RÖKSLUT 2006 - SFDs tema 2006 Aktuell avhandling

Sluta Röka Linjen visade sig vara en kostnadseffektiv folkhälsointervention med ungefär en av tre rökfria efter 12-månader. Den här typen av service ger god avkastning på investering då kostnaden 3 023-3 898 kronor per vunnet levnadsår ska jämföras med andra vanligtvis använda interventioner såsom blodtrycksbehandling med kostnader på 250 000 kronor per vunnet levnadsår. Utöver direkta hälsofördelar kan det också röra sig om folkhälsoeffekter och spridningseffekter. Ett lyckat resultat kan nämligen spridas till familj, vänner och kollegor vilket ytterligare ökar kostnadseffektiviteten.

INTRODUCTION
THE GLOBAL TOBACCO EPIDEMIC
Tobacco is the major preventable cause of death globally (WHO 2004). The World Health Organisation (WHO) projects that by 2025, today's five million tobacco-related deaths will have almost doubleded (WHO 2004). Altogether there are almost 1.3 billion smokers worldwide. In high income countries, tobacco is the leading risk factor, accounting for 12% of the disease burden (Ezzati et al., 2002). Over 13 million Europeans suffer from a serious chronic disease as a result of their smoking, and over half a million die every year. Those that die in middle age as a result of their smoking lose on average 22 years of life. In 2004 the most common cause of death in Europe was cancer accounting for 20% of all deaths. The overwhelming majority of lung cancer cases are caused by tobacco smoking (Boyle & Ferlay 2005) and while there has been a substantial decrease in incidence in males, the situation for females is worrying.
In Sweden, the smoking prevalence among men has declined during the 1980s and 1990s whereas smoking among females is considerably higher compared to many other European countries (FHR 2005). In 2004, 14 % of men and 19% of women smoked on a daily basis. The heaviest smokers were in the 45-65 age group and the least were found among the youngest and oldest groups. Smoking is related to approximately 6 400 premature deaths annually and a further 500 die from exposure to second-hand smoke (Statistics Sweden 2004). Social inequalities in smoking persist among men with prevalence being higher among those in low income groups. In recent years, there has been a tendency towards a similar pattern among women. (FHR 2005). Sweden has a national public health strategy "Public health objectives 2002/03:35" which provides the basis for creating conditions for better public health for the entire population on equal terms. One of its eleven target areas focuses on reduced use of tobacco. The Swedish Council on Technology Assessment in Health Care carried out a systematic review on smoking cessation guidelines (SBU 1998) and recommended that resources for professional counselling and dissemination of smoking cessation be made available in every region. However, no national tobacco guidelines have been issued.
The effects of tobacco place a heavy burden on health care systems. The cost of treating tobacco-related illness is very high not only for governments, but also for individuals and their families. Given this, effective tobacco control has the "potential to be one of the most rational, evidence-based policies in medicine" (WHO 2004).

ADDICTION AND DEPENDENCE
Addiction and dependence are terms whose definition has a social as well as a scientific dimension. In principle, they may be distinguished from each other, but in practice such a distinction serves little purpose and thus the terms are used interchangeably. They are socially and scientifically defined in that their meaning can be, and has been, changed to reflect changing perceptions. Under the current definition, the terms refer to a state in which a drug or stimulus has unreasonably come to control behaviour (American Psychiatric Association 1995). This definition is very different from that used in the past and to which the general public usually subscribes (Bull WHO 1964). The earlier and popular view is that addiction refers to a state in which an individual needs to continue to take a drug in order to stave off unpleasant or dangerous withdrawal effects. The main shortcoming of this approach to defining addiction is that it addresses just one aspect of a wider problem. Certainly, many drug addicts experience withdrawal discomfort when they abstain, and this provides an important motive for continuing to use the drug. However, it has also long been recognized that this motive plays a relatively modest role in the apparently unreasonable continued use of a drug, despite protestations of users that they want to stop, and despite the harm their drug use is doing both to them and to those around them.
Many characteristics of tobacco use are strikingly similar to those of heroin, alcohol, and cocaine (Surgeon General 1988). None of these drugs are essential to normal physiologic functioning. Tobacco and other drug addictions differ from such behaviour as overeating or compulsive jogging in that the drug addictions are determined primarily by the drug's action on the brain. Cigarette smoking and tobacco use meet the criteria for drug dependence that are presented in the US Surgeon General's report, The Health Consequences of Smoking (Surgeon General 1988). Nicotine is clearly the dependence-producing component of tobacco use, and the concept of dependence has been addressed by the American Psychiatric Association (APA 1994).
Addiction to nicotine has been established as the psychopharmacologic mechanism that maintains cigarette smoking behaviour (Surgeon General 1988). Nicotine activates the brain's mesolimbic dopaminergic reward system (Pontieri et al., 1996) and produces dependence resulting in physical and neurobiological withdrawal symptoms on abrupt cessation (Epping-Jordan et al., 1998). Nicotine has a distributional half life of 15-20 minutes and a terminal half-life in the blood of two hours. Smokers therefore experience a pattern of repetitive and transient high blood nicotine concentrations from each cigarette, so that regular hourly cigarettes are often needed to maintain raised concentrations further, overnight blood levels drop to those of non-smokers (Jarvis 2004). Failure to maintain these concentrations results in symptoms of nicotine withdrawal (APA 1994). Hence, describing nicotine addiction as a disease of the brain seems justified.

TOBACCO PREVENTION
There are two main approaches to smoking prevention. The first is to prevent tobacco use initiation, that is, prevent young people from starting. The second is to treat tobacco dependence in established users and to prevent them from relapsing when they have stopped. Relapse appears to lead back into regular smoking unless an effort is made to alter the smoking behaviour (Ossip-Klein et al., 1986). This thesis focuses on the second approach. Tobacco control may be achieved by decreasing demand for tobacco products through taxation, consumer education, research, bans on advertising and promotion, warning labels, control on smuggling, restrictions on public smoking, and education of children and adolescents. Cessation methods traditionally include pharmacological treatment, behavioural support through face-to-face counselling, and more recently through quitlines and internet programmes. There is evidence that many of these methods are effective in helping smokers to quit (Stead et al., 2003; Silagy et al., 2004; Zhu et al., 2002). Pharmacological agents include nicotine replacement therapy (NRT) and buproprion. On balance, NRT (Silagy et al., 2005) and buproprion (Hughes et al., 2004) approximately double the effectiveness of other cessation efforts.
Studies have consistently shown that methods of assistance for smoking cessation such as behavioural counselling can significantly increase success rates in quitting (Fiore et al., 2000). Of smokers who receive intensive cessation-focused interventions, about 70% resume smoking within a year of treatment (Fiore et al., 2000). However, among unaided quitters, the relapse rate is closer to 97% (CDC 1999). Behavioural cessation interventions include group sessions, social support networks, or individual counselling and can be clinic, school, community, or population-based. Formats range from informal contacts with peers or professional counsellors to regularly scheduled intensive counselling programmes. More recent initiatives include the use of internet-based interactions and telephone counselling (quitlines). When offered the choice between a telephone helpline and personal face-to-face consultation at a clinic, most smokers (75-85%) prefer telephone counselling (Mc Afee et al., 1998).
Quitlines
Quitlines are telephone-based tobacco cessation services and since the late 1980's, they have been established in many countries such as Australia, Brazil, Canada, New Zealand, in many U.S. states, South Africa, Iran, some Asian and most European countries (World Bank 2004). They vary greatly in degree of sophistication. Many have been set up recently and are in the early stages of development.
The contexts in which they operate vary considerably, both in terms of socio-economic factors, literacy, telephone density, and use of information technology. (World Bank 2004). Estimates from several countries show that quitlines may have reached approximately 2-3% of the smoking population in the course of a year (Stead et al., 2003). However, they are considered to have an impact beyond that which can be measured in terms of quit rates amongst callers and fulfil a symbolic role, communicating to smokers that smoking cessation is important (Wakefield & Borland 2000). Most quitlines are accessed through a toll-free telephone number and provide individual telephone counselling that may be combined with a variety of services such as free educational materials, free-of-charge NRT, and referral to local programs. Counsellors answer callers' questions about the cessation process and help them develop an effective plan for quitting (World Bank 2004). Telephone counselling can be reactive or proactive (Lichtenstein 1996). Reactive quitlines only respond to incoming calls. Proactive quitlines handle incoming calls and then follow up the initial contact with additional outbound calls, to help initiate a quit attempt and/or to assist in preventing relapse. It is important to have an understanding of the characteristics of a quitline when discussing performance and results. Proactive telephone counselling has been shown to have a marked effect on callers' probability of success in quitting and in maintaining long-term abstinence from tobacco use, comparable to the effects of pharmacotherapies (World Bank 2004). Although reactive helplines have been widely implemented, controlled evaluation has been limited. Evaluations involving these services have been more likely to compare variants in service than to use a no intervention control. Two studies support use of a reactive quitline in the context of a comprehensive tobacco control programme (Zhu et al., 1996; Ossip Klein et al., 1991).
Meta-analytical reviews have established that proactive telephone counselling is an effective intervention for smoking cessation (Lichtenstein et al., 1996; Fiore et al., 2000; Stead et al., 2003). The most recent of these (Stead et al., 2003) examined 13 studies of proactive interventions and found that callers who received counselling were successful at least 50% more often than those who only received self-help materials OR 1.56 (95% CI 1.38-1.77). A large randomised, controlled trial served as the basis for the California Smokers' Helpline, the first publicly supported and state-wide quitline. This study found that the telephone counselling increased the percentage of smokers making a quit attempt and decreased the rate of relapse for those attempts. It also found a strong dose-response relationship between the level of intended treatment intensity (i.e., number of follow-up sessions) and the treatment effect (Zhu et al., 1996). Other research has demonstrated continued effectiveness in randomised controlled trials and "real world" settings (Borland et al., 2001; Zhu et al., 2002; World Bank 2004). In 2003, "The National Action Plan for Tobacco Cessation in United States" (Fiore et al. 2004) recommended the establishment of a federally funded National Tobacco Quitline that would provide a national portal to available state or regionally managed quitlines. Worldwide, there are several approaches for managing quitlines with some of them being non-governmental organisations, group health cooperative's, health maintenance organisations, private companies, charities but mostly as part of the public health care system.

SWEDISH HEALTH INDICATORS AND HEALTH CARE
By international standards, health in Sweden is relatively good. Public health has steadily improved in recent years, in terms of average life expectancy and premature mortality as is obvious from some health indicators, (Table 1).
Deaths in injuries, alcohol-related diseases and suicide have also been on the decline for many years. The proportion of the population with allergic conditions, however, doubled during the 1980s, with more than one third of people living in Sweden reporting that they suffer from some form of allergy or over-sensitivity. Another public health problem is the growing proportion of overweight individuals among children, young, and the middle-aged. Mental health and psychosomatic problems are on the rise among children and young people. The number of elderly has risen substantially-with the greatest growth in the age group 80 years and older. There are differences in health between different socio-economic groups, and these differences are growing (FHR 2005). In 2003, the cost for health services in Sweden exceeded 225 billion Swedish kronor (31bn USD) . This represents a substantial share (9.2%) of Sweden's gross domestic product (GDP) and an intermediate position among 15 EU countries. Health services in Sweden are overwhelmingly tax-financed, through county and municipal taxes. Patient fees (i.e., out-of-pocket) charged by the county councils account for 2.7% of the revenues. Privately financed care is marginal, approximately 500 million SEK annually. (SI 2003). The health care system in Sweden is highly decentralised. Mainly the 20 county councils (Stockholm County Council being one) and 290 municipalities in Sweden finance and manage health services within their respective areas. Health policy is a national-level responsibility that rests with the Government and the Parliament. A fundamental principle is that the provision and financing of health services for the entire population is a responsibility of the public sector (SALAR 2005). The county councils and municipalities are the main providers of health care, with only about 10% of all health services delivered by private providers. All counties contract to varying degrees with private providers, mainly in primary care where approximately 25% of the primary care centres are managed privately. There are nine regional hospitals, some 70 county and provincial hospitals and just over 1000 health centres. The number of physicians and nurses are 3 and 9 per 1000 inhabitants respectively which is similar to the EU average (OECD 2005). Health care providers such as physicians or nurses are natural partners for quitlines and referral to quitlines for comprehensive cessation counselling can have a profound impact on patient health (World Bank 2004). Therefore linkages with health care providers create important opportunities for quitlines.

QUITLINE IN SWEDEN - SRL
The Swedish quitline - Sluta Röka Linjen (SRL) has been in operation since May 1998 and has served over 70 000 people and over 50 000 of these calls have been tobacco cessation calls (SRL Database). It is a nationwide free-of-charge telephone service operated by Tobacco Prevention in Stockholm, part of the Stockholm Centre of Public Health. Historically, financial support was provided by the Swedish Cancer Society, the National Institute of Public Health, the Swedish Lung and Heart Association and Apoteket AB (Swedish Pharmacies) and since 2004, by the Ministry for Health and Social Affairs. The service is available during: Monday - Thursday, 9.00-20.00 and Friday 9.00-16.00, weekends closed. When the service is closed, or all lines are busy, an answering machine and a 24-hour interactive voice response serves as back-up. Smokers or concerned citizens may call toll-free for advice or smoking cessation counselling. The quitline is based on three interrelated elements: flow of patients, counselling, and preparatory measures for evaluation. The typical caller is a woman of 47 years of age with 12 years of education. The calls are geographically evenly distributed with slightly more calls from urban clients. The counselling is provided by health professionals (with few exceptions) like nurses, health educators, dentists, dental hygienists, psychologists, and doctors. All counsellors receive at least six months of training followed by supervision for another six. Continuing education, mentoring and de-briefing are provided for the counsellors. At present, Autumn 2005, the service employs 18 counsellors.
Clients calling the Swedish quitline receive tailored information by mail according to the Stages of Change (see 1.5.2). They are offered four follow-up phone calls in accordance with findings indicating that there is a relationship between the intensity of treatment and outcome measured as rate of smoking abstinence (Fiore et al., 2000). The average length of time for the first call is 22 minutes and for the following calls approximately 12 minutes. All callers are encouraged to call back as often as they need. A computerised client record is kept to enable the smoking cessation counsellors to effectively identify a caller and to allow for easy continuation of the treatment. The quitline is promoted as a referral service for the primary health care.
Research into routines for Nordic general practitioners' (GPs) work with tobacco prevention revealed that eight out of ten reported shortage of smoking cessation experts to refer to as a main problem. (Helgason & Lund 2002). Many physicians conceive even short advice to be too time-consuming and feel that the results (outcome) may not be adequate to justify the time spent (Cabana et al., 1999). A review analysing why physicians do not follow clinical guidelines showed that, depending on the nature of the medical problem, different barriers emerge stressing the need to assess each aspect separately (McAvoy et al., 1999). Hence, physicians in primary care or elsewhere are invited to refer smokers to quitlines where advice, assistance, and follow-up can be arranged. The importance of the individual physician has been highlighted, (Fiore et al., 2000; Cummings et al., 1989) but relatively few physicians actively engage in smoking cessation support (Helgason & Lund 2002). According to a primary health care survey carried out by the Swedish National Institute of Public Health in 2003, less than half the country's health care centres used smoking cessation counsellors to help those wanting to stop smoking (NIPH 2004).

The treatment protocol
The treatment protocol is best described as a mix of motivational interviewing (Miller & Rollnik 2002), cognitive behaviour therapy, the Transtheoretical Model (TTM), and pharmacological consultation. Materials which are tailored to the characteristics of individual smokers are more likely to be effective (Lancaster & Stead 2005). The tailored treatment material sent to people calling the quitline makes use of the Stages of Change, and this printed material is offered free of charge. The four existing folders were developed with each corresponding to one of the four stages. 1) What you gain if you quit, 2) Prepare to quit smoking, 3) NRT and withdrawal symptoms, and 4) Hold on!

Theoretical framework
One of the most widely used models of individual health behaviour of change is the Transtheoretical Model (TTM). It focuses on the intention to change and on the decision making of the individual. The model was developed by James Prochaska and Carlo DiClemente in the early 80's, based on the experiences of people attempting smoking cessation with and without professional help. Inspired by others before them, the two researchers attempted to make explicit various aspects of the intentional behaviour change process in a unifying model (Prochaska & DiClemente 1983).
One of the advantages of the TTM is that it postulates that the process of change takes time and involves progress through a series of stages that characterise different degrees of readiness to change (Prochaska & DiClemente 1983; Velicer et al., 2000) and that people in different stages of change need different interventions to progress in their behaviour change (Prochaska et al., 1992). Health promoters have been developing tailored interventions by matching messages to the individuals' readiness to change (Prochaska et al., 1992; Rakowski 1999). Over the past two decades, there has been a substantial increase in the use and evaluation of stage-matched interventions with regard to a variety of health behaviours (Rakowski 1999). In Sweden smoking is becoming less acceptable, and many smokers express a desire to quit. Individual differences in factors related to smoking cessation including differences in readiness to change, may be important when designing effective interventions (Prochaska & DiClemente 1983).
The Swedish quitline makes use of the principles outlined in the Stages of Change of TTM. Stages are used as outcome variables to assess success in study I. The central organising construct of this model is an approach to assess readiness to change health behaviour (Prochaska & DiClemente 1983; Prochaska et al., 1992). The TTM presumes that behavioural change, for most people, occurs gradually through five different stages, ranging from being unaware or unwilling to make a change (precontemplation) to attempting to maintain a behaviour change. Relapse is considered to be a part of the process of establishing a life-long change (Prochaska et al., 1992). The stages are both stable and dynamic, that is, they may be constant over a longer period but are still open to change. Precontemplation is a stage where individuals have no intention of stopping an unhealthy behaviour or starting a healthy one in the near future, usually within 6 months.
Contemplation is the stage in which people are considering a behavioural change within the next six months but have not yet made a commitment. Preparation is the stage in which people have made decisions to change their behaviour within a given period (usually within 30 days). Action is the stage where people have changed their behaviour within the past 6 months.
Maintenance is the final stage in the change process. People are defined as being in the maintenance stage after sustaining the behaviour change for at least 6 months (Prochaska et al. 1992). Evidence in support of the TTM as applies to tobacco use is strong, but not conclusive (Spencer et al. 2002). The model has recently been brought into question (West 2005) which will be elaborated in the discussion section (5).

PERSPECTIVES
Public health
Public health is collaborative actions to improve sustained population-wide health and reduce health inequalities (Beaglehole & Dal Poz 2003). Hallmarks of public health practice include the focus on actions and interventions which require collective (or collaborative or organized) actions, sustainability, and the need to embed policies within supportive systems. The goals of public health are population-wide health improvement, which implies a concern to reduce health inequalities.
The importance of this definition is that it is broad enough to include an overview of the activities of the medical care system and recognizes the importance of responding to the underlying social, economic, and cultural determinants of health and disease. Public health research is a multidisciplinary activity. It involves the application of the entire range of biological, social, and behavioral sciences to the health problems of human populations (Beaglehole & Bonita 2004). The WHO Framework Convention on Tobacco Control (WHO FCTC) - an international effort to protect the public's health from the "consequences of tobacco consumption and exposure to tobacco smoke" - recommends comprehensive tobacco control strategies to be implemented by participant members. Through the FCTC, efforts to reduce tobacco use, one of the most significant risk factors for premature death and disease, are strategically coordinated for an effective global response. While the FCTC provides the framework for action against tobacco, the actual work to combat tobacco use must necessarily occur at country level (WHO 2004). Evidence is needed when a new technology is introduced. This is the case with the Swedish quitline, an individualised quit smoking service which is provided to a large geographic area from a single centralized base. Since essential elements were documented -from the client to financial records- prerequisites for an evaluation existed.

Real world research
One of the challenges in carrying out investigations in the real world lies in seeking to say something sensible about a complex, relatively poorly controlled, and generally "messy" situation. Another way of saying this was developed by Robson who claimed that the laboratory approximates a "closed" system shut off from external influences, while studies outside the laboratory such as this thesis operate in "open" systems (Robson 2004). Much inquiry in the real world is essentially some form of evaluation. The intention is that the research and its findings will be used in some way to make a difference to the lives and situations of those involved in the study, and /or to others. This takes us into the field of evaluation research.
The purpose of an evaluation is to assess the effects and effectiveness of something, typically an innovation, intervention, policy, practice or service (Robson 2004). It is commonly referred to as program evaluation. In all aspects of carrying out an evaluation, great attention has to be paid to feasibility. The design must take note of constraints on time and resources; on how information is to be collected; on the permissions and co-operation necessary to put this into practice; on what records and other information are available. The Swedish quitline provided the above mentioned aspects regarding both feasibility and relevance. Inherent in the concept of real world is the notion of relevance. The tobacco issue was listed by WHO as one of the three major threats (the others being HIV/AIDS and malaria) to global health (WHO 1999).
Establishing trustworthiness is fundamental in research. Two key issues about the inquiry itself are involved here, that of validity and generalisability. Validity refers to the accuracy of a result. Does it "really" correspond to, or adequately capture, the actual state of affairs? Are any relationships established in the findings "true", or due to the effect of something else? Generalisability refers to the extent to which the findings of the enquiry are more generally applicable, for example, in other contexts, situations or times, or to persons other than those directly involved. Additional problems may come under the heading of reliability referring to the stability or consistency with which we measure something. All these issues will be discussed further in the methodological part of the discussion. Finally, it is not only the treatment and related effects of outcome that is the focus of this thesis, but also the ability to estimate the costs of the treatment.

Health economics
"Health economy can be defined as the application of the theories, tools and concepts of economics as a discipline to the topics of health and health care" (Kobelt 2002). Since economy as a science is concerned with the allocation of scarce resources, health economics is concerned with issues relating to allocation of scarce resources to improve health. This includes both resource allocation within the economy to health care system and within the health care system to different activities and individuals (Kobelt 2002). There is an increasing call for measuring the effectiveness of programs in financial terms. Cost-effectiveness analysis (CEA) is one option and was used to establish the value for money for the Swedish quitline.
A health economic evaluation is a way of establishing the "value for money" of different health care technologies (Kobelt 2002). Economic evaluations have become an important source of information to aid decision making about the allocation of resources. Economic analyses are always comparative and are applied to explicit alternatives. A treatment cannot be cost-effective by itself, but only in relation to one or several relevant alternatives, and for defined patient groups (Drummond et al., 1997). If a treatment strategy is both better and less costly, it dominates the alternatives. Outcomes are measured as health improvements expressed as either survival measured as lives saved or life years saved or as disease measures such as events avoided or delayed or patients successfully treated. Such analyses can be criticized for taking a very narrow measure of outcome and failing to include many of the potential benefits of the health promotion intervention. Their main advantage, however, is that they allow quantification. Other measures are quality-adjusted survival expressed as quality-adjusted life years (QALYS), and monetary value, expressed as willingness-to-pay for a benefit (Kobelt 2002). There are different types of economic evaluations and these are distinguished primarily by the way in which outcomes are treated. In general, if the question being studied is whether a treatment is a good use of resources within the disease area, the comparison should be with similar treatment and the outcome measure can be disease specific. The type of evaluation will be a CEA, if there is a single outcome (Kobelt 2002). The major advantage for economic evaluation is that it explicitly values the costs and benefits of policy options.
Although the beneficial impact of quitlines has been supported by three meta-analyses (Lichtenstein 1996, Fiore 2000, Stead Lancaster 2003) and by multiple individual studies (Borland et al., 2001; El-Bastawissi et al., 2002) no evaluation of effectiveness and cost-effectiveness of the Swedish national quitline has been conducted.

Tanja Tomson, Folkhälsovetare, Med dr Centrum för Folkhälsa Avd. för Folkhälsoarbete Box 175 33 118 91 Stockholm

E-post: tanja.tomson@sll.se

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