Comprehensive Smoking Cessation Policy for All Smokers: Systems Integration to Save Lives and Money
David B. Abrams
Office of Behavioral and Social Sciences Research
National Institutes of Health
Abstract In terms of the end points for cessation policy, three outcomes will reduce overall smoking prevalence: (1) reach and motivate more current smokers to make more frequent quit attempts, especially reaching the underserved; (2) ensure quitters know about and use appropriate evidence-based programs; and (3) enact policy that guarantees continuity of delivery of effective services via a comprehensive system of care management for all smokers. Policies that achieve these three goals will save millions of smokers from premature death and the burden of disease and will also save billions of dollars in excess cost to our nation.
Research provides evidence that effective smoking cessation interventions exist, including behavioral and pharmacological programs able to reach smokers through many delivery channels. Using evidence-based programs significantly increases success, from almost double to as much as fourfold the cessation rate of quitting on one’s own. Yet less than half of current smokers make serious quit attempts annually, and less than a quarter of those that do try will use proven interventions, and over 95 percent of self-quitters will relapse. Weak dissemination of unappealing cessation products relative to the tobacco industry’s marketing, results in many smokers harboring misinformation about the safety and efficacy of treatments with smokers tending to simultaneously believe that new cigarette products may be less harmful.
Having effective cessation programs and services is necessary but not sufficient to reduce population prevalence. The last decade has disproved the adage “if you build it, they will come.” Saving millions of lives and billions of dollars requires nothing short of aggressive, proactive, direct-to-consumer marketing of appealing cessation products. Strong political will is also critical; it is important to put into national policy what is known about effective ways to promote smoking cessation and to support the financial and other resources required to establish a unified delivery system of cessation care management for all smokers.
For a smoker, it is long and arduous journey from starting to smoke to enjoying smoking in ones carefree youth to wanting to stop. For much of that journey, the smoker is not motivated to quit and does not make any quit attempts at all. Somewhere along the way the smoker may change, either suddenly or gradually over time. Smokers can move from being unmotivated and not making any quit attempts to wanting to quit (over 70 percent say they want to quit) and then
to making serious quit attempts (about 45 percent try seriously to quit each year). If at first a smoker is not successful at quitting (over 90 percent are not), the arduous journey continues with cycles of trying to quit but relapsing to trying again. Some smokers may give up and feel too exhausted or perhaps even a bit ashamed to keep trying or to risk admission of repeated failure to their family, friends, and relatives. All too often a smoker may use unproven treatments or willpower to quit (over 75 percent do that). There are other barriers that a smoker needs to overcome, such as the cost of formal treatment or a lack of ability to discern ineffective from evidence-based treatments. There is no Consumer Reports or Good Housekeeping Award to guide one’s choice of cessation products and services. Perhaps a lucky smoker may eventually quit on his or her own or with the use of an effective cessation product or service. Finally, the journey ends when the smoker either quits for good or suffers and dies from a smoking related cause (about one third to one half of lifetime smokers will die of a smoking-related disease).
Now that research has helped us understand so much of this journey, the challenge is to put what we know into practice and policy, and there is not a moment to lose as over 430,000 of our friends and fellow U.S. citizens die prematurely each year from their smoking addiction (that equals three fully loaded jumbo jets crashing with no survivors every single day, including weekends and holidays).
There is substantial room to find more leverage points to improve the overall cessation outcome rate at every step of the way along a smoker’s journey to freedom from their addiction. This opportunity can only be fully realized with strong political will to do the right thing by designing cessation policies that support a comprehensive, systems approach to cessation intervention. This approach should provides aggressive, direct-to-consumer marketing and education campaigns to improve smoker’s health literacy about the dangers of smoking and the best tools for quitting. It should also cover the critical leverage points along the entire smokers’ journey, from being a slave to smoking to eventual freedom from tobacco addiction, and should provide interventions tailored to the smoker’s needs. This can be achieved through cessation policies that support a comprehensive care management network as well as cessation policies that ensure adequate resources and aligned financial incentives at federal, state, and local levels across both the delivery systems within the health care industry and across the broader public health system.
Effective cessation programs are available but greatly underutilized, despite the social climate that is making it more difficult to smoke (e.g., bans in worksites, higher taxes). Decades of research, clinical practice guidelines, and meta-analyses provide solid evidence of the efficacy and cost effectiveness of smoking cessation interventions. Interventions include behavioral and pharmacological options ranging in intensity and cost from minimal (e.g., self-help) to maximal (e.g., inpatient treatment).
Less than 50 percent of the over 45 million current U.S. smokers make a quit attempt each year. Of those that try to quit, over 75 percent do so on their own without evidence-based programs and, of those, over 95 percent relapse. Using even a minimal intensity/brief cessation program generally doubles the likelihood of success. There is also a dose-response relationship such that use of more intensive programs and use of combined pharmacological and behavioral programs can triple to quadruple the likelihood of success.
As indicated by the available scientific evidence and computer simulation modeling (see work of Levy, Appendix J, and Mendez, Appendix K), even a conservative increase in the reach (number or percentage of smokers out of all current smokers who make a quit attempt each year) and a modest improvement in effectiveness (percent of smokers who use evidence-based programs and thereby increase their chances of maintenance of cessation) can play a very significant
role in the mix of policy components that will reduce overall population prevalence. A more aggressive adoption and implementation of known best practices can make an even larger impact, using policies that reach those smokers who are not motivated to quit, those with the greatest health disparities, the highest smoking rates and those with comorbid complications that make treatment more difficult.
In terms of policy, an integrated approach is needed at individual and at systems levels that can capitalize on all the proven cessation components and provide a continuum of care that will address the following three goals:
(1) Proactively reach more smokers and create strong consumer knowledge, motivation and demand for cessation.
Having effective treatment programs is necessary but not sufficient to reduce population prevalence. The last decade has disproved the assumption “if you build it, they will come.” Different smokers’ knowledge and needs must be targeted using social marketing and other behavioral principles and financial incentives. Smokers have misperceptions and gaps in their health literacy about tobacco product safety and about the value, safety, and efficacy of using proven cessation methods. Innovations must be found to specifically target smokers who are hard to reach and hard to motivate (i.e., smokers at disproportionate risk because they are from lower Socioeconomic Status (SES) groups or minorities, are under- or uninsured, have comorbid psychiatric/substance abuse disorders, or are adolescent or young adult smokers). Bio-behavioral vulnerability, cognitive expectations, and emotional and socio-demographic characteristics at individual and aggregate (e.g., community) levels are some of the critical elements that must be considered to ensure more smokers become: (1.a) more health literate about why and how to quit, (1.b) more motivated to make more frequent quit attempts, and (1.c) more likely to use their knowledge to choose and use the appropriate evidence-based treatments when quitting.
(2) Make the full range of proven cessation treatments accessible and freely available in a coordinated, aligned delivery system of comprehensive care management.
It is essential to: (2.a) establish and enforce policies for universal financial coverage of evidence-based cessation treatments; and (2.b) ensure service capacity is flexible, accessible, and meets the diverse needs of different smokers to use the appropriate type, intensity, and mode of treatment. A comprehensive care management system means that each smoker will receive continuity of care based on screening and triage into a level and type of treatment that meets their needs to enable smokers to receive the appropriate treatment (e.g., a Stepped Care approach; see Abrams et al. 1993;1996;2003, for details). Treatments can range from minimal/brief intensity (e.g., over the counter nicotine replacement, self help, or Internet-based interventions), to medium intensity (e.g., proactive telephone/brief primary care/managed care-based interventions), to maximum intensity (e.g., outpatient and inpatient multi-session clinical care delivered by specialists trained to treat severe nicotine addiction and comorbid psychiatric/substance abuse disorders).
(3) Establish a coherent, unified national policy for the integration of all the effective components that enhance cessation into a comprehensive system of care management.
Systems integration is arguably the single most critical missing ingredient needed to maximize the as yet unrealized potential to significantly increase population cessation rates. Systems integration includes: (3.a) putting what is known into widespread practice and policy and overcoming the barriers to implementation at every level (national, state, and local) of organizational systems structure, (3.b.) achieving continuity of care delivery via the alignment of the organizational infrastructure and the financial incentives within which health care and public health services are delivered, and (3.c) using quality indicators to ensure fidelity in the adoption and implementation of best cessation practices and continuous quality improvement based on measurable indicators. Key indicators for improving the fidelity of care include: surveillance; program, process and outcomes tracking measures as well as use of public access “report cards” to enhance consumer choice and to improve accountability across providers and their health service delivery organizations.
Since smoking is an addiction (a chronic, refractory, relapsing condition), for many smokers effective intervention requires a proactive and coherent strategy of strong care management—the same kind of “chronic disease care management” model being adopted for other expensive life-threatening conditions like diabetes and hypertension. An integrated system of care management with appropriate and aligned financial incentives must become part of the fabric of health care, public health, and policy at local, state, and national levels. An adequately financed system of care must be put in place and must be sustained over decades to cumulatively accelerate the trajectory of smoking prevalence reduction in the entire population within our lifetime.
While much is known about each of the successful components that will increase cessation rates, what is lacking is the integration of all the components to support a continuum of care management services. In many respects the single most critical issue for increasing population cessation rates lies in a lack of full “systems integration” of cessation tools and services that are already well known to be effective. Systems integration implies using the integrated knowledge base that we already have to inform the establishment of an overarching policy or set of policies. These policies must, in turn, support a comprehensive, seamless system of intervention care management at every level of societal structure (i.e., governmental, private sector, state and local public health, health care stakeholders, and delivery systems).
A comprehensive system of care management will require policies that align incentives, resources and political will for the greater long range good of improving the nation’s health. Full implementation of a comprehensive, integrated “systems approach” to smoking cessation can significantly accelerate population prevalence reduction, saving lives and money. Policies are urgently needed that will result in increases in: (a) all smokers’ interest in and motivation to quit but particularly targetting the underserved and those with comorbid conditions; (b) smokers’ health literacy about the range of safe and effective treatments available and how best to use them; (c) smokers’ demand for and use of proven cessation interventions that are tailored and targeted to their specific profiles; (d) maintenance of cessation (reductions in relapse rates); and (e) access to affordable treatment by restructuring the health and health care delivery systems via aligned financial incentives and policies that support continuity of care as well as the screening and delivery of comprehensive services at federal, state, and local levels (a system of comprehensive care management).
The major components of cessation treatment products and services are based on solid scientific evidence. Saving millions of lives and billions of dollars requires nothing short of strong political will to put into national policy what is known about effective ways to promote smoking
cessation and to make the financial investment required to support a unified system of cessation care management for all smokers.
REVIEW OF EVIDENCE
This appendix is structured into five sections, which focus selectively on the following areas:
Overview and rationale for investing in smoking cessation.
Understanding of smoker characteristics to reach more smokers and increase demand for cessation.
Evidence for efficacy and effectiveness of cessation interventions.
Future directions in cessation research and implementation.
Systems integration to increase the cessation rate and the trajectory of reduced prevalence.
OVERVIEW AND RATIONALE FOR INVESTING IN SMOKING CESSATION
There are still over 45 million smokers in the US, comprising about 23 percent of the population (CDC 2004b). It is estimated that as many as half the current smokers, over 20 million human beings, will die prematurely of a smoking caused disease (Camenga and Klein 2004). Among the possible investments in preventive or palliative health care services available and reimbursed (e.g., treatment for diabetes, hypertension, cancer), smoking cessation remains one of the most cost-effective interventions per quality-adjusted life year saved (Cromwell et al. 1997; Fiore et al. 2004). Tobacco related diseases are costing over $150 billion each year (CDC 2002) and reduce life expectancy by about 14 years (CDC 2002).
While primary prevention of smoking initiation among future generations will have a long term societal benefit, for the immediate future an urgent, aggressive, and vigorous effort directed at helping all current smokers to achieve lifelong cessation will save many lives and much money. Levy and colleagues (2000b), using a simulation model, projected that even if 100 percent of smoking initiation by all youth under 18 years of age was prevented, it would still take decades to reduce smoking prevalence by 50 percent if cessation rates remained at current levels. In another simulation model, Mendez and colleagues (1998) reported that if adoption of smoking at age 18 years remained constant at rates of 20, 25, 30 or 35 percent, then overall population prevalence of smoking would reach a steady state by 2045 of 12.2 percent, 15 percent, 18.4 percent, and 21.5 percent respectively.
Another reason to increase cessation is that it will save millions from premature disability and save money. As already demonstrated in California, cancer rates, heart disease, and savings in health care expenditures can be achieved by reducing smoking prevalence (Fichtenberg and Glanz, 2000: Warner et al. 1995; 1999). Nationwide, the overall cancer death rate in the United States has begun to fall for the first time in recorded history, primarily because of reductions in incidence and prevalence of lung cancer. These reductions are a direct result of smoking rates having declined from over 45 percent in the 1960s to under 23 percent in 2003 (CDC 2004a; Cole and Rodu 1996). In fact, Thun and colleagues (2006) reported that about 40 percent of the contribution to overall cancer deaths comes from the dramatic reduction in smoking prevalence since the 1960s.
There are other direct and indirect benefits to increasing the cessation rate at the population level. The following benefits are briefly noted. Accelerating smoking cessation among adults
will, in turn, reduce the number of role models who smoke, the number of children at risk for taking up smoking, the damage to the unborn fetus from maternal smoking during pregnancy (Buka et al. 2003), the amount of second hand smoke exposure to nonsmokers of all ages but especially to children, the risks and damage caused by fires from cigarettes, losses in productivity and absenteeism at work, and other direct and indirect costs of smoking and of passive exposure in terms of health and well being.
SECTION 1 SUMMARY
Increasing cessation rates to dramatically reduce population prevalence of smoking is possible but challenging. If an aggressive and immediate investment is not made in cessation interventions and policy, the consequences are devastating in terms of lives lost prematurely, reduced quality of life, and hundreds of billions of dollars in unnecessary expenses. Thus much more must be done to increase cessation among current smokers if a dramatic reduction in population smoking prevalence is desired and if millions of current smokers’ lives are to be saved. Failing to act now to implement a nationwide comprehensive smoking cessation system of care is an extraordinary opportunity lost, with devastating consequences.
UNDERSTANDING OF SMOKER CHARACTERISTICS TO REACH MORE SMOKERS AND INCREASE DEMAND FOR CESSATION
As outlined above, from a systems perspective, full impact of cessation interventions on the intended target population is a product of the proportion of the population reached and the efficacy of the intervention delivered to them (Impact = Reach × Efficacy; see Abrams et al. 1993; 1996; 2003 for details). There are several ways to improve reach and efficacy from both individual and systems levels of intervention. Glasgow and colleagues (1999; 2003; 2006a) have expanded the concept of impact in their RE-AIM (Reach, Efficacy, Adoption, Implementation, Maintenance) model to include the individual and systems level considerations that reflect the need to measure and improve the fidelity of adoption and implementation of interventions, using measures of key indicators of quality and integrity of program, process, and outcomes evaluation at both the individual level and the delivery system level (see Abrams et al. 1993; 1996; 2003; Dzewaltowski et al. 2004; Glasgow at al. 1999; 2003; 2006a for more details). This section is focused primarily on the issue of reaching diverse groups of smokers, designing programs and services that can anticipate their needs, and planning for the increased demand for resources assuming that we are able to reach more of them and increase their motivation to make quit attempts.
Individual Bio-Behavioral Vulnerabilities and Demographics
There are a number of important individual and aggregate (i.e., group or population level) smoker characteristics associated with differences in smoking prevalence, motivation to quit, and with some cessation outcomes. Some of these factors are important in considering how best to reach more smokers, motivate them to try to stop smoking—and encourage them to use the best interventions available to ensure success—such as to reduce the high rates of relapse after quit attempts. Selected factors are briefly reviewed here to support the major recommendations of this appendix. A comprehensive critical review is beyond the scope and space limitations of this report. Factors include gender, education, income, SES, racial and ethnic background, and age.
There are also differences among subgroups of smokers in bio-behavioral variables such as their susceptibility to and their level of dependence on nicotine; the pattern of smoking over the years that they smoked; their motivation to quit; and their knowledge about the risks and benefits of smoking, the value of using smoking cessation programs, as well as the types of treatments available and how best to use them.
Dependence is defined by the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM IV-R) (APA 1994) using a fixed set of symptoms. Depending on the number of symptoms used to define dependence (Piper et al. 2006) and the response bias in the population of smokers surveyed, the percentage of dependent smokers can be as high as 87 percent (Hale et al. 1993). Withdrawal symptoms are also related to severity of dependence, and these symptoms may increase temptations to smoke to alleviate the withdrawa,l especially in the first 30 days after cessation. Although a “cut point” for dependent versus not dependent is useful for some purposes, it is widely accepted now that there is an underlying continuum of dependence, from mild to severe (Shiffman et al. 1998) among all smokers. Greater nicotine dependence is related to lower motivation to quit; increased difficulty in trying to quit smoking; failure to quit; increase in prevalence of psychiatric of substance abuse comorbidity (e.g., depression, alcoholism) and, in some studies, to better treatment outcome with nicotine replacement therapy (Hughes 1996; Shiffman et al. 1998). However, it is important to note that nicotine replacement, evidence-based behavioral treatments, and now other pharmacological aids (see later in this appendix) increase all smokers’ chances of quitting, regardless of level of dependence. The PHS (public health service) guideline therefore recommends that all smokers be advised to use nicotine replacement therapy (NRT) and other evidence-based treatments when trying to quit, except when nicotine replacement is contraindicated, such as during pregnancy or immediately post myocardial infarction (Fiore et al. 2000).
A detailed review of gender and smoking is beyond the scope of this chapter. The U.S. Surgeon General (DHHS 2004b) reported that since 1980, 3 million women have died prematurely from smoking related disease. Women differ from men in their biological responses to nicotine (Perkins et al. 1999). Some studies support the hypothesis that women have more difficulty quitting than men while others do not (Killen et al. 2002; Wetter et al. 1999). Sex-specific variables such as concerns about weight gain, stress reduction, and the need for social support may also underlie differences between men and women smokers. Some research suggests physical activity may help women smokers quit (Marcus et al. 1999). A recent report calls for more research to clarify the differences between men and women to improve treatment of women smokers (DHHS 2004).
Differences in demographic characteristics are most evident in smoking rates among those at disproportionate risk due to comorbidity (e.g., psychiatric, alcohol/substance abuse), disparities in SES, and among some racial and ethnic minorities. Smoking is over four times more prevalent (43 percent) in adults with lower educational attainment such as a GED than in those with a graduate degree (8.9 percent). Smoking rates are 17.0 percent for Asian Pacific islanders versus 34.0 percent for Alaskan American natives; 11.6 percent for those with more than 16 years of education versus 35.4 percent for those who did not complete high school; 12 percent for those older than 65 versus 29 percent for those 44 years of age or younger (CDC 1998). Augustson and Marcus (2003) defined hardcore smokers as established smokers over age 25 years, smoking 15 or more cigarettes per day and reporting no recorded history of quit attempts. Hardcore smokers make up 17.6 percent of all smokers, are more likely to be male, unmarried, unemployed, and
have a lower level of education. This hardcore subgroup may be a significant public health challenge in terms of reaching and treating them (Augustson and Marcus 2003).
At the state level of aggregation, Utah has the lowest prevalence (12.7 percent) and Kentucky the highest (32.6 percent) an almost threefold difference. Smoking prevalence is also lower than the national average (23 percent) in those states with strong, visible, comprehensive, and sustained antismoking programs (e.g., 16.4 percent in California and 19 percent in Massachusetts) (CDC 2004a). One population-based study suggests that higher smoking prevalence within a state may be associated with lower motivational levels of readiness to quit, fewer quit attempts, and heavier smoking (Etter 2004).
Generally, over 80 percent of adult smokers become regular users before the age of 18 years (CDC 1998). There has been a 32 percent increase in youth adoption of smoking between 1991 and 1997 in the United States (CDC 1998) and a 28 percent increase among college students (Rigotti et al. 2000). A unique window of opportunity exists for early cessation intervention among youth and young adults. This younger cohort of smokers has not received attention. Young smokers are a target population that has “slipped through the cracks” between the prevention and the treatment models of intervention (see Appendix D by Flay and Appendixes by E through H by Halpern-Felsher).
The past decade has seen numerous studies document strong relationships between smoking and psychiatric comorbidities. Depression, alcohol and other substance abuse disorders, adult attention deficit/hyperactivity problems, psychotic disorders, and anxiety disorders are associated with increased prevalence of smoking (Hughes 1993). One recent population-based study estimated that 44 percent of persons suffering from current mental illness were smokers (Lasser et al. 2000). Smokers with a history of depression are more likely to be diagnosed as nicotine dependent and to progress to more severe levels of dependence than persons without a history, and are less likely to quit smoking (Glassman 1997; Patten et al. 1998). Smoking rates of over 85 percent are observed in alcoholics, opiate addicts, and poly-drug users (Fertig and Allen 1995).
More alcoholics die of tobacco-related causes than from their alcoholism (Hurt et al. 1994). Smokers with a history of alcoholism are more likely to be nicotine dependent. Moreover, psychiatric comorbidities, whether historical or current, appear to significantly impede efforts at smoking cessation (Hughes et al. 1995;1996); conversely, quitting smoking may significantly increase risk of relapse to major depressive disorder, at least among those with such a prior history (Glassman et al. 2001). Studies have been conducted on some populations at disproportionate risk, including racial and ethnic minorities, women, older Americans and a limited number on adolescents and young adults (see Appendix P by Wallace).
Preventing relapse among smokers who currently make quit attempts will have a very important impact on reducing population prevalence, along with reaching more smokers and motivating them to try to quit. Those smokers with comorbid complications and bio-behavioral vulnerabilities, such as increased dependence, do tend to relapse more often whether they quit on their own or even in formal evidence-based treatment. Although use of evidence-based interventions improves cessation outcomes for all smokers across the board, smokers who do have comorbidity and smoke more heavily generally do not achieve cessation at the same rates as smokers without such additional risks. While there is little evidence in support of treatment “matching” of smoker characteristics to specific treatment components (e.g., depressed smokers do not generally benefit more from cognitive behavioral treatment for depression (Brown et al. 2001), smokers who are at higher risk due to certain bio-behavioral or socioeconomic vulnerabilities may in-
deed benefit from more intensive, longer, or specialized clinical interventions (see review below of treatment efficacy).
In summary, the full impact of cessation interventions on the intended target population is a product of the proportion of the population reached and the efficacy and fidelity of implementation of the intervention delivered (Impact = Reach × Efficacy; see Abrams et al. 1993; 1996; 2003; Glasgow et al. 2003; 2006a,b for details). Thus, in addition to trying to motivate more smokers to make quit attempts, there is an enormous opportunity to further increase cessation outcomes. The vast majority of smokers who do make quit attempts, as many as 85–98 percent in studies of brief and self-help interventions, will relapse. As reviewed below and in subsequent sections, few smokers know about treatment efficacy, few use any treatments at all, and those who do use an evidence-based program may not use or have access to the best programs to address their individual vulnerabilities. Consequently, overall cessation can be improved by increasing the interest and motivation of smokers to make more quit attempts and to use evidence-based interventions when quitting to improve the likelihood of cessation and to reduce the likelihood of relapse.
Increasing Demand for Cessation
One way to increase the overall impact of cessation at the population level is to increase the reach of current interventions using social marketing and other behavioral principles to enhance smokers’ motivation and interest in cessation. The following material reviews some of the factors that, in concert with the socio-demographic and bio-behavioral characteristics of smokers presented above, might be considered in making a case for increasing consumer demand for smoking cessation products and services. Characteristics of smokers and patterns of smoking at individual and group levels need to be considered in any plan for marketing and communications strategies to reach more smokers and to increase their motivation to quit and their demand for use of evidence-based cessation.
There is an enormous opportunity for improvement in cessation outcomes by reaching and motivating many more smokers to make quit attempts each year, by encouraging the use of proven cessation programs when trying to quit, and by targeting those with disparities in smoking rates and comorbidities. Increasing smoker motivation to make more quit attempts requires a multi-pronged set of intervention strategies targeted at multiple levels: (1) at all nonsmoking individuals and at smokers (e.g., increasing their health literacy, correcting misperceptions about smoking, and disseminating the facts about the safety and efficacy of cessation programs); and (2) at multiple systems levels of social and environmental structures and policies that can make smoking behavior more difficult and quitting easier at the peer, neighborhood, community, state and national levels (e.g., homes, schools, workplace bans; mass media campaigns and free OTC-NRT [over-the-counter nictotine replacement therapy]; tax disincentives).
Social marketing principles include the tailoring and targeting of campaigns to specific audience characteristics. Social marketing approaches would conceptualize smoking cessation programs as an attractive line of “products” that must be appropriately priced, packaged, positioned, and promoted in a competitive marketplace. In addition to the socio-demographic and bio-behavioral characteristics of smokers reviewed above, a number of other considerations may be
useful to improve the marketing and the reach of existing smoking cessation programs and services.
Effective social marketing to increase consumer demand must be driven by solid and appropriate social marketing principles, theories, and evidence. The marketing approach includes a number of elements such as understanding of each target audience’s needs, characteristics, and perceptions including, for example, the accuracies and inaccuracies in smokers’ knowledge of tobacco use and cessation and various approaches to risk perception, motivational enhancement (see Emmons 2003), and economic incentives.
About 43 percent of smokers make a quit attempt per year (Hughes et al. 2003). Thus, although over 70 percent of smokers say they intend to quit, 57 percent do not do so in a given year. Of those that make a quit attempt, some studies report that less than 20 percent of quitters use proven treatments, and relapse after an unaided quit attempt is more than twice as high as when a proven treatment is used (Zhu et al. 2000). Moreover, of smokers motivated to quit, 78 percent believed they were just as likely to quit on their own as with cessation intervention assistance (Zhu et al. 2000). Those participants who did believe cessation methods were effective were more likely to intend to quit (OR 1.8), make a quit attempt (OR 1.8), and to use intervention assistance when quitting (OR 3.62). Zhu and colleagues (2000) also reported that smokers who used an intervention (self-help, counseling and/or NRT versus those who quit on their own were twice as likely to succeed (7 percent vs. 15.2 percent), abstinent at 12-month follow up) and that heavy smokers were more likely to use assistance than light smokers, women more than men, and older more than younger smokers. Thus, there is an enormous opportunity to increase population prevalence of smoking cessation by reaching and motivating the 57 percent of smokers who currently make no quit attempts per year. Among those who do make a quit attempt, their success rate could at least be doubled for those 80 percent who quit on their own if only they used an evidence-based intervention. Reaching and motivating more smokers to make quit attempts each year and having them use proven treatments when they do quit would dramatically increase population cessation rates nationwide.
Some smokers come into treatment due to pressure from others. Motivation is best when it is intrinsic (comes from the smoker him/herself) and is tied to a realistic evaluation of the benefits of stopping versus the benefits of continuing to smoke (Curry et al. 1991; Curry et al. 1997). When a smoker is not really ready to quit and lacks self-confidence to try, then it is neither surprising that he or she will fail to quit when asked to try nor that the treatment provider will become discouraged from advising him/her to quit again in the future. Both smokers and their providers often have unrealistic expectations (Abrams et al. 1991; 1993; 1996; 2003). The mismatch between smoker readiness (not ready) and provider enthusiasm (you should quit today) is most evident in settings that require a provider to proactively reach out to smokers who are not seeking treatment for their smoking. Such settings include non-volunteer populations such as all the smoking members of a managed care organization, a worksite, a hospital, or in a substance abuse rehabilitation program (Abrams and Biener 1992; Abrams et al. 1993; 1996; 2003).
The Stages of Change (SOC) model (Prochaska and Velicer 2004) lends itself to the development of interventions that are tailored to the smoker’s motivational readiness to change. The SOC model also provide a useful roadmap for smokers in that it provides milestones (pre-contemplation, contemplation, preparation, action, maintenance) and guidelines for processes used at every phase of the journey from smoking initiation to various patterns of use to various efforts at cessation, relapse, and recycling to the ultimate success of permanent maintenance of cessation. Both smokers and the health delivery systems (public health and health care) can
therefore use metaphors such as the journey from smoking to cessation to develop interventions that take into account continuity of care and the need for a systematic and dynamic approach to management of the cessation process (chronic disease management model; see further in this appendix as well as Abrams et al. 2003). Population surveys show that only a small minority of current smokers (14–28 percent) is motivated to quit in the next 30 days (Abrams and Biener 1992; Velicer et al. 1995). Members of managed care groups such as Health Maintenance Organizations (HMOs) have higher levels of motivational readiness than the general population, with as many as 70 percent planning to quit within 6 months (Hollis et al. 1993).
Wewers and colleagues (2003) measured the distributions by readiness to change. Desire or intention to quit, using the Stages of Change measure, was examined from data collected in 3 Tobacco Use Surveys (1992–1993, 1995–1996, and 1998–1999). Results indicated a similar distribution across all three time points indicating very little movement in the stages of readiness to change in the U.S. population during the 1990s. The percent in each stage was 59.1 percent in pre-contemplation (not seriously thinking of stopping within the next 6 months), 33.2 percent in contemplation (planning to stop in the next 6 months but not in the next 30 days or planning to stop in the next 30 days but made no quit attempts in the past 12 months), and 7.7 percent in preparation (planning to stop in the next 30 days and made a quit attempt of at least 24 hours duration in the past 12 months) (Wewers et al. 2003). However, Etter (2004) reported that there was an association between smoking prevalence and stages of change in the United States across the 50 states, such that a higher prevalence of smoking was associated with lower motivation to quit, fewer quit attempts, and higher cigarette consumption.
Among youth 55 percent of middle school students and 61 percent of high school students said they wanted to stop smoking, and overall 59 percent of current smokers reported they had tried to stop smoking in the 12 months preceding a national Behavior Risk Factor Survey (CDC 2001). Among middle school students, 80 percent thought secondhand smoke was harmful to them while 89.8 percent of high school students thought secondhand smoke was harmful to them. Research also indicates that 24 percent of young girls aged 12–18 years believed that they could stop smoking whenever they wanted to even if they smoked regularly, and this myth was even more prevalent among girls who were already smokers (41 percent) (Portor Novelli Communication styles 2002).
The PHS clinical guide (Fiore et al. 2000) does recommend motivational enhancement interventions for individual smokers who are not motivated to quit (for more details on motivational factors see Emmons 2003). Moreover, the PHS guide (Fiore 2000) recommends that smoking status and then intervention (the five A’s) be made a “vital sign” along with temperature and blood pressure in all encounters between patients and any aspect of the health care delivery system. Evidence is presented that such a system can increase identification of smokers from 38 percent to over 65 percent in a health care setting and that this, in turn, can also double the cessation rate among smokers from 3 to 6.4 percent. If these PHS guidelines were implemented nationwide by all health care providers and all health care organizations, it alone would dramatically increase the number of smokers reached and provide an opportunity to motivate them, educate them about the best ways to stop smoking, and provide them with evidence-based cessation interventions.
Smoking prevalence and patterns of uptake, use, and cessation are also strongly influenced by the advertising and targeted marketing of the tobacco industry. The tobacco industry in the United States spent over $15.15 billion in 2003 on marketing its lethal products (FTC 2005). The tobacco industry continues to aggressively promote smoking with attractive new products, novel
incentives, and creative marketing strategies. Forces promoting smoking and future innovations in tobacco products include so-called “potentially reduced exposure products” (PREPs), discount prices, free samples, and desirable paraphernalia such as T-shirts and sports bags. The industry has been especially successful at targeting young adults and minority groups over the last decade. Media and marketing efforts to promote cessation or to increase demand and motivation for cessation programs pale in comparison to the myriad of forces used by the tobacco industry to encourage and sustain smoking behavior and their market share of specific brands and products. Recent concerns have been raised that tobacco industry-sponsored programs for prevention and cessation may be using interventions that either have not been evaluated or are relatively weak or ineffective, thereby competing with more effective programs and potentially diluting the impact of more powerful evidence-based programs in schools, communities, and on the Internet (Mandel et al. 2006).
Shiffman and colleagues (2001) examined the effects of counter-advertising messages on tobacco industry-created beliefs about the effects of “light” and “ultra light” on quitting beliefs and intent. Smokers of these cigarettes continue to belief they are less harmful than regular cigarettes, and debunking these myths may encourage cessation (Kozlowki et al. 2000). The study found that messages focused on the sensory perceptions that these cigarettes were less harsh resulted in the most positive changes in beliefs about safety, delivery, and intent to quit. The authors concluded that addressing sensory dimensions may be a promising strategy for changing smoker’s misperceptions about “light” and “ultra light” cigarettes and enhancing their intent to quit. In a follow up study, Shiffman and colleagues (2004) examined the effects of marketing PREPs on smoker beliefs. They concluded that reduced-risk tobacco product claims undermine adult cessation and youth prevention. PREPs appeal to smokers contemplating cessation and exposure to PREPs claims appears to undermine smokers’ readiness to quit, especially among young adults ages 18–25 years. Media campaigns that educate smokers about beliefs in the addictiveness of smoking, the dangers of secondhand smoke exposure, and the tobacco industries’ use of deceptive advertising are associated with smokers’ increased consideration of cessation, especially if there are children in the home (Netemeyer et al. 2005). A recent article outlined 12 common myths that undermine tobacco control methods. Some myths stem from misunderstanding, while others seem to be deliberately promulgated by the tobacco industry (Freiden and Blakeman 2005). Media counter-advertising to creative tobacco industry marketing is an important component in increasing smokers’ interest in cessation and neutralizing tobacco industry targeting of smokers and potential smokers to undermine their motivation to stop smoking or not start smoking.
McDonald (1999) reviewed the field of population-based recruitment to examine the use of potential communications strategies to encourage enrollment in smoking cessation. Recruitment (i.e., reach) was defined as the number of smokers who enrolled in a cessation program divided by the estimated total number of smokers in the target population. Over 30 studies reported the results of 40 recruitment campaigns and the median recruitment rate was 2 percent. Studies that used interactive recruitment methods (e.g., telephone, interpersonal communications) were 66.5 times more successful than those using passive recruitment (e.g., direct mailing). McDonald (1999) suggests more attention is paid in designing population-based recruitment strategies and the use of interpersonal channels of communication.
Hammond and colleagues (2004) examined smokers’ awareness and perceived effectiveness of cessation methods in a random digit dial survey of 616 smokers in Canada (76 percent response rate). 87 percent of respondents said they wanted additional information on where to get
help quitting, 86 percent wanted information about how to quit, 85 percent wanted information on the benefits of quitting, 70 percent wanted information about a toll free telephone quitline, and 68 percent wanted to see a website address. They reported poor recall of cessation intervention methods with recall percentages as follows: 11 percent cited counseling programs, 6 percent behavioral tools, 5 percent brief physician counseling, and only 43 percent OTC NRT, despite nicotine patch being so heavily advertised by the pharmaceutical industry.
Yong and colleagues (2005) reported that older smokers (>60 years of age) perceived themselves to be less vulnerable to the harmful effects of smoking (self-exempting beliefs), less concerned about the health effects of smoking, less confident about being able to quit (self-efficacy), and less willing to want to quit. However, price of cigarettes, health providers advice, cheap quitting medication, and health risk information were predictors of quitting intention, and cigarette price and cheap medication were also associated with more recent quit attempts. In an interesting study of the characteristics of smokers who want to quit but have not (dissonant smokers), Paretti-Watel (2003) reported five different profiles using a cluster analysis. The clusters included younger smokers who were not interested in cessation but were sensitive to price of cigarettes; two groups who were healthy, moderate smokers who had many failed quit attempts and who preferred cessation without any medical assistance and were not concerned about adverse health effects; and two groups who were highly addicted yo nicotine and who preferred medical help with cessation—this group was in poorer health and afraid of smoking-related diseases. The study suggests that there are a variety of subtypes of smokers and that marketing strategies to reach, motivate, and help them with cessation efforts will need to be targeted and tailored to these characteristics. However, prospective controlled studies have not been done to show that such tailored strategies will significantly increase readiness to quit and use of proven interventions when quitting.
Cummings and colleagues (2004) investigated what smokers say about the impact of different population-based interventions to motivate them to think seriously about stopping smoking using a random digit dial cross-sectional telephone survey of adult current cigarette smokers. A total of 815 smokers were asked which of eight interventions would motivate them to think seriously about stopping smoking in the next 6 months. The offer of free nicotine patches or gum (53 percent) and cash incentives (49 percent) were the most frequently mentioned interventions that smokers said would get them to think seriously about stopping smoking. The degree of motivation to stop smoking was the most consistent and strongest predictor of how respondents answered the question about the influence of the various intervention options.
No two smokers are identical; smokers smoke and stop smoking for different reasons, and each smoker has a unique profile of genetic predisposition and environmental experiences individual difference characteristics. To accelerate movement along the journey from smokers who are not motivated to make quit attempts to those who successfully maintain cessation for the remainder of their lives requires intervention planners and policymakers to offer a wide array of interventions that are likely to appeal to different subgroups of smokers and individual smoker needs in order to have a population impact. A variety of targeted and tailored interventions need to be considered as well as the offering of incentives that reward smokers for making quit attempts and for maintenance of cessation.
There is an inexorable social movement across the developed nations to increase restrictions on smoking and to protect the general public from the harms of environmental tobacco smoke
(ETS) exposure. The typical sequence of implementation of restrictions in a nation includes first workplace bans (initially voluntary and later mandatory) then increasing restrictions in public places, on mass transport, in restaurants and in bars and clubs as well as recommending voluntary restrictions in private homes and cars.
About 69 percent of U.S. worksite are smoke-free (American Cancer Society 2003). Employees in workplaces with total smoking bans have higher rates of cessation and smoked fewer cigarettes (Longo et al. 2001). But meta-analyses suggest little direct impact of workplace restrictions on cessation (Moher et al. 2005). Workplace studies aimed at the workforce as a whole included 14 studies of smoking bans; meta-analyses supported the hypothesis that bans reduced consumption during the working day and possibly overall consumption and quit attempts but not overall cessation.
To study the effects of restrictions on smoking, Borland and colleagues (2004) and Hammond and colleagues (2006) surveyed smokers in four countries (Canada, United States, United Kingdom, and Australia). In general, results were similar across the four countries. For the United States results were as follows (weighted for age and sex and stratified for major geographic regions): 65.5 percent reported smoking was not permitted anywhere in their workplace; among those who went to a restaurant in the past 6 months, 19 percent reported total indoor bans and 11.9 percent said there were restrictions; 15 percent of smokers said they never allow smoking at home while 34 percent had some restrictions on smoking at home and 40 percent had no restrictions at home. Total bans in smokers’ homes declined with age, cigarette consumption, and self-exempting beliefs and increased with education, income, reported bans in restaurants and bars, presence of a nonsmoker adult in the home, better reported health, and believing that ETS was harmful to others. Farkas and colleagues (2000) reported that adolescents ages 15 to 17 years who lived in homes with smoking restrictions were 74 percent as likely to be smokers as adolescents who households without smoking restrictions. Likewise, adolescents who worked in smoke-free environments were 68 percent as likely to smoke as those in workplaces with no smoking restrictions
Fong and colleagues (2006) reported on the impact of smoke-free workplace legislation on smokers in Ireland which, on March 29, 2004, became the first country in the world to implement comprehensive smoke-free legislation in all workplaces with few exemptions. Fong and colleagues (2006) used a quasi-experimental design and interviewed 1,000 randomly selected adult smokers from Ireland and 600 from the United Kingdom before the ban (December 2003– January 2004) and after the ban (December 2004–January 2005). As expected, reported smoking in bars and pubs dropped after the ban from 98 to 5 percent in Ireland and remained at near 98 percent in the United Kingdom. In restaurants, the smoking rate dropped from about 84 percent in both Ireland and the UK to 3 percent in Ireland and about 62 percent in the UK. In shopping malls the rate dropped from 30–40 percent in Ireland and United Kingdom to near zero in Ireland and 20 percent in United Kingdom. In worksites, the rate dropped from over 61 percent in Ireland and just under 40 percent in the United Kingdom to about 14 percent in Ireland and about 38 percent in the United Kingdom. Ninety-eight percent of Irish smokers reported there was less smoke in pubs than the prior year, while only 35 percent of UK smokers said there was less smoke in pubs than a year ago.
In general, a barrier to policy change is the perception that smokers would not support a smoke-free law. Fong and colleagues (2006) examined these perceptions before and after the ban in Ireland compared with the United Kingdom and noted that the odds ratio (OR) was 6.38 (4.37–9.32) for the increase in support among Irish smokers for a total ban in pubs compared to
UK smokers. During the one year interval between the surveys, support increased from about 2– 7 percent in the United Kingdom and Ireland before the Irish ban to over 40 percent in Ireland and about 10 percent in the United Kingdom. Significant differences in the same direction were noted in restaurants (OR 3.91 [2.89–5.30]) and workplaces (OR 2.78 [2.08–3.72]), as well as at fast food outlets, shopping malls, train stations, and in trains. Overall, 81 percent of Irish smokers reported that the smoke-free law was a good or very good thing, and the proportion of Irish homes with smoking bans also increased. After implementation of the law, 62 percent of Irish smokers supported the total ban in pubs compared with 26 percent of UK smokers. Moreover, 79 percent of Irish smokers who reported quitting smoking after the ban said that the smoke free law made them more likely to quit, and 90 percent stated the law helped them to avoid relapse. 46 percent of Irish smokers who were still smoking after the ban said the law made them more likely to quit and 59 percent of Irish smokers said the law made them cut down on the number of cigarettes they smoked.
The Irish smoke-free workplace law has been a public health success with very high compliance. It resulted in a dramatic reduction in ETS smoke; a substantial increase in support for the law among smokers; reports from smokers that the law has helped them to quit, try to quit, or cut down on the amount they smoke; and there is no evidence of shifting smoking to private venues. The pre-implementation campaign may have helped achieve these results.
Frieden and colleagues (2005) reported on the effectiveness of a large-scale distribution of free NRT patches in New York City. After increases in cigarette taxes and the implementation of smoke-free workplace legislation, a large-scale distribution of free NRT was undertaken and evaluated at 6-month follow up. An estimated 5 percent of all eligible New York City smokers of 10 or more cigarettes per day (34,090 smokers) who called a toll-free quitline were given a 6-week course of NRT and brief follow-up counseling was also attempted. Most (64 percent) were non-white, foreign born, and/or resided in a low-income neighborhood. Using a conservative intent to treat analysis (all non-respondents were smoking at 6-month follow-up). the cessation rate was 20 percent. Those who received counseling were also more likely to quit than those who did not (38 vs. 27 percent). They estimated the cost per quit was $464. Easy access to free NRT cessation medication in diverse populations can help large numbers of smokers to quit.
In a related report, Friedan and colleagues (2005) examined the impact of the comprehensive tobacco control measures of increased excise taxes, legal action for smoke-free workplaces, and increased cessation services—including the free NRT patch program, education, and evaluation. The authors reported that from 2002 to 2003 smoking prevalence in New York City decreased by 11 percent from 21.6 to 19.2 percent, equivalent to about 140,000 fewer smokers. During that time, cigarette purchases outside of New York City doubled, effectively reducing the effective price increase by 33 percent. They concluded that concerted action can have an impact on sharply reducing local smoking rates in a defined population (New York City) but that further effectiveness will require a comprehensive and coordinated national plan to reduce evasion of the local tax increase.
The task force on Community Preventive Services (Hopkins et al. 2001) reviewed the evidence for making an impact on quitting of 15 tobacco control strategies and strongly recommended multi-faceted media campaigns (i.e., media combined with other tobacco control interventions). Fiore and colleagues (2004), as part of their recommendations to encourage an additional 5 million smokers to quit, recommended funding a $1 billion national media campaign out of a $2.00 a pack earmarked tax as well as a national proactive telephone quitline at a cost of $3.2 billion per year. Media campaigns can encourage and increase cessation attempts and cessa-
tion across a variety of populations and can be tailored to address high-risk groups and disparities (Boyd et al. 1998; Siegel 2002).
Sociodemographic and selected behavioral and social environmental factors are also associated with facilitating cessation. For example, Saihpush and colleagues (2003) reported that knowing ETS exposure is harmful and smoking onset before age 14 was associated with greater likelihood of cessation. In addition, the odds of quitting were 4.5 times as likely for smokers living in homes where smoking was banned and 3.2 times greater for smokers reporting that few or none of their friends smoked. Their study suggests that it is difficult to quit smoking if the proximal environment is filled with smokers and thus interventions need to take the social context into consideration in smoking cessation programs.
Mass media campaigns can be effective at increasing interest in and motivation to quit when they are part of integrated community interventions, such as the comprehensive programs, monetary and other incentives (e.g., free NRT, tax disincentives, workplace bans), and interventions illustrated in the New York City and other case study and research trial examples reviewed above.
SECTION 2 SUMMARY
Current effective cessation programs exist but are greatly underutilized, despite the social climate that is making it more difficult to smoke (e.g., bans in worksites, higher taxes). The percent of all the 45 million current U.S. smokers who make a quit attempt each year is less than 45 percent. Of those that try to quit, over 75 percent do so on their own and over 95 percent of them fail to sustain abstinence. Using even minimal intensity or brief evidence-based cessation programs and services generally doubles the likelihood of success (see review below), and furthermore, there is a dose–response relationship such that more intensive programs and combined pharmacological and behavioral coaching programs can quadruple the likelihood of success. There is substantial room to improve the overall cessation outcome rate at every step of the journey from being an unmotivated current smoker who does not even make a quit attempt to reducing or preventing relapse among any smoker who makes a quit attempt.
The tobacco industry-sponsored marketing activities have also been shown to change smokers risk perceptions and expectations about safe cigarettes and motivation to quit. In short, they create myths and misinformation and undermine motivation to quit. Many smokers are also not aware of the safety and proven efficacy of formal treatment programs; for example, some smokers (as many as 67 percent) believe NRT may be as dangerous to one’s health as smoking. Thus, there is a strong need for more aggressive campaigns directed at smoking consumers that will improve their health literacy about tobacco products and about the value and safety of using evidence-based interventions. Many smokers have significant gaps in their health literacy, lacking specific knowledge of cessation methods, success rates, and how best to use cessation resources.
The weak marketing of cessation products and services relative to the tobacco industry’s capability results in many smokers harboring misinformation about the safety and efficacy of treatment, such as the misperception that PREPs are indeed relatively “safe.” The countervailing tobacco industry forces undermine smokers’ motivation to quit and weakens their health literacy about the health damaging effects of tobacco products and the beneficial effects of proven cessation products and services (e.g., Cummings et al. 2002; Cummings et al. 2004a; Cummings et al. 2004b). Having effective and efficient proven programs and services is necessary but not suffi-
cient to reduce population prevalence. The last decade has disproved the assumption “if you build it, they will come.” This supply side strategy of “if you build it, they will come” has not generated enough successful quitters to make a significant impact on reducing overall population smoking prevalence; both supply and demand strategies are needed.
In sharp contrast to the ongoing massive tobacco industry marketing campaigns, the financing in support of cessation and the marketing and promotion of information about cessation is miniscule. Herein lies a vast, largely unrealized, and untapped potential. Research studies illustrate the potential power of using financial incentives, mass media, and other strategies to motivate and support cessation (e.g., giving free NRT and telephone counseling in New York City). There are a number of other contextual and systems level factors that may discourage smoking and motivate smokers to quit: smoke-free laws and their enforcement (e.g., the workplace bans in Ireland and elsewhere), free state-supported proactive telephone quit lines, free OTC NRT, and low cost Internet-based cessation and relapse prevention (available 24/7/365 worldwide via the World Wide Web). Recent movement in the direction of increasing financial support for cessation includes the decision by the very influential federal Centers for Medicare and Medicaid Services (CMS) to reimburse for some of the proven cessation treatment services in their Medicare program as of March 2005. New generations of improved pharmacotherapies, behavioral counseling programs, and other innovations will also become available (see later sections in this appendix).
There are also large disparities in smoking rates with much higher prevalence among lower SES groups, some racial and ethnic minorities, and those with comorbid psychiatric/substance abuse conditions (see Wallace, Appendix P). Few smokers are fully informed consumers. The majority of smokers are relatively unaware of the differences in quality, content, safety, and efficacy of the various proven and unproven cessation interventions that are marketed to them. They neither know how to choose a program that best suits their needs nor what to do if the have difficulty quitting with a program and need a more intensive cessation care plan.
SECTION 2 RECOMMENDATIONS
The current smoker’s journey towards successful cessation needs a clear roadmap and milestones. This roadmap must be widely disseminated to educate and guide smokers through the phases from not being motivated to quit to making as many quit attempts as is needed (relapse and recycling) and learning how best to use the specific types of evidence-based programs that suite their unique individual profiles of patterns and needs until they can permanently maintain cessation.
There is a pressing need to focus on increasing consumer demand for cessation among smokers using well-established, theory-driven methods from social marketing and behavioral, social, and economic sciences. Creating strong consumer demand for quality programs requires greater emphasis on social marketing principles to address factors such as: product, providers, price, placement, promotion, and policy. Smokers must be educated that smoking is a journey from adoption to addiction to cessation.
A substantial investment must be made in research and in practice to determine what different smokers need and want, to clearly educate and communicate to them what is available to meet their needs, how to use the tools available for quitting, and what it is they should be doing
to improve their cessation success. Cessation products and services need to be made more attractive, accessible, and convenient.
Moreover, mass media and other channels of communication must be coordinated, aligned, and sustained in comprehensive, coordinated policy plans over time to motivate and promote cessation using key messages persistently and in novel ways.
Special emphasis must be placed on those smokers who are hard to reach, hard to motivate, hard to treat, and hard to maintain contact with. Surveillance and other modern epidemiological and geographic coding tools must be used to identify subpopulations of smokers based on sociodemographics, disparities, comorbidities and other factors in order to identify and target pockets of high smoking prevalence—those with low motivation to quit; little knowledge of cessation programs; and those communities and neighborhoods that lack the resources, the access, and the finances needed to provide proven cessation programs and services.
It is recommended that the federal government and health care delivery systems develop policies that mandate and implement a substantial, sustained, and effective marketing strategy to reach all smokers, with emphasis on hard-to-reach groups and communities with high pockets of prevalence. The campaign should deploy novel, persistent cues to action; should be designed to increase consumer awareness of the range of best practices available for cessation; should increase consumer ability to identify which programs meet best-practice guidelines; should motivate and provide strong incentives (e.g., contingent reward) for smokers to make quit attempts using evidence-based programs and services; and should help smokers understand the journey from smoking to cessation and the phases in the process of trying to quit— cessation, relapse and recycling—until permanent cessation success is achieved.
Among the areas to consider:
Develop a credible “consumer report” and certification to identify for consumers those cessation treatments and services that meet evidence-based quality standards.
Use social marketing principles and novel, persistent, and compelling cues to action to mount substantial and sustained mass media, direct-to-consumer marketing and other communication strategies and channels to reach all smokers with targeted messages addressing ways to increase consumer demand for cessation and encourage use of evidence-based intervention programs when quitting.
Focus special social marketing strategies on the hard-to-reach and hard-to-motivate groups, such as those with the highest levels of smoking prevalence, greatest comorbidity, and those at largest disproportionate risk. Target “pockets of high risk prevalence”; in other words, the hardest to reach, hardest to motivate, and hardest to treat smokers (this means the 57 percent who make no quit attempt in a given year, those with comorbid psychiatric or substance abuse disorders, the uninsured, the unemployed, and those of lower SES and educational backgrounds who have the highest smoking prevalence rates are the least likely to be able to afford the more intensive and effective treatments and have poor or no access to health care settings.
Increase consumer awareness of the processes involved in cessation, the range of best practices available for cessation, and provide realistic expectations of the commitment required for success.
Use specific incentives to motivate smokers to make serious quit attempts (e.g., free NRT, full reimbursement for treatment services, quit and win contests).
Increase enforcement and use of policies that restrict smoking and protect nonsmokers from secondhand smoke exposure, motivating smokers to consider cessation and reducing the number of proximal cues in the environment (other smokers) that tempt smoking and precipitate relapse.
Health plans, insurers and public agencies—individually or collaboratively—should use specific incentives to motivate smokers to make serious quit attempts using proven behavioral strategies including monetary incentives (e.g., free NRT, full insurance reimbursement for cessation treatment services and medications).
In terms of outcomes, goals, and objectives, it is recommended that a national adequately funded and effective multi-media campaign be implemented to:
educate smokers about the types of evidence-based interventions available and how they can choose and use these programs more appropriately and dispel the myths smokers have about cessation methods;
reach and motivate many more smokers to increase the percentage of smokers who make quit attempts per year, especially the 57 percent of smokers not interested in making quit attempts, those at high risk, minorities, young adults 18–30 years of age, the uninsured, and smokers with health disparities; and
encourage the smokers who do make a quit attempt each year to always use evidence-based programs when they try to quit (less than 30 percent do now), including educating them about smoking as a journey and informing them that they have the option to keep trying different cessation methods if at first they do not succeed at quitting. Specifically, educate smokers about a Stepped Care approach to cessation so that they can try less intensive and easily accessible programs (e.g., national or state telephone quit-lines, evidence-based internet programs with or without OTC NRT), as well as to consider the more intensive programs involving face-to-face contact, formal clinics, multi-session cognitive-behavioral treatments, prescription medications, and specialized services, especially if they have tried and failed to quit using less intensive methods, have psychiatric or substance abuse comorbidities, and are more heavily addicted to smoking.
The following outcome targets are recommended:
Goal #1: Increase consumer demand for evidence-based cessation programs and services.
Objective #1: Double the proportion of smokers who make quit attempts each year from the current rate of 40–45 percent per year to 60–70 percent within five years and 80–90 percent within 10 years).
Mount a substantial and sustained mass media/social marketing strategy to reach all smokers (especially the hard-to-reach groups at disproportionate risk).
Debunk the myths and misinformation that smoking consumers have and increase consumer demand and awareness of the realistic processes and the range of evidence-based cessation programs and practices available and how best to use them.
Use specific incentives to motivate smokers to make quit attempts using proven behavioral strategies including monetary incentives and disincentives (e.g., free NRT giveaways as in New York City; full reimbursement for all evidence-based treatment services, contests, and worksite incentives).
Lower the barriers to cessation and make the bar to try to quit so low that many more smokers will be tempted to try to quit and to try again more quickly if the do not succeed.
Increase environmental restrictions on smoking and reduce secondhand smoke exposures and encourage nonsmokers and ex-smokers to support smokers in their efforts at reducing the harm of smoking to the smokers themselves and to those around them as a step towards cessation.
EFFICACY AND EFFECTIVENESS OF CESSATION INTERVENTIONS
Generally, there is broad consensus supported by a wealth of evidence from randomized controlled trials (RCTs), meta-analyses, and critical reviews showing that proven smoking cessation interventions (either behavioral or pharmacological) will roughly double the quit rates of users versus controls (see PHS Clinical Guide by Fiore et al. 2000 as well as Hughes et al. 1996 and Raw et al. 1998). Combined behavioral and pharmacological treatments can result in as much as a three to fourfold increase in cessation outcomes. Given the evidence and excellent consensus reports that have been published to date, a comprehensive review of the evidence supporting the best practice recommendations of the PHS report will not be covered in detail here (Fiore et al. 2000).
Although the empirical evidence for efficacy of cessation interventions (Fiore et al. 2000) is based on over 6,000 studies, with over 300 Randomized Controlled Trials (RCTs) meeting stringent criteria for inclusion in intensive meta-analyses, the RCTs are limited in generalizability to the relatively small samples of smokers recruited and treated under ideal conditions. Participants generally are motivated to quit, aged in their 40s, and tend to be of higher SES. Participants are self-selected volunteers; in other words, samples of convenience not representative of the diversity of smokers in the population at large). Participants in clinical RCTs represent less than 5 percent of smokers: those who are ready to quit in the next 30 days (Biener and Abrams 1991; Prochaska and Velicer 2004; Velicer et al. 1995).
In general, greater intensity of treatment (duration and number of contacts, more modalities of intervention) improves cessation outcomes. Although the following classification is an oversimplification, for many purposes, intervention intensity can be classified into three categories: (1) none to minimal, (2) low to moderate, and (3) maximal. Abstinence at a minimum of 6-month follow-up is related to the intensity of the intervention in a dose-response fashion. Abstinence rates range from: (1) about 2–10 percent for smokers quitting on their own, using self-help materials or when they are in the control condition of RCTs; (2) 10–20 percent for brief, low-to-moderate intensity interventions; (3) 20 to over 30 percent for maximally intensive individual or
combined pharmacological and behavioral interventions (see PHS Clinical Guilelines by Fiore et al. 2000 for summaries).
Some evidence supports the concept that tailoring of interventions to individual smoker characteristics or targeting of intervention to group characteristics (e.g., race or ethnic background, gender, age) improves outcomes and that smokers with comorbidity (e.g., psychiatric disorders, alcohol or substance abuse) perform more poorly, especially without using a proven treatment (Niaura and Abrams 2003). As intervention strategies shift from treating individuals in clinical settings to intervening on defined populations in communities, factors such as cost, training of providers, and the pragmatics of coordinated systems of delivery become paramount (i.e., moving from clinical to dissemination to policy research evidence). Interventions of different types and of varying intensity and quality can also target different “defined” populations based on geographic (e.g., neighborhood and community), socio-demographic (e.g., age, gender, race, ethnic and cultural background), pockets of high risk prevalence (low SES groups, the uninsured, alcohol and substance abusers, those with psychiatric comorbidity) or other defining criteria.
In general, RCT interventions, when targeted and tailored to specific defined populations such as African Americans, women, older smokers, and other groups have reported similar or lower outcome efficacy compared with clinical trials interventions reported in the PHS Guide (Fiore et al. 2000). Research targeting smokers with medical comorbidity, such as cardiac patients, generally have higher rates of cessation and maintenance of cessation than other groups reported in the PHS guide when treated as part of their acute medical conditions such as after heart attack or cancer diagnosis (DHHS 2004).
Smokers with psychiatric comorbidities, depression, and alcohol or substance abuse disorders also appear, in some studies, to be able to quit at reasonable rates compared with smokers without comorbid complications (Prochaska et al. 2004), but other studies suggest smokers with comorbidities have more difficulty with cessation and may be less inclined to seek or receive appropriate levels of specialized treatment that their comorbidities may require for ultimate success.
In general, the range of effect sizes and cessation rates reported in the meta-analyses of the PHS Guide (Fiore et al. 2000) can be used to estimate the impact of cessation interventions in clinical RCTs conducted in different settings with different subgroups of smokers. Effects are in the range of about 5 to over 30 percent abstinence rates as a function of the dose–response relationship between intervention program intensity (unaided, low, moderate, high) and outcomes (Fiore et al. 2000). When attempting to calculate population-level impact, however, the results are limited in generalizability because of the types of participants and recruitment methods used in clinical RCTs and lack of information regarding the denominators of the population they were recruited from (Glasgow et al. 2006a;b)
There is a positive dose response relationship between amount and intensity of intervention and outcomes suggesting that some type of Stepped Care model for intervention may be warranted with smokers who either fail at lesser levels of care (e.g., brief treatment) or who have comorbid complications known to diminish outcome efficacy (see Abrams et al. 1993; 1996; 2003; Orleans and Slade 1993 for details). For example, smokers may be assigned to one or the other of a two-tier intervention, either standard care (e.g., brief behavioral counseling and/or OTC NRT), or more intensive specialized care in an outpatient clinic staffed with specialists in addiction treatment, psychiatric comorbidity, and ability to review and provide prescription medications.
Interventions that are translated from clinical to community settings to proactively reach more smokers in a cost-effective manner reveal considerable variability in outcome effectiveness as a function of more heterogeneous users or target group characteristics, program, provider, delivery system and other contextual or setting factors. In general, effectiveness is less than that reported in RCTs and effect sizes are more difficult to calculate with confidence.
Channels of intervention delivery must also be factored in, such as health care organizations and medical settings from hospitals to private practice, worksites, schools, telephone quit lines, the Internet, and other print and electronic media. Systems-level models are needed to address the diversity of channels and of populations of users. Models become more relevant such as Stepped Care, the tailoring of interventions to motivational readiness to quit (e.g., SOC model, motivational interviewing), and the targeting of interventions to channels or to population groups. The dose–response relationship between intervention intensity and cessation outcomes supported by the PHS guide meta-analyses (Fiore et al. 2000), provides some empirical support for a Stepped Care Model (Abrams et al. 2003). The guide also provides evidence that behavioral problem solving and social support enhances outcomes for those who are ready to quit. However, the PHS Clinical Guidelines (Fiore et al. 2000) reported there was insufficient evidence to endorse Stepped Care interventions or the SOC model at that time.
Telephone quit lines have been studied for almost two decades and provide a model for translating research into public health applications (Ossip-Klein and McIntosh 2003). Quit lines operate in more than half the states in the United States and in many other countries. Overall, when implemented appropriately quit lines can be viewed as effective and efficient brief interventions on their own. Quit lines can also be used in combination with other interventions. Quit lines can play an important role in reaching and motivating smokers to quit, and in providing flexible, convenient and low or no cost evidence-based programs for smokers. Generally, well-advertised quit lines can reach 1.1–5.9 percent of the adult smokers in the targeted area over a one year period. One challenge is to maintain a balance between promotion and utilization. Sufficient funds are needed to maintain a sufficiently high level of promotion to justify use of the service and employment of the trained counselors while at the same time not stimulating excessive demand that overwhelms the capacity of the service (Ossip-Klein and McIntosh 2003). Multiple individual studies and several meta-analyses report odds ratios in the 1.20 to 1.34 range (Stead et al. 2003). This efficacy is found when quitlines are used as the primary intervention. When quitlines are combined with other interventions, results are mixed. Significant effects were reported when quitlines were used to augment hospital-initiated interventions for cardiac patients, and in some studies were effective when combined with stages of change materials and NRT (Prochaska et al. 2001; Solomon et al. 2000) but not others (Lando 1997; Ockene 1991; Prochaska et al. 1993). Several studies are evaluating quit lines for cessation among adolescent and young adult smokers but no data are available as yet.
A number of studies have been published that explicitly focus on interventions designed for dissemination including tailored print and computer “expert systems”, telephone quit lines, Internet programs, and brief counseling in primary care and other settings. Space does not permit a comprehensive review of these studies but some exemplars and general trends can be noted. Zhu and colleagues (2002) reported on callers to the California quit line, randomized to receive self-help materials plus up to 7 proactive telephone calls (n = 1973) or to self-help and reactive
telephone support (i.e., only if they called back). A mean of 3 calls were delivered to 72.1 percent of callers in the proactive arm and 31.6 percent of reactive callers. The rates of abstinence at 6 and 12 months follow up were 12.8 and 9.1 percent in the proactive call arm and 8.6 percent and 6.9 percent in the reactive call arm. However the true denominator of all smokers who could have been in the defined population who could have called in but did not do so is unknown.
Fiore and colleagues (2004), based on a careful review of the evidence and the extensive deliberations of an expert panel, recommend funding a national telephone quit line (cost $3.2 billion per year) along with an associated aggressive mass media marketing campaign ($1 billion per year) to promote its use as a means of achieving an additional 5 million quitters per year and saving 3 million lives. In a more comprehensive integrated system of care, combinations of such a quitline, along with OTC-NRT, 24/7/365 Internet support for cessation and relapse prevention, and a system for determining how to deliver stepped-up intensive care for those with comorbid complications that require more intensive treatment than a quitline can provide, could all be considered to further improve outcomes (see also Abrams et al. 2003; Cobb et al. 2005; Strecher et al. 2005).
The U.S. Food and Drug Administration (FDA) approved prescription only (Rx) NRT in the form of chewing gum (2 milligrams) in 1984, a transderamal patch in 1991 and a 4 milligram gum in 1992. Both provide a temporary alternative source of nicotine, relieving withdrawal symptoms and helping smokers quit. The gum and patch were reclassified as OTC products in 1996. Other products were introduced as well: nasal spray (1996, Rx), inhaler (1997, Rx), and lozenge (2003, OTC). The non-nicotine product, Zyban®, was introduced after 1996.
Using data from the National Cancer Institute’s (NCI) tobacco use supplement (TUS) to the current population survey (CPS), Shiffman and colleagues (1997; 2004) reported that in 1999 about 40 percent of smokers attempted to quit in the last year compared with about 35 percent in 1996 and 38 percent in 1993. The data are correlational but do seem to track the introduction of NRT and its going OTC: producing a spike in use in 1993, then declined as use of prescription only NRT reached a steady state in 1996 and then another spike in 1999 after NRT went OTC. Shiffman and colleagues (1997) also reported that sales of NRT increased 152 percent after the NRT’s went OTC and estimated that this resulted in an additional 114,000 to 304,000 new quitters annually (Shiffman et al. 1997). In a 2000 study report by CDC, it was found that the largest increase in NRT use coincided with the switch of nicotine gum and patch to OTC and that the introduction of two newer forms of pharmacotherapy (nasal spray and oral inhaler) had almost no impact on use (CDC 2000). Longitudinal data from COMMIT (Community Intervention Trial for Smoking Cessation) indicated that annual NRT use doubled from 1993–1995 to 1997– 2000) (Cummings and Hyland 2005).
In the mid-1980s, over 90 percent of former smokers reported stopping without use of any formal treatment or pharmacotherapy (Fiore et al. 1990) Studies evaluating commercial NRTs consistently report quit rate increases of 1.5 to 2-fold that of placebo (Silagay et al. 2002).
Should pharmacologic treatments be seen as adjuncts to behavioral treatments or stand-alone therapies? At least for NRT, it appears that the two work additively (Hughes et al. 1999b), although formal tests of this proposition are lacking, especially for combinations of behavioral treatments with the patch and behavioral treatments with non-NRT compounds. It is important, therefore, to know what kind of behavioral treatment components work best with pharmacologic agents and what format and delivery systems are best suited to each product and situation. Is
there dose-related incremental efficacy when intensity of behavioral treatment (components and/or contact) is increased and overlaid, for example, on use of the patch? Stated more simply, how much more can behavioral treatment add to patch efficacy?
Hughes (1995) also posed several hypotheses concerning the mechanisms by which behavioral and pharmacologic treatments might combine to increase treatment efficacy: (1) behavioral treatments improve skills necessary to achieve and maintain abstinence, whereas pharmacologic treatment improves withdrawal; (2) pharmacologic treatment provides relief of withdrawal early on and provides the necessary bridge through the most difficult period, whereas behavioral treatment provides skills necessary to prevent relapse subsequently; (3) behavioral skills may be specifically helpful for a subset of smokers, whereas pharmacologic treatment helps another subset; and (4) one treatment may increase compliance with the other (Hughes 1995). There have been no systematic investigations of these or other proposed mechanisms whereby behavioral and pharmacologic treatments may potentiate one another.
The issue of combining pharmacotherapies deserves additional attention. There is mixed evidence that combinations of NRT products boost efficacy compared with use of individual products (Blondal et al. 1999; Bohandana et al. 1999; Sutherland 1999). However, combined use of the patch and gum appears to alleviate withdrawal symptoms more than either product alone (Fagerstrom 1994), and there is no evidence for increased toxicity (Kornitzer et al. 1995). The combination of bupropion and the patch was also found to be efficacious, at least in the short term, with no evidence of increased adverse events for the combination (Jorenby et al. 1999). So the question remains: for which smokers are combinations of particular products useful?
The PHS Guideline (Fiore et al. 2000) makes it clear that several forms of NRT are efficacious: nicotine gum, the transdermal nicotine patch, the nicotine inhaler, and nicotine nasal spray. Two non-nicotine pharmacologic treatments, bupropion hydrochloride—an atypical anti-depressant with noradrenergic and dopaminergic activity—and clonidine—a centrally acting antihypertensive agent—have also demonstrated efficacy since the 1996 Guideline and are recommended treatment options (Fiore et al. 2000; Hurt et al. 1997). Bupropion has received FDA approval for smoking cessation, whereas clonidine has not. Table A-1 depicts the 6-month abstinence estimated ORs and 95 percent confidence intervals (CI) for the different treatments relative to placebo. Overlapping CIs indicate that the treatments have statistically non-distinguishable effects. A recent head-to-head comparison of the nicotine patch, gum, inhaler, and spray showed no differential efficacy (Hajek et al. 1999). Despite some evidence that high-nicotine-dependent smokers may benefit more from nicotine gum (especially the 4 milligram gum) and nasal spray (Herrera et al. 1995; Sutherland et al. 1992), the majority of the evidence suggests that smokers in general benefit from all forms of demonstrated efficacious pharmacotherapies. Therefore, the choice of treatment should depend to a large degree on factors such as patient and provider preference, affordability, and side effects.
It is also clear that NRT works with little or no adjunctive behavioral treatment. This is not to say, however, that behavioral treatment is not important. Rather, it appears that the amount of behavioral treatment sets the base rate for quitting and that adding NRT doubles this quit rate (Hughes 1995; Hughes et al. 1999).
The FDA granted approval for OTC sales of the gum in 1995 and the patch in 1996. This decision was based on extensive clinical and safety experience (Shiffman et al. 1997), trials demonstrating efficacy in OTC-like environments, and the desire to increase smokers’ access to proven effective therapies and thereby increase the likelihood that motivated smokers would use NRT and quit (Hughes et al. 1999). Some studies have suggested that the public health benefit of
OTC has been considerable (Shiffman et al. 1998). However, the efficacy of the gum and patch in this environment is less than that observed in controlled clinical trials and probably depends to a significant degree on factors such as under-dosing, ceasing use prematurely, using inappropriately, and having an (un)availability of supplemental behavioral treatment. For example, use of a program consisting of telephone support and tailored cessation materials boosted quit rates significantly for those OTC patch and gum users who availed themselves of this resource compared with patch users who did not (Shiffman et al. 2000; Shiffman et al. 2001).
For light versus heavy smokers, trials of NRT with treatment consistently indicate similar success rates for light versus heavy smokers, but trials of NRT without treatment (e.g., OTC NRT) suggest that heavy smokers do worse than light smokers when using NRT.
Community Dissemination and Implementation Trials
In moving from clinical trials to large-scale community dissemination research, intervention strategies shift from “reactively” treating highly motivated individuals to “proactively” reaching the vast majority of unmotivated smokers in broader, defined populations such as entire communities. Factors such as fidelity of implementation, cost-effectiveness (and efficiency), training of non-specialist (i.e., generalist) providers, and the pragmatics of “coordinated systems of delivery” become paramount. Interventions of different types, modes, methods, and channels of delivery are used to reach and target “defined” populations based on geography, demography (e.g., age gender, race, ethnicity), setting, or other criteria (e.g., low SES groups, the uninsured, alcohol and substance abusers, those with psychiatric comorbidity, and prison populations). Interventions can also vary in the degree of targeting or tailoring of program content to the individual difference characteristics of the subpopulations of smokers they are designed to reach (for details see Wallace Appendix P).
There are an increasing number of well-conducted dissemination studies of effectiveness and cost-effectiveness delivered through different channels and modalities. Such “real world” interventions range in intensity, duration, content, quality, reach, and cost (e.g., telephone quit lines, OTC-NRT, Internet cessation, health care providers in hospitals, clinics, primary care practice, managed care organizations [MCO], worksites, alcohol and substance abuse programs) (Cobb et al. 2005; Keller et al. 2005; Frieden et al. 2005; Hughes et al. 2003; Metzger et al. 2005; OssipKlein and McIntosh 2003; Shiffman et al. 1997; Solomon et al. 2005; Stead et al. 2003; Taylor and Curry 2004; Zhu et al. 2002). Dissemination trials report more variability in fidelity of implementation of best practices and mixed or weaker cessation outcomes than the results reported in clinical RCTs delivered under “ideal” conditions.
National Trials: National Health Plan Study in Great Britain
In a recently published evaluation of a national smoking cessation intervention supported by the British National Health Service, (Raw et al. 2005) reported that 28 percent of British smokers attempted to quit, 18 percent of all smokers used treatment (64 percent of the quitters); 9 percent (32 percent of quitters) bought Nicotine Replacement Therapy Over the Counter (NRT-OTC); 6 percent used prescription only pharmacotherapy (21 percent of quitters); and 3 percent used a cessation clinic (11 percent of quitters) and 5 percent quit without help (36 percent of quitters). Assuming success rates of 10 percent for NRT-OTC; 10 percent for Pharmacotherapy; 20 percent for Clinic Treatment; and 5 percent for unaided cessation, the percent of smokers who
stopped smoking was 2.6 percent. This study demonstrated making a national impact on the population of smokers in Great Britain.
There are limitations to the implementation of the British experience (Raw et al. 2005) that suggest the overall impact of their program could have been much greater. First, on the “demand side,” the program was poorly advertised and weakly marketed (i.e., there was little “buzz” and an inadequate effort to stimulate consumer demand or to reach and motivate all smokers in Great Britain). Second, on the “supply side,” the program relied entirely on the existing infrastructure of the heath care system, providers were inadequately trained and only weakly supportive. Moreover, only traditional clinic-based cessation was offered—a serious limitation to access and usage in light of the possible brief, minimal, and community-based programs that could have been offered.
The British study may be seen as a lower limit to estimating the effectiveness of the potential impact of a cessation treatment plan that is supported and reimbursed by third party payers and implemented nationwide. Dissemination studies do reach a more representative and less motivated subset of the smoking population. However, even dissemintion/implementation/community participatory research studies are limited in generalizability to the defined population that was targeted for the study. Moreover, because such studies do not successfully recruit the entire defined population (and oftentimes do not report on or use the true denominator in their calculations of cessation rates) the effect sizes of interventions delivered on a large scale to so called “real world” populations are less reliable and more variable. Results may also be difficult to interpret because the traditional randomized controlled trial may not be the best method to evaluate these studies and the time frames for expecting population level outcomes may be too short as in the ASSIST and COMMIT studies funded by the NCI in the 1990s (Cummings 1999; COMMIT Research Group 1995).
Prochaska and Velicer (2004) summarized a number of dissemination trials using tailored print materials based on the trans-theoretical SOC model. In one random digit dial study that proactively recruited 80 percent of the defined population, 23 percent cessation was reported at 18-month follow-up (Prochaska et al. 2001) using three rounds of tailored intervention over 6 months. In a defined population of smokers in an HMO, 85 percent of 4,653 were proactively recruited and yielded 23.2 percent cessation at 18 month follow up for three rounds of tailored print communications delivered over 6 months.
In contrast to the lower bound estimate of population impact on cessation prevalence derived from the National Health Plan Study in Great Britain (Raw et al. 2005—reviewed above), the Prochaska and colleagues (2001) study suggests an upper bound of reaching 80 percent of the total smoking population and obtaining a 23 percent effect size on cessation at 18-month follow-up.
Relapse and Recycling
Interventions for smoking typically consist of discreet periods of treatment leading to abstinence or relapse. The vast majority of quit attempts lead to relapse. Relapse is all too common: depending on the population sample, treatment intensity and type and the definitions of cessation between 65 and 95 percent of quit attempts end in relapse (Pierce and Gilpin 2003) with the greatest proportion of relapse (44 percent) occurring within 14 days of a serious quit attempt (Garvey et al. 1992). The relapse rates for those making unaided quit attempts in the general population is difficult to estimate but is likely to be even higher than 95 percent. The relapse curves for nicotine are similar to heroin and alcohol addiction (Hunt and Bespalec 1974).
It is not clear that encouraging rapid recycling will improve long-term cessation. Some studies have noted differences between groups encouraged to recycle or not, overall results have been discouraging. Lando and colleagues (1996) reported that a telephone support intervention significantly increased recycling but not long term abstinence. Tonneson and colleagues (1993b; 1996) found that introducing nicotine replacement after one year did not appreciably increase abstinence (6 percent for nasal spray and 0 percent for patch). These studies rely on small sample sizes of smokers motivated for treatment using the typical clinic trials or individual level model. It may be that the potential is much greater for using rapid recycling to improve overall cessation rates at the population level, among the 43 percent of all smokers (almost 20 million smokers) who make a quit attempt each year, most of whom do so on their own without any evidence-based intervention.
Relapse prevention and recycling is a huge public health opportunity but the research base to inform effective and efficient recycling/relapse prevention intervention is sparse. Several recent studies provide some direction for future research and for public policy. Brandon and colleagues (2003) suggest relapse prevention interventions be offered as a free standing intervention offered to all persons who have recently quit regardless of whether they used a formal treatment or not. They mailed a series of relapse prevention booklets to recent quitters and, in an initial efficacy trial, reported significantly reducing relapse rates. Among subjects who were abstinent less than 3 months after baseline, 88 percent of those who received the mailed materials were still abstinent at 12 months follow up versus only 65 percent in the no mail group. The intervention was also of minimal intensity and highly cost effective: the cost of keeping a smoker from relapsing at any time during the 12 months following their quit was $174. The cost effectiveness of cessation treatments recommended by the PHS clinical practice guidelines range from $2,186 for group counseling without NRT to $8,962 for NRT with brief counseling (Cromwell et al. 1997).
Relapse should be regarded as part of the learning experience along the pathway to cessation. Just like learning to ride a bicycle for the first time, persistent effort, practice, and openness to the correction of past mistakes will lead to eventual mastery and success (Bandura 1997). If one falls off the bicycle, one has to get back up and try again to become proficient at negotiating the curves and the bumps in the road. Thus, the idea of recycling smokers who have slipped back into smoking is included in the treatment planning process.
Population Impact of Cessation Interventions in the Real World
The full impact of cessation interventions is a product of the proportion of the intended population reached and the efficacy of the interventions delivered to that population (Impact = Reach × Efficacy; see Abrams et al. 1993; 1996; 2003). Impact can be calculated under ideal conditions based on clinical trials data. Then the impact equation can be “discounted” or adjusted for the real world, for example by using an estimate of the degree to which the larger target population (proactively recruited) is harder to reach, harder to motivate, less likely to receive treatments of optimal quality and fidelity, less likely to adhere to treatment, and harder to follow up than the participants in the clinical trials under ideal circumstances.
SECTION 3 SUMMARY
In general, the outcome effectiveness of trials that can be widely adopted and disseminated remains in the moderate to good range. Dissemination studies and a number of meta-analyses provide reasonable and reliable data as a basis for projecting the impact on a population-wide
basis of the efficient implementation of best practices. Outcomes in various controlled and quasi-controlled trials can range from 1–30 percent quit at 6–12-month follow-up, in general somewhat lower than, but also able to approach, those of the more well documented clinical trials. For example, quit lines increase abstinence by as much as 30–50 percent over control conditions (Fiore et al. 2000). In a review of OTC NRT studies, Hughes and colleagues (2003) reported quit rates of 8–11 percent at 6-month follow-up in five studies; rates of 1 percent-6 percent in two other studies; and, in a meta-analysis of 4 trials, the odds ratio for OTC NRT versus placebo was 2.5 (95 percent CI 1.8–3.6).
Based on the growing evidence from dissemination research trials and the extensive deliberations of an expert panel, Fiore and colleagues (2004), recommended funding a national telephone quitline as a means of reaching more smokers and achieving an additional 5 million quitters per year as well as saving 3 million lives over the next two decades.
It is more difficult to estimate the effects of multi-level and multi-dimensional systems components (e.g., mass media campaigns, tax disincentives, and enforcement of bans/restrictions) that interact with intervention types, modes, and channels and with different smoker characteristics to produce an overall “impact” on cessation rates. It is likely a combination of multiple strategies that will ultimately translate into the high population prevalence rate reductions that are desired. More complex combinations of policies, delivery systems, programs, and individual characteristics can be examined using computer simulation modeling (e.g., Friend and Levy 2001; Levy and Friend 2002a,b; Levy et al. 2005; Mendez et al. 1998).
The following outcomes goals and objectives are recommended:
Goal #2: Increase the long term (>1 year) cessation success rate of smokers who make a serious quit attempt by encouraging greater use of evidence-based treatments when smokers make a quit attempt.
Objective # 2: Double the proportion of smokers who use a proven intervention when they do make a quit attempt from less than 25 percent now to over 50 percent within 5 years and over 70 percent within 10 years). This should increase the population cessation effectiveness rates from an average of 5–10 percent per year to 10–20 percent per year within 10 years.
Ensure that smokers ready to quit have full knowledge of how to quit and what to expect and that they also have access to the full range of evidence-based cessation options documented in the Clinical Guidelines (OTC and Prescription pharmacotherapy as well as brief and more intensive behavioral counseling delivered via diverse intervention modes such as telephone, brief face to face individual or group support, clinic services, internet and others for motivation, cessation and relapse prevention).
Reduce the rate of relapse among quitters who achieve initial cessation by providing support for cessation and reducing the time lag between consecutive quit attempts for those who relapse. Develop and make available specific new programs and services directly targeted at recent quitters and designed to either prevent relapse or encourage rapid recycling back into another cessation attempt if they have recently slipped back into smoking after a quit attempt. The Internet is an especially promising tool here given both preliminary data (Cobb et al. 2005), its 24/7/365 availability and ability to provide a variety of expert and peer social support networking).
Provide clear guidelines and access to specialized, intensive, and Stepped Care (or stepped up care) for smokers who have known comorbid complications; those at highest risk for medical, psychiatric, alcohol/substance abuse complications; and those who have tried and failed to quit on their own or with brief or minimal intervention efforts (such as OTC medications alone or brief counseling alone).
SUMMARY OF SECTIONS 1–3 ESTIMATING THE POPULATION IMPACT OF CESSATION INTERVENTION POLICY
The full impact of cessation interventions is a product of the proportion of the intended population reached and the efficacy of the interventions delivered to that population (Impact = Reach × Efficacy; see Abrams et al. 1996; 2003). Impact can be calculated under ideal conditions based on clinical trials data. Then the impact equation can be “discounted” or adjusted for the real world, for example by using an estimate of the degree to which the larger target population (proactively recruited) is harder to reach, harder to motivate, less likely to receive treatments of optimal quality and fidelity, less likely to adhere to treatment, and harder to follow up than the participants in the clinical trials under ideal circumstances (see Abrams et al. 1993; 1996; Dzewaltowski et al. 2004; Glasgow et al. 2006a,b). The parameters that need to be considered when adjusting an efficacy metric downwards to convert it to an effectiveness estimate are consistent with the reporting of criteria in the “RE-AIM” model recommended by Glasgow and colleagues (Dzewaltowski et al. 2004; Glasgow et al. 1999; Glasgow et al. 2003; Glasgow et al. 2006a,b).
The committee commissioned a series of simulation models to estimate cessation’s overall impact on smoking prevalence outcomes over 20 years (presented in detail elsewhere; see appendixes by Levy and by Mendez and the full report). The simulation models provided a heuristic guide for projecting the potential increases in population cessation rates that might be expected over the next 2 decades, given parametric input assumptions. The simulation model to project the impact of smoking cessation interventions on population prevalence employed the SimSmoke algorithms developed by Levy, Friend, and colleagues (Friend and Levy 2001; Levy and Friend 2002a,b; Levy et al. 2004)
Based on the evidence from the reviews, meta-analyses of clinical (efficacy) and dissemination (effectiveness) trials, and guided in part by the simulation modeling, two primary goals emerged for significantly accelerating cessation rates to make an impact at the population level. The first goal addresses the reach dimension (reviewed in Section 2 above) and recommended a doubling of the number of smokers who make a quit attempt each year over a 10-year period. The second goal involved the efficacy to effectiveness dimension of implementing and using evidence-based treatments (reviewed in Section 3 above). Goal #2 recommended we enhance cessation rates and reduce relapse rates by doubling over 10 years the number of smokers who use evidence-based cessation treatments when they do make a quit attempt.
It is important to note that in setting the parameters for the algorithms in the simulation modeling (see appendix by Levy and by Mendez and the full report) it was decided to use measures of reach and efficacy that were anchored by more conservative and consistent evidence-based estimates. Therefore, the simulation modeling projections of the impact of cessation interventions on overall smoking prevalence are also relatively conservative. The computer simulation algorithms were tied to the lower to middle bounds of the reviews of the evidence for reach and effectiveness in Sections 2 and 3 above, rather than the more ambitious upper bounds recom-
mended in Goals #1 and #2. Thus there is room for an even stronger contribution of cessation to reducing overall population prevalence if the impact can be enhanced to achieve the ambitious but not impossible levels that are recommended in the 5- and 10-year goals and objectives for Goal #1 (reach), and Goal #2 (effectiveness).
FUTURE DIRECTIONS IN CESSATION RESEARCH AND IMPLEMENTATION
Lowering the Bar to Cessation: Harm Minimization and Programs for Smokers Not Currently Motivated to Quit
Shiffman and colleagues (1998) have outlined principles that should guide a harm reduction philosophy and approach to tobacco control. Among these principles are the assumptions that: (1) the purpose of reducing exposure to tobacco toxins is to reduce the death and disease caused by tobacco; (2) the long-range goal should be to leave smokers both tobacco and nicotine free and should not reduce the likelihood of eventual cessation; (3) any method used to reduce exposure, especially pharmacologic agents such as NRT products, should pose no added safety risks; (4) exposure reduction therapies should not worsen an individual’s level of nicotine dependence and should not lead to increased population prevalence of nicotine dependence or expansion of use beyond the smoking population; and (5) pharmacologic means, if used to reduce tobacco toxin exposure, should not appeal to adolescents. The degree to which pharmacologic interventions, and in particular NRT products, can result in acceptable, safe, and verifiable reductions in toxin exposure will be the target of considerable research and intervention efforts for some time to come.
Some smokers may not quit for a long time, and it is estimated that as many as 50 percent of smokers will never quit (Hughes et al. 1999a; Hughes et al. 1999b). Many smokers repeatedly fail after trying the very best interventions available. Since smoking at any level is harmful, it is hoped that continued engagement in treatment will eventually lead to longer periods of abstinence rather than a reduced level of smoking. For a subgroup who will not quit even with the highest levels of care, the treatment emphasis may have to change from abstinence to harm minimization (Baer et al. 1993; Hughes et al. 1999a; Marlatt 1998; Shiffman et al. 1998; Warner et al. 1997).
The pharmaceutical, public health, and sociobehavioral science communities as well as the tobacco industry are all converging on the need for innovative new approaches to reducing the huge amount of devastating and preventable death disability, disease burden, and cost of smoking on individuals’ families and society. The not too distant future may contain a variety of new approaches to smoking cessation and reducing the harm caused to current smokers who will not or cannot stop smoking.
Hughes and colleagues (2004) suggests that interventions to reduce harm may ultimately encourage cessation. Smokers not currently interested in quitting (n = 616) were randomized to receive telephone-based: (1) reduction counseling plus nicotine replacement therapy (NRT) plus brief advice to quit, (2) motivational advice plus brief advice, or (3) no treatment. More smokers in the reduction (43 percent) and motivational (51 percent) conditions made a 24-hr quit attempt over 6 months than smokers in the no-treatment condition (16 percent), but the 2 active conditions did not differ. Similarly, 18, 23, and 4 percent of each condition were abstinent (7-day point
prevalence) at 6 months. Results indicate smoking reduction using NRT does not undermine cessation but rather increases the likelihood of quitting to a degree similar to motivational advice
Although new cessation products and services as well as harm minimization strategies will continue to be introduced into the marketplace in the coming years (by the tobacco industry, the pharmaceutical industry, service providers, social, and behavioral scientists) and although these innovations may improve outcome efficacy and/or reduce toxic exposures to some extent, it is unlikely to dramatically improve outcome efficacy in the near to medium term time frame of the next 5 to 10 years. However, immediate and potentially dramatic increases in population cessation rates can accrue from improving the utilization and reach of the current proven interventions and by reducing the risk of relapse following initial cessation
The Internet can reach millions of smokers cost-effectively. Many cessation websites exist, but few have been evaluated and, of over 300 websites, less than 10 met criteria for having content outlined as effective in the PHS guideline (Bock et al. 2004). As a result, the potential impact of the Internet on smoking prevalence remains unknown. A preliminary, uncontrolled, large-scale evaluation of a broadly disseminated smoking cessation website used worldwide (QuitNet®) was recently reported (Cobb et al. 2005). Consecutive registrants (n = 1,501) were surveyed 3 months after they registered on the web site to assess 7-day point prevalence abstinence. Results must be interpreted cautiously as this is an uncontrolled study with a 25.6 percent response rate. Approximately 30 percent of those surveyed indicated they had already quit smoking at registration and were using the website for relapse prevention. Excluding these participants, an intention to treat (ITT) analysis yielded a 7 percent point prevalence abstinence (for the responders only, abstinence was 30 percent).
In a European study, 3,501 purchasers of a nicotine patch who proactively logged on to use a free Internet program and then consented to participate in a research study (76 percent) were randomly assigned to a tailored versus an untailored program (Strecher et al. 2005). To be eligible, the participant’s target quit date had to be within 7 days of enrollment. At 3-month follow-up, using ITT analysis of continuous abstinence for 10 weeks, the tailored condition (22.8 percent) outperformed the untailored condition (18.1 percent). Although this study was a large randomized trial, it is unclear the degree to which results generalize to the broad population of smokers who seek cessation information and treatment on the Internet. Participants were restricted to those who could afford and did purchase a specific brand of patch and to those who chose to utilize an online support program. Collectively, these studies are a promising start in evaluating Web-based smoking cessation programs. However, more studies are needed.
Two other issues deserve comment: (1) Continued development of pharmacologic approaches to smoking cessation (what’s in the product-development pipeline) and (2) the potential for long-term use of pharmacologic treatments to sustain cessation. New forms of NRT continue to be developed and evaluated. The nicotine lozenge and sublingual tablet are approved for use in Europe (Britton et al. 2000) and will probably be introduced to the U.S. consumer as prescription products in the near future. It is unclear whether these products confer a significant advantage over other NRT products.
Pharmacotherapy is an important adjunct to smoking cessation treatment. Currently marketed pharmacotherapies include nicotine replacement products (gum, patch, nasal spray, inhaler,
and lozenge) and bupropion. In clinical trials, existing pharmacotherapies on average double cessation rates compared to placebo. Limitations of the available pharmacotherapies are that the effectiveness is only modest (cessation rates 10–20 percent depending on the population of smokers and concomitant behavioral therapies) and the fact that many dependent smokers have already tried and failed these therapies. Most studies of retreatment with the same medication find very low cessation rates.
Thus it is imperative that new medications be developed to aid smoking cessation. Such medications might be more effective than existing medications, which is particularly important for highly dependent smokers. Even if new medications are not more effective than currently available medications, new medications would provide an alternative to current medications and would encourage more smokers who failed cessation in the past to consider quitting another quit attempt.
At this time, several new medications are under development and others hold great promise. Research on drugs that act on nicotinic cholinergic receptors have led to the discovery of verenicline, a nicotine receptor partial agonist. A partial agonist is a drug that stimulates a receptor, but at the same time blocks the actions of other receptor agonists. In this case, verenicline produces some direct nicotine-like effects on receptors, but blocks the effects of nicotine from tobacco. The promise of such a medication is that it would block the satisfaction from smoking a cigarette while at the same time producing nicotine-like effects to prevent withdrawal symptoms.
Varenicline, a novel pharmacotherapy, was approved by the FDA as an aid to smoking cessation treatment in May 2006 (FDA 2006). Varenicline is an ά4β2 nicotinic receptor partial agonist that is believed to aid smoking cessation by moderately increasing the release of dopamine in the mesolimbic system, thereby reducing abstinence-related craving and withdrawal (Coe et al. 2005). Varenicline also appears to reduce the rewarding effects of nicotine during smoking via this same mechanism. (Coe et al. 2005) The efficacy of varenicline has been assessed in six controlled clinical trials, of which 3 have been published (as of July 6, 2006). In one randomized controlled study involving 1,027 subjects, 23 percent of participants in the varenicline group (1 milligram twice per day for 12 weeks, starting 1 week before quitting smoking) were continuously abstinent during weeks 9 through 52 compared with 10.3 percent in the placebo group (OR, 2.66; 95 percent CI, 1.72–4.11; P < .001) and 14.6 percent in the bupropion SR group (OR, 1.77; 95 percent CI, 1.19–2.63; P = .004) (Jorenby et al. 2006). In a second double-blind study involving a total of 1,025 patients, continuous abstinence rates during weeks 9 through 52 were 21.9 percent for varenicline vs 8.4 percent for placebo (OR, 3.09; 95 percent CI, 1.95–4.91; P < .001) and vs 16.1 percent for bupropion SR (OR, 1.46; 95 percent CI, 0.99–2.17; P = .057) (Gonzales 2006). A third published study assessed the effect of an additional 12 weeks of therapy with varenicline on the likelihood of long-term abstinence. Patients were treated with openlabel varenicline for 12 weeks, and patients who had stopped smoking by week 12 (n = 1236) were then randomized to double-blind treatment with either varenicline or placebo for an additional 12 weeks and then followed for 28 weeks post-treatment. The continuous abstinence rate was significantly higher for the varenicline group than for the placebo group for weeks 13 to 24 (70.5 percent vs. 49.6 percent; OR, 2.48; 95 percent CI, 1.95–3.16; P < .001) as well as for weeks 13 to 52 (43.6 percent vs. 36.9 percent; OR, 1.34; 95 percent CI, 1.06-1.69; P = .02) (Tonstad et al. 2006). Nearly 30 percent of participants in these three trials reported nausea, a rate significantly higher than with either bupropion or placebo (Klesges et al. 2006). Abnormal dreams were also common and much more likely in the varenicline groups. However, overall side effect rates were similar across the varenicline and bupropion conditions (Klesges et al.
2006). Varenicline was combined with counseling in all 3 studies. In summary, varenicline is an efficacious pharmacologic treatment for tobacco dependence that offers clinicians and patients a new powerful option for tobacco dependence treatment, though more experience is needed with this agent in real-world settings before its place among nicotine dependence treatments is fully understood (Klesges et al. 2006; Niaura et al. 2006).
Another drug under development is rimonabant, a cannabinoid-1 receptor antagonist. The cannabinoid receptor is the site of action of THC, the active constituent of marijuana. Cannabinoid receptors seem to be involved in a variety of appetitive behaviors, including drug use and food consumption. Clinical trials suggest that rimonabant might both facilitate smoking cessation and prevent bodyweight gain, which usually occurs after one quits smoking.
Another promising line of drug development is research on nicotine vaccines. Vaccination generates antibodies to nicotine that could block the reinforcing effects of nicotine. Nicotine vaccination is intended to prevent relapse to smoking after cessation. The idea is that if one relapses, the smoker would not find the cigarette rewarding and would not continue to smoke.
These three medications are currently in clinical trials, and their ultimate contribution to smoking cessation therapy has not yet been established. However, these examples demonstrate the potential of developing novel medications for smoking cessation.
The development of new medications to aid cessation for smoking cessation is a high priority, particularly for the treatment of the most highly dependent smokers. Basic science research on nicotinic receptors as well as agonists and antagonists that act on these receptors, and research on other neurotransmitter and receptor systems involved in the actions of nicotine, is likely to be the key to new medication development. Of particular importance is developing medications that will be useful in treating smokers with psychiatric comorbidity. Such medications might both aid smoking cessation and for example treat depression or other mental health disorders for which smoking may be perceived as beneficial.
Adolescent and Young Adults: An Important Opportunity and an Important Priority for Research
Children are exposed to nicotine early in life—over 80 percent of adult smokers become regular users before the age of 18 years (CDC 1998). But there has been a 32 percent increase in youth adoption of smoking between 1991 and 1997 in the United States (CDC 1998) and a 28 percent increase among college students (Rigotti et al. 2000).
Little is known regarding the smoking habits of young adults, as well as the feasibility of implementing intervention strategies (Backinger and Leishow 2001; Sussman et al. 1999; Sussman 2001). Lloyd-Richardson and colleagues (2001a,b) investigated characteristics among young adults attending technical school. A random sample of 784 students (response rate 82.5 percent) attending a large technical school completed a survey. They were primarily male (70 percent) and white (85 percent), with an average age of 26 years. Thirty-three percent were current smokers, smoking an average of 16 cigarettes per day, and 91 percent of smokers had tried to quit an average of 3 times in the past year, 78 percent endorsed at least a moderate level of motivation to quit smoking (i.e., “often think of quitting, but no plans yet”), with 50 percent interested in use of the nicotine patch and 43 percent interested in use of bupropion hydrochloride (Zyban®). These data suggest prevalence of smoking among technical school students is higher than among traditional 4-year college students (28 percent) (Wechsler et al. 1998) as well as among the general population of the United States (median 23 percent) (CDC 2004b).
Sussman and colleagues (1999) reviewed 34 studies conducted on adolescent regular tobacco users but employing both cessation and prevention interventions (see Flay in Appendix D). Of the 17 cessation-focused studies, there was great variability in their research designs, cessation programs, measures, and outcomes. Target populations and settings varied as well but were generally in the age range 14 to 22 years. Follow-up period also varied from 1 month to 24 months and was not reported in some studies. Sussman and colleagues (1999) reported that background (some studies were uncontrolled) or control group quit rates for this age group over 6 months varied from 0 to 11 percent and the average of the intervention’s quit rates at follow up were approximately 13 percent. Younger smokers are difficult to recruit and difficult to motivate to use smoking cessation programs. Many programs were adapted from adult programs and are not tailored to younger smokers. Colby and colleagues (1998; 2005) reported on a promising preliminary study using motivational interviewing adapted from adult interventions with alcohol abusers to encourage adolescent smokers to stop.
Killen and colleagues (2004) randomized 211 adolescent smokers to nicotine patch plus bupropion SR or nicotine patch plus placebo. All participants also received group behavioral skills training and relapse prevention training weekly. At weeks 10 and 26 of follow up abstinence rates for the combined treatment versus placebo arms were 23 and 8 percent versus 28 and 7 percent, respectively.Compared to non African American teens, African Americans reported a 1 year later onset of smoking onset and a slower uptake trajectory to regular smoking. Rabius and colleagues (2004) reported that among 3,500 callers to the ACS quitline, 12 percent (420) were smokers aged 18 to 22 years. All smokers were randomized to either self-help booklets by mail or up to 5 sessions of telephone counseling. Using intent to treat analysis, Rabius and colleagues (2004) found 3-month cessation rates of 20 versus 9 percent for these younger smokers compared with 15 and 10 percent cessation rates for older smokers.
Finally, we note that there have been efforts to treat adolescent smokers with NRT (e.g., Moolchan et al. 2005). Despite evidence of safety, tolerability, and decreased withdrawal symptoms among adolescents treated with the nicotine patch, efficacy has not been demonstrated (Hurt et al. 2000). However disappointing, we must recognize that treatment of the adolescent smoker is still in its infancy. The use of NRT with teens and young adults is understudied (Benowitz 1998). This clearly reflects the gap in our knowledge base and points to the need for more research. One area about which we are particularly ignorant is at what point in the youth uptake trajectory (from initial use, experimentation, to regular use and progression to dependence) might it be helpful to prescribe NRT. Initiation and early smoking among youth is characterized by irregular patterns of use and long periods without exposure to nicotine. Even more regular users typically cannot smoke wherever and whenever they want to. Since there is upregulation of nicotinic brain receptors (see Dani and Heinemann 1996 and later in this appendix), a constant infusion of nicotine as delivered by NRT may increase abuse liability and withdrawal sensitivity especially in irregular smokers. Such potential problems, combined with the ethics involved with possibly exposing naive youth to nicotine for research purposes, are likely reasons why data are not available.
SECTION 4 SUMMARY
This area is beginning to receive the attention it deserves in recent years with several trials underway. The youth tobacco cessation collaborative (YTCC) was formed in 2003 to bring funders of youth cessation studies together and a monograph was published to help focus the field, share information and standardize measures and methods The YTCC recommended three goals:
Identify and advocate for policies and environments that support youth tobacco cessation.
Increase motivation in quitting and quitting attempts among young smokers and generate increased interest and participation in effective cessation programs
Increase advocacy and support for youth tobacco cessation among youth themselves and their peers, providers, decision makers, community gatekeepers, and the public.
Outcomes in adolescent cessation are disappointing. Smokers typically enter treatment in their 40s (based on trials). But quitting early multiplies benefits: risk accumulates with duration, even more than amount. More research is needed to improve the marketing to adolescents and motivation to use cessation interventions as well as to increase the utility, availability, tailoring, and effectiveness of adolescent smoking cessation interventions delivered in a variety of channels: high schools, work settings colleges, technical schools, pediatric and primary care practice and other locations where young adults are found.
This is a unique opportunity for early intervention and to bridge the gap between prevention (see Appendix D by Flay) and cessation treatment among those ages 10 to 30, a group that has “slipped through the cracks” between the prevention and the treatment research communities (Backinger and Leishow 2001; Moolchan et al. 2005; Sussman 2001).
DELIVERY SYSTEMS AND INTEGRATION
A Coherent Unified Strategy for Care Management Based on the Chronic Disease Care Management Model
Ideally, delivery systems such as managed care organizations or mental health clinics should be designed to support and track the quality of care delivered over time and even by multiple providers (see Curry et al. 2005). For example, a managed health care organization may have a policy that requires all providers in all settings (e.g., emergency room, primary care, specialty care) to screen for smokers and develop, document, and implement an individualized treatment plan for each smoking member of the health plan. In medical, psychiatric, and substance abuse treatment settings, the Health Plan Employer Data and Information Set (HEDIS 3.0) report cards are designed to track the mandate of the National Committee for Quality Assurance (Davis 1998). Surveys that inform these report cards evaluate whether all providers are asking about tobacco abuse as a vital sign (along with taking temperature and blood pressure) at each and every contact with the health care system. A training and certification process is needed for treatment providers. A certification/license is awarded for qualified trained service providers at two levels: (1) counselors in smoking cessation and (2) specialists in treatment of nicotine addiction and comorbid conditions.
There is evidence of a substantial return of investment within 2–3 years for those institutions that invest in comprehensive smoking cessation (e.g., health care, worksites) (AHIP 2004). With direct and indirect costs of smoking estimated at over $150 billion per year and with the aging “baby boomers” putting an enormous strain on the health care system in the coming two decades, a credible and convincing case can be made that the single biggest, fastest, and most cost-effective impact on reducing the escalating costs of health care and enhancing the overall health of Americans can come from helping more people quit smoking (Orleans and Alper 2000).
In recent years there has been significant improvement in third party, federal, and state insurance coverage for some components of evidence-based treatments recommended in the PHS clinical guidelines (Fiore et al. 2000). However, coverage remains spotty. If cessation treatment is covered, the programs typically invests in only the minimum recommended level of coverage, falling short of adopting the more effective, costly, and intensive components of the PHS Guide recommendations (Fiore et al. 2000).
In their role as employers, states purchase health insurance for over 5 million employees and retirees. A survey of state employees insurance plans was conducted in 2002–2003. Of the 45 states that responded to the survey, only 6 required cessation coverage that was fully consistent with the PHS Guideline recommendations for all employees (Fiore et al. 2000). These states required coverage for some form of group or individual counseling and one or more FDA approved medications for smoking cessation. 10 states required coverage for at least some employees and a total of 29 out of the 45 states required coverage for at least one PHS recommended treatment for at least some employees. The survey did not capture the degree to which costs were shared (copay/deductible). Insurance coverage remains variable and there is room for improvement.
A 2002 National survey (McPhillips-Tangum 2004) among managed care organizations (MCO’s) found that 30 percent had no written policy on coverage and 42 percent provided no coverage for behavioral interventions. Of those that do provide behavioral coverage, it is often the least effective: 54 percent offered self help materials only and 51 percent offered brief telephone counseling. As part of their routine prescription benefits, 89 percent covered prescribed medication. Warner and colleagues (2004) suggest that these figures may underestimate the national availability of covered services.
Medicare announced as of March 2005 that it will cover up to two cessation attempts per year and each attempt may include four counseling sessions for a total of 8 sessions per year. They also plan to cover pharmacotherapy in the prescription benefit coverage. An estimated 9.3 percent of persons over age 65 smoke, and of the 440,000 smokers that die each year of smoking related causes, an estimated 300,000 of them are over age 65 (www.cms.hhs.gov/coverage).
In 1998, only half of the 5 million Medicaid recipients nationwide who were current smokers were covered for any type of smoking cessation treatment (Schauffler et al. 2001). Doescher and colleagues (2002) conducted a pilot study of enhanced tobacco cessation services for low income smokers. They included NRT and pharmacist delivered smoking cessation counseling as the benefit for low income managed Medicaid patients and a state insurance program. They concluded that such a program is feasible but there are significant implementation barriers, including low participation rates and rapid turnover of insured.
McMenamin (2004) examined physician and enrollee knowledge of Medicaid coverage for tobacco addiction treatment in two states with comprehensive coverage. Only 36 percent of enrolled smokers and 60 percent of physicians knew that their state program offered any cessation treatment coverage, and physicians were more than twice as likely to know about pharmacological coverage than coverage for counseling. Warner and colleagues (2004) simulated the financial impact and cost effectiveness of smoking cessation in a hypothetical managed care organization MCO using data from three large MCO’s. Quitters gained an average of 7.1 years of life with a direct coverage cost of $3,416 for each life year saved. The net cost to the MCO plan was $0.41 per patient per month (PMPM).
Tobacco use cessation programs, including appropriate use of pharmacotherapy, should be covered by all insurance, managed care, and employee benefit plans, in-
cluding Medicaid and Medicare. This coverage should be a lifetime benefit. A specified percentage of revenues from tobacco excise taxes, or payments made by tobacco companies under court orders or litigation settlements, should be allocated specifically to a fund with the sole purpose of supporting marketing, dissemination and use of cessation programs for tobacco users. This fund should be managed and distributed by an independent private entity. First priority should be given to funding cessation services for persons not covered by insurance.
Fiore and colleagues (2004) point out that extending tobacco treatment to all individuals with federal coverage (including all Medicare and Medicaid recipients nationwide, department of defense beneficiaries, federal employees, and all federally supported clinics) will ensure that 100 million families will have comprehensive insurance coverage for cessation interventions and it will address health disparities in that it will support interventions for the socio-economically disadvantaged and those that suffer disproportionately such as veterans and Medicaid beneficiaries.
Health plans, insurers and public health agencies—individually and collaboratively— should implement a comprehensive, coordinated, and integrated system of care management for smoking cessation at the local, state, and national levels.
Delivery infrastructure and financial incentives should be aligned to enable and encourage service providers to provide—and smokers to receive—evidence-based assistance.
All smokers should be identified and contacted, be motivated to quit, and receive appropriate levels of intervention or referral and Stepped Up care in intensity if needed.
Services should be provided continuously rather than episodically and should support the smoker for as long as necessary to achieve sustained abstinence.
A performance based surveillance, quality assurance, tracking, and report card system should be implemented to monitor key indicators of progress at the systems level to produce timely summaries of individual group and systems aggregate performance and to permit self correction and continuous quality improvement among those falling behind performance benchmarks and best practice criteria.
Surveillance Report Cards
Thus, above and beyond the current surveillance programs in place to measure smoking patterns in largely cross-sectional national surveys (e.g., NHIS, CPS; YBRFS), more specific national, state, and local monitoring and surveillance systems must be put in place to track key indicators of progress being made in reaching and enabling increased cessation rates. Key indicators must include individual and aggregate or “systems” level measures (Glasgow’s REAIM model; see Dzewaltowski et al. 2004; Glasgow at al. 1999; 2003; 2006a for details) of intermediate and final outcomes. Performance standards and “report cards” must be developed (e.g., using enhanced JACHO an HEDIS guidelines) to track progress towards goals, identify laggards, and motivate improvements.
Goal # 3: Implement a comprehensive, coordinated, and seamlessly integrated system of care management for smoking cessation.
Intervention should be offered and delivered at every opportunity in which there is contact between a smoker and the health care, public health, and other organizational systems such as schools, worksites, and community organizations. The system of care management must embrace the concepts of: (1) identifying and tracking all smokers (smoking as a vital sign and proactive follow up once identified); (2) providing for continuity of care and tailored interventions as appropriate to the smokers level of motivation and needs) at every contact with the system (e.g., following the four A’s for cessation and four R’s for motivation to quit (i.e., proactive care management), and (3) using algorithms for targeted and tailored interventions and for Stepped Care as needed (smokers are stepped up to more specialized and intensive intervention programs if they have comorbid complications and/or a cessation history of failure to quit on their own or at lower levels of intensity of intervention. To do so will require that health systems:
Align financial incentives at every level to contingently reinforce the recommendations of the evidence-based practice guidelines and enable the care management system to manage tobacco addiction as a chronic refractory, including eliminating out of pocket costs for smokers to quit when they use evidence-based cessation interventions.
Provide a care management system to smokers and implement it in all managed care and other health service delivery systems nationwide. (e.g., through electronic medical records and an Internet-based system of access [confidential and secure for intervention providers and smokers]).
Register and track all smokers. The “smoker registry” is used as a confidential medical record to ensure all current smokers in the United States are properly cared for. Smokers will then have a delivery system in place to receive (1) timely health care checkups and specific screenings for early detection of the chronic conditions for which smoking produces excessively high risk (cancers, especially lung, cardiovascular disease, pulmonary diseases, and other conditions and comorbidities associated with smoking such as psychiatric, alcohol, and substance abuse disorders; (2) timely feedback on their health status at every checkup, coupled with either (for those not motivated to quit) (3) motivational enhancement counseling (motivational interviewing) to consider smoking cessation and education/information about smoking cessation interventions tailored to their needs and characteristics; or (4) (for smokers already motivated and ready to quit) a brief or a more intensive smoking cessation and relapse prevention intervention or direct referral to intervention resources with recommendations for the type, mode and level of treatment needed using evidence-based triage algorithms for Stepped Care and tailored treatment based on the past history and current status.
Objective # 3a: within 5 years, 100 percent of health services, public health programs, and third party insurers across the nation will implement a system that has aligned incentives and that supports at every level the ability for service providers to give and smokers to receive evidence-based care.
All smokers should be proactively contacted, be motivated to quit, and should receive appropriate levels of intervention or referral to smoking cessation counselors or to specialists in treating smokers with comorbidity complications; these interventions can be stepped-up in intensity
and complexity of interventions if previous interventions have been used and have not been successful. They must be supported for as long as is necessary to achieve sustained abstinence.
Objective # 3b: At every contact with the health care system, 90 percent of health care providers will identify and intervene with smokers providing the five R’s (motivational enhancement) for those not ready to quit and the five A’s to those ready to quit).
Objective # 3c. Implement a performance based surveillance, quality assurance, tracking, and report card system to monitor key indicators of progress at the systems level, to produce timely summaries of individual group and systems aggregate performance, and to permit self correction and continous quality improvement among those falling behind performance benchmarks and best practice criteria. Expand and adapt the current JACHO and HEDIS required tracking systems.
The monitoring system can provide timely feedback and benchmark comparisons about goals and targets met as well as about normative group comparisons (e.g., report cards to individual providers indicating their performance on key indicators, such as the five A’s, and the average performance of similar offices in the local, state, or national data base) to motivate and encourage continuous quality improvement towards best practice goals.
For a smoker, it is long and arduous journey from starting to smoke to enjoying smoking in ones carefree youth to wanting to stop. For much of that journey the smoker is not motivated to quit and does not make any quit attempts at all. Somewhere along the way the smoker may change, either suddenly or gradually over time. Smokers can move from being unmotivated and not making any quit attempts to wanting to quit (over 70 percent say they want to quit) and then to making serious quit attempts (about 45 percent try seriously to quit each year). If at first a smoker is not successful at quitting (over 90 percent are not), the arduous journey continues from cycles of trying to quit but relapsing to trying again. Some smokers may give up trying to quit and withdraw out of fear of failure, shame or embarrassment. Sometimes the smoker may use unproven treatments or will power to quit (over 75 percent do that) and perhaps the smoker may use an effective product or service. Finally, the journey ends when the smoker either quits for good or suffers and dies from a smoking related cause (about a third to a half of lifetime smokers will die of a smoking related disease). Now that research has helped us understand so much of this journey the challenge is to put what we know into practice and policy. And there is not a moment to lose as over 400,000 of our friends and fellow U.S citizens die prematurely each year from their smoking addiction (that equals three fully loaded jumbo jets crashing with no survivors every single day including weekends and holidays). There is substantial room to find more leverage points to improve the overall cessation outcome rate at every step of the way along our fellow smokers journey to freedom from their addiction. This opportunity can only be fully realized with strong political will to do the right thing and by designing cessation policies that support a comprehensive, systems approach to cessation intervention. An approach that provides aggressive, direct-to-consumer marketing and education campaigns to improve their health literacy about the dangers of smoking and the best tools for quitting. An approach that covers the en-
tire smoker’s journey and provides interventions tailored to the smokers’ needs. This can be achieved through cessation policies that support a comprehensive care management network with aligned financial incentives at federal state and local levels across both the health care industry and the public health system.
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