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The Framework Convention on Tobacco Control (FCTC) asks countries to develop and disseminate comprehensive evidence based guidelines and promote adequate treatment for tobacco dependence, yet to date no summary of the content of existing guidelines exists. This paper describes national tobacco dependence treatment guidelines of 31 countries.
A questionnaire on tobacco dependence treatment guidelines was sent by email to a convenience sample of contacts working in tobacco control in 31 countries in 2007. Completed questionnaires were received from respondents in all 31 countries. During the course of these enquiries we also made contact with people in 14 countries that did not have treatment guidelines and sent them a short questionnaire asking about their plans to produce guidelines.
The survey instrument was a seventeen item questionnaire asking the following key questions: do the guidelines recommend brief interventions, intensive behavioural support, medications; which medications; do the guidelines apply to the whole healthcare system and all professionals; do they explicitly refer to the Cochrane database; are they based on another country's guidelines; are they national or more local; are they formally endorsed by government; did they go through peer review; who funded them; where were they published; do they include evidence on cost effectiveness of treatment.
According to respondents, all of their countries' guidelines recommended brief advice, intensive behavioural support, and nicotine replacement therapy (NRT); 84% recommended bupropion; 19% recommended varenicline; and 35% recommended telephone quitlines. Nearly half (48%) included cost effectiveness evidence. Seventy one percent were formally supported by their government and 65% were financially supported by the government. Most (84%) used the Cochrane reviews as a source of evidence, 84% went through a peer review process, and 55% were based on the guidelines of other countries, most often the US and England.
Overall, the guidelines reviewed closely followed the evidence base, recommending brief interventions, intensive behavioural support and NRT, and most recommended bupropion. Varenicline was not on the market in most of the countries in this survey when their guidelines were written, illustrating the need for guidelines to be periodically updated. None recommended interventions not proven to be effective, and some explicitly recommended against specific interventions (for lack of evidence). Most were peer reviewed, many through lengthy and rigorous procedures, and most were formally endorsed or supported by their governments. Some countries that did not have guidelines expressed a need for technical support, emphasising the need for countries to share experience, something the FCTC process is well placed to support.
The World Health Organization (WHO) has described two principal approaches to increasing tobacco cessation: a public health approach that seeks to change the social climate and encourage smokers to try to stop, and a health systems approach that focuses on helping them stop by increasing their chance of success (1). The public health approach includes interventions like bans on advertising and promotion, raising tobacco taxes and restricting smoking in public places, and the health systems approach offers treatment (see definition below) to smokers that need help because they are dependent (2,3). These two approaches are complementary and ideally a country should include both in their tobacco control programmes. Failure to offer help to dependent smokers sends them the wrong signal about governments' concern for their health, and may discourage quit attempts and thus undermine public health measures. Offering help to dependent smokers will make public health approaches more acceptable politically and more effective (2,3).
A logical first step towards developing a tobacco dependence treatment system is developing an official policy on treatment and official treatment guidelines. The first US Public Health Service Clinical Practice Guideline (4) was published in 1996 and led directly to the development and publication of the first English tobacco dependence treatment guidelines in 1998 (5,6). The English guidelines, together with other developments at the time, led to the creation of a national tobacco dependence treatment system, illustrating the potential impact of treatment guidelines (7,8).
The FCTC (9) recognizes the importance both of treatment as part of a country's tobacco control programme, and of treatment guidelines, and Article 14 asks Parties to the Convention to develop and disseminate evidence based guidelines and to promote effective treatment for tobacco dependence. In late 2008 the third Conference of the Parties (COP) to the FCTC set up a working group to write guidelines to help countries implement Article 14 (3). A review of existing guidelines may provide useful information for this process, yet until now there has been no systematic attempt to describe the origin and content of existing treatment guidelines.
This paper reports a survey of tobacco dependence treatment guidelines. We describe the guidelines' key characteristics and some aspects of the process by which they were produced. A parallel survey of tobacco dependence treatment systems is reported in another paper (10).
“Tobacco dependence treatment includes (singly or in combination) behavioural and pharmacological interventions such as brief advice and counselling, intensive support, and administration of pharmaceuticals, that contribute to reducing or overcoming tobacco dependence in individuals and in the population as a whole” (11). We use the term smoking cessation to mean all cessation of tobacco use, whether it occurs as a result of public health tobacco control measures or individual support of dependent users through treatment. Tobacco dependence treatment is the narrower activity of helping and supporting tobacco users overcome their dependence on nicotine. The term smoking, where used, should be taken to include all tobacco use.
We surveyed a convenience sample of people working in tobacco control in 31 countries. The sample comprised contacts made in the following manner: in 2005 we asked to hear from people whose countries had tobacco dependence treatment guidelines, through the listserves of the Society for Research in Nicotine and Tobacco and UICC Globalink; in 2007 we contacted the Framework Convention Alliance (FCA) who were surveying 27 of the first 41 countries that ratified the FCTC (12) and asked if we could send our guidelines questionnaire to their contacts these countries; finally in 2007 we repeated the SRNT and Globalink listserve enquiries. From these enquiries we identified people in 31 countries. Guidelines questionnaires were sent and returned via email between July and October 2007. All contacts completed and returned the survey. Most of the 31 informants were members of the SRNT and Globalink listserves. Most worked outside government but a few were government officials. Some were treatment specialists, many were not, but all were active in the tobacco control field. The sample (see Table 1) included countries from all four World Bank income bands (13) and three of the six WHO regions: Europe, the Americas, and the Western Pacific. We did not receive any responses from countries in the WHO African, South East Asian or Eastern Mediterranean regions. A fuller description of the methods is available on the website (details from publisher). During the course of these enquiries we also made contact with people in 14 countries that did not have treatment guidelines. We sent them a short questionnaire asking about their plans to produce guidelines and about their needs.
In developing the questionnaire we consulted two earlier survey instruments about treatment, “A tool to assess the available services for smoking cessation at the country or regional level” (14) and the Tobacco Control Scale (15). A draft was circulated to a group of treatment specialists for comment (see acknowledgements) and it was finalised after receiving their feedback. We list here the key questions asked: do the guidelines recommend brief interventions, intensive behavioural support, medications; which medications are recommended; do the guidelines apply to the whole healthcare system and all professionals; do they explicitly refer to the Cochrane database; are they based on another country's guidelines; are they national, regional or more local; are they formally endorsed or supported by government; did they go through peer review; who funded them; where are they published; do they include evidence on cost effectiveness of treatment. The full questionnaire is available on the website (details from publisher), as is the questionnaire for those without guidelines.
Table 1 shows the year the guidelines were published, the key guideline recommendations, and whether they included cost effectiveness evidence, by country, with countries listed by World Bank income level and within income level, alphabetically. Informants in all 31 countries reported that their guidelines recommended brief interventions and intensive behavioural support, while 35% recommended telephone quitlines and 16% recommended self-help booklets and books. All 31 guidelines recommended NRT, 26 (84%) recommended bupropion and 6 (19%) recommended varenicline. Few specified which NRTs were recommended but of those that did, three specified gum and patch and four specified “all NRTs”. Eight guidelines recommended nortripyline and four recommended clonidine. Some guidelines listed interventions that they did not recommend because of insufficient evidence of effectiveness, including laser therapy, electro-stimulation, herbal and homoeopathic products, hypnosis and acupuncture. Fifteen informants (48%) said their guidelines included cost effectiveness evidence.
All 31 respondents said that their guidelines were national, not regional or more local (Table 2). This was followed by a question asking them to define `national'. The full answers of those that provided this extra detail are presented on the website (details from publisher). Nine respondents defined `national' as meaning that the guidelines were produced by government departments or agencies and 19 said that they were government funded. Twenty two informants (71%) said that their guidelines were for the whole healthcare system and all professionals, whilst five said they were for primary healthcare and hospitals only, three for primary care only and one for hospitals only. Twenty two informants (71%) said that their guidelines were formally endorsed or supported by their national government and nine that they were not.
Twenty six informants (84%) said that their guidelines referenced or explicitly referred to the Cochrane database. Seventeen informants (55%) said that their guidelines were based on those of another country: 15 were based on the US guideline, eight on the UK guidelines, and one based on those of the Russian Federation. Other guidelines mentioned as sources were those of Australia and New Zealand. (We report here how respondents answered the questionnaire, and interpret mention of the UK guidelines to refer to the English guidelines, as in health policy the UK does not exist, and is four countries not one: England, Northern Ireland, Scotland, Wales). There was overlap on this item, with several countries saying their guidelines were based on those of several countries, particularly the US and UK. Only European countries based their guidelines on the English guidelines, whilst the US guideline was more widely used as a source, including by Latin American countries (Table 2).
The majority of informants (26 of 31 or 84%) said that their guidelines went through a peer review process and five that they did not (Table 2). Many guidelines were subjected to a rigorous and demanding multi-stage review process and in many countries professional organisations were involved in this process. Respondents' descriptions of the process are presented on the website (details from publisher) along with lists of professional organisations formally endorsing the guidelines.
We asked if any one individual, group of individuals, or organisation was primarily responsible for leading the process that led to the guidelines. The answers suggest that broadly speaking, guidelines were more often initiated by professional societies than by governments, but given that so many were government funded, clearly there was often cooperation. The answers also suggest that key, committed individuals were often central to the process.
Five informants said that their guidelines had no financial support, 20 (65%) reported that they were solely government funded, two that they were solely funded by professional societies/organisations, one that they were funded solely by the pharmaceutical industry, and one solely by a private publishing house. Two guidelines received support from more than one source: one from a professional society and the pharmaceutical industry, and one from a variety of funders including WHO and pharmaceutical companies.
Nine of the guidelines were published in scientific journals and seven on websites. The USA guideline was published in 1996 and updated in 2000 and 2008. England, France and Sweden published their first guidelines shortly afterwards in 1998, and the English guidelines were updated in 2000. The remaining guidelines in this survey were published from 2002 onwards.
Of the 14 respondents that told us their countries did not currently have guidelines, 10 said they were planning treatment guidelines and four said they were not. Of these 14 countries nine were low or low-middle income and five upper-middle or high income. Of those not planning guidelines, lack of expertise and money were often cited as reasons, and some who said they were planning guidelines also said they needed financial support and expertise. Apart from money, the kind of help asked for included:
Our major finding was that the guidelines surveyed were strong on several points:
Clearly however guidelines need to be updated periodically to take account of new evidence and new treatments. Varenicline was not yet on the market in most of the countries in our survey when their guidelines were written. It only came on the market in June 2006 in the USA and December 2006 in the UK (16). Only guidelines published in 2006 or later, or that were being updated during our survey, recommended varenicline (Table 1). The fact that only one third of the guidelines recommended quitlines may reflect the strength of the evidence, or differing interpretations of the strength of the evidence, when they were written.
It is interesting to note that fewer than half of the guidelines included cost effectiveness evidence. The English experience shows that inclusion of cost effectiveness evidence was important in persuading the government that tobacco dependence treatment is a good investment for the health care system (17), suggesting that treatment guidelines should include cost effectiveness evidence. It also shows that guidelines can have multiple audiences – not just healthcare professionals, including those that pay for health services. This was the case in England, for example, where the guidelines were funded by a government agency but did not, at the time they were being written, represent official government policy (17).
In many countries guidelines went through a rigorous review process that often involved many individual experts and professional organisations, resulting in the guidelines having broad and authoritative support. It seems likely that this inclusiveness will make the guidelines more influential and thus have a greater impact on policy, although it is also likely that this process will make the guidelines more expensive.
The relationship between government support, including funding, and guideline development appears to be complex. The English experience suggests that broad professional support was important in influencing the government to establish treatment services, however we have also noted that leadership of the guidelines process more often came from committed individuals and professional societies rather than government per se. Genuine collaboration is almost certainly important, but it also seems unlikely that guidelines will have much real impact without eventual government commitment to their implementation.
Use of the Cochrane reviews as a source of evidence by almost all (84%) the guidelines is testimony to the reputation and value of this resource. Over half – 17 – of the guidelines were based on those of another country, 15 on the US guideline and eight on the English guidelines. These data suggest that the US guideline was one of the first, possibly the first national guideline, and the finding that so many countries based theirs on or used as a source the US and/or English guidelines, strongly suggests the value of shared experience. It is notable that respondents in some of the countries that do not have guidelines highlighted their need for technical expertise and of examples of other guidelines to work from.
It is encouraging that sound, evidence based tobacco treatment guidelines are in place in a variety of countries of varying income levels and on several continents. However guideline development requires a substantial investment of time and often of money also. It is thus relevant to note that the three WHO regions not represented in responses to our survey, the African, South East Asian and Eastern Mediterranean regions, have a majority of low and low-middle income countries, especially in the case of Africa, and that the countries without guidelines were also predominantly low and low-middle income countries. It seems highly likely that lack of resources is a significant barrier to developing treatment guidelines, as was suggested by the responses of the countries without guidelines.
This paper has several limitations. It used a convenience sample with a relatively small number of countries, and the sample included early signatories to the FCTC which are likely to be countries with a strong commitment to tobacco control, thus we do not know how representative it is of countries with guidelines and how generalisable our findings are. Conversely, given how the sample was acquired, it is possible we discovered almost all the countries that had guidelines. Our results also depend on the self-report of individuals who completed the survey, and we had no practical means of validating the accuracy of their responses. Furthermore, most were responding in English rather than their own language. Ideally, and given the resources, such a survey might attempt to establish the status of informants within their country and thus to an extent the validity of the data, and we hope in our next survey to use such a method, as was used in the Joossens Raw Tobacco Control Scale survey (15).
We have noted that most countries in our survey used the Cochrane Library as a source of evidence and that more than half based their guidelines on those of another country, mostly those of the US and UK. But we also noted that many low income countries did not respond to our survey and may not have guidelines, a supposition supported by the responses of countries that told us they do not have guidelines. This prompts questions about the suitability of guidelines based on an evidence base mainly from high income countries, and about how the FCTC process might help countries wishing to develop treatment guidelines and services. We believe that guidelines cannot just be imported without adaptation from one country to another. At the very least they will have to reflect the healthcare infrastructure of a country, including the availability of professionals to do the work and the organisation of the healthcare system, and they will probably also reflect income level and what treatments a country can afford. They should also reflect the state of development of a country's tobacco control programme (3). We hope these findings may be helpful to the FCTC Article 14 working group, which will, over the next few years, write guidance for countries to help them develop their own evidence based guidelines and promote effective treatment. The working group will be well placed to do this, having as it does almost 20 countries representing all of the World Bank income bands and all WHO regions. The broad composition of this group should ensure guidance that reflects the needs of countries at different stages of development and with differing income levels.
We gratefully acknowledge the Society for the Study of Addiction for financial support for the data analysis and writing up of this report, Doreen McIntyre and the Global Treatment Partnership for financial support of the survey, and Catherine Slevin for research assistance with the survey. We thank the following for advice on various aspects of the project including developing the questionnaire: Mira Aghi, Peter Anderson, Linda Bailey, Rick Botelho, David Graham, Joe Gitchell, Paul Hooper, John Hughes, Natasha Jategaonkar, Luk Joossens, Hayden McRobbie, Yumiko Mochizukiy, Hana Ross, Peter Selby, Karen Slama, Fran Stillman, Ken Wassum, Robert West, Heather Wipfli. Finally we sincerely thank the many country contacts who filled in the questionnaire and without whom this survey could not have happened.
The Society for the Study of Addiction is a learned society based in Britain. The Global Treatment Partnership is a project funded by Pfizer and other organisations, hosted by the International Non-Governmental Coalition Against Tobacco (INGCAT), whose director was, at the time of the project, Doreen McIntyre.