegian support for tobacco control that is provided through several Norwegian agencies and international collaborations. The Knowledge Centre for the Health Services (NOKC) has therefore been mandated to carry out a review of the literature to document the effect of interventions for preventing the use of tobacco in LMICs.

Goal
To document the effect of interventions that aim to prevent tobacco use in Low and Middle Income Countries (LMIC). We will attempt to answer the following question:

• Which interventions are effective in preventing the use of tobacco?

Background
Whereas there has been an increase in public awareness and generally decreasing use of tobacco products in many high income countries, low and middle income countries now remain a large and vulnerable market for tobacco products. In these areas, the large population growth means there is a growing potential for new users of tobacco as well as a general increase in consumption of tobacco. Large trans-national companies have realized this potential market and have therefore shifted their focus to these countries. While aggregate consumption decreased by 0.2% per year in high income countries between 1970 and 2000, consumption in LMIC increased by 5% per year in the same period (FAO 2003).

Ten to twenty years later, the growth in smoking rates is followed by an increase in the incidence of diseases such as ischemic heart disease, lung, oral cavity and larynx cancers; and twenty to forty years later, chronic obstructive airway disease (Lopez 1994, Slama 2008). Already at the current smoking rates, health services in LMIC are constrained by lack of resources and burden of infectious diseases. As the prevalence of smoking related non communicable diseases such as chronic obstructive pulmonary disease, ischemic heart disease, cerebrovascular diseases etc. increases, the total burden on the health care systems in this countries will continue to grow.  It is therefore important that efforts to control the growing consumption of tobacco in LMIC are strengthened.

In response to the tobacco epidemic, the WHO Framework Convention on Tobacco Control was formulated (WHO, 2003). Countries that are signatory to this treaty are obliged to strive for the right of all people to the highest standard of health including protection from exposure to tobacco smoke. This framework details core demand reduction provisions such as price and tax measures, non price measures like regulation of contents of tobacco products, tobacco advertising; as well as supply reduction measures like provision of support for economically viable alternative activities, control of illicit trade in tobacco products.

Several interventions for the control of tobacco use have been documented in systematic reviews. Some of these interventions have been documented to have positive effects. For example, nicotine replacement therapy increases the chance of stopping to smoke by 50-70% (Stead LF, 2007). Proactive telephone counseling among smokers that contacted help lines resulted in almost 40% decrease in smoking rates among those randomized to receive multiple calls (9 studies, RR 1.39, 95% CI 1.26-1.50). When not initiated by calls, telephone counseling increased quitting rates by about 30% (44 studies, RR 1.29, 95% CI 1.20 – 1.38) (Stead LF 2009). Mass media campaigns when included as part of a complex set of interventions can result in reduced smoking rates (Bala M, 2008). Five out of nine large studies reporting smoking prevalence showed a decreasing rate, three out of seven documenting quantity of cigarettes smoked showed decreasing amounts consumed. Over half of the studies reporting quit rates showed increases in rates of abstinence.

Some population level interventions such as tax increases on tobacco products, bans on advertising and smoke free public places have shown to be effective in reducing cigarette consumption rates (WHO, 2004). However, most of the evidence is drawn from surveys. Other interventions such as warnings and fines for retailers selling cigarettes to minors have not shown a clear effect on the perception of young smokers in acquiring cigarettes or their smoking behavior (Stead LF, 2008).

The available evidence on the effectiveness of interventions to reduce or prevent tobacco-consumption is largely drawn from studies done in high income settings. Thus, it is questionable if findings can be applied to other settings. Implementation of interventions for the control of tobacco may be context specific and require adaptation to local circumstances in order to make them relevant. We will therefore systematically review the literature to identify studies implemented in LMICs in an attempt to assess the effect and document any unique characteristics of interventions for tobacco control in these areas.

Methods
We will search the CENTRAL Cochrane database for references from the Cochrane Tobacco Addiction Group Specialised Register. We will then use a search strategy that specifies Low and Middle income countries to identify potentially relevant references. The specialized register is maintained by the Cochrane Tobacco Addiction Group and is regularly searched and populated by studies identified from MEDLINE, EMBASE, PsychLIT/PsychINFO, Science Citations Index (SCI) and Social Science Citations Index (SSCI) via Web of Science, Hand searching, and searching of Conference abstracts. As of 28^th April 2009, most of the key databases were searched up to August 2008 and Medline up to February 2009.  We will screen the reference lists of eligible articles for any additional relevant articles. We will identify key websites of organisations dedicated to the control of tobacco use e.g. Research for International Tobacco Control (RITC) a program of the International Development Research Center (IDRC) and search them for relevant publications. Through a snowballing process, key researchers working on tobacco control in LMIC and identified from the process above shall be contacted for information on any additional studies or tobacco control groups that may be relevant.

Abstracts and subsequently full text articles for those deemed relevant shall be screened by the project working group according to the following criteria:

Participants
All groups including special interest groups such as young people/adolescents and pregnant women in Low and Middle income countries. We will exclude any studies using simulations, and animal studies.

Interventions

Using the MPOWER six policies that were developed from the WHO Framework Convention on Tobacco Control (WHO, 2003) as a guide we shall identify any intervention that is intended to:

• Monitor tobacco use and prevention policies such as establishment of monitoring systems for prevalence of tobacco use, industry marketing
• Protect people from tobacco smoke e.g. Bans on smoking in public places, workplaces
• Offer help to quit tobacco use including pharmacotherapy, telephone help lines, cessation incorporated into primary care
• Warn about the dangers of tobacco such as changes in labelling and packaging of cigarettes, anti-tobacco counter advertising e.g. using the mass media
• Enforce bans on tobacco advertising, promotion or sponsorship such as including legislation, where possible attempts at its enforcement shall be documented
• Raise taxes on tobacco

Others such as: Interventions to reduce the supply of tobacco and cigarettes e.g. Support for economically viable alternative activities such as crop diversification and buy outs, surveillance for illicit trade in tobacco products; Psychosocial therapy/Social support groups.

We will include interventions aimed at the individual as well as the population level.

Control/Comparison Group

• No intervention
• Delayed Intervention
• General information on smoking prevention distributed to all participants
• One intervention compared to another intervention

Types of Studies

• Randomized controlled trials,
• Cluster randomised trials,
• Quasi-experimental controlled trials (e.g. controlled before-and after studies)

For population level interventions e.g. mass media, we shall include controlled before and after studies and interrupted time series. The criteria suggested by the Cochrane Effective Practice and Organisation of Care (EPOC) for inclusion of interrupted time series and controlled before and after studies will guide us. However, we will consider including controlled before- and after studies that only include one control comparison (EPOC-criteria demand at least two intervention- and two control groups), and also adjusting down the number of measurements required for interrupted time series to a minimum of three before and three after the timing of the intervention. We will consider the quality of included studies at the time of analysis.

Outcomes
Primary Outcome – Smoking quit rates or smoking status; rates of smoking initiation among new smokers. Where possible, we shall identify and analyse studies where smoking status was verified using biochemical analysis. Abstinence shall be defined according to the Russell standard (West 2005) as a self-report of smoking not more than 5 cigarettes from the start of the abstinence period followed by a negative biochemical test, whenever possible. Abstinence at 6 and 12 month time points shall be documented. Biochemical verification using carbon monoxide in expired air at a cut-off point of 9 parts per million whenever possible will be documented. Where a sample of those that quit smoking has been taken for biochemical verification, this should have been randomly selected. For those using cotinine for verification of smoking status, an attempt to rule out use of nicotine replacement therapy should have been made.

Secondary outcomes

These shall include the following outcomes:

• Changes in smoking behaviour such as the number of cigarettes smoked, smoking rates
• Prevalence of quit attempts
• Change in Knowledge about smoking
• Change in cigarette sales

Articles that meet the above criteria will be eligible for inclusion in the review. Data will then be extracted and subsequently analysed. We anticipate that the interventions delivered will be very diverse and not warrant  meta-analysis, but a judgement on this will be made when we have reached the analytical stage of our review. Methodological quality of included studies will be assessed using Risk of Bias assessment (Higgins 2008) . We will grade the quality of the evidence using the GRADE-instrument.

Activities, milestones and timeplan
References retrieved from searching of the literature shall be screened in duplicate for relevant studies according to the above criteria. Full text articles for relevant studies shall be retrieved and screened by two reviewers. Any articles where the two reviewers are not in agreement on their inclusion shall be discussed by both reviewers. A third reviewer shall be asked to resolve any disagreements that may arise.

All relevant studies shall be extracted by one reviewer and another reviewer will cross check all entries for any errors and correct any that may arise. Data will then be summarized and a report written up on the findings. The project started in July 2009 and shall be completed by December 2009.

Publication and dissemination

• The end product of this project will be a report that will be submitted to the Norwegian Cancer Society after internal and external peer review.
• The target groups for this report are staff at the Norwegian Cancer Society as well as other Norwegian national and international organizations working on tobacco control and/or development issues especially in Low and Middle-income countries.
• Electronic copies of this report will be submitted to the Norwegian Cancer Society and other target audiences.  
• If possible, a Cochrane review shall be written and submitted for publication.

References

The World Bank. Data and Statistics of Country Groups by Income. Available at: http://web.worldbank.org/WBSITE/EXTERNAL/DATASTATISTICS/0,,contentMDK:20421402~pagePK:64133150~piPK:64133175~theSitePK:239419,00.html#Low_incomeAccessed on 17^th August 2009.

Food and Agricultural Organisation of the United Nations. Projections of tobacco production, consumption and trade to the year 2010. Rome, Italy:FAO 2003.

Slama K. Global perspective on tobacco control. Part 1. The global state of the tobacco epidemic. International Journal Tuberculous Disease 2008; 12(1):3-7.

Lopez, A., Collishaw, N., & Piha, T. (1994). A descriptive model of the cigarette epidemic in developed countries. Tobacco Control, 3(3), 242-247.

The World Health Organisation Framework Convention on Tobacco Control. Available at: http://www.who.int/tobacco/framework/WHO_FCTC_english.pdf.  Accessed 20th August 2009

Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD000146. DOI: 10.1002/14651858.CD000146.pub3

Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD002850. DOI: 10.1002/14651858.CD002850.pub2

WHO Tobacco Free Initiative.Building blocks for tobaccocontrol: a handbook. Geneva, World Health Organisation 2004.  (http://www.who.int/entity/tobacco/resources/publications/general/HANDBOOK%20Lowres%20with%20cover.pdf , accessed 08 October 2009).

Bala M, Strzeszynski L, Cahill K. Mass media interventions for smoking cessation in adults. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD004704. DOI: 10.1002/14651858.CD004704.pub2

Stead LF, Lancaster T. Interventions for preventing tobacco sales to minors. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD001497. DOI: 10.1002/14651858.CD001497.pub2

West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction 2005; 100:299-303.

World Health Organisation. Why is tobacco a public health priority? http://www.who.int/tobacco/health_priority/en/. Accessed 17-8-2009.

Effective Practice and Organisation of Care Group (EPOC) http://www.epoc.cochrane.org/Files/Website/Reviewer%20Resources/inttime.pdf. Accessed 20 - 08- 2009

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org.