Chapter  140:  Tobacco Use: Prevention, Cessation, and Control

Literature Searches

We searched MEDLINE®, the Cumulative Index to Nursing and Applied Health (CINAHL), The Cochrane Library, Psychological Abstracts, and Sociological Abstracts using Medical Subject Headings as search terms or key words when appropriate; we also manually searched reference lists. With our Technical Expert Panel (TEP), we generated a list of inclusion and exclusion for each question. We limited our review to human studies conducted in developed countries and published in English. We considered studies with participants ages 13 and older, of both sexes, and of diverse racial and ethnic populations. We limited studies to those with study duration of more than 6 months and minimum sample sizes of 30 for randomized controlled trials (RCTs) and 100 for other experimental or observational studies. We excluded articles that did not report outcomes related to our KQs or provide sufficient information to be abstracted. We also excluded all editorials, letters, and commentaries.

Finally, for work on KQs 1, 2, 3, and 5, we relied on prior systematic reviews (publication dates in parentheses):

• The Guide to Community Preventive Services (2005),

• Treating Tobacco Use and Dependence (2000),

• Reducing Tobacco Use: A Report of the Surgeon General (2000),

• Several Cochrane Collaboration Reviews (1998-2005),

• Treating nicotine use and dependence of pregnant and parenting smokers: an update (2004),

• Smoking cessation approaches for persons with mental illness or addictive disorders (2002),

• A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery (2004), and

• Growing up tobacco free: preventing nicotine addiction in children and youths (1994).

We included original research studies (1) published beyond the date range included in the systematic reviews, (2) concerning topics related to the questions not covered by the reviews, and (3) providing sufficient detail regarding their methods and outcomes.

We made decisions about including studies only after dual review. We assessed the quality of trials or other types of study using criteria from the U.S. Preventive Services Task Force and the National Health Service Centre for Reviews and Dissemination. We rated strength of evidence using categories (strong, sufficient, insufficient) based on criteria from the Task Force on Community Preventive Services.

KQ 1. Effective Population- and Community-Based Interventions to Prevent Tobacco Use in Adolescents and Young Adults

Population-based interventions. Prior systematic reviews investigating tobacco prevention among adolescents and young adults reported strong evidence of effectiveness for increasing the unit price of tobacco products and mass media campaigns run concurrently with other interventions. Evidence of effectiveness was sufficient for restricting tobacco product distribution, regulating the mechanisms of sale, enforcing access-to-minors laws, and merchant education and training when conducted in conjunction with community mobilization.

Two population-based studies had some success in reducing tobacco initiation among adolescents and young adults. Alone, they provided little conclusive evidence about such programs. One study on regulating and enforcing youth access laws augments sufficient evidence from prior reviews. We found no other research to add to existing evidence for population-based interventions.

Community-based interventions. Prior reviews reported limited and mixed evidence of effectiveness of community-based efforts aimed at tobacco prevention. Sufficient evidence was found for short-term effects (less than 2 years) of school-based prevention programs.

Interventions implemented in a single school year or conducted over multiple school years produced mixed results in 10 school-based studies. Consistent with prior reviews, we found sufficient evidence to demonstrate that prevention measures conducted in schools have positive short-term effects but insufficient evidence for long-term effects. We found no community-based studies.

Provider-based interventions. We did not identify any systematic reviews evaluating provider-based tobacco prevention. Our only provider-based study had no intervention effects, giving us insufficient evidence to determine the effectiveness of such efforts.

KQ 2. Effective Strategies for Increasing Consumer Demand for and Use of Proven Individually Oriented Cessation Treatments

Multicomponent strategies to increase the number of users who attempt to quit. Prior reviews found strong evidence of effectiveness for telephone cessation support to increase tobacco use cessation for adults, especially when combined with other counseling formats. We identified three studies of telephone counseling with related print materials. Consistent with prior reviews, two trials reported significant increases in cessation in the short term. One trial reported no difference.

Two studies showed telephone counseling targeting youth and young adults achieves quit rates comparable to those for adults. Though promising, the small number of studies is insufficient to confirm the effect of telephone counseling for these groups.

Strategies to improve the success of quit attempts. Prior systematic reviews reported consistent evidence that counseling by a trained therapist in one or more face-to-face sessions is effective for assisting smokers in their quit attempts. Evidence was insufficient to evaluate whether groups are more effective than intensive individual counseling or to support the use of particular psychological components beyond typically included support and skills training. Limited evidence suggests that adding group therapy to other forms of treatment produces extra benefit.

Prior systematic reviews reported insufficient evidence of the effectiveness of self-help in assisting smokers in their quit attempts. Meta-analyses reported strong, consistent evidence that pharmacologic treatments for smoking cessation can help people quit smoking and some evidence that the combination of the nicotine patch with a self-administered form of nicotine replacement therapy is more effective than a single form of nicotine replacement.

We identified studies evaluating the efficacy of self-help strategies, counseling, single pharmaceuticals, combination pharmacotherapy, and pharmacotherapy combined with psychological counseling. Studies in our review of strategies to improve success of quit attempts were consistent with previous reviews in finding that self-help strategies alone are not efficacious and that the use of counseling, pharmacotherapies either alone or in combination, or pharmacotherapies combined with psychological counseling increases the likelihood of successful quitting.

Strategies to improve the success of quit attempts for special populations. In a meta-analysis comparing augmented smoking cessation treatment with usual care for hospitalized patients, smoking cessation treatments were effective for hospitalized patients. Another review showed no strong evidence that clinical diagnosis affects the likelihood of quitting among hospitalized patients. The same review found that intensive intervention (inpatient contact plus followup for at least 1 month) with hospitalized patients was associated with a significantly higher quit rate compared to control. Prior reviews of interventions with pregnant smokers included studies with substantial variation in the intensity of the intervention and the extent of reminders and reinforcement through pregnancy and found that participants in intervention conditions experience significant reduction in continued smoking in late pregnancy. An earlier review showed that smoking cessation treatments are effective across different racial and ethnic minorities and should be offered to members of those groups.

We found results both consistent and inconsistent with prior reviews for interventions with special populations. When evaluating interventions with hospitalized patients by diagnosis, studies in our review were in agreement with findings of a prior review showing no strong evidence that clinical diagnosis affects the likelihood of quitting. Results of our review were inconsistent with two prior reviews indicating that hospitalized patients were more likely to quit smoking as the intensity of intervention increased. Although some studies in our review found significant gains in abstinence in the short term, all studies showed an absence of effect at 12-month assessment. The findings of our review remain consistent with those of prior reviews that counseling does increase the likelihood of abstinence among pregnant smokers. Investigators found quit rates for indigenous Maori in New Zealand similar to those observed in other trials of bupropion. These findings are consistent with an earlier review showing that smoking cessation treatments are effective for racial and ethnic minorities.

KQ 3. Effective Strategies for Increasing the Implementation of Proven Population-Level Tobacco Use Cessation Strategies, Particularly by Health Care Systems and Communities

Community-based strategies. Past systematic reviews reported little convincing evidence that community interventions reduce adult smoking. Three new studies focusing on different strategies and populations produced inconsistent results. Positive results emerged only in a trial using community-based pharmacists to discuss smoking cessation when smokers sought a variety of other services. These results are consistent with prior reviews.

Provider and health care system-based strategies. Prior reviews reported strong evidence of effectiveness for provider reminder systems with provider education, with or without client education, and for multicomponent interventions that include client telephone support. However, they reported insufficient evidence of effectiveness to recommend provider education alone and provider feedback and assessment. Sufficient evidence in our review indicated that implementing provider-based interventions such as training improves provider delivery of cessation treatment, but evidence was insufficient to conclude that implementing these approaches leads to higher abstinence.

In examining interventions in health care systems, we found sufficient evidence that academic detailing improves provider delivery of effective smoking cessation treatments. Family physicians and providers in office-based private practices, public clinics, hospitals, and orthodontist offices improved their knowledge and use of effective strategies from personal educational visits in their own practice setting, including education, audit, and feedback.

The evidence was insufficient to suggest that resultant improvement in treatment practices leads to significant, long-term increases in cessation among those being treated. Too few studies reported quit rates for the population served; those that did showed no long-term, consistent effects on cessation. One study tested the relationship between provider attitudes and smoking behavior on uptake and use of effective interventions, but found no effect.

Evidence was promising but insufficient to suggest that interventions proven effective in earlier trials could be sustained as part of routine care. Only one study examined this important aspect of improving the odds of maintaining an effective program. Investigators found that successfully implementing a proven strategy after completion of the original trial is possible, that the sustained program produced quit rates comparable with those observed in the trial, and that success was more likely among cancer, cardiovascular, and pulmonary patients.

KQ 4. Effect of Smokeless Tobacco Product Marketing and Use on Population Harm from Tobacco Use

Prior systematic reviews did not address these issues directly. Two new studies focused on smokeless tobacco use. One reported smokers were more likely to quit smoking than become users of smokeless tobacco, and users of smokeless tobacco were significantly more likely than nonusers of tobacco to become smokers. Another study found advertising exposure increased adolescent susceptibility to smokeless tobacco, resulting in a sevenfold increase in current use. We found no evidence on how smokeless tobacco marketing affects population harm. Based on these studies, we found insufficient evidence to draw firm conclusions about the impact of marketing these products on increased use or substitution of smokeless tobacco for smoking.

KQ 5. Effectiveness of Prevention and of Cessation Interventions in Populations with Co-occurring Morbidities and Risk Behaviors

Tobacco cessation for persons with comorbidities. Past reviews agree that, absent relevant studies on smoking cessation in psychiatric populations, clinicians should use smoking cessation treatments recommended for the general population. Three studies evaluated smoking cessation for people with psychiatric conditions. In one, pharmacotherapy was effective (consistent with prior reviews). In a second study, counseling and cognitive behavioral therapy were not effective for adults with a history of major depressive disorder (MDD), except in a secondary analysis categorizing adults into single-episode MDD and recurring MDD. In the third study, motivational interviewing or brief advice was not effective for adolescents hospitalized for psychiatric and substance use problems. Prior reviews did not report effective adolescent interventions. Evidence is insufficient and inconsistent to draw conclusions about the effectiveness of interventions in these populations or to overturn the current recommendation.

Tobacco cessation for persons with substance abuse addictions. Prior meta-analyses reported that people with chemical and nicotine dependency should receive counseling and pharmacotherapy to assist with smoking cessation. These types of interventions had positive short-term effects for stopping smoking but not for long-term abstinence. Two studies of smoking cessation interventions among alcohol and substance abusers reported significant effects for smoking cessation when compared to a control group. Both studies treated nicotine dependency concurrently with other addiction treatment. One study reported no effects on abstinence for other addictive substances; the other reported lower alcohol abstinence with concurrent treatments. The findings support past recommendations that counseling and pharmacotherapy have positive short-term effects for such interventions, but the body of evidence is insufficient, given the number of studies, to merit recommendations.

General Conclusions

In most instances, evidence from new research covered in our review was consistent with previous systematic reviews. Even in combination with previous reviews, our findings are insufficient to draw new or different conclusions from those offered by earlier reviews. Overall, the evidence base to address the numerous issues raised for the SOS conference has critical gaps and deficiencies, particularly for questions unaddressed by prior reviews.

Future Research

Lacunae in the literature can be addressed by both future research and improvement in methods. We recommend efforts to examine the following key-question-specific issues, focusing on whether, how, and how well certain programs work to influence tobacco initiation, use, or cessation.

KQ 1: Tobacco prevention

• Effect of tobacco industry and product restrictions (specifically, laws that regulate the content, labeling, promotion, and advertising of tobacco products) on adolescents and young adults;

• Community mobilization with increased enforcement of tobacco youth access laws and regulations;

• Concurrent implementation of effective population-based tobacco interventions (e.g., pricing, restricting access, regulations, and media campaigns) in different combinations;

• Community-based tobacco prevention strategies implemented simultaneously;

• Combinations of school-based interventions with community mobilization, media campaigns, and enforcement of tobacco youth access laws and regulations; and

• Tobacco prevention efforts in provider-based settings for adolescents and young adults.

KQ 2: Attempts to quit tobacco use

• Role of mass media in driving individuals to quit lines and other cessation services;

• Audience research on effectiveness of messages to motivate target audiences of adolescents, young adults, and persons with low income and educational status;

• Comparisons of specific components of telephone counseling and their relative impact on enrollment and continuation, individual motivation to quit, and smoking status;

• Appropriateness of cessation services such as number and timing of calls, role of feedback to the caller's primary provider, and participants' satisfaction;

• Relative population impact of proven cessation interventions, such as proactive telephone counseling support compared with in-person intervention;

• Differential rates of success and enrollment and whether they offset or enhance each other;

• Effectiveness of multiple intervention formats, of combination pharmacotherapy, and of adjuncts other than pharmacotherapy in comparison with individual counseling;

• Ways to reduce withdrawal symptoms and cravings among those attempting to quit using tobacco products;

• Ways to minimize side effects associated with use of individual pharmacotherapies and combined pharmaceutical regimes; and

• Techniques to increase persistence of effect on smoking abstinence over time.

KQ 3: Cessation efforts in different settings

• Ways to reach out to smokers in the general population and to special populations with messages that motivate individuals to become aware of, promote, and use existing cessation services;

• Interventions to change provider practice patterns and related smoking outcomes for patients;

• Academic detailing strategies and their impact across and within practice types;

• Relationship of provider attitudes and smoking behavior to provider use of effective interventions; and

• Institutional barriers hampering adoption of effective strategies in health systems and among providers.

KQ 4: Smokeless tobacco marketing and use

• Impact of tobacco industry marketing on use of smokeless tobacco and whether populations are differentially affected;

• Possible links between point-of-purchase tobacco promotion and advertising and increased use of smokeless tobacco among adolescents and young adults; and

• Treatments to complement efforts aimed at smokeless tobacco cessation.

KQ 5: Populations with psychiatric comorbidities and risk behaviors

• Tailored treatments and therapies for populations with psychiatric comorbidities and risk behaviors;

• Effects of combined pharmacotherapies for population with psychiatric comorbidities and risk behaviors;

• Effects of pharmacotherapy for people with a history of depression and people currently diagnosed with clinical depression;

• Timing (e.g., simultaneous, before, or after) of tobacco use treatment and treatment for psychiatric and substance abuse problems; and

• Barriers to tobacco treatment in patients with other health problems such as contraindications of pharmacotherapy and validity of clinicians' concerns about hindering sobriety.

Improved Methods

Investigators need to use markedly better and more rigorous methods for all new research into tobacco prevention, control, and cessation. Critical improvements include more rigorous and longer studies, standardized definitions of interventions, appropriate measurement tools (including biomarkers for verification), better statistical and analytic approaches (e.g., use of intent-to-treat methods), improved tactics for reducing attrition, and better documentation of methods and results.

Technical Expert Panel

We identified experts in the field of tobacco use, prevention, cessation, and control to provide assistance throughout the project. The Technical Expert Panel (TEP) (see Appendix E)^* contributes to AHRQ's broader goals of (1) creating and maintaining science partnerships and public-private partnerships and of (2) meeting the needs of an array of potential customers and users of this product. The TEP served as both a resource and a sounding board during the project. Our TEP comprised seven individuals: one clinical educator, three representatives from professional and advocacy groups concerned with smoking and health, and three experts in social marketing, media campaigns, and prevention.

To ensure accountability and scientifically relevant work, we asked the TEP for advice at all stages of the project. TEP members participated in conference calls and e-mail exchanges to

• Refine the analytic framework and key questions at the beginning of the project,

• Refine the scope of the project, and

• Discuss inclusion and exclusion criteria.

Because of their extensive knowledge of the literature on these topics and their active involvement in professional organizations and in the clinical field, we also asked TEP members to participate in external peer review of the draft report.

A Note on Terminology

Adolescents are defined as individuals ages 13 to 18, and young adults are defined as college age, approximately 18 to 24 years of age. Adults are defined as individuals ages 18 and older and overlap the young adult category. Comorbidity and co-occurring morbidities refer to a dual diagnosis of concurrent disorders such as depression and nicotine addiction.

Organization of this Report

Chapter 2 describes our methods, including the development of key questions and their analytic framework, our search strategies, and inclusion/exclusion criteria. In Chapter 3, we present the results of our literature search and synthesis on five of the six key questions that OMAR posed for this review. We also report on the numbers of publications reviewed, present findings on prior reviews and current literature, and grade the quality of all articles. Chapter 4 discusses these findings further, rates the overall strength of the bodies of literature, and highlights methodological shortcomings of the extant research; the chapter also offers recommendations for future research (of particular interest to NIH and AHRQ) and restates the major conclusions. Appendices (available electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm) begin with a detailed description of our search strings (Appendix A), followed by our quality rating forms (Appendix B), detailed evidence tables (Appendix C), a list of excluded studies (Appendix D), and acknowledgments, including the TEP and peer reviewers (Appendix E).

Key Questions

KQ 1 seeks to understand how to use community- and population-based interventions to prevent initiation of tobacco use among adolescents and young adults across diverse populations. For those individuals who do become dependent on tobacco products, eventual disease, disability, and death can be avoided if they quit using tobacco products. KQ 2 seeks to identify strategies that increase the likelihood that tobacco users will want and use effective individual treatments. Because creating demand for tobacco use cessation is insufficient as a strategy if tobacco users do not respond by using these services or if effective treatments and strategies are not available in communities and health care systems, KQ 3 asks for a summary of proven strategies to increase the implementation of proven population-level tobacco use cessation strategies in health care systems and communities.

Although consensus exists around some tobacco use cessation strategies, controversy surrounds other suggested strategies for harm reduction, such as the use of smokeless tobacco products. Arguing that the harm associated with smoking cigarettes is much greater for both the individual and for those around the smoker than the harm associated with products that are not directly smoked, marketers are promoting smokeless tobacco use as a safer and much less costly alternative to smoking. KQ 4 asks about the effect of smokeless tobacco product marketing and use on population harm. This complex question requires us to assess, with regard to tobacco-related morbidity and mortality, (1) the impact of smokeless tobacco marketing on smokeless tobacco initiation, (2) the prevalence of smokeless tobacco use alone and/or the substitution of smokeless tobacco for cigarette smoking, and (3) the association of smokeless tobacco use with overall harm and changes in harm (either positive or negative).

Although most cessation strategies are appropriate for most special populations, recent reviews have highlighted issues of effectiveness with some populations, such as those with co-occurring morbidities and risk factors;³⁰ this population is the focus of KQ 5. Finally, KQ 6 focuses on directions for future research prompted by answers to the above topics.

Recent systematic reviews have identified effective strategies at the individual, community, and population levels for preventing initiation, helping tobacco users to quit, and implementing strategies within the health care system and communities that help tobacco users to quit. These reviews dealt with issues affecting diverse populations, including populations with co-occurring morbidities and risk behaviors. The issues driving these recent reviews are similar to those issues addressed in KQs 1, 2, 3, and 5 of this review. Therefore, we updated or expanded searches completed for these recent reviews or undertook entirely new searches for issues not addressed in recent reviews. We explain our search and synthesis strategy in more detail below.

Analytic Frameworks

Our overall analytic framework (Figure 1), describes the progression from tobacco initiation to tobacco dependence to tobacco-related morbidity and mortality, along with populations of interest, intervention strategies, and possible associations and outcomes for all KQs except KQ 6 (on research).

Figure 2 depicts in more detail the relationship of our overall model to issues relating to each of the KQs. The framework indicates the population of interest, the level of intervention (individual or population), activities evaluation (e.g., prevention, cessation, marketing), and the expected outcomes of the intervention. To understand what is known about how to interrupt this progression from initiation to dependence to disease, disability, and death, we focused this systematic review on individual, community, and population strategies for tobacco use prevention, cessation, and control.

KQ 1. Effective Population- and Community-Based Interventions to Prevent Tobacco Use

For KQ 1, we focused our review on five main strategies:

• 1

  Unit price increases on tobacco products,

• 2

  Mass media education campaigns combined with other interventions to reduce tobacco use initiation,

• 3

  Interventions to reduce youth access to tobacco products (i.e., laws that regulate and enforce bans on sales of tobacco products to, or their purchase or consumption by, children and adolescents),

• 4

  School-based education interventions to prevent tobacco use, and

• 5

  Tobacco industry and product restrictions (i.e., laws that regulate the content, labeling, promotion, and advertising of tobacco products).³¹

Recently, the Guide to Community Preventive Services (hereafter, Community Guide) reviewed strategies 1, 2, and 3 and studies that combined two or more interventions in a coordinated effort to restrict minors' access to tobacco products.⁷ The Institute of Medicine's report, Growing Up Tobacco Free,³² and the 2000 report of the Surgeon General, Reducing Tobacco Use,² reviewed all five strategies. The Cochrane Collaboration reviewed strategies 2³³ and 4.³⁴

We undertook new searches for strategies not yet reviewed by the Community Guide (i.e., numbers 4 and 5), updated the searches for strategies 1 through 3, and searched for strategies other than those identified above. We explored the literature for the differential effect of prevention strategies among diverse populations, including those among adolescents and young adults who are most likely to initiate tobacco use and become regular users.

KQ 2. Effective Strategies for Increasing Consumer Demand for and Use of Individually Oriented Cessation Treatments

Interventions to increase the number of tobacco users who seek assistance in quitting and who successfully quit include efforts to increase the number of users who attempt to quit, to improve the success rate for quit attempts, and to support both of these goals.⁷ This question focuses on both sets of interventions.

Proven individual strategies for helping smokers to quit include counseling and behavioral therapy and, except when contraindicated, the use of firstline and secondline medications.⁵ More often than not, individuals are trying to quit without the type of assistance that can double or even triple the chances of success.⁵ Other strategies intended to motivate tobacco users to attempt to quit or to reduce relapse among recent quitters include telephone support and mass media interventions.

Telephone support provides an option for individuals reluctant to discuss tobacco use with their health care providers. In some cases, telephone support also allows on-demand assistance, provides a no-cost service, or includes provision of pharmacotherapies. These features remove or at least mitigate some of the barriers that tobacco users may perceive or experience in their attempts to receive assistance from their health care providers.

Mass media interventions are designed and implemented to provide cessation information and motivation for tobacco users who are trying to quit.⁷ The three main subtypes of mass media interventions are campaigns, cessation series, and cessation contests. Mass media campaigns provide brief, recurring messages; cessation series consist of broadcasted instructional segments; and cessation contests are community-wide events of short duration that recruit and motivate users of tobacco products to participate in a program to quit by a certain date.⁷ Mass media intervention strategies can also drive tobacco users to call telephone quit lines, thereby increasing the number of smokers who seek help.⁷

Reviews of community interventions to increase tobacco use cessation have focused on four main approaches: (1) multicomponent efforts to increase patient tobacco use cessation, which include telephone information or counseling support; (2) mass media campaigns combined with other interventions; (3) mass media cessation series; and (4) mass media cessation contests. The Community Guide focused on all four issues,⁷ the 2000 Surgeon General's Report focused on only the second and third,² the Clinical Practice Guideline focused on the first,⁵and the Centers for Disease Control and Prevention (CDC) Best Practices publication focused on the second.³⁵

Using the searches in the sources identified above as a base, we updated the searches for all strategies. We expanded searches for interventions lacking sufficient evidence at the time of the most recent review, for new interventions or strategies introduced in the literature since the most recent review, and, to the extent possible, for the differential impact of all strategies on diverse populations. Our cessation searches specifically looked for studies related to the following factors: race or ethnicity, socioeconomic status, education level, gender, age (i.e., adolescents and adults), hospitalization, and pregnancy.

KQ 3. Effective Strategies for Increasing Implementation of Population-Level Tobacco Use Cessation Strategies

The Cochrane Collaboration published a systematic review focused on community interventions.³⁶ Reviews of health care system interventions to implement effective treatments appear in the Community Guide,⁷ the 2000 Surgeon General's report,² the Clinical Practice Guideline,⁵ and Melvin and Gaffney.³⁷

The Cochrane Collaboration review assesses the effectiveness of community interventions in reducing the prevalence of smoking among adults (18 years of age and older).³⁶ It addressed two main questions: (1) Do community-based interventions reduce smoking (measured by prevalence, cigarette consumption, quit rates, or initiation rates) compared with no intervention in comparison communities? (2) Which characteristics of these studies are related to their efficacy? Selected studies evaluated the effectiveness of community interventions in which smoking behavior change was a part of the intervention program using either a controlled trial that randomized communities or geographical regions or a nonrandomized controlled trial that allocated communities or geographical regions.

Even when tobacco users feel comfortable approaching their providers, they may not receive effective treatments. Some providers indicate that they do not know how to intervene effectively with smokers,³⁸ that they experience disappointment and discouragement given the cyclical nature of relapse and remission they observe among smokers,⁵ and that they are not trained to deal with co-occurring morbidities and risk behaviors. Finally, for both providers and tobacco users, the costs associated with providing or receiving effective treatment are barriers. For example, many providers are not reimbursed for cessation counseling, and tobacco users may have no health insurance or only limited health insurance coverage for cessation treatments.

Recent reviews of interventions that help providers and health care systems implement strategies to increase cessation of tobacco use by clients highlight numerous, sometimes multifaceted programs. Among programs studied are provider reminder systems with or without client education,^{2, 5, 36, 37} health care provider education alone or with feedback and assessment,^{5, 7, 36, 37} reduction of client out-of-pocket costs for effective cessation therapies,^{2, 5, 7} and multicomponent interventions that include client telephone support.^{5, 7, 36, 37} Melvin and Gaffney reviewed the literature for interventions that increase the likelihood that health care providers will provide effective strategies to pregnant and postpartum women either proactively or in response to client demand.³⁷

We updated and expanded, as necessary, the recently completed reviews on both community and health care interventions. The existing reviews on these topics were comprehensive and needed little expansion. We expanded searches for interventions lacking sufficient evidence at the time of the most recent review and for new interventions or strategies introduced in the literature since the most recent review.

KQ 4. Effect of Smokeless Tobacco Product Marketing and Use

KQ 4 asks us to examine whether substituting smokeless tobacco for smoking results in less smoking-related harm on a population basis and whether smokeless tobacco marketing leads to greater use and/or substitution of smokeless tobacco for smoking. Evidence in reports of the Surgeons General and other sources link smokeless tobacco causally with oral leukoplakia and oral cancers.^{2, 39} Smokeless tobacco may also increase the risk of cancers in other sites.¹⁷ We examined the harms associated with smokeless tobacco use and determined whether others have used data on these harms to model the potential health effects of substituting smokeless tobacco for smoking. Some studies' approaches to promoting smokeless tobacco use are related to current use of these products.⁴⁰–⁴⁵

We are unaware of any studies that have followed the entire analytic framework we suggest—assessing (1) the impact of marketing smokeless tobacco on its use or its substitution for smoking cigarettes, (2) the impact of smokeless tobacco use on overall harm, and (3) the possibility of reduced harm associated with smokeless tobacco use in terms of overall tobacco-related morbidity and mortality. We reviewed the relevant literature to determine whether any studies describe any or all of these relationships. We believe that assessing the public health significance of harm reduction associated with smokeless tobacco use will be difficult given that only 3.4 percent of Americans ages 12 and older used these products in the past month.² Also, this statistic includes women's smokeless tobacco use and deflates the importance of this health issue because most of these users are young men. The current rate of smokeless tobacco use is 6 percent among men and only 0.3 percent among women.²⁰

We also note that recently some tobacco companies have begun to market their smokeless tobacco products directly as less harmful alternatives to tobacco, likening them to nicotine replacement products and emphasizing that smokeless tobacco does not carry the same risks to others as smoking does with secondhand or environmental tobacco smoke.⁴⁶ We searched for studies examining this harm reduction relationship. The review for KQ 4 focuses on adolescents, young adults, and adults, especially in relation to harm reduction for tobacco-related morbidity and mortality. We focused on studies of marketing approaches for adolescents and young adults given their routine and repeated targeting by the tobacco industry and their greater likelihood of using smokeless tobacco products. However, we believe that it is too early to determine if these harm reduction approaches to smokeless tobacco marketing are effective in increasing its use.

KQ 5. Effectiveness of Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors

The term “psychiatric comorbidity,” as used in the Treating Tobacco Use and Dependence clinical practice guideline, refers to the co-occurrence of smoking with another psychiatric disorder.⁵ We use this narrow definition because individuals with psychiatric illnesses are approximately twice as likely as the general population to smoke tobacco. These individuals also tend to smoke more heavily than other smokers.⁴⁷–⁵⁰

Co-occurring risk behaviors include those behaviors that trigger tobacco use, such as alcohol or other substance use or abuse. As many as 20 percent of patients seeking smoking cessation services may have a history of alcohol abuse or dependence.⁴⁸–⁵⁰ Among abusers of alcohol and drugs, smoking occurs at rates well above population averages (e.g., greater than 70 percent).⁵¹–⁵³

Treatment of individuals with these co-occurring morbidities or other risk behaviors remains a controversial topic, because some believe that smoking cessation and nicotine withdrawal exacerbate a patient's comorbid condition and, thereby, present unique case management challenges.

The clinical practice guideline examined the efficacy of tobacco treatment among patients with psychiatric comorbidity.⁵ Another recent review of smoking cessation approaches for individuals with mental illness or addictive disorders examined empirical studies conducted between 1991 and 2000.³⁰ The majority of interventions combined medication and psychoeducation. We updated and expanded these reviews to examine the effectiveness of cessation interventions in populations with co-occurring morbidities and risk behaviors.

No previous review addressed the effectiveness of prevention interventions in this population. We examined studies identified through searches focused on populations with co-occurring morbidities and risk behaviors to determine if any analyses reported smoking prevention and cessation outcomes. We found few studies on smoking cessation and no studies on prevention (because the population is already smoking).

KQ 6. Needed Research

Current systematic reviews include recommendations for further research and areas of insufficient evidence. Through this newer review, we identified findings that are both consistent and inconsistent with previously identified needs for research, and we pinpointed important gaps in research.

Inclusion and Exclusion Criteria

After discussions with our Technical Expert Panel (TEP), we generated a list of article inclusion and exclusion criteria (Table 2) for these KQs. We limited our review to human studies conducted in developed countries and published in English. We considered studies with participants ages 13 and older of both genders from diverse racial and ethnic populations.

We excluded editorials, letters, commentaries, articles that did not report outcomes related to our key questions, and studies that did not provide sufficient information to be abstracted. To avoid reporting short-term fluctuations among the populations and to ensure sufficient sample sizes to observe changes over time, we limited our review to randomized controlled trials (RCTs) with 30 or more individuals or observational studies and nonrandomized controlled trials with 100 or more individuals, followed for a minimum of 6 months, with or without comparison groups. Our TEP concurred with this plan.

Literature Search and Retrieval Process

Databases and search terms. To identify the relevant literature for our review, we conducted systematic searches based on search terms and hand-searched reference lists. We searched standard electronic databases: MEDLINE®, the Cumulative Index to Nursing and Applied Health (CINAHL), Cochrane Collaboration libraries, Cochrane Clinical Trials Register, Psychological Abstracts, and Sociological Abstracts.

Based on the inclusion/exclusion criteria specified above, we generated a list of Medical Subject Heading (MeSH) search terms, supplemented by key word searches to search MEDLINE® (Table 3). Comparable terms were used to search other databases. Finally, we asked our TEP and external peer reviewers to suggest articles that we might have missed.

Article selection process. Once we had identified articles through the electronic database search, review articles, and bibliographies, we examined abstracts and the full text of the articles to determine whether the studies met our inclusion criteria. Two reviewers initially evaluated abstracts for inclusion or exclusion; only one reviewer was needed to include an article, but two reviewers were required to exclude an article. Dr. Ranney, the Study Director, reconciled all conflicts. As articles appeared that met inclusion criteria at the abstract review stage, we obtained the article's full text. For the full text review, two reviewers read each article and determined whether it met our eligibility criteria. Again, Dr. Ranney adjudicated any disagreements. Dr. Ranney and Dr. Cathy Melvin, our Scientific Director, reviewed articles excluded by the first two reviewers and assigned reasons for exclusion or, when appropriate, included them in the pool for abstraction.

Development of Evidence Tables and Data Abstraction Process

Senior staff for this systematic review jointly developed evidence tables using two designs: one design for primary data collection studies and one for systematic reviews. The designs are intended to provide sufficient information so that readers can understand the study and determine its quality; we emphasized presenting information essential to answering the main questions. The formats of the two sets of evidence tables were based on successful designs used for prior systematic reviews.

The primary data collection evidence tables contain information on

• Study characteristics (author, year, study setting, funding source, time period covered);

• Research objective, population, and study design (inclusion, exclusion criteria);

• Sample design (technique and size);

• Definitions of smoking;

• Intervention methods, description, and assessment;

• Baseline data;

• Statistical analysis, data verification, and dependent variables;

• Results (outcome measures); and

• Quality rating and comments.

The evidence tables for systematic reviews report on

• Study demographics (author, year, geographic area, funding source, time period covered);

• Study characteristics (inclusion criteria, population, characteristics of studies, method of review, study design, what studies are included in the meta-analysis);

• Aim of review;

• Main results; and

• Quality rating (adverse events).

For this work, the RTI-UNC EPC team decided to abstract data from included articles directly into a proprietary systematic review database program, TRIALSTAT. We trained data abstractors intensively, thoroughly familiarizing them with the abstraction form design (Appendix B ^†), required information and formats, and examples of abstracted articles. As the work progressed, we shared various reporting requirements with abstractors to ensure that information appeared in a consistent and easily understandable manner.

For the primary data literature, the first reviewer (a research assistant from the University of North Carolina at Chapel Hill) entered data from the article into the database. The second, senior reviewer (either Dr. Ranney or Dr. Melvin) read the article and edited the initial table entry for accuracy, completeness, and consistency. For the systematic review literature, Dr. Ranney entered data from the review into the database, and Dr. Melvin read the article and edited the initial table entry for accuracy, completeness, and consistency. In both cases, the two abstractors reconciled all disagreements by consensus discussion.

The final evidence tables are presented in their entirety in Appendix C. Below are the table titles for each question. Within each evidence table, entries are listed alphabetically by the last name of the first author. Abbreviations and acronyms used in the tables appear in a glossary at the beginning of the appendix.

• KQ 1

  • Evidence Table 1. Effective population-based interventions

  • Evidence Table 2. Effective school-based interventions

  • Evidence Table 3. Effective provider-based interventions

• KQ 2

  • Evidence Table 4. Multicomponent interventions to increase the number of users who quit smoking

  • Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations

• KQ 3

  • Evidence Table 6. Population-based strategies to increase the implementation of proven population-level tobacco use cessation strategies

  • Evidence Table 7. Provider and health care systems strategies to increase implementation of population-level tobacco use cessation

• KQ 4

  • Evidence Table 8. Effect of smokeless tobacco product marketing and use on population harm from tobacco use

• KQ 5

  • Evidence Table 9. Tobacco cessation interventions for persons with co-occurring morbidities and risk behaviors

• Systematic Review and Meta-analysis

  • Evidence Table 10. Systematic and meta-analysis reviews

Quality and Strength of Evidence Evaluation

Quality of studies. We assessed the internal validity (i.e., quality) of trials based on predefined criteria developed by the US Preventive Services Task Force (ratings are good, fair, or poor)⁵⁴ and the National Health Service Centre for Reviews and Dissemination.⁵⁵ We assessed and reported external validity (i.e., generalizability) but did not use these judgments in our quality ratings.

We developed three quality rating forms, two for the primary data literature (one for randomized controlled trials and one for observational studies and non-randomized controlled trials) and the other for the systematic review literature. We tested several drafts of these forms, revising them as needed to ensure that they efficiently captured the desired information. The final grading forms can be found in Appendix B. Elements of internal validity assessment for primary data literature included, among others, randomization and allocation concealment, similarity of compared groups at baseline, use of intention-to-treat analysis, and overall and differential attrition. The assessment of the systematic review literature focused on issues of validity, such as whether the search strategy was systematic and comprehensive, and issues of reliability, including whether the authors used a standard method of critical appraisal.

Two independent reviewers assigned quality ratings; they resolved any disagreements by discussion and consensus or by consulting a third, independent party. Primary data articles that had one or two minor study design issues were considered “good”; an example of such an article is one in which an intention-to-treat analysis was not conducted, but the author addressed the issue of loss to followup by surveying those who did not complete the study. We had a wide and diverse range of “fair” articles, which were articles that had several minor study design issues, such as lack of reporting on baseline group differences or a weak sampling technique. Articles that had multiple major study design issues, such as postrandomization of exclusions, high refusal rates, high attrition rates, no comparison of groups at baseline, and lack of information about control or comparison groups, received a quality grade of “poor.”

All but one of the systematic literature reviews and meta-analyses were of good quality; the exception was “fair.” The systematic reviews assessed were primarily from the Cochrane Collaboration, which is known for conducting comprehensive literature searches and employing stringent appraisal criteria. The two meta-analyses were of high quality; one is recognized in the field of tobacco control as the “gold standard,” and the other was rated “good.”

Strength of the available evidence. We rated the strength of the evidence for the interventions based on the criteria developed for the Task Force on Community Preventive Services,⁵⁶ which we deemed most applicable to the study designs in this review (Table 4). Our evaluation employed three domains to determine the strength of the evidence for each intervention: quality of the research, including design suitability and study execution; quantity of studies, including the number of studies and the adequacy of the sample size; and consistency of findings among the studies. The available evidence for an intervention was determined to be strong, “sufficient,” or “insufficient.”

Bodies of evidence rated as strong included an adequate number of studies that were of good or fair quality, had study designs that were appropriate for the intervention being evaluated or issue being addressed, and were consistent in the direction of their findings. Sufficient bodies of evidence also contained studies of good or fair quality, but the suitability of the studies' designs was not as consistently appropriate and, therefore, more relevant studies were required to rate the evidence in the category. As per the Task Force model, the reasons for determining that a body of evidence was “insufficient” included unsuitable study designs, too few studies to determine the effectiveness of an intervention, too small an effect size, and inconsistent findings among studies of an intervention.⁵⁶ We graded the strength of evidence applicable to each of the key questions separately.

Population-Based Interventions to Limit Access and Reduce Initiation

Nicotine addiction begins at an early age; 89 percent of adult daily smokers have tried cigarettes before age 18.³² In 2004, current use of tobacco was reported by 28 percent of high school students and 11.7 percent of middle school students.⁸ Cigarettes are the most commonly used tobacco product for both middle and high school students.

Population-based intervention efforts to reduce tobacco use initiation among adolescents and young adults include at least four mechanisms: (1) increases in the unit price of tobacco products; (2) laws that regulate and enforce bans on sales, purchases, and consumption of tobacco products by underage youth; (3) laws that regulate the content, labeling, promotion, and advertising of tobacco products; and (4) mass media education campaigns.

Synthesis of prior systematic reviews. Past reviews have evaluated interventions to limit access to tobacco products and reduce tobacco use initiation among adolescent and young adults. They include (1) increasing the unit price of tobacco products, (2) enforcing tobacco laws and regulations, (3) implementing tobacco industry and product restrictions, and (4) disseminating mass media campaigns.^{2, 7, 32, 33}

Increasing the unit price of tobacco products. An increase in the excise tax on tobacco, which requires passage of legislation or a statewide referendum, results in an overall increase in the cost of tobacco products. For adolescents and young adults with limited incomes, higher prices make cigarettes less attractive.⁷ Several earlier reports agree on the positive effects of economic approaches to reducing tobacco initiation.^{2, 7, 32} Recommendations from the Institute of Medicine state that a tax increase of $2.00 for each pack would make tobacco less accessible and raise money for tobacco control, health care, and other uses. Unit price has a direct influence on the demand for cigarettes.² Eight studies that evaluated intervention strategies that increased the price of tobacco products provided price elasticity of demand estimates by combining information on local tobacco product prices and price changes or differences in survey responses over time on tobacco use and consumption.⁷ A 10 percent price increase in tobacco prices results in an approximately 4 percent decrease in consumption of tobacco products by adolescents (13 to 18 years of age). A similar strong effect is found for young adults (18 to 24 years of age).⁷

Enforcing tobacco laws and regulations. Minors obtain tobacco from retailers (merchants), commercial sources (vending machines), and social sources (other adults); all contribute to initiation and regular use of tobacco.⁷ Restricting distribution, regulating the mechanisms of sale, enforcing minimum age laws, and providing merchant education and training have some success in reducing minors' access to tobacco.² Multicomponent interventions designed to reduce minors' access to tobacco include numerous strategies: stronger restrictions on retailer sales of tobacco products; restrictions directed at youth purchases, possession, and use; active reinforcement of tobacco sales laws; and retailer education interventions with or without reinforcement.^{7, 32} Thirteen multicomponent studies, with 10 different combinations of interventions, investigated how restricting minors' access to tobacco affects tobacco initiation. Only five of these studies used differences or changes in tobacco use among youth as the outcome variable. Four of the studies coordinated community mobilization efforts with retailer education with enforcement, stronger local ordinance for retailers, enforcement of retailer sales laws, school-based education, or local ordinances directed at youth tobacco purchase, possession, or use.⁷ Interventions to reduce youth access to tobacco products that combined two or more interventions in a coordinated effort decreased students' self-reported tobacco use by 5.8 percentage points over a period of 2 to 4 years.⁷

Tobacco industry and product restrictions. In 1998, the Master Settlement Agreement prohibited tobacco advertising that targets people under 18 years of age. Despite this agreement, tobacco companies consistently allocate a higher proportion of their expenditures for advertising of youth brands to youth-oriented magazines.⁶⁷ Reviews on tobacco industry and product restriction are still in progress.³¹ Strategies for regulating tobacco packaging, labeling, and contents are long-term steps, recommended by the Institute of Medicine Committee on Preventing Nicotine Addiction in Children and Youths,³² to sustain progress toward reducing health consequences of tobacco use. Warnings on cigarette packages in the United States are weaker and less conspicuous then those in other countries. In addition, purchasers of tobacco do not receive information about toxic constituents in tobacco smoke. To protect adolescents and young adults from inducement that might influence their decision to start smoking, implementing stricter regulations on packaging, advertising, and promotion is imperative and will likely reduce both prevalence and uptake of tobacco use.²

Mass media education campaigns. Mass media education campaigns disseminate brief recurring messages with the intent of providing information that will motivate children and adolescents to remain tobacco free.⁷ Campaign methods include broadcast messages on television and radio, billboards, print, and movies. Media campaigns increase awareness of the strategies that the tobacco industry uses to promote tobacco and they attempt to facilitate changes in both tobacco use behaviors and public tobacco policies. They also use educational messages relating to demand reduction to provide information and support to adolescents to help them decide to remain tobacco free.⁷ Reviews of mass media campaigns and community interventions that include a media component report some evidence that these are effective, particularly when combined with other intervention activities such as school- and community-based education programs and increases in excise taxes on tobacco.^{33, 64}

A review of 12 studies evaluated the effectiveness of mass media campaigns in reducing tobacco use among adolescents.⁷ The studies conducted the media campaign in conjunction with other intervention strategies such as school- and community-based educational programs, contests, and increased excise taxes. Mass media campaigns conducted concurrently with other interventions generally showed reductions of tobacco use among youth in the intervention communities. Five of these studies reported absolute differences in self-reported tobacco use. The media campaigns decreased the number of adolescents using tobacco by approximately 2.4 percentage points.⁷ Campaigns that last 2 years increase the effectiveness of the campaign.

Synthesis of current literature. Fifteen original studies examined interventions designed to reduce tobacco initiation among adolescents and young adults (KQ 1).⁶⁸–⁸² In reviewing these studies, we used a three-level component rating scale to assess the quality of each study. We rated them good, fair, or poor based on the rigor of the study design and how well the study was conducted. Quality review ratings for KQ 1 consisted of 1 good rating, 12 fair ratings, and 2 poor ratings (poor ratings had one or more fatal flaws in design or conduct of the study). Therefore, we discuss 13 studies for KQ 1. Information on the two studies we rated as poor are in the evidence tables (Appendix C).^† We organized the KQ 1 studies by population-based (Evidence Table 1), school-based (Evidence Table 2), and provider-based interventions (Evidence Table 3).

Population-based interventions to reduce tobacco initiation. Two of the 13 studies were population-based.^{73, 79} As shown in Table 6, the studies were conducted in the United States and received quality ratings of fair. Sample sizes ranged from 1,316 to 3,831 adolescents ages 12 to 17. One study addressed youth access, specifically youth access ordinances and regulations,⁷⁹ and the other was an intervention designed to prevent adolescent tobacco and alcohol use by targeting family risk factors.⁷³

We did not find studies implementing other prevention strategies related to unit price of tobacco products, tobacco industry and product restrictions, or media campaigns alone or in combination with other tobacco prevention interventions. With the exception of tobacco industry and product restrictions, these interventions have been covered extensively in past systematic reviews. New studies investigating these topics either did not meet our inclusion criteria, in particular did not report on the outcome variable for KQ 1 (i.e., reduced initiation of tobacco use among adolescents and young adults), or are not in publication.

Restricting adolescents' access to tobacco products is a population-based intervention aimed at reducing tobacco initiation. A study using Massachusetts statewide youth tobacco access ordinances and regulations examined the effects of these provisions on youth perceived access to tobacco products, youth purchase attempts, and youth tobacco use.⁷⁹ In this cross-sectional study, the investigators surveyed youth from across Massachusetts using a random sample of households. Interviewers collected demographic data from the adult resident, screened for eligibility, and requested permission to interview all youth in the household between the ages of 12 and 17. After excluding inconsistent reports of resident's town, zip code, or telephone exchange and towns having no identified youth respondents, interviewers collected data from 3,831 participants in 314 towns. The Massachusetts Tobacco Control Program produces a biannual report on six provisions of youth access ordinances from each town:

• 1

  Licensing (requires retailers to have a license to sell tobacco products),

• 2

  Fines for merchants who sell tobacco products to minors;

• 3

  Vending machine restrictions (a complete ban or restricted to adult-only establishment)

• 4

  Ban on free-standing displays of tobacco products

• 5

  Ban on sale of single cigarettes and

• 6

  Ban on distribution of free samples.

The six provisions were used as predictor variables in the analysis. Additionally, a measure of antismoking sentiment provided a baseline measure in each town before expansion of the local youth access ordinance. The antismoking measure was highly correlated with the town-level socioeconomic measure. The outcome variables were dichotomous; smoking status was defined as “ever smoker” (has smoked or puffed a cigarette in one's lifetime) or “current smoker” (has smoked at least one cigarette in the past 30 days).⁷⁹

In the fully adjusted model, only two provisions were statistically significant and only one in the expected direction. Youth living in towns that ban free-standing displays were less likely to perceive tobacco as easy to purchase (adjusted odds ratio [AOR], 0.6; 95% confidence interval [CI], 0.5–0.9; P = 0.007). Counterintuitively, youth reported easy access in towns that required tobacco vendors to have a license (odds ratio [OR], 1.3; 95% CI, 1.1–1.5; P = 0.009). Overall, 37 percent believed that it was easy to buy cigarettes in their town. No associations were found between youth access ordinances and attempts to purchase or between ordinances and tobacco use. Individual factors associated with increased attempts to purchase were associated with being older (P≤ 0.01) and male (P = 0.004). Individual factors associated with tobacco use were being older, living with a smoker, and having a close friend who smokes (P < 0.0001).⁷⁹

The second population-based study enrolled 1,316 adolescent-parent pairs throughout the contiguous United States through random-digit dialing into a family-directed program called Family Matters.⁷³ Pairs completed baseline interviews by telephone, were matched with another pair by date and time of completion, and were randomly assigned to either receive the Family Matters program or serve as controls. This program used both global attributes of families, such as supervision and attachment, and substance-specific family characteristics, such as parental drug use, to reduce tobacco initiation. The program assumes that changing global family characteristics (supervision, supportiveness, involvement, and communication) and substance-specific characteristics (parent expectations and attitudes toward child's drug use; parental monitoring, rules, and encouragement about drug use; availability of and outside influences regarding drugs; parental drug use) will change a third domain—adolescent cognitions regarding drug use and, in turn, will ultimately influence adolescent use.⁷³

The investigators completed successive mailings of four booklets to parents and their 12- to 14-year-old children between July 1996 and September 1997 (1 year and 2 months). Following each mailing, telephone discussions occurred between parents (or guardians) and health educators. Families who completed the program spent an average of 4.5 hours doing the program; parents spent an additional hour talking with the health educator by telephone. The program measured exposure to the Family Matters program, adolescent tobacco and alcohol use, three sets of mediator variables, and sociodemographic characteristics at 3- and 12-month followups. Self-reported smoking status, without biochemical verification, categorized never-smoked adolescents as nonusers and adolescents who smoked even a puff of a cigarette as users.⁷³

Baseline data showed fewer non-Hispanic whites students in the Family Matters intervention than in controls. The effects of the intervention were present only among non-Hispanic white adolescents—a subset of the population (n = 791). Adolescents in the control group were more than 1.5 times as likely to smoke at the 3-month followup assessment than adolescents in the Family Matters intervention (OR, 1.59; P = 0.008, lower bound CI = 1.19 for a one-way test of significance). No significant effects were evident at the 12-month followup. The conceptual model underlying the Family Matters program was validated for non-Hispanic whites only.⁷³

Community-Based Interventions to Prevent Tobacco Initiation

Community-based interventions are coordinated, widespread programs in a particular geographic area, such as a school district, or in a grouping of people who share common interests or needs.⁶⁴ The Surgeon General's report on Reducing Tobacco Use ² and two Cochrane reports on school-based programs and community interventions review smoking prevention strategies for young people.^{34, 64}

Synthesis of prior systematic reviews. Previous reviews have found limited support for school- and community-based interventions to reduce tobacco use initiation among adolescents and young adults.^{34, 64} No prior systematic reviews were identified for provider-based interventions. School-based interventions reviewed include various educational strategies. Examples include classroom programs or curricula that provided information, used social influence approaches, and taught social competence. These programs often moved beyond the school population to involve parents and the community.³⁴ Community-based interventions for preventing smoking among young people integrate an array of strategies such as community empowerment, dissemination of health education materials, media advocacy, youth antitobacco activities, contests, letters to schools and parents, school programs, and use of peer leaders to raise awareness and discourage tobacco use.⁶⁴

School-based smoking prevention programs. Schools in the United States have existing tobacco use prevention policies and programs, but current interventions are not optimal. Effective educational strategies conducted in conjunction with other interventions such as mass media and community activities, can postpone or prevent smoking onset in 20 percent to 40 percent of adolescents.² Such multifaceted programs reach adolescents on multiple levels by enlisting the positive influences of parents, community organizations, the mass media, and school programs.

An extensive review of all randomized controlled trials (RCTs) of behavioral interventions in schools to prevent tobacco use (ages 5 to 12 and 13 to 18) identified 16 studies of acceptable quality.³⁴ The various strategies included information-giving methods, social influence approaches, generic skills training, and community interventions. Short-term positive effects were found in eight studies; however, no long-term effects were significant. Long-term is defined as 2 years after the end of the program; anything less than 2 years was considered a short-term effect.³⁴

Community-based smoking prevention interventions. Some support exists for the premise that community interventions are effective at reducing the uptake of tobacco in young people. Of 13 studies comparing community interventions to no interventions, only 2 showed lower smoking prevalence. A comparison of a multicomponent community intervention with a community receiving a mass media campaign alone also showed a lower rate of smoking prevalence. Three studies compared community interventions to school-based interventions, but only one found differences in reported smoking prevalence.⁸³

Synthesis of current literature. Of the 13 studies addressing KQ 1, 10 involved school-based efforts⁶⁸–^{72, 74}–^{76, 81, 82} and 1 tested a provider-based intervention.80 Sample sizes ranged from 26 to 99 schools and 103 to 8,352 participants. These studies were conducted in the United States (5), the Netherlands (2), Australia (1), Canada (1), Norway (1), and the United Kingdom (1). We rated one study as good and the rest as fair.

Community interventions have been covered comprehensively in past systematic reviews.^{2, 64} We did not identify any community-based tobacco prevention studies; those that we learned about either did not meet our inclusion criteria or are not yet in publication.

School-based interventions to reduce tobacco initiation. An effective method for reaching adolescents and young adults is to use school systems. Implementing tobacco prevention interventions in schools is convenient and allows for both optimum exposure of the intervention strategies and regular assessment of effectiveness. The school-based tobacco prevention studies in this report are heterogeneous in terms of prevention strategies, definitions of tobacco use, and length of follow-up assessments. Biochemical verification of self-reported smoking status, unless otherwise stated, was not used in these studies. Virtually all the studies defined smoking status differently.

Table 7 lists the various definitions of abstinence and tobacco use in the 10 school-based tobacco prevention studies reviewed. Interventions that sustain significant outcomes 2 years after the end of the intervention are considered to have long-term effects. School-based tobacco prevention programs were divided by length of exposure. Programs were implemented either within a single school year or over multiple school years. Single-year interventions are discussed first, followed by multiple-year interventions.

Five school-based interventions were conducted within a single school year.^{68, 69, 71, 75, 81} As shown in Table 8, these interventions used classroom instruction, computer-based programs, competition, parent involvement, community advocacy, and personalized letters. Students were in grades six through eight in middle, lower secondary, and vocational schools.

One study implemented the intervention in a primarily Hispanic population,⁸¹ another in primarily non-Hispanic, white populations,⁷⁵ and the other studies did not specify ethnicity of the population studied.^{68, 69, 71} The sample size for the five studies implementing within-school-year interventions ranged from 16 to 52 schools and 1,970 to 8,352 students.

The length of exposure students received was as short as 8 weeks⁸¹ and as long as 8 months.⁷⁵ Followup assessments ranged from 6 months to 24 months. All prevention strategies included classroom lessons that included educational instruction typically combined with one or several other activities such as group discussion, role-play, videos, skills training, or computer-based lessons.^{68, 69, 71, 75, 81} Drug Abuse Resistance Education (D.A.R.E.), a well-known, school-based tobacco prevention program in the United States, also included parent involvement and a community youth action team in the multicomponent intervention.⁷⁵

Three single-year smoking prevention programs compared their effects with those in control groups that received either standard smoking information, the original drug prevention program already in place, or the same classroom lessons without cultural sensitivity.^{69, 71, 81} An 8-month prevention program used educational strategies and competition to reduce tobacco initiation in 26 lower secondary education (mean age 13) schools in The Netherlands.⁷¹ Three lessons on knowledge, attitudes, and social influences were followed by a class agreement either not to start smoking or to stop smoking for the next 5 months. To increase students' motivation, the National Institute Against Smoking rewarded classes in which less than 10 percent of the students were smokers at the end of the 5 months; it also conducted a photography contest to find the best photograph that expressed a nonsmoking class.⁷¹

Smoking status measured by self-report was assessed at baseline, at the end of the intervention, and at 1-year followup. At the end of the intervention, the proportion of nonsmokers who became smokers had increased less in the intervention group (9.6 percent) than in the control group (14 percent) (OR, 0.61; 95% CI, 0.41–0.90). The proportion of smokers had also increased significantly less in the intervention group (2.6 percent) than in the control group (7.9 percent) (OR, 0.62; 95% CI, 0.43–0.90). The groups did not differ significantly at 1-year followup.

Aveyard et al. implemented a computer-based tobacco prevention intervention in 52 schools in West Midlands, United Kingdom.⁶⁹ During school year 9, students ranging in age from 13 to 14 years received three class lessons and three interactive computer sessions (including video clips of young people discussing their smoking). The intervention continued throughout the ninth-grade year; the investigators administered a self-report questionnaire at baseline and at years 1 and 2.⁶⁹ At followup in years 1 and 2, the intervention and control groups did not differ significantly in effect (year 1: AOR, 1.14; 95% CI, 0.93–1.39; year 2: AOR 1.06; 95% CI, 0.86–1.31).⁶⁹

Project FLAVOR (Fun Learning about Vitality, Origins, and Respect), a school-based program that incorporates a curriculum sensitive to multiple cultures, focused on psychosocial risk factors to prevent tobacco initiation in eight of 16 middle schools in Southern California.⁸¹ The students were predominantly Hispanic (57 percent) and Asian American (27 percent) sixth and seventh graders. The culturally sensitive intervention programs provided eight weekly classroom sessions conducted by health educators that addressed smoking-related psychosocial concepts through activities such as role-playing, trivia games, and art projects.⁸¹

Students were surveyed at baseline and at 1-year followup. Overall, 8 percent of the intervention group and 11 percent of the control group initiated smoking (OR, 0.75; 95% CI, 0.48–1.18), but this difference was not significant. For one subgroup—Hispanic male never smokers—the intervention prevented smoking initiation between the two grades (OR, 0.49; 95% CI, 0.27–0.88).⁸¹

Two single-school-year smoking prevention programs compared classroom instruction to an alternative, more innovative tobacco prevention program.^{68, 75} Vocational students (mean age 13) in 36 schools in The Netherlands participated in an in-school and out-of-school intervention to reduce tobacco initiation.⁶⁸ The in-school and out-of-school interventions and a combined in- and out-of-school intervention were compared with a control group (not described). The in-school intervention had three classroom lessons consisting of educational instruction by the teacher reading from the workbook, a classroom discussion, a workbook task, and an additional task that summarized the main points of the lesson. The out-of-school intervention comprised three tailored letters with smoking prevention messages; the letters were illustrated with a picture puzzle and several cartoons. It also included a competition in which students could win CD vouchers. The letters were mailed to students' homes at 3-week intervals.⁶⁸

Students' self-reported their smoking status at pretest and 6, 12, and 18 months following the intervention. Immediate treatment effects were not apparent at 6 months; at 12 months the in-school intervention was more effective at discontinuing smoking than the control condition (OR, 0.49; 95% CI, 0.29–0.84). At 18 months, the tailored out-of-school intervention was effective in preventing smoking initiation compared with the control condition (OR, 0.42; 95% CI, 0.18–0.96). The combined approach was not as successful as the in-school and the out-of-school efforts.⁶⁸

D.A.R.E., based on the decisionmaking model, has been widely implemented in elementary schools and extensively evaluated. D.A.R.E. Plus, a new multicomponent curriculum used in middle and high schools, has received less attention than the original program.⁷⁵ An independent evaluation of D.A.R.E. and D.A.R.E. Plus in 24 Minnesota middle and junior high schools was conducted with seventh- and eighth-grade students (51.6 percent male, 67.3 percent white, 7.5 percent African American, 12.7 percent Asian American, 3.6 percent Hispanic, 4.0 percent American Indian, and 4.9 percent of mixed or other ethnicity). The research team matched students on socioeconomic status, drug use, and size of school and randomly assigned schools to one of three conditions: D.A.R.E. only, D.A.R.E. Plus, or control group. The D.A.R.E. program, taught by trained D.A.R.E. police officers, consisted of 10 sessions providing skills in resisting influences to use drugs, building character, and building citizenship skills. The D.A.R.E. Plus program has three components: (1) “On the VERGE,” a classroom-based, peer-led, parental involvement program; (2) Youth Action Teams to implement in-school extracurricular activities; and (3) Youth Action Teams to address neighborhood and school-wide issues. The control group was eligible to receive D.A.R.E. Plus in 2001.⁷⁵

Students received D.A.R.E. and D.A.R.E. Plus for about 8 months from September 1999 through April 2000.⁷⁵ The researchers collected baseline measures from seventh graders in fall 1999; the first followup was in spring 2000 (i.e., at the end of the intervention); and the final data collection occurred among eighth-grade students in spring 2001 (i.e., 12 months following the intervention). Self-reported smoking status was reported through surveys.⁷⁵

The investigators used a three-level, linear, random-coefficient model to test for significant differences over time; they reported group slopes. No outcomes comparing D.A.R.E. with the control schools were significant. Boys in the D.A.R.E. Plus condition were significantly less likely than those in the control schools to show increases in tobacco use and intentions to use tobacco (P = 0.04). Boys in the D.A.R.E. Plus condition were significantly less likely than those in the D.A.R.E. condition to show increases in tobacco use and intentions to use tobacco (P = 0.04). No effects for tobacco use among girls were significant.⁷⁵

Interventions implemented within a school year were able to reduce tobacco initiation among adolescents shortly after the completion of the intervention.^{68, 71} Two studies reviewed in this report found effects for boys but not girls; one of these studies, the culturally sensitive intervention, reduced tobacco initiation exclusively among Hispanic boys.^{75, 81}

Several school-based interventions (in the United States, Australia, Canada, and Norway) occurred over multiple school years.^{70, 72, 74, 76, 82} The interventions included classroom instruction, teacher training, parent involvement, extracurricular school activities, community assessment, advocacy, and projects.^{70, 72, 74, 76, 82} Students ranged from seventh graders through 12th graders. Study populations varied. One study implemented the intervention in a primarily Latino population;⁸² another involved both rural and urban communities with a high percentage of Native Americans (12.5 percent nonwhite);⁷² and the other studies did not specify ethnicity of the population.^{70, 74, 76} The sample size for the five multiple-year studies ranged from 22 to 99 schools and 813 to 4,276 students.

Students were exposed to smoking prevention interventions from 2 to 3 years. Investigators collected follow-up measures at the end of the interventions^{70, 72, 74, 76, 82} and up to 6 months following conclusion of the interventions.⁸² Two studies used control groups that were later eligible for the intervention;^{72, 76} other control groups received some type of prevention activities.^{70, 74, 82} Only two multiple-year studies relied significantly on classroom instruction;^{72, 74} the other tobacco prevention studies used multicomponent interventions that included school, family, and community activities.^{70, 76, 82}

Project ALERT, a well-known adolescent drug prevention program, aims to change students' perceptions of drug norms and the social, emotional, and physical consequences of drug use. A revised version of Project ALERT emphasizes curbing alcohol misuse (rather than abstinence), increases attention to current smokers, and brings parents into the prevention process.⁷²

In urban and rural communities in South Dakota, Project ALERT was evaluated in 55 middle schools with seventh- and eighth-grade students (13 percent nonwhite; 51 percent male).⁷² The curriculum included 11 lessons in seventh grade and three lessons in 8th grade that used interactive teaching methods focusing on motivation and resistance skill-building. Another important element of this program was home learning, which sought to involve parents in substance use prevention. The control schools receive a delayed experimental program at the conclusion of the study.

Students completed surveys at baseline in the fall of seventh grade and 18 months later in the spring of 8th grade. Self-reported smoking status was validated by collecting salivary cotinine levels for a random subsample of 654 students. At 18 months, cigarette initiation rates in Project ALERT (25.5 percent) were significantly lower than in the control group (31.6 percent, P < 0.01). From the baseline assessment to the 18-month followup, Project ALERT reduced the proportion of new smokers by 19 percent (P < 0.01).⁷²

BE smokeFREE comprises an intensive intervention conducted over 3 school years. The program delivered classroom sessions at least five times per year from sixth through 8th grade.⁷⁴ A nationally representative sample of 99 secondary schools in Norway implemented this program.⁷⁴ Three treatment groups—the model intervention (i.e., classroom instruction, teacher in-service training, and parent involvement), the model intervention without the teacher in-service, and the model intervention without parent involvement—were each compared with a control group. The classroom instruction contained nontraditional school activities such as videos, games, and group work. The intervention used 8 hours in seventh grade, 5 hours in eighth grade, and 6 hours in ninth grade. During eighth grade, however, students and teachers requested adjustments to the intervention. Therefore, in ninth grade, students developed, carried out, and evaluated their own campaign to promote a smokefree lifestyle among the seventh graders. Parent involvement (not described) was included in the intervention. The control group received education on smoking and health but only for about half the number of hours as the intervention groups.⁷⁴

Students self-reported smoking behaviors on surveys administered by teachers at the end of each of the 3 academic years. The proportions of smokers were significantly higher in the control group than in the model intervention for all 3 follow-up years (1995, F = 5.66; P < 0.01; 1996, F = 7.19; P < 0.001; 1997, F = 4.05; P < 0.05). In both the interventions without teacher in-service training and without parent involvement, the proportions of smokers on all follow-up occasions were higher than in the model intervention but lower than in the control group (1995, F = 2.84; P < 0.01; 1996, F = 3.98; P < 0.001; 1997, F = 2.46; P < 0.05). The odds of becoming a smoker during the intervention period were significantly lower in the model intervention than in the control group for daily smoking (Wald's 9.81, P = 0.02), for weekly smoking (Wald's 15.65, P = 0.0001), and for any smoking (Wald's 16.54, P = 0.0001).⁷⁴

Several school-based tobacco prevention programs not only involve students but also include parents and surrounding communities. In one particular intervention, students were recruited from elementary schools with tobacco prevention programs.⁷⁰ Thirty Canadian high schools selected for the study enrolled at least 30 students who had participated in an elementary school smoking prevention study; receiving such students was an eligibility requirement for schools.⁷⁰

In the 15 intervention schools, the investigators recruited teachers, staff, students, and community members to participate in antismoking activities. Teachers helped students, staff, and community members to plan and implement prevention and cessation activities tailored to each intervention school to build commitment and strengthen school social norms toward not smoking. The research staff provided consultation, conducted semiannual workshops for teachers and student leaders, developed resources for dissemination to all intervention schools, produced newsletters, and provided a $1,000 per school annual budget.

Students in the ninth and tenth grades were exposed to the intervention for 1 year; data on smoking status were collected by survey at the end of the year. Investigators collected a “bogus” biochemical verification using carbon monoxide (CO) breath samples to enhance validity of the self-reported data. The control schools had “usual” programs but these were not described.⁷⁰

Extracurricular activities produced by the intervention schools consisted of quit-and-win contests, poster contests, displays, health fairs, and smoking surveys (not associated with the study survey). On average, 3.8 intervention activities occurred in the 9th grade and 3.5 activities in 10th grade. At baseline, intervention schools had a marginally higher proportion of students who had previously been in the elementary intervention condition (P = 0.10). After adjusting for the baseline difference, male nonsmokers at baseline were significantly less likely to be “regular” smokers in 10th grade in the intervention schools than males in the control schools (9.8 percent vs. 16.4 percent, P = 0.02). Among females, intervention and control groups did not differ.⁷⁰

High schools from San Francisco and San Jose, California, were randomly allocated in a school-based intervention study conducted in 10 continuation high schools.⁸² Advocacy activities related to advertising, availability, and use of tobacco were implemented in the intervention school to reduce tobacco initiation among students. Twenty-five 11th and 12th grade students volunteered to participate from each school (43 percent Latino, 21 percent white, 15 percent of mixed ethnicity, 13 percent Asian or Pacific Islander, 4 percent African American, and 4 percent other).⁸²

The three-phase intervention lasted 2 years. It included advocacy and empowerment classes that dispelled misconceptions about cigarette smoking and raised students' awareness of environmental influences (e.g., tobacco company advertising). It also helped students to develop advocacy skills (e.g., by practicing persuasive communication) and to conduct a community assessment and advocacy project. The control groups received an existing substance abuse curriculum not specific to tobacco that was developed for continuation high school students.⁸²

Students completed surveys at baseline, at the end of the semester, and 6 months after the end of the intervention. The two groups differed slightly at baseline for smoking and sociodemographic characteristics, but the investigators did not report percentages. The results, reported as net percentage changes from baseline smoking to after intervention, showed no significant changes after the intervention or at 6-month followup for nonsmokers (0.2 percent net change, P = 0.93).⁸²

Using community organization theory, one group studied 7th through 10th grade students in 22 schools in New South Wales, Australia; the researchers encouraged intervention schools to adopt their own Health Promoting Schools (HPS) program.⁷⁶ A key individual identified for each school took responsibility for planning, implementing, and monitoring HPS strategies such as developing a minimum set of health promotion actions for the school.

The schools received this community-based tobacco prevention intervention for 2 years. In November 1995, the investigators collected baseline data; in November 1997, they administered a posttest survey to the same cohort. They used a self-reported retrospective diary; students reporting having smoked any amount of cigarettes within the past 7 days were considered smokers.

In the final analysis, the research team matched pre-post data, which considerably reduced the sample size (N = 1,852). The odds of males smoking at posttest were almost half the odds of females (AOR, 0.55; 95% CI, 0.35–0.87). The proportion of students who had smoked in the last week did not differ significantly by treatment condition, indicating that the intervention was not effective.⁷⁶

Provider-based interventions to reduce tobacco initiation. Only one study (Table 9) used providers to reduce tobacco initiation.⁸⁰ The study participants were survivors of pediatric cancer from St. Jude Children's Research Hospital in Memphis, Tennessee, who were currently disease-free and at least 1 year from completion of antineoplastic therapy. On enrollment, the investigators randomly assigned 103 patients, stratified by age (ages 10 to 13 years and ages 14 to 18 years), gender, and race, to the tobacco-risk counseling intervention or a standard care group. The intervention occurred in a single session with periodic reinforcement of tobacco goals by telephone. A physician feedback letter reinforced the antitobacco messages, and tobacco literature was mailed to the patient. To reinforce previously established goals and address barriers, the investigators did follow-up telephone counseling at 1 and 3 months. Patients in the control group were asked about their tobacco use and briefly advised about the health risks associated with tobacco use. All tobacco users were advised to stop; nonsmokers were encouraged to continue to resist tobacco.⁸⁰

Patients in the intervention and control groups were assessed by questionnaire at baseline and at 6 months and 12 months following the intervention.⁸⁰ Baseline measures were similar across the two groups; 95.1 percent of the participants were classified as nonsmokers. At 12 months, multivariate comparison of difference scores for patient smoking status (12-month scores minus baseline scores) found no differences (all were P > 0.10), indicating the intervention had no effect on smoking initiation.

Increasing the Number of Users Who Attempt to Quit

Spontaneous and unassisted rates of tobacco use cessation among tobacco users are low (3 percent to 10 percent).⁵ Interventions to increase the number of tobacco users who seek assistance in quitting and who successfully quit include efforts to increase the number of users who attempt to quit, improve the success rate for quit attempts, and achieve both of these goals.⁷

Proven individual strategies for helping smokers to quit include counseling, behavioral therapy, and, except when contraindicated, the use of first-line and second-line medications.⁵ More often than not, individuals are trying to quit without assistance that can double or, in some cases, triple their chances of success.⁵

Synthesis of prior systematic reviews. Reviews of population-wide interventions to increase tobacco use cessation have focused on five elements: (1) multicomponent efforts to increase patient tobacco use cessation, which include telephone information or counseling support; (2) mass media campaigns combined with other interventions; (3) mass media cessation series; (4) mass media cessation contests; and (5) increases in the unit price of tobacco products. The Task Force on Community Preventive Services (hereafter, Task Force) focused on all five issues.⁷ The 2000 update of the 1996 Agency for Health care Policy and Research (AHCPR) guideline (Treating Tobacco Use and Dependence)⁵ and a 2003 Cochrane Review concentrated on the first topic (multicomponent efforts).⁶⁶

Multicomponent efforts. Based on a systematic review of 32 studies evaluating the effectiveness of telephone cessation support, the Task Force found strong evidence of effectiveness for telephone cessation support to increase tobacco use cessation when implemented with other interventions such as educational approaches or clinical therapies in clinical and community settings.⁷ Telephone support was coordinated with additional interventions, including client education, provider-delivered counseling, nicotine replacement, a smoking cessation clinic, and a televised cessation series. Effective telephone counseling interventions combined either proactive telephone support (i.e., the provider initiated contact) or reactive telephone support (i.e., the caller initiated contact, with provider followup) and client cessation materials. In the 30 studies comparing differences in cessation of tobacco use based on use of or exposure to telephone support, tobacco use cessation increased 2.6 percentage points (range, -3.4 to +23) in follow-up periods of 5 weeks to 34 months (median, 12 months).⁷

On the basis of a meta-analysis of various formats of psychosocial treatments (e.g., self-help, proactive telephone counseling, group counseling, and individual counseling), Fiore et al. found proactive telephone counseling to be effective at increasing abstinence rates relative to no intervention (OR, 1.2; 95% CI, 1.1–1.4).⁵ The estimated abstinence rate based on this meta-analysis was 13.1 percent (95% CI, 11.4–14.8). The guideline update also found, as did the Task Force, that interventions delivered in multiple formats increased abstinence rates compared with no format. Odds ratios for one format were 1.5 (95% CI, 1.2–1.8); for two, 1.9 (95% CI, 1.6–2.2) and for three or four, 2.5 (95% CI, 2.1–3.0). Estimated abstinence rates were 15.1 (95% CI, 12.8–17.4), 18.5 (95% CI, 15.8–21.1), and 23.2 (95% CI, 19.9–26.6), respectively, compared with a no-counseling format.

In another meta-analysis using all less-intensive intervention arms as the control (as opposed to those providing tailored self-help materials), telephone counseling increased quit rates (OR, 1.56; 95% CI, 1.38–1.77).⁶⁶ Investigators found no differences in quit rates in four trials that added telephone counseling support to a face-to-face intervention, in four trials that added telephone counseling support for users of nicotine replacement therapy, or in trials comparing different types of telephone counseling.

Mass media campaigns combined with other interventions. Mass media educational campaigns employ brief, recurring messages over time to provide information or motivation to tobacco users and others (e.g., family members, households, peers) with the goal of increasing or improving efforts to stop using tobacco products. Campaigns can focus on cessation, include cessation themes within a broader range of tobacco messages, or be combined with other interventions such as an excise tax increase or other related, community-wide education efforts.

Mass media campaigns, when combined with other activities, were effective in increasing tobacco use cessation by approximately 2 percentage points, in reducing overall tobacco consumption measured on a population basis by almost 13 percent, and in lowering the prevalence of tobacco use by approximately 3 percentage points.⁷ Mass media campaigns can also increase the number of people who seek telephone support for quitting smoking. The Task Force found “strong” evidence of the effectiveness of such campaigns when combined with activities to increase tobacco use cessation and reduce tobacco consumption; activities include excise tax increases or other community-wide educational efforts.⁷

Mass media cessation series. Mass media cessation series consist of broadcasted instructional segments designed to recruit, inform, and motivate users of tobacco products to try quitting and to succeed.⁷ Cessation series can be coordinated with broadcasts or print promotions that precede the series itself, community education, or organization of cessation groups in the community. Such series can last a period of several weeks to several months.

After reviewing nine studies evaluating cessation series, the Task Force found insufficient evidence to determine the effectiveness of such interventions in increasing the number of people who successfully stop using tobacco products.⁷ Studies included cessation series combined with other interventions such as community education, organized cessation groups or programs, or telephone support.

Mass media cessation contests. Cessation contests are community-wide events of short duration that use mass media to recruit and motivate users of tobacco products to participate in a program to quit by a certain date or during a specified time period. Mass media and small media (e.g., posters and flyers) promote available services and recruit tobacco product users.

The Task Force found insufficient evidence to determine the effectiveness of such contests in increasing the number of people who quit using tobacco products.⁷ This conclusion was based on only one study that showed some improvement in self-reported cessation at 6-month followup.

Summary. Proactive telephone counseling is effective in increasing tobacco use cessation. Mass media education campaigns combined with other interventions are also effective in increasing tobacco use cessation. However, other types of mass media education, such as media cessation series and cessation contests, were not found to be effective.

Synthesis of current literature. Seven randomized trials describing multicomponent interventions to increase tobacco use cessation met inclusion criteria (Table 10). Four involved counseling support; of these, three investigated proactive telephone counseling and support for cessation,⁸⁴–⁸⁶ and one trial of genetic susceptibility counseling incorporated smoking cessation counseling.⁸⁷ Two other studies were long-term follow-up studies of intervention effect; one study included participants in a randomized trial of a computer-tailored smoking intervention⁸⁸ and the other included participants in a randomized trial of the Lung Health Study (LHS) smoking intervention.⁸⁹ The final study focused on adolescents to examine the effectiveness of a family-directed program addressing tobacco and alcohol use among teens.⁹⁰ We did not find any new articles meeting our criteria that addressed the effects of mass media and tobacco price on increasing the number of tobacco users who attempt to quit or who are successful in quitting.

Adults were the target group in four studies,⁸⁶–⁸⁹ and adolescents and young adults were the target group in the other three.^{84, 85, 90} Trials enrolling only adults examined interventions designed to increase tobacco use cessation by providing proactive telephone counseling support⁸⁶ and incorporating genetic susceptibility to lung cancer into smoking cessation counseling.⁸⁷ Of the studies enrolling only adolescents and young adults, one tested the efficacy of self-help materials with or without proactive telephone counseling to increase cessation among teen smokers;⁸⁴ the other examined the effects of telephone counseling on smoking cessation among smokers 18 to 25 years of age and smokers over 25 years of age.⁸⁵

For the trials, recruitment strategies included radio and newspaper advertisements,⁸⁶ contact with youth in shopping malls and an amusement park,⁸⁴ telephone calls to a random sample of families with children 12 to 14 years of age,⁹⁰ chart review and clinician referral,⁸⁷ and a survey of callers to a national quit line.⁸⁵ In the studies of persistent intervention effect, investigators recruited the original subjects in one study by mailed announcements to a random sample of residents in a defined area⁸⁸ and, in the other, by random sample of an unspecified population for a multicenter trial.⁸⁹

Smokers were defined in various ways at intake: daily smokers;⁸⁶ daily smokers for 1 year and with an expired CO level of greater than 8 parts per million (ppm);⁸⁹ having smoked a cigarette within the last week;⁸⁴ more than an occasional smoker;⁸⁸ current, daily smokers willing to make a quit attempt within the next 2 weeks;⁸⁵ smokers with some level of lung impairment;⁸⁷ and use of tobacco on 1 or more days during the past 30 days.⁹⁰

Interventions were very different across trials, although all involved distribution of self-help print materials. Some interventions were tailored to stages of change; others were not. The intervention in one trial had five conditions involving combinations of counseling with variable numbers of follow-up calls (two or six) and different print materials (booklet or pamphlet).⁸⁶ In another intervention group, participants received an eight-page personal counseling letter written by a computer according to answers that participants gave on a 62-item enrollment questionnaire and two 16-page self-help booklets corresponding to their current stage of change and the next stage of change.⁸⁸ At 2, 4, and 12 months after entering the study, intervention participants could answer tailoring questions again to receive a new letter. In another trial, content of calls was customized and based on each participant's stage of readiness to quit.⁸⁴ Calls were designed to encourage use of self-help booklets, move the participant toward quitting, and assist those ready to quit.⁸⁴ In another study, the intervention used three booklets with standard advice plus up to five sessions of proactive telephone counseling.⁸⁵ One study incorporated genetic susceptibility for lung cancer counseling and related print material (an eight-page test result booklet) into usual smoking cessation counseling.⁸⁷ Only one trial included nicotine replacement therapy as part of the study, but the therapy was made available to both the intervention and control groups.⁸⁷

Followup to assess smoking status occurred at various times in the current trials: 3 and 6 months;⁸⁵ 3 and 12 months;⁹⁰ 3, 6, and 12 months;⁸⁶ 4 and 8 months;⁸⁴ and 6 and 12 months.⁸⁷ In the persistence of effect studies, followup occurred at 7 and 24 months⁸⁸ and at 11 years.⁸⁹ Followup occurred at the specified time after baseline in three studies,^{84, 87, 88} after the quit date in one,⁸⁵ and after completion of the intervention in another.⁹⁰

Outcome measures included various definitions of abstinence: 1-month abstinence (not smoking even a puff of a tobacco cigarette, cigar, or pipe in the last 4 weeks);⁸⁸ 1-week abstinence (not smoking even a puff of a tobacco cigarette, cigar, or pipe in the past 7 days);^{84, 86}–⁸⁸ no smoking in the past 48 hours;⁸⁵ and self-reported cessation with no time frame specified.⁸⁹ Continuous abstinence, which five studies used as a primary outcome, was defined as abstinence at all reporting periods.⁸⁴–^{87, 89}

Smoking status results. Of the four trials of counseling support, three focused on telephone counseling and associated print materials.⁸⁴–⁸⁷ One study reported statistically significant increases in continuous abstinence among those receiving telephone counseling compared with control participants receiving only print materials (5 percent vs. 1 percent, P < 0.05).⁸⁶ Another study reported statistically significant higher rates of prevalence of reported abstinence during the past 48 hours for participants in the treatment group compared with those in the control group in two age categories (younger than 18 years of age and 18 to 25 years of age). At 3-month followup, differences by age were 19.6 percent vs. 9.3 percent (P < 0.005) for younger smokers and 15.1 percent vs. 9.6 percent for older smokers.⁸⁵ The trial of counseling support showed that smoking cessation was greater for the group receiving genetic feedback and counseling than for controls at 6 months but not at 12 months.⁸⁷ Finally, one trial failed to show any significant group differences in either abstinence at each follow-up assessment or in continuous abstinence.⁸⁴

Other outcomes. Beyond smoking status, four studies also assessed other primary and secondary outcomes associated with multicomponent interventions: quit attempts, days of smoking abstinence, and use of nicotine replacement. One study of persistent effect found that more participants in the intervention group than in the control group reported making a 1-month quit attempt and having more days of smoking abstinence.⁸⁸ More participants in the intervention group than in the control group had used nicotine replacement products in two studies.^{85, 88} Two studies showed no difference in nicotine replacement therapy use across groups.^{86, 87}

Adolescents and young adults. Two studies in this review showed that telephone counseling that targets youths achieved success comparable to that shown for adult smokers.^{84, 85} This finding suggests that younger smokers can benefit from telephone counseling. Three-month quit rates were 19.6 percent for persons 18 to 25 years of age who received telephone counseling and 9.3 percent for those who received self-help booklets only (P < 0.005). The proportions reporting abstinence during the preceding 48 hours at both the 3- and 6-month follow-up interviews were also significantly different in the treatment group for this age cohort (9.8 percent vs. 3.2 percent, P < 0.01)⁸⁵

Persistence of effect. Two studies reported long-term follow-up results of previous RCTs. The trial of a computer-tailored smoking cessation program showed, at the 7-month assessment, a significant increase in 4-week abstinence rates and 7-day quit rates compared with rates for controls. At 24 months after intervention, these differences had disappeared.⁸⁸ The second follow-up study found that smokers exposed to an aggressive smoking intervention program who sustained abstinence for a 5-year period were very likely to still be abstinent after 11 years.^{87, 89}

Improving the Success Rate of Quit Attempts

Synthesis of prior systematic reviews. Self-help approaches. In a meta-analysis including self-help as one format for assisting smokers in their quit attempts, Fiore et al. showed that self-help was of marginal efficacy.⁵ Further meta-analysis of studies in which self-help constituted the sole difference in treatment arms also indicated that self-help is of marginal efficacy. Little evidence supported the view that providing multiple types of self-help, when offered without any person-to-person intervention, significantly enhanced treatment outcomes.

Lancaster and Stead reported that providing smokers with materials to support quit attempts is of limited benefit unless the materials take into account each smoker's individual characteristics.⁵⁹ Advice and behavioral counseling can help smokers to quit.⁵⁹ Giving the same type of support via written materials or other media has not been found to be very helpful, although people given no other support may experience a small benefit.

These same authors examined 33 trials that compared self-help materials to no intervention or tested materials used in addition to advice.⁵⁹ In 11 trials in which self-help was compared with no intervention, a pooled effect just reached statistical significance (N = 13,733; OR, 1.24, 95% CI, 1.07–1.45). Four other trials in which the control group received alternative written materials did not show an effect for the smoking self-help materials. The review failed to find evidence of benefit from adding self-help materials to either face-to-face advice or to nicotine replacement therapy.

Seventeen trials used materials tailored for the characteristics of individual smokers; meta-analysis by Lancaster and Stead supported a small benefit for tailored materials (N = 20,414; OR, 1.42; 95% CI, 1.26–1.61).⁵⁹ The evidence was strongest for tailored materials compared with no intervention, but it also showed that tailored materials were more helpful than standard materials. A small number of other trials failed to detect benefits from using additional materials or targeted materials or to find differences between different self-help programs.

Counseling. In another review, Lancaster and Stead looked at trials of counseling by a trained therapist in one or more face-to-face sessions (separate from medical care).⁶⁰ All trials involved sessions lasting more than 10 minutes, with most including further telephone contact for support. A review of 21 trials with more than 7,000 participants showed that individual counseling for smoking cessation was more effective than the control (OR, 1.56; 95% CI, 1.32–1.84). In a subgroup of three trials in which counseling had been tested as an adjunct to nicotine replacement therapy, the point estimate of effect was smaller and did not reach significance (OR, 1.34; 95% CI, 0.98–1.83). Meta-analysis did not detect a greater effect of intensive counseling than brief counseling, although the confidence intervals are wide and do not exclude the possibility of a clinically useful dose-response effect (OR, 0.98; 95% CI, 0.61–1.56).

In another review by Stead and Lancaster of 16 studies that compared a group program with controls receiving no intervention, cessation increased with the use of a group program (N = 4,395; OR, 2.04; 95% CI, 1.60–2.60).⁶⁵ In seven trials, group programs were more effective than no intervention controls (N = 815; OR, 2.17; 95% CI, 1.37–3.45). No evidence emerged that group therapy was more effective than a similar intensity of individual counseling. Also, limited evidence suggested that programs with components for increasing cognitive and behavioral skills and avoiding relapse were more effective than programs of the same length or shorter without these components.

Group therapy was shown to more than double the chances of quitting as compared with self-help and other less intensive interventions.⁶⁵ Evidence is insufficient to evaluate whether groups are more effective than intensive individual counseling and to support the use of particular psychological components in a program beyond the support and skills training normally included. Only limited evidence suggests that adding group therapy to other forms of treatment (adjunctive group therapy), such as advice from a health professional or nicotine replacement, produced extra benefit.⁶⁵ Not all smokers making a quit attempt want to attend group meetings, but those who do are likely to find the meetings helpful if such activities offer assistance equivalent to intensive individual counseling.⁶⁵

In updating the 1996 AHCPR clinical practice guideline, Fiore et al. found that minimal interventions lasting less than 3 minutes increased overall tobacco abstinence rates.⁵ They also reported a strong dose-response relation between length of person-to-person contact during a counseling session and successful treatment outcomes. In general, intensive interventions were more effective than less intensive interventions.

The Fiore et al. review also indicated that intensive interventions for smoking cessation should include an assessment to ensure that tobacco users are willing to make a quit attempt using an intensive treatment program.⁵ Other assessments can provide information useful in counseling (e.g., stress level, presence of comorbidity), but little consistent evidence exists to show that a smoker's status on a specialized assessment is useful in treatment matching. Regardless of their standing on specialized assessments, all smokers have the potential to benefit from cessation interventions. Tailored interventions based on specialized assessments (e.g., stages of change) do not consistently produce higher long-term quit rates than nontailored interventions of equal intensity. Because of the evidence of a strong dose-response relation, the intensity of a smoking cessation program should be defined as a session lasting longer than 10 minutes, with four or more sessions, for a total contact time longer than 30 minutes.

In terms of format, Fiore et al. used meta-analysis to compare self-help, proactive telephone counseling, group counseling, and individual counseling with no format.⁵ All four formats increased the likelihood of success in quitting; group counseling (OR, 1.3; 95% CI, 1.1–1.6) and individual counseling (OR, 1.7; 95% CI, 1.4–2.0) had the two highest odds ratios.

The use of adjuvant self-help material is optional, but follow-up assessment intervention procedures should be used.⁵ Smoking cessation interventions that used more than two formats were more effective than interventions that used a single format.

Particular types of counseling and behavioral therapies are especially effective.⁵ Practical counseling (e.g., problem-solving and skills-training approaches) and the provision of intratreatment social support and extratreatment social support (e.g., help in securing social support outside of treatment) are associated with significant increases in abstinence rates, as are aversive smoking techniques (e.g., rapid smoking). Tobacco dependence treatments are effective across diverse populations (e.g., populations varying in gender, age, and ethnicity).

The review in the 2000 Surgeon General's report found that pharmacologic treatment of nicotine addiction, combined with behavioral support, enabled 20 percent to 25 percent of users to remain abstinent at 1 year after treatment.² Even less intense measures, such as physicians' advising their patients to quit smoking, produced cessation rates of 5 percent to 10 percent.

Evidence was mixed on the efficacy of self-help manuals as an aid to smoking cessation. Programs using advice and counseling—whether minimal or more intensive—have helped a substantial proportion of people quit smoking. The success of counseling and advice rises with the intensity of the program and may be improved by increasing the frequency and duration of contact.

Pharmaceuticals. Fiore et al. found that pharmacotherapies such as bupropion sustained release (SR) or nicotine replacement therapies (e.g., nicotine gum, nicotine inhaler, nicotine patch, nicotine nasal spray) consistently increased abstinence rates.⁵ They conducted two sets of meta-analyses. One meta-analysis examined first-line pharmacotherapies (i.e., those agents found to be safe and effective for smoking cessation and approved by the US Food and Drug Administration [FDA] for such use). The other was for second-line pharmacotherapies (i.e., agents where evidence of their efficacy for treating tobacco dependence exists, but they have a more limited role than first-line pharmacotherapies both because the FDA has not approved them for a tobacco dependence treatment indication and because they raise more concerns about potential side effects than first-line medications).

First-line pharmacotherapies, which include bupropion and the nicotine replacement therapies, consistently increased abstinence rates.⁵ Second-line pharmacotherapies, including clonidine and nortriptyline, also demonstrated efficacy. The combination of the nicotine patch with a self-administered form of nicotine replacement therapy (either gum or nasal spray) was more effective than a single form of nicotine replacement. Evidence was inconsistent on effectiveness of other pharmaceutical treatments (e.g., antidepressants other than bupropion SR and nortriptyline, anxiolytics, benzodiazepines, beta-blockers, silver acetate, and mecamylamine).

The Surgeon General's report indicated strong, consistent evidence that pharmacologic treatments for smoking cessation (nicotine replacement therapies and bupropion, in particular) can help people quit smoking.² Clonidine and nortriptyline may have some utility for smoking cessation, but, as noted, the FDA has not approved them for this indication.

Synthesis of current literature. We identified 31 studies not covered by earlier publications that involved self-help, counseling, and pharmaceutical therapies. (Table 11).⁹¹–¹²¹ Of these, we rated 10 articles as poor quality and do not discuss them further in this section.⁹²–^{96, 108, 110, 111, 117, 118} Detailed data on all studies can be found in Evidence Table 5.

Self-help approaches. Two studies examined a self-help approach to improving cessation rates. One study involved patients recently discharged from intensive care units (ICUs).¹¹⁵ This intervention included (1) verbal encouragement to remain nonsmoking at ICU discharge and at 8-week and 6-month clinic follow-up visits, (2) instructions for patient's immediate family not to smoke in the same room as the patient, and (3) a 6-week self-help ICU rehabilitation manual for the patient and his or her relatives. The manual emphasized the importance of remaining nonsmoking and provided practical tips for smoking cessation along with other general tips.

Patients receiving an ICU rehabilitation package were much less likely to return to smoking after discharge from the ICU than control patients, even though control patients received verbal encouragement to quit smoking during the recovery period.¹¹⁵ The investigators could not determine whether the smoking cessation advice in the ICU rehabilitation package or the whole package in general was responsible for the high quit rate. Including an exercise program in the package may have enhanced the likelihood of quitting smoking.

The other trial included patients undergoing lung cancer screening.¹⁰⁹ Participants in one intervention group received a handout with a list of 10 Internet sites related to stopping smoking and a brief description of each site; those in another group received two self-help booklets for smoking cessation, one of which provided up-to-date information on available pharmacotherapies for nicotine dependence.

In this trial, the groups did not differ significantly in 7-day point prevalence quit rates or in advancement in motivational readiness.¹⁰⁹ At 1-year followup, more of the subjects receiving Internet-based resources reported making a stop attempt (68 percent vs. 48 percent; P = 0.011).

Counseling. Five studies evaluated the effects of counseling—two studies in the hospital setting,^{112, 120} one in a combination of primary care clinics and hospitals,¹¹⁹ and two in private practices.^{105, 121} All female adult smokers were eligible for enrollment in one hospital-based studies¹²⁰ and all adult smokers in the other.¹¹² All diabetic adult and young adult smokers were eligible for enrollment in the combined-setting study.¹¹⁹ All interventions included nurse counseling, self-help materials, and follow-up contact either in person or by telephone, and all interventions were compared with usual care of brief advice to quit smoking, related self-help materials, or both. In the trial for women admitted to hospital with cardiovascular or peripheral vascular disease, the nicotine patch was offered (if not contraindicated) to those women who were smoking more than 19 cigarettes per day and who had not succeeded after trying to quit at least once.¹¹⁹

One hospital-based study examined the effects of three smoking cessation counseling interventions for inpatients. Interventions included modified usual care, brief advice, and brief advice plus more extended counseling during and after hospitalization.¹¹² Pharmacological aids were not provided. Inpatients in four hospitals were randomly assigned to each condition and followed up at 7 days and 12 months after discharge. Another hospital-based intervention involved smoking cessation and relapse prevention among women admitted to the hospital with cardiovascular or peripheral vascular disease.¹¹⁹ Neither of these hospital-based interventions increased biochemically verified abstinence rates at 12 months postdischarge, although self-reported abstinence rates were significantly higher for the most comprehensive intervention group.¹¹²

In the combined-setting study of diabetic patients seen in primary clinics and hospitals compared with a control group, those receiving nurse-managed assistance in quitting were, at 6-month followup, significantly more likely to quit smoking.¹¹⁹ This work, biochemically validated, produced quit rates of 17.0 percent for the intervention group and 2.3 percent for the control group (P = 0.001). Among those who did not quit, the intervention significantly decreased the mean number of cigarettes smoked per day (for the experimental group, 20.0 at baseline and 15.5 at followup; for the control group, 19.7 and 18.1, respectively, at the two measurements; P < 0.001).

The two different interventions for adults in private practices showed no significant differences in quit rates at 12-month followup.^{105, 121} One of these studies also showed no significant differences in quit rates at 3 months or in continuous abstinence between 3- and 12-month followups.¹²¹ The other study found no significant differences in biochemically confirmed quit rates between intervention and control groups at 6-month followup, 6-month sustained abstinence, or 12-month followup.¹⁰⁵

The three studies in this section among hospitalized patients are also included in a separate section of this report about interventions among hospitalized patients.^{112, 119, 120}

Single pharmaceutical therapy. Five studies examined the effect of a single pharmaceutical treatment on smoking cessation.^{100, 101, 106, 107, 114} Three studies evaluated the effect of bupropion, one studied the effect of nicotine gum and of different doses of nicotine gum, and one the comparative efficacy of transdermal nicotine and nicotine nasal spray. Two studies were based in hospitals: one accepting adults age 20 and over¹⁰¹ and the other involving adults employed by the hospital.¹⁰⁶ Three studies were population-based and enrolled only adults.^{100, 107, 114} One study examined efficacy of bupropion use in the indigenous Maori population in New Zealand.¹¹⁴

A 6-month, multicenter, parallel group, randomized, double-blind, placebo-controlled study compared 7-week treatment with bupropion SR (Zyban®) with placebo as an aid to smoking cessation in health care workers.¹⁰⁶ All participants were motivated to quit smoking and received behavioral counseling. Continuous smoking abstinence at week 7 was achieved by 43 percent in the bupropion group and 18 percent in the placebo group (P < 0.001). Side effects, although frequent, were simple and reversible in both groups and generally consistent with the findings of previous studies. Dizziness, insomnia, and pruritus appeared more frequently in the bupropion group than in the placebo group.

A randomized blinded trial examined the efficacy of bupropion SR for smoking cessation among an outpatient population. Of the 244 participants, 121 received a 7-week course of bupropion and 123 received placebo.¹⁰¹ All participants received 2 months of transdermal nicotine replacement therapy and 3 months of cognitive behavioral counseling. During treatment the investigators observed a trend toward increased quit rates among participants randomized to bupropion. The self-reported end-of-medication quit rates were 64 percent for the bupropion group and 57 percent for the placebo group (P = 0.23). The trend favoring bupropion persisted at 3 months of followup (P = 0.12) but was not apparent at 6 months and 1 year of followup (both P = 0.78). The 12-month quit rates, validated by either saliva cotinine or spousal proxy, were 22 percent in the bupropion group and 28 percent in the placebo group (P = 0.31). Based on biochemical validation, 19 percent of the bupropion group and 24 percent of the placebo group had quit smoking by 1 year (P = 0.36).

Holt et al. attempted to determine whether bupropion combined with smoking cessation counseling was effective for the indigenous Maori population of New Zealand.¹¹⁴ At 3- and 6-month followup, rates of abstinence in the bupropion group were significantly higher than rates in the placebo group. A model-based secondary analysis found a risk ratio of 2.44 in favor of bupropion for all time points. Bupropion was also safe and generally well tolerated, although three subjects did not complete treatment with bupropion because of a rash.

Garvey et al. used the Heaviness of Smoking Index, a subset of the Fagerstrom Test for Nicotine Dependence, to classify smokers planning a cessation attempt as low or high in nicotine dependence.¹⁰⁷ Subjects within each level of dependence were then randomly assigned to placebo, 2-mg, or 4-mg nicotine gum treatment. Subjects were also provided brief (5 to 10 minutes per visit) behavioral counseling during a 1-year period of followup. At 1 year postcessation, quit rates were 11.2 percent, 19.5 percent, and 18.4 percent for low-dependence smokers receiving placebo, 2-mg, and 4-mg gum, respectively (P linear trend = 0.20). For high-dependence smokers, quit rates at 1 year were 6.1 percent, 15.7 percent, and 20.7 percent for the placebo, 2-mg, and 4-mg gum conditions, respectively (P linear trend = 0.002). The interaction of nicotine-gum dose and dependence group was not significant (P = 0.42). The 2-mg and 4-mg doses did not differ significantly in effectiveness, although both doses were significantly more effective than placebo gum. Other variables related to abstinence at 1 year postcessation were a longer period of abstinence on a prior quit attempt, being married, higher education level, and having a nonsmoking spouse or significant other. Results indicate that nicotine gum is a significant aid to smoking cessation, more than doubling the odds of successful cessation compared with the odds for placebo gum users. The 4-mg dose provided a nonsignificant increase in cessation rates for high-dependence smokers.

Lerman et al. conducted a randomized, open-label clinical trial to evaluate the comparative efficacy of transdermal nicotine and nicotine nasal spray and identify predictors of treatment outcome in two university-based smoking cessation research programs.¹⁰⁰ Intervention consisted of behavioral group counseling and 8 weeks of therapy with nicotine nasal spray or transdermal nicotine. Abstinence rates for the transdermal nicotine and nicotine nasal spray groups were not significantly different at 6-month followup (15.0 percent vs. 12.2 percent, respectively; P > 0.2). Interactions in abstinence rates for subgroups of smokers were statistically significant (P < 0.05). Smokers who had low to moderate dependence levels, were not obese, and were white achieved higher abstinence rates with transdermal nicotine, whereas smokers who were highly dependent, obese, or members of minority groups achieved higher abstinence rates with nasal spray.

Combined pharmacotherapies. Three studies examined the effect of combined pharmacotherapies on smoking cessation.^{91, 99, 116}

In one, Bohadana and colleagues recruited subjects through a local newspaper and randomized them to either the intervention group (which received a nicotine inhaler and nicotine patch) or a control group (which received a nicotine inhaler and placebo patch).⁹¹ Smoking at intake was defined as smoking 10 or more cigarettes per day for 3 or more years and an expired CO level of 10 ppm or more.

Abstinence rates at 6 weeks, measured as expired CO of 10 ppm or more, were significantly higher for those receiving the nicotine inhaler and the nicotine patch than for those receiving the nicotine inhaler and placebo patch (60.5 percent vs. 47.5 percent, P = 0.09).⁹¹ At 6-month and 12-month followup, however, the groups did not differ significantly in continuous abstinence. One-year survival analysis showed a significant association between abstinence and treatment with nicotine inhaler plus nicotine patch (P = 0.04). In an examination of weight gain, subjects in the intervention group had gained less weight than the control group by week 2 (P < 0.01), but after 12 months, differences in mean weight gains were not significant. Mean nicotine substitution at week 6 was 60.1 percent in the intervention group and 24.6 percent in the control group (P < 0.001). At 12 months, the frequency of respiratory symptoms in abstinent subjects had fallen significantly compared with their baseline (for morning cough, P < 0.001; for morning phlegm, P = 0.002; for wheezing, P < 0.001; and for shortness of breath, P < 0.001). A trend toward improved lung function was observed but not significant at 12-month followup compared with baseline. Subjects in the control group reported significantly more intense withdrawal symptoms at week 1 (P < 0.001) and craving symptoms at week 6 (P = 0.04) than those in the intervention group. The most common adverse events were throat irritation (from the inhaler) and itching (from the patch).

Jorenby et al. recruited adult subjects through media advertisements.¹¹⁶ They randomized those in the intervention group to three conditions: bupropion only, nicotine patch only, or both bupropion and nicotine patch. Subjects in the control group received placebo pills and a placebo patch. Smoking at intake was defined as smoking at least 15 cigarettes per day. Self-report of smoking status and expired CO were used to assess smoking status at 6- and 12-month followups.

The abstinence rates at 12 months were 15.6 percent in the placebo group compared with 16.4 percent in the nicotine patch group, 30.3 percent in the bupropion-only group (P < 0.001), and 35.5 percent in the group given bupropion and the nicotine patch (P < 0.001).¹¹⁶ Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant. By week 7, participants in the placebo group had gained an average of 2.1 kg. Weight gain in the other groups was 1.6 kg in the nicotine patch group, 1.7 kg in the bupropion-only group, and 1.1 kg in the combined treatment group (P < 0.05). Subjects in the combined therapy group had gained significantly less weight than those in the placebo group (P < 0.05) or the bupropion-only group (P < 0.05). Groups did not differ significantly in mean weight changes after week 7. Adverse events were rare and tolerable; they included insomnia and headache.

In the third trial, Killen and colleagues recruited participants by placing program announcements in local newspapers and examined the efficacy of a smoking cessation treatment that combined nicotine replacement therapy via a transdermal system (TNS) with the antidepressant paroxetine (a selective serotonin reuptake inhibitor [SSRI]).⁹⁹ Smokers (N = 224) were randomized to one of three groups: (1) TNS and placebo; (2) TNS and 20 mg paroxetine; and (3) TNS and 40 mg paroxetine. Assignment to treatment was double-blind. TNS treatment was provided for 8 weeks; paroxetine or placebo was provided for 9 weeks.

Abstinence rates at weeks 4, 10, and 26 were as follows: (1) TNS and placebo: 45 percent, 36 percent, and 25 percent; (2) TNS and 20 mg paroxetine: 48 percent, 33 percent, and 21 percent; and (3) TNS and 40 mg paroxetine: 57 percent, 39 percent, and 27 percent.⁹⁹ The differences were not statistically significant. The combined treatment was more effective in reducing both craving and depression symptoms associated with smoking cessation. A subgroup analysis compared outcomes only among compliant participants. Abstinence rates at weeks 4, 10, and 26 were as follows: (1) TNS and placebo: 46 percent, 35 percent, and 24 percent; (2) TNS and 20 mg paroxetine: 64 percent, 43 percent, and 33 percent; and (3) TNS and 40 mg paroxetine: 74 percent, 51 percent, and 38 percent. The differences between paroxetine groups and the control group at week 4 were statistically significant.

Pharmacotherapy and psychological interventions. We identified six studies designed to examine the effect on cessation rates of interventions that had both pharmacotherapy and psychological counseling.^{97, 98, 102}–^{104, 113} Four studies were population-based studies of adults; two studies included members of a large health care system.

The population-based trial examined the effectiveness of the combination of fluoxetine (another SSRI antidepressant) and cognitive behavioral treatment (CBT).¹¹³ One and 3 months after the quit date, fluoxetine increased the likelihood of abstinence, as compared with placebo, among smokers with minor depression but not among those with little or no depression. As an adjunct to CBT, fluoxetine increased cessation by selectively benefiting medication-compliant smokers who displayed even subclinical levels of depression. Investigators were unable to predict cessation outcome on the basis of drug assignment, individual differences, or their interaction. Thus, they would not suggest that an interventionist could simply use the personal attributes they studied to predict which smokers might benefit from adjunctive fluoxetine before knowing something about whether a smoker is likely to adhere to an intensive treatment regimen involving medication plus CBT.

No evidence suggested that the more nicotine-dependent smokers derived special benefit from fluoxetine.¹¹³ The moderating effect of depression on fluoxetine responsiveness was independent of the effect of nicotine dependence; this effect persisted even after the variance explained by nicotine dependence was removed. These findings suggest that adjunctive antidepressant treatment offers little selective benefit for highly nicotine-dependent smokers.

Carpenter et al. studied the efficacy of smoking reduction aided by nicotine replacement therapy compared to motivational advice or no treatment by using a telephone-only intervention among smokers not currently interested in quitting.⁹⁸ They randomized these smokers (N = 616) to receive (1) telephone-based reduction counseling plus nicotine replacement therapy plus brief advice to quit, (2) telephone-based motivational advice plus brief advice, or (3) no treatment.

Over 6 months, more smokers in the reduction-counseling arm (43 percent) and the motivational arm (51 percent) made a 24-hour quit attempt than smokers in the no-treatment arm (16 percent; P ≤ 0.01).⁹⁸ The two active intervention groups, however, did not differ on this outcome variable (P ≥ 0.05). Similarly, 18 percent, 23 percent, and 4 percent in each group were abstinent (7-day point prevalence) at 6 months (P ≤ 0.01). Results indicated that smoking reduction using nicotine replacement does not undermine cessation; rather, it increases the likelihood of quitting to a degree similar to that from motivational advice.

Using a chronic disease model of smoking, Hall et al. undertook to determine the effects of long-term antidepressant and psychological treatment.⁹⁷ They randomly assigned 160 subjects who smoked at least 10 cigarettes a day to one of four treatment groups in a two-by-two design (nortriptyline [a tricyclic antidepressant] versus placebo by brief versus extended treatment). All subjects received 8 weeks of a transdermal nicotine patch, five group counseling sessions, and active drug or placebo treatment. Interventions for subjects in brief treatment ended at this point. Subjects in extended treatment continued taking nortriptyline or placebo to week 52 and received 9 monthly counseling sessions, with checkup telephone calls midway through each session. Subjects were assessed at baseline and weeks 12, 24, 36, and 52.

At week 52, point-prevalence abstinence rates with missing subjects imputed as smokers were 30 percent for placebo brief treatment, 42 percent for placebo extended treatment, 18 percent for active brief treatment, and 50 percent for active extended treatment.⁹⁷ With missing subjects omitted, these rates were 32 percent, 57 percent, 21 percent, and 56 percent, respectively. Differences were significant for the active extended condition at each of 24, 36, and 52 weeks.

In a randomized controlled trial, Macleod et al. investigated the effectiveness of telephone counseling as an adjunct to nicotine replacement therapy by transdermal patch in smoking cessation.¹⁰⁴ Smokers were randomized to either replacement therapy alone or replacement therapy plus telephone counseling (five sessions spaced according to a relapse-sensitive call schedule). Continuous abstinence rates over 28 days among participants receiving telephone counseling were significantly greater than among those not receiving telephone counseling at both 3 and 6 months (31.6 percent vs 25.1 percent; P = 0.04 at 3 months; and 30.1 percent vs 22.4 percent; P = 0.01 at 6 months). Similarly, 90-day continuous abstinence rates at 6 months were significantly greater for participants receiving counseling (26.7 percent v 18.6 percent; P = 0.004).¹⁰⁴

Two studies from the same research team examined characteristics associated with more clinically relevant smoking endpoints following treatment with bupropion SR in a large health care system.^{102, 103} In both studies, the researchers randomized smokers to receive one of four combinations of bupropion (150 mg or 300 mg) and behavioral counseling (tailored mailings or proactive telephone counseling); they assessed point-prevalent smoking status at 3 and 12 months. The Swan, Jack, et al. study focused on predictors of outcome;¹⁰² the Swan, McAfee, et al. study focused on group differences.¹⁰³

Findings related to smoking abstinence were the same in both studies. Bupropion dose was not associated with rates of smoking at 12 months. However, the odds ratio for 12-month smoking was 24 percent higher for those who received the tailored mail program than those enrolled in the proactive telephone-counseling program (OR, 1.24; 95% CI, 1.06–1.47).

Strategies to Improve the Success Rate for Quit Attempts for Special Populations

Synthesis of prior systematic reviews. Hospitalized patients. In a meta-analysis of four studies meeting selection criteria and relevant to the analysis comparing augmented smoking cessation treatment with usual care for hospitalized patients, Fiore et al. found that smoking cessation treatments have been shown to be effective for hospitalized patients.⁵ Augmented smoking cessation interventions among hospitalized patients increased rates of smoking abstinence. Because the meta-analysis was limited to four studies, the investigators made no attempt to categorize the augmented treatment with respect to type or intensity. For reference only, the augmented interventions in the analyzed studies included elements such as self-help via brochure or audio/videotape, chart prompts that reminded physicians to advise smoking cessation, pharmacotherapy, hospital counseling, and postdischarge counseling telephone calls.

In the Rigotti et al. review of interventions for smoking cessation in hospitalized patients, intensive intervention (inpatient contact plus followup for at least 1 month) was associated with a significantly higher quit rate than control (Peto OR, 1.82; 95% CI, 1.49–2.22, six trials).⁶³ Interventions with less than a month of followup produced no significant benefit (Peto OR, 1.09; 95% CI, 0.91–1.31, seven trials). They found no evidence to judge the effect of very brief interventions (<20 minutes) delivered only during the hospital stay. Longer interventions delivered only during the hospital stay were not significantly associated with a higher quit rate (Peto OR, 1.07; 95% CI, 0.79–1.44, three trials). Although the interventions increased quit rates irrespective of whether nicotine replacement therapy was used, the results for replacement therapy were compatible with other data indicating that it increases quit rates.⁶³

Pregnant women. Prior reviews included studies with substantial variation in the intensity of the intervention and the extent of reminders and reinforcement through pregnancy. All three reviews concluded that participants in intervention conditions experienced significant reduction in continued smoking in late pregnancy.^{5, 37, 61}

Racial and ethnic minorities. A prior review of interventions specifically designed for particular racial or ethnic groups demonstrated the efficacy of a variety of smoking cessation interventions for minority populations. The resultant recommendation is that members of racial and ethnic minorities should be provided treatments shown to be effective in the Treating Tobacco Use and Dependence guideline.⁵

Synthesis of current literature. We identified 13 studies not covered by prior reviews dealing with special populations; 10 studies dealt with hospitalized patients,^{112, 115, 119, 120, 123}–¹²⁸ two studies dealt with pregnant women,^{122, 129} and one with indigenous Maori.¹¹⁴ We described one of these studies in the self-help portion of this chapter and two in the counseling portion, but, because they dealt with hospitalized patients, we included them here as well.^{115, 119, 120} Of these, we rated four articles as poor quality (three for hospitalized patients¹²⁶–¹²⁸ and one for pregnant women¹²⁹) and do not discuss them further in this section. Detailed data on all studies can be found in Evidence Table 5.

Hospitalized patients by diagnosis. Three studies focused on improving cessation rates among hospitalized patients with specific smoking-related diagnoses.^{119, 120, 123} One study involved smoking cessation and relapse prevention among women admitted to the hospital with cardiovascular or peripheral vascular disease,¹²⁰ one included diabetic smokers,¹¹⁹ and one involved patients under the age of 78 years admitted for myocardial infarction, unstable angina, or care after coronary bypass surgery performed at other hospitals.¹²³ All interventions included nurse counseling, self-help materials, and follow-up contact either in person or by telephone, and all interventions were compared with usual care of brief advice to quit smoking and/or related self-help materials. In the trial for women admitted to hospital with cardiovascular or peripheral vascular disease, the nicotine patch was offered (if not contraindicated) to those women who were smoking more than 19 cigarettes per day and who had not succeeded after trying to quit at least once.¹¹⁹

All three of these hospital-based interventions failed to increase biochemically verified abstinence rates at 12 months after discharge. One, however, showed significant differences in self-reported abstinence at 12-month followup.¹²³

Hospitalized patients by intensity of intervention. Four studies examined the effect of varying the intensity of smoking cessation intervention among hospitalized patients.^{112, 115, 124, 125} One study involved patients recently discharged from intensive care units (ICUs).¹¹⁵ This intervention included (1) verbal encouragement to remain nonsmoking at ICU discharge and at 8-week and 6-month clinic follow-up visits, (2) instructions for patient's immediate family not to smoke in the same room as the patient, and (3) a 6-week self-help ICU rehabilitation manual for the patient and his or her relatives that emphasized the importance of remaining abstinent and provided practical tips for smoking cessation along with other general tips. In the study of recently discharged ICU patients, those receiving the intervention were much less likely to return to smoking after discharge from the ICU than control patients who received only the first component of the intervention. Investigators could not determine whether the smoking cessation advice in the ICU rehabilitation package or the whole package in general was responsible for the high quit rate.¹¹⁵ Including an exercise program in the package may have enhanced the likelihood of quitting smoking.

Reid et al. evaluated the efficacy of a stepped-care approach to smoking cessation treatment among smokers with coronary artery disease (CAD).¹²⁵ Stepped care refers to the practice of initiating treatment with low-intensity intervention and then exposing treatment failures to successively more intense interventions. Smokers hospitalized with CAD were provided a brief cessation intervention. The participants then were assigned randomly to either a more intensive stepped-care treatment (counseling and nicotine patch therapy) or no additional treatment.

In the second study of this type, Ratner et al. designed an intervention to help smokers abstain from smoking before surgery, maintain abstinence postoperatively, and achieve long-term cessation.¹²⁴ Their intervention included counseling and nicotine replacement therapy. Finally, one study examined the effects of three smoking cessation counseling interventions for hospital patients: (1) modified usual care, (2) brief advice, and (3) brief advice plus more extended counseling during and after hospitalization.¹¹² Pharmacological aids were not provided. Inpatients in four hospitals were randomly assigned to each condition and followed up at 7 days and 12 months postdischarge.

None of these studies showed significant differences in 12-month abstinence. In two studies, significant differences in abstinence emerged for the short term (i.e., 3 months and 6 months). In the stepped-care intervention study, treatment increased smoking cessation rates from 42 percent to 53 percent during a 3-month follow-up period (P = 0.05).¹²⁵ In the Ratner et al. study, treatment group participants (73.0 percent) were more likely to abstain from smoking before surgery than were controls (53.0 percent) (X² [1, N = 228] = 8.89; P = 0.003), and they were also more likely to be abstinent 6 months after surgery (31.2 percent vs. 20.2 percent) after controlling for covariates in a logistic regression analysis.¹²⁴

Pregnant women. A three-group randomized controlled trial was conducted from 1996 to 2001, with 583 women and their partners randomized to usual care (UC), a woman-only (WO) intervention, or a partner-assisted (PA) intervention.¹²² Followups occurred at 28 weeks of pregnancy and 2-, 6-, and 12-months postpartum. Women in the UC condition received provider advice to quit and a self-help guide. The WO group received UC components plus a late-pregnancy relapse prevention kit (booklet and gift items) and six counseling calls (three in pregnancy and three postpartum) initiated by a health advisor. Women in the PA group received the WO intervention, and their partners received telephone counseling and a support guide emphasizing skills to help the woman build and maintain her confidence to quit smoking. Partners who smoked also received cessation aids and related counseling.

Intent-to-treat analyses showed no significant differences by condition in women's reports of abstinence at any followup.¹²² In late pregnancy, more partners were abstinent in the PA condition (15 percent) than in the UC condition (5 percent) (P = 0.02).

Racial and ethnic minorities. In a study of whether bupropion combined with smoking cessation counseling was effective in treatment of tobacco use in indigenous Maori in New Zealand, the investigators found quit rates similar to those observed in other trials of bupropion and no special problems related to bupropion use.¹¹⁴

Population-Based Strategies

Tobacco users are more likely to quit using tobacco if they are engaged in community-wide, comprehensive programs that use multiple channels to engage individuals.^{7, 130} Comprehensive evidence-based programs usually include cessation services, policy initiatives such as smoke-free environments, increases in the unit price of tobacco products, worksite initiatives to increase cessation, and mass media education campaigns.⁷ Cessation services range broadly: widespread mass media campaigns to encourage quitting, provision of printed self-help materials, and intensive group or individual-based cessation therapies offered in-person or over the telephone or Internet.¹³¹

Synthesis of prior systematic reviews. A Cochrane review was the only previous report that evaluated the effectiveness of community-wide interventions to increase the implementation of proven population-level strategies for tobacco use cessation. The report defined a community intervention as a coordinated, multidimensional program aimed at changing adult smoking behavior, which involves several segments of the community and is conducted in defined geographical areas, such as town, city, county, or other administrative district. The aim was to identify factors in the design, implementation, or evaluation of such programs that may have influenced the smoking behavioral outcomes. The review included 32 studies that met inclusion criteria and two additional studies that compared more intensive with less intensive interventions but not with an “untreated” community.

The authors examined changes in smoking prevalence using cross-sectional follow-up data in 27 studies. For all adults, the net decline in smoking prevalence ranged from -1.0 percent to +3.0 percent per year in 10 studies.³⁶ Analyses for women showed a net decline ranging from -0.2 percent to +3.5 percent per year (11 studies); those for men indicated a net decline ranging from -0.4 percent to +1.6 percent per year (12 studies). The authors were unable to provide estimates for changes in cigarette consumption or quit rates because their included studies reported such measures in different ways and, in the case of quit rates, over different time periods. In sum, little convincing evidence exists that community interventions reduce smoking among adults.

Synthesis of current literature. We identified three new studies that met inclusion criteria (Table 12). Two randomized trials aimed to deliver effective strategies to large numbers of smokers at a low cost.^{131, 132} A pretest-posttest controlled group study investigated the effects of community intervention on smoking behavior and its determinants.¹³³

One RCT (rated good) examined the effectiveness of a computer-tailored advice program for callers to a reactive telephone help line service in Australia. The RCT assessed whether the computer-tailored advice enhanced a series of callback telephone counseling sessions as an alternative and complementary effort to proactive telephone callbacks.¹³¹ This strategy was designed not only to reach larger numbers of smokers but also to test whether varying the intensity of the intervention and personalizing cessation assistance influenced cessation. Slightly more of the participants who received a combined intervention, namely, the computer-tailored advice plus callback telephone counseling, made an attempt between baseline and 3-month followup than did the other two groups (computer-tailored advice only; control group receiving no extra help).¹³¹ Significantly more people in the combination program who tried to quit in fact succeeded. The difference in point prevalence between the groups declined over time. It was not significant at the 12-month followup because of a nonsignificant trend among the groups that did not receive callbacks to start quitting.

Use of nicotine replacement therapy varied across the groups.¹³¹ The group receiving only computer-tailored advice reported significantly lower use rates than the other two groups (i.e., the control and the group that received the combination intervention). The investigators analyzed the potential effect of replacement therapy on smoking status at 3 months using logistic regression. Nicotine replacement significantly improved outcomes (OR, 2.04; 95% CI, 1.22–2.73; P < 0.001), as did callback telephone counseling (OR, 1.84; 95% CI, 1.36–3.02; P < 0.001); computer-tailored advice had no effect (OR, 1.11; 95% CI, 0.72–1.72; P = 0.63).

The results indicate the questionable value of computer-tailored cessation materials, but they are largely consistent with other research showing an association between the greater likelihood of quitting smoking and the use of nicotine replacement therapy or callback counseling. The ineffectiveness of the computer-tailored advice program was most probably attributable to the fact that the program did not meet the needs of smokers who were already motivated to quit and actively seeking help.¹³¹ No evidence suggested that combining the two interventions (i.e., the computer advice and telephone counseling) was effective because, in an earlier trial of the callback service, the quit rates were marginally higher than those observed in this study.¹³¹

The other trial (rated fair), seeking to deliver effective strategies to large numbers of people, evaluated whether a structured smoking cessation program based in community pharmacies in Northern Ireland and London would result in a higher smoking cessation rate compared with ad hoc advice from pharmacists.¹³² The intervention package, “Pharmacists' Action on Smoking” (PAS), used a one-to-one counseling format with structured followup; the intervention was compared with brief, unstructured advice. Study site pharmacies displayed a poster on smoking cessation throughout the study; television, radio, and newspaper media were used to advertise the project to the general public. Smoking cessation was promoted to those using the pharmacy for nonmedical reasons, those asking for advice on minor ailments, and those being dispensed medicine by prescription.

Significantly more subjects assigned to the PAS intervention had abstained for 12 months (cotinine-confirmed) than those not assigned to the PAS intervention: 14.3 percent vs. 2.7 percent (X² = 16.2; P < 0.001).¹³² Use of nicotine replacement therapy was similar in both groups initially, but data were insufficient to estimate the contribution of either replacement therapy or counseling about replacement therapy use (or both) to overall cessation rates. Pharmacy type and size had no impact on the 12-month cessation rates.

The pretest-posttest control group design with two posttests (rated fair) evaluated the effects of a regional Dutch Heart Health Community intervention on smoking behavior and its determinants.¹³³ The community intervention included a regional mass media-led smoking cessation campaign (“Congratulations!”) using radio commercials, advertisements, and messages in papers, billboards, posters, and postcards in waiting rooms and public buildings. Smaller local activities arranged by representatives of local organizations supplemented these regional efforts. The investigators hypothesized that this combination of regional and local strategies would be more effective than a national mass media-led smoking cessation campaign consisting of various television programs, an information line, nonsmoking courses, mailings to various organizations, billboards in bus shelters, brochures, posters, and other materials.

The researchers found no significant differences between the intervention region and the control region on smoking behavior and its determinants at either 24 months or 36 months after baseline.

Provider and Health Care System-Based Strategies

Interventions in health care systems focus on two main approaches. One approach involves changing provider behavior relative to offering tobacco treatment services through provider education alone or with feedback and assessment. Another approach involves changing health care systems so that health care providers will be more likely to offer effective strategies either proactively or in response to client demand.³⁷

Synthesis of prior systematic reviews. Two reviews provide information on this issue in terms of interventions based in settings other than full communities. One report is from the Task Force on Community Preventive Services;⁷ the other is the 2000 update of the 1996 AHCPR guideline.⁵

Zaza et al. reviewed six interventions that health care systems can use to increase cessation of tobacco use by their members.⁷ They reported “strong” evidence of effectiveness for provider reminder systems with provider education, with or without client education, and for multicomponent interventions that include client telephone support. Provider reminders with provider education include efforts to educate and prompt providers to identify and intervene with tobacco-using clients and to provide supplementary educational materials when appropriate. “Sufficient” evidence of effectiveness enabled the Task Force to recommend use of health care provider reminders alone and reductions in patient out-of-pocket costs. Provider reminders can carry various types of information and can be delivered by a variety of methods, including chart stickers, vital sign stamps, medical record flowsheets, and checklists. Lowering patient out-of-pocket costs reduces financial barriers that impede access to effective cessation therapies. Finally, the authors reported “insufficient” evidence of effectiveness to recommend provider education alone and provider feedback and assessment.

To facilitate adoption of effective tobacco treatment in health care settings, the AHCPR guideline update used meta-analyses to identify six effective systems strategies.⁵ These included (1) implementing a tobacco user identification system in every clinic; (2) providing education, resources, and feedback to promote provider intervention; (3) dedicating staff to provide tobacco dependence treatment and assessing the delivery of this treatment in staff performance evaluations; (4) promoting hospital policies that support tobacco dependence services; (5) including tobacco dependence treatments (both counseling and pharmacotherapy) identified as effective as paid or covered services for all subscribers or members of health insurance packages; and (6) reimbursing clinicians and specialists for delivery of effective tobacco dependence treatments and including those interventions among the defined duties of the clinicians.

Synthesis of current literature. Twelve new studies met all inclusion criteria (Table 13).¹³⁴–¹⁴⁵ Of these studies, three were RCTs;^{140, 142, 144} four, cluster RCTs;^{134, 138, 139, 145} four, cross-sectional designs,^{135, 136, 141, 143} and one, a time series design.¹³⁷

Four randomized trials, three rated fair quality and one rated good, investigated efforts to train providers in effective strategies.^{134, 140, 142, 144} One study also trained general medicine residents.¹³⁴ Eight studies describing interventions conducted in health care systems to improve use of effective cessation strategies met all inclusion criteria and received quality ratings of fair.¹³⁵–^{139, 141, 143, 145} Six of these studies used some variation of an academic detailing approach (i.e., personal educational visits to clinicians in their own practice setting) to increase system support for cessation interventions.^{135, 138, 139, 141, 143, 145} One study examined the effect of physician attitudinal and behavioral variables on participation and effectiveness of general practitioners in offering a minimal smoking cessation intervention.¹³⁶ The group effectiveness study evaluated how a previously proven effective smoking cessation intervention is integrated into standard hospital practice.¹³⁷

Provider-based interventions. Researchers in one study designed training programs to help general practitioners and their practice assistants¹⁴⁰ and general medicine residents.¹³⁴ The aim was to help providers acquire and apply skills to help their patients quit smoking. Two other studies implemented AHCPR strategies⁵ in practice and internal medicine clinics to facilitate adoption of effective tobacco treatment in health care settings.^{142, 144}

Both training programs included skills training in counseling approaches tailored to smokers' readiness to quit smoking and instruction in the use of written self-help materials for patients. General practitioners' office assistants were also trained to apply the randomization and informed consent procedures.¹⁴⁰ To evaluate the effects of the training, Pieterse et al. randomized eligible smokers into two groups.¹⁴⁰ One group received brief (10-minute) counseling sessions with the physician that are based on the stages of change model, a self-help manual, and follow-up sessions led by practice assistants; the other group received usual care consisting of no counseling or advice on smoking except when initiated by the patient or when indicated by the contact reason (in which case, counseling was limited to straightforward stop-smoking advice and possibly referral to local municipal health organizations).

At 1-month followup, smoking abstinence rates were greater among those in the intervention group than among controls (OR, 2.56; 95% CI, 1.8–3.8).¹⁴⁰ This relationship held at the 12-month followup (OR, 1.51; 95% CI, 1.1–2.1). Continuous abstinence was also greater among intervention group subjects than among controls (OR, 3.04; 95% CI, 1.7–5.6).

In evaluating training for general medicine residents, Cornuz et al. stratified residents by clinic either in an intervention group trained in smoking cessation or in a control group trained in dyslipidemia.¹³⁴ The control group received training in the intervention 4 months later, after the 3-month patient recruitment period had ended. Eligible patients identified as smokers were randomly assigned to intervention (i.e., residents trained in smoking cessation) or control clinics (i.e., residents trained in managing dyslipidemia).

According to smokers' self-reports, trained residents used all counseling strategies significantly more often than control residents.¹³⁴ These strategies included assessing motivation to quit (29 percent vs. 19 percent, P = 0.05), offering help to quit (23 percent vs. 7 percent, P = 0.003), discussing benefits of cessation (21 percent vs. 12 percent, P = 0.05) and obstacles to cessation (16 percent vs. 6 percent, P = 0.01), giving a brochure (14 percent vs. 1 percent, P < 0.001), discussing strategies to prevent relapse (15 percent vs. 6 percent, P = 0.01), and setting a quit date (8 percent vs. 2 percent, P = 0.02). Compared with control residents, trained residents expressed significantly higher self-confidence (mean scores of 7.7 vs. 5.2; P = 0.002) and also a nonsignificantly higher level of self-perceived effectiveness in smoking cessation counseling (mean scores of 6.8 vs. 5.4; P = 0.09) 3 months after training.¹³⁴ At 12-month followup, 1-week smoking abstinence was significantly higher in the intervention group than in the control group (13 percent vs. 5 percent, cluster-adjusted OR, 2.8; 95% CI, 1.4–5.5). The proportion of smokers willing to quit was significantly higher in the intervention group than in the control group (94 percent vs. 80 percent; P = 0.007). Daily cigarette consumption tended to be lower in the intervention than in the control group, but the groups did not differ significantly. The groups also did not differ significantly in the proportion of smokers in the precontemplation stage or the proportion of smokers who moved forward one stage, applying the principles of educational outreach to improve clinical decisionmaking.

Katz et al. tested the effectiveness of a multimodality intervention to implement the AHCPR Smoking Cessation Clinical Practice Guideline in six family practice and two internal medicine clinics.¹⁴⁴ The intervention consisted of a tutorial for intake clinicians that instructed them on how to assess the patient's smoking status and how to provide brief smoking cessation messages to each smoker with feedback on performance, real-time reminders (i.e., modified vital sign stamp), onsite pharmacotherapy, and proactive telephone counseling.

Face-to-face interviews were conducted with clinic patients immediately after their office visit to assess how the clinic staff had performed guideline-recommended activities. In addition, clinic patients were contacted by telephone by study personnel, blinded to treatment group, and asked about their smoking habits at 2 and 6 months following the exit interview. Clinic patients who reported not smoking at 6 months were mailed kits for saliva collection to verify biochemically self-reported abstinence.¹⁴⁴

During the intervention period, more patients at intervention clinic sites were asked about their smoking status (OR, 3.1; 95% CI, 1.2–8.2; P = 0.02) and their willingness to quit smoking (OR, 6.4; 95% CI, 3.7–10.8; P < 0.001), were given literature about quitting (OR, 21; 95% CI, 8.8–49; P < 0.001), were assisted with setting a quit date (OR, 33; 95% CI, 11–100; P < 0.001), or were engaged in a discussion about pharmacotherapy (OR, 3.9; 95% CI, 2.5–6.3; P < 0.001). Among patients treated during the intervention period, those at intervention clinic sites were more likely than those at control sites to report being abstinent at the 2-month mark (16.4 percent vs. 5.8 percent, adjusted OR, 3.3; 95% CI, 1.9–5.6; P < 0.001) and the 6-month mark (15.4 percent vs. 9.8 percent; adjusted OR, 1.7; 95% CI, 1.2–2.6; P = 0.009) and to report continuous abstinence (10.9 percent vs. 3.8 percent). Although planned collection of confirmatory salivary cotinine tests of self-report cessation had very low response rates, the confirmed abstinence rates at 6 months showed no difference between intervention clinics and controls.¹⁴⁴

A secondary analysis¹⁴² of data from the same RCT of guideline implementation determined whether intake clinicians (registered nurses [RNs] and less costly personnel (licensed practical nurses [LPNs] and medical assistants [MAs]) are similar when performing smoking cessation activities that AHCPR guidelines had recommended.⁵ Using patient exit interviews, the investigators obtained information on differences in performance among RNs compared with MAs, RNs compared with LPNs, and LPNs compared with MAs. Patients were queried whether their intake clinician asked about their smoking, assessed their willingness to quit, gave them advice about quitting, and assisted them in quitting.

Performance of all guideline-recommended counseling activities was significantly greater for all types of nursing personnel at test sites than at control sites.¹⁴² MAs were significantly less likely to assess willingness to quit (adjusted OR, 0.4; 95% CI, 0.2–0.8, P = 0.005); they also tended to offer advice and assistance in quitting less often than RNs. Similar findings were observed for LPNs assessing willingness to quit (adjusted OR, 0.5; 95% CI, 0.3–1.0; P = 0.03). After accounting for personal beliefs, self-efficacy, and role satisfaction in cessation counseling, subset analysis in subjects with complete survey data revealed that being seen by an MA was no longer associated with statistically significant differences in performance. These results indicate that MAs and LPNs were less likely than RNs overall to perform actions recommended by the AHRQ smoking cessation recommendations.

Health care systems interventions. Practice sites for academic detailing interventions included community health centers, clinics in the Women, Infants, and Children (WIC) program, orthodontists' offices, primary care clinics, and family physician practices. Specific elements of an academic detailing approach varied across the six studies, but included

• An in-service training for staff members on how to asses and document smoking status as a part of regular collection of vital signs;¹⁴⁵

• A 1.5-hour workshop, antitobacco materials, reimbursement for provision of antitobacco prescriptions, and quarterly check-up visits;¹³⁵

• Provider training to deliver a smoking intervention based on national clinical practice guidelines tailored to the woman's stage of change and delivered through three channels (obstetric, pediatric, and WIC providers);¹³⁹

• An office practice management system to routinely screen for smoking status, prompt/remind providers to intervene, document the encounter, distribute materials and arrange followup;¹³⁹

• Establishment of program boards to coordinate the transfer of documentation among clinics, including periodic meetings with representatives from all clinics;¹³⁹

• Two to three day site visits designed to communicate with Directors, Pharmacy Service Chief, smoking cessation coordinators and primary care nurses about barriers to implementation of AHCPR Smoking Cessation Guidelines;¹⁴³

• Audit, feedback, and academic detailing for family physicians;¹³⁸ and

• Four or five physician-centered office visits in the intervention counties to encourage physician adoption of a smoking cessation strategy based on the “4As” model from the National Cancer Institute (NCI) and distribution of a copy of the NCI manual How to Help Your Patients Stop Smoking.¹⁴¹

Studies examined whether significant effects were achieved on clinician uptake and use of cessation strategies, on cessation rates among patients served by these clinicians, or both. Investigators used various approaches to assess clinician uptake and use of cessation guidelines and other evidence-based strategies, including exit, telephone, and other interviews of patients, medical record audit, and mail or telephone provider surveys. Study designs included three randomized trials with cluster randomization,^{138, 145} two cross-sectional¹³⁹ studies,^{135, 143} and a community-based quasi-experimental study.¹⁴¹

A multifaceted, practice-based intervention involving audit, feedback, and academic detailing to improve family physicians' use of evidence-based smoking cessation strategies enrolled 60 family physicians from 39 practices.¹³⁸ Their provision of smoking cessation advice was measured by patient recall, medical record audit, and self-report. Improvements between baseline and posttest in patient recall of physician advice about nicotine replacement patches and gum were significantly greater in the intervention group (P = 0.0056) than in the control group (P = 0.002).¹³⁸ Substantial increases occurred in patients' recall of assessment of smoking status and family physicians' use of quit dates, behavioral advice, and written materials in the intervention group, but these changes were not significantly greater than those in the control group. Notation of patient's smoking status and smoking cessation advice in medical records remained suboptimal in both groups.

Providers in community health centers and WIC offices received training to deliver a smoking intervention based on national clinical practice guidelines.¹³⁹ The program included (1) provider training tailored to the woman's stage of change and delivered through three channels (obstetric, pediatric, and WIC providers); (2) an office practice management system to screen routinely for smoking status, prompt/remind providers to intervene, document the encounter, distribute materials, and arrange followup; and (3) establishment of program boards to coordinate the transfer of documentation among clinics, including periodic meetings with representatives from all clinics. Providers in control clinics provided usual care. Five community health centers were randomized to intervention or usual care. Subjects were pregnant or postpartum women who were current smokers or smokers who had quit during pregnancy.

The intervention and usual care groups differed significantly in 30-day abstinence rates at the end of pregnancy among women who had not quit spontaneously upon learning of their pregnancy (26 percent vs. 12 percent; OR, 2.57; P = 0.05).¹³⁹ This effect remained at 1 month postpartum but was lost at 3- and 6-month postpartum followups.

Staff members in outpatient primary care clinics who usually take vital signs for each patient received in-service training on how to assess and document smoking status as part of the regular collection of patient information.¹⁴⁵ On exiting the clinic, patients were asked questions about their smoking habits and smokers were asked to participate in a follow-up telephone interview in 1 year. These later interviews revealed no statistically significant difference between either the intervention or control clinics for point-prevalence abstinence from baseline to the intervention phase. Chi square analysis indicated that abstinence was independent of being asked about smoking, receiving advice to quit, being prescribed nicotine replacement therapy, or having a follow-up appointment.

Orthodontists in private practice offices participating in a controlled trial to decrease the incidence of tobacco use among adolescents were enrolled in a cross-sectional interview study to determine the rate and determinants of tobacco prevention and cessation counseling to youth.¹³⁵ The experimental group received a 1.5-hour workshop, antitobacco materials, reimbursement for provision of antitobacco prescriptions, and quarterly check-up visits. Control group clinicians did not receive training materials or visits.

Orthodontists in the experimental group were more likely than those in the control group to ask their patients whether they use tobacco (4.8 percent vs. 2.9 percent; P < 0.01), to provide at least some cessation counseling to their patients who smoked (91 percent vs. 70 percent; X², 8; P < 0.01), and to report mostly positive reactions from tobacco users for cessation counseling (X², 7.8; P < 0.05).¹³⁵ Demographic, office, and clinic practice variables were not associated with cessation counseling. Higher rates of cessation counseling were associated (all P < 0.05) with asking patients whether they used tobacco, belief that counseling is important, belief that clinicians should receive counseling training, intention to attend training, and disagreement that counseling is not part of their job description.

The study that tested implementation of the tobacco guideline randomized 20 Veterans Affairs Medical Centers to an intervention or control group.¹⁴³ A multicomponent intervention was designed to increase three specific guideline recommendations: (1) documentation of tobacco use status in medical records, (2) delivery of cessation intervention to all smokers, and (3) liberal use of pharmacotherapy for smoking cessation. In a 2-day training meeting, the three target strategies were presented to physicians, nurses, psychologists, and pharmacists. The training recommended using electronic medical records to identify smokers, giving smoking cessation treatment within the primary care setting rather than using referral-based care, and removing restrictions to prescriptions of smoking cessation aids. Site visits by an interventionist provided academic detailing on barriers to implementation strategies.¹⁴³

Cross-sectional surveys were conducted at baseline and 1 year later (i.e., after the intervention) among a sample of randomly selected patients who had seen their primary care provider within 6 weeks. A cohort of current cigarette smokers identified at baseline also completed a follow-up survey 1 year after the intervention. At the 1-year point, medical records showed a significant effect on smoking status documentation (intervention medical records were more likely to document smokers than were those of the control group, 67 percent vs. 60 percent, P = 0.0007). The groups did not differ in quit rates, providers asking about smoking status, or being counseled to quit smoking.

In a community-based quasi-experimental study, Goldstein et al. delivered an academic detailing intervention to physicians in intervention counties during a 15-month period. The multicomponent office-based intervention aimed to increase primary care physicians' adoption, implementation, and maintenance of the NCI “4As” as a smoking cessation strategy. The intervention included four or five physician-centered visits and distribution of a copy of the NCI manual How to Help Your Patients Stop Smoking. The program was implemented through personal educational visits to clinicians in their own practice settings.¹⁴¹

Among smokers reporting a physician visit during the study period, the investigators reported a borderline significant effect at 24-month followup for those residing in intervention areas compared with those residing in control areas (OR, 1.35; 95% CI, 0.99–1.83; P = 0.057).¹⁴¹ Patients of experimental group physicians reported that about 60 percent of their doctors talked to them about smoking and advised them to quit; the figure was about 55 percent for control group physicians (X², 13.8; P = 0.000 [sic]).¹⁴¹ In a subgroup analysis, after controlling for confounding factors, Goldstein et al. also reported that, among smokers who visited an enrolled physician, those residing in physician intervention counties were significantly more likely than those residing in control counties to quit smoking at 24 months (adjusted OR, 1.80; 95% CI, 1.16–2.75, P = 0.008). Stage of change at baseline was the only other significant predictor of smoking cessation at 24 months (adjusted OR, 2.75; 95% CI, 1.89–3.98; P = 0.000 [sic]).

One interview-based study (rated fair) examined the effect of physician attitudinal and behavioral variables on participation and effectiveness of general practitioners (GPs) to offer a minimal smoking cessation intervention.¹³⁶ Attitudinal variables included (1) individual GP assessments of the influence of GPs in general, and of themselves in particular, on prevention efforts aimed at both smokers and other patients and (2) assessments of the potential that modern medicine has to affect disease outcome through screening and treatment. Behavioral variables included individual reports of knowing their own cholesterol level, being careful about diet, exercising regularly, and watching their weight. Matched pairs of smoking and nonsmoking GPs were invited to participate in a regional smoking cessation intervention.

Among the GPs who initially accepted, a significantly higher proportion of GP nonsmokers than GP smokers participated in the study (54.1 percent vs. 45 percent, X², 5.147; P < 0.05).¹³⁶ Nonetheless, those GP smokers who did participate achieved results similar to those of nonsmokers when comparing the success or lack of success in their patients' reports of quitting smoking. The smoking status of GPs was not significantly related to either point prevalence smoking status at 1 and 6 months or to sustained abstinence. These findings suggest that when minimal advice has an effect, that effect can be attributed more to the systematic nature of the intervention provision than to the attitudes or reported practices of the provider offering the advice.

A group effectiveness study (rated fair) evaluated how an RCT smoking cessation intervention, previously proven effective, was integrated into standard hospital practice.¹³⁷ Although this study had no comparison group, it provides useful, detailed data about continuation of a smoking cessation program. The intervention examined a nurse-managed smoking cessation program for general hospitalized patients, which continued for 3 years after trial completion. The intervention included physician advice, bedside education and counseling by a nurse specially trained in smoking cessation techniques, take-home materials (i.e., a videotape, workbook, and relaxation audiotape), nicotine replacement therapy if requested or indicated, and four nurse-initiated, postdischarge telephone counseling calls.

Of the patients identified as smokers, 50 percent enrolled in the program, 18 percent wanted to quit on their own, 20 percent did not want to quit, and 10 percent were ineligible.¹³⁷ The 12-month self-reported cessation rate (7-day point prevalence) was 35 percent if patients lost to followup were considered smokers and 49 percent if they were not. Patients hospitalized for cancer, cardiovascular, or pulmonary reasons were most likely to participate, and they had the highest self-reported cessation rates (cancer: 63 percent, cardiovascular: 57 percent, and pulmonary: 46 percent).

Effects of Smokeless Tobacco Product Marketing and Use

Adolescents and young adults continue to be a strategically important market segment for the tobacco industry.¹⁵ During 2001, the largest tobacco manufacturers spent $236.7 million on smokeless tobacco advertising and promotion, using images that portray the attractiveness of tobacco products.¹⁸ Growth in sales of smokeless tobacco moist snuff has been attributed to advertising and marketing campaigns that encourage young nonusers to experiment with low-nicotine starter products. Once adolescents or young adults begin to use smokeless tobacco, the tobacco companies' intent is to move new users to higher nicotine brands as nicotine dependence progresses.² An estimated 7 percent of high school students are current users of smokeless tobacco; males are the primary consumers.²⁰ Adolescents who use smokeless tobacco are more likely than nonusers to become smokers.¹⁵

Recently, tobacco companies have begun to market their smokeless tobacco products as less harmful alternatives to smoking tobacco, emphasizing that smokeless tobacco does not carry the same risks to others that are associated with smoking (i.e., secondhand and environmental tobacco smoke).⁴⁶ We believe it is too early to determine whether these harm reduction approaches to smokeless tobacco marketing are effective in increasing product use; however, we have included this issue in our literature search for KQ 4.

Synthesis of past literature reviews. Two types of smokeless tobacco are sold in the United States: chewing tobacco (i.e., loose leaf tobacco, plug, or twist) and snuff (i.e., finely ground tobacco that can be dry, moist, or in sachets).^{18, 19} Smokeless tobacco can lead to nicotine addiction and dependence.¹⁷ Evidence from the Surgeon General and others has linked smokeless tobacco causally with oral leukoplakia and oral cancers.^{2, 39} Since 1964, the Surgeons General reports have continuously examined the role cigarettes and smokeless tobacco play in developing cancers of the oral cavity and pharynx. As research has progressed, conclusions indicate that all forms of tobacco use (i.e., cigarettes, pipes, cigars, snuff, chewing tobacco, betel, and other smoked and smokeless products) can cause malignancies in any part of the oral cavity and pharynx except the salivary glands.^{1, 2, 6} Specific risks associated with the use of smokeless tobacco products are advanced periodontal disease, tooth decay, leukoplakia, stomach and pancreatic cancers, and heart disease.¹

Treating nicotine addiction (from cigarettes, pipes, cigars, and smokeless tobacco) will help prevent most of the approximately 30,200 new cases of cancer and 7,800 deaths from these cancers that occur annually in the United States. Eliminating smokeless tobacco use will prevent 12,300 new cases of esophageal cancer alone and 12,100 deaths from esophageal cancer annually.¹

Limited research indicates that increases in smokeless tobacco prices will reduce the use of smokeless tobacco, particularly by adolescents and young adults. Nonetheless, the tax on smokeless tobacco is well below that on cigarettes. Although increases in cigarette prices may reduce smoking among youth, increases may also boost the likelihood of smokeless tobacco use.²

Recommendations from the updated AHCPR tobacco cessation guideline advise treating users of smokeless tobacco with the same counseling cessation interventions recommended for smokers.⁵ Studies of pharmacotherapies to address nicotine dependence on tobacco have not provided sufficient evidence showing long-term abstinence among users; specifically, gum and nicotine patches have not increased abstinence rates.⁵ Because oral lesions caused by smokeless tobacco use are common, dental clinicians are in a suitable position to use minimal interventions to reduce smokeless tobacco use.^{2, 5} Recently, behavioral interventions by dental clinicians using oral examinations with feedback about the mucosal changes associated with smokeless tobacco use have had positive effects on abstinence (OR, 2.41; 95% CI, 1.79–3.24).⁵⁷ This finding suggests that dental health clinicians are in an opportune position to deliver brief but efficacious interventions to smokeless tobacco users.

Prior systematic reviews did not address issues relevant to KQ 4. Past reviews focused on risks associated with the use of smokeless tobacco and on the potential offered by smokeless tobacco cessation treatments. Information on tobacco product marketing is more likely to be disseminated in editorials, summary articles, and newspaper articles that were excluded from this review.

Synthesis of current literature. Our review of smokeless tobacco product marketing and use found no studies evaluating whether substituting smokeless tobacco for smoking results in less smoking-related harm; we also did not identify any studies indicating that any researchers have used data on harm and harm reduction associated with smokeless tobacco to model the potential health effects of substituting smokeless tobacco for smoking. We found two studies (both rated fair) that assessed whether smokeless tobacco marketing leads to greater use of these products or to substitution of smokeless tobacco for smoking (Table 14).^{146, 147} Both studies were population-based, used a cross-sectional design, and recruited only adolescent boys or young adult males.

In the larger study (N = 3,996 responders; response rate 62 percent), adolescent and young adult males 11 to 19 years of age provided information on their smoking and smokeless tobacco use behavior through responses on the Teenage Attitudes and Practice Survey (TAPS-I and -II) in 1989 and 1993.¹⁴⁷ The investigator used responses on these US-wide surveys to assess 4-year initiation rates of smokeless tobacco use and cigarette smoking in relation to each other; the investigator also examined switching between products.

In a multiple logistic regression analysis, which was adjusted for age and race, males who had been regular users of smokeless tobacco were more than three times as likely as never-users of smokeless tobacco to become smokers (OR, 3.45; 95% CI, 1.84–6.47). Current smokers were not different from never-smokers in the rate of initiating current regular use of smokeless tobacco (OR, 1.45; 95% CI, 0.5–4.22). Among males who were regular smokeless tobacco users but not smokers at baseline, 44.8 percent continued to exclusively use smokeless tobacco at followup, 25.5 percent switched to smoking at followup, 14.3 percent continued to use smokeless tobacco while also smoking at followup, and 15.2 percent were no longer using tobacco. Of the smokers at baseline who were not users of smokeless tobacco, 78.7 percent were still smokers 4 years later, 0.8 percent switched to using smokeless tobacco exclusively, 3.6 percent continued to smoke but also used smokeless products, and 16.9 percent stopped using tobacco altogether.¹⁴⁷

The other study (N = 2,814) assessed susceptibility to smokeless tobacco advertising in terms of risk factors in a study among adolescent and young adult males in California.¹⁴⁶ This analysis used the Youth Attitudes and Practice Survey (conducted in 1990, 1992, and 1993); the majority of the analysis was based on data from 1993. The investigators contacted a stratified random sample of young adults and adolescents 12 to 17 years of age through random-digit dialing and interviewed them to assess trends in smokeless tobacco use. The researchers specifically identified risk factors that distinguished youth who used or were at risk of using smokeless tobacco. Risk factors included current tobacco use, exposure to tobacco advertising and other smokeless tobacco users, susceptibility to use smokeless tobacco, level of rebelliousness, peers' use of drugs or alcohol, and peer norms.

Findings from the 1993 survey documented that the highest rate of smokeless tobacco use occurred among subjects 16 and 17 years of age (6.6 percent; 95% CI, 4.1–9.1). Exposure to smokeless tobacco advertisements was twice as high among males 16 to 17 years of age than among those 12 to 13 years of age (43.8 percent [95% CI, 38.8–48.8] and 21 percent [95% CI, 17.4–24.6], respectively). Recall of smokeless tobacco advertisements was significantly associated with smokeless tobacco use (AOR, 7.5; 95% CI, 3.1–18.1; P < 0.001). In addition, cigarette smokers were at greater risk of being smokeless tobacco users than youth who did not smoke (AOR, 3.3; 95% CI, 1.9–5.7; P < 0.001).¹⁴⁶

Populations with Psychiatric Conditions

People with psychiatric conditions are twice as likely to smoke as the general population and to smoke more heavily than other smokers.³⁰ As many as 30 percent of smokers seeking cessation treatment have a history of depression.⁵ Smoking cessation rates reported for the psychiatric population are lower than rates reported for the nonpsychiatric population.³⁰

People with psychiatric conditions may use nicotine to self-medicate. Neurobiological and psychosocial factors reinforce the use of nicotine in populations with co-occurring disorders. Traditional antipsychotics used for certain psychiatric conditions may result in increased smoking, whereas patients taking atypical antipsychotics may smoke less.¹⁴⁸ Smoking improves processing of auditory stimuli in patients and may lessen negative symptoms by increasing dopamine in the prefrontal and frontal cortex.¹⁴⁸ Smoking is also an integral part of psychiatric culture because it provides a daily pastime for patients who may otherwise have few activities to pursue.³⁰ With new smoking bans enforced in health care facilities, more information on the outcomes of smoking cessation strategies tailored to these specific populations is needed.

Synthesis of prior systematic reviews. Approaches to increase quit rates among individuals with psychiatric conditions include medications, educational strategies, and cognitive behavior modifications.³⁰ Smoking behavior in psychiatric populations remains a challenge, with health concerns and costs similar to those for nonpsychiatric populations. Although psychiatric populations have lower smoking cessation rates than nonpsychiatric populations, in the absence of relevant RCTs on smoking cessation for populations with psychiatric comorbidities, experts agree that clinicians should use smoking cessation treatments recommended for the general population, such as pharmacotherapies and counseling.^{5, 30}

Synthesis of current literature. We found six studies related to KQ 5; all relate to cessation efforts.^{113, 149}–¹⁵³ We found no studies on prevention per se; as this question is phrased, the populations of interest are already smoking. Table 15 presents information on five of these six studies. One study¹⁵³ was graded as poor because of postrandomization of exclusions and other major flaws, so it is not discussed further. Detailed information is presented in Evidence Table 9 (Appendix C).^§ Of the studies discussed for KQ5, we rated one as good and the other four as fair.

Three studies addressed smoking cessation interventions for populations with co-occurring morbidities.^{113, 150, 151} These RCTs, all rated fair, were conducted in the United States. One study implemented a smoking cessation intervention in a psychiatric hospital;¹⁵¹ the others were population-based interventions.^{113, 150} One trial included adolescents and the other two enrolled adults; the sample sizes ranged from 179 to 253.

Brown and colleagues compared the efficacy of a standard CBT smoking cessation treatment with standard smoking cessation treatment combined with CBT for depression.¹⁵⁰ Through newspaper, radio, and television advertisements, the study recruited regular smokers (i.e., smoked cigarettes for at least 1 year and currently smoke 10 cigarettes each day) between ages 18 and 70 years with a history of major depressive disorder (MDD) determined by structured interviews using the DSM-III-R. The 179 participants enrolled in the study received eight group counseling sessions over 6 weeks and standard CBT. Participants in the treatment group received “The Coping with Depression Course,” which served as the basis for the CBT.¹⁵⁰

Self-report of smoking status was collected and verified by expired CO at each treatment session from the quit date to the end of treatment; follow-up data were collected by telephone at 1, 6, and 12 months. No statistical differences were identified in 7-day point prevalence abstinence rates at 1, 6, and 12 months for the standard CBT (30.1 percent, 24.7 percent, and 24.7 percent, respectively) compared with the depression-based CBT (39.5 percent, 24.4 percent, and 32.5 percent, respectively). In the final steps of the generalized estimating equations (GEE) analysis, significant interactions occurred between treatment and heavy smoking (OR = 3.73; P = 0.02) and between treatment and recurrent depression (OR = 3.62; P = 0.02).¹⁵⁰

A second study from Brown and colleagues randomly assigned adolescent smokers between 13 and 17 years of age who had been hospitalized for psychiatric and substance use disorders into either a motivational interviewing (MI) or a brief advice (BA) tobacco cessation intervention.¹⁵¹ The MI arm consisted of two in-person, 45-minute motivational interviews during hospitalization.¹⁵¹ Participants in the MI arm received comprehensive manuals about relapse prevention and coping skills for mood management. Additionally, two courses of free transdermal nicotine patch therapy were offered to medically eligible participants. At the end of the MI intervention, participants received up to six postdischarge telephone counseling sessions, and their parents received up to four brief telephone counseling sessions. BA participants received 5 to 10 minutes of advice to quit smoking by one of the student therapists, a copy of the “I Quit!” self-help pamphlet, and (for those who were eligible) a one-time offer of a transdermal nicotine patch treatment regime.

The MI arm had 116 participants and the BA arm had 75 participants. The population was primarily female (62.3 percent) and white (94.8 percent). The mean age of participants was 15.4 years, and 68.6 percent met the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) criteria for nicotine dependence. Psychiatric disorders included mood, anxiety, disruptive behavior, attention deficit, and substance-related disorders. The investigators assessed nicotine dependence at 1, 3, 6, 9, and 12 months. Smoking abstinence, measured by self-report, was confirmed through biochemical verification using saliva cotinine.¹⁵¹

To assess whether MI would lead to more and longer quit attempts, reduced smoking, and more abstinence from smoking, Brown et al. employed hierarchical linear modeling, GEE analyses, and logistic regression.¹⁵¹ The findings did not show higher quit attempts for those receiving MI than those receiving BA (mean quit attempts = 1.1 vs. 1.3, P = not significant [NS]). Seven-day point prevalence abstinence at 1, 6, and 12 months was not significantly different between the groups (see Table 15 for point prevalence rates). The mean number of days for the longest quit attempt was 48.2 days for the MI group and 60.9 days for the BA group; however, this difference was not significant.

Two findings were associated with significantly less smoking among adolescent psychiatric patients.¹⁵¹ Examination of covariates revealed that having an anxiety disorder increased the odds for quit attempts (AOR, 1.99; 95% CI, 1.08–3.71); in the hierarchical linear model, higher discharge self-efficacy scores were associated with less smoking during followup (b₁ = -0.02, standard error = 0.007; P = 0.007). MI and BA were equally ineffective smoking cessation interventions for this population.

Hitsman et al. hypothesized that smokers with greater depressive symptoms and those with elevated weight concerns would be more likely to achieve tobacco abstinence when receiving fluoxetine (combined with CBT) than when receiving a placebo (and CBT).¹¹³ The first arm involved nine 1-hour, individual CBT sessions plus 30 mg fluoxetine for a total of 10 weeks. Participants were required to set a quit date within 2 weeks of drug treatment initiation. Participants quit smoking at the third CBT session, and medication stopped at the ninth CBT session, at which time the 6-month follow-up period began. Patients with fluoxetine levels less than or equal to 150 ng/ml were considered compliant. The second arm was the same as the first arm except that the fluoxetine dose was 60 mg, and fluoxetine blood levels less than or equal to 300 ng/ml were considered compliant. The third arm of the trial was also the same as the first except that participants received a placebo.

Participants were considered to be smoking if expired CO was greater than 8 ppm and saliva cotinine values were greater than 10ng/ml. Level of depression, nicotine dependence, weight concerns, and self-efficacy about quitting were also assessed. Baseline measures were similar across all treatment groups. Hitsman et al. applied predictive models using logistic regression with a hierarchical approach to variable selection to analyze the data. Separate hierarchical logistic regression using intent-to-treat analysis failed to yield any stable predictive models for smoking status at 1 week and 1, 3, and 6 months after the quit date.¹¹³

An interaction between fluoxetine treatment and the depression score occurred at 1- and 3-month followup for treatment-compliant patients only (n = 169). Participants treated with fluoxetine had a positive association between degree of depression and likelihood of abstinence (OR, 1.35; 95% CI, 1.00–1.81); for controls, the opposite was true, and increasing depression scores were associated with decreasing likelihood of abstinence. The fluoxetine effect was greater for individuals with depression scores in the upper quartile of the depression scale (Hamilton Rating Scale for Depression [HRSD], 3; OR, 2.0; 95% CI, 0.85–4.7) than for individuals in the lower quartile of the depression scale (HRSD, 1; OR, 1.10; 95% CI, 0.38–3.19). At 3 months, the interaction effect was sustained; fluoxetine selectively benefited smokers with higher initial levels of depression (OR, 1.39; 95% CI, 1.02-0.89) and patients receiving fluoxetine showed a positive association between degree of depression and likelihood of abstinence (highest quartile HRSD = 3; OR, 1.44; 95% CI, 0.53–3.91). Smoking characteristics predicting treatment compliance were nicotine intake at baseline, saliva cotinine (X², 11.4; P < 0.001), and expired CO (X², 5.3; P < 0.05).¹¹³

Populations with Substance Addictions

Smoking rates for alcohol and drug users are well above those for the average population, exceeding 70 percent.⁵ The risk of death is significantly higher for individuals with concurrent addictions of alcohol and nicotine than for individuals who abuse only alcohol or tobacco. Consequently, alcoholics are thought to be more likely to die from cigarette-related diseases than from alcohol-related diseases.¹⁵⁴

The best way to approach smoking cessation treatment with people who have chemical addictions remains controversial. Additionally, some in the substance abuse treatment community argue (on the basis of untested assumptions) that smoking cessation treatment threatens the process of alcohol rehabilitation.¹⁵⁴ Others claim that the opportunity to engage this population in smoking cessation treatment may be lost by delaying treatment until after sobriety.²⁴

Synthesis of prior systematic reviews. Multimodal strategies using nicotine replacement therapy in conjunction with psychosocial intervention strategies are effective in treating tobacco addiction in patients with alcohol and other substance abuse problems.⁹ Fiore et al. report that people with chemical and nicotine dependency should receive counseling and pharmacotherapy to assist with smoking cessation.⁵ Although these types of interventions had positive short-term effects for stopping smoking, maintaining long-term abstinence was not successful.⁹ Evidence is clear that smoking cessation treatment does not interfere with recovery from chemical dependency.⁹ This finding eliminates obstacles to providing this population with concurrent treatment for substance abuse and nicotine dependency.

Synthesis of current literature. Three studies examined smoking cessation treatments for alcohol and substance abusers; we excluded one study from this discussion because of a quality rating of poor.^{149, 152, 153} The other two studies, both conducted in the United States, received a good¹⁴⁹ and a fair¹⁵² rating. One study used a prospective cohort study design;¹⁵² the other was a RCT.¹⁴⁹ Both enrolled adults in substance use disorder programs; the samples size ranged from 706 to 499.

To examine long-term smoking cessation outcomes, Joseph evaluated the feasibility of a smoke-free policy and a nicotine treatment program implemented in a drug and alcohol treatment hospital.¹⁵² Patients admitted to the treatment facility were consecutively enrolled in the study. In 1988, before implementation of the smoke-free policy, patients were not provided with specific information about smoking or cessation. Patients in the facility when the smoke-free policy changed (i.e., those admitted to the hospital between May and July 1988) were excluded from the study. After implementation of the smoke-free policy, patients were required upon admission to acknowledge the smoke-free policy, sign a contract agreeing to abstain from nicotine during their treatment period, and agree to attend a smoking cessation program specifically designed for substance use patients. The program included (1) didactic lectures on the pharmacology of nicotine, (2) films, and (3) a discussion group.

Joseph used a one-page, standardized, self-administered questionnaire to assess smoking status and motivation to quit at admission and again during the third week of hospitalization.¹⁵² Structured telephone interviews at 1 year after hospitalization assessed substance use other than nicotine. The prepolicy patients (n = 156) completed posthospitalization telephone interviews at 16.2 months, and postpolicy patients (n = 163) at 10.7 months. Approximately 55 percent of the sample was lost to followup. The telephone interview assessed the long-term outcome of the patient's chemical dependency. Improvement in chemical dependency was defined as less or no use of the substance for which patients were treated at the time of hospitalization. Other outcomes were smoking status, motivation to quit, and use of substances other than nicotine.

At 3-week followup, the 24 percent of patients in the prepolicy group and 61 percent in the postpolicy group “want[ed] to quit” smoking (P ≤ 0.001).¹⁵² The proportion of patients who abstained from smoking for more than 1 week was significantly higher in the postpolicy group than in the prepolicy group (41 percent vs. 9 percent, P < 0.001). Postpolicy patients cut down significantly more on the number of cigarettes smoked while in the hospital than did the prepolicy patients (93 percent vs. 46 percent, P < 0.001). At the 1-year follow-up interview, 8 percent of the postpolicy patients and 3 percent of the prepolicy patients had quit smoking (P < 0.05). The groups did not differ significantly at the 1-year followup for nonnicotine substance use.

Joseph and colleagues compared the effects of treatment for nicotine dependence and intensive treatment for alcohol dependence, delivered concurrently, with the same nicotine dependence treatment delayed by 6 months.¹⁴⁹ Eligible participants included both men and women between the ages of 21 and 75 who met the criteria for alcohol dependence or abuse according to the DSM-IV and who smoked more than five cigarettes each day for a year. Participants with no interest in quitting were excluded from the study.

The nicotine dependence intervention included a combination of behavioral and pharmacological treatments. A 1-hour individual counseling session and up to three followup sessions conducted in person or by telephone were offered to participants. Participants in the action stage of change received a free prescription for nicotine replacement therapy unless they declined or had a medical contraindication. A combination of patches and nicotine gum was offered to participants who smoked more than 20 cigarettes per day. The intervention was identical in both treatment arms but delayed in one, which effectively established a temporary control group.¹⁴⁹

Biochemically validated self-reports were collected for both smoking and alcohol outcomes. Seven-day point prevalence abstinence rates were assessed at 3, 6, 12, and 18 months; 30-day and 6-month alcohol abstinence was measured at 6, 12, and 18 months. Using a simple likelihood ratio chi-square test and intent-to-treat analysis, the 7-day point prevalent smoking abstinence rates at 3 months were 15.5 percent in the concurrent treatment group and 4.4 percent in the delayed group (P < 0.0001). At 6 months, abstinence rates were 10.5 percent in the concurrent treatment and 5.2 percent in the delayed treatment group (P = 0.02); the delayed group, however, had not received the intervention at 3 and 6 months. Thereafter, at 9 and 12 months, the treatment groups did not differ significantly. The rate of prolonged smoking abstinence at 18 months for both groups was similar: 8.8 percent for concurrent treatment and 8.9 percent for delayed treatment. However, the participation rate in the concurrent treatment was significantly higher than in the delayed treatment (78.5 percent vs. 64.5 percent, P = 0.005; OR = 2.01; 95% CI, 1.35–2.99).

The alcohol abstinence outcomes at 6, 12, and 18 months for 6-month alcohol abstinence was lower in the concurrent treatment group (41 percent, 33 percent, and 41 percent, respectively) than in the delayed treatment group (56 percent, 42 percent, and 48 percent; P = 0.004, P = 0.11, and P = 0.01, respectively).

KQ 1. Effective Population- and Community-based Interventions to Prevent Tobacco Use in Adolescents and Young Adults

Population-based tobacco prevention interventions. Two studies implemented population-based tobacco prevention interventions.^{73, 79} Thomson et al. examined the effects of statewide youth tobacco access ordinances in Massachusetts and had one result in the expected direction.⁷⁹ Residents of towns with fewer free-standing tobacco product displays were less likely to perceive tobacco as easy to purchase. The study found an association between increased attempts to purchase tobacco and being older and male, but the study did not determine whether adolescents in towns with more tobacco access ordinances and regulations had less tobacco initiation. The second population-based study conducted within families was time intensive and required many resources to implement,⁷³ but it was successful at reducing tobacco initiation for a subset of the population (i.e., non-Hispanic whites). These two studies alone provided little evidence to draw conclusions about population-based tobacco prevention interventions.

Prior systematic reviews reported strong evidence of effectiveness for two approaches to tobacco use prevention among adolescents and young adults: (1) increasing the unit price of tobacco products, and (2) mass media campaigns run concurrently with other interventions such as increased excise taxes or school- and community-based tobacco prevention programs.⁷ We found no other research to add to existing evidence on increasing unit price for tobacco products or on mass media campaigns alone or in conjunction with other tobacco prevention efforts.

Sufficient evidence of effectiveness was determined for tobacco prevention strategies that mobilize community support in conjunction with restricting tobacco product distribution, regulating the mechanisms of sale, enforcing access-to-minors laws, and educating and training merchants.⁷ The findings from the Massachusetts study on statewide youth tobacco access ordinances augments the already sufficient evidence of effectiveness for tobacco prevention strategies that coordinate community-wide interventions to regulate and enforce access-to-minors laws.⁷⁹

Community-based tobacco prevention interventions. Ten studies implemented school-based tobacco prevention programs.⁶⁸–^{72, 74}–^{76, 81, 82} The studies had adequate sample sizes and used appropriate cluster analysis for school-level data. Limitations of school-based tobacco prevention studies include high attrition rates, lack of long-term follow-up assessments, and inconsistent definitions of smoking status and abstinence.

Programs done over a single school year provided mixed results. At the end of the interventions or shortly afterwards, two studies, one using classroom instruction and the other using personalized letters, reduced tobacco initiation.^{68, 71} Two other studies, however, both using classroom instruction (with one incorporating extracurricular activities and parent involvement), were effective only for boys.^{75, 81}

Interventions done over multiple school years, which provide longer or repeated exposure to prevention treatment, also produced mixed results. Two studies significantly reduced tobacco initiation rates,^{72, 74} one study reduced tobacco uptake for boys but not girls,⁷⁰ and two other studies had no effect.^{76, 82} No school-based study reported long-term effects.

Past systematic reviews report limited support for community- and school-based tobacco prevention programs for reducing tobacco initiation.^{34, 64} Long-term effects (i.e., greater than 2 years) have not been found with school-based interventions. Although educational strategies conducted together with population and community tobacco prevention efforts have postponed tobacco initiation,² this result was not evident in our studies. Existing evidence is sufficient to demonstrate that tobacco prevention measures conducted in school settings have positive short-term effects on preventing adolescents from initiating tobacco use.^{68, 70}–^{72, 74, 75, 81} Without definitive findings, evidence is insufficient to draw conclusions on the effectiveness of school-based programs to produce long-term effects. These results are consistent with past reviews that suggest school-based prevention strategies show limited effectiveness over the long run.³⁴

Provider-based tobacco prevention interventions. The only provider-based study we reviewed found no intervention effects.⁸⁰ Therefore, existing evidence is insufficient to determine whether tobacco prevention conducted in provider settings is effective for preventing tobacco use among adolescents. Past systematic reviews have not evaluated provider-based tobacco prevention strategies in health care settings.

Gaps in Tobacco Prevention Literature

Population-based tobacco prevention interventions. With the exception of tobacco industry and product restriction, earlier systematic reviews had extensively evaluated tobacco prevention strategies and provided intervention recommendations that included increasing tobacco product prices, enforcing tobacco laws and regulations, and conducting mass media education campaigns. Our review identified two population-based studies (only one related to past reviews and recommendations). Population-based tobacco prevention research lacks tobacco industry and product restriction interventions. More research is needed on the effects of price increases in combinations with other strategies. Too few studies of good and fair quality report on the effects of enforcing tobacco youth access laws and regulations aimed at retailers, and many studies do not use reduced initiation as the outcome variable. More rigorous research on the enforcement of youth access laws and regulations and their impact on smoking initiation among adolescents and young adults is needed to help build the evidence base.

Limited information is available on the effectiveness of implementing several population-based interventions simultaneously. Implementing tobacco prevention strategies that we know are effective concomitantly may greatly influence the uptake of tobacco use among adolescents and young adults.

Community-based tobacco prevention interventions. The body of evidence for school-based tobacco prevention is large; our review found several recent school-based tobacco prevention studies. Improving this body of evidence entails producing more rigorous research through adequate use of randomization, using control groups without contamination or confounding issues, achieving low attrition rates, and consistently using operationally defined outcome variables. The lack of long-term effects of school-based programs is problematic, so sustainability of effects remains unknown.

Additionally, we found no research about comprehensive interventions that include combining school-based prevention programs with other effective interventions such as media campaigns or enforcement of tobacco youth access laws and regulations. More research on community-based tobacco prevention interventions is needed, because our review found no other community-based interventions beyond what has been reported in prior systematic reviews.

Provider-based tobacco prevention interventions. Virtually no evidence is available to report on provider-based tobacco prevention for adolescents. Provider-based tobacco prevention may be practical only for dental or orthodontic practices, where many adolescents have repeated visits. Research in this area has focused on measuring implementation, content of counseling, and frequency of counseling, but studies did not report on our outcome variable for KQ 1 (i.e., reduced initiation of tobacco use).¹³⁵ Additional evidence is needed to assess whether provider settings are a viable place to implement tobacco prevention for this age group.

KQ 2. Effective Strategies for Increasing Consumer Demand for and Use of Proven Individually Oriented Cessation Treatment

Multicomponent strategies to increase the number of users who attempt to quit. Telephone counseling. Findings from recent reviews show that proactive telephone counseling is effective in increasing tobacco use cessation for adults, especially when combined with other counseling formats. We identified three studies of fair quality that focused on telephone counseling with related print materials.⁸⁴–⁸⁶ These studies, on their own, yielded insufficient and inconsistent evidence to draw conclusions about the efficacy of telephone counseling. Two trials reported significant increases in cessation in the short term among those using telephone counseling;^{85, 86} one trial reported no difference in either abstinence at each followup or in continuous abstinence.⁸⁴ When considered within the context of recent systematic reviews and meta-analyses, results from two studies in our review were consistent with that body of evidence; each demonstrated a positive effect of telephone counseling along with relevant printed materials on quitting smoking.^{85, 86}

We found only two studies targeting youth and young adults with telephone counseling. Both showed that telephone counseling for youth and young adults resulted in quit rates comparable to those for adults. The small number of studies led us to conclude that, although promising, the evidence is currently insufficient to draw conclusions with regard to the effect of telephone counseling on adolescents and young adults.

We found no study evaluating other multiple formats for increasing the number of users who attempt to quit. One study that evaluated counseling enhanced by providing information on genetic susceptibility to lung cancer showed a short but unsustained effect on cessation rates. Results of studies evaluating persistence of effect in the long term were inconsistent.

Numerous design and measurement issues complicate the interpretation of study findings for this portion of the review. Smokers were defined in various ways in these studies; no two studies applied the same definition. The trials evaluated very different interventions; they also used different measures of smoking status and abstinence and different follow-up intervals. The five studies using continuous abstinence as an outcome, however, did consistently define it as abstinence at all reporting periods.

Strategies to improve the success of quit attempts. Our review included studies evaluating the efficacy of cessation strategies such as self-help, counseling, single pharmaceuticals, combined pharmacotherapies, and pharmacotherapies combined with psychological counseling. Three studies were determined to be of good quality; all others were fair. Our findings for self-help strategies were consistent with those of earlier reviews. We found insufficient evidence of the efficacy of self-help strategies given the small number of new studies and discrepancies across their reported effects. In the one study that showed an effect, we could not estimate the independent effect of practical tips for smoking cessation compared with other components of the intervention such as tips on exercise.¹¹⁵ These findings were consistent with those of other recent reviews showing the marginal efficacy of self-help when offered without any person-to-person intervention.

Our review of counseling showed mixed results. Two studies reported increased abstinence with counseling treatment; three showed no effect. This evidence is insufficient on its own to make a recommendation differing from those of prior reviews indicating that even brief individual cessation counseling is efficacious.

In our review of pharmaceutical approaches to increasing the success of quit attempts, we reviewed five studies, all of fair quality. Three studies evaluated the effect of bupropion, one studied the effect of nicotine gum and of different doses of nicotine gum, and one examined the comparative efficacy of transdermal nicotine and nicotine nasal spray.

Findings are consistent with those of prior reviews showing that nicotine gum is a significant aid to smoking cessation, more than doubling the odds of successful quitting. No differences in dose response (2 mg vs. 4 mg) for nicotine gum were found in one study.

Results were mixed for bupropion. Two studies showed a significant benefit of bupropion compared with placebo at 6-month assessment. Patients ready to quit participated in one study;¹⁰⁶ participants at all stages of readiness in an indigenous population group were enrolled in another.¹¹⁴ In the final study, bupropion use in outpatients regardless of stage of readiness to quit showed a nonsignificant trend in favor of abstinence in the short term (3 months) but not at longer periods (e.g., 6 and 12 months).¹⁰¹ These mixed findings for bupropion are insufficient on their own to warrant a change in findings from previous reviews concluding that bupropion is a first-line pharmacotherapy for smoking cessation.

In a trial evaluating the comparative efficacy of transdermal nicotine and nicotine nasal spray, abstinence rates for the two groups were not significantly different at 6-month followup (15.0 percent vs. 12.2 percent, respectively; P > 0.2).¹⁰⁰ These results are consistent with estimates of significant effect for transdermal nicotine and nicotine nasal spray found in prior reviews. Smokers with low to moderate dependence levels, who were not obese, and who were white achieved higher abstinence levels with transdermal nicotine. By contrast, smokers who were highly dependent, obese, or members of minority groups achieved higher abstinence rates with nasal spray.¹⁰⁰ These findings provide useful information for those offering these pharmaceuticals to their patients.

Three studies assessed the efficacy of combined pharmaceutical therapy. Two of these studies showed a significant increase in long-term cessation (i.e., 12 months) compared with one pharmacotherapy alone. One of these studies was consistent with prior reviews showing that a combination of nicotine patch with a self-administered form of nicotine replacement therapy was more effective than a single form of replacement therapy. The other study showed the significant benefit of bupropion alone and in combination with the nicotine patch over the long term (12 months) compared with placebo. The third study showed no overall benefit of the patch and paroxetine combined, but did demonstrate significant differences between paroxetine groups and placebo in the short term (4 weeks).

We identified six studies combining pharmacotherapy and psychological interventions; interventions varied by type of pharmacotherapy and by content, format, and intensity of counseling. Five of these studies demonstrated a significant improvement in abstinence in treatment groups receiving combination pharmacotherapy and psychological interventions. These studies provide sufficient evidence of the efficacy of combined pharmacotherapy and psychological interventions and add to findings from previous reviews that pharmacotherapy either alone or in combination with counseling is effective.^{5, 30} The single study on fluoxetine is not sufficient to add it to the list of efficacious pharmacotherapies.

Strategies to improve the success of quit attempts for special populations. Nine studies evaluated strategies to increase the success of quit attempts among special populations. Three studies focused on hospitalized patients in different diagnostic categories;^{119, 120, 123} four examined the impact of varying the intensity of interventions for hospitalized patients;^{112, 115, 124, 125} one dealt with pregnant women¹²² and one with the indigenous Maori population in New Zealand.¹¹⁴

Hospitalized patients. When considering interventions for hospitalized patients by diagnosis, two studies of fair quality and one of good quality found results similar to those in prior studies; that biochemically validated abstinence rates at 12 months postdischarge, although reported as higher for the intervention group, were not statistically significant.^{119, 120, 123} In one study, significant differences at 12 months in compliant patients did not hold with intent-to-treat analysis.¹²³ Overall, studies in our review were in agreement with findings of the Rigotti, et al. review showing that there was no strong evidence that clinical diagnosis affected the likelihood of quitting.⁶³

Four studies considered whether cessation varied with counseling intensity for hospitalized patients.^{112, 115, 124, 125} All three studies compared an intensive intervention (defined as inpatient contact plus followup for at least 1 month) with usual care and/or a less intensive intervention. One study showed significant differences in self-reported, but not biochemically validated, abstinence at 12-month followup. Two studies showed significant increases in abstinence at 3- or 6-month assessments but not at 12-month assessments. One study found a significant increase in abstinence but was unable to attribute it directly to the intervention.

Pregnant women. One study using enhanced counseling to prevent postpartum relapse, telephone counseling during and after pregnancy, and partner assistance in quitting demonstrated no significant improvement in abstinence.¹²²

Ethnic groups. In a study of whether bupropion combined with smoking cessation counseling was effective in treatment of tobacco use in indigenous Maori in New Zealand, the investigators found quit rates similar to those observed in other trials of bupropion.¹¹⁴ They also reported no data to suggest that the Maori encountered any special problems related to bupropion use.

Gaps in the Literature for Increasing Demand for and Use of Cessation Treatments

Very few studies examined the relative population impact of proven cessation interventions. For example, information on how proactive telephone counseling support compares with a face-to-face intervention would be useful; similarly, whether nicotine replacement therapy is offered in either of these (or other) situations would be useful for those designing combination interventions. Little is known about differential rates of success of and enrollment in various programs and how each may either offset or enhance the other. These research questions are especially important given the move toward provider referral to quit-line services.

We found no studies comparing the specific aspects of telephone counseling with each other. Issues about the number and timing of calls and the role of feedback to the caller's primary provider have not been studied sufficiently.

We did not identify sufficient studies of the role of mass media in increasing use of cessation services among specific subsets of the population. Research on specific messages and their effectiveness in reaching and motivating target audiences such as adolescents, young adults, and persons with low income and educational status could improve the impact of such interventions.

We found very few studies examining the effectiveness of multiple intervention formats, of combination pharmacotherapy, or of adjuncts other than pharmacotherapy to individual counseling in increasing the success of smoking cessation interventions. Similarly, very few studies examined differences in either withdrawal symptoms or side effects associated with continuation or success of pharmacotherapy. Persistence of effect on smoking status over time was reported by only two studies; larger, prospective trials are likely needed to increase the evidence base for this issue. Finally, very few studies focused on ways to reach or treat special populations such as adolescents and young adults.

KQ 3. Effective Strategies for Increasing the Implementation of Proven Population-Level Tobacco Use Cessation Strategies, Particularly by Health Care Systems and Communities

Population-based implementation strategies. We found insufficient evidence to suggest that community-based interventions increase implementation of proven cessation strategies. Three studies, one of good quality and two of fair quality, focused on very different strategies and populations and produced inconsistent results.¹³¹–¹³³ Positive results were shown only in a trial using community-based pharmacists to discuss smoking cessation with smokers coming to their pharmacies for a variety of services.¹³² The positive results observed with pharmacist-led interventions suggest that further research into how pharmacists might be engaged in and support community-based strategies would be useful.

Provider- and health care system-based tobacco use cessation strategies. One prior systematic review reported “strong” evidence of effectiveness for provider reminder systems with provider education, with or without client education, and for multicomponent interventions that include client telephone support; “sufficient” evidence of effectiveness for provider reminders alone and reductions in patient out-of-pocket costs; and “insufficient” evidence of effectiveness to recommend provider education alone and provider feedback and assessment.⁷

A meta-analysis identified six systems strategies to facilitate adoption of effective tobacco treatment in health care settings: (1) implementing a tobacco user identification system in every clinic; (2) providing education, resources, and feedback to promote provider intervention; (3) dedicating staff to provide tobacco dependence treatment and assessing the delivery of this treatment in staff performance evaluations; (4) promoting hospital policies that support and provide tobacco dependence services; (5) including tobacco dependence treatments (both counseling and pharmacotherapy) identified as effective as paid or covered services for all subscribers or members of health insurance packages; and (6) reimbursing clinicians and specialists for delivery of effective tobacco dependence treatments and including those interventions among the defined duties of the clinicians.

Four studies showed that provider training improved provision and uptake of smoking cessation strategies.^{134, 142, 144} When examining the effect of these changes on smoking abstinence, two studies reported significant increases in abstinence compared with control, and one reported no differences at 6-month followup after biochemical verification of self-reported abstinence.¹⁴⁴ Our review supports the efficacy of provider-based strategies to increase the implementation of proven cessation strategies, but falls just short of providing sufficient evidence that these improvements in implementation will increase cessation.

In our review of interventions carried out in health care systems, we found sufficient evidence that academic detailing approaches improved provider delivery of effective smoking cessation treatments. Family physicians and other providers in office-based private practices, public clinics, hospitals, and orthodontist offices improved their knowledge and use of effective strategies as a result of personal educational visits in their own practice setting that included education, audit, and feedback.

The evidence was insufficient, however, to suggest that these improved treatment practices lead to significant, long-term increases in cessation among those being treated. Too few studies reported quit rates for the population served. Those studies reporting quit rates showed no consistent effects on cessation in the long term. One study found significant improvement in cessation in the short term; this occurred among pregnant women.¹³⁹ This finding is especially important given the immediate positive health outcomes associated with quitting in the short term for a pregnant woman and her fetus.

No evidence was found to conclude that provider attitudes and smoking behavior have an effect on uptake and use of effective interventions. The only study to test this relationship found no effect.¹³⁶

Evidence was also insufficient to suggest that interventions proven effective in earlier trials could be sustained as a part of routine care. Only one study examined this important aspect of improving the odds of maintaining an effective program.⁸⁶ The investigators found that successfully implementing a proven strategy after completion of the original trial is possible; they also determined that the sustained program produced quit rates comparable to those observed in the trial and that success was more likely among cancer, cardiovascular, and pulmonary patients.

Gaps in the Literature for Increasing Implementation of Cessation Strategies

We found inconsistencies in the literature evaluating academic detailing as an approach to improving implementation of cessation strategies. Additional studies are needed that use a standard definition of academic detailing, that observe changes not only in practice patterns but also in related smoking cessation outcomes, and that systematically assess the impact of academic detailing across and within practice types. At a minimum, all subsequent studies should incorporate all proven components of an academic model, such as provider reminder systems.

We found only one study describing how provider attitudes and smoking behavior affected provider use of effective interventions. Similarly, we found only one study examining the factors affecting incorporation of effective interventions into usual care. Many studies reported on implementation strategies to improve smoking cessation services in practice settings, but few studies collected data on whether these system-based improvements translate into increased quit rates.

KQ 4. Effect of Smokeless Tobacco Product Marketing and Use on Population Harm From Tobacco Use

Smokeless tobacco product marketing and use. Two studies with quality ratings of fair focused on smokeless tobacco use.^{146, 147} They investigated (1) how smokeless tobacco use affects smoking behaviors and (2) how exposure to smokeless tobacco advertising affects use. Tomar reported that smokers were more likely to quit smoking than become users of smokeless tobacco.¹⁴⁷ More importantly, users of smokeless tobacco were significantly more likely than nonusers of tobacco to become smokers.¹⁴⁷ One study does not provide sufficient evidence to draw conclusions on whether smokeless product marketing results in substituting smokeless tobacco for smoking.

Our review found one study that indicates smokeless tobacco marketing may lead to greater use at least for adolescents.¹⁴⁶ Choi et al. found that exposure to advertising increased adolescents' susceptibility to smokeless tobacco. One predictor of current use of smokeless tobacco is exposure to smokeless tobacco advertising, resulting in a sevenfold increase in current use.¹⁴⁶ Again, one study does not provide sufficient evidence to determine whether tobacco marketing increases smokeless tobacco use.

Prior systematic reviews did not address issues relevant to KQ 4. Past reviews focused on risks associated with the use of smokeless tobacco and on the potential offered by smokeless tobacco cessation treatments.^{1, 2, 5}

Gaps in Smokeless Tobacco Product Marketing and Use

Smokeless tobacco product marketing and use. The gaps in research on smokeless tobacco product marketing and use are substantial. No studies addressed two of three concerns presented in this review: (1) whether substituting smokeless tobacco for smoking results in less smoking-related harm on a population basis, and (2) whether data on harms and harm reduction associated with smokeless tobacco are used to model the potential health effects of substituting smokeless tobacco for smoking. Additional evidence is necessary to determine how smokeless tobacco use affects smoking behaviors and how exposure to smokeless tobacco advertising affects use.

KQ 5. Effectiveness of Prevention and of Cessation Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors

Tobacco cessation for persons with co-occurring morbidities. Three studies evaluated smoking cessation for persons with psychiatric conditions.^{113, 150, 151} Hitsman et al. hypothesized that smokers with greater depressive symptoms would be more likely to achieve abstinence when receiving fluoxetine combined with cognitive behavioral therapy (CBT) than when receiving a placebo and CBT.¹¹³ Brown et al. compared standard CBT with CBT tailored for depression for adults with a history of major depressive disorder (MDD).^{150, 151} A second study by Brown and colleagues treated adolescent smokers hospitalized for psychiatric and substance use problems with either motivational interviewing or brief advice tobacco cessation interventions.¹⁵¹ Two of the three studies^{113, 151} used some form of pharmacotherapy. Hitsman et al. achieved significant results in an adult population, but Brown et al. did not in an adolescent population.^{113, 151} Counseling paired with CBT produced smoking cessation rates for people with a history of MDD but depression-based CBT did not significantly increase smoking cessation rates over standard CBT for this population.

Consistent with prior reviews, pharmacotherapy was effective.^{5, 30} Participants treated with fluoxetine had a higher likelihood of abstinence than did participants treated with placebo, and fluoxetine benefited smokers with higher initial levels of depression.¹¹³ The effects of counseling and CBT are also congruous with the prior reviews, but depression-based CBT does not statistically increase abstinence rates above standard CBT abstinence rates.¹⁵⁰ Neither motivational interviewing nor brief advice tobacco cessation interventions were effective for adolescents hospitalized for psychiatric and substance use problems.¹⁵¹ Prior reviews did not report effective smoking cessation interventions for adolescents in this population.

Our review of the effect of smoking cessation interventions for persons with co-occurring morbidities supports prior reviews. Nonetheless, because we found only a limited number of studies and inconsistent results, it does not provide sufficient evidence to make further recommendations about the effectiveness of smoking cessation interventions in populations with psychiatric conditions.

Tobacco cessation for persons with substance abuse addictions. Two studies investigated smoking cessation among alcohol and substance abusers.^{149, 152} Joseph evaluated the feasibility of a smoke-free policy and a nicotine treatment program implemented in a drug and alcohol treatment hospital.¹⁵² In another study, Joseph et al. investigated the effects of concurrent versus delayed smoking cessation intervention in substance use and abuse treatment centers.¹⁴⁹ These studies used some form of counseling or classroom smoking cessation instruction with pharmacotherapy; compared with control groups, these approaches produced significant results. Joseph et al. found no difference in smoking cessation rate between concurrent and delayed interventions, a point that suggests that the intervention is effective for smoking cessation regardless of when it is implemented. However, alcohol abstinence was negatively affected (i.e., lower) in the concurrent treatment group compared with the delayed treatment group.¹⁴⁹

Consistent with prior systematic reviews,⁹ pharmacotherapy and psychological counseling significantly influence abstinence rates compared with control interventions in this population. The evidence is not consistent regarding the impact of smoking cessation treatment on non-nicotine substance use.^{149, 152} Although the two studies reported significant short-term effects for smoking cessation, only one study reported long-term (i.e., 12-month) abstinence rates. More than 50 percent of the participants were lost to followup in this study.¹⁵² The studies support findings from past reviews on the positive short-term effects of such interventions;³⁰ however, the body of evidence in our review is insufficient to point to further recommendations.

Gaps in the Literature for Effectiveness of Prevention and of Cessation Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors

The gaps in this evidence base remain significant for these populations. We found no research publications on tobacco prevention for populations with co-occurring morbidities and risk behaviors. Although the term co-occurring suggests that these populations are already smoking, tobacco prevention efforts, typically directed at adolescents, need to consider testing prevention strategies tailored for psychiatric and substance-addicted populations.

Additional studies need to determine whether smoking cessation treatment should be done at the same time as, at the beginning, or at the end of treatment for psychiatric and substance-addicted populations. Research to rule out any possibility of adverse effect from concurrent treatment regimes of psychiatric or substance use conditions and nicotine addiction is necessary to move forward with smoking cessation treatment for this population. More research explaining interaction effects among depression and smoking cessation interventions is needed.

Several studies allude to negative perceptions and attitudes of treatment center staff as barriers to treating nicotine addiction simultaneously with psychiatric conditions, especially, with substance abuse problems. Research exploring the legitimacy of these statements should be pursued. We believe the current opportunity to contribute to this area of tobacco research is extensive.

Inadequate Randomization and Concealment Allocation

Randomization procedures were rated inadequate in more than 25 percent of the randomized controlled trials (RCTs) we reviewed. Few studies used methods that ensured a chance assignment of participants in the treatment and control groups. Preset plans, alternation method, and hospital numbers were used in randomization schemes. Many studies failed to report how investigators achieved randomization. Only 25 percent of the RCTs reported adequate concealment allocation.

Deficient Study Designs

In the absence of RCTs, particularly for studies on the effects of smokeless tobacco marketing on use and population harm, we accepted cross-sectional and cohort study designs. RCTs are the ideal, but, in some instances, more suitable study designs were appropriate for answering the KQs. Other study design deficiencies concerned control groups, recruiting, and power analyses. In about one-quarter of the studies, the control group was not adequately described. Studies lacked descriptions of comparison or control groups. A small number of studies employed convenience and volunteer samples, and studies rarely reported a power analysis.

Refusal and Attrition Rates

Both refusal rates and attrition rates for tobacco cessation studies are quite high. Participants not ready to stop tobacco use will not participate, and those who do participate often drop out of studies because of noncompliance. Other issues contributing to refusal and attrition rates were parental refusal (i.e., tobacco prevention studies), relocation, discharge from hospital, and side effects of drugs. Investigators used intent-to-treat analysis in about two-thirds of the studies.

Construct Validity Problems

Some intervention studies assessed tobacco use behaviors with a single item (e.g., “Have you smoked in the past 7 days?”). A single question measuring tobacco use may not provide adequate information about the key construct, tobacco use. Multiple items measuring tobacco use help to determine whether the behavior measured is actually the intended behavior.

Studies often used a single version of the prevention or cessation intervention in comparison with a control group. This creates a “mono-operation bias,” in which the results of the study reflect only the particular version of the intervention and not the actual construct. Implementing a single version of a program, in a single place at a single point in time, may not capture the full breadth of the concept of the program. Arguably, the results of the study reflect only the peculiar version of the intervention implemented, not the actual construct proposed.

Reliability of Results

Biochemical verification was rarely used for tobacco prevention studies with adolescents. Randomized controlled trials, particularily pharmacotherapy studies, used biochemical verification such as expired carbon monoxide or salivary cotinine to verify self-reported tobacco use. Low response rates for expired carbon monoxide or salivary cotinine were reported. Although the reliability of self-reported data is assumed to be adequate for population-based studies on other topics, such data will typically underrepresent smoking status. Studies that used biochemical verification of smoking status did not routinely report statistics on discrepancies between self-report and biochemical verification. Often, investigators who used surveys and questionnaires to assess tobacco use, self-efficacy regarding quitting, perceived quitting intentions, and other variables did not document whether they (or others) had tested the instrument for reliability or other psychometric properties.

Inconsistent Terminology

Studies lacked consistent and clear definitions of tobacco use. The definition of nonsmokers in KQ 1 ranged from “never smoked even one cigarette or a puff of one” to “no smoking in past 30 days” or “past 12 months” to “no intention of smoking in high school.” The definition of cigarette smoking in the other KQs ranged from “10 cigarettes per day on average over last year” to “having smoked greater than 100 cigarettes during a subject's lifetime” and “having smoked at least 1 cigarette in the last week.” This degree of variation in the dependent variable in smoking cessation studies makes comparing effect sizes across studies challenging if not impossible.

Characteristics of Poor-Quality Studies

Table 16 documents the principal reasons for rating studies that we included and reviewed as poor quality. Only KQ 4 had all good or fair studies; KQ 2 had the highest number of poor studies. Problems with studies varied considerably, but we note in particular problems with study design (including selection of participants), lack of reporting of basic data (baseline; group comparisons), and attrition.

KQ 1. Effective Population- and Community-based Interventions to Prevent Tobacco Use in Adolescents and Young Adults

Population-based tobacco prevention programs. Future research in population-based tobacco prevention for adolescents and young adults needs to examine tobacco industry and product restrictions. In particular, how laws that regulate the content, labeling, promotion, and advertising of tobacco products affect adolescent and young adult tobacco use warrants greater attention. However, before tobacco prevention research in this area can move forward, changes in legislation are required. Continued research on whether enforcing tobacco youth access laws and regulations, when they are implemented community wide, can significantly reduce tobacco use support is important to build this body of evidence.

Other research using various combinations of population-based interventions may show that their effectiveness is greater than using interventions independently. Most important, future population-based studies on price increases, tobacco youth access laws and regulations, mass media campaigns, or tobacco industry and product restriction need to use control or comparison groups in their study designs to measure the impact that the intervention strategies have on the uptake of tobacco use among adolescents and young adults.

Community-based tobacco prevention programs. More community-based research that integrates an array of strategies such as community empowerment, dissemination of health education materials, media advocacy, youth antitobacco activities (e.g., contests, peer leadership programs), and letters to schools, parents, and tobacco retailers is urgently needed. Although sufficient evidence exists on the positive short-term effects of school-based tobacco prevention programs, more (and better-designed) studies demonstrating positive long-term effects will improve understanding of how best to prevent adolescents from initiating tobacco use. The approaches to tobacco prevention need to be comprehensive (e.g., combining school-based interventions with community mobilization, media campaigns, and enforcement of tobacco youth access laws and regulations). In general, the body of evidence for community-based tobacco prevention requires more rigorous research through adequate use of randomization, use of control groups without contamination or confounding issues, low attrition rates, and consistent and universal utilization of operationally defined outcome variables.

Provider-based tobacco prevention programs. Future research using providers as a conduit for tobacco prevention education should assess whether such settings are a viable place to implement tobacco prevention for adolescents and young adults. Because dental clinicians may be better suited for tobacco prevention, particularly in the case of smokeless tobacco use and for younger subjects, additional research in these settings is warranted.

KQ 2. Effective Strategies for Increasing Consumer Demand for and Use of Proven Individually Oriented Cessation Treatment

Increasing the number of users who attempt to quit. Additional research will further our understanding of how to increase consumer demand for and use of individually oriented cessation treatment. The role of mass media in driving individuals to quit-line and other cessation services should be examined. Audience research on the effectiveness of specific messages in reaching and motivating target audiences such as adolescents, young adults, and persons with low income and educational status can inform and increase the impact of mass media. For expanding the use of quit-line or other telephone support services, future research should compare specific components of telephone counseling and their relative impact on enrollment and continuation in these services as well as their impact on individual motivation to quit and smoking status. Future research could investigate issues related to suitability and appropriateness of the services such as the number and timing of calls, the role of feedback to the caller's primary provider, and the participants' satisfaction with cessation services.

The relative population impact of various proven cessation interventions should also be examined. One example is to determine how proactive telephone counseling support compares with in-person intervention, regardless of whether nicotine replacement therapy is offered. Documenting whether differential rates of success and enrollment offset or enhance each other on a population basis will also be an important addition to the knowledge base. These research questions are especially important given the move toward provider referral to quit-line services.

Strategies to improve the success rate for quit attempts. To improve the success rate of cessation services, well-designed studies should examine the effectiveness of multiple intervention formats, of combination pharmacotherapy, and of adjuncts other than pharmacotherapy in comparison with individual counseling for all smokers and for special populations of smokers. Adjuncts to counseling could include patient incentives, biomarker feedback, and other approaches designed to increase the likelihood of quitting. Future studies should also examine ways to reduce withdrawal symptoms and cravings among those attempting to quit using tobacco products. Research on ways to minimize the side effects associated with use of various individual pharmacotherapies and combined pharmaceutical regimes is also needed. Identifying ways to increase the persistence of effect on smoking cessation over time also warrants further study.

KQ 3. Effective Strategies for Increasing the Implementation of Proven Population-Level Tobacco Use Cessation Strategies, Particularly by Health Care Systems and Communities

Population-based implementation strategies. Some evidence, albeit inconsistent, suggests that interventions at the community level increase the implementation of tobacco use cessation strategies at the population level. Well-designed investigations should examine ways to reach out to smokers in the general population and to special populations such as adolescents and young adults with messages that motivate smokers and nonsmokers to become aware of, promote, and use existing cessation services.

Provider- and health care system-based tobacco use cessation strategies. Future research to improve strategies that providers and health care systems might employ should focus on well-designed studies of effective ways to change not only provider practice patterns but also related smoking cessation outcomes. To provide more awareness about what does and does not work with academic detailing, studies should assess the impact of academic detailing across and within practice types. At a minimum, future studies should incorporate all proven components of an academic model such as provider reminder systems.

Either within or separate from the academic detailing research, studies should explore how provider attitudes and smoking behavior affect provider use of effective interventions. Research is also needed to understand how other institutional barriers might hamper the adoption of effective strategies in health care settings and among providers. Better appreciation of the factors that affect incorporation of effective interventions into usual care is critical. More studies are also needed to understand how implementation of effective interventions by providers and/or health systems translates into increased abstinence from smoking.

KQ 4. Effect of Smokeless Tobacco Product Marketing and Use on Population Harm From Tobacco Use

Smokeless tobacco marketing and use. The field of smokeless tobacco marketing and use is wide open for new research. Future research should investigate whether new tobacco industry marketing strategies are increasing use of smokeless tobacco, and, if so, whether the observed increase applies differentially to specific user populations. Of special importance is examining possible links between point-of-purchase tobacco promotion and advertising and increased use of smokeless tobacco among adolescents and young adults. We see many opportunities to build evidence in the area of smokeless tobacco product marketing; we advise researchers to advance this research with rigorous study designs.

Robust research has established links between use of smokeless tobacco and certain cancers.¹ For that reason alone, future research should move away from investigating whether smokeless tobacco is a viable substitute for smoking and toward developing strategies to reduce its use. Research should continue to pursue possible treatments (i.e., counseling, pharmacotherapy) to assist or complement efforts aimed at smokeless tobacco cessation.

KQ 5. Effectiveness of Prevention and of Cessation Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors

Populations with psychiatric comorbidities and risk behaviors. Specifying the best approaches for smoking cessation treatment in populations with co-occurring morbidity and risk behaviors remains controversial. Because populations with these additional ailments and risk behaviors smoke at higher rates than others,^{9, 30} successfully accomplishing therapy may require pharmacotherapy and tailored treatments.^{9, 113}

Investigators need to examine the effects of pharmacotherapy, particularily antidepressants alone or in combination with counseling, not only for people with a history of depression but also for people currently diagnosed with clinical depression. Additional pharmacotherapy studies using antidepressants such as fluoxetine alone or in combination with other nicotine replacement therapy will help determine whether rates of smoking cessation in psychatric and substance abuse populations can be improved (relative to those in the general population).⁹

Comprehensive research on concurrent versus delayed treatment for smoking cessation and chemical dependency is warranted in light of recent inconsistent results regarding adverse effects on sobriety or other drug use.^{9, 149, 152} Investigators need to determine the benefits gained from higher participation rates with concurrent treatment against the cost of the adverse effects and the lost opportunity to engage this elusive population with delayed smoking interventions.

Finally, barriers to smoking cessation treatment in patients with other health problems, such as contraindications of pharmacotherapy, and the validity of concerns on the part of clinicians about hindering sobriety should also be investigated.

Methods Recommendations

Apart from the topics recommended above, we emphasize the need for investigators to use markedly better and more rigorous methods for all new research into tobacco prevention, control, and cessation. Essential scientific and technical improvements cut across many aspects of study design and conduct. Among the more critical are the following:

• Improved study designs using rigorous research methods such as control or at least adequate comparison groups, adequate randomization procedures, and tobacco use as the dependent variable for specific tobacco prevention strategies;

• Consistent definitions and measurement of baseline smoking status, abstinence, and continuous abstinence;

• Clear descriptions of interventions and comparison and control groups;

• Use and reporting of psychometrics of reliable and valid assessment instruments;

• Consistent definition of academic detailing;

• Use of biochemical validation of self-reported smoking status as appropriate;

• Use of intent-to-treat analysis; and

• Better methods of addressing drop-out and attrition, reporting power calculations, and taking loss to followup more into account in statistical analyses.

Finally, we note the absence of important documentation of study design, conduct, and other details in much of the literature reviewed. We hope that both investigators and those publishing their studies can find a way to provide more detail on methods, study populations, interventions, and the like, if not in published form then through web-based media.