Evidence Report/Technology Assessment Number 140 Tobacco Use: Prevention, Cessation, and Control Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-02-0016 Prepared by: RTI International?University of North Carolina Research Triangle Park, North Carolina Investigators Leah Ranney, Ph.D., M.A. Cathy Melvin, M.P.H., Ph.D. Linda Lux, M.P.A. Erin McClain, M.A., M.P.H. Laura Morgan, M.A. Kathleen N. Lohr, Ph.D. AHRQ Publication No. 06-E015 June 2006 This report is based on research conducted by the RTI International?University of North Carolina at Chapel Hill, North Carolina (RTI-UNC) Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290- 02-0016). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers; patients and clinicians, health system leaders, and policymakers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Suggested Citation: Ranney L, Melvin C, Lux L, McClain E, Morgan L, Lohr K. Tobacco Use: Prevention, Cessation, and Control. Evidence Report/Technology Assessment No. 140. (Prepared by the RTI International?University of North Carolina Evidence-Based Practice Center under Contract No. 290-02-0016). AHRQ Publication No. 06-E015. Rockville, MD: Agency for Healthcare Research and Quality. June 2006. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. This project was funded by the National Institutes of Health Office of Medical Applications of Research (NIH OMAR). The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome comments on this evidence report. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by e-mail to epc@ahrq.gov. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Barnett Kramer, M.D., M.P.H. Beth Collins Sharp, Ph.D., R.N. Director Director, EPC Program Office of Medical Applications of Research Agency for Healthcare Research and Quality National Institutes of Health Ernestine Murray, R.N., M.A.S. EPC Program Task Order Officer Agency for Healthcare Research and Quality ii i Structured Abstract Objectives: The RTI International?University of North Carolina at Chapel Hill Evidence-based Practice Center (RTI-UNC EPC) systematically reviewed the evidence on (a) the effectiveness of community- and population-based interventions to prevent tobacco use and to increase consumer demand for and implementation of effective cessation interventions; (b) the impacts of smokeless tobacco marketing on smoking, use of those products, and population harm; and (c) the directions for future research. Data Sources: We searched MEDLINE?, Cumulative Index to Nursing and Applied Health (CINAHL), Cochrane libraries, Cochrane Clinical Trials Register, Psychological Abstracts, and Sociological Abstracts from January 1980 through June 10, 2005. We included English-language randomized controlled trials, other trials, and observational studies, with sample size and follow- up restrictions. We used 15 Cochrane Collaboration systematic reviews, 5 prior systematic reviews, and 2 meta-analyses as the foundation for this report. Review Methods: Trained reviewers abstracted detailed data from included articles into evidence tables and completed quality assessments; other senior reviewers confirmed accuracy and resolved disagreements. Results: We identified 1,288 unique abstracts; 642 did not meet inclusion criteria, 156 overlapped with prior reviews, and 2 were not published articles. Of 488 full-text articles retrieved and reviewed, we excluded 298 for several reasons, marked 88 as background, and retained 102. Evidence (consistent with previous reviews) showed that (a) school-based prevention interventions have short-term (but not long-term) effects on adolescents; (b) multicomponent approaches, including telephone counseling, increase the number of users who attempt to quit; (c) self-help strategies alone are ineffective, but counseling and pharmacotherapy used either alone or in combination can improve success rates of quit attempts; and (d) provide training and academic detailing improve provider delivery of cessation treatments, but evidence is insufficient to show that these approaches yield higher quit rates. Recent evidence on the following topics was insufficient to change prior review findings: (a) effectiveness of population-based prevention interventions; (b) effectiveness of provider- based interventions to reduce tobacco initiation; (c) effectiveness of community- and provider- based interventions to increase use of proven cessation strategies; (d) effectiveness of marketing campaigns to switch tobacco users from smoking to smokeless tobacco products; and (e) effectiveness of interventions in populations with comorbidities and risk behaviors (e.g., depression, substance and alcohol abuse). No evidence was available on the way in which smokeless tobacco product marketing affects population harm. Conclusions: The evidence base has notable gaps and numerous study deficiencies. We found little information to address some of the issues that previous authoritative reviews had not covered, some information to substantiate earlier conclusions and recommendations from those reviews, and no evidence that would overturn any previous recommendations. v Contents Executive Summary ........................................................................................................................ 1 Evidence Report ............................................................................................................................ 9 Chapter 1. Introduction ................................................................................................................. 11 Scope of the Problem ............................................................................................................... 11 Tobacco Use and Its Impact ..................................................................................................... 11 Need and Purpose of This Systematic Review ......................................................................... 12 Uses of This Report .................................................................................................................. 13 Production of This Evidence Report......................................................................................... 14 Technical Expert Panel ......................................................................................................... 14 A Note on Terminology ........................................................................................................ 14 Organization of this Report................................................................................................... 14 Chapter 2. Methods....................................................................................................................... 17 Key Questions and Analytic Framework.................................................................................. 17 Key Questions....................................................................................................................... 17 Analytic Frameworks............................................................................................................ 18 Previous Reviews...................................................................................................................... 18 KQ 1. Effective Population- and Community-Based Interventions to Prevent Tobacco Use .................................................................................................................................... 20 KQ 2. Effective Strategies for Increasing Consumer Demand for and Use of Individually Oriented Cessation Treatments ......................................................................................... 21 KQ 3. Effective Strategies for Increasing Implementation of Population-Level Tobacco Use Cessation Strategies ................................................................................................... 22 KQ 4. Effect of Smokeless Tobacco Product Marketing and Use........................................ 22 KQ 5. Effectiveness of Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors .................................................................................................................. 23 KQ 6. Needed Research........................................................................................................ 24 Literature Review Methods....................................................................................................... 24 Inclusion and Exclusion Criteria........................................................................................... 24 Literature Search and Retrieval Process ............................................................................... 24 Literature Synthesis .................................................................................................................. 26 Development of Evidence Tables and Data Abstraction Process......................................... 26 Quality and Strength of Evidence Evaluation....................................................................... 28 Peer Review Process ................................................................................................................. 29 Chapter 3. Results ......................................................................................................................... 31 Results of Literature Searches .................................................................................................. 31 KQ 1. Effective Population- and Community-Based Interventions to Prevent Tobacco Use .. 34 Population-Based Interventions to Limit Access and Reduce Initiation .............................. 34 Community-Based Interventions to Prevent Tobacco Initiation .......................................... 38 KQ 2. Effective Strategies for Increasing Consumer Demand For and Use of Proven Individually Oriented Cessation Treatments ......................................................................... 49 vi i Increasing the Number of Users Who Attempt to Quit ........................................................ 49 Improving the Success Rate of Quit Attempts...................................................................... 54 Strategies to Improve the Success Rate for Quit Attempts for Special Populations ............ 68 KQ 3. Implementation of Proven Population-Level Tobacco Use Cessation Strategies.......... 71 Population-Based Strategies ................................................................................................. 71 Provider and Health Care System-Based Strategies ............................................................. 74 KQ 4. Effect of Smokeless Tobacco Product Marketing and Use on Population Harm from Tobacco Use .......................................................................................................................... 84 Effects of Smokeless Tobacco Product Marketing and Use................................................. 84 KQ 5. Effectiveness of Prevention and Cessation Interventions in Populations with Co- Occurring Morbidities and Risk Behaviors........................................................................... 87 Populations with Psychiatric Conditions .............................................................................. 87 Populations with Substance Addictions................................................................................ 91 Chapter 4. Discussion ................................................................................................................... 95 Quality of Literature and Strength of Evidence........................................................................ 95 KQ 1. Effective Population- and Community-based Interventions to Prevent Tobacco Use in Adolescents and Young Adults ............................................................................. 95 Gaps in Tobacco Prevention Literature ................................................................................ 97 KQ 2. Effective Strategies for Increasing Consumer Demand for and Use of Proven Individually Oriented Cessation Treatment ...................................................................... 97 Gaps in the Literature for Increasing Demand for and Use of Cessation Treatments ........ 100 KQ 3. Effective Strategies for Increasing the Implementation of Proven Population-Level Tobacco Use Cessation Strategies, Particularly by Health Care Systems and Communities ................................................................................................................... 101 Gaps in the Literature for Increasing Implementation of Cessation Strategies .................. 102 KQ 4. Effect of Smokeless Tobacco Product Marketing and Use on Population Harm From Tobacco Use.......................................................................................................... 102 Gaps in Smokeless Tobacco Product Marketing and Use .................................................. 103 KQ 5. Effectiveness of Prevention and of Cessation Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors .............................................................. 103 Gaps in the Literature for Effectiveness of Prevention and of Cessation Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors .................................. 104 Limitations of Evidence Base ................................................................................................. 104 Inadequate Randomization and Concealment Allocation................................................... 104 Deficient Study Designs ..................................................................................................... 105 Refusal and Attrition Rates................................................................................................. 105 Construct Validity Problems............................................................................................... 105 Reliability of Results .......................................................................................................... 105 Inconsistent Terminology ................................................................................................... 106 Characteristics of Poor-Quality Studies.............................................................................. 106 Future Research Recommendations........................................................................................ 106 KQ 1. Effective Population- and Community-based Interventions to Prevent Tobacco Use in Adolescents and Young Adults ........................................................................... 106 vi ii KQ 2. Effective Strategies for Increasing Consumer Demand for and Use of Proven Individually Oriented Cessation Treatment .................................................................... 109 KQ 3. Effective Strategies for Increasing the Implementation of Proven Population- level Tobacco Use Cessation Strategies, Particularly by Health Care Systems and Communities ................................................................................................................... 109 KQ 4. Effect of Smokeless Tobacco Product Marketing and Use on Population Harm From Tobacco Use.......................................................................................................... 110 KQ 5. Effectiveness of Prevention and of Cessation Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors .............................................................. 110 Methods Recommendations................................................................................................ 111 Conclusions................................................................................................................................. 111 References and Included Studies ................................................................................................ 113 Figures Figure 1. Overall analytic framework for tobacco use initiation and cessation............................ 19 Figure 2. Analytic framework for smoking cessation................................................................... 20 Figure 3. Tobacco use: prevention, cessation, and control article disposition ............................. 32 Tables Table 1. Final Key Questions........................................................................................................ 17 Table 2. Tobacco use: inclusion/exclusion criteria....................................................................... 25 Table 3. Medical subject headings and text words* ..................................................................... 26 Table 4. Modified body of evidence assessment table from Guide to Community Preventive Services ................................................................................................................................... 29 Table 5. Systematic reviews and meta-analysis used for this report ............................................ 33 Table 6. Effective population-based interventions ....................................................................... 37 Table 7. School-based tobacco prevention program smoking status definitions.......................... 40 Table 8. Effective school-based interventions .............................................................................. 41 Table 9. Effective provider-based interventions........................................................................... 48 Table 10. Multicomponent interventions to increase the number of users who quit smoking ..... 52 Table 11. Strategies to improve success rates for quit attempts for general and special populations.............................................................................................................................. 58 Table 12. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies .............................................................................................. 72 Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider-based and health care settings .................................................................................. 75 Table 14. Characteristics and results of studies assessing the effects of smokeless tobacco marketing ................................................................................................................................ 86 Table 15. Tobacco cessation interventions for persons with co-occurring morbidities and risk behaviors ................................................................................................................................. 88 Table 16. Characteristics of studies rated poor quality............................................................... 107 ix Appendixes Appendix A: Exact Search Strings Appendix B: Sample Data Abstraction Forms Appendix C: Evidence Tables Appendix D: List of Excluded Studies Appendix E: Acknowledgments Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/downloads/pub/evidence/pdf/tobaccouse/tobuse.pdf x Executive Summary Introduction The RTI International?University of North Carolina at Chapel Hill Evidence-based Practice Center (RTI?UNC EPC) conducted a systematic review of the literature on issues of tobacco use, prevention, cessation, and control on behalf of the National Institutes of Health (NIH), Office of Medical Applications of Research (OMAR), through the Agency for Healthcare Research and Quality (AHRQ). OMAR commissioned this review to summarize the available literature, frame the discussions regarding benefits and harms, and highlight the limitations of the entire evidence base for a State-of-the-Science (SOS) conference in June 2006. We synthesized existing literature on five main research issues needed to make progress toward public health gains worldwide. Specific substantive key questions (KQs) were: 1. What are the effective population- and community-based interventions to prevent tobacco use in diverse populations of adolescents and young adults? 2. What are effective strategies for increasing consumer demand among diverse populations for and use of proven individually oriented cessation treatments? 3. What are effective strategies for increasing implementation of proven population-level tobacco use cessation strategies, particularly by health care systems and communities? 4. What effect does smokeless tobacco product marketing and use have on population harm from tobacco use? 5. What is the effectiveness of prevention and of cessation interventions in populations with co-occurring morbidities and risk behaviors? Methods 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): 1 ? 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. Results 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. 2 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 3 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 4 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. 5 Discussion 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; 6 ? 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. 7 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. 8 Evidence Report Chapter 1. Introduction Scope of the Problem Tobacco use is the leading cause of preventable illness and death in the United States: it causes numerous cancers, heart disease, stroke, complications of pregnancy, and chronic obstructive pulmonary disease.1,2 Each year, 440,000 deaths and $157 billion in health-related economic costs result from tobacco use.3 Approximately 44.5 million people, or 20.9 percent of the adult population, reported smoking in 2004.4 Almost one-third of all tobacco users will die prematurely because of their dependence on tobacco.5 Tobacco Use and Its Impact The morbidity and mortality caused by tobacco use, documented by the reports of the Surgeons General since 1964, are clear and pervasive.1,2,6 Tobacco use begins primarily in adolescence and frequently leads to nicotine addiction.7 High rates of tobacco initiation among adolescents,8 variable smoking cessation rates in general and at-risk populations,9 and inconsistent implementation of smoking cessation interventions underscore the need for evidence-based research outlining recommended tobacco prevention and cessation strategies. With aggressive marketing of tobacco products, particularly smokeless tobacco, continuing to expand and build market share through product development,10 smoking cessation interventions must maximize their exposure to tobacco users during critical periods of transition or ?teachable moments? to reduce the significant morbidity and mortality rates associated with tobacco use. Many factors affect an individual?s tobacco use and associated tobacco-related mortality and morbidity. Disparities in both are reported by race and ethnicity, gender, level of education, socioeconomic status, and geographic region.2,11 Individuals most likely to smoke and to suffer and die from smoking-related disease are less educated, more likely to live in poverty, and more likely to be American Indians and Alaska Natives.8 Most adult smokers (98 percent) began smoking as adolescents or young adults; 82 percent started before age 18, and 16 percent started between the ages of 18 and 24.12 Each day more than 3,000 additional children and adolescents become regular tobacco users; one-third of them will die from tobacco-related causes.13,14 Predictors for smoking initiation vary by race and ethnicity; for example, black males are more responsive to peer pressure than other groups. Overall, children most likely to begin smoking are those engaged in other unhealthy or risky activities such as drinking, truancy, and delinquency.12 Preventing youth tobacco initiation and the transition from experimentation to addiction are both difficult. Adolescents are more susceptible than people in other age groups to influences from their families, friends, peers, society, and the tobacco industry that encourage tobacco use.15 Half of American youth have tried cigarettes by the time they are seniors in high school, and nearly one-quarter (23 percent) of seniors are current smokers. The prevalence of current smoking among high school seniors peaked in 1997 before beginning a decline that continued through 2004. However, this important decline in smoking has decelerated sharply. Among 8th graders the decline has halted and, because of strong cohort effects for smoking, the decline is 11 predicted to stop in the upper grades as well. The slowdown in price increases for tobacco products together with reductions in funding at both the national and state levels for antismoking campaigns have contributed to these developments.16 The smoking rate among young adults ages 18 to 24 is 23.8 percent, slightly higher than that among high school seniors. The national health objective for 2010 is to reduce the prevalence of cigarette smoking among adults to 12 percent or lower.8 Because data suggest that smoking initiation is a problem among both adolescents and young adults, a strong focus on preventing tobacco use initiation among these age groups is needed. Smokeless tobacco can also lead to nicotine addiction and dependence.17 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 These products, which contain 28 carcinogens, are known to increase the risk of developing oral cancers.19 An estimated 7 percent of high school students are current users of smokeless tobacco.20 Once users are dependent on tobacco, whether cigarettes or smokeless products, quitting is very difficult, although an estimated 70 percent of smokers would like to quit.8,21 The drug dependence resulting from tobacco use hampers efforts to sustain abstinence from tobacco for either a prolonged period or a lifetime.5 As a result, many users make multiple attempts to quit. In 2004, an estimated 14.6 million (40.5 percent) US adult smokers reported trying to quit by stopping smoking for at least 1 day during the preceding 12 months.8 In 2000, an estimated 70 percent of smokers said they wanted to quit, but few succeeded without help.22 Tobacco use treatment doubles quitting success rates.5 The rate of smoking is higher among people with psychiatric conditions and substance abuse problems.9,23 Populations with co-occurring morbidities have shown a lack of responsiveness to smoking cessation treatments; fewer than 15 percent of psychiatric patients quit.23 For people suffering from alcoholism, quitting tobacco before achieving sustained abstinence is particularly difficult.24 People with comorbidities often have overlapping conditions such as multiple addictions and/or psychiatric, cognitive, or medical conditions that may require more sensitive or specialized strategies and services for smoking cessation.9 Barriers to the use of these services exist for both tobacco users and health care providers. Some smokers are reluctant to disclose their smoking status to their clinicians, do not believe that their clinicians can help them to quit smoking, or assume that they will get ?attitude? from their clinicians instead of help with quitting tobacco use.25 More than one-third of current smokers report that they were never asked about their smoking status or urged to quit by their clinician.26,27 Fewer than 15 percent of smokers who saw a physician in the past year reported being offered assistance in quitting.28 Among current smokers and former smokers who were trying to quit and had seen a health care provider in the past year, only 61.8 percent received advice to quit from those providers.29 Individuals who continue to use tobacco products put themselves and their families at considerable risk of harm associated with tobacco use. By continuing to use tobacco, they are increasing their risk of smoking-attributable mortality and morbidity. They also expose members of their families and households to secondhand smoke and its health and safety consequences. 12 Need and Purpose of This Systematic Review The National Institutes of Health (NIH) Office of Medical Applications of Research (OMAR) reviews and evaluates clinically relevant NIH research program information and promotes the effective transfer of this information to the health care community. OMAR accomplishes this objective through its Consensus Development Program. This includes major Consensus Development conferences and State-of-the-Science (SOS) conferences when only less definitive evidence is available. As background for an upcoming SOS meeting, OMAR commissioned this systematic review on ?Tobacco Use: Prevention, Cessation, and Control? through the Agency for Healthcare Research and Quality (AHRQ). The aim is to summarize the available literature, frame the discussions regarding benefits and harms, and highlight the limitations of the entire evidence base. Through this report, OMAR seeks to increase the scientific rigor of the June 2006 SOS conference. The findings of our review clarify what is known about effective interventions and strategies for tobacco prevention and treatment as a means of providing authoritative background information for participants at the SOS conference. More broadly, we expect that our findings will be useful to major stakeholders in this arena, including policymakers, advocacy groups and community organizations, directors of smoking prevention and cessation programs, health care providers, smokers, and adolescents and young adults. We also identify future research priorities useful to government agencies and private sector funding organizations. Uses of This Report Quite apart from its use at the OMAR SOS conference in June 2006, we anticipate that this report will be of value to members of the various professional organizations whose missions include the prevention and cessation of tobacco use in all populations. These organizations include the American Legacy Foundation, the American Cancer Society, the American Heart Association, the Campaign For Tobacco-Free Kids, the March of Dimes, the National Heart, Lung and Blood Institute, the National Cancer Institute, and the Indian Health Service in the Department of Health and Human Services. More generally, the report will assist these and other organizations in their mission to inform and educate practitioners, policymakers, insurers, media representatives, high-risk populations, youth, and the general public. From this review, NIH and relevant institutes can guide funding policies by identifying serious gaps in the research on tobacco prevention and cessation strategies in diverse populations, strategies for implementing proven tobacco cessation treatments, and the effects of smokeless tobacco product marketing on population use. This review can also inform practitioners on the current evidence about outcomes associated with tobacco initiation and cessation, as well as tobacco implementation practices and smokeless tobacco marketing and use. Researchers will benefit from the concise analysis of the current status of the field, which will enable them to design future studies to address deficiencies in the field. Health educators can use this report to improve health communication. Finally, policymakers can use this report to allocate resources toward future research and initiatives that are likely to be successful. 13 Production of This Evidence Report 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 * Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 14 studies (Appendix D), and acknowledgments, including the TEP and peer reviewers (Appendix E). 15 Chapter 2. Methods In this chapter, we document the procedures the RTI International?University of North Carolina Evidence-based Practice Center (RTI?UNC EPC) used to develop this comprehensive evidence report on tobacco use prevention, cessation, and population harm. To provide a framework for the review, we first present the key questions and their underlying analytic framework. We then discuss the previous publications and analyses on which we built our systematic review. Following that section, we describe our strategy for identifying articles relevant to our key questions, our inclusion/exclusion criteria, and the process we used to abstract relevant information from eligible articles and generate our evidence tables. We also discuss our criteria for grading the quality of individual articles and rating the strength of the evidence as a whole. Finally, we explain the peer review process. Key Questions and Analytic Framework This report spans key questions regarding prevention of tobacco use among youth, Table 1. Final Key Questions tobacco cessation for diverse populations of KQ 1. What are the effective population- and adults in a variety of settings, and population community-based interventions to prevent harm resulting from smokeless tobacco tobacco use among adolescents and young marketing. Table 1 lists the key questions adults, including among diverse populations? KQ 2. What are effective strategies for increasing (KQs) as they were related from the Agency consumer demand for and use of proven for Healthcare Research and Quality individually oriented cessation treatments, (AHRQ). including among diverse populations? KQ 3. What are effective strategies for increasing Key Questions the implementation of proven population-level tobacco use cessation strategies, particularly by health care systems and communities? KQ 1 seeks to understand how to use KQ 4. What is the effect of smokeless tobacco community- and population-based product marketing and use on population interventions to prevent initiation of tobacco harm from tobacco use? use among adolescents and young adults KQ 5. What is the effectiveness of prevention and cessation interventions in populations with across diverse populations. For those co-occurring morbidities and risk behaviors? individuals who do become dependent on KQ 6. What research is needed to make the most tobacco products, eventual disease, disability, progress and greatest public health gains and death can be avoided if they quit using nationally and internationally (based on work tobacco products. KQ 2 seeks to identify for questions 1?5)? 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 17 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. Previous Reviews A good deal of research has been published on these issues, and some has been compiled in previous overviews and syntheses. Where possible, we elected to include systematic reviews as updates. We selected previous reviews that specifically covered all or parts of the key questions above as the basis for this report (see Chapter 3, Table 5). As a result, if studies already evaluated in existing reviews that met our inclusion criteria addressed the same outcomes of interest for the KQs, we did not reabstract data from them. By contrast, we did examine and extract data from studies published after these existing reviews for this report. To make this approach clear, we briefly describe existing appraisals of the evidence on each KQ (as depicted in Figures 1 and 2) before presenting our specific methods of literature searches and analysis. 18 Figure 1. Overall analytic framework for tobacco use, initiation, and cessation KQ4 KQ3 Implementation strategies Population strategies Marketing Reminder systems Media campaigns smokeless Provider education Restrictions and bans products KQ2 and KQ5 Strategies to Increased use of improve success smokeless rate tobacco Increased quit rates Individual cessation treatment Strategies to Increased use of increase number of cigarettes quitters Decreased consumption and use Increased cessation Population KQ1 ? Adolescent, young adults, and diverse populations Tobacco Morbidity and KQ2 ? Adolescents, young adults, adults, and diverse Initiation dependence mortality populations KQ3 ? Adults and diverse populations KQ4 ? Adolescents, young adults, and adults KQ5 ? Adolescents, young adults, and adults with co-occurring morbidities and risk behaviors Interventions Strategies to reduce initiation Outcomes Population-based Community-based Possible association KQ1 Adapted from Hopkins et al., 200131 19 Figure 2. Analytic framework for smoking cessation Adapted from Hopkins et al., 200131 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 20 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 21 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 22 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. 23 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. Literature Review Methods 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. 24 Table 2. Tobacco use: inclusion/exclusion criteria Category Criteria Study population Humans, all races, ethnicities, and cultural groups KQ 1: Adolescents (13-18 years of age), young adults (18-24 years of age), and diverse populations KQ 2: Adolescents, young adults, adults (18 years of age and older), and diverse populations KQ 3: Adults and diverse populations KQ 4: Adolescents, young adults, and adults KQ 5: Adolescents, young adults, and adults with comorbidities and risk behaviors Study outcomes KQ 1: Reduced initiation of tobacco use KQ 2: Increased quit rates; greater numbers of smoking cessation participants (i.e., increased participation) KQ 3: Increased quit rates; change in provider behaviors concerning smoking cessation KQ 4: Increased use; increased substitution of smokeless tobacco for smoking; harm reduction KQ 5: Reduced initiation of tobacco use; increased quit rates Study geography Developed countries: United States, Canada, United Kingdom, Western Europe, Australia, and New Zealand Time period KQ 1: Studies that addressed prevention of adolescent and youth tobacco use: January 1, 2000, to June 10, 2005 Studies that addressed product restrictions in the tobacco industry aimed at countering youth tobacco use: January 1, 1980, to June 10, 2005 KQ 2 and KQ 3: January 1, 1999, to June 10, 2005 KQ 4 and KQ 5: January 1, 1980, to June 10, 2005 Publication languages English only Admissible evidence (study Original research studies that provide sufficient detail regarding methods and results to design and other criteria) enable use and adjustment of the data and results; relevant outcomes must be able to be abstracted from data presented in the papers. Eligible study designs include ? Randomized controlled trials (RCTs); ? Nonrandomized controlled trials; and ? Observational studies: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies. Single case reports or small case series are excluded. Sample sizes must be appropriate for the study question addressed in the paper. RCTs: 30 or more participants Observational studies and nonrandomized controlled trials: 100 or more participants KQ, key question 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. 25 Article selection process. Once we had identified articles Table 3. Medical subject headings and text words through the electronic database Medical Subject Headings search, review articles, and Tobacco use cessation Marketing bibliographies, we examined Smoking cessation Social marketing abstracts and the full text of the Smoking/prevention and control Choice behavior articles to determine whether Smoking (and as text term) Advertising Primary prevention the studies met our inclusion criteria. Two reviewers initially Community networks Tobacco, smokeless evaluated abstracts for Community health services Spit tobacco (text term) Community health planning Chewing tobacco (text term) inclusion or exclusion; only one Community health aides Dip tobacco (text term) reviewer was needed to include Community health nursing Oral tobacco (text term) an article, but two reviewers Community health centers Community mental health services Comorbidity were required to exclude an Community medicine Risk-taking article. Dr. Ranney, the Study Community mental health centers Risk factors Director, reconciled all Depressive disorder Randomized controlled trials Depression conflicts. As articles appeared Single-blind method Bipolar disorder that met inclusion criteria at the Double-blind method Attention deficit disorder with abstract review stage, we hyperactivity Random allocation Stress disorders, post-traumatic obtained the article?s full text. Diabetes mellitus For the full text review, two Consumer satisfaction Hypertension reviewers read each article and Consumer participation Heart diseases Health services needs and demand Asthma determined whether it met our Obesity eligibility criteria. Again, Dr. Health plan implementation Ranney adjudicated any Diffusion of Innovation Patient education 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. Literature Synthesis 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); 26 ? 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 o Evidence Table 1. Effective population-based interventions o Evidence Table 2. Effective school-based interventions o Evidence Table 3. Effective provider-based interventions ? KQ 2 o Evidence Table 4. Multicomponent interventions to increase the number of users who quit smoking o Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations ? Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 27 ? KQ 3 o Evidence Table 6. Population-based strategies to increase the implementation of proven population-level tobacco use cessation strategies o Evidence Table 7. Provider and health care systems strategies to increase implementation of population-level tobacco use cessation ? KQ 4 o Evidence Table 8. Effect of smokeless tobacco product marketing and use on population harm from tobacco use ? KQ 5 o Evidence Table 9. Tobacco cessation interventions for persons with co-occurring morbidities and risk behaviors ? Systematic Review and Meta-analysis o 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.? 28 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. Table 4. Modified body of evidence assessment table from Guide to Community Preventive Services Evidence of Effectiveness Execution of Study Design Design Suitability Number of Studies Strong Good Greatest At least 2 studies Good Greatest or moderate At least 5 studies Good or fair Greatest At least 5 studies Sufficient Good Greatest At least 1 study Good or fair Greatest or moderate At least 3 studies Good or fair Greatest, moderate, or least At least 5 studies Insufficient Insufficient execution Insufficient design Too few studies Task Force on Community Preventive Services, 200556 Peer Review Process Among the more important activities involved in producing a credible evidence report is conducting an unbiased and broadly based review of the draft report. External reviewers for this report included clinicians and representatives of professional societies and advocacy groups, including TEP members (see Appendix D).? We charged peer reviewers with commenting on the content, structure, and format of the evidence report and asked them to complete a peer review checklist. We revised the report, as appropriate, based on their comments. ? Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 29 Chapter 3. Results This chapter presents results of our literature search and our findings for five key questions (KQs) regarding tobacco prevention, cessation, and control. These form the background for a State-of-the-Science (SOS) conference scheduled for June 12?14, 2006, under the auspices of the Office of Medical Applications Research (OMAR) of the National Institutes of Health (NIH). We report here on the following issues: ? KQ 1, initiation of tobacco use among young people; ? KQ 2, demand for and use of cessation treatments; ? KQ 3, increasing use and implementation of health care and community cessation programs; ? KQ 4, impact of smokeless tobacco product marketing on use, and ? KQ 5, cessation treatments for individuals with comorbidities and risk behaviors. KQ 6 is covered in Chapter 4 and deals with the limitations of these bodies of literature and our recommendations for future research. We discussed specific approaches for the first three KQs with our Technical Expert Panel (TEP) because, as noted in Chapter 2, we had a considerable pool of existing publications on which to draw. In each section below, we report first on previous reviews that covered the KQ, then on specific details about the yields of the literature searches and characteristics of the studies, and finally on literature pertaining to each question. Where appropriate, we provide summary tables presenting selected information on each included study that had a quality rating of good or fair. Appendix C* contains all the full evidence tables for each question. Evidence tables are organized by major analytic topic; studies are then listed alphabetically by author. A glossary at the beginning of the appendix defines all acronyms and abbreviations appearing in the tables. If several articles report on a single study, they are grouped in a single entry (row); if a study or article has information concerning more than one KQ, it appears in every relevant evidence table. Results of Literature Searches Our literature searches yielded 1288 possible articles (see Figure 3). (Appendix A presents the search terms and yield for each database searched in June 2005.) Beginning with the 1,288 titles and abstracts, we excluded 642 entries at the abstract level because it was apparent that they did not meet our inclusion criteria. * Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 31 Figure 3. Tobacco use: prevention, cessation, and control article disposition Title and abstracts identified through searches Citations excluded N = 1,288 N = 642 Published in abstract form only N = 2 Full text not obtained ? overlapped with included meta-analysis N = 156 Full text articles excluded: N = 298 1 Foreign language Full text articles retrieved 106 Wrong outcome/off topic N = 488 12 Sample size too small 3 Outside specified geographic area 93 Wrong publication type 22 Wrong study design 8 Followup too short Marked as background 53 Wrong date N = 88 Full text articles included in review N = 102 To focus our review on the most rigorous research and avoid duplicating previous reviews, we did a cross-walk (i.e., checked for duplicate articles) between the 644 citations and the citations from related systematic reviews and meta-analyses (Table 5). Articles that overlapped with systematic reviews and meta-analyses are listed in Appendix D. This process further narrowed the pool to 488 articles, which we then pulled and fully reviewed. Of the reviewed articles, 102 studies were included in this report. Table 5 lists the systematic reviews, meta- analyses, and dates of included literature used as a basis for topics equivalent to KQs 1, 2, 3, and 5. Specifically, the following publications have extensively covered tobacco prevention and cessation intervention strategies in diverse populations: ? The Guide to Community Preventive Services (2005), ? Treating Tobacco Use and Dependence (2000), ? Reducing Tobacco Use, A Report of the Surgeon General, (2000), ? The Cochrane Collaboration reviews (1998?2005), ? Treating nicotine use and dependence of pregnant and parenting smokers, (2003), 32 ? A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery (2004), ? Smoking cessation approaches for persons with mental illness or addictive disorders (2002), and ? Growing up tobacco free: preventing nicotine addiction in children and youths (1994). The cross-walk identified 156 common citations. Because these reviews served as the starting point for the evidence-based report, we did not abstract the 156 shared citations. Table 5. Systematic reviews and meta-analysis used for this report Included Review Type Authors Topic Research Cochrane Ebbert JO, Rowland LC, Montori V, Vickers Interventions for smokeless tobacco use 1992 to Mar. KS, Erwin PC, Dale LC, Stead, LF57 cessation 2004 Cochrane Lancaster T, Stead LF58 Physician Advice for Smoking 1974 to 2003 Cessation Cochrane Lancaster T, Stead L59 Self-help interventions for smoking 1981 to Apr. cessation 2005 Cochrane Lancaster T, Stead LF60 Individual behavioural counseling for 1984 to Feb. smoking cessation 2005 Cochrane Lumley J, Oliver SS, Chamberlain C, and Interventions for promoting smoking 1976 to Mar. Oakley L61 cessation during pregnancy 2004 Cochrane Moher M, Hey K, Lancaster T62 Workplace interventions for smoking 1981 to Feb. cessation 2005 Cochrane Rigotti NA, Munafo MR,Murphy MFG, Interventions for smoking cessation in 1974 to 2002 Stead LF63 hospitalised patients Cochrane Secker-Walker RH, Gnich W, Platt S, Community interventions for reducing 1970 to Jan. Lancaster T36 smoking among adults 2002 Cochrane Sowden A, Arblaster L33 Mass media interventions for preventing 1983 to Aug. smoking in young people 1998 Cochrane Sowden A, Stead L64 Community interventions for preventing 1983 to Sept. smoking in young people 2002 Cochrane Stead LF, Lancaster T65 Group behaviour therapy programmes 1981 to Feb. for smoking cessation 2005 Cochrane Stead LF, Lancaster T, Perera R66 Telephone counseling for smoking 1991 to Oct. cessation 2002 Cochrane Thomas R34 School-based programmes for 1980 to Jan. preventing smoking 2002 Systematic el-Guebaly N, Cathcart J, Currie S, Brown Smoking cessation approaches for 1990 to 2000 review D, Gloster S30 persons with mental illness or addictive disorders Meta-analysis Fiore MC, Bailey WC, Cohen SF, et al.5 Clinical practice guideline update: 1995 to 1999 Treating Tobacco Use and Dependence Meta-analysis Prochaska JJ, Delucchi K, Hall SM9 A meta-analysis of smoking cessation 1991 to 2003 interventions with individuals in substance abuse treatment or recovery Systematic Lynch BS, Bonnie RJ32 Growing up tobacco free: preventing 1990 to 1993 review nicotine addiction in children and youths Systematic Melvin, CL, Gaffney, C37 Treating nicotine use and dependence 1994 to 2003 review of pregnant and parenting smokers: An update Systematic US Department of Health and Human Reducing tobacco use: a report of the Not reported review Services Surgeon General Systematic Zaza S, Briss PA, Harris KW7 The Community Preventive Services 1976 to May review Guide: Tobacco (Chapter 1) 2000 33 We included original research studies that (1) were published beyond the date range included in the systematic reviews, (2) concerned topics related to the questions not covered by the reviews, and (3) provided sufficient detail regarding their methods and outcomes. The approaches for each specific question are as follows. For KQ 1, we included studies published between January 1, 2000, and June 10, 2005, that addressed topics 1 through 4 in Chapter 2. We also relied on the synthesis of previous reviews and meta-analyses for research and recommendations published before 2000. We included all primary data collection studies that addressed product restrictions in the tobacco industry (i.e., laws that regulate the content, labeling, promotion, and advertising of tobacco products), which represents subjects that the other systematic reviews did not cover. For KQ 2 and KQ 3, we included studies published between January 1, 1999, and June 10, 2005. We relied on the synthesis of past reviews and meta-analyses for research and recommendations published before 1999. For KQs 4 and 5, we included research found between January 1, 1980, and June 10, 2005, pertaining to the specific question. KQ 1. Effective Population- and Community-Based Interventions to Prevent Tobacco Use The primary goals of population- and community-based interventions are to prevent or delay experimentation with tobacco and to prevent the transition from experimentation to regular use. Additionally, these interventions motivate and encourage people to quit. For the purpose of this report, population-based interventions employed traditional population sampling techniques such as random-digit dialing, and nationwide surveys to recruit participants and collect data. These interventions are easily generalizable to large groups of people. Community-based interventions are directed at a distinct segment of society that shares similarities or fellowship, and generalizability is limited by the uniqueness of the community studied. As shown in our analytic frameworks for KQ 1 (in Chapter 2), we examined the effectiveness of population- and community-based strategies to prevent tobacco use by reducing tobacco initiation among adolescents and young adults. Prevention of tobacco use is measured by differences or changes in (1) self-reported tobacco use among adolescents and young adults, (2) self-reported purchases of tobacco products, (3) tobacco obtained from commercial sources (e.g., vending machines), and (4) retailer sales of tobacco products to minors.7 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. 34 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 35 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. ? Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 36 Table 6. Effective population-based interventions Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Ennett et al., RCT G1: Booklets mailed 1,316 Effects present for non- Hispanic Fair 200173 to parents followed by adolescent- whites only (n=791) 4 mailings telephone discussion parent pairs United States over 14 with health educator (adolescents Adolescents in the control group months and parents ages 12?14 were more than 1.5 times as 48 contiguous C1: Did not receive years) likely to smoke at the 3-month states 3 and 12 ?Family Matters? followup than adolescents in the months program intervention (OR, 1.59; P = 0.008, lower bound CI, 1.19 for a one-way test of significance) Program parents were more likely to discuss peer and media influences and set rules about smoking Thomson et Cross- G1: parent 3,831 youth Youth living in towns that ban Fair al., 200479 sectional involvement in (12?17 years) free-standing displays were less community-level likely to perceive tobacco as United States NA tobacco ordinances easy to purchase (AOR, 0.6; 95% CI, 0.5-0.9; P = 0.007) Boston, MA NA Increased perceived access was associated with being older (P < 0.0001) and male (P ? 0.002) AOR, adjusted odds ratio; C1, control group; CI, confidence interval; G1, intervention group 1; NA, not applicable; NR, not reported; OR, odds ratio; RCT, randomized controlled trial. 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 37 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 38 or needs.64 The Surgeon General?s report on Reducing Tobacco Use2 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 39 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. Table 7. School-based tobacco prevention program smoking status definitions Author/Year Smoking Status Definition of Smoking Status Single-School-Year Smoking Prevention Programs Ausems et al., Never smoker Never smoked a cigarette or even took a puff of a cigarette 200468 Noncurrent smoker Smoked in the past but not in the past month Current smoker Smoked during the past month Aveyard et al., Nonweekly smoker Smoked less than one cigarette per week 200169 Regular weekly smoker Smoked at least one cigarette per week Crone et al., 200371 Nonsmoker Never smokers, experimenters that no longer smoke, and quitters Smoker Smokes at least once a week or less than once a week and experimenters that continue to smoke Perry et al., 200375 Nonsmoker Not specified Current smoker Measured by amount of current tobacco use (response categories not specified) Unger et al., 200481 Nonsmoker Never smokers Smoker Tried smoking between 6th and 7th grade Multiple-School-Year Smoking Prevention Programs Brown et al., 200270 Never smoker No history of smoking Tried once Tried once Experimental smoker Smoked less than once a week Quit Smoked and quit Regular Smoked weekly Ellickson et al., Ever smoker Lifetime use 200372 Past-month smoker Frequency of use within past month Weekly Smoker Frequency of use within past year Josendal et al., Nonsmoker Nonsmokers and smoked less than weekly 200574 Smoker Smoked daily or weekly Schofield et al., Nonsmoker Did not smoke within the past 7 days 200376 Smoker Smoked within the past 7 days Winkelby et al., Nonsmoker Never smoked or former tobacco smokers 200482 Experimental smoker Smoked less than one pack per week Regular smoker Smoked more than one pack per week 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. 40 Table 8. Effective school-based interventions Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Single School Year Interventions Ausems et al., RCT G1: In school: 3 36 schools At 12 months, the in-school Fair 200468 lessons Number of intervention prevented more 5 months students not students from continuing to The G2: Out of school: 3 reported compared with controls Netherlands 6, 12, and 18 tailored letters (OR = 0.49, 95% CI, 0.29 ? months G3: Both 0.84) Middle and high (school level); C1: Control, not At 18 months, the tailored vocational described letters intervention prevented schools more smoking initiation compared with the controls (OR = 0.42, 95% CI, 0.18 ? 0.96) Aveyard et al., RCT G1: 3 computer- 52 schools At 1- or 2-year followup, no Fair 200169 based program 8,352 evidence of change in stage Up to 6 lessons with videos students or regular smoking United Kingdom sessions over and 3 classroom an academic lessons related to Adolescents year Transtheoretic Model (ages 13 to 24) living in West 1 and 2 years C1: Standard lessons Midlands Crone et al., RCT G1: 3 classroom 26 schools At 20 months, nonsmokers Fair 200371 lessons on 2,562 who became smokers 8 months knowledge, attitudes, students increased less in intervention The and social influence groups than control group, the Netherlands 8 and 20 program successfully months C1: Usual drug decreased smoking for regular Lower prevention program smokers and maintained secondary nonsmoking for nonsmokers schools versus control Those with perceived social pressure were more likely to be smokers Perry et al., RCT G1: D.A.R.E. 24 schools D.A.R.E. Plus significantly Fair 200375 curriculum taught by 6,237 less likely than D.A.R.E. to 8 months police officers (10 students show an increase in current United States sessions) smoking or intentions to use 8 and 20 tobacco for boys Middle and months G2: G1 plus D.A.R.E. junior high Plus?peer led, No significant differences for schools in parental involvement girls Minneapolis/St. in extracurricular Paul, activities Minnesota Control: Delayed program?D.A.R.E. offered in next school year C1, Control Group; D.A.R.E., Drug Abuse Resistance Education; G1, intervention group; RCT, randomized controlled trial 41 Table 8. Effective school-based interventions (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Unger et al., RCT G1: 8 weekly 16 schools Overall, intervention effect Fair 200481 classroom sessions 1,970 was not significant 8 weeks over by health educators students United States an academic relating smoking Hispanic boys in the year issues to several intervention group were less 6th and 7th cultures likely to report ever smoking graders in 12 months at 1 year followup than the Southern C1: Without the control group California cultural references Multiple School Year Interventions Brown et al., RCT G1: Extracurricular 30 schools, Male never smokers at Fair 200270 activities, teacher- 2,776 baseline in the intervention Students facilitated students group were significantly less Canada receiving likely to become ?regular? tobacco C1: Usual care smokers in 10th grade than High schools prevention in controls (9th and 10th elementary grades) schools No significant effect for recruited for females intervention in 9th and 10th grade At the end of each academic year Ellickson et al., RCT G1: 11 interactive 55 schools Treatment results for G1, G2 Fair 200372 teaching lessons in 4,276 combined through 8th grade; NR (11 lessons 7th grade, and 3 students other results NR United States in 7th grade lessons in 8th grade, and 3 lessons booster lessons in 9th At 18 months, cigarette Urban, rural, in 8th grade) and 10th initiation rates in G1+G2: were and middle significantly lower than in the schools in 18 months G2: Same as G1 but controls South Dakota no booster sessions Project ALERT significantly C1: Regular reduced proportion of new prevention smokers curriculums Josendal et al., RCT G1: Classroom (5 99 schools Full program (G1) had Good 200574 times per year), 4,223 significantly fewer smokers Minimum class teacher in-service, students than controls across all 3 Norway and lessons 5 parental involvement years times per year: 7th to 9th grade 8 hours in 7th G2: Same as GI, but Intervention without the schools grade; 5 hours no teacher in-service parental involvement or the in 8th grade; 6 course teacher in-service (G2 or G3) hours in 9th had significantly fewer grade G3: Same as GI, but smokers than the controls no parental End of each involvement Odds of becoming a smoker academic (daily, weekly, any) during the year?7th, 8th, C1: Education on intervention period were 9th grade smoking and health, significantly lower in the full but about half of the program group (G1) than in number of hours as in the controls G1 or G2 42 Table 8. Effective school-based interventions (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Schofield et al., RCT G1: Self-help, group 22 schools Proportion of students who Fair 200376 counseling, social 1,852 smoked in past 7 days did not 2 school years support students differ significantly by treatment Australia condition, intervention not 24 months C1: Offered and effective 7th to 10th received none of the grades in New experimental activities Significantly greater South Wales improvement in smoking school district knowledge for the intervention group compared with the control Positive attitudes toward smoking significantly decreased among smokers Winkelby et al., RCT G1: Three-phase 10 Regular smokers had greatest Fair 200482 advocacy and continuation statistically significant net Weekly lessons empowerment high decrease in tobacco use United States and activities schools over an C1: Existing 813 No differences in nonsmokers High Schools academic substance abuse students at baseline between (11th or 12th semester curriculum, not intervention and control grades) in San specific to tobacco groups in uptake of smoking Francisco and At the end of at followup San Jose, each semester California and 6 months after the end of the semester 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 43 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- 44 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 interventions70,72,74,76,82 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 45 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 46 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. 47 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 Table 9. Effective provider-based interventions Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Tyc et al., RCT G1: Self-help, 103 cancer Intervention group had Fair 200380 individual counseling, survivors (10 to higher mean knowledge Education and health professional 18 years of age) and perceived vulnerability United States counseling telephone counseling, scores and lower intention- over 3 months video to-use tobacco scores St Jude?s Children?s 6 and 12 C1: Brief advice to stop Research months smoking or continue Hospital, not smoking Memphis, Tennessee C, Control Group; G, Intervention Group; RCT, randomized controlled trial. 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. 48 KQ 2. Effective Strategies for Increasing Consumer Demand For and Use of Proven Individually Oriented Cessation Treatments We discuss KQ 2 in two main parts: evidence concerning interventions aimed at increasing the number of smokers who attempt to quit, and evidence about strategies for improving the impact of those interventions. As with KQ 1, in both cases we first review the existing information from recent systematic reviews, and then we turn to the new literature uncovered by our searches. Appendix C? presents the two evidence tables (Evidence Tables 4 and 5) with the details of studies from the current literature. 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 ? Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 49 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. 50 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 51 Table 10. Multicomponent interventions to increase the number of users who quit smoking Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Bauman et al., RCT G1: Mailing of booklets 85 parent- No statistically significant Fair 200090 and telephone adolescent difference in tobacco use 2 months counseling pairs between control and United States treatment for baseline 3 and 12 months C1: NR cigarette users Population- postcompletion based or dropout Etter et al., RCT G1: Tailored counseling 2,934 adults At 7 months, significantly Fair 200488 letters and booklets more people in the 12 months intervention than in the Switzerland, C1: A single letter control group were Western 7 and 24 months identifying person as abstinent for at least 1 Europe post-baseline part of the control group month (G1: 5.8%; C1: 2.2%; P ? 0.001) Population- based No difference between groups at 24 months. Lipkus et al., RCT G1: 2 self-help booklets 402 No differences in Fair 200484 in mail; 6-minute video; adolescents abstinence at 4- or 8-month 2 months 3 telephone counseling followup or for sustained United States abstinence 4 and 8 months C1: 2 self-help booklets Community- post-baseline in mail; 6-minute video; Participants completing based no telephone more counseling calls were counseling more likely to report cessation at 4 and 8 months (8-month OR = 1.54, 95% CI, 1.15-2.07, P < 0.007) McBride et al., RCT G1: Provider advice to 557 Significantly more Fair 200287 quit smoking; referral to adults; low participants of G2 than G1 10 weeks smoking specialist; self- SES; African were not smoking at 6 United States help guide; if eligible, American months (G1: 10%, G2: 6 and 12 months nicotine patches 19%; P = 0.03) and had Practice/ sustained abstinence provider G2: Self-help guide; if (G1: 5%, G2: 11%; settings eligible, nicotine P = 0.08) patches and refills; biomarker feedback and tailored booklet Murray et al., RCT G1: Ipratropium 4,517 adults More participants in G1 Fair 200289 bromide inhaler, than in C1 had sustained 3 months placebo inhaler abstinence (G1: 21.9%, United States, C1: 6.0%; P ? 0.001) Canada 11 years C1: Usual care Practice/ provider settings ACS, American Cancer Society; C, control group; G, intervention group(s); NR, not reported; OR, odds ratio; RCT, randomized controlled trial; SES, socioeconomic status. 52 Table 10. Multicomponent interventions to increase the number of users who quit smoking (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Rabius et al., RCT G1: ACS booklets and 3,522 G1 group had higher rates Fair 200485 standard advice plus young adults, of 48-hour abstinence than Varies by quit up to 5 sessions of adults C1 group at 3 months (18? United States date, up to 5 proactive telephone 25 years: G1: 19.6%, followup calls, up counseling C1: 9.3%; P < 0.005; over Population- to 2 weeks 25 years: G1: 15.1%, C1: based postquit date C1: ACS booklets and 9.6%; P < 0.001) standard advice 3 and 6 months Participants abstinent at 3 months were called at 6- month followups: (18?25 years: G1: 9.8%, C1: 3.2%; P < 0.01;over-25 years: G1: 8.8%, C1: 5.3%; P < 0.005) Smith et al., RCT G1: Telephone 632 Intervention groups Fair 200486 counseling, 2 follow-up adults combined (G1, G2, G3) calls, booklet had significantly higher Canada continuous abstinence 3, 6, and 12 G2: Telephone rates than control group: Population- months counseling, 2 follow-up (G1, 2, 3: 5%, based calls, pamphlet C1: 1%; P ? 0.05) G3: Telephone counseling, 6 follow-up calls, booklet G4: Telephone counseling, 6 follow-up calls, pamphlet C1: Print materials only 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 53 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. 54 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 55 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 56 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 57 Table 11. Strategies to improve success rates for quit attempts for general and special populations Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Aveyard et al., RCT G1: Pro-Change self-help 2471 No statistically Fair 2003105 system with workbook and 3 adults significant difference in 9 months questionnaires to generate quit rates between United Kingdom tailored feedback intervention and control 12 months groups (G1=11%, Practice/ post baseline G2: G1 plus three telephone G2=12%, G3=10%, Provider Settings calls C1=10%) in biochemically-confirmed G3: G1 plus three nurse visits abstinence for 6- months sustained C1: 2 standard self-help quit abstinence and 12- guides and 2 tip cards months point prevalence Bohadana et al., RCT G1: Nicotine inhaler and nicotine 400 Abstinence was greater Fair 200091 patch adults at 3 months for 26 weeks intervention group than France, C1: Nicotine inhaler and placebo control group (P = 0.02) Western Europe 6 weeks; 3, 6, patch and 12 months No significant difference Practice/provider between groups at 6- settings and 12-month followups Canga et al., RCT with G1: Interview with nurse; self- 280 Those in the Fair 2000119 * systematic help materials; 3 months of young intervention were randomization transdermal NRT if eligible; 5 adults, significantly more likely Spain, follow-up contacts adults than those in the control Western Europe 6 months to quit at 6-month C1: Usual care for diabetic followup (validated): Practice/provider 6 months smokers established in the (P ? 0.001) settings Navarre diabetes care program Hospital Carpenter et al., RCT G1: Telephone-based reduction 616 At 6 months, those Fair 200498 counseling and NRT and brief adults receiving either 24 weeks advice to quit intervention had greater United States percentages of ?24 hour 3, 6, 12 and 24 G2: Motivational advice (5Rs) quit attempts? (G1: 43% Population-based weeks and brief advice and G2: 51%) than those who received no C1: No treatment treatment (C1: 16%) (P < 0.01) Clark et al., RCT G1: Internet cessation resources 171 No statistically Fair 2004109 handout with Web site adults, significant differences in Given addresses > 50 smoking status found at United States materials at years of 1-month or 1-year time of chest C1: Standard self-help age followup Hospital CT scan material?NCI handout, ACS booklet Practice/provider 1 and 12 settings months ACS, American Cancer Society; C, Control Group; CBT, cognitive behavioral therapy; CT, computed tomography; ICU, intensive care unit; G, Intervention Group(s); NCI, National Cancer Institute; ng/ml, nanogram per milliliter; NRT, nicotine replacement therapy, RCT, randomized controlled trials. *: General and special populations ?: Special populations only 58 Table 11. Strategies to improve success rates for quit attempts for general and special populations (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Dalsgareth et al., RCT G1: 2 motivating phone 336 adult Continuous abstinence Fair 2004106 calls, 5 clinic visits, and hospital at 26 weeks: 7 weeks sustained-release employees G1 = 18% Denmark bupropion hydrochloride C1 = 7% 26 weeks post- P = 0.008 Hospital baseline C1: 2 motivating phone calls, 5 clinic visits, and placebo Garvey et al., RCT All subjects received Self 608 adults At 1 year follow-up quit Fair 2000107 help booklet and brief rates for low 2 months behavioral counseling, dependence were United States (5-10 minutes per visit, for Placebo 11.2% 1, 7, 14, 30 days 1 year) 2 mg gum 19.5% Population- and 2, 3, 6, 9, 4 mg gum 18.4% (NS) based and 12 months G1: Low dependence 2 mg post-cessation gum High dependence smokers quit rates at 1 G2: Low dependence 4 mg year gum 2 mg gum compared to placebo (15.7% vs. G3: High dependence 2 6.1%, P = 0.02) mg gum 4 mg gum compared to placebo (20.7% vs. G4: High dependence 4 6.1% P = 0.002) mg gum Hall et al., 200497 RCT G1: Brief nortriptyline: 160 adults At 12 weeks Fair nortriptyline for 12 weeks; nortriptyline was more United States Brief: 12 weeks 5 counseling sessions and effective than placebo Extended: 52 NRT patch at week 5 (OR = 0.69, 95% CI; Population- weeks 0.49-0.92, P = 0.02) based C1: Brief placebo: placebo and placebo at 52 12, 24, 36, 52 for 12 weeks; 5 counseling weeks (OR = 0.47; 95% weeks sessions and NRT at week CI; 0.30-0.75, P = 5 0.001); however 52 weeks of nortriptyline G2: Extended nortriptyline: did not differ G1 + extended significantly from pharmacotherapy and placebo at that same counseling (1/month) for time frame 52 weeks C2: Extended placebo: G2 but used placebo instead of nortriptyline 59 Table 11. Strategies to improve success rates for quit attempts for general and special populations (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Hennrikus et al., RCT G1: 2 smoking cessation 2,095 Cotinine corrected Fair 2005112 * manuals; community adults intention-to-treat 6 months resources directory; analysis found United States medical record label to cue percentage of 7 to 18 days, to providers; postdischarge abstinence at 12-month Hospital 12 months letter followup (P > 0.05) NS postdischarge G2: G1 plus extended bedside counseling session and 3 to 6 telephone calls for 6 months postdischarge C1: 2 cessation manuals and community resources directory Hitsman et al., RCT G1: Individual cognitive 253 No significant results Fair 1999113 behavioral therapy, adults found at 1, 3, and 6 10 weeks fluoxetine 30mg for 10 month followup. United States weeks, fluoxetine 1 week, 1, 3, compliance level set at Individual differences Population- and 6 months < 150ng/ml that predict cessation based postquit date when fluoxetine is G2: Same as G1, except combined with CBT fluoxetine dose of 60mg include higher levels of and fluoxetine compliance weight concern, degree level set at 300ng/ml of depression, and levels of nicotine C1: Individual cognitive dependence behavioral therapy plus placebo Holt et al., RCT G1: Bupropion; counseling 134 People in the Fair 2005114 * adolescents; intervention group were 2 months C1: Placebo and young adults; significantly more likely New Zealand counseling adults than those in the control 3 and 7 weeks, to be continuously Community- 3, 6, 9, and 12 abstinent at 3 months based months posttarget quit Population- date based Jones et al., RCT G1: Verbal 61 Of the smokers pre-ICU Fair 2001115 * encouragement to adults admission, more 6 months patients to remain returned to smoking in United Kingdom nonsmokers and for the control group at 6- 8 weeks, 6 immediate family not to mos followup Hospital months postICU smoke in the same room discharge as the patient, plus self- help manual C1: G1 without the manual 60 Table 11. Strategies to improve success rates for quit attempts for general and special populations (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Jorenby et al., RCT G1: bupropion and 893 Those receiving Fair 1999116 nicotine patch adults buproprion and patch 9 weeks were most likely United States G2: bupropion and (P ? 0.001) to be 10 weeks, 3, 6, placebo patch abstinent at 6 and 12 Community- and 12 months months based post start of G3: placebo tablets and study nicotine patch C1: placebo tablets and placebo patch Killen et al., RCT G1: NRT transdermal 224 adults No significant Good 200099 system patch for 8 weeks differences in 17 weeks plus 20 mg paroxetine for abstinence groups United States 9 weeks found between groups 4, 10 and 26 at any follow up time Population- weeks G2: NRT transdermal period based system patch for 8 weeks plus 40 mg paroxetine for 9 weeks C1: NRT transdermal system patch for 8 weeks plus placebo for 9 weeks Lancaster et al., RCT with G1: Brief advice to quit 497 No significant Fair 1999121 systematic from general practitioner, adults differences found randomization plus: extended counseling between groups at 3 United Kingdom a nurse; leaflet on and 12 month followups 6 weeks cessation; fact sheet on Practice/provider NRT; invitation to contact settings 3 and 12 months the research nurse for postquit date more intensive, tailored counseling; NRT if necessary C1: Brief advice to quit from the patients? general practitioners Lerman et al., RCT G1: 8 weeks of nicotine 299 adults No statistically Fair 2004100 nasal spray and 7 significant difference 8 weeks sessions of behavioral found between United States group counseling treatment groups at 6 8 weeks and 6 months (G1: 12.2%, Population- months G2: 8 weeks of G2: 15%, NS) based transdermal nicotine therapy (i.e., patch) and 7 Smokers who were sessions of behavioral highly dependent, group counseling obese, or members of minority groups achieved higher rates of abstinence with nasal spray 61 Table 11. Strategies to improve success rates for quit attempts for general and special populations (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating MacLeod et al., RCT G1: Nicotine Patch and 5 854 adults Telephone counseling Good 2003104 telephone counseling calls improves cessation 10 weeks rates when used in Australia C1: Nicotine Patch only conjunction with the 1, 2, 3 and 6 patch Population- months based 28-day continuous abstinence rates at 6- months: G1 30.6%, C1 22.4%, P = 0.01 90-day continuous abstinence rates G1 26.7%, C1 18.6%, P = 0.004 McBride et al., RCT G1: Usual care plus late 583 Pregnant No statistically Fair 2004122 ? pregnancy relapse kit, and 6 women and significant difference First trimester counseling calls their partners between groups at any United States to delivery and follow up point 12 months G2: G1 plus the partners Military Medical postpartum received telephone In late pregnancy, more Center counseling and support partners abstinent in G2 28 weeks guide (partners who smoked group (15%) than C1 pregnant received cessation aids and group (5%) P = 0.02 counseling) Postpartum C1: Usual Care: provider 2, 6, and 12 months Peterson 2004120 RCT G1:Brief physician 277 adults No significant Fair * counseling and usual care women differences between 3 months plus nurse managed, groups at 12 month United States cognitive behavioral relapse follow ups 12 months prevention intervention given Hospital pre-discharge, <5 structured telephone contacts discharge, and relapse management counseling as needed C1: Brief physician counseling, a self-help pamphlet, and list of community resources Quist-Paulsen et RCT G1: Self-help booklet on how 240 adults At one year, the quit Good al., 2003123 ? to quit smoking plus cardiac rate was far greater 5 months nurse consultation during in- (57%) in the intensive Norway patient days and phone nurse intervention 12 months consultation for up to 5 versus the minimal Hospital ? months following discharge intervention group cardiac ward (37%) (absolute risk C1: Group sessions with reduction 20%, 95% CI nurses with minor emphasis 6.4-33.0; P = 0.004) on smoking cessation and no further advice or instruction on how to quit 62 Table 11. Strategies to improve success rates for quit attempts for general and special populations (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Ratner et al Randomized G1: 2 face to face 237 surgical Those receiving the Fair 2004124 ? pretest-posttest counseling sessions and 9 patients counseling (73%) were control group telephone counseling more likely to be Western Canada experiment sessions abstinent than the controls (53%) (P = Teaching NR C1: Standard hospital 0.003) at 6 months but hospital treatment the difference is not 6 and 12 significant at 12 months months after surgery Reid et al RCT G1: Self-help booklet given 254 coronary Smoking cessation Good 2003125 ? in the hospital, then follow- artery rates increased from 8 weeks up by nurse counselor at 4 disease 42% at hospitalization Canada weeks after discharge; if hospitalized to 53% at 3 month 3 months and 1 patient smoking, nurse patients follow up (P = 0.05), but Hospital, tertiary year provides 3 twenty minute not significant at 1 year care cardiac face to face sessions over 8 follow up facility weeks and offered nicotine patch therapy Simon et al., RCT G1: 7 week course of 244 adults No statistically Fair 2004101 Bupropion, 2 months (86% male) significant differences in 7 weeks transdermal nicotine smoking cessation rates United States replacement therapy, 1 visit at end of medication 3, 7 weeks, 3, 6 with counselor (30-60 6, and 12 months Hospital and 12 months minute session), and 5 telephone follow-up calls The addition of 7-week treatment with C1: Same as G1 except Bupropion did not participants received significantly increase placebo instead of quit rates over NRT and Bupropion counseling Swan et al; 2003 RCT All participants received 1524 adults Abstinence significantly Fair and 2003102,103 Bupropion SR for 7 weeks greater at both 3 12 months months and 1 year for United States G1: 150 mg Bupropion SR, those receiving 3 and 12 brief counseling call day intensive counseling Practice/ months after quit date, personalized and higher dose of provider intervention materials, and bupropion (G4) vs (G1, settings access to 24 hour G3) and (G3) at higher automated support line dose with brief counseling G2: G1 except 300 mg Bupropion SR The 300 mg dose was associated with more G3: 150 mg Bupropion SR, adverse events self-help materials, support materials for family and friends, an in-depth telephone counseling session, 4 brief telephone counseling calls, and access to toll free quitline for 1 year G4: G3 with 300 mg of Bupropion SR 63 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 64 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 65 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 66 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. 67 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 68 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 69 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. 70 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 KQ 3. Implementation of Proven Population-Level Tobacco Use Cessation Strategies Understanding and implementing evidence-based interventions remain major challenges for public health and clinical practice. Adoption and implementation of population-level tobacco use cessation strategies are no exception. Here we summarize current research on the efficacy of community and health care systems interventions to increase the implementation of such strategies. As elsewhere, we present information from prior systematic reviews and then summarize current literature. We start first with population-based strategies and then consider strategies based in provider settings and health care systems. 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 71 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 Table 12. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Borland et al., RCT G1: Offered self-help ?Quit 528 No difference in Good 2003131 Pack?; 3 computer- adolescents, smoking prevalence at 6 months generated tailored letters young adults, 12-month followup Australia and adults 3, 6, and 12 G2: Offered self-help ?Quit Population-based months Pack?; 3 computer- baseline generated tailored letters; callback counseling service C1: Offered printed, self- help ?Quit Pack? Maguire et al., RCT G1: Initial interview with 484 adults Significantly more Fair 2001132 pharmacist; smoking participants in G1 had a 3 months cessation contract; NRT validated (urinary United Kingdom offered if appropriate; cotinine) nonsmoking 3, 6, 9, and 12 leaflet; weekly followup for status at 12 months Community-based months 4 weeks, then monthly (G1: 14.3% followup for 3 months C1: 2.7%; P ? 0.001) C1: Normal pharmaceutical service (including the provision of NRT, as appropriate) provided by pharmacist Ronda et al., Pretest- G1: Regional mass Media- 8,939 adults No significant Fair 2004133 posttest led smoking cessation differences between control campaign; local activities interventions regarding Netherlands, organized by local smoking status and Western interested working groups determinants of Europe smoking behavior C1: Older mass media-led Community-based smoking cessation campaign, no local activities C, comparison group; G, intervention group(s); NRT, nicotine replacement therapy; RCT, randomized controlled trials. 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 72 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 73 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 74 Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider-based and health care settings Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Cornuz et al., RCT with cluster G1: Active learning 251 young Those patients seen by Fair 2002134 randomization training program for adult and intervention group residents; received adult residents more likely to Switzerland, 3 months the control training patients be abstinent for at least 1 Western Europe 4 months later week at 1-year followup 1 year 35 residents (P = 0.005) Practice/provider C1: Traditional settings didactic training program on management of dyslipidemia; received the intervention training 4 months later Goldstein et al., Cross-sectional G1: Physicians 2,346 At 2-year followup, Fair 2003141 provided ?4 As? to adults patients who received the NR patients ?4 As? were significantly United States more likely to quit 6, 12, 18, and 24 G2: Smokers smoking (P = 0.006) Practice/provider months provided with settings, computer- community-based generated, stage- tailored cessation information at home G3: Physician delivered ?4 As? to patients, and patients received computer- generated, stage- tailored smoking cessation information at home C1: No intervention Joseph et al., RCT G1: Organizational 5,678 adults No effect on change Fair 2004143 support, 2 day scores between groups 2 days training sessions, reporting whether their United States smoking cessation physician asked about 6 and 12 months medication smoking or provided Practice/provider counseled settings C1: NR ?4 As? approach to tobacco-cessation counseling: (1) ask about tobacco use; (2) advise to quit; (3) assist with quitting; and (4) arrange for followup; C, control group; FP, family practitioner; G, intervention group; GP, general practitioner; NR, not reported; RN, registered nurse; WIC, Women, Infants, and Children program 75 Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider-based and health care settings (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Katz et al., 2004142 RCT G1: Study personnel 1,221 adult Intervention group RNs Fair worked with intake patients were the most likely to United States 2 months clinicians to ask about smoking, implement guideline 72 clinicians assess willingness to Practice/provider Immediate intervention; quit, advise patients to settings clinicians completed quit, and assist patients survey prior to in quitting (P = NR) Community-based implementation; After clinic visit, study personnel interviewed patients to evaluate whether they received cessation counseling C1: Intake clinicians completed survey just before tutorial session at end of intervention period, but had no help with guideline implementation Katz et al., 2004144 RCT G1: Multicomponent 2,163 adult Significantly more Good office based patients patients from practices United States 10.5 months intervention who received the including a tutorial intervention were more Practice/provider 2 and 6 months for intake clinicians likely to be asked by their settings on the AHRQ clinician about their Guideline, smoking status, performance willingness to quit, given feedback, offer of literature about quitting, free NRT, and assisted in setting a quit proactive counseling date, engaged in a discussion about C1: Staff received pharmacotherapy, or general information remain abstinent on the AHRQ Guideline Pbert et al., RCT with cluster G1: Clients visited 550 adult Women in the Fair 2004139 randomization community health pregnant intervention group more centers and WIC women likely than those in the United States 10 months offices that received control to be abstinent at provider training, an the end of pregnancy Practice/provider End of office reminder (G1: 26%; C1: 12%; OR: settings pregnancy, 1, 3, system, and 2.57; P = 0.05) and 1 and 6 months establishment of month postpartum postpartum program boards to (G1: 26%; C1: 11%; OR: coordinate the 3.01; P = 0.04) transfer of No effect remained at 3- documentation and 6-month followup among clinics C1: Usual care 76 Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider-based and health care settings (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Pieterse, 2001140 RCT with simple G1: Brief physician 530 young At 12 months, smoking Fair randomization counseling; self-help adults, adults abstinence rates were The Netherlands, manual; follow-up greater among those in Western Europe NR sessions the intervention compared with controls Practice/provider 1 and 12 months C1: Usual (G1: 13.4%; C1: 7.3%; settings treatment?no OR = 1.51, CI: 1.1, 2.1; counseling or advice P < 0.05), as were on smoking except consecutive abstinence when initiated by the rates (G1: 8.2%; C1: patient or when 3.1%; OR = 3.04, CI: 1.7, indicated by the 5.6l; P < 0.001) contact reason Piper et al., 2003145 RCT G1: Smoking added 1,611 adult Significant increase Fair to vital sign stamp smokers (31%) in asking behavior United States NR of physicians in the C1: Usual vital sign smoking plus vital sign Practice/provider 12 months stamp without clinics (P = 0.0002); no settings smoking difference in abstinence rates Russos et al., Cross-sectional G1: Orthodontists 126 adults In a typical week more Fair 1999135 given antitobacco clinicians in G1 vs. C1 2 years materials, training provided prevention United States session on tobacco counseling to patients 2 years prevention, written (Mean: 25.4% vs. 3%, Practice/provider postbaseline antitobacco Mann-Whitney U = settings prescriptions and 696.5, z = -7.0, P < 0.01) reimbursement for and at least some distribution, cessation counseling quarterly visits and (91% vs. 72%, ?2 = 8.4, calls; office staff P < 0.01) asked to make office tobacco-free C1: Orthodontists given no training, materials, or visits, nor asked to change their offices or practices Slama et al., Cross-sectional G1: NA 372 adult None of the GPs? Fair 1999136 patients smoking-related attitudes NA C1: NA and reported behaviors France, Western 2,680 were significantly related Europe 1 and 12 months general to their participation in practitioners the study or to their Practice/provider patients? rates of settings smoking cessation at 1 or 12 months 77 Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider -based and health care settings (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Smith et al., Time series G1: During 1,077 Including only those who Fair 2002137 hospitalization: adults were reached at 12 3 months physician advice on months, 49% reported United States smoking cessation, being smoke-free for the 1 year bedside education previous 7 days. Hospital and counseling with Including the 211 who nurse, take-home were not reached at 12 materials, NRT if months (intent to treat) requested or and counting them as indicated, 4 nurse- smokers, self-reported initiated smoking cessation rate postdischarge was 35% phone counseling calls C1: NA Young et al., RCT with cluster G1: Family 1,788 adult Improvements between Fair 2002138 randomization physicians received patients baseline and posttest in three academic patient recall of FP Australia 4 months detail visits, 60 advice about nicotine resources for FPs, family replacement patches and Practice/provider 6 months resources for practitioners gum were significantly settings postbaseline practices. and greater in the resources for intervention than the patients control group (P = 0.0056 and C1: Similar P = 0.0002, respectively) intervention to G1 in terms of intensity and format, but focused on cervical screening 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 78 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 79 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 80 ? 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. 81 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 82 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 83 highest self-reported cessation rates (cancer: 63 percent, cardiovascular: 57 percent, and pulmonary: 46 percent). KQ 4. Effect of Smokeless Tobacco Product Marketing and Use on Population Harm from Tobacco Use In our systematic review of the effects of smokeless tobacco product marketing and use on population harm from tobacco use, we specifically examined three issues: (1) whether substituting smokeless tobacco for smoking leads to less smoking-related harm on a population basis, (2) whether smokeless tobacco marketing leads to greater use or substitution of smokeless tobacco for smoking (or both), and (3) 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. As elsewhere, we present information from prior systematic reviews and then summarize current literature. 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 84 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 85 Table 14. Characteristics and results of studies assessing the effects of smokeless tobacco marketing Author Year Quality Setting Design Survey N Results Rating Choi et al., Cross-sectional Youth 2,814 Among adolescent boys, recall of Fair 1995146 Attitudes adolescents, smokeless tobacco advertisements was and young adult associated with smokeless tobacco use: California Practice males OR, 7.5; 95% CI, 3.1-18.1 Survey Population- based Tomar et al., Cross-sectional Teenage 3,996 Significantly more users than nonusers Fair 2003147 Attitudes adolescents, of smokeless tobacco became smokers and young adult during 4 years of followup: United States Practice males OR, 3.45; 95% CI, 1.84-6.47 Survey Population- (TAPS-I based and -II) CI, confidence intervals; OR, odds ratio. 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 86 KQ 5. Effectiveness of Prevention and Cessation Interventions in Populations with Co-Occurring Morbidities and Risk Behaviors Our final systematic review investigated smoking prevention and cessation interventions in populations with co-occurring morbidities and risk behaviors. For this report, we define a person with co-occurring disorders as one who has a psychiatric condition and a nicotine addiction. Psychiatric conditions include depression, anxiety, personality disorders, traumatic stress disorder, attention deficit disorder, eating disorders, disruptive behavioral disorders, and schizophrenia. We also identify risk behaviors as behaviors that trigger or exacerbate tobacco use, such as alcohol abuse and other chemical dependencies. As with other sections, we present information on previous systematic reviews as the background or context for recommendations to date. We then examine specific studies identified over and beyond those reviews. 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 87 Table 15. Tobacco cessation interventions for persons with co-occurring morbidities and risk behaviors Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Studies in Psychiatric Populations Brown et al., RCT G1: Group CBT for 179 formerly In the main analysis, Fair 2001150 smoking cessation depressed smoking abstinence 6 weeks plus additional CBT adults did not differ when United States on coping for CBT tailored for 1, 6, and 12 depression depression was added; Population-based months in a secondary C1: Group CBT for analysis CBT tailored smoking cessation for depression had alone significant interactions with both heavy smoking and recurrent depression Brown et al., RCT G1: In-person 191 7-day point prevalence Fair 2003151 motivational hospitalized rates Variable, interviewing adolescents At 1 month United States dependent sessions, offer of for ? MI arm: 11% upon the nicotine patch, psychiatric ? BA arm: 11% Psychiatric hospital length of stay postdischarge disorders telephone counseling At 6 months 1,3,6,9, and (MI) ? MI arm: 13.3% 12 months ? BA arm: 8.5% C1: Brief in-person advice, on cessation, At 12 months pamphlet and shorter ? MI arm: 14% course of nicotine ? BA arm: 9.9% patch (BA) P = NS Anxiety disorders increased odds for quit attempts in adolescents with psychiatric disorders (AOR, 1.99; 95% CI, 1.08-3.71) Hitsman et al., RCT G1: Individual 253 adults At 1 and 3 months, for Fair 1999113 behavioral therapy; treatment-compliant 10 weeks fluoxetine 30mg; quit patients, fluoxetine had United States date set, compliance a positive association 1 week; 1, 3, level at 150ng/ml with degree of Population-based and 6 months depression and G2: Same as G1 likelihood of except fluoxetine is a abstinence (OR, 1.35; 60mg dose and 95% CI, 1.00-1.81) compliance level set at 300ng/ml C1: Same as G1 except received placebo 88 Table 15. Tobacco cessation interventions for persons with co-occurring morbidities and risk behaviors (continued) Author Design Year Exposure Quality Setting Followup Intervention N Results Rating Studies in Substance-Addicted Populations Joseph et al., RCT G1: Individual 499 At both 3 and 6 Good 2004149 behavioral therapy; substance months, smoking 10 weeks recommended use disorder abstinence rates were United States nicotine patches (21 adults significantly greater in 3, 6, 9,12, mg for 6 weeks, 14 the treatment groups Residential and 18 mg for 2 weeks, and than the temporary substance use months 7 mg for 2 weeks) for control group disorder treatment smokers; (P < 0.000 and program combination of P = 0.02, respectively) patches and nicotine gum for smokers of >20 cigarettes per day C: Temporary control group with treatment delayed for 6 months Joseph, 1993152 Prospective G1: No specific 706 adults Patients who want to Fair cohort study information on enrolled in a quit smoking United States smoking or substance At 3-week followup 3 weeks cessation; smoking abuse ? Prepolicy: 24% Hospital allowed in treatment ? Postpolicy: 61% 1 year after designated rooms program (P < 0.001) hospitalization and not during group sessions Patients who quit smoking G2: Upon admission, At 1-year followup patient signed ? Prepolicy: 3% contract to abstain ? Postpolicy: 8% from nicotine during (P < 0.05) stay; cessation program provided; clonidine patches available AOR, adjusted odds ratio; C, control group; CBT, cognitive behavioral therapy; G, intervention group(s); ng/ml, nanogram per milliliter; NS, not significant; OR, odds ratio; RCT, randomized controlled trials. (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 ? Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 89 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. 90 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 (?2, 11.4; P < 0.001), and expired CO (?2, 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 91 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 92 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). 93 Chapter 4. Discussion This chapter reviews the quality of the literature and strength of the evidence base for selected outcomes relating to tobacco prevention, smoking cessation intervention, and smokeless tobacco marketing. The confidence that readers can have in our findings, conclusions, and recommendations is contingent on the quality of the research reviewed and the overall robustness of the evidence. Key question (KQ) 6, addressed in this chapter, concerned limitations in the literature and gaps in the knowledge base that point to needed future research. Our information and suggestions pursuant to this question will be especially pertinent to participants at the National Institutes of Health (NIH) State-of-the-Science Conference on Tobacco Use on June 12?14, 2006. Quality of Literature and Strength of Evidence As described in Chapter 2 and documented in the evidence tables (Appendix C??), we selected articles for this review using rigorous criteria and assessed them using a component quality rating scale of ?good,? ?fair,? and ?poor.? The prior systematic reviews that we used for several key questions or parts of questions were all of good or fair quality. We also evaluated the strength of the body of evidence based on the suitability and quality of execution of the study design, the amount of evidence available, and the coherence or consistency of available evidence. The strength-of-evidence categories were strong, sufficient, and insufficient. The suitability of the study design for assessing effectiveness is based on how well the study design protects against potential threats to validity.56 Concurrent comparison groups, prospective measurement of exposure, multiple outcome measurements conducted over time, and assessment of exposure that precedes assessment of outcome are ways to avoid potential threats to validity. Suitability of the study design was contingent on whether the study had concurrent comparison groups, no comparison group but multiple prepost measurements, or single prepost measurements and was assessed as greatest, moderate, or least, respectively. For assessing the quality of study execution (see Chapter 2), we considered the following areas that posed possible threats to validity: (1) study population, (2) intervention descriptions, (3) sampling, (4) exposure and outcome measurement, (5) data analysis, (6) interpretation of results, (7) followup, (8) bias, and (9) confounding. We evaluated studies based on limitations in one or more of these areas. The number of studies needed to assess the strength of the body of evidence is variable and depends on the suitability and execution of the studies. 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 ?? Appendixes cited in this report are provided electronically at http://www.ahrq.gov/clinic/tp/tobusetp.htm. 95 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 96 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 97 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. 98 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. 99 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. 100 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 101 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 102 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 studies113,151 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 103 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. Limitations of Evidence Base 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 104 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 105 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. Future Research Recommendations Our review highlighted several gaps in the literature that could be addressed by future research and by improvement in methods. Future research should address the issues highlighted below. 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. 106 Table 16. Characteristics of studies rated poor quality Intervention Design* Sample Size Reasons for Rating Key Question 1 Group counseling, social support77 All methods (e.g., randomization, sampling) not well RCT delineated 450 No baseline data reported analytical methods not well described Video, classroom instruction78 No baseline data reported RCT No treatment versus comparison data reported 3,038 Post randomization exclusions Key Question 2 Self-help materials129 High attrition rate RCT No intention-to-treat analysis 918 No power analysis Baseline differences Self-help, computer-based program, telephone Intervention group volunteer sample counseling, group counseling, social support, media Control group care not reported campaign, individual counseling by health Exposure to intervention low professional111 Findings not generalizable? Quasi-experiment High attrition 538 Self-help, individual counseling by health professional, Self-selected sampling technique social support118 Baseline differences regarding motivation to quit Cohort study Incomplete reporting of data 110 Self-help, group counseling108 Self-selection of intervention Before/after study Small group sample sizes 119 High attrition rate No report of comparison of groups Findings not generalizableH Individual counseling, High attrition rate Acupuncture92 Completers analysis RCT 141 Pharmaceuticals110 High rate of noncompliance RCT High overall rate of attrition 1,384 Pharmacotherapy93 Removed study participants perceived not to be motivated RCT (similar to a ?run-in period?) 134 Attrition moderately high Limited reporting on adverse events Randomization not described Pharmacotherapy126 Attrition rate not reported RCT Allocation to groups predictable 245 No adverse events reported Poor randomization Pharmaceuticals, group counseling117 Large differences in baseline comparisons between white RCT and black participants negate any conclusions from findings 5,887 Pharmacotherapy, cognitive behavioral counseling96 Randomization not reported RCT No power analysis 150 High attrition rate No adverse events reported Pharmacotherapy, cognitive behavioral counseling127 High attrition rate RCT Randomization not reported 248 No adverse events reported No power analysis 107 Table 16. Characteristics of studies rated poor quality Intervention Design* Sample Size Reasons for Rating Pharmacotherapy, self-help, counseling128 High attrition rate RCT Lacked power 137 Significant baseline differences not reported Telephone quit line94 High attrition rate Cohort study Confounded by ?additional support? 1594 Baseline data not reported for Proactive Treatment group No reliability or validity measures for instruments Inclusion/exclusion criteria not reported Telephone counseling, group meetings95 No true control group RCT Randomization not reported 756 Population not described Inclusion/exclusion criteria not reported Intention-to-treat analysis not reported Key Question 3 Video, telephone counseling, individual counseling by Sampling not explained health professional, group counseling, social support, No control group pharmaceuticals155 Limited generalizability? Before/after study 299 Self-help, individual counseling by health professional, Inadequate allocation of concealment and blinding telephone counseling, video156 Contamination of usual care group RCT Attrition not reported 1,173 Key Question 5 Group counseling, pharmaceuticals153 Sampling technique not reported RCT Study criteria changed after one-third of participants 3,976 recruited; post-randomization Attrition not reported Adverse events not reported No systematic measure of nicotine replacement therapy use among participants * RCT, randomized controlled trial. ? Generalizability is noted but did not figure directly in the quality rating. 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 108 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. 109 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).9 110 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. Conclusions This review updates the literature found in previous systematic reviews. In most instances, the evidence in our review was consistent with that in those publications. On its own or in combination with findings from earlier reviews, the information from newer work is insufficient to draw new conclusions or conclusions different from those that prior reviews offered. The new studies examining tobacco prevention for adolescents and young adults in our review found short-term effects for school-based interventions but no evidence to draw conclusions for long-term effects. Insufficient new evidence exists on population-, community-, and provider-based interventions for reducing tobacco initiation among adolescents and young adults. 111 Findings from studies in our review, although insufficient in number and quality to draw conclusions on their own about the effectiveness of multicomponent strategies such as telephone counseling, are consistent with previous reviews indicating the efficacy of these approaches. Studies in our review of strategies to improve the success of quit attempts were consistent with previous reviews. Fundamentally, self-help strategies alone are not efficacious; counseling, pharmacotherapies either alone or in combination, or pharmacotherapies combined with psychological counseling all increase the likelihood of successful quitting. When considering interventions for special populations, we found results both consistent and inconsistent with prior reviews. When evaluating interventions with hospitalized patients by diagnosis, studies in our review agreed with findings of a prior review showing that there was no strong evidence that clinical diagnosis affects the likelihood of quitting.63 Results of our review were inconsistent with two prior reviews indicating that hospitalized patients were more likely to quit smoking as intensity of the intervention increased.5,63 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 showing that counseling does increase the likelihood of abstinence among pregnant smokers. Investigators found quit rates for indigenous Maori in New Zealand to be similar to those observed in other trials of bupropion.114 Consistent with earlier findings, we also found insufficient evidence of effectiveness for population-based interventions to increase implementation of proven cessation strategies. Sufficient evidence in our review indicated that implementing provider-based interventions, such as training, and health systems-based interventions, such as academic detailing, improved provider delivery of cessation treatment, but the information was insufficient to conclude that implementing these approaches leads to higher quit rates. We found no evidence on how smokeless tobacco product marketing affects population harm and only insufficient evidence on whether smokeless tobacco product marketing increases use and leads users to substitute smokeless tobacco for smoking. 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Med Care 2000; 38(5):451-9. 120 Appendix A Search Strategies by Database Appendix A. Search Strategy #1 Search "Tobacco Use Cessation"[MeSH] OR "Smoking 17017 Cessation"[MeSH] OR "Smoking/prevention and control"[MeSH] #2 Search "Smoking"[MeSH] AND "Primary Prevention"[MeSH] 479 #3 Search #1 OR #2 17275 #4 Search #1 OR #2 Limits: Adolescent: 13-18 years, Adult: 19-44 years, 7383 Middle Aged: 45-64 years, English, Humans #5 Search ("Community Networks"[MeSH] OR "Community Health 345024 Services"[MeSH] OR "Community Health Planning"[MeSH] OR "Community Health Aides"[MeSH] OR "Community Health Nursing"[MeSH] OR "Community Health Centers"[MeSH] OR "Community Mental Health Services"[MeSH] OR "Community Medicine"[MeSH] OR "Community Mental Health Centers"[MeSH]) #9 Search ("Randomized Controlled Trial"[Publication Type] OR 310410 "Randomized Controlled Trials"[MeSH]) OR "Single-Blind Method"[MeSH] OR "Double-Blind Method"[MeSH] OR "Random Allocation"[MeSH] #10 Search #4 AND #5 AND #9 402 #11 Search ("Consumer Satisfaction"[MeSH] OR "Consumer 84543 Participation"[MeSH]) OR "Health Services Needs and Demand"[MeSH] #12 Search #4 AND #11 129 #13 Search "Health Plan Implementation"[MeSH] OR "Diffusion of 52494 Innovation"[MeSH] OR "Patient Education"[MeSH] #14 Search #4 AND #13 334 #15 Search "Tobacco, Smokeless"[MeSH]OR "spit tobacco" OR "chewing 1893 tobacco" OR "dip tobacco" OR "oral tobacco" #16 Search #4 AND #15 160 #17 Search ("Marketing"[MeSH] OR "Social Marketing"[MeSH]) OR 39557 "Choice Behavior"[MeSH] OR "Advertising"[MeSH] #18 Search #4 AND #17 402 #19 Search "Comorbidity"[MeSH] OR ("Risk-Taking"[MeSH] OR "Risk 1406831 Factors"[MeSH]) OR ("Depressive Disorder"[MeSH] OR "Depression"[MeSH]) OR "Bipolar Disorder"[MeSH] OR "Attention Deficit Disorder with Hyperactivity"[MeSH] OR "Stress Disorders, Post-Traumatic"[MeSH] OR "Diabetes Mellitus"[MeSH] OR "Hypertension"[MeSH] OR "Heart Diseases"[MeSH] OR "Asthma"[MeSH] OR "Obesity"[MeSH] #20 Search #4 AND #19 1742 #21 Search #20 AND #9 250 A-1 Cochrane and the CCTR (smoking or tobacco) AND (tobacco or quit) AND community Reviews = 3 Trials = 89 Psychological Abstracts (smoking or tobacco) AND (cessation or quit) AND community = 79 Sociological Abstracts (( smoking or tobacco )and( cessation or quit )) and (( community )and( intervention or Program or plan )) = 48 Cumulative Index for Nursing and Allied Health (smoking AND (cessation OR quit) ) AND community AND trial = 36 1237 unduplicated records A-2 Appendix B Sample Review Forms/ Quality Rating Forms Title Abstraction Form 1. Original research (no editorials, letters to the editor) published in English after 1980 or a Cochrane review? Yes No Cannot determine 2. Study located in any of the following countries: USA, Canada, United Kingdom, Western Europe, Australia, New Zealand Yes No Cannot determine 3. Addresses one or more of the following (check all that apply): Population and Community based interventions for preventing tobacco use (KQ1) Strategies for increasing consumer demand for and use of individually oriented cessation treatments (KQ2) Strategies for increasing the implementation of population-level cessation strategies (KQ3) Effects of smokeless tobacco product marketing and use on population harm (KQ4) Effectiveness of interventions in populations with co-morbidities and risk behaviors (KQ5) Future research (KQ6) Cannot determine by the title or abstract None of the above 4. Study design is one of the following: RCT (n>30) RCT (n=?) Meta-analysis B-1 Observational Study (n=?) Observational Study (n>100) Case series Case report Cannot be determined Observational Study (n<99) Model or simulation study None of the above designs (Flag this response) Cochrane systematic review 5. If an RCT is excluded because of small sample size check here: Yes 6. Use for background ? If Yes, check here and flag article. Yes B-2 Full Text Review Form 1. Is this article a) referenced in a systematic review, or an editorial or comment? b) Cochrane systematic review or meta analysis? Yes No 2. Study is located in any of the following countries: USA, Canada, United Kingdom, Western Europe, Austrailia, New Zealand Yes No 3. The study is one or more of the following: KQ1 - Population and community based interventions for preventing tobacco use in adolescents and young adults (RCTs published Jan 2000 & later only) or refers to tobacco industry and product restriction (1980 to present) KQ2 - A 6mo or longer intervention designed to increase the number of tobacco users (i.e. adults/diverse pops) who seek individually-oriented treatments or increase use of proven intervention strategies {i.e., counseling, behavorial, & Pharmo} (published Jan 1999 & later only) KQ3 - A 6 mo or longer study of strategies to increase the implementation & use of proven pop-level tobacco cessation interventions, particularly those in communities & healthcare settings (published Jan 1999 & later only) KQ4 - Influence of smokeless tobacco marketing on initiation & use, and the effects on population harm KQ5 - 6 mo or longer study of effectiveness of cessation interventions in pops with co-morbidities & risk factors KQ6 - Future research None of the above 4. Study design is one of the following: RCT (n>30) B-3 Cohort Study (n>100) - Smokers & non-smokers followed over time to compare outcomes Case Control (n>100) - Subjects who have a certain condition are compared with people who don't Cross Sectional (n>100) - Like case-control studies, but more than two categories (such as just "smoker" & "non-smoker") None of the above (please flag if meta-analysis or systematic review) Cochrane Systematic review or meta analysis 5. If an RCT is excluded because of sample size <30, please check here and flag: Yes 6. Use for background? If yes, please check & flag (write background in flag box) Yes B-4 Abstraction Form for Systematic Review or Meta-analysis 1. Is this a systematic review of meta-analysis? Systematic Review Meta-analysis 2. Author et al, date 3. Geographic Area United States Canada United Kingdom Western Europe Australia New Zealand 4. Funding Source 5. Aim of Review 6. Time Period Covered B-5 7. Inclusion Criteria 8. Population 9. Characteristics of studies (Interventions) 10. Method of Review 11. What studies are included in the Meta analysis? 12. Study Design 13. Main Results 14. Adverse Events B-6 No Yes Not Applicable 15. Quality Rating Good Fair Poor Comments: B-7 Abstraction Form for Articles 1. Abstractor Initials 2. If the article should have been excluded in level 2 exclude and provide reason in text box...otherwise include. Exclude Enter Reason Include 3. Key Question KQ1 KQ2 KQ3 KQ4 KQ5 KQ6 4. Author/Year 5. Geographic Area United States Canada United Kingdom Western Europe Australia B-8 New Zealand 6. Funding Agency 7. Study Objective 8. Population Adolescents, Young Adults, Adults, Men (only), Women (only), Pregnant women, African Americans, American Indians, Latino, Low SES, Describe 9. Risk Behavior(s) 10. Psychiatric condition(s) B-9 11. Study Setting School-based Community-based Population-based Hospital Worksite Practice/provider settings Describe 12. Study Design RCT with simple randomization RCT with systematic randomization RCT with stratified randomization RCT with cluster randomization Cohort Study Case Control Before and after study Time series Control trial Cross-sectional 13. Describe study design 14. Sampling Technique B-10 15. Sample Size Total sample I1 I2 I3 C1 16. Inclusion Criteria: 17. Exclusion Criteria: 18. Intervention Methods Self-Help Individual Counseling by Health Professional Individual Counseling by non Health Professional Group Counseling Telephone Counseling Computer-based Program Social Support Video B-11 Media Campaign Pharmaceuticals Parent involvement Extra-curricular activities Classroom instruction Community-Activities Describe 19. Intervention I1 I2 I3 C1 20. Method of Assessment 21. Definition of Smoking B-12 Cigarettes Smokless tobacco NR 22. Baseline Data 23. Statistical Analysis 24. Data verification 25. Results Dependent Variables Outcome measures 26. Adequate Randomization Yes No NR 27. Attrition Rates B-13 28. Quality Rating Good Fair Poor Comments B-14 Quality Review Form for RCT Studies 1. Is this a drug study? Yes No 2. Was randomization adequate? Yes No Not Randomized NR 3. Was allocation of concealment adequate? Yes No Not randomized NR 4. Are the groups similar at baseline? Yes No NR 5. Was the eligibility criteria specified? Yes No 6. Was blinding adequate? Yes B-15 No Yes, but method not described NR NA 7. The outcome assessor (Researcher) was blind to the study participants. Yes No Yes, but method not described NR 8. Are participants blind to the study treatment? Yes No Yes, but method not described NR 9. Reporting of crossovers, adherence, and contamination. Yes No 10. Was attrition less then 25%? Please report percentage. B-16 Yes No Not Reported Percentage 11. Was the differential attrition less than 15%? Yes No NR Percentage 12. Was a power analysis calculated for the study? Yes No NR 13. Did the study use Intention To Treat analysis (impute missing responses)? Yes No 14. Did post randomization of exclusions occur in the study? Yes No Unable to determine NR B-17 15. What is the quality rating for this study? Please provide a rational in the comment box. Good Fair Poor comments: Quality Assessment for External Validity 16. The control group standard of care was described? Yes No Comments: 17. Is the study population representative of the population of interest? Yes No Comments: Quality Assessment for Adverse Events The next questions are for drug studies only. 18. Non-bias selection? B-18 Yes No Not clear 19. Low overall attrition at follow-up (less than 25%)? Yes No Not clear 20. The adverse events were pre-specified and defined? Yes No Comments: 21. Ascertainment techniques (instruments) were non-biased and adequately described? Yes No Comments: 22. Statistical analysis of potential confounders? Yes No Comments: 23. Was there adequate duration of follow-up (at least 6 months)? B-19 Yes No Comments: 24. What is the overall adverse event assessment quality? Good Fair Poor Comments: B-20 Quality Review Form for NonRCT Studies Study quality is evaluated using six categories (Descriptions, Sampling, Measurement, Analysis, Interpretation of Results, and other). Some problems with a study can be included under several of the categories. Use your best judgement to list the problems under the most appropriate category. Answer the questions based on the quality of execution of the study's design. Always provide comments for limitations. External Validity (Generalizability of the Study Results) 1. Was the study population well described? (Study should describe both intervention and comparison populations and all relevent characteristics such as age, gender, SES) Yes No NR Limitations 2. Was the intervention well described? (What was done?, how was it delivered?, who was targeted?, and where it was done?) Yes No NA NR Limitations: 3. Did the authors specify the sampling frame or universe of selection for the study population? Yes No NR NA Limitations: 4. Did the authors specify the screening criteria for study eligibility? Yes B-21 No NR NA limitations: 5. Was the population that served as the unit of analysis the entire eligible population or a probability sample? Population Probability Sample Limitations: 6. Are there other selection bias issues not identified above? (This might include a very low participation rate (or a high refusal rate), a volunteer sample (as opposed to a convenience sample selected by the investigators), an inappropriate control or comparison group, or extremely restricted sampling inappropriate for measuring the effectiveness of the intervetion being studied. Yes No NA Limitations: Internal Validity and Reliability 7. Did the authors attempt to measure exposure to the intervention? (observation, interviews, self administered questionnaire, Record review, lab test) B-22 Yes No NA Limitations: 8. Was the exposure variable valid? (i.e., measured exposure in different ways, consistency checks for self-reports) Yes No NA limitations: 9. Was the exposure variable reliable? (meausres of internal consistency were used, Cronbach's alpha, inter rater reliability) Yes No NA Limitations: 10. Were the outcome and other (or predictor) variables valid? Yes No NA NR Limitations: 11. Were the outcome and other (or predictor) variables reliable? Yes No B-23 NA NR Limitations: 12. Did the authors conduct appropriate statistical testing by: (Select all that apply) B-24 Conducted statistical testing when appropriate. Reported which statistical test were used. Controlled for design effects in the statistical model. Controlled for repeated measures in populations that were followed over time. Controlled for differential exposure to the intervention. Used a model designed to handle mult- level data when they included group-level and individual covariates in the model. Describe other problems with the data analysis. 13. Was the attrition greater then 25% (if a survey, please write in the response rate)? B-25 Yes No NA Survey response rate 14. Did the author assess whether the unit of analyses were comparable prior to exposure to the intervention? Yes No NA 15. Did the author correct for controllable variables or institute study procedures to limit bias apporpriately (e.g., randomization, restriction, matching, stratification, or statistical adjustment)? B-26 Ye s No NA 16. Based on your overall impression of the study please rate quality of article. Important issues: who are the participants and how are they selected, are good instruments used to measure the results, are the results analyzed using appropriate methods. Finally can the results be replicated and are the outcomes generalizable...if not, this study may have a fatal flaw. Good studies (an outstanding study, one to two minor limitations) Fair studies (limitations but mostly minor limitations) Poor studies (the study had fatal flaws in sampling, assessment measures, or statistical analysis) B-27 Good Fair Poor Comment 17. New Text Box Question B-28 Quality Review Form for Systematic Reviews and Meta-analysis 1. Is this a systematic review or meta-analysis? Systematic Review Meta-analysis 2. Is the systematic review based on a focused question of research? Yes No Not reported 3. Are the eligibility criteria for the studies clearly described? Yes No Not reported 4. Did the search strategy employ a comprehensive, systematic literature search? Yes No Not reported 5. Did at least 2 people independently review studies? Yes No Not reported 6. Did the authors use a standard method of critical appraisal before including studies? Yes No B-29 Not reported These questions are for meta-analysis only 7. Was publication bias assessed? Yes No Not reported 8. Was heterogeneity assessed and addressed? Yes No Not reported 9. Did statistical analysis maintain trials as the unit of analysis? Yes No Not reported 10. What is the quality rating for this study? Please provide rational for response. Good Fair Poor Rational: B-30 Appendix C Evidence Tables Glossary # number % percent 2x 2 times or twice 3x three times or thrice ACS American Cancer Society ALSAC American Lebanese Syrian Associated Charities ANOVA Analysis of Variance AOR adjusted odds ratio ASH Action on Smoking and Health database ASSIS Applied Social Sciences Index and Abstracts b regression coefficient b/w between BA Brief Advice C Control group Calif California CBT cognitive behavioral therapy CD cardiovascular disease CDC Centers for Disease Control C-DISC Clinical Data Interchange Standards Consortium Chi sq Chi square CI confidence intervals CNS central nervous system CO carbon monoxide COPD Chronic Obstructive Pulmonary Disease CSAHS Central Sydney Area Health Services CT computed topography CVD CD d.f. degrees of freedom DARE Drug abuse resistance education Dec December DHSS Department of Health and Social Services DSM-IV Diagnostic and Statistical Manual ? Fourth Edition dz diagnosis et al. et alia FEV forced expiratory volume FP family physician FTQ Fagerstrom Tolerance Questionnaire FVC forced vital capacity g grams G Group GEE generalized estimating equations GLIMMIX General Linear Model for Mixture Distributions GP general practitioner GSTM1 glutathione s-transferase, MU-1 C-3 HDRS Hamilton Depression Rating Scale HMO Health Maintenance Organization HPS health promoting schools HPS Health Promotion School hr(s) hour(s) HRSD Hamilton Rating Scale for Depression HS high school HSPP Hutchinson Smoking Prevention Project ICU intensive care unit IG immunoglobins ITT intent to treat kg kilogram LCS Lung Cancer Substudy LHS 1, 2, or 3 Lung Health Study LPN licensed practical nurse MA medical assistant mg milligram MI Motivational Interviewing mo(s) month(s) N number NA not applicable NCCTG North Central Cancer Treatment Group NCI National Cancer Institute ng/ml nanograms per millileter NHLBI National Heart, Lung, and Blood Institute NHS National Health Services NIAS National Institute Against Smoking NIDA National Institute on Drug Abuse NNS nicotine nasal spray NP nicotine patch NR not reported NRT nicotine replacement therapy NS not significant NSW New South Wales OR odds ratio P p-value pg page ppm parts per million PTSD posttraumatic stress disorder RCT randomized controlled trial RN registered nurse RR relative risk RS Spearman?s Rank Correlation SAS statistical package SD standard deviation SEQ Self-Efficacy Questionnaire C-4 SES socioeconomic status SI smoking intervention SLF Smoke Free Leitrim SLT social learning theory SPSS Statistical Package for the Social Sciences ST smokeless tobacco SE Standard error t time TN Tennessee TTM Transtheoretical Model txt treatment UCSF University of Calif San Francisco UK United Kingdom US US VA Veterans Administration v. versus w/ with WIC Women, Infants, and Children wk(s) week(s) ?2 Chi sq yr(s) yr(s) C-5 Evidence Table 1. Effective population-based interventions Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Ennett et al., 2001 To identify mediators through which the ? Probability sample of families Geographic area: Family Matters Program influenced throughout 48 contiguous States of adolescent smoking and drinking US US entered into a randomized trial Population: ? Partcipants identified through Funding agency: ? Adolescents random-digit dialing National Institute on Drug Abuse ? 12 to 14 yr olds and their families ? Eligible families screened ? Offered opportunity to participate in Study setting: Study type: study and told that they had a 50/50 Population-based RCT w/ simple randomization chance of receiving Family Matters program Inclusion criteria: Families had to have an adolescent age 12 ? 1,316 adolescent?parent pairs to 14 yrs old and live in contiguous 48 agreed to enrolled in study states ? Pairs completed baseline interviews by telephone, matched w/ another Exclusion criteria: pair by date and time of completion, NR and then randomly assigned either to receive Family Matters or to serve as controls Sample size: Total: 1,316 adolescent-parent pairs G1: NR C1: NR Definition of smoking: Cigarettes ? Non-user: never smoked, not even a puff ? User: smoked even a puff C-6 Evidence Table 1. Effective population-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: ? Adolescents in C more than Quality rating: ? Self-help ? Repeated measures 1.5 times likely to smoke at Fair ? Telephone counseling logistic regression w/ follow up than family matters w/ parents GEE using a one group (OR = 1.59, P = 0.008, Comments: sided tail test lower bound CI, 1.19) ? No description of Intervention: G1: Family Matters ? Mediation analysis ? Program parents significantly control follows approach more likely to discuss peer and intervention consists of successive outlined by Baron and media influences (b = -.76, ? Sample size for mailings 4 mailings over Kenny to assess P < 0.01), set rules about G1 and C1 NR 14 mos of 4 booklets to whether extent to smoking (b = -0.46, P < 0.01) parents of 12- to 14-yr-old Adequate which change in adolescents and telephone ? Non Hispanic white randomization: behavioral outcomes discussions b/w parents participants only, program Yes as a result of Family and health educators after parents significantly more Matters program is Attrition rate: each mailing likely to encourage their C1: NR accounted for by children not to smoke 26% change in proposed (b = -0.42, P < 0.01), Method of assessment: mediators improvements in parent 3- and 12-month followup Data verification: involvement via telephone interview w/ Self-report (b = -0.10, P < 0.05), and parent/guardian and positive effect on adolescent?s adolescent Dependent variables: intentions to smoke (b = -0.15, P ? 0.01) Baseline data: ? Smoking status Fewer non-Hispanic ? Global family Mediating effects for full model: Whites in G1 than in C1 mediators stricter parent supervision (b = (supervision, support, 0.16, P < 0.01) and decreased communication and parental use of tobacco (b = involvment) 0.60, P < 0.01) ? Substance specific mediators (expected Expected consequences and consequences, intention to use (b = 1.82, and b parental attitude, = 0.85, P < 0.01) decreased parental smoking encouragement, parent substance use, rules about use, monitoring, availability, nonfamily influences) C-7 Evidence Table 1. Effective population-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Thomson et al., 2004 To test whether community-level youth ? University of Massachusetts obtained Geographic area: access ordinances reduce adolescents' a statewide random sample of perceived access to tobacco, purchase US households by random-digit dialing attempts, and tobacco use ? Interview conducted w/ an adult Funding agency: Population: resident to collect demographic data NCI, Flight Attendant ? Adolescents, 12 to 17 yrs ? Requested permission to interview all Medical Research Institute youth in household b/w ages 12 to 17 Study setting: Study type: yrs Population-based Cross-sectional ? Screen interviewers completed 66% Describe study design of sample and 6,006 eligible youths identified ? Representative sample of youth from across Massachusetts Sample size: Inclusion criteria: ? Total: 3,831 ? Age 12 to 17 Definition of smoking: ? Resident of Massachusetts Cigarettes ? Parental consent ? Ever smoker: smoked or puffed ? Youth assent cigarette in lifetime ? Current smokers: smoked at least Exclusion criteria: one cigarette inpast 30 days ? Youth report of resident town disagreed w/ ZIP code and phone exchange indicators ? Towns having no identified youth C-8 Evidence Table 1. Effective population-based interventions (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: ? 37% of youth perceived easy Quality rating: ? Parent involvment X2uare access to purchase tobacco Fair ? Implementation of state GEE ? Less likely to perceive easy to wide youth tobacco access Comments: ordinances Data verification: purchase w/ ban on free displays Strengths: accounted Self-report AOR = 0.6, 95% (CI 0.5-0.9; P = 0.007) for clustering in Intervention: analyses G1: Community-level Dependent variables: ? Youth reported easy access in tobacco ordinances ? Youth perceived access towns that required tobacco Limitations: moderate C1: NA to tobacco vendors to have a license OR = participation rate; ? Attempts to purchase 1.3, 95% (CI 1.1 ? 1.5, P = 0.009) generic data on Method of assessment: tobacco ? Increased perceived access ordinance Phone survey ? Tobacco use associated w/ being older (P < enforcement; cross- 0.0001) and male, (P ? 0.002) sectional data Baseline data: ? 33% of 512 youth who smoked a White: 78% cigarette in past 6 mos reported Adequate HispaniC1: 9% purchasing cigarettes randomization: Other: 13% NR ? Result associated w/ bans on free samples and single cigarette sales Attrition rate: in unadjusted model only 76% of eligible youth ? Attempts to purchase cigarettes: had parental consent AOR = NS for all ordinances ? Tobacco use: NS in adjusted model C-9 Evidence Table 2. Effective school-based interventions Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Ausems et al., 2004 To compare effects on smoking prevention ? 19 schools already participating in Geographic area: among Dutch first grade vocational school Healthy Schools and Stimulant children using a newly developed computer- Western Europe Program tailored (personalized messages/letters) ? Randomly assigned within regionally Funding agency: out-of-school program, an existing in-school defined blocks to in-school and out-of European Commission and program, and a combined approach school conditions the Dutch Cancer including both in-school and out-of-school ? Remaining 17 schools randomlly Foundation programs assigned to out-of school or control Study setting: Population: conditions School-based ? Adolescents Sample size: ? Vocational school children in the G1: 9 schools Netherlands G2: 8 schools Study type: G3: 10 schools C1: 9 schools ? RCT w/ cluster randomization ? Six out of 8 area health departments Definition of smoking: agreed to participate, and within these Cigarettes areas local vocational schools invited to ? Never-smokers: students who have participate never smoked even one cigarette or a Inclusion criteria: puff of one Dutch vocational schools ? Non-current smokers: students who have smoked in past, but not during Exclusion criteria: past month NR ? Current smokers: students who have smoked during past month C-10 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: ? Twelve months after pretest (posttest 2), in-school Quality rating: ? Computer-based program ? All effect analyses done intervention successful in Fair ? Classroom instruction separately for posttests preventing vocational school ? Computer generated 1?2?3 Comments: students from continuing to letters ? Since running large ? Refusal rate NR smoke, compared w/ students in regression models w/ ? Randomization Intervention: control condition OR = 0.49; 95% MIXOR might cause description unclear G1: In-school intervention: CI 0.29?0.84 problems, model regarding number ? Three lessons, each ? Eighteen months after pretest reduction first applied, of schools in txt lasting about 50 min, (posttest 3), tailored out-of-using SPSS 9.0 to groups student and teacher school intervention successful in determine final models ? Out-of-school manuals available preventing smoking initiation, containing significant intervention poorly ? Each lesson consisted of compared w/ students in control covariates and implemented (65% general introduction by (OR = 0.42; 95% CI, 0.18?0.96) interaction terms for of personalized teacher, reading text in prediction of smoking at ? Effect of combined approach not letters read by workbook, classroom posttests 1?2?3 larger than sum of effects of in- participants) discussion, workbook task school and out-of-school effects. and additional task that Data verification: Adequate summarized main points of Self-reports randomization: lesson Yes Dependent variables: ? First lesson explained Smoking rates, based on Attrition rate: ingredients of tobacco, both smoking initiation School level and physical and mental among never-smokers and ? Posttest 1: 5.6% reactions of smoking, smoking continuation (2 schools) while second discussed among ever-smokers ? Posttest 2: 8.3% norms concerning (3 schools) smoking, and third Baseline data: ? Posttest 3: 18.5% emphasized pressures to ? Smoking behavior: (NR) smoke and skills that are ? Ever smoking: 59.7% helpful in resisting ? Current smoking: 19.5% Student level: cigarettes ? Mean age (yrs): 13.1 ? Posttest 1: 17.3% ? Gender (%, male): 52.1 ? Posttest 2: 5.4% ? Origin (w/ both parents ? Posttest 3: 24.6% Dutch): 73.0% ? Religious (adhering to a religion): 61.4% ? Family composition (w/ two parents): 82.1% ? Father?s occupation (paid job): 68.7% ? Pocket money (%, > 6.8 euro): 23.5 C-11 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Ausems et al., 2004 (continued) C-12 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments G2: Out of school intervention: ? Three tailored letters w/ smoking prevention messages, sealed in envelopes and mailed to students? homes at 3-wk intervals; researchers signed letters and added telephone numbers; students? pretest smoking behavior not disclosed in letters; to prevent arguments in students? families, letters tailored to individual characteristics ? Pretest questionnaire on attitudes, social norms, self-efficacy, smoking intention and smoking behavior used to create a database file containing personal information ? Computer program combined database file w/ message file using decision rules that linked students? answers to personal messages; all messages thus selected combined in a letter format; letters illustrated w/ a picture puzzle and several cartoons; and competition included where students could win one of two CD vouchers G3: Combination of in- and out-of-school interventions C1: Control Method of assessment: ? Questionnaire for students at 6, 12 and 18 months ? After a pretest, teachers questioned about effectiveness of process C-13 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Aveyard et al., 2001 To re-evaluate whether addition of a TTM- ? Sampling description referenced from Geographic area: based intervention to existing health previous study (Aveyard et. al., 1999) education school curriculum would protect United Kingdom ? Once schools agreed to participate young people from becoming smokers and individuals randomly allocated to Funding agency: help those who smoked quit compared w/ intervention or control NR unknown effect of existing health ? Arms balanced by ordering schools educationRe-evaluation employed different Study setting: into five groups based on numbers of periods of followup and fully exploring School-based students in yr 9; allocated each effects of using an ITT analytical approach school a number b/w 1 and n Population: (maximum number in group) ? Adolescents, ages 13 to 16 ? Computer program generated n/2 ? Living in West Midlands, UK random numbers b/w 1 and n, and schools allocated to intervention Study type: ? One school allocated to intervention RCT w/ cluster randomization dropped out after randomisation and Inclusion criteria: before baseline questionnaires Yr 9 student (age 13 to 14) in participating administered school, assented and parents consented All Yr 9 students (aged 13 to 14) in Exclusion criteria: participating schools invited to participate ? Parent or student refusal ? Smoking status could not be assessed at Sample size: followup(s) G1: 4,125 C1: 4,227 Definition of smoking: Cigarettes ? Regularly smoking at least one cigarette per wk C-14 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis Quality Intervention Details and Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: No evidence of change of stage Quality rating: ? Computer-based program ? Random effects at either 1 yr or 2 yr followup: Fair ? Video logistical regression G1 vs C1 ? Classroom instruction ? Logistical regression ? 1 yr AOR = 1.13, 95% (CI, Comments: 0.91 - 1.41); 40% refusal rate; Intervention: ? Bivariate analysis, no details on G1: During Yr 9, received ? Frequencies ? 2 yr AOR = 1.25, 95% (CI, ? Kappa assessment 0.95 - 1.64) baseline data; C ? Three whole class exposure to other lessons and three ? Sensitivity analysis No change in regular smoking at prevention interactive computer Data verification: either follow up: programs not sessions (including video Self-report ? G1 vs C1: assessed clips of young people 1 yr AOR = 1.14, discussing their smoking) Dependent variables: Adequate (95% CI, 0.93, 1.39) ? Movement in stage of randomization: ? Followed by ? 2-yr AOR = 1.06, Yes questionnaires assessing change (95% CI, 0.86, 1.31) stages of change, ? Smoking status Attrition rate: smoking uptake or Subgroup analysis by initial Baseline data: Yr 1: cessation smoking status NS for benefit for NR, but stated no G1: 11% ? ? Feedback on results of prevention of smoking or large differences b/w C1: 10.7% questionnaire, counseling smoking cessation groups in these Yr 2: about how to move predictors of smoking G1: 14% forward in stages, and at baseline C1: 16.9% feedback on progress ? Predictors included: over time points smoking status, C1: Standard lessons on stage of change, and smoking as part of English potential national curriculum, possibly confounders, i.e., risk up to three additional factors for smoking in lessons on smoking (already future available from teaching resources), which included quizzes and group work on health effects of smoking and different methods of persuading someone to quit smoking, all unrelated to TTM; no data collected on receipt of information Method of assessment: Self-report questionnaire administered at baseline, 1 yr and 2 yr followups C-15 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Brown et al., 2002 To evaluate an extracurricular HS tobacco 30 high schools Geographic area: control intervention developed by teachers and students Matched pairs prior to randomization by: Canada ? Size of school Funding agency: Population: ? Number of students projected to NHLBI ? Adolescents attend who participated in an ? Cohort followed from 7-8th grade through elementary school study Study setting: 9-10th grade ? Proportion of cohort students from School-based Study type: elementary school study control condition ? RCT w/ cluster randomization and paired- matching Sample size: ? Matched pairs prior to randomization G1: 1,563 ? Randomized within pairs to Intervention C1: 1,465 and Cs Definition of smoking: Inclusion criteria: Cigarettes ? School board participated in prior ? Experimental smoker: smoked less elementary school smoking prevention than once a wk study ? Regular smoker: smoked weekly ? At least 30 students from elementary school cohort projected to attend HS Exclusion criteria: NR C-16 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis Quality Intervention Details and Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Grade 10 smoking rates for Quality rating: ? Extra-curricular activities Cluster-randomized never smokers: Fair ? Mobilization of staff and designs (as discussed ? Male regular smoking rates students to involvement in in Donner) and applied lower Comments: anti-smoking activities a procedure that uses a G1: 9.8% ? Randomization variance term C1: 16.4% technique Intervention: appropriate to P = 0.02 incomplete G1: Extracurricular randomization of ? Control schools activities: Quit and win schools (Liang) Smoking rates despite baseline received ?usual? contests, poster contests, status (NS): care but not displays, health fairs, Data verification: ? Females: described smoking surveys ? Bogus CO breath G1: 28.3% ? Some slight ? Average of 3.8 samples collected to C1: 24.8% baseline data intervention activities in enhance validity of P = NR differences 9th grade and 3.5 self-reported ? Males: ? Limited activities in 10th grade smoking behavior G1: 21.1% generalizability ? A teacher facilitated ? Data collected from C1: 26.4% students, staff, and absent students by P = NR Adequate community members in mail or phone, but no ? Overall: randomization: planning and bogus CO samples G1: 24.9% Yes implementing prevention collected C1: 25.7% Attrition rate: and cessation activities tailored to each Dependent variables: P = NR G1: 5% C1: 5% intervention school to ? Social model risk build committment and score strengthen not smoking ? Elementary school as a school social norm risk score ? Research staff provided ? Smoking status consultation, conducted Baseline data: semiannual workshops for Baseline data similar teachers and student except proportion of HS leaders, developed students in elementary resources for school study dissemination to all intervention cohort : intervention schools, G1: 84% produced newsletters, C1: 75% and provided a $1000 per (P = 0.10) school annual budget C1: Usual care, details NR Method of assessment: Surveys completed by cohort at end of their 9th and 10th grade yrs; data collectors blind to txt status C-17 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Crone et al., 2003 To assess effect of a peer pressure based Community Health Sources Geographic area: antismoking intervention on adolescents in ? 48 school identified; lower secondary (middle) school Western Europe 18 willing to participate; 8 additional schools recruited Funding agency: Population: None ? Adolescents ? Schools stratified by size and use of national drug education ? 1st grade of lower secondary education in Study setting: the Netherlands (mean age 13) ? Randomized to intervention or control School-based by toss of coin by independent Study type: person RCT w/ stratified randomization Sample size: Inclusion criteria: G1: 14 schools, 1,444 students ? Adolescents in lower secondary C1: 12 schools, 1,118 students education in the Netherlands Definition of smoking: Exclusion criteria: Cigarettes ? If already participating in another study ? Smoker: all students who experiment w/ smoking or who smoke weekly or daily C-18 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Proportion increase at end of Quality rating: ? Video ? Used multilevel intervention: Fair ? Classroom instruction techniques to account ? Nonsmokers: ? Competition by NIAS for clustering; G1: 9.6% Comments: that reward class w/ ? Compared intervention C1: 14.2% ? Refusal rate < 10% smokers and Cs in terms of OR 0.61 (62.5%) proportions of smokers (95% CI, 0.41-.90) ? Not generalizble Intervention: before and after ? Smokers: ? Significant G1: Three lessons on intervention and G1: 2.6% differences in knowledge, attitudes, and proportion who started C1: 7.9% baseline data social influence, followed smoking, controlling OR = 0.62 ? Very high by a class agreement not for differences at (95% CI, 0.43 - 0.90) attrition but used to start smoking or to stop baseline Perceived social pressure: ITT smoking for next 5 months ? Performed ITT ? More likely to be smokers ? Two extra video lessons Adequate analysis OR = 2.21 on smoking and social randomization: influence were available Data verification: (95% CI, 1.53 - 3.18) Yes as an optional extra Self-report ? Effects at one yr followup: NS Attrition rate: during the 5 months A competition Dependent variables: Schools: ? Smoking status Overall attrition: administered by the NIAS that rewarded ? Changes in attitude 11.5% (3/26) classes that had fewer toward smoking G1: 7.1% (1/14) than 10% smokers at ? Perceived social C1: 16.7% (2/12) the end of the 5 month influence Student attrition: period ? Self-efficacy Overall: 63.3% ? A photography contest ? Intention to remain a (1,621/2,562) to pick best photos that smoker G1: 61.4% expressed a non- Baseline data: (887/1,444) smoking class C1: 63.9% Males (%): C1: Used drug prevention G1: (714/1,118) 49.5 program normally given to C1: 60.9 students (which P = < 0.001smoker intervention schools used Mean age: 13 yrs as well) ? Given option to use intervention program one yr after study Method of assessment: Surveys administered at baseline, at end of intervention, and at 1 yr followup C-19 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Ellickson et al., 2003 To evaluate revised Project ALERT drug ? 48 school clusters (high schools and Geographic area: prevention program across a variety of their feeder middle schools) Midwestern schools and communities US ? Schools organized in 3 strata by Population: community size and type (city, town, Funding agency: NIDA, the BEST Foundation ? Adolescents, 7th and 8th graders in rural) South Dakota (Urban and rural ? Blocks of school clusters consisted of for a Drug-Free Tomorrow; the Conrad N. Hilton communities) 3 clusters from same stratum located in same geographic region of state., Foundation Study type: within each block, 1 school cluster Study setting: RCT w/ stratified randomization randomly assigned to each School-based experimental condition Inclusion criteria: ? Results are combined through 8th ? Middle schools in South Dakota grade for this study w/ one C ? Parental consent obtained Sample size: Exclusion criteria: G1: 34 middle schools, 2,553 students NR C1: 21 middle schools, 1,723 students Definition of smoking: Cigarettes ? Cigarette use: ever, past month, and weekly C-20 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: At 18-month followup, cigarette Quality rating: Classroom instruction ? Adjusted for multiple use in the past month: Fair Intervention: baseline covariates, ? Baseline non-users: Comments: G1: 11 lessons in 7th including covariates G1+G2:8.6% grade and 3 lessons in 8th for school geographic C1: 11.1% ? Slight baseline location and P = < 0.01 differences but grade that, using enrollment size to ? Baseline experimenters: controlled for in interactive teaching methods, they sought to account for blocking G1+G2:28.9% analysis change students' beliefs ? Used Bayesian model C1: 36.6% ? Clear description about drug norms and to impute missing data P = < 0.05 of school for covariates; a ? Baseline users: assignment social, emotional, and ? Possible physical consequences of generalized estimating G1+G2:56.8% using drugs, to help equation that assumed C1: 70.8% disruption of students identify and resist a linear model for P = < 0.05 randomization process pro-drug pressures from natural logarithm of parents, peers, media, and the odds of use and At 18-month followup, weekly cigarette use: Adequate others, and to build constant correlation ? Baseline non-users: randomization: resistance self-efficacy; among responses Yes followed by booster from students from G1+G2:4.0% C1: 6.6% Attrition rate: lessons in 9th and 10th same schools used to P = < 0.05 9% grades account for possible G2: 11 lessons in 7th intraschool correlation ? Experimenters: G1+G2:18.0% grade and 3 lessons in 8th Data verification: C1: 23.5% grade that, using Self-reported smoking P = < 0.05 interactive teaching status validated by ? Users: methods, they sought to assessing salivary G1+G2:45.1% change students' beliefs cotinine levels for a C1: 56.0% about drug norms and random subsample of P = < 0.10 social, emotional, and 654 students physical consequences of using drugs, to help Dependent variables: students identify and resist Cigarette, marijuana, and pro-drug pressures from alcohol use; beliefs parents, peers, media, and about consequences, others, and to build prevalence and resistance self-efficacy; expectations of use, self- not followed by any efficacy booster lessons Baseline data: C1: Did not receive ? Non-white: 12.5% experimental program; (largely Native schools could continue American) other prevention curricula ? Female: 50% already in place ? Students in C1 less Method of assessment: likely to be White and Students completed more likely to have surveys at baseline and 18 used marijuana than months later students in G1 and G2 C-21 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Josendal et al 2005 To evaluate the BEsmokeFREE school- ? Nationally representative sample of Geographic area: based, smoking-prevention program for 99 secondary schools from a list of all adolescents in Norway Western Europe secondary schools in Norway Funding agency: Population: ? Schools sorted by ascending postal ? Adolescents code number, every 11th school Norwegian Cancer Society included in study; schools allocated to ? Norwegian 7th, 8th , and 9th grade (mean groups by investigators choosing a Study setting: age 13) random number b/w 1 and 44 School-based Study type: ? Starting w/ that number, every 44th ? RCT w/ cluster randomization school selected for C and next three schools on list of comparable size (+/- Inclusion criteria: 10%) allocated to three intervention After being sampled by technique groups described, the school had to agree to participate Sample size: G1: 25 schools, 1,125 students Exclusion criteria: G2: 25 schools, 933 students NR G3: 25 schools, 1,005 students C1: 25 schools, 1,092 students Definition of smoking: Cigarettes ? Smokers: daily smokers, and weekly smokers ? Nonsmokers: smoking less than once a wk, and not smoking at all C-22 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Proportion of smokers higher in C1 Quality rating: ? Video Multilevel, multiple logistic vs G1 for 3 followup yrs: Good ? Parent involvment regression analyses used ? 1995: F(d.f. = 2.61; 125.49) = ? Classroom instruction to examine odds of 5.66; P < 0.01 Comments: smoking among students in ? 1996: F(2.34; 114.46) = 7.19; ? Study design and Intervention: intervention groups P < 0.001 randomization G1: Intervention compared w/ students in 1997: F(2.39; 112.42) = 4.05; technique clearly ? administered by teachers C1, adjusted for gender P < 0.05 described and other staff at school and smoking habits at ? Intervention ? Given to students in baseline In G2 and G3, proportion of theoretically grades 7 and followed smokers on all followup occasions anchored; cohort through 7, 8, 9 Significance tested w/ higher than G1 but lower then C1 description of grade Pearson's ?2, corrected for ? 1995: F(d.f. = 9.74; 886.65) = scales reported in ? Number of hrs of design effect; correction 2.84; P < 0.01 referenced article intervention: grades 7 thru implies chi sq value ? 1996: F(7.87; 739.55) = 3.98 ? Explored attrition 9 were 8, 5 and 6 hrs, converted to an F-value w/ P < .001 by surveying drop respectively number of d.f. that may ? 1997: F(6.00; 485.98) = 2.46; outs ? Classroom instruction deviate from integer values P < .05 Adequate contained non-traditional school activities such as Data verification: Odds of becoming a smoker during randomization: video, games, and group Self-report intervention period statistically Yes work lower in G1 compared to C1: Dependent variables: Attrition rate: ? During grade 8 ? Daily smoking (Wald?s 9.81, d.f. ? Frequency of smoking ? G1+G2+G3: 11.2% adjustments to intervention = 3, P = 0.02) ? Number of cigarette hrs C1: 5.8% were requested by ? Weekly smoking (Wald?s 15.65, ? Number of cigarettes ? Smokers more students and teachers d.f. = 3, P = 0.0001) smoked per wk likely to drop out ? In grade 9, students ? Any smoking (Wald?s 16.54, d.f. ? Use of cannabis than non-smokers developed and carried out = 3, P = 0.0001) ? Frequency of cannabis and evaluated their own use campaign to promote a smoke free lifestyle among Baseline data: the 7th graders Baseline data reported but ? Classroom curriculum, limited to smoking teacher in-service course, frequencies and parental involvement Mean age: 13 yrs G2: Same as G1 Classroom curriculum and parental involvement but teacher did not receive in-service training on intervention G3: Same as G1 Classroom curriculum w/ teacher in- service course but no parent involvement C1: Education on smoking and health about half the number of hrs as intervention Method of assessment: Surveys administered in classroom by teachers at end of each academic yr (7th, 8th, and 9th grades), then mailed to evaluators. C-23 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Perry et al., 2003 To evaluate effect of middle and junior HS ? Targeted Minnnesota school districts Geographic area: D.A.R.E. and D.A.R.E. Plus programs on w/ schools w/ 7th grade populations drug use and violence US of at least 200 Funding agency: Population: ? 24 Junior high schools matched on ? Adolescents, 7th and 8th grade SES, drug use and size; schools NIDA randomly assigned to 1 of 3 ? Junior High Schools and communities in conditions DARE only, DARE Plus, or Study setting: Minneapolis-St Paul region, Minnesota C School-based Study type: Sample size: RCT w/ simple randomization G1: 8 schools; 2226 students Inclusion criteria: G2: 8 schools; 2221 students Minnesota school district, 7th graders in Fall C1: 8 schools; 1790 students 1999 Definition of smoking: Exclusion criteria: NR NR C-24 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Using growth curve analysis: Quality rating: ? Parent involvment Growth curve analysis; D.A.R.E. Plus less likely than Fair ? Extra-curricular activities 3-level linear, random- control to show an increase in coefficients model current smoking for boys Comments: ? Classroom instruction G2: (.28) std = 0.05 ? Randomization ? Community-activities Data verification: C1: (.31), std = 0.05 and sampling Intervention: Self-report technique G1: D.A.R.E. middle and Dependent variables: D.A.R.E. Plus less likely than incomplete junior HS curriculum D.A.R.E. curriculum alone to ? Use of cigarettes, ? No baseline ? 10 sessions taught by show an increase in tobacco use alcohol, and comparison data police officers in 1999- behavior and intentions. marijuana; multidrug G1: (.95), std = 0.11 Adequate 2001 use; violent behaviors; G2: D.A.R.E curriculum G2: (.68), std = 0.11 randomization: expectations No, group- and D.A.R.E. Plus C1: (.96), std = 0.12 concerning drug use, randomization program in 1999-2001: perceived access/offer NS outcomes for females method NR; exactly ? Classroom sessions, of drugs, parental 8 schools per peer led, parent rules and intervention involvement communication about ? Community leader drugs Attrition rate: involvement program ? Outcome expectations ? 16% overall consisting of extra about tobacco ? Minimal curricular anti-smoking differential activities in and out of Baseline data: attrition per school, including Male: 51.6% authors neighborhood activities White: 67.3% to address African American: 7.5% neighborhood issues Asian American: 12.7% related to drug use and HispaniC1: 3.6% violent behavior American Indian: 4.0% C1: Delayed program: Mixed or other: 4.9% Schools could receive D.A.R.E. Plus programs in 2001-2002, after final followup Method of assessment: Self-administered questionnaire C-25 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Schofield et al., 2003 To determine whether HPS intervention ? Intervention randomly allocated to Geographic area: program led to lower smoking uptake and selected secondary schools improved knowledge and attitudes among a Australia ? Randomly selected 24 of 31 cohort of students, and to examine factors secondary schools in Hunter and Funding agency: independently predicting posttest smoking Taree schools districts of New South National Health and Medical status Wales Research Council Population: ? 22 of 24 schools participated, w/ 12 (Australia); Hunter Centre ? Adolescents schools assigned to intervention, 10 for Health Advancement ? 7th -8th grade cohort followed 2 yrs to to control Study setting: grades 9-10 in New South Wales Sample size: School-based Study type: G1: 1,007 C1: 845 ? RCT w/ cluster randomization (cohort prepost design) Definition of smoking: ? Students followed over two yr period; Cigarettes cohort prepost design used to evaluate ? Smoking status at posttest: having intervention effectiveness smoked any amount of cigarettes Inclusion criteria: within past 7 days Students in Yr 7-8 at one of participating schools who gave assent, whose parent(s) gave active consent, and whose pre and posttests could be matched for comparison Exclusion criteria: NR C-26 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Posttest results: Quality rating: ? Self-help Univariate analysis Smoked in last wk: NS Fair ? Group counseling Bivariate analysis G1: 17.5% ? Social support Multivariate analysis C1: 20.5% Comments: Logistic regression Crude OR for G1 = 0.82 (0.65, ? Refusal rate: 40% Intervention: 1.04) ? High attrition G1: Each school had Data verification: ? Intervention not liaison office responsible Self-report Maximum knowledge score: consistently for introducing minimum Dependent variables: G1: 64% implemented across set of actions and C1: 60% ? Smoked in last wk schools, though facilitating tailoring and implementation of the ? Smoking knowledge Prepost change: high fidelity in ? Smoking attitudes G1: 12% implementing "key following actions: components" of ? Ensure curriculum towards schools C1: 7% P = 0.001 intervention, covers smoking effects, Baseline data: authors mention distribute parent Large variations in Smoking attitudes: potential smoking pamphlet, baseline smoking rates NS at pre or posttest contamination via implement school (11-33%) so smoking smoking policy, Solely among smokers (from control schools w/ and school controlled for distribute letters to combined groups), positive personnel in regression (details tobacco retailers, attitudes to smoking supportive of HPS NR) discussion group/survey decreased from pretest to intervention w/ parents, followup posttest (P = 0.01), but not program, but no At pretest, smokers had: data to action from discussion among non-smokers ? Less positive attitudes support/refute group, and training of than nonsmokers ? Study properly SRC/peer leaders to (mean for smokers: addressed deal w/ smoking issues 4.3; mean for non- clustering issue ? Schools also smokers 4.7, mean through analytical encouraged to take over difference = 0.4, 95% methods other additional anti CI-0.3, 0.5) smoking activities of Adequate ? Fewer perceived their choice randomization: negatives about C1: Control schools not Yes smoking (smokers' offered any of the mean: 3.6, non- Attrition rate: resources or actions to smoker's mean = 3.9, G1: 48% reduce smoking that mean difference = 0.2, C1: 52% intervention schools 95% CI, 0.1, 0.3) (Authors mention received, but if they more smokers than requested assistance, non-smokers lost to project team offered follow up) support for other health- related issues and promised smoking-specific support at completion of study period Method of assessment: Self-reported retrospective diary (of having smoked within past 7 days), as assessed via questionnaire C-27 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Share et. al., 2004 To evaluate impact of a school-based SLF program participant cohort Geographic area: intervention-SFL-which aimed to involve the matched w/ a C located in North community, increase tobacco knowledge, Western Health Board area (not Western Europe strenghthen refusal skills, and improve defined) Funding agency: decision-making ability Sample size: Europe Against Cancer Population: G1: 450 Programme ? Adolescents, ages 13 to 15 C1: NR Study setting: ? Leitrim, Sligo, and Donegal County, Ireland students Definition of smoking: School-based NR Study type: RCT w/ simple randomization Inclusion criteria: ? SLF program participants ? Aged 9 to 10yrs attending 4th grade (1996-97) in North Western Health Board area (not defined) Exclusion criteria: NR C-28 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Tried smoking: Quality rating: Classroom instruction ? SPSS G1: 59% Poor Intervention: ? Pearsons chi sq C1: 55% Comments: G1: Primary school phase: ? Spearman's Rank Current smoking: ? No information materials about smoking, correlation G1: 19% on selection of healthy lifestyle, and Data verification: C1: 24% subjects from growing up provided for Self-report classroom instruction; Females in C 2x as likely to primary smoke everyday and 50% more intervention ? Teachers determined Dependent variables: likely to currently smoke than ? Unable make order/timing of lessons; ? Smoking females in intervention group, (P inferences from visits from health experimentation < 0.05) original baseline promotion staff,and yr ? Current smoking data because end celebration; ? Smoking knowledge Feel grown if smoke: followup ? Postprimary school ? Attitudes about G1: 30% instrument not phase: quizzes, smoking C1: 43% compatible competition, visits by ? Family member (P < 0.01) ? No reliability health promotion staff, smoking testing of newsletter, website, ? Reasons for continued Don't mind if friends smoke: instrument peer education project, smoking G1: 72% ? No information smoke free school C1: 67% buses campaign, and Baseline data: (P < 0.05) on annual events day(no Baseline data (i.e: at age randomization, 9 to 10) NR Family: correlation b/w student or C classroom materials smoking experimentation and ? No baseline data provided) Male parent/sibiling smoking: and analytical C1: NR G1: 52% ? Mother (rs = 0.165, P < 0.01) methods not well Method of assessment: C1: 45% ? Father (rs = 0.172, P < 0.05) described Self-report questionnaire Age 13: ? Both parents (rs = 0.346, Adequate at study's end G1: 12% P < 0.01) randomization: (administered face to face C1: 14% ? Brother (rs = 0.162, P < 0.01) NR in intervention group and ? Sister (rs 0.277, P < 0.01) 11 control schools; Age 14: Attrition rate: "posted" (mailed) to other G1: 72% G1: 22% control schools) C1: 77% C1: NR Age 15+: G1: 16% C1: 9% C-29 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Simons-Morton et al.,2004 To examine associations b/w initial and ? Seven middle schools (in 1 Maryland Geographic area: continuing peer affiliation and parent school district) recruited and influences and smoking stage progression US randomized: Population: o 3 to txt condition and 4 to control Funding agency: ? Adolescents, 6th, 7th, and 8th graders ? Starting w/ 1996 school yr., 2 NR successive cohorts of 6th-grade Study type: students recruited and followed Study setting: through 9th-grade School-based RCT w/ simple randomization Inclusion criteria: Sample size: ? 6th grader in 1996 or 1997 at one of 7 Total: 3,039 at start, 1,320 final schools in un-named Maryland School C1: NR District Definition of smoking: ? Consent by parents Cigarettes Exclusion criteria: ? Never: no smoking in past 30 days or Special education students past 12 months + no intention of smoking in HS ? 12-month smoker: smoking in past 12 months but not in past 30 days ? Recent smoker: smoking 1 to 2 times in past 30 days ? Frequent smoker: smoking 3+ times in past 30 days ? Intent to smoke: none in past 30 days or past 12 months but intent to smoke in HS C-30 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Final sample: Quality rating: ? Video LGC analysis (Curran, ? White: 66% Poor ? Classroom instruction 2000): structural ? Black: 25% equation modeling + Comments: Intervention: ? Other: 9% hierarchical linear ? Baseline data G1: The Going Places modeling NR Program: parent education ? Variance of intercept factor in linear LGC model 2.23 (SE = ? C sample size (materials sent home), Data verification: school media, social skills Self-report 2.05; P < 0.001) indicating NR ? No txt vs curriculum (to increase significant differences in school engagement and Dependent variables: tobacco use at beginning of comparison prevent multiple problem ? Background variable 6th grade group data behavior such as ? Smoking ? Variance of slope factor 0.289 reported ? Friends w/ problem (SE = 0.038; P < 0.01) ? 151 special substance use, aggression, and antisocial behaviors indicating significant education behavior) ? Parenting practices differences in smoking stage students ? 18 class sessions in 6th progression over time excluded after grade, 10 in 7th grade, 6 ? Path coefficients: intercept of assessment 1, suggested in 8th grade adolescent smoking to slope of C1: NR friends who smoke variable = possibility of post 0.31(P < 0.01) indicating randomization of Method of assessment: adolescents at higher initial exclusions ? Students surveyed at smoking stages had increased Adequate beginning and end of # of friends smoking over time randomization: 6th grade, toward end ? Path coefficient b/w parent NR 7th & 8th grades, and involvement and adolescent beginning of 9th grade smoking = -0.15, (P < 0.01) Attrition rate: ? Two trained proctors indicating parent monitoring 36.3% collected data; teachers and expectations overtime are not involved w/ survey negatively associated w/ smoking stage progression Baseline data: NR ? Path coefficient directly leading from parent involvement (-.15) and indirectly to the slope of adolescent smoking stage (- .46) through the slope of friends who smoke (.66) indicating that parenting practices overtime protect against smoking progression both directly and indirectly by limiting the adoption of friends that smoke P < 0.01 C-31 Evidence Table 2. Effective school-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Unger et al., 2004 Determine whether a multicultural Sixteen middle schools in Southern Geographic area: curriculum prevents initiation of smoking Calif randomly assigned to receive among middle school children at 1-yr multicultural curriculum or standard US followup curriculum (8 schools in each group) Funding agency: Population: Sample size: National Institutes of Health and the Calif Tobacco- ? Adolescents G1: 1,040 students, 8 schools C1: 930 students, 8 schools Related Disease Research Study type: Program RCT w/ cluster randomization Definition of smoking: Study setting: Cigarettes Inclusion criteria: School-based ? Smokers: trying smoking b/w 6th and Students participated if they and their 7th grade parents provided active written consent Exclusion criteria: NR C-32 Evidence Table 2. Effective school-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Initiation among never smokers Quality rating: Classroom instruction ? X2 and ANOVA (yr 1 followup): Fair Intervention: analyses assessed G1: 8% G1: C1: 11% Comments: Project FLAVOR (Fun prevention equivalence of 2 P = NR ? Randomization Learning about vitality, scheme NR origins, and respect) groups Among male, Hispanic, never ? No ITT analysis provided 8 weekly ? Logistic regression classroom sessions used to examine smokers, OR of smoking Adequate conducted by health attrition based on intitation by 7th grade: OR = 0.49 (95% CI, 0.27 -.88) randomization: educators that addressed experimental NR smoking-related condition, baseline Overall intervention effect NS: psychosocial concepts smoking, and OR = 0.75 (95% CI, 0.48, 1.18) Attrition rate: G1: 16.83% through activities such as experimental condition role-playing, trivia games x baseline smoking C1: 16.77% and art projects, relating ? Multi-level logistic Higher among these issues to values of regression w/ school baseline ever several cultures, such as as a random effect to smokers (22%) Asian Yin-Yang concepts, control for intraclass than never and telenovela (soap correlation assessed smokers (16%), opera) role play effect of intervention P = < 0.05 C1: 8 weekly classroom on smoking initiation sessions conducted by b/w sixth and seventh health educators that grades addressed smoking- Data verification: related psychosocial Self-report concepts through activities such as role-playing, trivia Dependent variables: games and art projects, Smoking status but without cultural Baseline data: references ? Groups similar at Method of assessment: baseline Surveys at baseline and 1 ? No significant yr followup differences in demographics or lifetime smoking prevalence b/w intervention and Cs ? HispaniC1: 57% ? Asian American: 27% ? Other: 16% C-33 Evidence Table 3. Effective provider-based interventions Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Tyc et al., 2003 To evaluate efficacy of a tobacco risk ? Stratified RCT w/ patients who were Geographic area: counseling intervention vs standard care for pediatric cancer survivors treated at preadolescent and adolescent cancer US St. Jude Children's Research survivors Hospital, Memphis, TN, currently Funding agency: Population: receiving txt there NCI, ALSAC ? Adolescents who were cancer survivors ? Recruited during outpatient visits Study setting: age 10 to 18 (treated at St. Jude ? Asked to participate and told Practice/provider settings Children's Research Hopital, Memphis, participation did not depend on TN) smoking status ? On enrollment patients randomly Study type: assigned (stratified by age, sex, race, RCT w/ stratified randomization and self-reported smoking status) ? Randomization scheme proposed by Inclusion criteria: Zelen (1974) ? Between 10 to 18 yrs old Sample size: ? Survivor of pediatric cancer G1: 53 ? Currently disease-free C1: 50 ? At least 1 yr from completion of Definition of smoking: antineoplastic therapy at St. Jude NR Children's Research Hospital (TN) Exclusion criteria: Patients who had brain tumors (due to cognitive, functional impairments that often result from txt) C-34 Evidence Table 3. Effective provider-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Mean K score: Quality rating: ? Self-help ? Descriptive G1: 24 Fair ? Individual counseling by ? Multivariate analysis of C1: 22.7 health professional variance, Comments: Mean PV score: ? Telephone counseling Repeated measures ? No psychometric ? G1: 35.9 validation of ? Video ? Mixed-model analysis C1: 32.5 researcher- Intervention: of variance and regression I scores: designed scales G1: Administered in single G1: 7.8 to measure session w/ periodic Data verification: C1: 10.0 knowledge and reinforcement of tobacco Self-report P = 0.002 perceived goals by telephone positive effects ? Educational video Dependent variables: No significant differences in PPE of tobacco discussed short- and ? Knowledge (of at 12 mos, nor in any of ? No verification or long-term physical and adverse dependent variables at 6 months definition of social consequences of consequences of tobacco use tobacco use tobacco use generally ? Limited ? Late effects risk and for cancer generalizability counseling focused on survivors) to primarily white potential chemotherapy ? Perceived Vulnerability cancer patience and radiation txt related (to tobacco related ? Possible ceiling toxicities exacerbated by health risks) and floor effects tobacco use and ? Intentions (I) (to use on Knowledge survivors? increased tobacco) and intention vulnerability to tobacco- ? Perceived PPE measures makes related health risks Baseline data: it difficult to relative to their healthy Baseline demographic access peers and questionnaire data meaningful ? Goal setting involving collected for both groups changes tobacco abstinence or w/ no significant Adequate cessation depending on differences b/w groups randomization: survivor?s smoking Yes status ? A physician feedback Attrition rate: letter that reinforced At 6 months: antitobacco message Overall: 30% delivered in intervention (31/103) ? Tobacco literature and G1: 32.1% (17/53) followup telephone C1: 28% (14/50) counseling at 1 and 3 months after At 12 months: intervention Overall: 21.5% (22/103) ? Face-to-face counseling G1: 20.1% (11/53) component of C1: 22% (11/50) intervention conducted by a master?s level psychologist over a 50- to 60-minute period, and followup telephone counseling conducted by a research nurse trained by V.L.T. C-35 Evidence Table 3. Effective provider-based interventions (continued) Study Characteristics Study Design Sample Design and Definitions Author: Tyc et al., 2003 (continued) C-36 Evidence Table 3. Effective provider-based interventions (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention delivered using scripted protocol tailored to patients? individual responses to questions posed during intervention and individual goal setting. C1: Patients asked about their tobacco use and briefly advised about health risks associated w/ tobacco use; all tobacco users advised to stop and nonsmokers encouraged to continue to resist tobacco Method of assessment: Knowledge scale: ? 25 true-false questions regarding adverse effects of tobacco use and w/ questions focused on increased risks of youth treated for cancer ? 8-item scale measuring patients' perceptions of their vulnerability to tobacco-related health risks C-37 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Bauman et al., 2000 To report effectiveness of a universal family- ? Eligible parent-adolescent pairs Geographic area: directed program (Family Matters) for matched (by date and time of baseline reducing/eliminating cigarette and alcohol US interview) then randomly assigned to use by adolescent users either Family Matters or C Funding agency: Population: ? Random digit dialing and basic query NIDA Grant Adolescents used to identify families w/ 12- to 14-yr old children Study setting: Study type: Population-based RCT w/ simple randomization Sample size: G1: 37 baseline tobacco users Inclusion criteria: C1: 48 baseline tobacco users ? In contiguous US state Definition of smoking: ? Consent Cigarettes ? Child age 12 to 14 yrs ? Use on one or more days during past ? Completion of baseline interview 30 days Exclusion criteria: NR C-38 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Of 85 baseline smokers, 74 Quality rating: ? Self-help GEE method, one-tailed completed followup at 3 months Fair ? Telephone counseling test (alpha 0.05), (62.2% still smoked) and 80 controlled for background completed followup at 12 months Comments: Intervention: variables. (66.3% still smoked) ? Include only G1: Family Matters: baseline users in ? Successive mailing of 4 Data verification: No statistically significant analyses in order booklets and telephone NR difference in tobacco use b/w to focus on discussion w/ health Dependent variables: control and txt for baseline cessation educator 2 wks after each cigarette users (OR = 1.42, lower Smoking 30 days before ? Only compare mailing bound CI, 0.57, P = 0.2846). interview entire baseline ? Adult family members groups to US or read booklets and do 15 Baseline data: previous study activities w/ adolescent Groups similar on all population rather ? Booklet topics: (1) measures except txt had than each other motivation, (2) family younger and fewer non- ? Used one-tailed characteristics, (3) Hispanic white participants tests tobacco and alcohol variables, Overall: ? Attrition high (4) variables outside 12 yrs: 30.6% among tobacco family 13 yrs: 35.3% users 14 yrs: 34.1% ? No biochemical C1: NR Male: 49% measure of use Method of assessment: Non-Hispanic white: 73.4% ? Small sample size Telephone interviews at 3 In 2-parent home: 78.8% Adequate and 12 months randomization: postcompletion or dropout Among smokers: No ? 21.6%, 40.5%, and Groups not similar at 37.8% were 12,13, and baseline by age and 14 yrs old respectively in race txt ? 10.4%, 29.2%, and Attrition rate: 60.4% were 12,13,and 14% overall; 40.5% 14 yrs old respectively in among tobacco control users in txt ? 35.1% male (txt) vs group(Control NR) 47.9% male (control); ? 70.3% vs 95.8% non- Hispanic white in txt vs control ? 75.7% vs 68.8% in 2- parent home in txt vs control C-39 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Etter et al., 2004 To determine whether effects of a computer- ? Baseline questionnaire sent to 20,000 Geographic area: tailored smoking cessation program were 18-60 yr old residents of French-maintained at 2-yr followup Western Europe speaking Switzerland, 3,124 agreed Population: to participate in study Funding agency: Adults ? 2,934 randomized to txt or Cs Swiss National Science Foundation, the Swiss Study type: Sample size: Cancer League, the Swiss RCT w/ simple randomization G1: 1,467 Federal Office of Public C1: 1,467 Health, and the Health Inclusion criteria: Authority of the Canton of ? 18 to 60 yrs old Definition of smoking: Geneva ? Resident of French-speaking Switzerland Cigarettes ? 1 mo Abstinence: not smoking even a ? More than an occasional smoker Study setting: puff of a tobacco cigarette, cigar, or ? Have a postal address Population-based pipe in last 4 wks Exclusion criteria: ? 1 wk Abstinence: not smoking even a NR puff of a tobacco cigarette, cigar, or pipe in last 7 days C-40 Evidence Table 4. Multi-component interventions to increase number of users who quit smoking (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: At 7 mo followup: Quality rating: Self-help X2 to compare 1 mo abstinence rates: Fair Intervention: proportions; t-tests to G1: 5.8% G1: After baseline compare means C1: 2.2% Comments: P = < 0.001 NR questionnaire: Data verification: ? Received 8-pg personal NR 1 wk abstinence rates: Adequate counseling letters randomization: written by a computer Dependent variables: G1: 8.0% C1: 3.3% NR according to answers ? Demographic P = < 0.001 Attrition rate: given by participants on characteristics 7-mo followup: 16% a 62 item questionnaire ? Stage of change At 24-mo followup: 24-mo followup: 12% ? Received 2 16-pg ? Level of tobacco 1 mo and 1 wk abstinence booklets corresponding dependence rates similar for both groups, to their current stage of ? Perceived drawbacks differences NS change and next stage of smoking Proportion of those who quit of change ? Self efficacy for at least 1 mo during study: ? Two, four, and 12 mos ? Use of self help G1: 30.9% after entering study, strategies C1: 24.7% participants could ? Current use P = < 0.001 answer tailoring ? Intention to use NRT questions again to Proportion of those who used receive new letter Baseline data: > 1 nicotine replacement C1: After completing Groups similar at product: baseline questionnaire, C baseline G1: 24.9% participants received a C1: 20.8% letter telling them that they P = < 0.008 were in C, and not contacted again until 6- and 23-mo followup surveys Method of assessment: Surveys at 7- and 24-mos postbaseline C-41 Evidence Table 4. Multi-component interventions to increase number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Lipkus et al., 2004 To test efficacy of self-help materials w/ or ? Teen smokers recruited from 11 Geographic area: without proactive telephone counseling to shopping malls and 1 amusement increase cessation among teen smokers. US park in Southeastern US ? Teens stratified on stage of readiness Funding agency: Population: Adolescents to quit, then randomized to (1)self- NCI grant help materials + video (C) or (2) self- help materials + video + telephone Study setting: Study type: RCT w/ simple randomization counselors (experimental group). Community-based ? 2-arm randomized intervention trial Sample size: ? G1: 193 Inclusion criteria: G2: 209 ? Age 15 to 18 Definition of smoking: ? Smoked a cigarette within last wk Cigarettes ? Gave verbal consent ? Smoked 1 or more within last wk ? Obtained parental consent if < 18 yr Exclusion criteria: NR C-42 Evidence Table 4. Multi-component interventions to increase number of users who quit smoking (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: No group differences Quality rating: ? Self-help ITT; logistic regression observed in abstinence at Fair ? Telephone counseling Data verification: either time point or for ? Video sustained abstinence Comments: Saliva cotinine kit mailed at G1: Abstinence rates: 16% ? Methods described in Intervention: month 4 postbaseline if teen and 21% for 4 and 8 mos, good detail (except G1: Two self-help booklets denied smoking in last 7 respectively randomization scheme) by mail and 6 minute video days; otherwise selfreport. C1: Abstinence rates: 11% ? Major limitation is high and 3 telephone counseling and 19% for 4 and 8 mos, attrition rates sessions Saliva kits retruned by 40% respectively C1: Two self-help booklets of those reporting cessation; Adequate randomization: by mail , 6 minute video, no rates of return did not differ Outcome Measures NR telephone counseling by group unchanged after adjusting Attrition rate: Method of assessment: Dependent variables: for multiple variables Control: 49% 6-item revised Fagerstrom Point-prevalent abstinence Sustained abstinence rates Intervention: 66% Nicotine Tolerance Scale; at 4 and 8 mos (C1) 7% and (G1) 9% Abstinence rates: self report (validated by postbaseline; sustained abstinence (proportion Participants completing 4 mos: saliva cotinine if denied reporting not smoking at more counseling calls more G1: 16% smoking in last wk); Shadel both followups) and likely to report cessation at C1: 11% and Mermelstein's 5-item predictors of cessation 4 and 8 mos postbaseline scale 8 mos: w/ ITT: (OR = 1.59, 95% CI, G1: 21% Baseline data: 1.14-2.22 for 4 mos and OR C1: 19% No arm differences on = 1.54, 95% CI, 1.15-2.07 sample characteristics for 8 mos) and to have sustained abstinence (OR = Age 17 or older: G1: 55% 2.03, 95% CI, 1.14-2.22 C1: 59% Intervention group less likely to watch some/all of video Male: G1: 47% (44% vs 62%, P < 0.05) and C1: 51% read some/all of booklet (57% vs 78%, P < 0.01) High School: G1: 85% Teens completing more C1: 78% calls more likely to report quitting at 4 and 8 mos (4 82% white, 10% black in mos: OR = 1.59, 95%CI, both groups 1.14-2.22, P < 0.007; 8 mos: OR = 1.54, 95% CI, 3 (SD 2) mean yrs smoking 1.15-2.07, P < 0.007) and in both groups have sustained abstinence (OR = 2.03, 95%CI, 1.14- 2.22, P < 0.006) The more calls teens accepted, the more negative they felt about smoking (r = 0.23, P < 0.05) and the more they reported wanting to stop (r = 0.23, P < 0.05) C-43 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: Lipkus et al., 2004 (continued) C-44 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Compared w/ teens who smoked more than the median number of cigarettes per day (>8), teens who smoked equal to or less than the median number of cigarettes a day more likely to have quit smoking at 4- mo (OR = 3.3, 95% CI, 1.7- 5.0, P < 0.0004) and at 8- mo followup (OR = 2.0, 95% CI, 1.2-3.3, P < 0.007) and to have sustained abstinence at both followups (OR = 2.5, 95% CI, 1.2-5.0, P < 0.01) Teens in preparation stage more likely than precontemplators to have quit at 4-mo (OR = 2.4, 95% CI, 1.0-5.4, P < 0.05) and at 8-mo (OR = 2.9, 95% CI, 1.4-6.0, P < 0.005) followups Stage of readiness not related to sustained abstinence C-45 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: McBride et al; 2002 To assess whether a multicomponent African-American patients (seen in adult Geographic area: intervention that included feedback about medicine, dental, urgent care and genetic susceptibility to lung cancer specialty clinics) current smokers, and US increased risk perceptions and rates of identified by chart abstraction and Funding agency: smoking cessation compared w/ a standard provider referral NCI cessation intervention Those eligible and agreed to participate Study setting: Population: called within 7 days of visits to complete Practice/provider settings ? Adults participant intake assessment ? African Americans Sample size: ? Low SES G1: 185 Study type: G2: 372 NR Definition of smoking: Eligible smokers randomized in a 1:2 ratio Cigarettes to enhanced usual care group or biomarker feedback (that included tailored feedback of ? Smoking: At least 1 cigarette in past 7 genetic susceptibility to lung cancer based days on presence or absence of GSTM1 and telephone counseling) group Inclusion criteria: ? Self-identify as African American ? Smoked at least one cigarette/day in prior 7 days ? Would consider genetic testing for GSTM1 Exclusion criteria: ? Not African American; being treated for substance abuse ? Smoked less than 7 cigarettes/wk ? Did not have a telephone ? Have medical conditions that contraindicate participation, e.g., Alzheimer?s disease, alcohol dependence ? Non-English speaking ? < 18 yrs of age C-46 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Proportion of participants not Quality rating: ? Self-help ? Baseline characteristics smoking at 6-mo followup: Fair ? Individual counseling by compared by intervention G1: 10% health professional arm w/ ?2 statistic for G2: 19% Comments: NR ? Telephone counseling discrete variables and t- Unadjusted P = 0.006 ? Pharmaceuticals tests for normally Adjusted P = 0.03 Adequate ? Genetic susceptibility distributed continuous and ordinal variables Proportion of participants not randomization: feedback Wilcoxon test statistic smoking at 12-mo followup is Yes ? Intervention: used when variables not NS: Attrition rate: G1: Enhanced Usual Care: normally distributed G1: 10% ? 6-month participants received G2: 15% ? Logistic regression used followup: 26% provider advice to quit Unadjusted P = 0.12 for main binary outcomes ? 12-month smoking and referred to Adjusted P = 0.34 of trial, abstinence from followup: 36% smoking specialist who smoking in prior 7 days at Continuous abstinence of No difference in assessed stage of 6- and 12-mo followups, participants: attrition b/w groups readiness to quit and and continuous G1: 5% appropriateness of NRT abstinence (not smoking G2: 11% ? Within 2 wks after clinic at both 6- and 12-mo Unadjusted P = 0.02 visit, all smokers sent a followups) Adjusted P = 0.08 self-help smoking ? All analyses done twice, cessation guide first unadjusted and then Rates of prevalent and especially designed for adjusted by adding sustained abstinence for African-American baseline variables that those w/ enzyme missing or smokers, ?Pathways to differed (P < 0.05) by arm present did not differ Freedom? and known to be significantly at followup: ? If eligible (smoked at associated w/ smoking ? 6 mos, 17 and 23%, least five cigarettes/day cessation, including respectively and in preparation stage number of chronic ? 12 mos, 18 and 15%; of readiness to quit), a illnesses (0 v. 1 or more), sustained, 12 and 12% 14-day supply of 15 mg smoking within 30 min of nicotine patches Among those who declined rising (no v. yes), and test, rates of prevalent ? Refill kits included a 7- desire to quit (below or abstinence at 6 and 12 mos day supply of patches equal to median v. above and sustained abstinence provided as needed; median) substantially lower (11, 11, ? Participants allowed to and 5% for each outcome and request up to eight refills Data verification: over study period (for a ? Salivary cotinine levels time point, respectively total of 10 wks of assessed for self-report of therapy) not smoking at 12-mo followup ? Efforts to biochemically confirm self-reported cessation unsuccessful ? 39% (24/61) of those who reported abstinence and agreed to provide a saliva sample returned one ? Rates of return did not differ b/w two arms (P = 0.78) C-47 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: McBride et al; 2002 (continued) C-48 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments G2: Biomarker Feedback: Data verification: ? Participants offered Salivary cotinine levels opportunity to have their assessed for those who blood tested for GSTM1 self-reported not ? Within 2 wks after clinic smoking at 12-mo visit, participants priority followup mailed an eight-pg test result booklet written at Efforts to biochemically a fifth grade reading confirm self-reported level that included test cessation unsuccessful; result, information about 39% (24 of 61) of those chemical constituents of who reported abstinence tobacco smoke and and agreed to provide a harms of exposure, saliva test regardless of genetic make-up Dependent variables: Primary: ? Those who declined test were sent an identical ? smoking status booklet that included Secondary: same graphical displays ? risk perceptions along w/ a generic ? worry description of test and a ? depression question mark in result box Baseline data: ? Within 1 wk after test Groups similar at result booklet mailed, baseline except: G1 arm participants called to participants had: discuss GSTM1 test and ? more chronic illnesses their result; counselors ? less desire to quit attempted a total of four smoking calls w/ each participant ? more likely to smoke over a 12-wk period; b/w within 30 min of first and second calls, waking participant sent than those in G2 arm ?Pathways? selfhelp guide and nicotine patches, if appropriate C1: NR Method of assessment: Self-report of 7-day point prevalence smoking status Salivary cotinine levels assessed at 6 and 12-mo followup Blood analyzed for G2 group to evaluate whether or not GSTM1 present C-49 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Murray et al., 2002 To evaluate long-term persistence of effects Original LHS recruited, in 10 clinics in Geographic area: on smoking and quitting on participants in U.S. and Canada, 5,887 adult volunteer the LHS intervention aimed at smoking smokers w/ some evidence of lung US cessation and to describe characteristics function impairment Canada that distinguish those who quit smoking Funding agency: from those continuing to smoke Following LHS 1, LCS enrolled 5,008 of original cohort, and followed at 6-mo NIH Population: intervals w/ telephone interviews to Study setting: ? Adults ascertain smoking status and morbidity Practice/provider settings Study type: Recruits randomized equally to three RCT w/ systematic randomization study arms Inclusion criteria: Sample size: ? Smokers who had some evidence of lung G1: 3,040 function impairment (at baseline, their C1: 1,477 ratio of FEV to FVC less than 0.70 and their FEV b/w 55 and 90% of predicted Definition of smoking: normal for their age, gender, height, and Sustained abstainers: race) ? participants who had been sustained ? Willingness to participate in a smoking quitters in LHS 1 cessation program if randomized to ? gave no report of smoking during smoking intervention LCS Exclusion criteria: ? if not enrolled in LCS, recalled no ? Serious health conditions likely to affect month w/ as much as one cigarette participation in followup visits and lung per day in interval b/w LHS 1 and function measurement LHS 3 ? Use of prescribed medications that might ? ex-smokers at LHS 3 baseline, alter lung function validated by expired air CO levels C-50 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Biochemically validated smoking Quality rating: Pharmaceuticals Comparisons b/w groups status at LHS 3 baseline - Fair Intervention: for quantitative variables Percent quit: G1: are based on t-tests, G1: 51.7 Comments: SI(described in other while those for C1: 42.9 NR articles) w/ ipratropium categorical variables are P = < 0.001 bromide inhaler and SIwith Adequate based on ?2 or Fisher?s placebo inhaler - both randomization: exact test; Logistic Sustained abstinence since LHS groups combined for Yes regression used to 1 baseline: analysis because analyze multiple G1: 21.9% Attrition rate: ipratropium bromide predictors of LHS 3 C1: 6.0% 16.7% inhaler had no effect on cross-sectional smoking P = < 0.001 smoking cessation C1: usual care (described status and sustained OR of abstinence in participants abstinence status assigned to G1 as opposed to in other articles) C1 = 4.45 Method of assessment: Data verification: Expired air CO levels ? Interviews in-person and used to validate non- via telephone smoking status ? Expired air CO levels Dependent variables: Smoking status Baseline data: Groups similar at baseline C-51 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Rabius et al., 2004 To examine effects of telephone counseling ? Cessation assistance offered to Geographic area: on smoking cessation among smokers 18 to smokers from anywhere in US that 25 yrs old and smokers over 25 yrs old US called ACS' general toll-free number for information about cessation Funding agency: Population: ? Young adults ? Adult current daily smokers willing to ACS Adults make a quit attempt in next 2 wks and ? gave consent , interviewed and Study setting: Study type: randomized to 2 txt or control Population-based RCT w/ simple randomization ? All participants received three ACS booklets that provide standard advice; Inclusion criteria: half of participants randomized to Of those who called a toll-free ACS number receive an offer of telephone to inquire about cessation, adult current counseling daily smokers willing to make a quit attempt in next two wks Sample size: Total: 3,522 Exclusion criteria: G1: Half of participants; exact N NR NR C1: Half of participants; exact N NR Definition of smoking: Cigarettes ? Current smoking: any smoking within last 48 hrs C-52 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Prevalence of reported 48 hr Quality rating: ? Self-help ? Logistic regression for abstinence at 3 mo followup Fair ? Telephone counseling studies of factors among 18-25 yr olds: predicting study G1: 19.6% Comments: Intervention: retention and quitting C1: 9.3% G1: Three ACS booklets w/ Adequate success, t-tests for P = < 0.005 standard advice plus up to randomization: comparing means five sessions of proactive ?2 for comparing Prevalence of reported 48 hr NR ? telephone counseling proportions abstinence at 3 mo followup for Attrition rate: C1: Three ACS booklets w/ over-25 yr olds: Overall: 36% standard advice Data verification: G1: 15.1% NR C1: 9.6% Attrition at 3-mo Method of assessment: P = < 0.001 followup: Interview at 15 wks after Dependent variables: 18-25 yr olds: 48% enrollment (approximately 3 Study retention by Proportion of 18-25 yr olds Over-25 yr olds: 34% mos postquit date); if intervention; abstinence; reporting 48 hr abstinence at both P = < 0.001 participants reported use of NRT or Zyban 3 and 6-mo followups: abstinence at 3 mo G1: 9.8% Attrition among those interview, then interviewed Baseline data: C1: 3.2% abstinent and eligible again at 6 mos postquit date Proportion of participants P = < 0.01 for followup at 6 mos: in younger age group (18- 18-25 yr olds: 36% 25 yrs old): Proportion of over-25 yr olds Over-25 yr olds: 15% 12% (n = 420), similar to reporting 48 hr abstinence at both P = < 0.001 larger population 3 and 6-mo followups: G1: 8.8% Logistic regression Women outnumbered men C1: 5.3% found that overall P = < 0.005 successfully followed Proportion of men: participants more Estimate of prolonged abstinence 18-25 yrs: 39% likely to be female (P at 6 mo followup (reported 48 hr Over 25 yrs: 33% = < 0.01) and better abstinence plus 5 or fewer P = < 0.01 educated (P = < ? Logistic regression analysis 0.01) than those not Proportion of married men: examining relationships b/w retained in study 18-25 yrs: 19% demographic variables, smoking over 25 yrs: 49% behavior and history, and txt P = < 0.001 condition found the following: among 18-25 yr olds, txt Frequency of cigarette condition only significant use: predictor of 48 hr abstinence at 18-25 yrs: 18 cigarettes 3-mo followup Over 25 yrs: 24 cigarettes (P = < 0.01) P = < 0.001 ? Among over-25 yr olds, 48 hr abstinence at 3-mo followup significantly higher in txt group (P = < 0.001), those w/ more education (P = < 0.01), and those w/ lower baseline smoking rates (P = < 0.001) C-53 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Smith et al.; 2004 To examine options for use, efficiency, and Counselors answered incoming toll-free Geographic area: effectiveness of telephone counseling for calls and determined study eligibility of structuring a population-based telephone callers; ineligible callers sent cessation Canada smoking cessation service materials designed to respond to their Funding agency: Population: needs (e.g., pregnancy); eligible callers Ontario Ministry of Health; randomized (stratified within Heart and Stroke ? Adults communities) to one of five conditions Foundation of Ontario Study type: Sample size: Study setting: RCT w/ stratified randomization Total: 632 Population-based Inclusion criteria: Definition of smoking: ? Current smokers Cigarettes ? At least 18 yrs of age ? Point abstinence: 7-day abstinence at ? Daily smokers time of followup call ? Non pregnant ? Continuous abstinence: 7-day ? Intend to quit within 7-20 days abstinence at all followup calls ? Live in specified geographic recruitment areas ? Consent to participate in study Exclusion criteria: NR C-54 Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Point abstinence at 3 mos: Quality rating: ? Self-help NR G1: (1, 2, 3, 4 collapsed) = 15% Fair ? Telephone counseling Data verification: C1: 13% Comments: ? Pharmaceuticals P = < 0.05 No biochemical NR Intervention: validation of self-reported Point abstinence at 6 mos: G1: Adequate Initial 50 minute smoking status G1: (1, 2, 3, 4 collapsed) = 15% randomization: telephone counseling, 2 performed C1: 14% P = < 0.05 Yes five to 10 minute followup Dependent variables: calls, booklet ? Smoking status Point abstinence at 12 mos: Attrition rate: G2: Initial 50 minute G1: (1, 2, 3, 4 collapsed) = 17% Attrition: 30.6% telephone counseling, 2 ? Participant rating of print materials C1: 20% ? Died: 0.003% five to 10 minute followup ? Participant rating of P = < 0.05 ? Withdrew: 7.1% calls, pamphlet telephone counseling ? Lost to followup: G3: Initial 50 minute Continuous abstinence: 23.2% telephone counseling, 6 Baseline data: G1: (1, 2, 3, 4 collapsed) = 5% five to 10 minute followup No significant differences C1: 1% calls, booklet across the 5 groups at P = < 0.05 C1: Print materials only baseline Method of assessment: Research staff, blind to txt conditions, called participants in all 5 conditions at 3,6, and 12 mos to assess smoking status; 7 attempts made at each followup call before recording it as missed C-55 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Aveyard et al., 2003 To examine the population impact and ? 3 wave recruitment process ? wanted Geographic area: effectiveness of the Pro-Change smoking to estimate the proportion of smokers cessation course based on the United Kingdom that could be recruited from British Transtheoretical Model (TTM) compared to general practice Funding agency: standard self-help smoking cessation ? 1st wave: used random sampling. West Midlands health literature West Midlands GP practices were authorities Population: selected with probability proportional Patients of general pracitioners employed at to size and then a fixed number of Study setting: patients (300) were selected for Practice/provider settings 65 West Midlands general practices invitation Study type: ? From wave 1, became clear that RCT insufficient patients would be recruited Inclusion criteria: so invited originally recruited practices Current smokers to repeat the process (2nd wave) ? When 2nd wave failed to reach target Exclusion criteria: number, non-randomly selected new All selected patients were eligible unless practices approached to participate. terminally ill, violent or other unusual ? In all waves, potential participants circumstances pertained were sent invitation packs containing a cover letter from GP to patients expressing concern about smoking, assuring patients never to late to quit, and offering to help stop smoking at the surgery, if not by trial entry. ? Participants signaled consent by returning baseline questionnaire ? On receipt of baseline questionnaire, participants then randomly assigned either to control group (standard self- help literature), manual intervention group (received Pro-Change system), the telephone group (received Pro- Change system plus 3 telephone calls) or the nurse group (received Pro-Change system, 3 telephone calls and 3 visits to practice nurse Sample size: G1: 683 G2: 685 G3: 413 C1: 690 Definition of smoking: Cigarettes ? Current Smoker - NR C-56 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: No statistically significant Quality rating: ? Self-help quit guides and ? Recruitment of new difference in quit rates between Fair tip cards practices in wave 3 intervention and control groups ? Workbook and where participants only (G1=11%, G2=12%, G3=10%, Comments: questionnaires allocated to 3 arms (no C1=10%) in biochemically- ? Authors conclude ? Telephone counseling one allocated to G3) confirmed abstinence for 6-months Pro-Change complicated analysis, sustained abstinence and system unlikely to ? Nurse visits b/c no guarantee overall 12-months point prevalence provide important Intervention: that participants? alternative to G1: Pro-Change self-help characteristics balanced current network of system with workbook and 3 b/w arms ? therefore, smoking cessation questionnaires to generate analyzed the data as 2 clinics and tailored feedback separate trials ? prescription of G2: G1 plus three telephone calculated the NRT calls percentage quitters in G3: Adequate G1 plus three nurse each arm and performed randomization: visits an overall chi-square C1: Yes 2 standard self-help quit test to calculate guides and 2 tip cards differences between Attrition rate: Method of assessment: arms 29% Asked the question ?are you ? Odds ratios for the risk currently a smoker?? at 12 of quitting relative to months post baseline - control arm and the verified by salivary cotinine, percentage and OR for obtained by visit to quitting in 3 intervention participant?s house or by groups (G1, G2, G3) mail combined vs. control arm were calculated Baseline data: ? To examine if difference No significant differences b/w 4-arm and 3-arm b/w any of the groups trials in effectiveness of intervention arms relative to control arm, added a multiplicative term for trial x trial arm to a logistic regression model ? The study reported results using intent-to- treat analysis, as well as results that used only those that followed-up Data verification: Self-report, salivary cotinine (values >14.2 ng/ml taken as indicative of active smoking) Dependent variables: ? Point prevalence of being quit at 12 months ? Point prevalence of sustained abstinence of at least 6 months C-57 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Bier et al., 2002 To examine the effect of acupuncture alone Blind random assignment to groups Geographic area: and in combination with education on smoking cessation and cigarette Sample size: NR consumption G1: 38 Funding agency: G2: 45 Population: C1: 58 Arizona Disease Control Age 18 years or older Research Commission Definition of smoking: Study setting: Study type: NR Prospective, quasi factorial design NR Inclusion criteria: ? Aged 18 years or older ? Attempted to stop smoking at least once without success Exclusion criteria: ? Actively psychotic ? Suffering from any neurological or physical illness or other impairment that would prevent understanding of research consent form ? Not able to read and write sufficiently to understand and complete the forms ? Not willing to participate in a treatment protocol involving acupuncture ? Currently taking phenothiazine, tricyclic antidepressants, lithium carbonate or beta blocking medication ? Chronically using sympathomimetic drugs such as ephedra, ephedrine, amphetamines, or sedative medication C-58 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Not Smoking (%) at 18 Quality rating: Individual counseling by ? Power analyses for months Poor health professional sample size (.05 for power G1: 20% of .80) G2: 40% Comments: Intervention: ? Mixed model with C1: 53% ? Very high attrition rate G1: Acupuncture, 20 repeated measures NS ? Group has a higher pack sessions over 4 weeks (5 per ? Covariance between any year history than in other week) Greater the estimated pack G2: Same as GI, but also 2 periods considered studies year history before treatment, received 5 weeks autoregressive the greater the decrease in Adequate randomization: educational smoking Data verification: total number of cigarettes Yes cessation program Self report smoked per day following Attrition rate: (multisession, treatment Dependent variables: At 18 months multicomponent behavioral Total: 66% training, education, social ? Beck Depression G1: 68% support, relapse prevention, Inventory score G2: 65% 1.5 hours twice per week for ? Zung Self-Rating Anxiety C1: 66% first week, then once per Scale week for next 4 weeks) ? # of cigarettes smoked per C1: Sham accupuncture, 20 day sessions over 4 weeks (5 per ? Age of initiation week) plus 5 weeks ? # of years smoking educational smoking ? Smoking or not smoking cessation program at visit (multisession, ? % decrease in smoking multicomponent behavioral ? Decrease in # of training, education, social cigarettes smokes support, relapse prevention, ? VAS Score 1.5 hours twice per week for ? Pack year history first week, then once per week for next 4 weeks) Method of assessment: Cigarette pack self monitoring chart, recording number and times cigarettes smoke in past 7 days, pre and post intervention; asked about smoking at clinic visit Baseline data: No significant differences C-59 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Bohadana et al; 2000 To investigate whether short-term (6-wk) ? Subjects from Nancy, France, and Geographic area: addition of a NPto nicotine inhaler txt surrounding towns recruited by means improves early smoking cessation rates, and Western Europe of local newspaper whether this txt combination improves ? First subject enrolled in March 1996, Funding agency: likelihood of abstinence at 6 and 12 months and followup completed in February Pharmacia and Upjohn Population: 1998 Consumer Healthcare ? Adults ? Approximately 1,000 people who Study setting: contacted the Centre Hospitalier Practice/provider settings Study type: Universitaire de Nancy-Brabois, 462 ? RCT w/ systematic randomization underwent a prospective telephone ? Double-blind, randomized, placebo- screen to enroll 400 subjects who met controlled trial inclusion criteria Inclusion criteria: Sample size: ? Aged 18 to 70 yrs Total: 400 ? Smoked 10 or more cigarettes per day for Definition of smoking: 3 or more yrs Cigarettes ? Expired CO level of 10 ppm or more ? 3-mo cessation rate, rate of ? Made 1 or more previous attempts to quit continuous abstinence at all time ? Personally motivated to stop smoking points: self-reported nonsmoking b/w ? Fluent in French wk 2 and mo 12 and an expired CO Exclusion criteria: level less than 10 ppm at each ? History of myocardial infarction within past followup visit 3 mos ? Unstable angina ? Severe cardiac arrhythmia ? Serious renal, pulmonary, endocrine, or neurological disorders ? Pregnancy or breastfeeding ? Use of any form of ST or nicotine substitution ? Participation in any smoking cessation program during past 6 mons ? Alcoholic or illegal drug user ? Use psychoactive drugs ? Have generalized dermatological diseases C-60 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Percentage of participants Quality rating: ? Individual counseling by ? Data analyzed on an completely abstinent at 6-wk Fair health professional ITT basis (ie, all followup: Pharmaceuticals subjects who entered G1: 60.5 Comments: ? study and received C1: 47.5 Attrition rate NR Intervention: medication, P = 0.009 G1: Nicotine inhaler Adequate irrespective of (plastic tube containing a randomization: medication use or 3-mo followup: perforated plastic plug outcome); Intergroup G1: 42.0 Yes impregnated w/ 10 mg of differences in ITT C1: 31.0 Attrition rate: nicotine, approximately 4 abstinence rates at all P = 0.02 1 person withdrew mg of which is available for time points calculated No significant difference in from study due to a inhalation, and menthol to by ?2 (or Fisher exact serious adverse reduce irritant effect of complete abstinence b/w G1 and test if necessary) C1 at 6- and 12-mo followups event, but overall nicotine) plus 30-cm2 ? Proportions of attrition rate NR NPcontaining 0.83 mg of participants remaining Pulmonary findings confirm nicotine per square abstinent over time beneficial respiratory effects of centimeter, delivering 15 calculated by smoking cessation and that mg per 16 hrs slowing down of decline in FEV C1: Nicotine inhaler comparing relapse w/ smoking curves of 2 volume in 1 second appears to (plastic tube containing a groups by means of be relatively rapid in those who perforated plastic plug log rank test quit smoking impregnated w/ 10 mg of nicotine, approximately 4 ? Continuous variables Mean body weight gain mg of which is available for compared b/w groups significantly higher in C1 than G1 inhalation, and menthol to by parametric t-tests by wk 2 (0.49 kg v. 0.99 kg) reduce irritant effect of whenever possible, (P = 01) nicotine) plus placebo and Mann-Whitney No significant difference in mean patch that contained no rank sum test used for data non-normally body weight gain at 1 yr (4.22 kg nicotine distributed and 5.06 kg P = 0.14) Method of assessment: Baseline assessments Data verification: Subjects in C1 reported included patient Self-reported smoking significantly more intense characteristics, vital signs, status validated by blood withdrawal symptoms at wk 1 (P < 0.001) and craving symptoms patient weight, smoking cotinine levels and at wk 6 (P = 0.04) than those in history, expired CO, blood expired air CO levels G1 cotinine, psychological Dependent variables: status, SES, pulmonary 3-mo cessation rate, rate Adverse events rare and measures (symptoms and of continuous abstinence tolerable function) and medical at all time points, nicotine history; during txt and inhaler use, nicotine followup, weight substitution, incidence of measured, smoking history withdrawal symptoms, and expired CO assessed, adverse events, and blood cotinine measured, changes in body weight craving and withdrawal symptoms and all adverse Baseline data: events; pulmonary No significant differences measures (symptoms and b/w 2 groups except for a function) collected at 12 greater number of mos cigarettes per day in G1 C-61 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Canga et al., 2000 Evaluate effectiveness of a nurse-managed ? Type 1 and 2 diabetics at 2 hospitals Geographic area: smoking cessation intervention aimed at and 15 primary care clinics helping diabetic smokers quit smoking Western Europe randomized to receive either usual Population: care or a nurse-led, face-to-face Funding agency: cessation counseling intervention NR ? Young adults ? All clinical records of Type 1 & 2 ? Adults diabetics registered at 15 primary Study setting: Study type: care clinics and 2 hospitals b/w Dec Hospital RCT w/ systematic randomization 1997 and Dec 1998 reviewed to Practice/provider settings confirm smoking status Inclusion criteria: ? Smokers contacted through a letter ? Type 1 and 2 diabetic patients registered and telephone call to participate in a in centers under study who were either general lifestyle study of diabetic current smokers or who had quit patients < 1 yr ago ? Smokers randomly assigned to Exclusion criteria: intervention or C using computer- ? Had quit smoking for over 1 yr or was generated allocation; randomized misclassified in medical record as a assignment blinded diabetic smoker Sample size: G1: 147 C1: 133 Definition of smoking: Cigarettes Current smoking: having smoked > 100 cigarettes during a subject's lifetime and having smoked at least 1 cigarette in last wk C-62 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis Quality Intervention Details and Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Proportion of smokers who quit Quality rating: ? Self-help ? Two-tailed Fisher's at 6-month followup (validated): Fair ? Individual counseling by exact tests used to G1: 17.0% health professional compare proportion C1: 2.3% Comments: ? Pharmaceuticals of quitters b/w both Difference: 14.7 (CI, 8.2, 21.3) NR groups P = < 0.001 Intervention: Adequate ? Two-tailed t-tests G1: Initial 40 min face-to- used to compare 6-mo followup, change in mean randomization: Yes face interview w/ a research change in average cigarettes per day: nurse that included number of cigarettes G1: -4.6 (CI, -3.2, -6.0) Attrition rate: personalized advice about smoked daily C1: -1.6 (CI, -0.4, -2.8) Overall = 0.71% benefits of quitting and Difference: -3.0 (CI, -1.1, -4.9) ? Incidence ratio, G1: 0.68% strategies that may be P = < 0.001 incidence difference, C1: 0.75% useful, based on patient's and number needed 6-mo followup, patients in clinical condition, smoking to treat w/ their precontemplation stage: history, and personal respective 95% CIs G1: 39.5% interests; self-help materials used to estimate C1: 56.4% w/ quitting cues; 3 months of effect of intervention Difference: -16.9% transdermal NRT offered to those w/ no Data verification: (CI, -5.3, -28.9) P = < 0.001 contraindications who Urinary cotinine levels smoked > 19 cigarettes per obtained from self- 6-month followup, patients in day and those who had not reported quitters and contemplation stage: succeeded after trying to analyzed using method G1: 9.5% quit at least once; followup developed by Jarvis, et C1: 29.3% program of 5 contacts al Difference: -19.8% scheduled according to negotiated cessation date: Dependent variables: (CI, -10.7, -34.1) P = < 0.001 1) telephone call the day ? Urinary cotinine before quit date, 2) a validated cessation 6-mo followup, patients in action followup visit 2 wks post quit ? Mean number of and maintence stages: date, 3) a letter 3 wks post cigarettes smoked G1: 17.0% quit date, 4) a followup visit daily C1: 2.3% 2 months post quit date, and ? Stage of change Difference: 14.8% 5) a final evaluation carried according to (CI, 8.2, 21.3) out 6 months post quit date Prochaska's model P = < 0.001 C1: Usual care for diabetic Baseline data: 6-mo followup, patients in smokers that is routinely Intervention and Cs relapse stage: provided by hospital or similar at baseline in G1: 33.3% primary care clinic and is demographic C1: 10.5% established in the Navarre characteristics, Difference = 22.8% diabetes care program, diabetes history, and (CI, 13.6, 32.0) including advice to quit history of tobacco use P = < 0.001 smoking Method of assessment: Followup interview conducted by a nurse at 6 months after initial interview; urinary cotinine levels obtained from those who self-reported quitting C-63 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Carpenter et al., 2004 To assess whether a behavioral treatment to Randomized Geographic area: reduce smoking combined with NRT followed by brief advice to quit versus Sample size: USA motivational advice plus brief advice to quit G1: 212 Funding agency: produces a greater incidence of quit G2: 197 National Institute on Drug attempts C1: 207 Abuse Population: Definition of smoking: Study setting: NR Abstinence: greater than or equal to 3 cigarettes per day Population-based Study type: RCT Inclusion criteria: ? Not Interested in quitting Exclusion criteria: ? No current smoker in household (96%) ? Smokes less than 10 cigarettes a day ? Less than 18 years of age ? Secondary Exclusion ? Nursing, pregnant, planning to become pregnant in next 9 months ? Cardiovascular disease or high blood pressure not controlled by medication ? Currently taking prescription medications for depression or asthma (79%) ? Not accessible by telephone throughout duration of the study C-64 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Percentage with ?24-hour Quit Quality rating: Telephone counseling ? Logistic regression Attempts? over 6 months Fair Intervention: G1: 43% Data verification: Comments: G1: G2: 51% Telephone based Self report C1: 16% ? Source of database reduction counseling and G1 vs G2: NS used to recruit NRT and brief advice to quit Dependent variables: G2: G1 + G2 vs C1: P < 0.01 people for study is Motivatiiona advide ? # of cigarettes per day unclear (5Rs) and brief advice over previous 7 days Percentage with ?24-hour Quit ? No biochemical C1: No treatment ? Intention to quit in next 1 Attempts? at 6 weeks (when verification to 6 months Method of assessment: intervention was completed) ? Stage of change G1: 36% Adequate Mailed questionnaire at ? Self-efficacy G2: 18% randomization: 0,3,6,12 and 24 weeks ? Quit attempts within past C1: NR NR Baseline data: 24 hours ? Point prevalence Percentage with ?24-hour Quit Attrition rate: ? Smoking habits abstinence (no smoking Attempts? after 6 weeks (when NR ? Urine cotinine levels at all in past 7 days) intervention was completed) ? Fagerstrom Test for G1: 64% Nicotine dependence G2: 82% ? Stage of change C1: NR% ? Demographics ? Parity Abstinence Rates ? Proportion having a G1: 18% partner G2: 23% ? Proportion whose partner C1: 4% smoked Seven-day Point Prevalence at ? Educational achievement 6 months: ? Household net income P<0.01 Smoking reduction using NRT does not undermine cessation but rather increases likelihood of quitting to a degree similar to motivational advice C-65 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Chalmers et al., 2001 Smoking reduction and cessation program Advertised study in a variety of medium Geographic area: implemented w/ registered nurses and participants allowed to select Canada Population: intervention type Funding agency: ? Adults Sample size: G1: 75 Health Canada, Tobacco ? Women (only) G2: 44 Programs Unit, Health Study type: Promotion Directorate and Self-selected intervention Definition of smoking: the Canadian Lung Cigarettes Association Inclusion criteria: NR ? RN Study setting: Practice/provider settings Exclusion criteria: ? No other type of nurses C-66 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Statistically significant changes at 8 Quality rating: ? Self-help ? SAS and Excel used wks in nurses' smoking practices Poor ? Group counseling ? Descriptive statistics found on number of nurses obtained and t-tests continuing to smoke, mean number Comments: Intervention: used in pre and posttest of cigarettes smoked, and No ITT, self-selection G1: Group participation analyses movement in stage of behavioral of intervention, no G2: Self-study change comparisons b/w G3: NR ? Variance difference groups. C1: NR considered across 4 time periods Adequate Method of assessment: ? Duncan's Multiple Range randomization: Questionnaires administered test implemented for all No prior to and at end of 8-wk post hoc comparisons Not randomised! interventions and at 6 and 12 ? Time-study analysis months postintervention techniques used to Attrition rate: organize data and Pretest: 0 (0%) observe and test for 8 wks: 27 (23%) trends 6 months: 47 (40%) 12 months: 62(53%) Data verification: None Dependent variables: Stage of quiting Baseline data: No comparisons made C-67 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Clark et al; 2004 To examine effectiveness of standard Community informed about low-dose Geographic area: written self-help materials for nicotine fast spiral chest CT screening study by dependence compared to written materials local and regional television and US consisting of internet-based resources on newspaper coverage carrying Funding agency: smoking abstinence rates in a lung cancer information on general outline of study NCI screening population and eligibility requirements, as well as funding by NCI Study setting: Population: Hospital ? Adults Sample size: Practice/provider settings Total: 171 Study type: RCT w/ simple randomization Definition of smoking: Cigarettes Inclusion criteria: ? Abstinence: no cigarettes in last 7 ? Asymptomatic days ? Men and women 50 yrs of age or older ? Current cigarette smokers w/ at least a 20 pack-yr history of smoking ? Access to a computer w/ Internet service ? Written informed consent to participate Exclusion criteria: ? History of any cancer within five yrs, other than non-melanomatous skin cancer, cervical cancer in situ, or localized prostate cancer ? Mentally incompetent ? Not healthy enough to potentially undergo pulmonary resection (i.e., have congestive heart failure or disabling dyspnea at time of enrollment) ? Serious illness that decreased life expectancy to less than 5 yrs C-68 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: No statistically significant Quality rating: ? Self-help Responses from 1-mo differences in smoking status Fair ? Computer-based followup survey, and found at 1-mo (13 vs 7%, P = program tobacco use variables 0.248) or 1-yr followup (5 vs Comments: collected at 1-yr 10%, P = 0.166, OR = 0.4, 95% NR Intervention: followup, compared b/w CI, 0.1-1.4) G1: Received handout w/ Adequate txt groups using ?2 a list of 10 Internet sites At yr 1 followup more subjects randomization: related to stopping For 1-yr smoking receiving internet-based Yes smoking and a brief abstinence outcome, resources, compared to C1, Attrition rate: description of each site; subjects that missed the reported that they had made an No attrition at 1-yr Web sites included: the visit or failed to provide attempt to stop smoking in last yr followup (study American Heart tobacco use information, (68 vs 48%, P = 0.011) followup coincided Association, ACS, NCI, classified as smoking w/ 1-yr followup for Cancer Information Recommendation of additional Service, CDC Tips, All other analyses followup from chest CT screening lung cancer Tobacco performed using exam not found to be associated screening) Information/Prevention available data w/ no w/ abstinence (OR = 0.5, P = Source, Mayo Clinic imputation of missing 0.267), making a quit attempt Nicotine Dependence values (OR = 0.8, P = 0.412) or Center, Quit Now! (the advancement in state of change For biochemically National Tobacco from baseline to 1-yr (OR = 0.6, confirmed 7-day smoking Campaign), the No Smoke P = 0.222) abstinence, exact binary Caf, Massachusetts confidence intervals Quitline, Nicotine calculated for each txt Anonymous, and the group and a logistic American Lung regression analysis Association; these sites performed using smoking include information on abstinence as dependent health risks related to variable and txt group as tobacco use, benefits of independent variable stopping smoking, specific behavioral strategies, Logistic regression used support for stopping, to assess whether review of stop smoking screening medications, and recommendations references to local associated w/ 1-yr resource tobacco use outcomes C1: Received a copy of In all cases, two-sided Clearing the Air: How to tests performed w/ P- Quit Smoking and Quit for values; < 0.05 used to Keeps (24-pg self-help indicate statistical manual describing multiple significance behavioral strategies for stopping smoking), a Data verification: publication of the National Self-reported smoking Cancer Institute; status confirmed w/ participants also given the expired air CO levels at 1 American Lung yr followup Association booklet, Quit Smoking Action Plan, which provides up to date information on available pharmacotherapies for nicotine dependence C-69 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Clark et al; 2004 (continued) C-70 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Method of assessment: Dependent variables: Questionnaire at 1-mo Biochemically-confirmed followup: smoking status ? Smoking status self- reported Baseline data: In-person visit at 1 yr Both groups similar at followup: baseline ? Smoking status and expired air CO levels assessed C-71 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Covey et al., 2002 To evaluate sertraline as an effective aid to ? Respondents were first screened by Geographic area: smoking cessation for smokers with a telephone, those who met initial history of major depression US criteria were seen at the first clinical Funding agency: Population: visit Adults ? Eligible participants obtained a 1 Pfizer, Inc week single-blind washout phase of Study type: one placebo tablet per day Study setting: RCT, double blind, placebo control study Population-based ? Once medically confirmed to meet Inclusion criteria: criteria, participants were randomly assigned in a double blind fashion to ? Subjects required to meet DSM-III-R receive sertraline (50mg tablet) or criteria for at least one episode of major placebo depression, which must have remitted more than 6 months befor the start of the Sample size: study G1: 68 ? Age 18 to 70 C1: 66 ? Daily use of 20 or more cigarettes for at Definition of smoking: least a year ? Smoking measured by cotinine level, ? One prior attempt to quit non-smokers < 25 ng/ml Exclusion criteria: ? Serious medical illnesses ? Use of a psychotropic medication ? Major depression, alcohol or drug dependence, panic disorders, post- tramatic stress disorder, anorexia nervosa, or bulimia nervosa within the past 6 months ? Life time diagnosis of bipolar disorder, antisocial or schizotypal personality disorder, severe borderline personality disorder, obsessive-compulsive disorder, or psychosis including schizophrenia ? Pregnancy or lactation C-72 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: At the end of treatment, Quality rating: Pharmacotherapy Chi square and t-tests of abstience rates were 28.8% Poor Intervention: significants for C1 and 33.8% for G1, this Comments: G1: Received sertraline for Data verification: was not significant Similar to a run-in periods 11.3 weeks: 1 week placebo Self-report and cotinine At 6 months, the abstience this study participants if not washout, 3 weeks for tested rates were G1=11.8 and motivated to quit after week medication buildup before Dependent variables: C1=16.7%, NS 1 (9%) quit day, 6 weeks at full dose (200mg), and a 9 day ? Abstience No modifying effects of Adequate randomization: taper period. ? Nicotine dependence depressed mood at baseline, Yes C1: Same as G1 but used level nicotine dependence level, or gender were observed Attrition rate: placebo ? Depression 25.4% ? Withdrawal symptoms Method of assessment: ? Compliance with NRT 7-Day point prevelance self- treatment report (biochemically verified by cotinine levels less than 25 ng/ml) Baseline data: Lower nicotine dependence scores for participants in G1; no other baseline differences C-73 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Croghan et al; 2003 To determine whether combined use of NP After dissemination of a local news Geographic area: and a NNS would improve smoking release (radio and print), interested abstinence rates compared to either therapy smokers contacted their regional US alone without behavioral counseling; to NCCTG cancer control site and Funding agency: determine frequency and severity of adverse underwent telephone screening NCI, Public Health Service events experience and NCI, DHHS Population: Brief discussion of study provided, informed consent obtained, Adults Medications provided by demographic information collected, and NcNeil Consumer Products Study type: an interview based on inclusion and exclusion criteria conducted over phone Study setting: RCT w/ stratified randomization Community-based ? Multi-center, randomized, open-label Study subjects who fulfilled basic study Practice/provider settings clinical trial ? Txt assignment carried out using a entry criteria were invited to attend an dynamic allocation procedure that information meeting, at which time balanced marginal distributions of details of study were explained and an stratification factors among three txt informed consent signed groups Sample size: ? Stratification factors used gender, number Total: 1,384 of cigarettes smoked per day reported at time of study entry (15?39 vs 40 or more Definition of smoking: cigarettes per day), and total yrs of Cigarettes smoking (fewer than 5 yrs vs 5?9 yrs vs ? At least 15 per day over past yr NR 10 or more yrs) ? Open-label, randomized, 3-intervention, multi-center trial. Inclusion criteria: ? 18 yrs of age or older ? Smoking at least 15 cigarettes per day for past yr ? Good health verified by medical history ? Female subjects of childbearing potential had to be using contraception, ? Ability to participate in all aspects of study C-74 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: CO confirmed 7-day point- Quality rating: Pharmaceuticals Tests of balance in prevalence smoking abstinence Poor Intervention: baseline characteristics rates at 6-wks after initial quit date: G1: 15 mg transdermal across txt arms carried out G1: 20.7% Comments: via ?2 procedures for G2: 13.6% Attrition quite high at NPfor 16 hr a day; new categorical variables, G3: 27.1% 6 mos (70%); overall, patch each morning; initiated Kruskal-Wallis tests for P = < 0.001 45% of participants within 7 days of ordinal-level data, and non-compliant w/ randomization and ANOVA for interval- and Differences in CO confirmed 7-day study protocols - a continued for 6 wks G2: NNS that delivered 0.5 continuous-level variables; point-prevalence smoking larger proportion effect of sociodemographic abstinence rates at 6 mos were NS than were compliant mg of nicotine per spray; variables on abstinence Abstinence rates (6 wks): (34%); study may not recommended dose one puff rate comparison have had enough per nostril as needed to a G1: 20.7% investigated via logistic power maximum of five doses per G2: 13.6% regression modeling Baseline data not hr or 40 doses per day; G3: 27.1% given by txt group initiated within 7 days of P < 0.001 Standard equality of randomization and NNS associated w/ more adverse Adequate binomial proportions, continued for 6 wks events than NP (P < 0.001): randomization: G3: 15 mg transdermal logistic regression burning in nose or throat (63% vs Yes modeling NPfor 16 hr a day, putting on 12%), watery eyes (48% vs 14%), Attrition rate: a new patch each morning, Data verification: sneezing (49% vs 21%) 6 wks: 47% plus nicotine nasal spray CO levels of expired air 6 mos: 70% that delivered 0.5 mg of collected to verify self- nicotine per spray, reported smoking status recommended dose of one Expired CO < 8 ppm puff per nostril as needed to confirmed smoking a maximum of five doses per abstinence hr or 40 doses per day; initiated within 7 days of Dependent variables: randomization and Smoking status: wk 6 continued for 6 wks biochemically confirmed 7- C1: NR day point prevalence smoking abstinence rate. Method of assessment: Subjects returned to clinic at Baseline data: 3 wks, 6 wks, and 6 mos No reported differences postintervention; self- among txt groups, but no reported smoking rates, data given expired air CO levels, and Overall, mean age = 42.0 reports of adverse events (+/-10.8); 58% female; collected Questionnaire mean 26.2 (+/-9.8) about smoking history, cigarettes per day; mean Fagerstrom, Health Status 23.2 (+/-10.7) yrs of Questionnaire smoking C-75 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Exclusion criteria: Croghan et al; 2003 Exclusion criteria included (continued) ? Recent (< 3 mos) history of myocardial infarctionangina pectoris, serious cardiac arrhythmia, or other medical conditions that the health care provider deemed incompatible w/ study participation ? Presence of current (within 30 days) psychiatric disorders (major depression, bipolar disorder, schizophrenia); current use of major psychiatric drugs(antipsychotics, lithium) ? Chronic nasal disorders such as nasal polyps, chronic nasal congestion, allergies, or sinusitis that would preclude use of a nasal spray ? Pregnancy or current breast feeding ? Current use of tobacco products other than cigarettes ? Current use of nicotine replacement therapy ? Use of an investigational drug within 30 days of start of study ? Concomitant use of clonidine, buspirone, doxepin, bupropion, or fluoxetine ? History of skin allergies or evidence of chronic dermatosis ? Participation within last 12 mos in a formal smoking cessation program C-76 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments C-77 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Dalsgareth et al., 2004 To evaluate treatment with buproprion ? Employees were informed of study via Geographic area: hydrochloride sustained release (Zyban) E-mail, notification accompanying compared with placebo as an aid to smoking Denmark paychecks, posters and personal cessation in healthcare workers contact Funding agency: Population: ? Eligible participants screened GlaxoSmithKline, Denmark Hospital employees from 5 hospitals in ? Participants underwent detailed Study setting: eastern part Denmark baseline interview to obtain health- Hospital disease profile and info on smoking Study type: behavior in general and at work RCT ? double-blinded ? Subjects were given info on Inclusion criteria: physiological and harmful effects of ? Age ?18 yrs old smoking as well as on the assumed mechanism of action and likely side- ? Average use of ?10 cigarettes per day effects of buproprion throughout the last year ? All subjects received behavioral ? Motivation to quit smoking counseling aimed at establishing Exclusion criteria: rational smoking cessation process ? Use of other pharmacological support for ? Each participant agreed on a target smoking cessation quit date of 8-13 days after baseline ? History of or current major depression ? Participants then randomly assigned reported by participant either to receive buproprion 150 mg or ? Sever neurological, cardiopulmonary, liver placebo or kidney disease Sample size: ? Epilepsy, predisposition to or former G1: 222 epidsodes of seizures C1: 114 ? Use of medicine known to lower seizure threshold Definition of smoking: ? Pregnancy and lack of sufficient Cigarettes contraception were additional exclusion ? User: smoked ?10 cigarettes daily criteria for fertile women. ? Continuous smoking abstinence: not even a puff C-78 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Twelve months after pretest Quality rating: ? Telephone counseling ? Intent -to-treat analysis, (posttest 2), in-school intervention Fair ? Clinic visits in which all randomized successful in preventing vocational Comments: ? Buprprion 150 mg over 7- patients who took ?1 school students from continuing to week period dose of study smoke, compared w/ students in ? Refusal rate NR medication were control condition OR = 0.49; 95% ? Randomization Intervention: counted CI 0.29?0.84 description unclear G1: 2 motivating phone ? Mantel-Haenszel chi- regarding number calls, 5 clinic visits, and square test at two-sided Eighteen months after pretest of schools in txt sustained-release bupropion 5% level of significance (posttest 3), tailored out-of-school groups hydrochloride used analysis of intervention successful in ? Out-of-school C1: 2 motivating phone smoking abstinence preventing smoking initiation, intervention poorly calls, 5 clinic visits, and endpoints compared w/ students in control implemented (65% placebo (OR = 0.42; 95% CI, 0.18?0.96) ? Analysis of covariance of personalized Method of assessment: was used for analysis of Effect of combined approach not letters read by Clinic visits at weeks change in weight from larger than sum of effects of in- participants) 3,7,12,23 and 26 (post- baseline and nicotine school and out-of-school effects. Adequate baseline) dependence; treatment, randomization: center and baseline Baseline data: Yes values were covariates No significant differences ? Participants with Attrition rate: b/w G1 and C1 missing cigarette counts School level after 7-week treatment ? Posttest 1: 5.6% phase assumed to be (2 schools) treatment failures ? Posttest 2: 8.3% (3 schools) Data verification: ? Posttest 3: 18.5% ? Self-report ? completion (NR) of daily diary cards ? Expired-air carbon Student level: monoxide ? Posttest 1: 17.3% measurements (<10 ? Posttest 2: 5.4% ppm CO was the cutoff) ? Posttest 3: 24.6% Dependent variables: ? Smoking status ? Tobacco craving ? Weight gain C-79 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Davies et al., 2005 To evaluate the impact of a stage-matched 90 % of patients approached agreed to Geographic area: smoking cessation intervention in a sample participate of hospitalized, low-income, African Southeastern US American smokers admitted to an indigent Sample size: Funding agency: care hospital 248 National Cancer Institute Population: Definition of smoking: Study setting: ? Low income hospitalized adult African NR Hospital Americans Study type: Experimental, pretest-posttest design Inclusion criteria: ? Adult ? African American ? Admitted to medical and surgery units of the study hospital ? Smoker Exclusion criteria: ? Life expectancy less than one year ? Mental conditions (not defined) C-80 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Intervention patients more Quality rating: ? Self-help ? Mann-Whitney U used to likely to advance in stage than Poor ? individual counseling examine intervention control patients effects by baseline stage Comments: Intervention: Z Test used to compare Dependence score increased ? ? 60% failed to complete 6 G1: Physician-delivered overall differences as stage of readiness month follow-up stage-specific advice to quit between treatment groups increased ? ITT analysis used for smoking; individualized (forward movement, Intervention had a higher cessation rates does not counseling based on the success in quitting proportion of subjects in the state that all of those with smokers stage of readiness smoking) no follow-up data were and individual smoking preparation and action stages ? T tests used for 5 at follow-up, significantly categorized as smokers pattern; self-help materials tailored to the African measures (Pros, Cons, (P < 0.05) for those at Adequate randomization: American smokers and their Confidence, 2 Nicotine contemplation stage at Not defined, plus there was support networks; and a Dependent measures) baseline a second adjustment made follow-up booster session in ? Intention to treat analysis used only for cessation Greater percentage of by assigning shared rooms the form of a phone call to either the intervention or following the patient?s rates intervention than controls progressed at least one stage control groups discharge from the hospital Data verification: (40% vs 21.7%, Attrition rate: (at @6 months) Self report P < 0.01) ? 152 of 248 were loss to C1: usual care (not defined) Dependent variables: ITT analysis for cessation non- follow-up Method of assessment: ? Sociodemographic significant (G1:7.9% vs C1: ? Reasons: In person and telephone characteristics 5.8%) - no telephone, survey at about 6 months ? Smoking history - telephones disconnected, Baseline data: ? Present smoking habit - changed residence, Between group differences ? Stage of change - became homeless, are not reported ? Decisional balance - went to prison ? Self-efficacy to remain - died abstinent ? Several follow-up ? Perceived nicotine interviews took place well dependence after 6 months ? Perceived health status ? Presence of chronic disease C-81 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Garvey et al., 2000 To investigate the long-term efficacy of 4-mg ? Recruited smokers from greater Geographic area: and 2-mg gum for smokers classified at Boston area via newspaper ads and baseline as low or high in dependence on United States press releases nicotine ? Subjects needed to obtain a letter Funding agency: Population: from their doctor stating they had no National Institute on Drug Abuse and the Department ? Smokers from greater Boston area obvious medical conditions that would prevent them from entering the study; of Veteran Affairs ? ?20 years old those who didn?t have primary care Study type: physician required to undergo testing Study setting: RCT at medical lab in Boston Community-based ? Subjects chose a quit-day and Inclusion criteria: reported for their baseline visits a ? Aged ?20 years, smoke ?5 cigarettes per median of 3 days before their quit day days ? at baseline, they completed ? Adequate health the Heaviness of Smoking Index and Exclusion criteria: a 2-question subset of the Fagerstrom ? Cardiologist deemed subjects in Test for Nicotine Dependence. ?inadequate? health based on medical Results were used to classify subjects tests, including hematology analyses, as either low-dependence or high- liver-function profiles, urinalyses and if dependence over 50 years old, electrocardiograms ? Subjects within each dependence group were assigned to placebo, 2- mg, or 4-mg gum treatment using a randomized, double-blind procedure ? Subjects were instructed on proper use of gum, recommended to use 9- 15 pieces of gum a day for 2 months, after which they would wean themselves from the gum ? would be weaned off by 5 months post- cessation Sample size: G1: 87 G2: 88 G3: 115 G4: 115 C1: 88 C2: 115 Definition of smoking: Cigarettes ? Current Smoker ? Smoking ?5 cigaretters per day ? Relapser ? if returned to a regular pattern of smoking at any time during the 1-year period of follow up ? Regular pattern of smoking ? 7 or more consecutive days or episodes of smoking ? Day of relapse ? the day post- cessation that began the regular pattern of smoking C-82 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: At 1 year follow-up quit rates for Quality rating: ? Self help booklet (all ? Wilcoxon rank sum tests low dependence were Fair groups) were used to compare Placebo 11.2% Brief behavioral percentage baseline 2 mg gum 19.5% Comments: ? counseling (all groups) cotinine replaced by 4 mg gum 18.4% (NS) ? 3 subjects ? Nicotine gum ? 2mg or each dose of nicotine withdrew from gum High dependence smokers quit 4mg study due to ? Logistic regression rates at 1 year adverse effects ? Intervention: analysis and pairwise 2 mg gum compared to placebo dizziness, nausea G1: Low dependence 2 mg dose comparisons were (15.7% vs. 6.1%, P = 0.02) and vomiting gum used to assess 4 mg gum compared to placebo G2: Low dependence 4 mg Adequate differences in (20.7% vs. 6.1% P = 0.002) gum randomization: abstinence rates among G3: No statistical differences between High dependence 2 mg Yes groups at each post- 2 and 4 mg gum doses. Both 2 gum cessation visit. Two G4: and 4 mg gum users significantly Attrition rate: High dependence 4 mg dummy variables (each (P < 0.008) more likely to abstain Overall attrition not gum coded 1 or 0) were used C1: than placebo at all post-cessation reported but 3 left Low dependence to represent the 3 assessments, except for day 1 due to adverse placebo nicotine-gum doses in events C2: High dependence these analyses Other variables related to placebo ? Chi-square tests for abstinence at 1 year post- Method of assessment: binomial trends were cessation were a longer period of used to examine the abstinence on a prior quit attempt, Follow up visits at 1, 7, 14, significance of dosage being married, higher education 30 days and 2, 3, 6, 9, and effects level, and having a non-smoking 12 months post-cessation ? Effects of nicotine gum spouse or significant other Baseline data: dose on withdrawal Placebo, 2-mg and 4-mg symptoms and urges to gum users were comparable smoke were assessed on most baseline variables ? for the 1st 30 days post- those in 4-mg group had cessation using higher mean CO values repeated-measures (P= 0.01) and heart rates analysis of variance (P = 0.02) ? For withdrawal indices, High-dependence smokers changes from baseline were more likely to be older on various indices of and less-educated, slightly withdrawal were more likely to be males, and dependent variables in they had significantly larger repeated-measures values on other indices of analysis; while values depencence obtained at 1,7,14,and 30 were used to supplement repeated- measures analysis ? Because of occasional missing data, number of subjects available for some statistical analyses were reduced) Data verification: Self-report, saliva cotinine and CO levels Dependent variables: Quit rates C-83 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Hahn et al; 2004 To evaluate impact of a quit and win contest Intervention group: sample of volunteer Geographic area: on smoking cessation among low-income registrants in a quit-and-win contest tobacco users US C1: participants randomly selected from Funding agency: Population: outside media campaign geographic ? Adults area using random digit dialing and American Legacy meeting inclusion criteria Foundation ? Low SES Study setting: Study type: Sample size: Total: 538 Community-based Two-group, quasi-experimental study Inclusion criteria: Definition of smoking: Intervention group: Cigarettes ? at least 18 yrs old ? Quitter: not used any form of tobacco ? volunteered to participate in a quit-and- in last 7 days win contest Smokless tobacco ? registered for contest by September 10, ? Quitter: not used any form of tobacco 2001 in last 7 days ? earned <$25,000 per yr C1: ? regular tobacco user who had smoked cigarettes or used another form of tobacco in last 30 days ? had not been exposed to promotional media campaign ? earned <$25,000 per yr Exclusion criteria: NR C-84 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Percentage of participants w/ Quality rating: ? Self-help Group comparisons self-reported 7-day point Poor ? Individual counseling by performed using ?2 of prevalence abstinence at 3- health professional equal proportions for month followup: Comments: ? Group counseling nominal variables G1: 23.3, ? High attrition Telephone counseling Kruskal? Wallis tests for C1: 3.1 ? Intervention ? ordinal variables, or two- P = < 0.001 group volunteer ? Computer-based Program sample t-tests for sample Percentage of participants w/ ? C care NR ? Social support continuous variables confirmed 7-day point prevalence ? Exposure to ? Media campaign Repeated measures abstinence at 3-month followup: intervention low Intervention: analysis for logistic G1: 11.3 ? Not G1: A community quit date regression based on C1: 0.7 generalizable requiring participants to GEE approach used to P = < 0.001 quit using tobacco for 30 determine predictors of Adequate days to be eligible for a quit status over three Percentage of participants w/ randomization: self-reported 7-day point large cash prize lottery; postcontest time periods NR prevalence abstinence at 6- provider advice on gender- specific cessation Each model included month followup: Attrition rate: information to participants control variables of G1: 21.2 Loss to followup by baseline age, gender, C1: 5.9 12-month followup: through weekly mailed postcards during 30-day race (Caucasian v. P = < 0.001 G1: 41% contest period; online other), education (HS), marital status confirmed 7-day point prevalence quit assistance; one-on- (married v. unmarried), abstinence at 6-month followup: one telephone quit and stage of change G1: 9.3 assistance through a toll- status to adjust for C1: 0.7 free number provided by differences in personal P = < 0.001 Cancer Information characteristics among participants Percentage of participants w/ Service?s smoking self-reported 7-day point cessation call center; a Data verification: prevalence abstinence at 12- media campaign that All participants who month followup: included paid radio and reported quitting were G1: 23.3 television advertisements, asked to provide a urine C1: 8.7 intensive billboard sample to test for P = < 0.001 promotions, magazine or cotinine; cotinine level newspaper registration, determined by Accutest Percentage of participants w/ newspaper features, NicoMeter confirmed 7-day point prevalence registration brochures, and abstinence at 12-month followup: promotional flyers; and Dependent variables: G1: 8.1 support from community Tobacco use status C1: 0.7 organizations, work sites, P = < 0.001 physicians, health professionals, and community leaders C-85 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Hahn et al; 2004 (continued) C-86 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis Quality Intervention Details and Baseline Data Outcome Measures Comments Community organization Baseline data: support included Participants more likely promoting the contest at to be married in the work sites and in intervention group than community newsletters, in the control recruiting participants via More than half of flyers at physician offices intervention group had at and health fairs, and least some college coordinating group education, while only 1/4 cessation classes to of C had any coincide w/ the contest. postsecondary C1: NR education; intervention Method of assessment: group significantly younger than control Telephone interviews (Median age: G1: 35.9, conducted at baseline, C1: 42.3, t = 5.3, 535 df, then 3, 6, and 12 months P = < 0.0001); those lost after baseline interview to followup at 1 yr were significantly younger than those who remained in study (loss to followup: mean age = 37.5, remained in study: mean age = 41.2, t = 3.0, P = 0.003) C-87 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Hall et al., 2004 To determine the effects of brief versus ? Subjects were recruited through Geographic area: extended treatment with nortriptyline and advertising, PSAs, and flyers group counseling United States ? Interested persons completed a Population: telephone screening and orientation Funding agency: General public meeting NIDA ? After informed consent was obtained, Study setting: Study type: potential subjects were invited to a RCT Population-based baseline physical assessment Inclusion criteria: ? For those who did not have any Smoked >=10 cigarettes per day exclusion criteria, 160 subjects smoking ? 10 cigarettes per day were Exclusion criteria: stratified by: ? Cardiovascular disease - baseline number of cigarettes ? History of seizure - history of nicotine replacement ? Severe allergies therapy ? Life-threatening disease - history of major depressive disorder ? Bipolar disorder ? Subjects were then randomized to ? Current major depressive disorder four treatment cells ? Use of l-dopa Sample size: ? Migraine headaches 160 subjects ? Current use of any psychiatric medication including bupropion Definition of smoking: ? Suicidal or psychotic symptoms Subject must meet all three criteria to be ? Current use of NRT considered abstinent: ? Previous treatment for cigarettes smoking ? self-report of not having had a with nortriptyline cigarette in past seven days, not even ? Treatment for drugs or alcohol within 6 a puff months ? carbon monoxide levels ? 10 ppm ? Psychiatric hospitalization within 1 year ? cotinine levels of ? 50 ng/ml ? Pregnancy or lactation C-88 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: A duration by dose by time of Quality rating: ? Transdermal nicotine ? Powered at 80% with assessment effect was significant Fair patch alpha = .05 (X2 = 11.90, df=3, P = 0.008) ? Group counseling ? Logistic regression was Comments: used to test the effect of Brief Nortriptyline vs brief placebo NR ? Bupropion drug/placebo dose and (OR = 0.69, 96%CI; 0.49-0.92, Intervention: Adequate treatment duration on P = 0.02) G1: randomization: Brief Nortriptyline: repeat 7-day abstinence Brief Nortriptyline vs extended Unknown ? did not Nortriptyline for 12 weeks; 5 ? Generalized estimating placebo (OR = 0.47, 95%CI; state how they counseling sessions and equation was used to test 0.30-0.75, P = 0.001) randomized NRT patch at week 5 C1: Brief placebo: Placebo hypotheses about point participants prevalence abstinence at Extended Nortriptyline did not for 12 weeks; 5 counseling weeks 24,36,52 differ significantly from extended Attrition rate: sessions and NRT at week 5 G2: Extended Nortriptyline: ? Compared baseline placebo ? 13% for brief G1 + extended variables among the four nortriptyline pharmacotherapy and groups using ANOVA for ? 7% for brief counseling (1/month) for 52 continuous and chi- placebo square for categorical to ? 10% for extended weeks nortriptyline C2: Extended placebo: G2 examine if randomization had been compromised ? 27% for extended but used placebo instead of Nortriptyline ? To identify potential placebo covariates, used point- Method of assessment: biserial correlations ? In-person self-report ? Differences in weeks of ? Carbon monoxide medication / placebo ? Urinary cotinine dispensed were determined by a two-way Baseline data: ANOVA with individual No significant differences comparisons with the among the intervention Tukey test conditions ? Differences in withdrawal symptoms were determined using repeated measures ANOVA ? Chi-square tests or Fisher?s exact tests were used to determine differences in side effects ? All tests for all analyses were two-tailed Data verification: ? Expired carbon monoxide and urinary cotinine were used at 24, 36, and 52 week follow-ups ? Expired carbon monoxide only was used at 12 week follow-up Dependent variables: ? Abstinence ? Nortriptyline adherence ? Withdrawal symptoms ? Side effects C-89 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Hand et al., 2002 To investigate the effectiveness of combined ? Recruitment began on October 1, Geographic area: NRT (Patch and inhaler) for smoking 1998 and all patients recruited during cessation in patients hospitalized for UK this month and in any even month smoking related disease. over the next 13 months were given Funding agency: Population: NRT Author?s endowment fund Adults ? Those patients recruited in the following month and in any odd month Study setting: Study type: over the next 12 months were given Hospital-based RCT advice and support Inclusion criteria: ? One extra month of patients were randomized to the NRT group ? Hospitalized inpatients or outpatients with resulting in unequal groups smoking related disease referred to counselor by hospital doctor Sample size: ? Age 18 or older G1: 136 (NRT and advise and support) C1: 109 (advice and support) Exclusion criteria: ? Patients with alcoholism, drug dependeny, Definition of smoking: active psychiatric illness, preterminal or Abstinence terminal patients, pregnant women, and ? Carbon monoxide levels less than patients who suffered a myocardial 10ppm infarction during previous month C-90 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: At week 1, abstinence rates were Quality rating: Pharmacotherapy Chi square test of higher for G1 compared with C1 Fair Intervention: significants (54% vs 33%, P < 0.001) Comments: G1: Received NRT Data verification: At 6 months this significant NA (combination of nicotine Carbon monoxide verified difference disappeared between patch and inhalator) for 3 the two groups. Adequate weeks; dosage determined Dependent variables: randomization: by number of cigarettes ? Smoking status At year 1, 14% of the total No smoked; plus G2 ? Compliance with NRT sample were verified as abstinent C1: Four weekly sessions treatment (G1=15%, C1=14%, NS) Attrition rate: 0% and patient encouraged to 30% of G1 used the full supply of set quit date (45 to 60 NRT and 43.9% of these patients minutes); followed by 3 successfully quit at year 1 weekly 15-30 minute sessions Method of assessment: Carbon monoxide validated Self-report at 1 week, 3, 6 and 12 months Baseline data: No baseline differences C-91 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Helgason et al., 2004 To assess variables related to 12-months Immediately after the first call all Geographic area: abstience using proactive compared to patients expressing an interest in beign reactive telephone quitline smoking registered as clients received a Sweden interventions registration from by mail confirming their Funding agency: Population: idenity NR Adults Sample size: Study setting: Study type: G1: 694 (reactive quitline) Population-based G2: 900 (proactive quitline) Cohort study Inclusion criteria: Definition of smoking: Abstience Contacted toll-free Swedish quitline from April to October 1999 ? Not a single puff of smoke during the last week Exclusion criteria: NR C-92 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Additional support (i.e., being Quality rating: Telephone quitline Logistic regression was used referred to the quitline by a Poor Intervention: to calculate Odds Ratios health professional) was Comments: G1: Tailored materials to the Data verification: associated with abstience and persisted with the exclusion of NA patients motivation to quit Self-report patients with severe smoking (stage of change) is offered Adequate randomization: related symptoms free of charge; treatment Dependent variables: NA protocal is described as a ? Smoking status Overall abstience was not Attrition rate: combination of motivational ? Stage of change significantly higher in the 30% interviewing, cognitive ? NRT use proactive compared with the behavioral therapy, and ? Exposure to second hand reactive group (33% vs 28%, pharmacological counseling smoke NS) G2: same as G1 with 4 to 5 ? Treatment compliance proactive counseling calls ? Periods of depressive When men and women are moods assessed separately, women Method of assessment: ? Use of additional support were signifcantly more likely to Self-report at 12 to 13 be abstinent in the procative months after first contact compared with the reactive Baseline data: group (34% vs 27%, P.03) NR C-93 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Hennrikus et al., 2005 Evaluation of effectiveness of three smoking Research assistant obtained list of all Geographic area: cessation interventions for a hospital-based general admissions from previous day at population four hospitals and screened patients US Population: meeting age and admission dz Funding agency: requirements for smoking status and Adults NIH other eligibility requirements Study setting: Study type: Research assistants approached RCT w/ systematic randomization Hospital patients for informed consent and asked Inclusion criteria: consenting patients to complete a ? Patient smoked a cigarette in wk before baseline interview; participants then admission and considered themselves a randomized by research assistant by regular smoker for at least 1 mo during yr looking up next available group before admission assignment on a list on which 3 ? Between 18 and 75 yrs old conditions were randomly ordered within ? Length of hospital stay of 24 hrs or blocks of 30 assignments greater Sample size: ? Ability to understand consent process G1: 703 ? Availability for telephone contact G2: 696 Exclusion criteria: C1: 696 ? Pregnancy Definition of smoking: ? Chemical dependency or psychiatric Cigarettes disturbance as primary reason for ? Regular smoker: smoked more than admission 100 cigarettes in lifetime ? Severe physical or mental distress ? Current smoker: uses cigarettes now C-94 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Quality rating: ? Self-help Using SAS statistical Percentage of those self- Fair ? Individual counseling by health package, multivariate reporting abstinence at 7- professional logistic regression day followup: Comments: ? Telephone counseling conducted to examine the C1: 26.0% NR ? Referral to community resources, outcome variable G1: 24.0% Adequate clinician reminder "abstinence from tobacco G2: 25.2% randomization: use; " Mantel-Haenszel P = > 0.05 Yes Intervention: test for homogeneity of G1: Participants given 2 smoking effects performed for each Percentage of those self- Attrition rate: cessation manuals designed for outcome to determine reporting abstinence at 12- ? 7-day followup: hospital in-patients, a directory of whether results from 4 mo followup: 13.5% smoking cessation community hospitals could be pooled; C1: 15.0% ? 12-mo followup: resources, a label in medical record ?2 analyses of G1: 15.2% 24.1% to cue doctors and nurses to provide relationships b/w txt G2: 19.8% brief (60 second) smoking cessation condition and outcomes P = < 0.05 advice and document that advice, also performed Percentage of those and a letter after discharge abstinent verified by reiterating that their health care Data verification: salivary cotinine at 12-mo providers would like for them to quit Salivary cotinine levels assessed for those who followup: and to encourage them to read C1: 8.8% manuals provided reported abstinence at 12- G1: 10.0% G2: Participants given 2 smoking mo followup G2: 9.9% cessation manuals designed for Dependent variables: P > 0.05 hospital in-patients, a directory of Abstinence; use of NRT smoking cessation community resources, a label in medical record Baseline data: to cue doctors and nurses to provide Groups similar at baseline brief (60 second) smoking cessation advice and document that advice, a letter after discharge reiterating that their health care providers would like for them to quit and to encourage them to read manuals provided, a more extended bedside counseling session in the hospital, and three to six telephone calls from a research nurse during 6 mos after discharge C1: Participants received 2 smoking cessation manuals tailored for hospital in-patients and a directory of smoking cessation community resources Method of assessment: Followup interviews 7-18 days and 12 mos post discharge; for those who reported abstinence at 12 mo followup, salivary cotinine levels assessed C-95 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Hitsman et al., 1999 To identify individual differences that predict Specific randomization scheme NR. Geographic area: cessation when fluoxetine is combined w/ CBT Sample size: US Total: 253 Funding agency: Population: VA Merit Review award by ? Adults Definition of smoking: Cigarettes NIDA, and Eli Lilly and Study type: ? Reported smoking Company RCT w/ simple randomization ? Expired CO greater than 8 ppm Study setting: Inclusion criteria: ? Saliva continine value greater than 10 Population-based Participants are: ng/ml ? 18 to 65 yrs of age ? have smoked daily for at least one yr ? exhibit a baseline expired CO level of greater than 8 ppm ? agree to declare a quit date within 2 wks after second study visit (Source: Borrelli, et al. 1997) Exclusion criteria: ? Clinically significant depression HDRS score greater than 14 ? Pregnancy ? Hypertension ? Use of psychotropic medication or current psychiatric illness ? Alcohol or drug abuse in past yr ? Current use of nicotine replacement ? Unstable medical condition or major health event in past 6 months ? Use of ST, pipes or cigars ? Recent experience of a major life event (e.g., divorce or major job change) ? Suicidal ideation ? History of bipolar disorder (Source: Borrelli, et al. 1997) C-96 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: At 1 wk postcessation: higher Quality rating: ? Individual counseling by Constructed predictive levels of depression predicted Fair health professional models using logistic failure to achieve abstinence (ITT ? Pharmaceuticals regression w/ analysis); higher levels of Comments: hierarchical approach to nicotine dependence and ? Authors didn't Intervention: variable selection. depression associated w/ report numbers G1: Nine, 1-hr individual Models evaluated w/ decreasing likelihood of of participants CBT sessions + fluoxetine parallel analyses using abstinence (analysis of txt- per arm of study, 30 mg for a total of 10 wks stepwise selection compliant patients) and likelihood baseline ? Participants required to procedure of abstinence for participants on demographic set a quit date within 2 characteristics of wks after drug txt began Data verification: fluoxetine tended to be higher than for those on placebo (P = those groups, ? Participants quit Expired CO and saliva 0.06); At 1 month postcessation: nor 6 month smoking at 3rd CBT continine higher levels of weight concern followup results session Dependent variables: predicted lower abstinence (?2 ? Inclusion/ ? Medication stopped at Depression, nicotine 4.8, P = 0.78); patients on exclusion criteria 9th CBT session, at dependence, weight fluoxetine had positive are described in which time 6-month concerns, self-efficacy association b/w degree of companion followup period began about quitting smoking depression and likelihood of article, Borrelli, ? CBT not explained abstinence (highest quartile et al. 1997 ? Patients w/ fluoxetine Baseline data: HRSD = 3, OR = 2, 95% CI, level less than or equal No significant difference Adequate 0.85-4.70); At 3 months randomization: to 150 ng/ml considered b/w txt groups in postcessation: patients treated w/ compliant baseline characteristics: NR fluoxetine had positive G2: Same as G1:, except age, gender, education, association b/w HRSD scores Attrition rate: fluoxetine dose of 60 mg smoking history, baseline and abstinence likelihood NR and fluoxetine blood level level of nicotine (highest quartile HRSD = 3, OR = less than or equal to dependence, depression, 1.44, 95% CI, 0.53-3.91) 300ng/ml considered weight concern, and self- compliant efficacy Smoking characteristics C1: Same as G1, except predicting txt compliance were given placebo nicotine intake at baseline, saliva cotinine (?2 = 11.4, P < 0.001), Method of assessment: and expired CO ( ?2 = 5.3, P < Self report of smoking, 0.05) expired CO, and saliva continine Also used depresion scale, nicotine dependence, weight restraint scale, and self-efficacy questionnaire C-97 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Holt et al., 2005 To determine whether bupropion is effective ? Self-recruitment from mall Geographic area: in txt of smoking cessation in indigenous advertisements Maori population of New Zealand New Zealand ? Recruited from Maori health networks ? Randomized (by computer generated Funding agency: Population: code) GlaxoSmithKline ? Adolescents ? Young Adults Sample size: Study setting: ? Adults G1: 88 Community-based Population-based Study type: C1: 46 ? RCT w/ systematic randomization Definition of smoking: ? Placebo controlled, double blind, parallel Cigarettes group study ? Smoke ? 10 per day on average over last yr Inclusion criteria: ? Self-indentified Maori ? Age 16 to 70 ? Smoked at least 10 cigarettes per day over last yr ? Desire to quit ? Nonpregnant women w/ reliable contraception Exclusion criteria: History of: ? epilepsy ? febrile convulsion ? CNS tumor ? head injury ? cerebrovascular dz ? anorexia ? bulima ? CD ? other severe illnesses ? pregnant or lactating ? drug/alcohol abuse ? unwilling to quit marijuana C-98 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Rates of continued abstinence in Quality rating: ? Individual counseling by Primary: normal bupropion and placebo groups, Fair health professional approximation to respectively = 44.3% vs17.4% at ? Individual counseling by binomial distribution 3 months (RR = 2.54; 95% CI Comments: non health professional Secondary: GEE 1.30-5.00); = 21.6% vs10.9% at ? No ITT analysis ? Telephone counseling Exploratory: general 12 months (RR = 1.99; 95% CI ? No attrition ? Pharmaceuticals additive model 0.79-5.00). reported ? Fell just short of Intervention: Data verification: Bupropion group more likely to sample size G1: Bupropion 150 mg Exhaled CO have insomnia (26% vs9% w/ RR needed once daily for 3 days, then Dependent variables: = 3.0 and 95% CI 1.1-8.2) according to 150 mg twice daily for 7 Continued abstinence power analysis wks; smoking cessation from smoking at 3 and ? No analysis for counseling 12 months (or other time confounders. Clinic visits (to assess points, secondarily) smoking status, exhaled Adequate CO, and adverse events) randomization: at 3 wk, 7 wk, Yes 3 mo, 6 mo, 9 mo, and 12 Attrition rate: mo after target quit date NR C1: Same as G1 except given identical placebo pills Method of assessment: ? Self-report ? Fagerstrom score ? exhaled CO Baseline data: Mean age (SD): 41.79 (9.2) txt vs 38.0 (11.1) placebo Mean Fagerstrom index (SD): 5.8 (2.2) txt vs 5.3 (2.0) placebo Mean initial weight (SD): 85.4kg (18.9) txt vs 80.2 (16.8) placebo; 69.3% female in txt vs 76.1% in placebo C-99 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Jones et al., 2001 Determine whether ICU patients' smoking Recovering ICU patients recruited to Geographic area: cessation after critical illness is aided by study 2 wks after ICU discharge, provision of a rehabilitation program randomized to receive either usual care United Kingdom Funding agency: Population: followup of unit visits and ICU clinic appointments or routine followup plus NR ? Adults an ICU rehabilitation manual Study setting: Study type: Hospital RCT w/ simple randomization Sample size: Inclusion criteria: G1: 31 (20 smokers) ? Minimum 48 hr ICU admission C1: 30 (16 smokers) ? Had been ventilated Definition of smoking: Exclusion criteria: Cigarettes NR NR C-100 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Of smokers preICU admission, Quality rating: ? Self-help NR those returning to smoking at 8-wk Fair ? Social support Data verification: followup: G1: 2 Comments: Intervention: Smoking status verified by C1: 5 Very small study; G1: Verbal encouragement information from a close RR = 0.24 (CI 0.03-1.84) due to type of article, to remain non-smoking at family member details about ICU discharge, at 8-wk clinic Of smokers preICU admission, randomization and vist, and six month clinic Dependent variables: those returning to smoking at 6-mo sampling NR visit; patients' immediate ? Smoking status followup: family instructed not to ? Levels of anxiety G1: 3 Adequate smoke in same room as ? Depression C1: 10 randomization: patient; 2 wks postdischarge ? PTSD-related symptoms RR = 0.11 (CI 0.02-.64) NR introduction to 6-wk self help No differences in anxiety, Attrition rate: ICU rehabilitation manual read by patient and relative depression or PTSD-related O% attrition that emphasized importance symptoms at 6 mos b/w patients of remaining non-smoking who continued to smoke and those and provided practical tips who had quit (Mann Whitney U, C1: Verbal encouragement HAD anxiety P = 0.51, HAD to remain non-smoking at Depression P = 0.74, Impact of ICU discharge, at 8-wk clinic Events Scale P = 0.50) vist, and six-mo clinic visit; patients' immediate family instructed not to smoke in same room as patient Method of assessment: Followup in clinic at 8 wks and 6 mos postdischarge Baseline data: No significant differences in baseline data among C1 and G1 C-101 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Jorenby et al; 1999 To determine whether buproprion plus NPis ? Subjects recruited at four study sites Geographic area: more effective for smoking cessation than by advertisements in the media either cessation aid alone or a placebo US ? First subject enrolled in August 1995, Population: and followup completed in March Funding agency: ? Adults 1997; subjects randomly assigned to Glaxo Wellcome one of four treatments w/ use of an Study setting: Study type: unequal-cell design Community-based ? RCT w/ systematic randomization ? Randomization not balanced within ? Double-blind, placebo-controlled, sites randomized control trial Sample size: Inclusion criteria: G1: 245 ? At least 18 yrs of age G2: 244 ? To smoke at least 15 cigarettes per day G3: 244 ? To weigh at least 45.4 kg (100 lb) C1: 160 ? To be motivated to quit smoking Definition of smoking: ? To speak English Cigarettes ? Only one smoker per household allowed ? Abstinent: no smoking since last clinic to enroll in study visit and expired air CO 10 ppm or Exclusion criteria: less Subjects excluded for following reasons: ? Continuously abstinent: no smoking ? Serious or unstable cardiac, renal, since quit date at expired air CO 10 hypertensive, pulmonary, endocrine, or ppm or less at every clinic visit over neurologic disorders, as assessed by 12 mos study-site physician ? Ulcers ? Seizure or dermatologic disorders ? A current dz of major depressive episode or a history of panic disorder, psychosis, bipolar disorder, or eating disorders ? Use of a nrt within six mos before study enrollment ? Pregnancy or lactation ? Abuse of alcohol or a non?nicotine- containing drug within preceding yr ? Use of a psychoactive drug within wk before enrollment ? Use of an investigational drug within mo before enrollment ? Prior use of bupropion ? Current use of other smoking-cessation treatments ? Regular use of any noncigarette tobacco product C-102 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Quality rating: Pharmaceuticals ?2 and ANOVA used to Proportion of participants Fair Intervention: test for baseline abstinent at 6 mo followup: differences in demographic G1: 38.8% OR = 2.7 (95% Comments: G1: sustained-release and smoking-history CI, 1.7-4.4) P = < 0.001 NR bupropion (subjects received variables G2: 34.8% OR = 2.3 (95% 150 mg of bupropion in Adequate randomization: CI, 1.4-3.7) P = < 0.001 morning and a placebo All statistical tests two- Yes G3: 21.3% OR = 1.2 (95% tablet in evening on days 1, sided and had an alpha CI, 0.7-1.9) P = 0.53 Attrition rate: 2, and 3 of txt; and one level of 0.05 C1: 18.8% 6 month followup: 30.8% bupropion tablet in morning Logistic-regression 12 month followup: 34.6% and one in evening on days Proportion of participants 4 to 63) plus NP(one patch analysis used to determine Adverse events: 8.8% abstinent at 12 mo per day; patches from wks 2 pairwise differences followup: to 7 each contained 21 mg among groups in G1: 35.5% OR = 3.0 (95% of nicotine, those used abstinence rates CI, 1.8-4.9) P = < 0.001 during wk 8 each contained Kaplan?Meier method G2: 30.3% OR = 2.3 (95% 14 mg, and those used used to analyze CI, 1.4-3.9) P = < 0.001 during wk 9 each contained differences in rates of G3: 16.4% OR = 1.1 (95% 7 mg) continuous abstinence; CI, 0.6-1.8) P = 0.84, G2: sustained-release homogeneity among C1: 15.6% bupropion (subjects received treatments and pairwise 150 mg of bupropion in All four groups had differences tested w/ log- morning and a placebo significant increases in rank test tablet in evening on days 1, withdrawal symptoms 2, and 3 of txt; and one Data verification: during first wk of txt (P < bupropion tablet in morning Expired air CO levels 0.001) but changes and one in evening on days assessed to validate self- smaller in three active-txt 4 to 63) plus placebo patch reported smoking status groups than in placebo G3: NP(one patch per day; group during first six days Dependent variables: patches from wks 2 to 7 after quitting date and ? Primary: smoking status each contained 21 mg of during following wks nicotine, those used during ? Secondary: withdrawl No txt effect on Beck wk 8 each contained 14 mg, symptoms, body weight, Depression Inventory and those used during wk 9 and Beck Depression Inventory scores scores each contained 7 mg) plus placebo pills 2x per day Baseline data: Subjects in combined- C1: placebo pills 2x per day No significant differences therapy group had gained plus placebo patch one time b/w groups significantly less weight per day than those in placebo group (P < 0.05) or Method of assessment: bupriopion group Followup at 10 wks, 3 mos, (P < 0.05) at wk 7 but no 6 mos, and 12 mos after significant differences b/w start of study; assessment groups in mean weight consisted of self-reported changes after wk 7 smoking status, vital signs, measurement of expired air CO, and the Beck Depression Inventory C-103 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Killen et al., 2000 To examine efficacy of smoking cessation ? Recruitment from local newspapers, Geographic area: treatment that combined nicotine then telephone interview screen, then replacement therapy via transdermal system US, San Jose, CA initial office visit screen with antidepressant paraxetine ? Double blind allocation Funding agency: Population: University of California Sample size: Adults Tobacco-Related Disease Total: 224 Research Program; Study type: About 75 in each group SmithKline Beechum RCT, double-blind Definition of smoking: Study setting: Inclusion criteria: ? Greater than or equal to 10 cigarettes Population-based ? Adults over age 18 per day ? Abstinence: nonsmoking not even a Exclusion criteria: puff for 7 consecutive days and saliva ? Pregnant, or lactating cotinine level below 20ng/ml an a CO ? History of severe liver or kidney disease, level below 9ppm epilepsy, bipolar disorder, schizophrenia, ? Smokers ? reported abstinence but ? Receiving active treatment for or reported failed to provide a saliva sample current depression or substance abuse ? Taking antidepressants, psychotropics, or other drugs that could interact with paraxetine resulting in potentially adverse consequences ? Unable to obtain permission from personal physician to participate in the study ? for patients with history of heart disease, diabetes, thyroid disease, recent chest pain, very high blood pressure, skin conditions or peptic ulcer C-104 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Abstinence Rates (NS) Quality rating: ? Self-help ? Intention to Treat analysis At 4 weeks Good ? Individual counseling ? Logistic regression G1: 48% G2: 57% Comments: Intervention: ? 75% poser to detect at NR G1: NRT transdermal least a 20% increase in C1: 45% system patch for 8 weeks abstinence At 10 weeks Adequate plus 20 mg paroxetine for 9 Data verification: G1: 33% randomization: weeks Yes ? Self report G2: 39% G2: NRT transdermal ? Saliva cotinine C1: 36% Attrition rate: system patch for 8 weeks concentrations Not clear plus 40 mg paroxetine for 9 At 26 weeks ? Blood level to determine weeks G1: 21% paroxetine compliance C1: NRT transdermal G2: 27% level system patch for 8 weeks C1: 25% plus placebo for 9 weeks Dependent variables: Chemical Confirmation ? Craving Method of assessment: At 4 weeks: 95% ? Adverse events At 10 weeks 98% ? In person interview and ? Smoking status At 26 weeks 86% biomarkers at initial clinic ? Compliance visit ? BMI Subanalysis of Compliant ? Telephone interview at 1, 4, 10 and 26 weeks ? Heart rate Persons At 4 weeks Via an interactive voice ? Blood Pressure ? G1: 64% response system at 24 ? Expired air CO level G2: 74% hours, weeks 2 and 6 ? Depressive symptoms C1: 46% P < 0.001 Baseline data: ? Demographics At 10 weeks ? Medical status questions G1: 43% ? Smoking history G2: 51% ? Screen for current major C1: 35% depression At 26 weeks ? Modified Fagerstrom G1: 33% Tolerance Questionnaire G2: 38% ? Self-reported depression C1: 24% symptoms ? Clinical diagnosis of Those who reported greater use depression of nicotine patches and those ? BMI with higher blood levels of ? Blood pressure and heart paroxetine in Week 4 were more rate likely to be abstinent C-105 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Lancaster et al., 1999 To determine whether receiving brief advice ? Opportunistic recruitment of patients Geographic area: from a GP plus extended counseling and attending the practice w/ unrelated followup from a trained nurse resulted in United Kingdom complaints patients' cessation more than brief advice ? Letters to patients identified as Funding agency: from a GP alone smokers by practice records NR Population: ? 497 patients from 6 practices Study setting: ? Adults systematically randomized to receive Practice/provider settings brief advice from a GP or brief advice Study type: from a GP plus extended counseling RCT w/ systematic randomization and followup from a trained practical nurse Inclusion criteria: ? Adults ages 18 and over who smoked at Sample size: least one cigarette per day G1: 249 C1: 248 Exclusion criteria: ? NR Definition of smoking: Cigarettes ? Smoker: At least one cigarette smoked per day and/or salivary cotinine levels < 113.5 nmol/l C-106 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Abstinence at 3 month followup: Quality rating: ? Self-help ? Chi sq used to test for G1: 9.2% Fair ? Individual counseling by differences b/w C1: 8.1%, NS health professional proportions and 95% CI Comments: ? Pharmaceuticals calculated Abstinence at 12 month followup: ITT analysis G1: 6.8% Adequate ? Intervention: C1: 11.3%, NS randomization: G1: Yes Brief verbal or written Data verification: Salivary cotinine levels Sustained abstinence (abstinent at advice to quit from the both 3- & 12-month followup): Attrition rate: patients' general obtained to validate self- G1: 3.6 3 mo followup: 19% practitioners, plus: extended reported quitters C1: 4.4 12 mo followup:25% counseling and followup from Dependent variables: Difference: -0.8% a trained practing nurse; ? Sustained abstinence at (CI, -4.3%, 2.6%) Health Education Authority 3 and 12 mos Validated (-3.3 vs4.0) leaflet on cessation; fact sheet on NRT; invitation to ? Biochemically validated Any forward change in stage of contact research nurse for ? Forward movement on change: more intensive, tailored stage of change G1: 20.9% counseling that included CO Baseline data: C1: 26.6% breath test and a G1 and C1 similar at Difference: -5.7% personalized message about baseline in terms of (CI, -13.2%, 1.7%) benefits of quitting - demographics and minimum one 15 min visit smoking status plus 1 followup, max five, 10- min followup visits; NRT if necessary C1: Brief advice to quit from patients' general practitioners Method of assessment: Surveys administered at 3 and 12 months post quit date; salivary cotinine assessed for self-reported quitters; those who did not provide followup information were assumed to be smokers C-107 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Lawrence et al., 2005 To evaluate the effect on quitting smoking at ? Recruited 16 of the 19 midwifery Geographic area: 18 months post partum of smoking services for West Midlands cessation intervention based on TTM West Midlands, UK ? 100 general practices randomized into delivered in pregnancy compared to current trial arms Funding agency: standard of care ? Allocated by computerized Department of Health and Population: minimization algorithm the West Midland Health Women patients at of antenatal clinics in Authorities Sample size: general practices G1: 305 Study setting: Study type: G2: 324 Practice/provider settings Cluster randomized trial C1: 289 Inclusion criteria: 393 (42%) eligible smokers were ? At least 16 years of age followed up on ? Still smoking at 12 weeks gestation Definition of smoking: Exclusion criteria: ? Urine cotinine of 1.5 ug/ml NR ? Abstinence: declared nonsmoking and no cigarette consumption in last 24 hours C-108 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Continuous abstinence since 10 Quality rating: Self-help ? Cluster randomization days PP: G1+G2 vs C1: 1.20 Poor Intervention: ? Random effects liners (95% CI: 0.29-4.88) regression Comments: G1: TTM-based self help Point Prevalence for Abstinence: NR manuals Data verification: G1+G2 vs C1: 1.15 (95% CI: G2: TTM-based self help Self report 0.66-2.03) Adequate manuals plus sessions with randomization: interactive computer Dependent variables: Seven of the 54 (13%) who quit NR program giving ? Cotinine saliva at end of pregnancy were still quit Attrition rate: individualized smoking ? Continuous and point 18 months later NR cessation advice prevalence abstinence No evidence that TTM-based C1: Standard care since pregnancy interventions were superior in Method of assessment: preventing relapse Medical chart abstraction 18 of the 54 (33%) of those who and follow-up telephone had quite 10 days PP were still interview quite at 18 months, though 11 of Baseline data: these were not continuously ? Smoking habits ? Urine cotinine levels ? Fagerstrom Test for Nicotine dependence ? Stage of change ? Demographics ? Parity ? Proportion having a partner ? Proportion whose partner smoked ? Educational achievement ? Household net income C-109 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Lerman, et al., 2004 To evaluate the comparative efficacy of ? Participants were recruited through: Geographic area: transdermal nicotine and nicotine nasal - local media ads for free smoking spray and identify predictors of treatment United States cessation treatment outcome - physician referral Funding agency: Population: ? Eligible participants randomly National Cancer Institute; Adults ?18 years old enrolled at Georgetown assigned to receive transdermal National Institute on Drug University and the University of nicotine or nicotine nasal spray Abuse, and Public Health Pennsylvania Services Research grant Sample size: Study type: 299 adults Study setting: RCT Population-based Definition of smoking: Inclusion criteria: ? Prolonged abstinence defined as not ? 18 years of age or older having smoked for 7 consecutive days ? Had smoked 10 or more cigarettes per at any time during the follow-up period day for the previous 12 months ? Point prevalence defined as 7 days of continuous abstinence immediately Exclusion criteria: before the follow-up point ? Pregnancy or lactation ? Uncontrolled hypertension ? Unstable angina ? Heart attack or stroke within the previous 6 months ? Current treatment or recent diagnosis of cancer, drug or alcohol dependence ? Current diagnosis or history of a psychotic disorder ? Current use of bupropion or nicotine- containing products other than cigarettes C-110 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: No statistically significant Quality rating: ? Nicotine nasal spray ? Calculated sample size of difference found between Fair ? Transdermal nicotine 140 per group to detect a treatment groups at 6 months therapy between-group difference (G1: 12.2%, G2: 15%, NS) Comments: Authors stated that ? Standardized behavioral in quit rates of 8% or greater with 80% power Abstinence rates similar to those stratification was group counseling (alpha = 0.05) achieved in other studies done by study site but Intervention: Chi square and Wilcoxon no mention of what ? G1: Smokers who were highly 8 weeks of nicotine rank-sum tests were used was stratified, or how dependent, obese, or members nasal spray and 7 sessions to examine differences in or why of minority groups achieved of behavioral group pre-treatment variables higher rates of abstinence with Adequate counseling G2: ? Chi square and Wilcoxon nasal spray randomization: 8 weeks of transdermal rank-sum tests were used Yes nicotine therapy (i.e., patch) to compare treatment and 7 sessions of behavioral groups on abstinence Attrition rate: group counseling outcomes 18% lost-to-follow-up Method of assessment: ? Logistic regression 8 weeks and six month analysis was used to telephone interviews plus examine the independent biochemical verification for effects of treatment group point prevalence assignment, pretreatment variables, and their Baseline data: interactions on prolonged Participants at the University abstinence and verified of Pennsylvania site were point prevalence significantly more likely to be abstinence non-white, obese, and have ? Wilcoxon rank-sum tests lower levels of education were used to examine differences between treatment group in use and percentage of cotinine replacement Data verification: ? Self-report for prolonged abstinence ? Self-report for point prevalence plus carbon monoxide reading < 10 ppm Dependent variables: ? Smoking status C-111 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: MacLeod et al., 2003 To investigate the effectiveness of telephone ? Recruited smokers from New South Geographic area: counseling as an adjunct to nicotine Wales via newspaper ads replacement therapy (NRT) by transdermal Australia ? Consent forms, questionnaires on patch in smoking cessation health, smoking history and attitudes Funding agency: Population: to quitting were mailed to people who GlaxoSmithKline ? Smokers from New South Wales responded to the ads. Study setting: ? ?18 years old ? Responses were screened by a Population-based pharmacist in accordance with the Study type: approved product information for RCT transdermal nicotine patches and eligibility criteria for the study Inclusion criteria: ? Those deemed eligible were randomly ? Aged ?18 years allocated to either NRT alone or NRT ? English-speaking plus telephone counseling ? Smoking ?10 cigarettes per day for the ? Participants were contacted by previous year telephone data collectors to verify ? Ready to begin a quit attempt within 1 their understanding of the study week (baseline) Exclusion criteria: Sample size: ? History of cardiovascular disease, G1: 412 diabetes or skin sensitivity C1: 442 ? Currently breastfeeding, pregnant or intending to become pregnant Definition of smoking: ? Using contraindicated medications Cigarettes ? Current Smoker ? Smoking ?10 cigaretters per day for the previous year ? 28-day continuous abstinence (used at 3 and 6 month follow up calls) ? complete abstinence, ?not even a puff? for at least the previous 28 days ? 90-day continuous abstinence ? the reported date of the last cigarette smoked was at least 90 days before 6 month follow-up call C-112 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Telephone counseling improves Quality rating: ? NRT - patch ? Intent-to-treat approach cessation rates when used in Good ? Telephone counseling used, where missing conjunction with the patch values on smoking status Comments: Intervention: imputed as smokers with 28-day continuous abstinence No biochemical G1: Nicotine Patch and 5 0 days abstinence in that rates at 6-months: G1 30.6%, C1 verification of telephone counseling calls, period, unless continuous 22.4%, P =.01 abstinence ? relied scheduled at 1,2,3,6 and 10 abstinence between calls solely on self-report weeks after baseline 90-day continuous abstinence was subsequently C1: Nicotine Patch only rates G1 26.7%, C1 18.6%, Adequate reported P = 0.004 randomization: Method of assessment: ? Statistical significance Yes Brief (5 minute) follow-up between groups was Logistic regression analysis telephone questionnaires tested by X2 tests and revealed the duration of patch Attrition rate: were administered at 1, 2, 3, logistical regression use and telephone counseling 16% and 6 months post-baseline (categorical variables) or made independent contributions t tests (continuous to prediction of 90-day Baseline data: variables) abstinence No significant differences ? Logistic regression b/w the 2 groups Odds of successful quitting analysis was conducted increased with each extra week with both treatment group of patch use when treatment and duration of patch use group held constant (OR=1.24, included as predictors of P < 0.05) 90-day abstinence When controlling for weeks of Data verification: patch use, the odds of success ? Self-report, bogus were higher for those in the pipeline technique used, counseling group (OR=1.46, with possibility of carbon P < 0.05) monoxide breath testing mentioned in the consent form and at the 3- and 6- month monitoring calls Dependent variables: ? 28-day continuous abstinence at 3 and 6 months ? 90-day continuous abstinence at 6 months C-113 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: McBride et al., 2004 ? To evaluate whether relative to usual care ? Introductory letters describing the Geographic area: and a previously evaluated woman-only study were sent on behalf of WAMC United States intevention, if training in optimal support to all women identified from behaviors and giving support to partners automated appointment logs with a Funding agency: increased abstinence rates among scheduled 1st prenatal visit. National Cancer Institute pregnany women during and after ? Women who did not call study?s toll- pregnancy free number w/in 10 days to decline Study setting: ? 2nd aims ? decrease postpartum relapse contact were called to complete Military Medical Center and increase rates of smoking cessation screening survey among partners ? Eligible women who agreed to Population: participate were stratified by smoking Pregnant woman who received prenatal status (smoker or recent quitter), their ? partner?s smoking status (smoker or care at the Womack Army Medical nonsmoker) and partner?s level of Centers willingness (not at all vs somewhat or ? Their live-in partners very) Study type: ? Once stratified, participants were then RCT randomly assigned to one of 3 conditions: usual care (UC), woman Inclusion criteria: only (WO) or partner assisted (PA) ? Eligible women were ?20 weeks pregnant ? Women and partners completed ? Aged ?18 years telephone surveys at baseline (about ? Current smokers or recent quitters 11 weeks of pregnancy) ? Living with an intimate partner ? Willing to have the partner contacted for Sample size: participation in the study G1: (WO): 192 G2: (PA): 193 Exclusion criteria: C1: (UC): 198 ? >20 weeks pregnant ? Partner not available, or refused partner Definition of smoking: contact Cigarettes ? Current Smoker ? NR ? Recent quitter ? smokers in the 30 days prior to pregnancy but not smoking at intake ? Prevalent abstinence ? no smoking in prior 7 days ? Sustained abstinence ? no smoking across all 4 follow-up times C-114 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: No statistically significant Quality rating: ? Provider advice ? Logistic regression was difference between groups at any Fair ? Self-help quit guides used to compare the 2 follow up point Comments: ? Telephone counseling experimental conditions to the control condition on No statistically significant By only including ? Pregnancy relapse kit each outcome measure, difference between groups in the women who agreed to ? Telephone counseling controlling for baseline proportion relapsed at any involve their partners, and support guide geared postpartum follow-up couples who were towards partners smoking-specific support variables and predictors inclined to support In late pregnancy (28 weeks), Intervention: known to be associated each other and more partners abstinent in G2 G1: Usual care plus late with smoking cessation attentuated treatment group (15%) than C1 group (5%) pregnancy relapse kit, and 6 trials effects may have P = 0.02 counseling calls ? Intent-to-treat approach been over- G2: G1 plus the partners used, where missing Women in all groups consistently represented received telephone values on smoking status reported a decline in positive Adequate counseling and support imputed as ?smoker? partner support from baseline to randomization: guide (partners who smoked ? Comparison on the 12-month postpartum (F=81.43, Yes received cessation aids and experimental conditions df=1322, P < 0.001) counseling) to the control condition on Attrition rate: C1: Usual Care: provider dichotomous secondary 19% advice to quit and self-help outcomes, such as guide postpartum relapse and Method of assessment: partners? prevalent ? Telephone surveys of the abstinence, were made women and partners at 28 with logistic regression weeks pregnant, ? Proportional hazards postpartum and 2, 6, and model was used to 12 months compare conditions on ? Self reported smoking time to relapse, where status assessed at each time to relapse defined as follow up with the the number of days b/w question ?have you woman?s delivery date smoked any cigarettes in and the date she the past 7 days?? resumed smoking ? Saliva samples collected ? Differences by condition by mail at 28 weeks for changes in women?s pregnancy and 12 months and partner?s smoking- postpartum from women specific support and and partners who general support across reported not smoking in time were tested with the previous 7 days mixed linear-model repeated measures Baseline data: analysis No significant differences b/w any of the groups Data verification: Self-report, salivary cotinine Dependent variables: ? Abstinence at 28 weeks, 2, 6 and 12 months postpartum ? Sustained abstinence C-115 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Mermelstein et al., 2003 To compare the relative efficacy of two types ? Participants recruited primarily Geographic area: of proactive telephone calls following a through paid advertisements, media group cessation program. US coverage of the program, flyers and referrals Funding agency: Population: Participants completing a group smoking ? 905 smokers attended the first group National Heart, Lung and cessation program meeting Blood Institute and National ? 771 smokers completed the group Cancer Institute Study type: program Study setting: RCT ? 756 smokers were assessed at least NR Inclusion criteria: once over the follow-up period NR Sample size: Exclusion criteria: G1: (basic): 375 NR G2: (enhanced): 381 Definition of smoking: Tobacco dependence as measured by the Fagerstrom Tolerance Questionnaire C-116 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Point Prevalence of Quality rating: ? Group meetings NR Abstinence: no significant Poor ? Telephone counseling Data verification: differences by condition at any assessment point Comments: Intervention: Expired air carbon monoxide ? No true control group (i.e., G1: Enhanced: Basic and saliva cotinine used to Post-hoc analysis by condition those in group program program (see C1 below) plus verify abstinence at each by gender at all assessment with no telephone follow- telephone counseling call major assessment point for points showed that men up). So no true content varied by participants reporting receiving the enhanced comparison of whether participants? smoking status abstinence condition were more likely to calls had an effect. (i.e., still smoking, abstinent, abstain while women were ? Random assignment slipped or relapsed); if still Dependent variables: more likely to abstain when ? Abstinence: no smoking at method NR smoking or relapsed also participating in the basic all in the past 7 days ? Population not described received a videotape; plus condition. ? Relapse: smoking one ? No inclusion/exclusion abstinent counseling on keeping motivation and self- one or more days of the criteria specified efficacy high using a variety past 7 after achieving an Adequate randomization: of techniques initial 7-day period of NR C1: BasiC1: 7 week group abstinence at the end of Attrition rate: treatment program of the group program 6-month: 1% telephone counseling giving 15-month: 4% only words of encouragement without specific guidance Method of assessment: 3-,6-,9-,12- and 15-month follow-ups via telephone Baseline data: No significant differences between conditions on any variables or on percentage with a history of depression C-117 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Murray et al., 2001 To evaluate hypothesis that Black smokers NR Geographic area: will respond differently than Whites to a smoking cessation intervention program Sample size: US where no adjustments are made in G1: 3,923 Funding agency: recognition of cultural differences C1: 1,964 Division of Lung Disease of Population: Definition of smoking: the National Heart, Lung, ? Adults Cigarettes and Blood Institute ? African Americans Defined as smoking at any clinic visit Study setting: Practice/provider settings Study type: RCT w/ simple randomization Inclusion criteria: ? Age 35-60 yrs ? Mild COPD ? Current smoker Exclusion criteria: ? Serious health conditions likely to to affect lung function or ability to stay in trial for 5 yrs ? Use of regular medications that might alter lung function C-118 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Quitting at 1 yr G1 vs C1: Quality rating: ? Group counseling Covariate data used to Blacks: AOR: 1.48 Poor ? Pharmaceuticals explore differences using Whites: AOR: 5.99 regression t-tests etc. P = 0.002 Comments: Intervention: Large differences G1: SI (12-wk group Data verification: Quitting at 5 yrs: in baseline program using a quit day ? Salivary cotinine G1 vs C1 comparisons b/w in second wk, followed by annually Blacks: AOR: 1.87 white and black 4 consecutive days of ? Expired CO Whites: AOR: 3.34 negate any group meetings) w/ throughout P = 0.06 differences that bronchodilator therapy intervention program occur in outcomes, G2: SI w/ placebo inhalers and subsequently at Significant txt effect for Blacks small sample size C1: Usual care- annual 4-mo intervals over 5 yrs of study (OR = 1.95, P physician visits = 0.04) Adequate Dependent variables: randomization: Method of assessment: Smoking cessation No ? Interviews at baseline Study not designed and annually for 5 yrs Baseline data: for this comparison Baseline data ? Annual saliva collection comparisons b/w 2 Attrition rate: groups showed NR significant differences Black population had more women (46% vs37%) P = 0.01, less education, less income, less likely to be married (48% vs70%), smoked less (23.5 vs32.9 per day) C-119 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Peterson, 2004 To evaluate whether a nurse-managed NR Geographic area: smoking cessation and relapse prevention program reduced smoking rates at 12 mos Sample size: US in women admitted to hospital w/ CD G1: 142 Funding agency: C1: 135 Population: National Heart, Lung, and Definition of smoking: Blood Institute ? Adults, Cigarettes ? Women (only) Study setting: ? Abstinent: no smoking in past 7 days Hospital Study type: RCT w/ systematic randomization Inclusion criteria: ? Female ? At least 18 yrs of age ? Admitted to hospital w/ CVD or peripheral vascular disease ? Had smoked cigarettes in month before admission ? Willing to make a serious attempt to quit smoking after discharge Exclusion criteria: ? Medical instability ? Alcohol or substance abuse ? Dementia ? Schizophrenia C-120 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: At 12-month followup, 7-day Quality rating: ? Self-help NR point prevalence for non- Fair ? Individual counseling by Data verification: smoking: health professional G1: 48% Comments: Self-reported smoking NR ? Telephone counseling C1: 42% status (abstinence in RBI: 14% (95% CI, -14 to 51), Intervention: past 7 days) verified by Adequate P = NS G1: randomization: Brief physician cotinine levels and NR counseling and usual care family/friends plus nurse managed, Dependent variables: Attrition rate: cognitive behavioural, Smoking status 11% relapse prevention intervention given before Baseline data: discharge, <5 structured NR telephone contacts 2?90 days after discharge, and relapse management counseling as needed C1: Brief physician counseling, a self help pamphlet, and a list of community resources Method of assessment: NR C-121 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Quist-Paulsen and To determine whether a nurse led smoking ? Invited to participate in study all Gallefoss, 2003 cessation intervention affects smoking patients admitted to Vest-Agder Geographic area: cessation rates in patients admitted for Hospital for myocardial infarction, coronary heart disease Norway unstable angina, or care after Funding agency: Population: coronary bypass surgery performed at Adults under 76 yrs of age other hospitals Vest-Agder Council for ? 1016 patients assessed for eligibility Public Health and the charity Study type: ? Nurses recruited patients 2-4 days Sykehuset i vaare hender RCT after admission Study setting: Inclusion criteria: ? Participants answered baseline Cardiac ward of a general Patients under the age of 76 admitted for questionnaire and were randomly ? hospital myocardial infarction, unstable angina, or allocated to usual care (control group) cardiac bypass surgery who had been or intervention daily smokers until the start of their ? Nurses given serially numbered present coronary symptoms. Patients had sealed envelopes from secretary to be sufficiently recovered to reliably otherwise uninvolved in study receive the intervention and had to live in ? Randomization was in blocks of Vest-Agder or Aust-Agder county. varying sizes ? 250 patients randomized; 10 were Exclusion criteria: later withdrawn ? Patients with serious illness associated with short life expectancies, serious Sample size: psychiatric problems, alcoholism, and G1: 118 dementia C1: 122 Definition of smoking: ? Daily smoker until start of present coronary symptoms C-122 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Quit rate at 12 months: Quality rating: ? Group sessions with cardiac ? Chi-square test used to G1: 57% Good nurses, including seeing a assess effect of C1: 37% (absolute risk video and getting info intervention reduction 20%, 95% CI 6.4 ? Comments: booklet ? NNT calculated with 33.0; P = 0.004) ? Well-reported? ? Telephone counseling confidence intervals interventions and methods NNT to get one additional ? Self-help ? Simple and multiple fully described person who would quit was 5 logistic regression ? Objective outcome Intervention: models used to test Assuming dropouts relapsed at measure (urine test) G1: Cardiac nurse consulted relation between 12 months, smoking cessation ? Loss-to-follow up treated patients 1-2 times during baseline characteristics rates were: as relapsed smokers hospital stay. Intervention and outcome measures yielding valid ITT analysis based on booklet focusing on ? G1: 50% fear arousal and prevention of ? SPSS used for all ? C1: 37% (absolute risk Adequate randomization: relapse. Booklet emphasized analyses reduction 13%, 95% CI 0% - Yes health benefits of quitting Data verification: 26%) Attrition rate: smoking after coronary event, Self-report and urine Smokers who stated they were ? 10 post-randomization including illustrations showing analysis still smoking were classified as exclusions mortality differences for those smokers ? LTF at 12 months(not who continued smoking after Dependent variables: coronary condition vs. those ? Number of days spent in Those who claimed they had including post- randomization who quit, information on how to ICU quit and had a nicotine exclusions): 9% (G1: prevent relapse, how to stop ? Myocardial infarction as metabolite concentration in 15.3%, C1: 3.1%) smoking, how to use nicotine reason for admission urine < 2.0 mmol/mol replacement.; also explained ? No previous coronary creatinine were classified as how to identify & cope with heart disease non-smokers high risk situations for relapse. ? Employment G1: average of 1.6 (SD 0.7) Nurses contacted participants consultations as inpatients and by telephone 2 days, 1 week, 3 1.6 (SD 1.5) as outpatients; weeks, 3 months & 5 months also received a mean of 8.5 after discharge. At 6 weeks (SD 3.2) telephone calls aoo participants in G1 had consultation at outpatient clinic Mean total time devoted to with nurse. each patient was 147 minutes C1: Patients were offered (SD 50) group sessions twice/week Use of nicotine replacements: with nurses where importance G1: 36% of smoking cessation was C1: 28% (without a statistically mentioned; a video was shown significant difference) and booklet distributed giving general information on 9% of patients who smoked coronary heart disease and while in hospital or at 6 wks advice on quitting smoking. No were abstinent at 12 months further specific instructions on how to quit were given Method of assessment: Self report and biochemical verification of smoking cessation rates at 12 months Baseline data: ? Fewer employed in C1 than in G1 ? More with post primary education in C2 than in G1 C-123 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Ratner et al., 2004 Test an intervention to help smokers abstain Elective-surgical patients in Geographic area: (fast) from smoking before surgery, maintain ? Cardiovascular abstinence postoperatively, and achieve Western Canada ? Opthalmology long-term cessation ? Orthopedics Funding agency: Population: ? Plastics National Cancer Institute of Patients admitted for presurgical ? Urology Canada assessment from Nov. 1999 to Oct 2001 Sample size: Study setting: Study type: 237 Teaching hospital Randomized pretest-posttest control group Definition of smoking: experiment ? Smoked in 7 days before surgery Inclusion criteria: ? Self-identified smokers within previous 7 days ? Remain in hospital for at least 24 hours following surgery ? Speak and write English ? Able to be contacted by phone ? Willing and able to participate Exclusion criteria: NR C-124 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Treatment group participants Quality rating: ? Counseling ? Univariate descriptive (73.0%) were more likely to Fair ? Nicotine replacement statistics fast than were controls therapy Hypothesis testing using (53.0%): Adequate randomization: ? Intervention: contingency tables and 2(1, N = 228) = 8.89, Yes chi-square P = .003, and more likely to be Attrition rate: ? 2 face to face counseling ? Treatment effect- multi- abstinent 6 months after 28.7% sessions step logistic regression surgery (31.2% vs. 20.2%). ? 9 telephone counseling sessions Data verification: There was no significant difference in the abstinence Method of assessment: ? Cotinine assay ? CO measure rates at 12 months after ? CO measure surgery, 2(1, N = 169) ? Cotinine assay Dependent variables: < 0.001, P = 1.00. ? Self-report ? # days until follow-up Baseline data: ? Age Similar in both groups ? Education ? Self-efficacy ? POMS ? Fagerstrom test ? Other household smokers ? Smoking stage of change C-125 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Reid et al., 2003 To determine whether stepped-care ? 8330 patients admitted for coronary Geographic area: treatment helped smokers hospitalized with angiography, PTCA, MI, or CABG CAD to quit smoking over 3-month and 1- Ottawa, Canada were screened year follow-up periods. ? 1379 (16.6%) were identified as Funding agency: Population: cigarette smokers NR ? Patients hospitalized with CAD ? 419 individuals who met all eligibility Study setting: ? Age of 18 years or more criteria Tertiary care cardiac facility ? Motivated to quit smoking ? 254 (60.6%) agreed to participate Study type: Sample size: RCT G1: 126 C1: 128 Inclusion criteria: Definition of smoking: ? At least 18 years or age ? 5 or more cigarettes a day ? Hospitalized with coronary artery disease ? Did not include users of pipes, cigars Exclusion criteria: or smokeless tobacco exclusively ? Unresolved unstable angina ? Life-threatening arrhythmias ? Vasospastic diseases (buerger?s disease, prinzmental?s variant angina) ? Pregnant or lactating women ? Those who lived more than 1 hour of travel time away C-126 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: At 3 months stepped-care Quality rating: ? Self-help ? Baseline subject treatment increased smoking Good ? Stepped-care treatment characteristics - t tests cessation rates from 42% to for continuous variables 53% during a 3-month follow- Comments: Intervention: and chi-square tests for up period (P = 0.05) ? Well-thought out design G1: called by a nurse- categorical variables. ? Well reported counselor 4 weeks after ? Primary analysis- a 1-year follow-up minimal discharge and questioned. If Fisher?s exact test was intervention group of 36% Adequate randomization: not smoking, provided positive used to compare 3- versus 39% for the stepped- Yes reinforcement and reminded month and 1-year rates care group (P = 0.36) Attrition rate: about relapse prevention A secondary analysis C1: 19.5% information in the booklet. If univariate and G1: 9.5% smoking, nurse counseling was multivariate logistic begun, 3 - 20 minute face to regression procedures face sessions over 8 weeks and nicotine patch therapy was Data verification: made available Self-reported with a C1: no additional counseling random sample of 25 after hospital discharge; free to tested for CO levels seek assistance from community or primary care Dependent variables: physician ? Demographic factors ? reason for admission Method of assessment: ? smoking history Surveyed by mail 3 months ? nicotine dependence and 1 year after hospital ? self-efficacy discharge. If the questionnaire ? motivational readiness was not returned promptly, the variables participants were called, and the questionnaire was completed by telephone Baseline data: ? Groups balanced for age, gender, education level, reason for admission, cigarettes per day, Fagerstrom score, years of smoking, quit attempts, motivational readiness to quit smoking, self-efficacy, and preference for cessation assistance C-127 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Rowe et al., 1999 To evaluate effectiveness of offering an ? Nurses and student nurses from a Geographic area: individualized approach to smoking college of nursing and a large cessation to qualified nurses and student United Kingdom hospital trust who self-identified as nurses in Northern Ireland smokers and wanting to quit were Funding agency: Population: invited to participate in study NR ? Adults ? Participants could choose to be in intervention group or control Study setting: Worksite Study type: Cohort study Sample size: G1: 22 (nurses) Inclusion criteria: G2: 32 (Student nurses) ? Qualified nurse ("nurse") or student nurse C1: 23 (nurses); 33 (student nurses) ? Smoked at least one cigarette daily Definition of smoking: ? Expressed desire to quit smoking Cigarettes ? Agreed to participate in study as an ? Unclear, but to enroll, had to report intervention or control participant smoking at least one cigarette daily Exclusion criteria: (also see Dependent Variables Did not meet all inclusion criteria section) C-128 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Verified quit rate: Quality rating: ? Self-help Frequencies G1: 22.7% vs 8.6% (C1) Poor ? Individual counseling by Fisher's Exact Test P < 0.05 Health professional Qualitative data G2: 25% vs 6% in C2 Comments: Participants self- ? Social support Data verification: P < 0.05 selected to Intervention: Self report of smoking intervention and G1: (Qualified nurses): status comparison group received individual For those reporting no status; at 1 yr counseling to: (1) assess smoking, verified through followup, participants health beliefs and motivation CO in expressed alveolar self-selected whether to quit smoking; (2) plan and air (2-10 ppm = non- to answer a implement strategy for smoker; 11-60 ppm = questionnaire for quitting (set quit date, smoker) and through smokers or for non- discuss coping strategies, salivary cotinine smokers; motivation identify social support, keep concentrations (20 ng/ml = and determination to smoking success and failure non-smoker) quit smoking higher diary) and make subjects Dependent variables: among intervention aware follow up would occur groups vscomparison at 6 wks, 6 months, 1 yr ? Verified quit rate groups, factors not postintervention. ? Perceptions of smoking controlled for in G2: (Student nurses): Same and health analyses; not given intervention as G1 ? Perceptions of their all data regarding C1: (Qualified nurses) and health promotion role intervention C2 (Student nurses) Baseline data: vscomparison groups received no smoking Nurses: G1 and C1 similar (sometimes %s cessation counseling or (age 23-56 yrs; 45% of G1 given, but not per assistance, but were and 49% of C1 had group status) followed up at 6 months and spouses, partners, or Adequate 1 yr postenrollment parents who smoked; randomization: Method of assessment: 95.5% female) Not a RCT, but Self-report on G1 and C1 similar in problematic group questionnaires and smoking history (89% membership biochemical verification of began smoking before because participants non-smoking status nursing, 64% smoked 20 self-selected into cigarettes daily; 82% had intervention or Followup conducted at 6 been smoking more than comparison group wks postintervention for 10 yrs) per their desire to intervention groups, at 6 68% G1 vs100% C1 tried receive smoking months and 1 yr for both to quit smoking previously cessation assistance intervention and Cs (no test) (intervention groups) or to try to stop Definition of smoking: smoking on their own Cigarettes (comparison group) ? Unclear, but to enroll, had to report smoking at least Attrition rate: one cigarette daily (also At 1 yr, 5% overall see Dependent Variables (no further attrition section) detail provided and unable to determine from tables presented) C-129 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Rowe et al., 1999 (continued) C-130 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Student nurses: 62% b/w 17-21, range 17-36; 60% had family members who smoked; 91% female; 91% single (no further detail by group) 97% of G2 and 94% C2 began smoking before entering nursing; range of smoking = 1-10 yrs, 68% smoked b/w 1- 6 yrs 88% G2 and 73% C2 smoked 10-20 cigarettes daily About 75% of each group had tried to stop smoking at least once before 100% of G2 and C2 accepted smoking did or might influence their or their family's/friends' health 78% of G2 and 45% C2 experiencing some ill health effect of smoking # Perception of role as health promoter: G1: 100% C1: 96% G2: 94% C2: 82% (no test) All Groups: Motivation to quit smoking ("want to very much" or "would like to"): G1: 100% vs C1: 65%, P < 0.01 G2: 61% vs C2: 61% (P < 0.01) C-131 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Saules, et al., 2004 To test effect of fluoxetine on smoking ? Participants recruited by flyers and Geographic area: cessation in the context of a program that notics distributed throughout the includes group cognitive-behavioral therapy US university and through paid (6 weeks) and transdermal nicotine patch advertisements in local newspapers Funding agency: (10 weeks) and radio stations. National Institute on Drug Population: ? Telephone screening of all Abuse and State of Adults respondents. Michigan ? Candidated attended a screening visit Study setting: Study type: at which expired CO reading were Randomized, double-blind, placebo- Population-based required to be greater ahn or equal to controlled trial 15 ppm. Inclusion criteria: Sample size: ? Adults 21-65 G1: 51 ? Smoking > 15 cigarettes/day G2: 51 ? Producing CO. 15ppm C1: Placebo Exclusion criteria: Note: planned sample size was 168 with ? Candidates in acute psychiatric crisis 56 participants per arm ? Met criteria for apsychieatric disorder Definition of smoking: within the past six months Self-reported smoking of any cigarettes ? Were currently taking psychiatric at all (or even part of one cigarette), CO medications greater than or equal to 10 ppm ? Clinically significant medical conditions ? Pregnant ? Inability to comprehend and respond to measures C-132 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: No significant differences Quality rating: ? Pharmaceuticals: Chi-square analysis observed in smoking status at Fair fluoxetine and transdermal NRT Data verification: end of trial (assuming that end of trial was at 12-months post Comments: Cognitive-behavioral Expired CO of less than 10 quit date although time frame Random assignment method ? counseling (CBT) ppm obtained for self- is not stated in the article text NR reported quitters or table for these Intervention: Adequate randomization: G1: Fluoxetine (20mg) 4 Dependent variables: assessments): NR weeks before quit date, Documented nonsmoking: C1: 35.4% Attrition rate: changed to 40 mg fluoxetine self-reported abstinence G1: 43.1% combined with CO less than 40% after one week, CBT starting G2: 43.1% 2 weeks before quit date and 10 ppm Drop-out was related to 15 mg NRT patch on Change in weight was smoking status, as 90% of morning after quit date visit significant for treatment group the people who did not G2: Fluoxetine (20mg) 4 (P = 0.010), smoking cessation complete the study had weeks before quit date and (P = 0.037) and their documented smoking at their for 15 weeks total, CBT interaction (P = 0.012). last assessment whereas starting 2 weeks before quit Withdrawal symptom scores only 32% of those who date and 15 mg NRT patch were significantly lower in both completed the study had on morning after quit date fluoxetine groups as compared documented smoking at the visit to the placebo group last assessment 2 C1: Placebo and CBT (P = 0.038) (X (1)=9.94, P = 0.002) starting 2 weeks before quit date and 15 mg NRT patch on morning after quit date visit Method of assessment: NR Baseline data: No significant differences across groups except for significant differences in baseline depression with elevated levels among those randomized to placebo. C-133 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Simon et al., 2004 Whether the addition of bupropion to Participants were recruited from the Geographic area: transdermal NRT and cognitive-behavioral three following sources: counseling would increase quit rates United States ? Lists of known smokers from previous compared with standard therapy using NRT smoking cessation clinical trials at the Funding agency: and cognitive-behavioral counseling only San Francisco VA Medical Center California Tobacco-Related Population: ? Hospital-based advertising at major Disease Research Program Adults teaching hospitals Study setting: ? Local Bay Area advertising and PSAs Study type: Hospital RCT Eligible smokers were assessed for their readiness to quit smoking Inclusion criteria: ? Smoked 20 or more cigarettes during the Subjects in the contemplation or week prior to enrollment preparation stages of quitting were ? Have a telephone and no plans to leave randomized to either treatment or the catchment area during the study control arm period Sample size: ? In the contemplation or preparation stages 244 adults of quitting according to the Prochaska and DiClemente Stages of Change model Definition of smoking: ? ? 20 years of age Non-smoker ? Self-report of no smoking for the past Exclusion criteria: seven days during each follow-up ? Contraindications to bupropion or NRT counseling call ? Serious psychiatric illness including major ? Follow-up self report of no-smoking in depression the past six months and twelve ? History of alcohol abuse within the past months three months or consuming more than 3 ? Among those who reported no alcoholic beverages per day smoking at 12 months, follow-up saliva cotinine level had to be less than 15 ng/ml Continous non-smoker ? Self-reported quitting at each follow- up assessment, and biochemical or proxy verification of no smoking at 12 months Smoker ? Self-reported no smoking but using NRT and salivary cotinine levels >= 15 ng/ml ? Stopped smoking cigarettes but using other tobacco products C-134 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: No statistically significant Quality rating: ? Bupropion ? 2-sample t tests and differences in smoking Fair ? Transdermal nicotine Wilcoxon rank sum tests cessation rates at end of replacement therapy for continuous variables medication 3, 6, and 12 Comments: No power analysis ? Cognitive-behavioral ? Chi square tests for months counseling categorical variables The addition of 7-week Adequate randomization: Intervention: ? Calculated relative risk treatment with Bupropion did Yes G1: 7 week course of and 95% CIs not significantly increase quit ? For multi-variate Attrition rate: Bupropion, 2 months rates over NRT and counseling ? 1% lost to followup transdermal nicotine analysis, used backward replacement therapy, 1 visit stepwise procedure to ? 2% died with counselor (30-60 minute examine relationship session), and 5 telephone between demographic follow-up calls and historical variables C1: Same as G1 except and smoking cessation participants received placebo ? Variables were retained instead of Bupropion in the model if they remained associated Method of assessment: with quitting at Follow-up at 7 weeks (end-of P ? 0.20 treatment), 3 months, 6 ? All regression models months, and 12 months by were adjusted for telephone treatment assignment Baseline data: ? Hosmer-Lemeshow No statistically significant goodness-of-fit test was differences in any of the used to assess baseline demographic of adequacy of the models medical characteristics ? 2-tailed P values < 0.05 between the samples in the 2 were considered study arms significant Males: 86% Data verification: Self-report plus cotinine saliva for those who self- reported quitting at the 12 month followup Dependent variables: Quit rates C-135 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Swana, et al., 2003 and Swan:a To identify individual characteristics ? Participants who called the study Swanb et al., 2003 predictive of more clinically relevant smoking center were screened over the Geographic area: end-points beyond end of treatment in telephone. smokers prescribed bupropion SR and US, Seattle ? Eligible volunteers were sent a counseling. pretreatment questionnaire and Funding agency: Swan:b To determine the differential consent form. National Cancer Institute effectiveness of 2 doses of bupropion in ? Participants were randomly assigned Bupropion SR provided by combination with behavioral interventions of to 4 treatment arms by a computer- Group Health Cooperative minimal to moderate intensity. generated number. Pharmacy ? The computer code calculated Population: probabilities of group assignment that Study setting: ? 18 years of age or older were dynamically modified based on Non-profit consumer- the number of members in each group governed health care Study type: so that final group sizes were equal. system serving 600,000 ? Data from a large, randomized residents of western effectiveness trial ? No restrictions such as stratification or blocking were used in the process. Washington (GHC) ? Two dosage levels of bupropion SR (Zyban, 150 and 300 mg) were crossed Sample size: with two behavioral treatment programs of G1: 382 lower or higher intensity to create a four- G2: 381 cell design. G3: 383 G4: 378 Inclusion criteria: ? Individuals at least 18 years of age Definition of smoking: ? Smoking an average of 10 or more ? Any smoking within the past 7 days (7 cigarettes per day in the 12 months prior day point prevalence) to enrollment ? Motivated to stop smoking ? Otherwise in good general health and had proper GHC coverage Exclusion criteria: ? Predisposition to seizure ? Current use of medications contraindicated for use with bupropoion SR or know to lower seizure threshold ? History of or current diagnosis of anorexia nervosa or bulimia or presence of any severe chronic medical condition ? Use of any investigational drug within 1 month of treatment with buropion SR ? Participation in GHC?s Free and Clear smoking cessation program in the previous 12 months ? Current depression ? Recent high frequency or binge drinking ? Abuse of other substances including recreational/street drugs ? Current pregnancy or plans to become pregnant ? Current nursing of a child C-136 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Swan 2003a Quality rating: ? Pharmacologic treatment ? Intent-to-treat analysis At 12-month follow-up, type of Fair ? Tailored mail program (ZAP) ? Logistic regression for behavioral treatment had a ? Proactive telephone assessing pretreatment strong association with point- Comments: counseling program (Free characteristics for their prevalent smoking (e.g., ? Lack of blinding and Clear Program) relationship to point- participation in the less- ? No biochemical prevalent smoking at 12 intensive TM program being confirmation of self- Intervention: months associated with a greater reported smoking status G1: 150 mg bupropion SR and likelihood of smoking) whereas ? No objective proactive telephone counseling Data verification: dose and the dose x treatment measurement of (Free and Clear Program) Self-report interaction had little or no adherence to the G2: 150 mg bupropion SR and Dependent variables: association with outcome therapeutic regime tailored mail ( Zyban OR=1.21 (95% CI, 1.08 - Advantage Plan - ZAP) ? Smoking: any smoking Adequate randomization: 1.35). G3: 300 mg bupropion SR and within the 7 days prior to NR proactive telephone counseling follow-up Swan 2003b Attrition rate: (Free and Clear Program) ? At 3 months: ? 3-month follow-up: 20.8% G4: 300 mg bupropion SR and 300mg G3: 35% vs 150 mg G1: ? 12-month follow-up: (ZAP) 24.4% (P=0.001); 14.9% 300mg G3: 35% vs 150mg Method of assessment: G2: 24.2% (P =0.001); 3- and 12-month follow-up 300mg Baseline data: G3: 35% vs 300mg ? Reported by gender not G4= 26.7% (P =0.01) treatment condition. At 12 months: ? Men had significantly more 300mg G3: 33.2% vs years of formal schooling, 150mg G2: 23.6% (P smoked more cigarettes per =0.004) day, had higher number of 300mg G3: 33.2% vs previous attempts to quit. 300mg G4: 25.7% (P =0.02) ? Women significantly more 150 mg G1: 31.4% vs likely to report perceived 150mg G2: 23.6% vs stress, social support (P =0.02) depression, ever having depression in lifetime or percentage of family ever depressed. C-137 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Wakefield et al., 2004 To determine whether a motivational ? Patients were screened by doctors Geographic area: interviewing intervention increased after scheduled appointments in the successful smoking cessation attempts of South Australia radiation therapy, medical oncology, patients with cancer attending a South Funding agency: and hematology departments at Royal Australian public hospital, as compared with National Health and Medical Adelaide Hospital over 20 month usual care Research Council period Study setting: Population: ? After several months, accrual of Hospital-based ? Cancer patients at South Australian public participants too slow, so patients hospital living remotely were approached to increase numbers Study type: ? Once patients consented to RCT participate, they completed a baseline questionnaire Inclusion criteria: ? 6-month follow up interviews were ? Participant must have a cancer diagnosis done and those who said had stopped ? Smoke tobacco more than weekly smoking were asked to provide either ? Speak English a urine sample for cotinine analysis or ? Be cognitively able to consent a CO reading using a breath monitor ? Have a prognosis exceeding 6 months ? Live close enough to maximize Sample size: biochemical confirmation at follow-up G1: 74 assessment* (changed to include patients C1: 63 living remotely to increase participation Definition of smoking: numbers) Tobacco Exclusion criteria: ? Current Smoker ? Smoke tobacco at See above least weekly C-138 Evidence Table 5. Strategies to improve success rates for quit attempts for general and special populations (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Outcome Measures: Quality rating: ? Visit with smoking cessation ? Data were analyzed ? At 6-month follow up, no Poor counselor using SPSS difference in biochemically Comments: ? Booklets ? Fisher?s exact tests and confirmed 3-month Study lacked power, had a ? NRT chi-square tests were prevalence quit rates ? Family advice to quit used to establish between the intervention high attrition rate and there whether groups differed (5%) and control (6%) were significant differences ? In-person or telephone follow-up conversation significantly across groups in groups at baseline categorical variables, ? Sensitivity analysis using Adequate randomization: Intervention: and t-tests were used more lenient criteria No G1: Specific advice and for continuous variables indicated quit rates of 29% booklets about benefits of ? An intention to treat for intervention group and Attrition rate: quitting for patients with analysis was used, as 18% for control group 36% cancer, telephone and in- well as an analysis (P = 0.32) person counseling using the excluding those lost to ? Predictors of smoking framework of motivational follow-up evaluation cessation at 6 months for all counseling, supplemented with ? Phi coefficients were patients included a smoking- NRT if patient smoked ?15 calculated to determine related cancer site, more cigarettes per day the degree of cessation attempts in the C1: brief advice to quit, widely- association between the year before the enrollment available quit-smoking intervention and control study, and no radiation brochures, and info about well- groups across variables therapy promoted state-based ? Binary logistic telephone quit-line service regression was used to Method of assessment: examine predictors of In-person follow up visit or smoking cessation telephone assessment at 6 months post-baseline Data verification: Baseline data: Self-report, urine cotinine and CO levels Patients in intervention group were more likely than control Dependent variables: patients to have ever tried to ? Quit rates ? 3 month quit (P = 0.04) and to have period prevalence, 7- made more quit attempts in the day period prevalence past year (P = 0.02) Control patients were more likely to live remotely (P = 0.04) C-139 Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Borland et al., 2003 To assess effectiveness computer- Recruited eligible callers of Victorian Geographic area: generated tailored advice for callers to Quitline telephone counseling and telephone helpline; to assess if it enhanced advice service Australia series of callback telephone counseling Funding agency: sessions in aiding smoking cessation. Sample size: G1: 523 NHMRC grant, Population: G2: 528 supplemented by The C1: 527 Cancer Council Victoria; ? Adolescents callbacks funded by Quit ? Young adults Definition of smoking: Victoria ? Adults NR Study setting: Study type: Population-based RCT w/ simple randomization Randomization done by shuffling questionnaires Inclusion criteria: ? English-speaking ? No obvious psychiatric or neurological problems ? Called quitline b/w October 1996 and August 1997 Exclusion criteria: ? Small # of callers who sought callback service proactively after self-help materials offered C-140 Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Quit attempts w/ 95% CI Quality rating: ? Self-help Data analyzed using SPSS G1: 56% (51.3-60.7) Good ? Telephone counseling ITT analysis G2: 62.8% (58.2-67.4) Comments: ? Computer-based Data verification: C1: 57.4% (52.5-61.5) Groups similar at program NR baseline in spite of Intervention: Dependent variables: Smoking point prevalence at suboptimal G1: Offered a 'Quit Pack' 12-mo followup: randomziation and a series of 3 ? Self-reported smoking G1: 22.6% (18.5-26.7) scheme computer-generated status at 3-, 6-,and 12- G2: 25.6% (21.3-29.9) Adequate tailored letters month followups, both C1: 22.1% (18.1-26.1) G2: randomization: Offered a 'Quit point prevalence and 9 Chi sq 1.5, P 0.46 months' sustained Yes Pack'and a series of 3 computer-generated absitinece Attrition rate: tailored letters and ? Duration of cessation Overall: 23.4% callback counseling ? Use of nicotine G1: 23.1% service replacement G2: 25.9% G3: NR ? Extent of participation in C1: 21.1% C1: Offered a 'Quit Pack', callback printed self-help materials Baseline data: consisting of: a 30 pg Smoked average of 22.8 booklet based on stage of cigarettes/day: disease, leaflets promoting Prepartion stage: 45% smoking cessation courses Contemplation stage: 54% and card w/ strategies to Groups similar at baseline reduce cravings by gender, age, education, Method of assessment: level of addiction, stage of Baseline interview; mailed readiness, quit attempts in survey at 3, 6, and 12 past yr months post baseline C-141 Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Maguire et al., 2001 To evaluate whether a structured ? 100 pharmacists working in Geographic area: community pharmacy-based smoking community pharmacies in N. Ireland cessation program would result in a higher United Kingdom and 24 in London participated in smoking cessation rate compared to ad hoc study Funding agency: advice from pharmacists ? Each asked to enroll 12 smokers Medical Research Council Population: Pharmacists promoted study to: and the Northern Ireland DHSS ? Adults ? People who used pharmacy for non- medical reasons, using window Study setting: Study type: displays, posters in-pharmacy and Community-based ? RCT w/ systematic randomization leaflets at cash registers ? Comparing a structured intervention w/ ? People reporting and asking for usual care advice on minor ailments, e.g. chest cold, asking them about smoking and Inclusion criteria: telling them about program ? More than 18 yrs of age ? People being dispensed medicines, ? Not pregnant asking them about smoking and ? Expressing a wish to stop smoking telling them about program Exclusion criteria: Sample size: ? NR G1: 265 smokers C1: 219 smokers Definition of smoking: NR C-142 Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Self-reported non-smoking status Quality rating: ? Self-help NR at 3-month followup: Fair ? Individual counseling by health professional Data verification: G1: 27.5% C1: 11% Comments: Urinary cotinine NR ? Media campaign assessed to validate self- Self-reported non-smoking status ? Pharmaceuticals reported non-smoking at at 6-month followup: Adequate Intervention: 12 months G1: 18.5% randomization: Yes G1: Initial interview lasting Dependent variables: C1: 8.2% b/w 10 and 30 minutes; Smoking status Self-reported non-smoking status Attrition rate: smoking cessation validated by urinary cotinine (50 G1: 10.2% contract; indication for Baseline data: ng/ml) at 12-month followup: C1: 14.2% NRT assessed and offered Numbers given but no G1: 14.3% if appropriate; leaflet; tests for significance C1: 2.7% weekly followup for 4 wks, ?2 = 16.2 then monthly followup for 3 P = <.001 months C1: Normal pharmaceutical service (including provision of NRT as appropriate) provided by pharmacist Method of assessment: ? Telephone interviews at 3, 6, and 12 mos ? Urinary cotinine assessed to validate self-reported non- smoking at 12 mos ? Qualitative assessments also conducted using semi-structured telephone interviews and focus groups C-143 Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Ronda et al., 2004 To assess whether Hartslag community A cohort research population of 1,200 Geographic area: smoking cessation intervention resulted in smokers (age 18 and over) recruited in increased smoking cessation in Maastricht each region by taking a stratified Western Europe region as compared to control region random sample of 6,500 inhabitants in Funding agency: Population: each region from computerized Netherlands Heart telephone registers, based on number Foundation ? Adults of inhabitants i n each municipality Study type: included in region Study setting: Community-based ? Cohort Study Sample size: ? A pretest?posttest C design w/ two G1: 4,242 (35.4% of whom were posttests smokers) Inclusion criteria: C1: 4,697 (34% of whom were ? Over 18 yrs old smokers) ? Living in intervention or control regions Definition of smoking: Exclusion criteria: Cigarettes ? NR ? Smoker: smoked at all in last 7 days C-144 Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco use cessation strategies (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Outcome measures: Quality rating: ? Self-help ? Multiple logistic No significant differences found Fair ? Telephone counseling regression analysis b/w G1 and control regions conducted to identify regarding smoking status and Comments: ? Media campaign potential dropout bias determinants of smoking NR Intervention: (w/ attendance v. behavior G1: Adequate Regional mass media- dropout as the randomization: led smoking cessation dependent variable NR campaign Proficiat and baseline values (Congratulations) for gender, age, Attrition rate: implemented in January education, and 37.9%, net attrition and February 2000 and condition as after excluding 2001, consisting of radio independent variables) unreachable commercials, ? Multiple logistic respondents from advertisements and regression analysis T0 to T2 18.7% messages in papers, used to identify billboards along roads, and potential baseline posters and postcards in differences b/w G1 waiting rooms and public region and control buildings; local activities region organised by working ? Independent variables groups consisting of in this analysis were representatives of local baseline values for organizations, such as a gender, age and non-smoking campaign for education parents of children in playgroups ? Only respondents who C1: National mass media- completed all surveys led smoking cessation included campaign Dat kan ik ook (I ? Analyses performed can do that too) using SPSS 10.0 implemented around the Data verification: turn of the century, NR consisting of various television programmes, an Dependent variables: info line, non-smoking Primary: smoking status courses, mailings to Secondary: intention to variousorganizations, quit, cessation self- billboards in bus shelters, efficacy, perceived social brochures, posters support for cessation Method of assessment: Baseline data: Short structured telephone Respondents from G1 interviews region significantly older, more often female, and more highly educated than respondents from control region C-145 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Cornuz et al., 2002 To assess efficacy of an educational ? 35 residents at 2 general medicine Geographic area: program based on behavioral theory, active clinics randomly assigned by learning methods and practice w/ Western Europe computer and stratified by clinic to standardized patients for internal medicine either intervention group trained in Funding agency: residents in helping patients abstain from smoking cessation or C trained in Swiss Federal Office for smoking and changing counseling practices dyslipidemia Public Health, Swiss Population: ? Patients screened for eligibility by Medical Association, Swiss ? Young adults research assistants Foundation for Health ? Adults ? Eligibile patients asked for written Promotion informed consent to participate in a Study setting: Study type: study about preventive care Practice/provider settings RCT w/ cluster randomization Sample size: Inclusion criteria: G1: 17 residents, 115 patients ? 16 to 75 yrs old C1: 18 residents, 136 patients ? Understood French Definition of smoking: ? Consulted an outpatient clinic for a Cigarettes followup or an emergency visit ? 1-wk point prevalence of abstinence: ? Had smoked 1 or more cigarettes daily no smoking in last wk during previous wk Exclusion criteria: ? NR C-146 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: At one-yr followup, 1-wk point Quality rating: ? Self-help To compare baseline data, prevalence of abstinence: Fair ? Individual counseling by ?2 and Fisher exact tests G1: 13% (95% CI, 7% to 21%) health professional used for categorical data C1: 5% (95% CI, 1% to 9%) Comments: and t-test and Wilcoxon P = 0.005 No comments Intervention: rank-sum test used for OR = 2.8 (95% CI, 1.4 to 5.5) G1: Intervention training Adequate continuous data; to program for residents based randomization: measure outcomes, Residents who recieved study on active learning of logistic regression training provided better counseling Yes counseling skills and performed w/ a (mean score 4 vs2.7, P = 0.002) Attrition rate: interventions that matched generalized estimating patients' readiness to quit; Smokers willingness to quit higher Loss to followup at 1 equation to stratify by clinic yr: after training, residents in IG (94% vs80%, P = 0.007) and adjust for clustering by G1: 33% supposed to reach the resident; all statistical No significant trend toward lower C1: 26.5% following objectives: analysis performed using daily cigarette consumption in G1. Systematically identify all STATA smoking patients, clearly advise smokers to quit, Data verification: assess each smoker's Self-reported abstinence readiness to quit, use validated at one clinic by applied counseling measurement of exhaled strategies and offer a CO by a research brochure that matched assistant blinded to group patient's stage of readiness, allocation propose an individual smoking cessation program, Dependent variables: follow smokers in short and Primary: Smoking status long term, and facilitate Secondary: Counseling implementation of smoking score, willingness to quit, cessation in routine practice; daily cigarette received control training 4 consumption months later, after 3 month Baseline data: patient recruitment period ? Both groups of residents had ended similar at baseline C1: Traditional diadactic ? Both groups of patients training program on similar at baseline management of dyslipidemia; received intervention training 4 months later, after 3 month patient recruitment period had ended Method of assessment: Baseline information collected by research assistant immediately after a patient's medical visit; 1-yr followup survey administered by mail; self- reported abstinence validated at one clinic by measurement of exhaled CO by a research assistant blinded to group allocation C-147 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Goldstein et al., 2003 To determine effect of a community-based ? A list of all licensed physicians Geographic area: academic detailing intervention on quit rates obtained from Rhode Island of a population-based sample of smokers US Department of Health, Folio?s Medical Population: Directory of Rhode Island, 1990, and Funding agency: local health care institutions NCI ? Adults ? Physicians received mailed invitations followed by postcards, and then Study setting: Study type: Community-based ? Cross-sectional phone calls from physician recruiters Practice/provider settings ? Community-based, quasi-experimental ? Principal Investigator contacted study nonresponders to complete recruitment process Inclusion criteria: ? All physicians providing direct care to ? Physicians eligible if they practiced a adults in Newport, Washington, and primary care specialty (i.e., family Kent counties targeted for medicine, internal medicine, obstetrics participation in intervention and /gynecology), provided primary care for at delayed intervention (control) arms of least 25% of their patients, completed PCS trial postgraduate training, and planned to practice in the state for the 3 study yrs Sample size: ? Patients recruited through random digit G1: 376 patients dialing G2: 385 patients ? Patients must be 18 to 75 yrs old G3: 332 patients ? Live in a household w/ a phone C1: 1253 patients ? Current smokers Definition of smoking: Exclusion criteria: Cigarettes ? Full-time hospital-based physicians ? Smoker: currently smokes cigarettes excluded ? Only one smoking patient per household included C-148 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Percentage of patients who quit Quality rating: ? Self-help ? Descriptive statistics smoking at 6-month followup: Fair ? Individual counseling by (mean, median, G1: 8.4 health professional proportions) used to G2: 7.6 Comments: ? Multi-component office- characterize study G3: 8.9 Adequate based intervention sample at baseline C1: 7.1 randomization: ? Academic detailing and to examine P = NR NR demographic Intervention: differences b/w study Percentage of patients who quit Attrition rate: G1: Physicians provided 4 groups which might smoking at 12-month followup: At 24 mos, of 2346 A's to patients confound study G1: 17.0 participants, 35% G2: Smokers provided w/ outcomes at 24 G2: 16.5 attrition in computer-generated, months G3: 16.9 controlled/delayed stage-tailored information ? Multivariate logistic C1: 16.1 G1, 35% attrition in about quitting smoking at regressions done to P = NR physician only IG, home examine differences in Percentage of patients who quit 35% attrition in G3: Physician delivered 4 smoking status at 24 smoking at 18-month followup: physician and A's to patients, and mos G1: 25.2 home G1 patients received computer-generated, Data verification: G2: 24.8 NR G3: 19.2 stage-tailored smoking C1: 20.0 cessation information at Dependent variables: P = NR home C1: No intervention Self-reported smoking status Percentage of patients who quit smoking at 24-month followup: Method of assessment: G1: 33.3 Telephone survey at 6, 12, Baseline data: G2: 26.3 18, and 24 mos ? Those residing in physician intervention G3: 25.7 areas (G1 & G3) less C1: 22.6 likely to be less than P = 0.006 HS educated and more likely to be college educated than C ? C more likely to be in preparation state of change for cessation than intervention groups ? Those visiting physicians more likely to be older female, higher education, report poorer health C-149 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Joseph, Arikian, et al., 2004 To test the effect of modest intensity, ? Telephone surveys were conducted Geographic area: practical systems change that might among 3 cohorts of patients increase delivery of smoking cessation US ? A cross-sectional survey was treatment within Veterans Affairs. conducted at baseline among a Funding agency: Population: sample randomly selected from Veterans Administration Health Services Research ? Adults (N = 5,678) patients who had seen their primary care provider within 6 months and Development Service ? 20 Veteran Affairs Medical Centers (preintervention) (CPG 97-039) (results from this analysis were not used because sample size too small) ? A second cross-sectional survey Study setting: sample was obtained 1 year after the Provider-based Study type: intervention using the same sampling ? Cross-sectional design (individual technique (post intervention) analysis) ? Preintervention smokers at baseline ? RCT w/ simple randomization were surveyed 1 year after (organizational analysis) intervention ? Medical records reviewed 6 months Inclusion criteria: before intervention and 6 months ? Existence of referral-based smoking following intervention for all subjects cessation program that treated a minimum who provided consent and smoked of 50 patients/year, information resource and a random sample of equal size of management capacity for data collection, subjects that did not smoke. institutional review board, and evidence of commitment to participation in the project Sample size: Total: 5,678 Adults Exclusion criteria: ? Facilities serving predominatly psychiatric Preintervention patients, or displayed communication G1: 2,112 problems. C1: 2,142 Post intervention G1: 641 C1:783 Definition of smoking: Cigarettes ? Current smokers C-150 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: G1: 11.4% quit smoking Quality rating: ? Multicomponent ? A McNemar odds on C1 13.2% quit smoking, NS Fair intervention change was calculated to assess difference in No effects of the intervention on Comments: Intervention: change between the change scores between groups for ? Organizational G1: Received intervention groups reporting that their provider asked level analysis was documentation of tobacco The significance of the about smoking, or being counseled ? not used (N = 20) use status in medical to quit at 1 year post intervention records; delivery of resulting odds was Adequate intervention to all smokers; computed by the Intervention had no effect on randomization: liberal use of smoking Pearson chi square smokers? report of being counseled Yes for VA hospitals cessation medication; ? For continuous variables to quit only not individual organizational support; site measured at facility level subjects visits; 2 day training a Wilcoxon rank sum Smokers only group, 30% of test was used. smokers in G1 were counseled Attrition rate: meeting; an interventionist at before the intervention and 44% ? Pre-intervention = coordinating site. Data verification: counseled after the intervention; 21% C1: NR Self-report (no biochemical C1 smokers counseled 39.1% ? Smokers followup Method of assessment: verification) and medical before intervention and 42.2% post = 13% Medical record review and record review intervention. Amomg smokers who ? Post- intervention telephone survey Dependent variables: had a change in counseling before = 16% and after the intervention, the Baseline data: ? Smoking status subjects in the intervention group No differences at baseline ? General health had 2 times the odds of being between intervention and ? Nicotine dependence counseled relative to controls control group sites. ? Services provided at last (OR=2.24, 95% CI, 1.17 to 4.28, visit to primary care P=.014). provider ? Mood Medical records: Post intervention ? Alcohol use had a significant effect on smoking ? Demographics status documentation where intervention records were more likely to document smokers (67% vs 60%, P=.0007) Smokers were more likely to be documented as smokers than non smokers were to be documented as nonsmokers C-151 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Katz et al., 2004 To compare MAs' and LPNs' performance NR Geographic area: of recommended smoking cessation activities w/ that of RNs Sample size: US G1: 724 patients Funding agency: Population: By intake clinician: National Cancer Institute ? Adults RN: 100 LPN: 154 and University of Wisconsin Study type: MA: 470 Comprehensive Cancer ? Secondary analysis of data from a RCT of C1: 497 patients Center. guideline implementation By intake clinician: Study setting: ? Intake clinicians (RNs, LPNs, MAs) paired RN: 153 Community-based w/ primary care physician (PCP) LPN: 256 Practice/provider settings ? Clinic randomized to receive help MA: 88 implementing AHRQ cessation guidelines vs control Definition of smoking: ? Patients interviewed after clinic visit Cigarettes ? At least one per day on average Inclusion criteria: ? NR Exclusion criteria: ? NR C-152 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Ask about smoking: Quality rating: ? Self-help Two-level hierarchical Control RN/LPN/MA: Fair ? Individual counseling by logistic regression 67%/35%/41% vstest site health professional Comments: Data verification: RN/LPN/MA: 92%/86%/78%. Secondary ? Individual counseling by Assess willingness to quit: NR analysis, so study non health professional control RN/LPN/MA = not designed to ? Telephone counseling Dependent variables: 15%/8%/7% vstest site RN/LPN/MA = 85%/75%/60%. answer this Proportion of patients Intervention: question receiving guideline- G1: In original RCT: study Advise to quit: control Missing important recommended personnel worked w/ RN/LPN/MA = 16%/7%/9% info that's reported counseling at time of intake clinicians to vstest site RN/LPN/MA = in original study scheduled clinic visit implement guideline 41%/46%/28%. Adequate intervention (tutorial w/ Baseline data: Assist in quitting: control randomization: feedback, real-time Patients seen by MA RN/LPN/MA = 17%/8%/9% NR reminder, self-help vsRN at control site = vstest site RN/LPN/MA = material, onsite 57% vs43% male 73%/69%/51%. Attrition rate: pharmacotherapy, and (P = 0.01), and 49% NR proactive telephone vs71% w/ regular (Also reported as difference in counseling) clinician (P = 0.02) proportion (& 95% CI) b/w RNs ? Survey administered to Patients seen by MA and other intake clinicians). intake clinicians vsRN at test site = 57% immediately preceeding vs75% w/ regular intervention clinician (P = 0.001) ? After clinic visit, study personnel interviewed consecutive adults who had routine, non- emergency appointment and who smoked ? 1 cigarette per day ? Patients asked whether they received cessation counseling from intake clinician C1: Intake clinicians completed survey just prior to tutorial session at end of intervention period, but had no help w/ guideline implementation Method of assessment: Exit interview of patients C-153 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Katz et al., 2004 To test the effectiveness of a multi-modality ? 12 eligible clinics were invited to Geographic area: intervention to implement the AHRQ participate; 9 clinics agreed to Smoking Cessation Clinical Practice US participate; 1 clinic participated only in Guideline in primary care settings the pilot phase Funding agency: Population: ? Matched clinic sites (8) by primary National Cancer Institute; Adults care discipline and health plan University of Wisconsin; affiliation (if any) GlaxoSmithKline donated Study type: ? For each pair of clinics, project transdermal nicotine RCT statistician used a random number patches for use in trial Inclusion criteria: generator to randomly assign each Study setting: Adults smoking at least one cigarette per clinic to receive either the intervention Provider-based day and having an appointment with a (test site, n=4) or usual care (control primary care clinician for routine, non- site, n=4) emergency care and willing to complete a Sample size: brief exit interview immediately after the G1: 4 clinics, 1141 patients clinic appointment C1: 4 clinics, 1022 patients Exclusion criteria: Definition of smoking: NR 7-day point prevalence C-154 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: During the intervention period, Quality rating: ? Multicomponent office Hierarchical logistic more patients at test sites were Good based intervention regression models used to asked about their smoking status estimate the odds rations (OR = 3.1; 95%,CI; 1.2 to 8.2; Comments: Intervention: for treatment assignment P = 0.02) or about their willingness Failed to reach G1: Tutorial for intake after adjustment for patient to quit smoking (OR = 6.4, 95%, original enrollment clinicians, group and characteristics CI; 3.7 to 10.8; P < 0.001), were target resulting in individual performance given literature about quitting (OR slightly lower power feedback for intake Data verification: = 21, 95%, CI; 8.8to 49; than originally clinicians, use of a modified Self-report and P < 0.001), were assisted with planned to detect vital signs stamp, an offer of confirmatory salivary setting quit date (OR = 33, 95%, differences in free nicotine replacement cotinine for self-reported CI;11 to 100; P < 0.001) or were cessation outcomes. therapy and proactive quitters engaged in a discussion about telephone counseling. Adequate pharmacotherapy (OR = 3.9, 95%, C1: Staff received only Dependent variables: randomization: ? Performance of CI; 2.5 to6.3; P < 0.001). general information on the Yes AHRQ Guideline recommended smoking Among participants treated during cessation activities by Attrition rate: the intervention period, those at Method of assessment: clinic staff G1: 11% test sites were more likely than Self-reported by telephone ? Abstinence at 2 and 6 C1: 10% those at control sites to report interview at 2- and 6-month months after the initial being abstinent at the 2- month follow-up clinic visit (7-day point (16.4% vs. 5.8%, adjusted OR = Baseline data: prevalence) 3.3, 95% CI, 1.9 ?5.6, P < 0.001) No statistically significant ? Continuous abstinence and 6-months (15.4% vs 9.8%; differences in smoking at 2 and 6 months (self- adjusted OR = 1.7, (95% CI = 1.2- cessation rates between reported abstinence at 2.6), P = 0.009) follow-up participants at test and both 2 and 6 month assessments and to report control sites during the assessments) continuous abstinence (10.9% vs baseline period, except in 3.8%, adjusted OR = 3.4 (95% CI, educational level 1.8-6.3), P < 0.001) During the intervention With biochemically confirmed period, patients at test sites abstinence at 6 months, showed were older, had more years no difference between G1 and C1 of education and smoked Very low response rate for planned more cigarettes per day than collection of confirmatory salivary patients at control sites cotinine tests of self-report No significant differences cessation between characteristics of intake clinicians at test sites and those at control sites with one exception, intake clinicians at control sites had more years of work experience than those at test sites C-155 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Pbert et al., 2004 To evaluate effect of a provider counseling ? Five community health centers Geographic area: and office systems intervention in obstetric, randomized to special intervention or pediatric, and Special Supplemental US usual care Nutrition Program for WIC clinics on ? Research assistants screened Funding agency: smoking and relapse rates in pregnant and women in WIC offices NHLBI postpartum wome Sample size: Study setting: Population: G1: 272 Practice/provider settings ? Adults C1: 278 ? Women (only) ? Pregnant women Definition of smoking: Cigarettes Study type: ? Abstinence: not smoking within last 7 RCT w/ cluster randomization days Inclusion criteria: ? Spontaneous quitter: quit smoking since learning of pregnancy and not ? Women receiving prenatal care and WIC smoking for at least 7 days prior to services and planning to receive pediatric baseline care at one of community health centers ? Speaking English or Spanish ? Having at least 2 months before their due date ? Being a current smoker or spontaneous quitter (quit smoking after learning of pregnancy) ? Planning to remain in area for at least 6 months following delivery Exclusion criteria: ? NR C-156 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: 30-day abstinence rates at end of Quality rating: Individual Counseling by ? A mixed-effects linear pregnancy among women who Fair non Health Professional modeling used to test did not spontaneously quit upon Comments: Intervention: hypotheses about txt learning of their pregnancy: G1: Clients visited conditions controlling G1: 26% NR C1: 12% community health centers for clustering of Adequate OR = 2.57 and WIC offices that respondents within randomization: P = 0.05 received: provider training each community Yes to deliver a SIbased on health center Linear logistic 30-day abstinence rates at 1-? Attrition rate: national clinical practice regression analyses month postpartum among 20% guidelines tailored to computed using women who did not woman?s stage of change spontaneously quit upon learning and delivered through GLIMMIX macro, of their pregnancy: three channels (obstetric, which uses iteratively G1: 26% pediatric, and WIC reweighted likelihoods providers); an office to fit a logistic C1: 11% regression OR = 3.01 practice management P = 0.04 system to routinely screen ? PROC MIXED All other effects not statistically for smoking status, procedure in SAS significant prompt/remind providers to used for analysis of intervene, document the number of cigarettes No effect remained at 3 and 6 mo encounter, distribute per day over time followup materials, and arrange ? Reported P values are for two-sided Intent to treat at 30 day followup: followup; and establishment of program alternative hypotheses Non-spontaneous quitters: 2.02 P = 0.09 boards to coordinate Data verification: Spontaneous quitters 0.95 transfer of documentation Salivary cotinine levels P = 0.95 among clinics, including ? 20 ng/ml assessed to periodic meetings w/ confirm 7 day abstinence representatives from all clinics Dependent variables: C1: Usual care Smoking status Method of assessment: Baseline data: Data collected from Groups similar at participants at five time baseline points during regular WIC appointments or by telephone: baseline interview upon enrollment, 9-month interview before delivery, 1-month postpartum interview within 30 days after delivery, 3-month postpartum interview, and 6-month postpartum interview C-157 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Pieterse, 2001 To test effectiveness of a minimal contact Smoking patients 18 to 70 recruited Geographic area: smoking cessation program implemented by from participating Dutch general Dutch general practitioners. practitioners' clinics Western Europe Funding agency: Population: Only info regarding randomization Dutch Cancer Society ? Young adults process: ? Adults ? Occurred within clinics and used a Study setting: Study type: prestructured allocation list Practice/provider settings ? RCT w/ simple randomization Sample size: ? Randomization occurring within practice G1: 269 sites according to a "prestructured C1: 261 allocation list" Definition of smoking: Inclusion criteria: Cigarettes ? 18 to 70 ? Non-smokers at followup defined as ? Self-reported smoker consistently providing non-smoker Exclusion criteria: responses to two questions 1) contact ? Controls exposed to txt name for someone to verify smoking ? Controls w/ severe tobacco-related health status and 2) self-reported smoking problems (thus given intervention) status C-158 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: 1-month followup smoking Quality rating: ? Self-help Logistic regression, abstinence rates greater among Fair ? Individual counseling by backward stepwise those in intervention compared to health professional procedures, univariate controls (OR = 2.56; CI, 1.8, 3.8) Comments: 2 Not clear about ? Individual counseling by ANOVA, ? tests Similarly, 12-month follow up randomization non health professional Data verification: smoking abstinence rates were procedures ? Telephone counseling Self-report. 13.4% (G1) vs 7.3% (C1), w/ an because only ? Pharmaceuticals No biochemical OR = 1.51 (CI, 1.1, 2.1), P < 0.05 vague information Intervention: verification provided G1: Brief (10-minute) Dependent variables: Consecutive abstinence greater counseling sessions w/ among intervention group (8.2%) Important potential ? Self-reported physician; self-help than among C (3.1%); OR = 3.04 influence identified abstinence from manual; followup sessions. (CI, 1.7, 5.6), P < 0.001 by authors -- smoking C1: Usual txt - no implementation of ? Point prevalence of counseling or advice on national mass-smoking smoking except when media stop- initiated by patient or when ? Consecutive smoking campaign, indicated by the contact abstinence from which started reason, in which case smoking (abstinent at shortly before counseling limited to a both 6- and 12-month second followup straightforward stop- followups) Adequate smoking advice and Baseline data: randomization: possibly a referral to local Significant difference in Yes municipal health G1 vsC1 in baseline organization measures of: Attrition rate: 1 month: Method of assessment: Percent smoking ? 10 Overall: 26% Self-report by cigarettes per day (G1: G1: 33% questionnaire 13.3, C1: 20.4; F = 4.3, P = 0.04) C1: 19% Motivation to quit score (G1: 6 month: 14.8, C1: 13.8, F = Overall: 26% (no 6.7, P = 0.01) info on each group). Otherwise, population considered 12 month: representative of Overall: 19% (no average Dutch visitor of info on each a general practice group). C-159 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Study Characteristics Study Design Sample Design and Definitions Author: Research objective: Sampling plan: Piper et al., 2003 To test effectiveness of expanded vital sign ? Convenience sample Geographic area: stamp to identify smokers and reduce ? Adults exiting health clinics (n = 5) smoking rates US were approached Funding agency: Population: ? Any adult smoker willing to participate Adult smokers attending health care clinics was enrolled National Cancer Institute Sample size: Study setting: Study type: Cluster RCT (clinics unit of randomization) G1: 5582 Provider-based C1: 3857 Inclusion criteria: ? Any adult smoker (older than 18 years) Definition of smoking: ? Attended only one health care clinic NR Exclusion criteria: None reported C-160 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Proportion of all participants asked Quality rating: Expanded vital sign stamps Chi square (response by any clinic staff person about Fair Intervention: rates not reported) smoking before and after Comments: G1: smoking status was Data verification: implementation of vital sign stamp revealed an overall increase of Response rates to added to the vital sign stamp NR follow up C1: usual vital sign stamp 9.6% in control group and 30.9% in Dependent variables: intervention clinics questionnaire at 1 without smoking status year not reported ? Smoking cessation Method of assessment: Mean increase in asking behavior ? Identification of smokers of physicians at vital sign clinics Adequate Follow up questionnaire ? Rates of smoking was statistically greater than that of randomization: after 1 year (method NR) counseling by physicians at control clinics NR Baseline data: physicians t = -3.61; P = 0.002) Attrition rate: Similar at baseline No statistically significant NR differences in abstinence rates (complete abstinence during past 7 days) between G1 and C1 after 1 year (P = 0.27). C-161 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Russos et al., 1999 To examine rate and determinants Orthodontists recruited from 154 Geographic area: (especially as related to social learning participating orthodontic offices within factors) of tobacco prevention and cessation various southern Calif counties US counseling by orthodontists participating in Funding agency: a controlled trial to decrease incidence of Sample size: Cigarette and Tobacco tobacco use among adolescents. G1: 63 C1: 63 Surtax Fund of the State of Population: Calif through the Tobacco- ? Adults Definition of smoking: Related Disease Research NR Program of the University of Study type: Calif ? Cross-sectional Study setting: ? Current study based on cross-sectional Practice/provider settings interview design survey of orthodontists randomized to intervention to enhance skills in delivering smoking prevention and cessation counseling to adolescent patients or to C (thus, interventions described relate to the RCT, not the cross-sectional survey) Inclusion criteria: ? Orthodontist from an office in one of the selected Calif counties ? Practiced at least 2 days a wk ? Had at least 75 adolescent patients ? Planned to remain in practice at least 2 yrs (for survey: participated in original study) Exclusion criteria: ? Not meeting inclusion criteria C-162 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Outcome measures: Quality rating: ? Self-help ? Nonparametric In a typical wk more clinicians in Fair ? Individual counseling by statistics (Kendall, experimental vsC provided non health professional Mann-Whitney) used prevention counseling to patients Comments: in bivariate analyses (Mean: 25.4% v 3%, Mann- Good, ? Telephone counseling documentation of ? Video ? Multivariate analysis Whitney U = 696.5, z = -7.0, P < ? Media campaign 0.01) and at least some reasons for attrition Data verification: cessation counseling (91% vs and distribution of Intervention: Telephone survey of 72%, chi sq = 8.4, P < 0.01) non-responders by G1: Anti-tobacco materials orthodontists G1 asked higher % (4.8) of their group; things to (e.g., posters), 1.5 hr Dependent variables: patients whether they use consider when training session on ? Provision of prevention tobacco than C1 (2.9), (U = trying to improve tobacco prevention, written 1349.0, z = -3.3, P < 0.01) providers' provision anti-tobacco prescriptions, and cessation G1 more likely to report mostly of tobacco use reimbursement for anti- counseling to patients positive reactions from tobacco prevention and tobacco prescription given ? Counseling content users for cessation counseling cessation advice to patients, quarterly visits ? Counseling (chi sq = 7.8, P < 0.05) Similar findings and calls; office staff asked determinants C1 more likely than G1 to say from comparison of to make office tobacco- Baseline data: they don't provide counseling results to other free (remove ashtrays, No significant differences because it's not their job or not studies distribute anti-tobacco (P > 0.05) found b/w G1 expected of them (chi sq = 3.7, P Adequate materials and prescriptions and C1 in terms of = 0.05) randomization: to all youth, to remind demographics, clinical G1 more likely to say lack of time Yes patients not to begin practices, office is significant barrier to giving tobacco use) characteristics, history of prevention counseling (chi sq = Attrition rate: C1: No training, materials, tobacco use, nor training 4.2, P < 0.05) Survey: or visits, nor asked to for tobacco counseling Demographic, office, and clinic G1 and C1: 18% change their offices or Mean age about 51, practice variables not associated each practices mean yrs in practice w/ prevention or cessation Method of assessment: about 24 yrs, about 230 counseling (P > 0.05) Mailed survey requesting adolescent patients, Higher rates of prevention and self-report from mean gross annual cessation counseling associated orthodontists income 445,000 (P < 0.05) w/: asking patients whether they used tobacco; belief that counseling is important; belief that clinicians should receive counseling training; intent to attend training; and to disagree that counseling is not part of their jobs C-163 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Slama et al., 1999 To examine participation and effectiveness ? 2,860 GPs from France interviewed Geographic area: of GPs in offering a minimal smoking about their attitudes and behaviors cessation intervention according to Western Europe ? From this group, 170 of 371 randomly attitudinal and behavior variables selected smoking GPs and 202 of Funding agency: Population: 375 randomly selected non-smoking French Ministry of Health; ? Adults GPs participated in survey European Union "Europe Against Cancer Study type: Sample size: Programme"; French Cross-sectional survey w/ GPs who Smokers: 170 smokers Committee for Health participated in a previous smoking cessation Non-smokers: 202 Education intervention C1: NA Study setting: Inclusion criteria: Definition of smoking: Practice/provider settings Cigarettes ? Participated in previous smoking cessation intervention study ? Abstinent: not smoking cigarettes Exclusion criteria: ? NR C-164 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Doctors who were smokers less Quality rating: Extra-curricular activities Chi sq tests likely than non-smoking GPs to Fair Intervention: Frequencies participate in the smoking G1: NA Proportions cessation trial, despite having Comments: originally consented to do so Interesting practical G2: NA Data verification: (45% vs 54.1%, chi sq: 5.147, applications to G3: NA Self report C1: NA P < 0.05) understanding Dependent variables: factors that might Method of assessment: None of the GPs' smoking influence ? Rate of participation in related attitudes and reported physicians' For GPs' attitudes and cessation trial by GP's behaviors significantly related to willingness to reported practices: self smoking status their participation in the study nor participate in report obtained by ? Effect of GPs' to their patients' rates of smoking interventions to telephone survey smoking-related cessation at 1 mo, 12 mos, or address smoking GPs' participation in attitudes and reported both cessation w/ intervention measured by practices patients; Limited patient information GP Conclusion: When minimal discussion of returned per protocol at 1 Baseline data: advice has an effect, it is due and 12 mo followups. 50% of eligible GPs intervention, more to systematic nature of the Patient smoking status: participated (45% though refers to provision of intervention than to self report at 1 and 12 mo smoked; 54.1% did not; previous article 2 the attitudes or reported followups ? = 5.147, P < 0.05) description practices of practioner giving Significant differences advice Adequate b/w participating and randomization: non-participating GPs in NR beliefs about usefulness of screening for cervical Attrition rate: (96.2% vs 91.6%, ?2 = Smoking GPs (%): 6.460, P < 0.011) and 1 wk: 11.8 breast cancer (98.1% v 2 wks: 8.2 94.8%, ?2 = 5.918, 3 wks: 12.9 P < 0.015) 4 wks: 32 Other differences NS Non-smoking GPs (%): 1 wk: 9.9 2 wks: 10.3 3 wks: 15.3 4 wks: 35.5 C-165 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Smith et al., 2002 To assess effectiveness of a nurse case- Patients admitted to Stanford (Calif.) Geographic area: managed smoking cessation program for Hospital who smoked any amount the general hospitalized patients, was continued month before admission were offered a US for 3 yrs after completion of RCT smoking cessation program during Funding agency: Population: hospitalization NCI, Canadian Cancer Society ? Adults Sample size: 12 month sample = 720 Study setting: Study type: Hospital ? Time series Definition of smoking: ? Single group effectiveness study using a Cigarettes program put into standard hospital ? 7 day point-prevalence as defined by practice. NHLBI (not even a puff for a minimum ? No comparison group for this study; of 7 consecutive days prior to instead, follows participants over time and assessment assesses smoking status at various points postintervention Inclusion criteria: ? Patients who smoked in month before hospital admission ? Wanted to quit smoking ? Agreed to participate in intervention Exclusion criteria: ? Did not speak English ? Impaired level of consciousness ? Terminal ? Primary reason for hospitalization was substance abuse ? Hospital stay less than 36 hrs C-166 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Including only those who were Quality rating: ? Self-help ? ANOVA reached at 12 mos, 49% reported Fair ? Individual counseling by ? ?2 being smoke free for previous 7 health professional Comments: ? Frequencies days Though no ? Telephone counseling ? Intent-to-treat analysis Including 211 who were not comparison group ? Video Data verification: reached at 12 mos (intent to in this study, it ? Pharmaceuticals ? Self-report by treat) and counting them as provides very good Intervention: telephone No smokers, self-reported smoking and detailed data G1: Used multiple- biochemical cessation rate is 35%. regarding reinforcement approach assessment continuation of a (multiple providers, smoking cessation components, and contacts) Dependent variables: program During hospitalization: 12 mo quit rate (7 day implemented Physician advice on point prevalence at 12 previously as part smoking cessation; mos) of a RCT; bedside education and Baseline data: only 52% of eligible counseling w/ specially Mean age: 52 patients trained nurse; take-home Males: 58% participated, but materials (video, this is considered workbook, relaxation Race/ethnicity: fairly high audiotape), NRT if ? Caucasian: 79% acceptance rate for requested or indicated, 4 African American: 5% the population; ? nurse-initiated it also presents ? Asian: 9% postdischarge phone data both w/ and ? HispaniC1: 1% counseling calls (2,7,21, without intent-to- and 90 days ? Other race: 6% treat approach; postdischarge) partial reasons for C1: No control or Hospitalization reasons: high attrition rate at comparison group ? Cardiovascular: 41% 12 mos include ? Cancer: 12% nurse not having Method of assessment: ? Pulmonary: 6% time to devote to In-person survey for ? Gynecological: 4% trying to make demographic information, ? Internal medicine: 19% follow up calls and and baseline smoking ? OrthopediC1: 10% only 3 attempts history and alcohol ? Other: 9% made to reach consumption participants by Postdischarge data Significant (P < 0.001) phone. Study also collected by telephone and differences in age, sex, addresses practical involved self-report ethnicity, primary reason hospital-related for hospitalization b/w issues to be total smokers identified, considered when ineligibles, participants, implementing an wanted to quit on own, inpatient smoking and did not want to quit cessation program groups Adequate randomization: No Attrition rate: Excluding 42 who died before assessment, 29% attrition rate (not reached or dropped out) C-167 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Soulier-Parmeggiani et al., To evaluate effectiveness of a smoking NR 1999 cessation program for outpatients Sample size: Geographic area: Population: G1: 299 Western Europe ? Adults Definition of smoking: Funding agency: Study type: NR NR ? Before and after study Study setting: ? Patients participated in 1-hr consultation Hospital groups once a wk for 4 wks; patients Practice/provider settings interviewed at baseline and 3, 6, and 12 months after intervention Inclusion criteria: ? NR Exclusion criteria: ? NR C-168 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Non-smokers at baseline and Quality rating: ? Individual counseling by Proportions of smokers each followup: Poor health professional calculated at baseline Baseline: 0% ? Group counseling and followup intervals End of intervention: 54% Comments: ? Telephone counseling Data verification: 3-mo followup: 39.4% Sampling not explained, no C, ? Social support 6-mo followup: 25.8% Patients' CO levels ? Video 12-mo followup: 20.9% limited measured at each generalizability ? Pharmaceuticals session and followup Adequate Intervention: Dependent variables: randomization: G1: One-hr group Smoking status NR consultations once per wk for 4 wks; followup Baseline data: Attrition rate: individual consultations by Collected data on 10.4% telephone at 1, 3, 6, and smoking history, 12 mos after intervention; addiction level as prescription of NRT; measured by FTQ, and individual strategy for motivation and cessation discussed w/ a confidence to quit provider; family support smoking recommended; video of benefits of cessation; dietitian-led session on preventing weight gain and individual diet recommendations; relapse prevention counseling C1: NR Method of assessment: ? Questionnaires filled out by patients at baseline and 3, 6, and 12 mos postintervention ? Patients' CO levels measured at each session and followup C-169 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Stevens et al., 2000 To evaluate implementation and ? Smokers b/w 18 to 70 yrs old Geographic area: effectiveness of hospital-based smoking identified by questionnaire upon cessation counseling delivered by US hospital admission respiratory therapists chosen from among ? Eligible smokers assigned to txt or Funding agency: hospital staff usual care by a random digit in their NCI Population: HMO member number Study setting: ? Adults Sample size: Hospital Study type: G1: 541 RCT w/ simple randomization C1: 632 Inclusion criteria: Definition of smoking: Cigarettes ? Between 18 to 70 yrs old ? Abstinence from smoking considered ? Being admitted to one of two participating as ? 6 months Kaiser Permanente hospitals in Portland, OR ? Second analysis included pipes or cigars ? Reporting regular smoking anytime in 3 months preceding hospitalization Exclusion criteria: ? Obstetric patients ? < 18 or >70 yrs old ? Hospitalized for psychiatric or drug or alcohol abuse diagnoses ? Patients w/ hospital stays less than 36 hrs ? Hospice patients C-170 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: NR Quality rating: ? Self-help ?2 tests and one logistic Poor ? Individual counseling by regression health professional Comments: Data verification: NR ? Telephone counseling Relied on self-report of ? Video smoking status Adequate randomization: Intervention: Dependent variables: Yes G1: If assigned to 6 month abstinence from intervention but did not smoking Attrition rate: agree to participate, NR received smoking Baseline data: cessation brochure only ? 57% women, mean If agreed to participate, age 47 yrs watched 12 minute video ? Mean smoking rate for hospitalized smokers; before hospitalization: offered one 20-minute 19 cigarettes per day counseling session w/ RT; ? Similar baseline choice of written materials characteristics among (e.g., NCI's intervention and Cs C1: no information Method of assessment: No statistically significant Mailed questionnaire and differences b/w groups at follow up by phone for baseline in terms of non-responders demographics or smoking, but race/ethnicity NR) C-171 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Young et al., 2002 To evaluate a multifaceted, practice-based ? All FPs in defined geographical area Geographic area: intervention involving audit, feedback, and in 1999 were invited to participate academic detailing to improve family Australia ? Following baseline data collection, physicians' smoking cessation advice practices stratified according to Funding agency: Population: number of participating FPs at CSAHS Tobacco Education ? Adults practice (1, 2-4, 5+) to ensure Team. (NSW Quit approximately equal numbers of FPs Campaign supplied free Study type: in each study group "Quit Kits," Pharmacia ? RCT w/ cluster randomization ? Within each stratum, practices then Upjohn donated NRT starter ? Each family practice, representing a randomly allocated to intervention or packs; NSW Cancer cluster, randomly allocated to receive C using random numbers generated Council supplied videos and either intervention in smoking cessation by SAS workbooks at cost.) advice (G1) or an intervention of identical Study setting: format and intensity but about cervical FP patients 18 to 70 recruited Practice/provider settings screening (C1) consecutively and invited to participate ? This constituted a 2 x 2 balanced in a study about health care in a general incomplete block design, used to equalize practice. nonspecific effects of research Sample size: participation b/w groups and thereby G1: 30 (FPs) in 20 practices minimize Hawthorne effect C1: 30 (FPs) in 19 practices ? Data from FPs' patients used to assess effectiveness of intervention by Definition of smoking: comparing baseline and posttest Cigarettes questionnaires ? NA Inclusion criteria: Smokless tobacco ? Family physicians from practices located ? NA within a defined geographical area in 1999 ? Patients: Aged 18 to 70 ? Attending FPs during specified data collection periods ? Spoke and read English ? Could read questionnaire Exclusion criteria: FPs: ? Ineligible if they worked < 2 days per wk ? Planning to leave practice within 6 months ? On extended or maternity leave ? Did not employ a receptionist ? Already participating in a clinical audit ? More than 50% of their patients spoke a language other than English at home Patients: ? Did not read or speak English ? Were unable to read or understand questionnaire ? Were too sick or distressed to participate ? Had participated previously C-172 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: Improvements b/w baseline and Quality rating: ? Self-help Frequencies, posttest in patient recall of FP Fair ? Individual counseling by proportions, univariate advice about nicotine health professional analysis, bivariate replacement patches and gum Comments: 2 Video analysis, ? , Wilcoxon's were significantly greater in ? Low consent rate ? ? Pharmaceuticals rank sum tests, Fisher's intervention than C (P = 0.0056 among FPs exact test, McNemar's and P = 0.0002, respectively) (35%), limiting Intervention: test for paired generalizability G1: FP received three proportions, Wilcoxon's Substantial increases in patient of findings academic detail visits sign rank tests for paired recall of assessment of smoking ? Some significant which combined audit and ordinal data, logistic status and FP use of quit dates, differences b/w feedback; resources for regression using GEE behavioral advice, written patients in G1 vs FPs (skills training video materials in intervention group, C1 and workbook package, Data verification: but changes not significantly ? Though many clinical practice guidelines, Self-report of FP greater than those in C comparisons of prompt sheet to assist w/ practices and patient improvements in smokers? excuses and recall of them, Medical chart review indicated FP notation of smoking cessation FPs' smoking self-exceptions); resources supplemented w/ patient cessation advice for practices (patient- medical chart review for advice remained suboptimal after verification intervention (G1 v C1) were mediated prompts, NS, could be due reminders for medical Dependent variables: 100% of FPs found following to both groups records) and resources for ? Patient recall of intervention components being trained to patients (patient brochures smoking cessation- be more mindful and free starter packs of related interactions w/ of addressing nicotine replacement gum) FP during clinic visit patients' health ? Sessions 1 and 2 ? Recall of: question risks, thus conducted by a medical from FP about reducing peer smoking status apparent effect ? Session 3 conducted by of intervention ? Smokers' recall of a non-medical public specific smoking ? High rate of health academic cessation advice attrition in both C1: Received similar groups and at intervention in terms of ? Discussion of health both time points intensity and format, but w/ risks of smoking regard to cervical ? Discussion of passive Adequate screening smoking randomization: ? Providing practical Yes Method of assessment: advice Attrition rate: ? Baseline: Demographic ? Setting a quit date Baseline follow up: questionnaires ? Providing written G1: 34% completed by materials C1: 27% participating FPs ? Recommending ? Patients at participating nicotine replacement Posttest follow up: practices also patches G1: 37% completed baseline and ? Arranging follow up C1: 31% posttest questionnaires appointment; referring ? Medical record audit to a smoking clinic Medical record audit of patient smoking status and cessation advice in chart for index consultation (for smokers only). C-173 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation Study Characteristics Study Design Sample Design and Definitions Author: Young et al., 2002 (continued) C-174 Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use cessation (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments ? Also assessed FPs thoughts about usefulness of intervention components Baseline data: FPs: Representative of reference FP population except for participating FPs more likely to be full- time vs part-time Personal and professional characteristics of FPs allocated to each group were comparable G1 vs C1: Mean age 46.4 v. 49.8; Female (%): 43 v. 33; Mean yrs in practice: 18 vs 19 Patients: 77% consented to participate 70% response rate Less likely to respond: Smokers vs non- smokers (57% v 73%, chi sq = 35.3, P < 0.001) Males (65% v 73%, chi- sq = 11.8, P < 0.001) Those from intervention practices (66% v 73% chi sq = 11.2, P < 0.001) C-175 Evidence Table 8. Effect of smokeless tobacco product marketing and use on population harm from tobacco use Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Choi et al., 1995 To assess trends in ST use and to identify Stratified random sample of adults and Geographic area: risk factors that distinguish youths who use all 12 to 17 yr old adolescents or who are at risk of using ST US Sample size: Funding agency: Population: 1990: 3,912 ? Adolescent males, ages 12 to 17 1992: 883 UCSF, Institute for Health and Aging ? Young adult males, ages 18 to 24 1993: 2,814 Study setting: Study design: Definition of smoking: ? Cross-sectional Cigarettes Population-based in Calif ? Telephone survey using random digit ? Current users: respondents who dialing smoked a cigarette within last 30 days Inclusion criteria: Residing in Calif Smokeless tobacco ? Current users: reported use of Exclusion criteria: smokeless tobacco within last 30 NR days C-176 Evidence Table 8. Effect of smokeless tobacco product marketing and use on population harm from tobacco use (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Ever experimented w/ ST: Quality rating: NA Multivariate logistic 1990: 15.2% (95% CI, 13.7-16.7) Fair Intervention: regression 1992: 12.3% (95% CI, 9.8 - 14.8) 1993: 13.8% (95% CI, 12.3-15.3) Comments: NA Data verification: Cross sectional study Method of assessment: NR Current use of ST (%) 1993: design; only reported Dependent variables: ? 12 to 13 yrs: analysis on 1993 Telephone survey OR = 0.3 (95% CI, 0.1 -0.05) data and youth ? Current use and ? 14 to 15 yrs: subjects; no clear susceptibility to use ST Current cigarette use OR = 2.6 (95% CI, 1.0 - 4.2) explanation of final ? ? 16 to 17 yrs: sample size ? Exposure to other ST OR = 6.6 (95% CI, 4.1 - 9.1) users Adequate ? Exposure to ST Susceptibility to use ST (%) in randomization: advertisements 1993: Yes ? Rebelliousness ? 12 to 13 yrs: Attrition rate: ? Participation in team OR = 16.8 (95% CI, 13.7 - 19.9) NR sports ? 14 to 15 yrs: ? Depression OR = 17.3 (95% CI, 14.8 - 19.8) ? Peer Use of drugs or ? 16-17 yrs: alcohol OR = 18.8 (95% CI, 14.6 - 23.0) ? Peer norms Exposure to SLT advertising (%) in Baseline data: 1993: NA ? 12 to 13 yrs: OR = 21.0 (95% CI, 17.4 - 24.6) ? 14 to 15 yrs: OR = 34.3 (95% CI, 30.3 - 38.3) ? 16 to 17 yrs: OR = 43.8 (95% CI, 38.3 - 48.8) Recall of ST advertisements in 1993: AOR 7.5 (95% CI, 3.1 ? 18.1), (P < 0.001) Susceptibility to use of ST in 1993: OR = 1.6 (95% CI, 1.2 ? 2.0), (P<.001) Cigarette smokers risk of being ST users in 1993: OR = 3.3 (95% CI, 1.9 -5.7), (P<.001) C-177 Evidence Table 8. Effect of smokeless tobacco product marketing and use on population harm from tobacco use (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Tomar; 2003 To assess 4-yr initiation rates of ST use and 1989 TAPS-I and its 1993 followup Geographic area: cigarette smoking in relation to each other TAPS-II: TAPS-I sampling frame and examine switching b/w products consisted of all teenagers aged 12?18 US Funding agency: Population: yrs on November 1, 1989, who resided in households interviewed for the NHIS NR ? Adolescents, ages 11 to 19 during last two quarters of 1988 and first ? Young adults two quarters of 1989 Study setting: ? Men Population-based Sample size: Study design: Total: 3,996 ? Cross-sectional ? Nationally-representative, cross-sectional Definition of smoking: telephone and mail survey Cigarettes ? Current smoker: reported smoking at Inclusion criteria: least 100 cigarettes in their lifetime ? 11 to 19 yrs of age at baseline and smoked at least 1 cigarette in 30 ? Reside in households interviewed for days preceding interview National Health Interview Survey ? Former smoker: smoked at least 100 ? Male cigarettes in their lifetime, but smoked Exclusion criteria: no cigarettes in last 30 days NR preceding interview ? Never smokers: had not smoked 100 cigarettes in their lifetime Smokeless tobacco groups: ? never user of ST ? used ST, but never regularly ? used ST regularly but not currently ? current, regular user of ST C-178 Evidence Table 8. Effect of smokeless tobacco product marketing and use on population harm from tobacco use (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: At 4 yr followup: Quality rating: NA ? Estimates of prevalence ? current smokers: 21.2% Fair Intervention: and initiation rates included 95% CI ? regular users of ST at sometime: Comments: NA 11.9% ? Multiple logistic ? Self report without Method of assessment: regression modeling ? current regular users: 5.7% any biochemical used to adjust for age After adjusting for age and race, verification; ? Computer-assisted telephone interviews and race/ethnicity males who had been regular users participants lost at ? Traditional telephone ? OR estimate interpreted of ST were more than 3 times as followup may have interviews as significantly different likely as never users of ST to been more difficult to capture because ? Mailed surveys (TAPS-I from reference group, at become smokers, 1989 data and TAPS-II 95% level of confidence, OR = 3.45 (95% CI, = 1.84 -6.47) they were more 1993 data) if its 95% CI, excluded likely to progress to 1.0 Current smokers not different from current smoking or ? All analyses of TAPS never smokers in rate of initiating regular use of ST data conducted using current regular ST use ? Definition of ST sampling weights OR = 1.45 (95% CI, = .5-4.22) use relied on developed by National NS respondents? self Center for Health characterization of Among males who were regular ST Statistics regular use users but were not smokers at Data verification: baseline: Adequate NR ? continued to exclusively use ST randomization: at followup: 44.8% NR Dependent variables: ? had switched to smoking at Attrition rate: ? ST use followup: 25.5% NR ? Cigarette use ? continued to use ST while also Baseline data: smoking at followup: 14.3% Prevalence of tobacco use ? no longer using tobacco: 15.2% at baseline (males only): Of smokers at baseline who were ? current smoker: 9% not ST users: ? former smoker: 1.6% ? switched to ST exclusively: 8% ? regular ST user at ? continued to smoke but also use sometime: 6.1% ST: 3.6% ? current regular ST user: ? quit using tobacco: 16.9% 2.7% C-179 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors Study Characteristics Study design Sample Design and Definition Author: Research objective: Sampling plan: Brown et al., 2001 To assess the efficacy of a standard, ? Potential participants screened by Geographic area: cognitive?behavioral smoking cessation telephone prior to an intake interview treatment vs standard cessation treatment US to confirm eligibility combined with CBT for depression in ? Eligible participants required to Funding agency: smokers with a positive history of MDD provide a $75 deposit, refunded National Institute on Drug Population: incrementally on completion of follow- Abuse; American Cancer up procedures Society ? Smokers with a positive history of MDD ? 358 invited to study center for Study setting: Study type: diagnostic interview to confirm Population-based RCT eligibility; 100 did not show up Inclusion criteria: ? 258 participants completed informed consent and participated in the ? Ages of 18 and 70 years interview; 5 withdrew prior to being ? Smoked for at least 1 year assigned to a treatment condition; 74 ? Currently smoking at least 10 cigarettes did not meet inclusion?exclusion per day criteria ? Had a history of MDD according to the DSM-III Sample size: G1: 86 Exclusion criteria: C1: 93 ? DSM?III?R diagnosis of current MDD, dysthymia, or other Axis I disorder Definition of smoking: ? DSM?III?R diagnosis of psychoactive ? Smoked at least 10 cigarettes a day substance abuse or dependence within for at least 1 year the past 6 months (other than nicotine) ? Current use of psychotropic medication ? Current weekly psychotherapy ? Use of other tobacco products ? Intent to use pharmacological aid to cessation C-180 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: No statistical difference between Quality rating: ? Group counseling ? Chi-square analyses groups were found for 7 day point Fair ? Tailored cognitive ? Repeated measures prevalence abstinence rates at 1, 6 behavioral therapy analyses for categorical and 12 months for C1 = 30.1%, Adequate Intervention: outcomes using 24.7%, 24.7%, respectively; G1 = randomization: 39.5%, 24.4%, 32.5%. NR G1: Eight 2-hr sessions over generalized estimating equation 6 weeks standard In the final step of the GEE Attrition rate: comprehensive CBT for Data verification: analysis a significant interaction ? 5% at 1 month smoking cessation, plus ? Self report was found between treatment and ? 8.9% at 6 months cognitive behavioral coping ? CO and saliva cotinine heavy smoking (P = 0.02), and ? 7.8% at 1 year for depression between treatment and recurrent C1: Eight 2-hr sessions over Dependent variables: depression (P = 0.02) 6 weeks; comprehensive, ? Demographic standard CBT for smoking characteristics (age, cessation gender, marital status, and years of education) Method of assessment: ? Nicotine dependence Assessment battery severity (FTND score, administered at number of years pretreatment; questionnaires smoking, average daily administered at each smoking rate, and saliva session during treatment; cotinine) follow-up phone interviews ? Depression severity and occurred at 1, 6, and 12 chronicity months posttreatment, and self-reported abstinence was verified biochemically Baseline data: Groups were similar C-181 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Brown et al., 2003 To test hypothesis that among adolescent Consecutive sample of eligible 13 to 17 Geographic area: smokers hospitalized for psychiatric and/or yr olds hospitalized for psychiatric substance use disorders, MIwould lead to and/or substance use disorder but not US more and longer quit attempts, reduced psychotic Funding agency: smoking, and more abstinence from Sample size: None listed smoking over 12 mo followup G1: 116 Study setting: Population: G2: 75 Psychiatric hospital ? Adolescents Aged 13 to 17 from Providence, RI Definition of smoking: ? Cigarettes Study type: ? Number of cigarettes smoked per day RCT w/ systematic cohort randomization Inclusion criteria: ? Hospitalized for psychiatric and/or substance use disorder ? Age 13 to 17 ? Smoked at least 1 cigarette/wk for 4 wks prior to hospitalization ? Access to phone Exclusion criteria: ? DSM-IV criteria for psychotic disorder ? Recent violent behavior ? Recent participation in another study ? Uncertain guardianship status ? Language incompatibility ? Sibling in study ? Significant cognitive impairment ? Residing too far away to complete followups ? Patient or parent refusal C-182 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Statistical Analysis and Intervention Details Baseline Data Results Quality Comments Intervention methods: Statistical analysis: Mean of anxiety Quality rating: ? Self-help Hierarchical Linear Modeling disorders: Fair ? Individual counseling by health GEE G1: 1.1 professional Linear and Logistic G2: 1.3 Comments: Telephone counseling Regression P = NS ? High refusal rate ? Pharmaceuticals Odds for quit attempts ? Due to slow ? Data verification: AOR 1.99 (95% CI, 1.08, participant flow, Intervention: Self-report plus biochemical 3.71) recruitment ended G1: Two in-person 45-minute MI verification (saliva cotinine) for before all cohorts sessions during hospitalization or those claiming tobacco use Longest quit attempt, days: completed, on outpatient basis; self-help abstinence G1: 48.2 resulting in pamphlet and manual; offer of up Dependent variables: G2: 60.9 imbalance of to two 8-wk courses of free P > 0.05 ? Point prevalence abstinence participants across transdermal NPtherapy if eligible; NS up to 6 postdischarge phone ? Quit attempts conditions Point prevalence ? Inconsistent txt counseling sessions; up to 4 brief ? Changes in smoking rate implementation parent intervention phone ? Longest quit attempt abstinence at 1, 6 and 12 mos: counseling sessions. Adequate Baseline data: P > 0.30, NS G2: 5-10 minute in-person advice randomization: ? Female: 62.3 to quit smoking; self-help Yes ? Mean age: 15.4 Smoking rate: (b = 0.05, pamphlet; offered one course of SE = 0.16, P = 0.74, NS) Attrition rate: transdermal NPtxt if eligible Race/ethnicity C1: NA Higher discharge scores 20 (9%) ? White: 94.8 on situational confidence Method of assessment: ? HispaniC1: 1.6 questionnaire associated Pre and postintervention ? African American: 0 w/ significantly less assessment of various outcomes ? Other Race: 3.6 smoking during followup (b at 1, 3, 6, 9, and 12 mo follow ups = -0.02, SE = 0.007, P = Other 0.007) Smoking: ? Mean age at first cigarette: ? Self-report and biochemical 10.85 verification for those claiming ? Smoked on avg: 91.19% of abstinence previous 3 mos Nicotine Dependence: ? Mean: 14.48 cigarettes on ? Fagerstrom tolerance smoking days questionnaire ? Daily smokers: 63.9 ? Psychopathology dz: ? Mean Fagerstrom tolerance C-DISC score: 4.9 ? Intent to change: Self-report to ? Met DSM-IV criteria for single item nicotine dependence: 68.6 ? Self-efficacy: SCQ ? Mean length inpatient stay: 9.11 days ? Used NRT during hospital stay: 26% C-183 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Hitsman et al., 1999 To identify individual differences that predict Specific randomization scheme NR. Geographic area: cessation when fluoxetine is combined w/ CBT Sample size: US Total: 253 Funding agency: Population: VA Merit Review award by ? Adults Definition of smoking: Cigarettes NIDA, and Eli Lilly and Study type: ? Reported smoking Company RCT w/ simple randomization ? Expired CO greater than 8 ppm Study setting: Inclusion criteria: ? Saliva continine value greater than 10 Population-based Participants are: ng/ml ? 18 to 65 yrs of age ? have smoked daily for at least one yr ? exhibit a baseline expired CO level of greater than 8 ppm ? agree to declare a quit date within 2 wks after second study visit (Source: Borrelli, et al. 1997) Exclusion criteria: ? Clinically significant depression HDRS score greater than 14 ? Pregnancy ? Hypertension ? Use of psychotropic medication or current psychiatric illness ? Alcohol or drug abuse in past yr ? Current use of nicotine replacement ? Unstable medical condition or major health event in past 6 months ? Use of ST, pipes or cigars ? Recent experience of a major life event (e.g., divorce or major job change) ? Suicidal ideation ? History of bipolar disorder (Source: Borrelli, et al. 1997) C-184 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Statistical Analysis and Quality Intervention Details Baseline Data Outcome Measures Comments Intervention methods: Statistical analysis: At 1 wk postcessation: higher Quality rating: ? Individual counseling by Constructed predictive levels of depression predicted Fair health professional models using logistic failure to achieve abstinence (ITT ? Pharmaceuticals regression w/ analysis); higher levels of Comments: hierarchical approach to nicotine dependence and ? Authors didn't Intervention: variable selection. depression associated w/ report numbers G1: Nine, 1-hr individual Models evaluated w/ decreasing likelihood of of participants CBT sessions + fluoxetine parallel analyses using abstinence (analysis of txt- per arm of study, 30 mg for a total of 10 wks stepwise selection compliant patients) and likelihood baseline ? Participants required to procedure of abstinence for participants on demographic set a quit date within 2 characteristics of wks after drug txt began Data verification: fluoxetine tended to be higher than for those on placebo (P = those groups, ? Participants quit Expired CO and saliva 0.06); At 1 month postcessation: nor 6 month smoking at 3rd CBT continine higher levels of weight concern followup results session Dependent variables: predicted lower abstinence (?2 ? Inclusion/ ? Medication stopped at Depression, nicotine 4.8, P = 0.78); patients on exclusion criteria 9th CBT session, at dependence, weight fluoxetine had positive are described in which time 6-month concerns, self-efficacy association b/w degree of companion followup period began about quitting smoking depression and likelihood of article, Borrelli, ? CBT not explained abstinence (highest quartile et al. 1997 ? Patients w/ fluoxetine Baseline data: HRSD = 3, OR = 2, 95% CI, level less than or equal No significant difference Adequate 0.85-4.70); At 3 months randomization: to 150 ng/ml considered b/w txt groups in postcessation: patients treated w/ compliant baseline characteristics: NR fluoxetine had positive G2: Same as G1:, except age, gender, education, association b/w HRSD scores Attrition rate: fluoxetine dose of 60 mg smoking history, baseline and abstinence likelihood NR and fluoxetine blood level level of nicotine (highest quartile HRSD = 3, OR = less than or equal to dependence, depression, 1.44, 95% CI, 0.53-3.91) 300ng/ml considered weight concern, and self- compliant efficacy Smoking characteristics C1: Same as G1, except predicting txt compliance were given placebo nicotine intake at baseline, saliva cotinine (?2 = 11.4, P < 0.001), Method of assessment: and expired CO ( ?2 = 5.3, P < Self report of smoking, 0.05) expired CO, and saliva continine Also used depresion scale, nicotine dependence, weight restraint scale, and self-efficacy questionnaire C-185 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Joseph, 1993 To evaluate effect of smoke-free policies in ? Enrolled consecutive patients Geographic area: in-patient alcohol txt wards and effect of ? Admitted to an inpatient substance these policies on long-term txt outcomes US abuse txt program prior to implementation of a smoke-free Funding agency: Population: ? Adults policy and those patients admitted NR after smoke-free policy was Study setting: Study type: implemented Hospital Prospective cohort study Sample size: Inclusion criteria: G1: 407 NR G2: 299 Exclusion criteria: Definition of smoking: Excluded patients admitted b/w May and NR July, 1988, because they would have overlapped w/ the implementation of smoke- free policy C-186 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Statistical Analysis and Intervention Details Baseline Data Results Quality Comments Intervention methods: Statistical analysis: Proportion of patients that want to Quality rating: ? Group counseling NR quit smoking while in hospital at Fair ? Classroom instruction Data verification: three-wk followup: G1: 24% Comments: Intervention: NR G2: = 61% ? Statistical methods G1: Patients not given P = < 0.001 NR specific information about Dependent variables: ? No biochemical smoking or cessation; Tobacco-use status; Proportion of patients that has verification smoking on the ward only motivation to quit; use of abstained from smoking for > 1 wk: ? High attrition permitted in 2 designated substances other than G1: 9% rooms and not allowed nicotine G2: 41% Adequate during group sessions Baseline data: P = < 0.001 randomization: G2: Patients required upon Demographic data from NR admission to acknowledge Proportion of patients that cut down both groups similar at the smoke-free policy and smoking while in hospital: Attrition rate: baseline Attrition at 1-yr sign a contract agreeing to G1: 46% followup: abstain from nicotine during G2: 93% G1: 61.7% their stay; smoking cessation P = < 0.001 G2: 45.5% program designed for Quit smoking as reported at 1 yr substance abusers delivered followup interview: (didactic lectures on G1: 3% pharmacology of nicotine, G2: 8% films, and discussion group); P < 0.05 quit smoking Clonidine patches available but not studied in a No significant difference found in 1- systematic fashion yr followup for non-nicotine substance use b/w groups Method of assessment: A one-pg, standardized, self- administered questionnaires given upon admission to hospital and third wk of hospitalization to assess smoking status and motivation to quit Structured telephone interviews at 1 yr posthospitalization (pre policy group interviewed at 16.2 mos and post policy group at 10.7 mos) conducted to assess use of substances other than nicotine Improvement in chemical dependency defined as less or no use of substance abuse they were treated for at hospital C-187 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Study Characteristics Study design Sample Design and Definition Author: Research objective: Sampling plan: Joseph, Willenbring et al., To compare the effects of smoking ? Treatment assignment accomplished 2004 treatment and intensive treatment for alcohol by stratifying by substance use Geographic area: dependence, delivered concurrently, with disorder treatment site and blocking treatment delayed by 6 months on smoking US within site in groups of 10. Computer outcomes and alcohol use generated random sequence was Funding agency: Population: concealed from study personnel National Institute on Alcohol Adult men and women ages 21-75 ? Initial screening included questions Abuse and Alcoholism; about interest in participating in a Health Services Research Study type: research study, stage of change and and Development Center for RCT Stratified random sampling potential concerns about participating. Chronic Disease Outcomes (Screen A) Research, Veterans Affairs Inclusion criteria: ? Patients passing Screen A invited to ? Met criteria for alcohol dependence or Study setting: do Screen B, a computerized self-abuse according to the Diagnostic and Residential treatment administered Quick Diagnostic Statistical Manual of Mental Disorders, 4th program Interview Schedule to confirm that ed. and who smoked more than 5 they met criteria for alcohol cigarettes per day for more than 1 year dependence. ? Completed first week of alcoholism ? 1,943 adults assessed for eligibility treatment ? 499 adults agreed to participate Exclusion criteria: Sample size: ? No interest in stopping smoking G1: 251 ? Diagnosis of dementia or schizophrenia G2: 248 ? Inability to comply with the protocol due to severe psychiatric symptoms or cognitive Definition of smoking: deficits Any smoking within past 7 days ? Refusal to provide the name of a contact or source of collateral information ? Unwillingness to attend visits as planned in the protocol C-188 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Statistical Analysis and Intervention Details Baseline Data Outcome Measures Quality Comments Intervention methods: Statistical analysis: Smoking Cessation Outcomes Quality rating: Behavioral counseling and ? Simple likelihood ratio Intention-to-Treat Analysis Good pharmacological treatment chi-square tests compared rates of 7 day point prevalent smoking Comments: Intervention: G1 (concurrent treatment): tobacco and alcohol abstinence rates at 3 months were ? Very low abstinence 15.5% in the concurrent treatment participation rate in Individual counseling (1-hour Logistic regression group and 4.4% in the delayed expired carbon face-to-face session) and up ? analyses modeled the group (P < 0.0001); at 6 months, monoxide testing, to 3 follow-up sessions 10.5% vs. 5.2% ( P = 0.02) (note 34% at 12 months conducted in person or by odds of smoking abstinence and that at 3 and 6 months the delayed and 25% at 18 telephone treatment group had not received months Participants in the action prolonged alcohol stage of change received a abstinence as a function intervention). At 9,12 and 18 ? 6.6% failed to of intervention group months there were no significant support self-free prescription for NRT, unless they declined or had and baseline measures differences between treatment reported that might affect groups. abstinence rates a medical contraindication Medication algorithm smoking and alcohol Alcohol Abstinence Outcomes Adequate recommended nicotine treatment outcomes At 6- 12- and 18-month visits, point randomization: patches (21 mg for 6 weeks, Data verification: prevalent alcohol abstinence was Yes 14 mg for 2 weeks and 7 mg Self-report abstinence lower in the concurrent treatment Attrition rate: for 2 weeks). A combination Smoking validated by group than in the delayed 18% at 6 months of patches and nicotine gum expired carbon monoxide; treatment group (P = 0.004, 20% at 18 months was offered to participants alcohol by breath alcohol P = 0.11, and P = .001, who smoked more than 20 concentration. respectively) cigarettes per day. Dependent variables: Method of assessment: ? Smoking: 7 day point ? Data collected at prevalence treatment site, research ? Smoking abstinence at study office or by 3, 6 and 12 months telephone at 6, 12 and 18 ? Prolonged (6-mo.) months after study smoking abstinence at enrollment 18 months ? Brief smoking outcome ? Number of quit and data were also collected relapse episodes at 3 and 9 months ? Participation in Baseline data: treatment No baseline group ? Alcohol: 6-months differences duration of alcohol ? 1-months duration of alcohol abstinence and number of drinking days in the past 6 months ? Relapse to alcohol C-189 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Study Characteristics Study Design Sample Design and Definitions Author: Study objective: Sampling plan: Murray et al., 1995 Explore relationship b/w alcohol NR Geographic area: consumption and smoking cessation Sample size: US Population: G1: 2,649 Canada ? Adults C1: 1,327 Funding agency: ? Describe: aged 35 to 60 Definition of smoking: Division of Lung Diseases Study type: Cigarettes of the NHLBI RCT w/ simple randomization Defined as smoking at any clinic visit Study setting: Multi-center clinical trial Practice/provider settings Inclusion criteria: ? Smokers ? Age 35 to 60 w/ evidence of early stage COPD Exclusion criteria: ? Serious health condition that is likely to affect lung function ? Use of regular medications that might interfere w/ study results ? Consumption of more than 25 alcohol drinks per wk or 8 drinks in one occasion once a mo or any consumption of alcohol in past yr for recovering alcoholics C-190 Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk behaviors (continued) Statistical Analysis and Intervention Details Baseline Data Results Quality Comments Intervention methods: Statistical analysis: Outcome measures: Quality rating: ? Group counseling Polychotomous ordinal No significant relationship b/w Poor ? Pharmaceuticals logistic regression amount of alcohol consumed at Data verification: baseline and smoking status after 1 Comments: Intervention: yr for G1. ? Changed exclusion G1: Bronchodilator inhaler or Self-report on CO in In G2, women baseline drinkers criteria after placebo inhaler and multi- expired air more likely not to be smoking after recruiting 1/3 of component counseling and 1 yr: participants nicotine gum; counseling Dependent variables: ? Current alcohol use G1:14% ? Post randomization intervention included a multi- History of alcoholism G2: 6.3% of subjects component approach w/ ? P = NR (excluded standard cognitive- ? History and current use recovering behavioral strategies such as of tobacco Currently drinking at end of alcoholics) stimulus control, avoidance, ? Family smoking intervention: ? No systematic role playing, assertiveness ? Attitudes towards G1: control of NRT use training, reinforcement, and smoking and stopping Smokers: 5.24 drinks/wk ? No information on relaxation techniques smoking Nonsmokers: 4.46 drinks/wk attrition ? Following counseling ? Physical dependence on (t = 1.94, 1,440df, P = 0.05) ? Within txt group program, regular nicotine (Fagerstrom) Within smoking cessation analysis maintenance program Baseline data: intervention (G1), those who drank scheduled on at least a Adequate Similar w/ an exception, eight or more drinks per occasion monthly basis randomization: less female alcoholics in C (binge drinkers) more likely to be ? Maintenance programs Yes than in txt group (2.8% current smokers (i.e., lower included weight vs5.8%) cessation rate) after 1 yr (men Attrition rate: management and exercise binge = 44.8%, no binge = 51%, P NR ? In addition an extended < 0.05) and (women binge = group intervention 27.3%, no binge = 41.8%, program offered to P < 0.01) participants who relapsed and want to try and quit Within intervention group, binge again; NRT available free drinkers smoked more cigarettes of charge to study per day than those without a history participants but not of binge drinking (Men binge = tracked systematically in 12.5, no binge = 10.3, P < 0.05) relationship to quit rates and (women binge = 14.3, no binge C1: Usual care = 10.7, P < 0.01) Method of assessment: ? Baseline interviews using When volume of drinking and self-reported alcohol and drinking of eight or more drinks per tobacco use occasion were compared in ? Intervention group (only), polychotomous ordinal logistic contacted monthly for 1st regressions, only binge drinking for yr then w/ clinic visits men predicted failure at smoking every 4 mos w/ alcohol cessation (Chi sq = 4.11, 1 d.f. used assessed at 12 mos P < 0.05, OR = 0.76) C-191 Evidence Table 10. Systematic and meta-analysis reviews Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Ebbert et al., Randomized trials of behavioral or To assess effects of Good 2004 pharmacologicial interventions to help behavioral and Geographic area users of ST to quit, w/ a followup of at pharmacotherapeutic Adverse events least 6 months interventions to treat ST Yes United Kingdom Funding source Population use All reported adverse Users of any tobacco product that is Main results events associated w/ No source of placed in mouth and not burned, No evidence of ST NRT such as skin support supplied including moist snuff, chewing tobacco abstinence for trials using reactions, nausea, Time period and betel quid bupropion, NRT, or headache and covered nicotine gum gastro-intestinal Characteristics of studies distress Databases (Interventions) searched Three trials showed Interventions studies could be systematically significant effects using pharmacologicial (NRT or bupropion) or through March behavioral interventions behavioral, either directed at individual 2004 ST users or a groups of users A subgroup of behavioral Method of review studies that randomized ? One author examined all titles individuals showed a generated from search and obtained pooled significant effect abstracts (OR 1.43, 95% CI, 1.06 ? Abstracts considerd by two authors for to 1.93); OR higher in full text review trials that included an oral ? Differences of opinion resolved by exam and feedback (OR consensus 2.41, 95% CI, 1.79 to 3.24) Study design Cochrane Systematic Review and meta analysis. Studies included in meta-analysis ? Eight behavioral trials ? Separate meta analyses performed on 4 studies that randomized individuals and on 4 studies that gave oral exams and feedback to ST users C-192 Evidence Table 10. Systematic and meta-analysis reviews (continued) Main Results/ Author, year Study Characteristics Aim of Review Quality Rating Author, year Inclusion criteria Main results Quality rating El-Guebaly et al., Studies that presented data on samples of Twenty-four studies, 8 Fair 2002 people with diagnoses of specific mental included schizophrenia, 8 Geographic area illness or addictive disorders , with not included depression, and 8 Comments restrictions as to methodology. Broader included persons with NR Canada studies reporting symptomatic sub groups addictive disorders Adverse events Funding source in their analysis were excluded Interventins used a NA NR Population combination of medication, Time period People with diagnoses of specific mental educational and cognitive- covered illness or addictive disorders behavioral approaches Reveiwed the Characteristics of studies Post-treatment quit rates following databases (interventions) for Schizphrenia ranged between 1991 Smoking cessation interventions targeted from 35% to 56%, and a 6 through 2001: at people with diagnoses of specific months quit rate of 12% Medline, CINAHL, mental illness or addictive disorders PsycINFO, Best Postreatment quit rates for evidence, Method of review depression ranged from Healthstar, NR 31% to 72%, and 12 Cochrane Study design months quit rates 11.8% to Database of 46% Systematic Qualitative narrative synthesis Reviews, Legal What studies are included in meta- Postreatment quit rates for Trac, Bioethicsline, analysis addictive disorders ranged Philosopher?s from 7% to 60%, and 12 NA Index, and months quit rates 13% to Dissertation 27% abstracts Aim of review To assess the impact of smoking cessation approaches on individuals with mental illness or addictive disorders C-193 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Lancaster et al., Randomized trials of smoking cessation To detemine Good 2005 w/ followup of at least six months, where effectiveness of different Geographic area at least one arm tested a self-help forms of self-help Adverse events intervention materials, compared w/ No United Kingdom Self help defined as a structured no txt and w/ other Funding source program of smokers trying to quit without minimal contact Internal: intensive contact w/ a therapist strategies; effectiveness Department of Population of adjuncts to self-help, Primary Health such as computer Any smoker except pregnant smokers Care, University generated feedback, and adolescent smokers. of Oxford UK telephone hotlines, and Characteristics of studies pharmacotherapies External: NHS (Interventions) Research and Main results Development ? Self-help interventions used by Self-help vs no Programme UK individual to assist a quit attempt not intervention: OR favored aided by health professionals, self-help intevention, Time period counsellors and group support although C1 narrowly covered ? Included written materials, audio, excluded 1 (N = 13,773; Databases videotape or computer programs OR 1.24, 95% CI, 1.07 - searched systematically Method of review 1.45) ? Two authors extracted data ? Two trials excluded through April ? Trials categorized according to due to significant 2005 amount of face to face contact heterogeneity provided to both txt and comparison ? Where controls intervention, and according to whether received an alterative txt group received any written form of written materials materials -- no evidence of an effect Study design (N = 4,807; OR .87, Cochrane Systematic Review and meta 95% CI, .68 to 1.12); analysis performed where appropriate ? Failed to find evidence Studies included in meta-analysis of an increased quit NR rate by adding self-help to advice or NRT ? Based on 3 studies self-help tailored materials were better than no intervention (N = 7,790 OR 1.38, 95% CI, 1.15 - 1.66) C-194 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Lancaster et al., Randomized and quasi-randomized To determine effects of Good 2005 trials w/ a least one txt are consisting of individual counseling Geographic area face to face individual counseling from a Adverse events health care worker not involved in Main results No United Kingdom routine clinical care and outcome of ? Studies comparing Funding source smoking cessation at least 6 months counseling w/ minimal Internal: Oxford after intervention contact controls University of reported counseling Population Primary Health significantly increases Any smoker except children, Care UK; likelihood of cessation adolescents, and pregnant women. External: NHS compared to less Research and Characteristics of studies intense support (OR Development (Interventions) 1.56 95% CI, 1.32- Programme UK 1.84) ? Face to face encounter b/w a smoking Time period patient and a counsellor trained in ? No evidence of benefit covered assisting smoking cessation from more intensive compared to brief Databases ? Excludes studies of counseling counseling (OR .98, systematically delivered by doctors or nurses 95% CI, .61-1.56); searched though involved in regular clinical care ? Cessation rates higher Dec 2004 ? Also excluded multiple risk factor in trials that used NRT, interventions and patients w/ Method of review coronary artery ? Two authors extracted data disease ? Studies summarized ? No significant ? Results reported as odds ratios differences occured ? Meta analysis used when appropriate b/w the comparison of counseling approaches Study design Cochrane Systematic Review w/ meta analysis of pooled studies Studies included in meta-analysis NR C-195 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Lancaster et al., ? Randomized trials of smoking To assess effectiveness Good 2004 cessation advice from a medical of advice from physicians Geographic area practitioner in which abstinence was in promoting smoking Adverse events assessed at least 6 months following cessation; to compare NA United Kingdom advice. minimal interventions by Funding source ? For inclusion in meta analysis: 1) had physicians w/ more NHS Research to have at least 2 txt groups, and 2) intensive interventions; to and Development allocation to groups must use formal assess effectiveness of Programme UK randomization various aids to advice in prom Time period Population covered ? Participants were smokers recruited in Main results Reviewed the any setting Small satistically following ? Pregnant smokers excluded significant increase in databases b/w odds of quiting (OR 1.74, 1972 and 2003. Characteristics of studies 95% CI,1.48 to 2.05); (Interventions) Intense advice vs no Tobacco Studies included physician advice to advice and minimal Addiction Group stop smoking vs no advice or comparing advice showed a small Register, Medline, different levels of physician advice to but significant advantage Embase, Psyclit stop smoking to more intense advice and the Cochrane Central Register Method of review ? Data extracted from published reports A subset of 10 trials of of Controlled Trials, by 2 people independently smoker NOT selected as handsearching of ? Disagreeements resolved by referral having smoking related to a third party disease showed a specialist Quality assessment performed on all marginal significant journals, and ? conference studies impact for more intensive interventions (OR 1.24, proceedings Study design 95% CI, 1.02 to 1.50); Cochrane systematic reivew and meta analysis Studies that included followup visits had a Studies included in meta-analysis higher success rate vs no Seventeen trials of brief advice vs no advice than those studies advice were pooled that didn't have followup visits (OR 2.55, 95% CI, 2.04 to 3.19) Lack of evidence as to effectiveness of aids used in addition to providing advice and motivational counseling vs brief advice did not increase cessation rates C-196 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Lancaster et al., ? Randomized trials in which the To assess effectiveness Good 2000 intervention was training of health of training health care Geographic area care professionals in smoking professionals to deliver Adverse events cessation smoking cessation No United Kingdom ? Only used trials w/ outcomes from interventions to their Funding source patient smoking rates at least 6 patients, and to assess Internal: months after intervention additional effects of Department of prompts and reminders to Primary Health Population the health professional to Care, University Health care practitioner or health care intervene of Oxford UK; practice Main results External: NHS Characteristics of studies ? 10 studies met criteria Anglia and Oxford (Interventions) ? Trained professionals Region Research ? Health care professionals trained in about 1.5 to 2.5 times and Development methods to promote smoking more likely to counsel Programme UK; cessation among their patients patients about smoking NHS Research ? Allocated health care professionals ? One study found a and Dvelopment into at least 2 groups by a formal significant effect of National Cancer method of randomization training on sustained Programme UK ? Studies that compared trained abstinence at one yr professionals to C and studies that Time period (8.8% trained group vs examined effectiveness of adding covered 6.1% and 4.4% in prompts and reminders to training Database comparison groups P < searched Method of review 0.001) systematically ? Two reviewers independently ? Prompts increase through May 2000 extracted data from published articles. frequency of health Disagreement resolved by referral to professions performing another person intervention but only 1 out of 3 studies Study design reported significant Cochrane Systematic Review using a abstinence rates narrative approach to synthesising data Studies included in meta-analysis NR C-197 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Lumley et al., Randomized and quasi-randomized To assess effects of Good 2004 trials of smoking cessation programs smoking cessation Geographic area implemented during pregnancy in programs implemented Adverse events settings such as hopitals, and during pregnancy on No United Kingdom community clinics health of fetus, infant, Funding source Population mother, and family NHS Central R & Healthy pregnant women, women Main results D Programme, seeking a pre pregnancy consultation, Dept. of Health ? 48 trials revealed a and health professionals. 1995-1996 UK; significant reduction in Victorian Health Characteristics of studies smoking in late Promotion (Interventions) pregnancy for Foundation Interventions include programs providing aintervention groups Australia; Dept. of information on risks of smoking to fetus (RR.09, 95% CI, .93 - Health, funding and infant, benefits of quitting, .95) this is an absolute for EPI Center, recommendations to quit, setting quit difference of 6 out of London University date, feedback about fetus and harmful 100 women continuing UK; Public Health levels of cotinine or CO, teaching smoking Branch Victoria cognitive behavior strategies, advice ? With biochemically Dept. of Human tailored to stages of change model, validated studies, Services rewards/incentives, social support or absolute difference Australia; La peer support, and NRT was same (RR.94, Trobe University 95% CI, .92 - .95) Method of review ? Smoking cessation Time period ? Two reviewers independently interventions covered extracted data from published reports signifcantly reduced Databases ? Quality review of methodology low birth weight, searched assessed preterm birth, and systematically ? Heterogeneity tested In all pooled increase birth weight though July 2003 analyses by 33 g (RR .81, 95% CI, .70 - .94), (RR .84, Study design 95% CI, .72 - .98), and Cochrane Systematic Review and meta (95% CI, 11g - 55g) analysis ? Intervention strategy Studies included in meta-analysis (reward + social NR support) showed significantly greater smoking reduction (RR .77, 95% CI, .72 - .82) ? Stages of change and relapse showed no significant reduction in smoking C-198 Evidence Table 10. Systematic and meta-analysis reviews (continued) Main Results/ Author, year Study Characteristics Aim of Review Quality Rating Author, year Inclusion criteria: Aim of review Quality rating Melvin et al., 2003 Randomized, comparison-controlled To review the Good Geographic area intervention trials for pregnant smokers at recommendations made in the individual level 2000 regarding treatment Adverse events United States NR Funding source Population for pregnant and parenting Pregnant smokers Main results The Robert Wood Johnson Characteristics of studies The 5 A?s approach is still Foundation (interventions) the best treatment for light Time period ? Brief counseling approach for pregnant and moderate smokers covered smokers Databases ? Improving disclosure of smoking status Clinicians offering care to postpartum women and systematically ? Spontaneous quitting and eminence of parents should asses search from cessation smoking status and second January 1994 ? Postpartum relapse prevention hand smoke exposure through March 31 ? Adjuncts to brief counseling 2002. ? Exposure to second hand smoke For parents willing to quit, around time of pregnancy the use of ? Disclosure of second hand smoke pharmacotherapy should around time of pregnancy be used to help ? Increasing compliance with best To assess compliance of practice practice guidelines with Method of review best practice guide Pre-screened published articles for evaluation of effectiveness, relevance, two reviewers assessed assessment of financial studies independently for inclusion, data incentives, and extracted by 1 reviewer and checked by a identification of methods is second, and used narrative synthese needed Study design Additional research is Systematic review of literature recommended on ways to improve disclosure, safety What studies are included in meta- and efficacy of analysis pharmacotherapy, use of NA biomarker feedback or incentives, partner involvement, and interventions to reduce second hand smoke C-199 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Moher et al., 2005 Interventions categorized into two To assess extent to Good Geographic area groups: 1)Interventions aimed at which different kinds of individual to promote smoking cessation workplace smoking Adverse events United Kingdom in the workplace setting (included programs help smokers No Funding source randomized control trials) 2) to reduce or stop Internal: Interventions aimed at workplace as a cigarette consumption. Department of whole (included controlled trials w/ Primary Health baseline and post interventionoutcomes Main results Care, Oxford and interrrupted times series studies) ? Group and individual University, counseling (particularly Population External: NHS by a physician), and Adults, over 18 yrs of age, in Research and NRT significantly employment, who smoked. Development increased cessation Program UK Characteristics of studies rates vs no txt or Time period (Interventions) minimal intervention controls covered ? Smoking cessation programs aimed at individual in workplace including ? Self-help interventions Databases searched individual and group counseling, self less effective systematically help materials, advice from physicians ? Tobacco bans aimed at workplace as a whole through October and NRT 2004. ? Interventions aimed at workforce decreased cigarette population to assess a comprehensive consumption at work approach to workers health, including but no evidence that smoking cessation total consumption decreased Method of review ? Quit rates not ? Prescreened published articles for increased by adding relevance social or environmental ? Two reviewers assessed studies support to workplace independently for inclusion programs Competitions ? Data extracted by 1 reviewer and and incentives checked by a second increased attempts to ? Because of considerable quit but less evidence heterogeneity studies were combined for actual quitting using qualitative narrative synthesis Study design Cochrane Systematic Review Studies included in meta-analysis NR C-200 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Prochaska et al., Randomized controlled designs of To examine outcomes of Good 2004 evaluations of a smoking cessation smoking cessastion Geographic area intervention where study participants interventions evaluated Adverse events were in addiction txt or recovery w/ individual in current No US addictions txt or recovery Funding source Studies used quantitative assessment Main results Calif Tobacco- Population Related Disease ? Abstinence rates for Adults aged 18 yrs and older. Research addictions txt were Program, and Characteristics of studies 12% vs 3% in National Institute (Interventions) intervention and Cs on Drug Abuse ? Psychosocial smoking cessation ? Abstinence rates for Time period interventions provided in all but 1 recovery were 38% vs covered study and included the following: brief 22% in intervention and Cs January 1966 advice, educational information, skill through based, behavioral, cognitive ? Summary RR for September 2003 behavioral, motivational, or staged addiction txt 2.03 (95% based interventions CI, 1.21 - 3.39; ? Eleven studies provided NRT, one heterogeneity, P = evaluated bupropion, and another 0.519) indicated a fluoxetine significant increase in likelihood of abstinence Method of review in intervention group ? Two reviewers independently ? Summary RR for conducted article abstraction recovery 1.77 (95%CI, ? One reviewer blinded to study author, 1.37-2.30; institution, artile title, journal, and yr of heterogeneity, P = publication 0.878) indicated a ? Qualilty assessment used a 3 pt scale significant increase in ? Discrepancies settled though likelihood of abstinence discussion or consulting a third in intervention group reviewer ? ANOVA comparing addiction and recovery Study design intervention effects ? Abstinence ratios used to measure were NS effect for smoking and substance use ? Long term follow up no ? Meta Analysis performed using 2X2 significant differences tables for txt and Cs in smoking outcomes ? To reduce bias .5 was added to every by condition cell in the table containing a zero ? Significant increase of ? Abstinence rates expressed as drug and alcohol relative risk w/ 95% CI; RR > 1.0 abstinence occurred in indicated favoring of intervention for intervention groups RR increased abstinence = 1.25 (95% CI, 1.07 ? Studies included in meta-analysis 1.46, heterogeneity, P ? 19 studies = 0.496) ? 12 conducted w/ 1,410 participants in ? NRT studies revealed addiction txt and 7 studies w/ 638 stronger effects and participants in recovery more recently published C-201 Evidence Table 10. Systematic and meta-analysis reviews (continued) Main Results/ Author, year Study Characteristics Aim of Review Quality Rating Author, year Inclusion criteria: Aim of review Quality rating Rigotti et al., 2002 ? Randomized and quasi-randomized To determine the Good Geographic area trials of behavioral, pharmacological or effectiveness of multicomponent interventions to help interventions for smoking Adverse events United Kingdom patients to stop smoking conducted with cessation in hospitalized No Funding source hospitalized patients patients. NHS Research and ? Trials of secondary prevention or Development cardiac rehabilitation that did not recruit Main results Programme UK on the basis of smoking history and Intensive intervention and Department of trials in patients hospitalized for (inpatient contact plus Primary Health psychiatric disorders or substance follow-up for at least 1 Care, Oxford abuse (including inpatient tobacco month) was associated University,UK addiction programs) were excluded. with a significantly higher quit rate compared to Time period Population control (Peto Odds Ratio = covered Patients who were hospitalized, or about 1.82 (95% CI, 1.49-2.22, Databases to be hospitalized and who were currently six trials). Inteventions with systematically smoking or had recently quit. less than a month of follow- searched through up did not show evidence March 2002 Characteristics of studies of significant benefit (Peto (interventions) Odds Ratio 1.99, (95%CI, Any intervention to increase motivation to 0.91-1.31, seven trials). quit, to assist a quit attempt or to help There was no evidence to recent quitters avoid relapse. judge the effect of very brief (<20 minutes) Interventions during the hospital stay were interventions delivered only categorized according to whether they during rhe hospital stay. included follow-up after discharge and by Longer inteventions level of intensity leading to four categories delivered only during the of intervention intensity: hospital stay were not ? Single contact in hospital lasting ? 15 significantly associated minutes, no follow-up support with a higher quit rate ? One of more contacts in hospital lasting (Peto Odds Ratio 1.07 in total > 15 minutes, no follow-up (95% CI, 0.79-1.44, three support trials). Although the ? Any hospital contact plus follow-up ? 1 interventions increased quit month rates irrespective of ? Any hospital contact plus follow-up ? 1 whether nicotine month replacement therapy (NRT) was used, the results for Method of review NRT were compatible with Pre-screened published articles for other data indicating that it relevance, three reviewers assessed increases quit rates. There studies independently for inclusion, data was no strong evidence extracted by 1 reviewer and checked by a that clincial diagnosis second, and used statistical methods for affected the likelihood of pooling described by Peto?s group (Yusuf quitting. 1985) Study design Cochrane Systematic Review What studies are included in meta- analysis 17 trials conducted in the US, the UK, Canada and Spain between 1990 and 2002 C-202 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Secker-Walker et Controlled trials of community To assess effectiveness Good al., 2002 interventions for reducing smoking of community prevalence in adult smokers where interventions for reducing Adverse events Geographic area primary outcome measure was smoking prevalence of smoking No United Kingdom behavior Funding source Main results Population No source of ? Changes in smoking Adults, 18 yrs and older support supplied prevalence measured using cross sectional Time period Characteristics of studies (Interventions) data in 27 studies covered Coordinated, multidimensional programs ? Net decline ranged Databases aimed at changing adult smoking from -1.0% to 3.0%/yr; searched behavior involving several segments of for women -.2% to systematically the community and conducted in a 3.5%/yr; for men -.4% through August, defined geographical area such as a to 1.6%/yr 2001 town, city, county, or administrative ? Two rigorous studies district found significant results:1) change in Method of review smoking prevalence ? Prescreened published articles for among light/moderate relevance smokers, 2) greater ? Two reviewers assessed studies quit rates among men independently for inclusion but community level ? Data extracted by 1 reviewer and changes not found checked by a second ? Projects that address ? Studies combined using qualitative smoking alone scarcely narrative synthesis more effective than general health Study design prevention projects Cochrane Systematic Review ? Longer project, Studies included in meta-analysis projects using NR formative research, and projects w/ higher levels of participation and awareness were more effective C-203 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Sinclair et al., Randomized trials which compared To assess effectiveness Good 2005 interventions by community pharmacy of interventions by Geographic area personnel to promote smoking cessation community pharmacy Adverse events amongst their clients who were smokers personnel to assist clients NA United Kingdom compared to usual pharmacy support or to stop smoking Funding source any less intensive program Main results University of Population Aberdeen UK ? Two trials met the Community pharmacy clients who are criteria w/ a total of 976 Time period smokers and wish to stop. smokers covered Characteristics of studies ? Both studies involved Databases (Interventions) training using stages of systematically Any intervention by community change model, and searched through pharmacy personnel to promote smoking compared a support March 2003. cessation amongst their clients program of counseling Pharmaceutical trials which compared and record keeping w/ only NRT w/ a control in the community a C who recieved pharmacy setting did not fall within normal services scope of this review ? Significant result for study 1 showed Method of review cotinine-validated ? Studies generated by search strategy continuous abstinence reviewed by two authors, according to at 12 months of 14.3% inclusion criteria in intervention group ? Data extracted by one author and and 2.7% in C checked by a second ? Study 2 did not show a statistically significant Study design effect at any followup, Cochrane Systematic Review but there was a Studies included in meta-analysis consistent trend toward NR benefits fro intervention ? Using a random effects model to pool results showed no evidence of significant benefits C-204 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Sowden et al., Randomized and non RCTs that To determine Good 2003 assessed effectiveness of multi- effectiveness of Geographic area component community (geographical or community interventions Adverse events school district) interventions to prevent in preventing initation of No United Kingdom uptake of smoking in young people smoking in young people. Funding source Population Main results NHS Center for Young people aged less than 25 yrs Reviews and ? Community Dissemination, Characteristics of studies interventions vs no UK (Interventions) intervention controls reported lower smoking Time period Interventions targeted at entire or parts covered of entire communities or lage ares w/ prevalence; intention of influencing smoking ? Community Databases behaviors of young people interventions vs searched school-based only systematically Method of review intervention found a through ? Prescreened published articles for significant smoking September 2002 relevance prevalence in one ? Two reviewers assessed studies study independently for inclusion ? Community ? Data extracted by 1 reviewer and interventions vs checked by a second, community w/ school- ? Studies combined using qulitative based component narrative synthesis found no differences in smoking cessation Study design rates Cochrane Systematic Review ? Community Studies included in meta-analysis intervention w/ media NR component vs media alone found significantly lower rate of increased smoking in community and media intervention C-205 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Sowden et al., Studies that evaluated effectiveness of To determine Good 1998 mass media campaigns influencing effectiveness of mass Adverse events Geographic area smoking behaviors in young people media campaigns in using the following designs: 1) RCT w/ preventing uptake of NA United Kingdom unit of analysis as school, community or smoking in young people. Funding source geographic area, 2) controlled trial w/o Internal: NHS randomization, 3) time series Main results Centre for ? Two of these six Population Reviews and control trial design Young people aged less than 25 yrs. Dissemination interventions found to UK; External: Characteristics of studies be associated w/ NHS Research (Interventions) reductions in smoking and Development behavior ? Mass media interventions using National Cancer communication channels such as TV, ? A media campaign Programme, radio, newspapers, bill boards, aimed at girls found England UK posters, leaflets or booklets intended 4% lower smoking Time period to prevent uptake of smoking in young rates for girls in the media county (8.6% vs covered people 12.4%, P < 0.01); OR Databases ? Also mass media campaigns of being a smoker in searched combined w/ school-based programs intervention county systematically designed to influence smoking compared w/ being a through June behaviors were included smoker in control was 1998 Method of review .74 (95% CI, .64 to .86) ? Stage 1: Reports of evaluations after adjusting for prescreened for relevance by at least baseline and gender one reviewer ? A media campaign ? Stage 2: Relevant studies assessed combined w/ a school- independently by 2 reviewers based program vs ? Stage 3: Data extracted from included school based program studies by one reviewer and checked alone found a lower by a second reviewer risk for weekly smoking ? Stage 4: Studies combined using at 2 yr in communities qualitative narrative synthesis w/ combined intervention (OR .62, Study design 95% CI, .49 to .78) ? Cochrane Systematic Review ? Both studies had ? Studies combined using qualitative effective campaigns w/ narrative synthesis solid theoretical basis, Studies included in meta-analysis used formative NR research in designing messages, and message broadcasts were intense over a extensive period of time ? Problems w/ other studies: allocation of communities, areas and schools, unit of analysis, differences in baseline measure, and high attrition C-206 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Stead et al., 2005 Randomized trials w/ a minimum of two To determine effects of Good Geographic area group meetings and followup at least 6 smoking cessation months programs delivered in a Adverse events United Kingdom Population group format compared No Funding source to self-help materials, no Smokers of either gender irrespective of Internal: intervention, individual initial level of nicotine dependency, Department of counseling, advice from except for pregnant smokers. Primary Helath Physician, and NRT Care, Oxford Characteristics of studies (Interventions) Main results University UK, External: NHS Studies where smokers met for ? Group therapy Research and scheduled meetings and received some significantly increased Development form of behavioral therapy delivered cessation vs self-help National Cancer over at least 2 sessions using same or different Programme UK content (N = 4395, OR Method of review 2.04, 95% CI, 1.60 - Time period ? Studies idenified and reviewed 2.60) covered independently by 2 authors and ? Higher quit rates Database disagreements referred to a third party comparing group to no searched ? If 2 group methods were compared w/ intervention N = 815, sytematically another method the groups were OR 2.17, 95% CI, 1.37 through February combined and compared w/ the non - 3.45); No significant 2005 group method difference comparing group w/ individual Study design therapy and only Cochrane Systematic Review and meta limited evidence that analysis performed if appropriate group produces extra Studies included in meta-analysis benefits when NR combined w/ physician advice and NRT C-207 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Stead, 2003 Randomized or quasi-RCTs in which To evaluate effect of Good Geographic area proactive or reactive telephone proactive and reactive counseling to assist smoking cessation telephone support to help Adverse events United Kingdom was offered to smokers or recent quitters smokers quit No Funding source Population Main results NHS Research Smokers or recent quitters and Development ? Procative phone Programme UK Characteristics of studies counseling + minimal (Interventions) intervention vs minimal Time period intervention only: covered ? Proactive or reactive telephone indicted a significant Databases counseling to assist smoking benefit from addition of searched cessation to any population phone counseling systematically ? Also studies that combined telephone when minimal through counseling w/ self-help materials intervention used September 2002 Method of review standard self-help Relevant studies identified by one material (OR 1.56, person and checked for inclusion or 95% CI, 1.38 - 1.77) exclusion by a second person ? Proactive phone Data extracted by one author and counseling increasec checked by a second quit rates from 4.1% to 7.5% when compared Study design to self-help or reactive Cochrane Systematic Review and if no counseling; Adding signficant heterogeneity studies pooled telephone counseling for a meta analysis to face to face Studies included in meta-analysis interventions failed to NR significantly increase OR (OR 1.08, 95% CI, .87- 1.33) ? Adding proactive counseling to NRT did not signficantly increasequit rates; proactive counseling compared to group counseling showed no differences ? Access to a hotline or reactive phone counseling showed a significant benefit in one out of 3 trials C-208 Evidence Table 10. Systematic and meta-analysis reviews (continued) Study Aim of Review Demographics Study Characteristics Main Results Quality Rating Author, yr Inclusion criteria Aim of review Quality rating Thomas et al., Studies where individual students, To review all RCTs of Good 2002 classes, schools, or school districts were behavioural interventions Geographic area randomised to intervention or Cs and in schools to prevent Adverse events followed for at least 6 months children and adolescents No United Kingdom Funding source Population starting smoking Children (aged 5 to 12) or adolescents Main results No source of (aged 13 to 18) in school settings support supplied ? Information curriculum Characteristics of studies interventions less Time period covered (Interventions) effective or showed no Classroom programs or curricula, difference compared to Databases including those associated w/ family or other models of systematically community interventions, intended to delivery searched through deter use of tobacco ? SLT (most widely used January 2002 theory) had 8 studies Method of review w/ positive effects and ? Prescreened published articles for 7 w/o positive effects relevance and HSPP study had ? Two reviewers assessed studies no effect independently for inclusion ? SLT lacks evidences ? Data extracted by 1 reviewer and about effectiveness checked by a second ? Limited evidence that ? 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Garteizaurrekoa smoking cessation intervention at the workplace: a Dublang, O. Sainz Martinez, J. I. Diez randomised controlled trial Azcarate, M. Foj Aleman and J. R. Banegas Sorensen, G, B. Thompson, K. Glanz, Z. Feng Work site-based cancer prevention: Primary 1996 and et al. results from the Working Well Trial Sorensen, G., A. M. Stoddard, et al. A comprehensive worksite cancer prevention 2002 intervention: behavior change results from a randomized controlled trial (United States Sorensen, G., A. M. Stoddard, et al. A comprehensive worksite cancer prevention 2003 intervention: behavior change results from a randomized controlled trial (United States COCHRANE: Rigotti et al., ?Interventions for smoking cessation in hospitalized patients.? Author Title Year Feeney, G. F., A. McPherson, et al. Randomized controlled trial of two cigarette quit programmes 2001 in coronary care patients after acute myocardial infarction Galvin, K., C. Webb, et al. Galvin, K., C. Webb, et al. (2001). 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Maccoby the effects of videotape delivery with and without same-age peer leader participation D-34 Meta-Analysis: Fiore MC, et al., ?Clinical Practice Guide: Treating Tobacco Use & Dependence? Author Title Year Practice guideline for the treatment of patients 1996 with nicotine dependence. American Psychiatric Association Colby SM, P. M. Monti, N. P. Barnett, D. J. Brief motivational interviewing in a hospital 1998 Rohsenow, K. Weissman, A. Spirito, R. H. setting for adolescent smoking: a preliminary Woolard and W. J. Lewander study Ginsberg, JP, R. C. Klesges, K. C. Johnson, L. The relationship between a history of depression 1997 H. Eck, A. W. Meyers and S. A. Winders and adherence to a multicomponent smoking- cessation program Glassman, AH, L. S. Covey, G. W. Dalack, F. Smoking cessation, clonidine, and vulnerability 1993 Stetner, S. K. Rivelli, J. Fleiss and T. B. Cooper to nicotine among dependent smokers Hall SM, R. F. Munoz, V. I. Reus, K. L. 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Weight gain as a function of smoking cessation 1994 and 2-mg nicotine gum use among middle-aged smokers with mild lung impairment in the first 2 years of the Lung Health Study Meenan RT, V. J. Stevens, M. C. Hornbrook, P. Cost-effectiveness of a hospital-based smoking 1998 A. La Chance, R. E. Glasgow, J. F. Hollis, E. cessation intervention Lichtenstein and T. M. Vogt Munoz RF, B. V. Marin, S. F. Posner and E. J. Mood management mail intervention increases 1997 Perez-Stable abstinence rates for Spanish-speaking Latino smokers Nides NA, R. F. Rakos, D. Gonzales, R. P. Predictors of initial smoking cessation and 1995 Murray, D. P. Tashkin, W. M. Bjornson-Benson, relapse through the first 2 years of the Lung P. Lindgren and J. E. Connett Health Study Orleans, C, N. R. Boyd, R. Bingler, C. Sutton, D. A self-help intervention for African American 1998 Fairclough, D. Heller, M. McClatchey, J. Ward, C. smokers: Tailoring Cancer Information Service Graves, L. Fleisher and S. 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Smith- Health education for pregnant smokers: its 1993 Yoder, L. Artz, M. Crawford, K. Amburgy and N. behavioral impact and cost benefit R. Boyd, Jr. META-ANALYSIS: Prochaska JJ, Delucchi K, Hall SM. A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. Journal of Consulting and Clinical Psychology. 2004; 72(6): 1144-56. Author Title Year Bobo, JK, H. E. McIlvain, H. A. Lando, R. D. Effect of smoking cessation counseling on 1998 Walker and A. Leed-Kelly recovery from alcoholism: findings from a randomized community intervention trial Burling TA, Burling AS, Latini D. A controlled smoking cessation trial for 2001 substance-dependent inpatients Cornelius JR, Perkin KA et al Fluoxetine versus placebo to decrease the 1999 smoking of depressed alcoholic patients Hayford, K. E., C. A. Patten, et al. 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Healton Gilbert, J, D. M. Wilson, J. Singer, A family physician smoking cessation program: An evaluation 1992 E. A. Lindsay and et al. of the role of follow-up visits Glasgow R.E, E. P. Whitlock, E. G. A brief smoking cessation intervention for women in low- 2000 Eakin and E. Lichtenstein income planned parenthood clinics Jason LA, E. Tait, D. Goodman, L. Effects of a televised smoking cessation intervention among 1988 Buckenberger and et al. low-income and minority smokers Klein, JD, M. Portilla, A. Goldstein Training pediatric residents to prevent tobacco use 1995 and L. Leininger Kottke TE, M. L. Brekke, L. I. A randomized trial to increase smoking intervention by 1989 Solberg and J. R. Hughes physicians. Doctors Helping Smokers, Round I Lando, HA, W. L. Hellerstedt, P. L. Brief supportive telephone outreach as a recruitment and 1992 Pirie and P. G. McGovern intervention strategy for smoking cessation Manfredi, C, K. S. Crittenden, R. Evaluation of a motivational smoking cessation intervention 1999 Warnecke, J. Engler, Y. I. Cho and for women in public health clinics C. Shaligram McBride, CM, D. Scholes, L. C. Evaluation of a minimal self-help smoking cessation 1999 Grothaus, S. J. Curry, E. Ludman intervention following cervical cancer screening and J. Albright McFall SL, A. Michener, D. Rubin, The effects and use of maintenance newsletters in a smoking 1993 B. R. Flay, R. J. Mermelstein, D. cessation intervention Burton, P. Jelen and R. B. Warnecke Ockene, JK, J. Kristeller, L. Pbert, The physician-delivered smoking intervention project: can 1994 J. R. Hebert, R. Luippold, R. J. short-term interventions produce long-term effects for a Goldberg, J. Landon and K. Kalan general outpatient population? R. H. Secker-Walker, L. J. Solomon, Reducing smoking during pregnancy and postpartum: 1998 B. S. Flynn, J. M. Skelly and P. B. physician's advice supported by individual counseling Mead Salina, D, L. A. Jason, D. Hedeker, A follow-up of a media-based, worksite smoking cessation 1994 J. Kaufman, L. Lesondak, S. D. program McMahon, S. Taylor and P. Kimball D-37 Appendix E Acknowledgments Appendix E. Acknowledgments This study was supported by Contract 290-02-0016 from the Agency for Healthcare Research and Quality (AHRQ), Task No. 6. We acknowledge the support of Kenneth Fink, M.D., M.G.A., M.P.H., former Director of the AHRQ Evidence-Based Practice Center (EPC) Program, and Ernestine Murray, B.S.N., R.N., M.A.S., the AHRQ Task Order Officer for this project. The investigators deeply appreciate the considerable support, commitment, and contributions of the EPC team staff at RTI International and the University of North Carolina (UNC). From UNC, we thank EPC Co-Director, Timothy S. Carey, M.D., M.P.H.; EPC Literature Search Specialist, B. Lynn Whitener, Ph.D., Gerald Gartlehner, M.D., M.P.H., Research Coordinator and Laura Morgan, Research Assistant. We also express our gratitude to Lisa Hund, M.P.H.; Abstractor, Tammeka Swinson, B.A.; Project Manager and Loraine Monroe, EPC word processing specialist, at RTI International. Technical Expert Panel We also extend our appreciation to the members of our Technical Expert Panel (TEP), who provided advice and input during our research process. The RTI-UNC EPC team solicited the views of TEP members from the beginning of the project. TEP members also provided insights into and reactions to work in progress and advice on substantive issues or possibly overlooked areas of research. TEP members participated in refining the analytic framework and key questions and discussing the preliminary assessment of the literature, including inclusion/exclusion criteria, and also provided input on the information and categories, including evidence tables. The TEP was both a substantive resource and a ?sounding board? throughout the study. It was also the body from which expertise was formally sought at several junctions. TEP members are listed below: Kathleen Adams, Ph.D. Cecelia Gaffney, M.Ed. Associate Professor, Department of Health Instructor in Family and Community Medicine, Policy & Management, School of Public Norris Cotton Cancer Center, Dartmouth Medical Health, Emory University School Atlanta, Georgia White River Junction, New Hampshire Dianne C. Barker, M.H.S. Harry Lando, Ph.D. Founder and Principal, Barker BiCoastal Professor, Division of Epidemiology, School of Health Consultants (BBHC) Public Health Los Angeles, California University of Minnesota, Minneapolis Matthew P. Barry, M.P.A. Herbert H. Severson, Ph.D. Senior Policy Analyst, Campaign for Senior Research Scientist, Oregon Research Tobacco-Free Kids Institute Washington, D.C. Eugene, Oregon E-1 Peer Reviewers We gratefully acknowledge the following individuals who reviewed the initial draft of this report and provided us with constructive feedback. External reviewers comprised clinicians, researchers, representatives of professional societies, and potential users of the report. We would also like to extend our appreciation to David Atkins, M.D., from AHRQ for contributing peer review comments. Our peer review panel also includes five members of the TEP. Peer review was a separate duty for these individuals and not part of their commitment as TEP members. All are active professionals in the field. The peer reviewers were asked to provide comments on the content, structure, and format of the evidence report and to complete a checklist. The peer reviewers? comments and suggestions formed the basis of our revisions to the evidence report. Acknowledgments are made with the explicit statement that this does not constitute endorsement of the report. Kathleen Adams, Ph.D. Cecelia Gaffney, M.Ed. Associate Professor, Department of Instructor in Family and Community Health Policy & Management, School of Medicine, Norris Cotton Cancer Center, Public Health, Emory University Dartmouth Medical School Atlanta, Georgia White River Junction, New Hampshire Dianne C. Barker, M.H.S. Nancy Kaufman, R.N., M.S. Founder and Principal, Aurora Health Care Barker BiCoastal Health Consultants Los Angeles, California Harry Lando, Ph.D. Professor, Division of Epidemiology, Matthew P. Barry, M.P.A. School of Public Health, Senior Policy Analyst University of Minnesota Campaign for Tobacco-Free Kids Minneapolis, Minnesota Washington, D.C. Lois Biener, Ph.D. Sharon Phelan, M.D. Senior Research Fellow Chair/Professor Obstetrics & Gynecology, Center for Survey Research, University of New Mexico University of Massachusetts Albuquerque, NM Boston, Massachusetts Brian Flay, Ph.D. University Distinguished Professor, Department of Public Health Oregon State University Corvallis, Oregon E-2 Author Title Year Sinclair, HK, C. M. Bond, A. S. Training pharmacists and pharmacy assistants in the stage- 1998 Lennox, J. Silcock, A. J. Winfield of-change model of smoking cessation: a randomised and P. T. Donnan controlled trial in Scotland Stevens VJ, R. E. Glasgow, J. F. A smoking-cessation intervention for hospital patients 1993 Hollis, E. Lichtenstein and et al. Ward Jand R. Sanson-Fisher Does a 3-day workshop for family medicine trainees improve 1996 preventive care? A randomized control trial Wilson, DM, D. W. Taylor, J. R. A randomized trial of a family physician intervention for 1988 Gilbert, J. A. Best, E. A. Lindsay, D. smoking cessation G. Willms and J. Singer D-38