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. 
ii 

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. 
iii

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. 

Director 

Agency for Healthcare Research and Quality 

Barnett Kramer, M.D., M.P.H. 

Director 

Office of Medical Applications of Research 

National Institutes of Health 

Jean Slutsky, P.A., M.S.P.H. 

Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality 

Beth Collins Sharp, Ph.D., R.N. 

Director, EPC Program 

Agency for Healthcare Research and Quality 

Ernestine Murray, R.N., M.A.S. 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 

v

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 followup 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 providerbased interventions to reduce tobacco initiation; (c) effectiveness of community- and providerbased 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. 

vii

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 
viii

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 
ix

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 
x

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
1 

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): 
2 

• 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. 
3 

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 metaanalysis 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 
4 

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 
5 

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. 
6 

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; 
7 

• 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. 
8 

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. 
Evidence Report 
11 

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 
12 

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. 
13 

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. 
14 

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. 
15 

studies (Appendix D), and acknowledgments, including the TEP and peer reviewers (Appendix 

E). 

 
17 

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, 

tobacco cessation for diverse populations of 

adults in a variety of settings, and population 

harm resulting from smokeless tobacco 

marketing. Table 1 lists the key questions 

(KQs) as they were related from the Agency 

for Healthcare Research and Quality 

(AHRQ).

Key Questions 

KQ 1 seeks to understand how to use 

community- and population-based 

interventions to prevent initiation of tobacco 

use among adolescents and young adults 

across diverse populations. For those 

individuals who do become dependent on 

tobacco products, eventual disease, disability, 

and death can be avoided if they quit using 

tobacco products. KQ 2 seeks to identify 

strategies that increase the likelihood that tobacco users will want and use effective individual 

treatments. Because creating demand for tobacco use cessation is insufficient as a strategy if 

tobacco users do not respond by using these services or if effective treatments and strategies are 

not available in communities and health care systems, KQ 3 asks for a summary of proven 

strategies to increase the implementation of proven population-level tobacco use cessation 

strategies in health care systems and communities. 

Although consensus exists around some tobacco use cessation strategies, controversy 

surrounds other suggested strategies for harm reduction, such as the use of smokeless tobacco 

products. Arguing that the harm associated with smoking cigarettes is much greater for both the 

individual and for those around the smoker than the harm associated with products that are not 

Table 1. Final Key Questions 

KQ 1. What are the effective population- and 

community-based interventions to prevent 

tobacco use among adolescents and young 

adults, including among diverse populations? 

KQ 2. What are effective strategies for increasing 

consumer demand for and use of proven 

individually oriented cessation treatments, 

including among diverse populations? 

KQ 3. What are effective strategies for increasing 

the implementation of proven population-level 

tobacco use cessation strategies, particularly 

by health care systems and communities? 

KQ 4. What is the effect of smokeless tobacco 

product marketing and use on population 

harm from tobacco use? 

KQ 5. What is the effectiveness of prevention and 

cessation interventions in populations with 

co-occurring morbidities and risk behaviors? 

KQ 6. What research is needed to make the most 

progress and greatest public health gains 

nationally and internationally (based on work 

for questions 1–5)? 
18 

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 tobaccorelated 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 cooccurring 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. 
19 

Figure 1. Overall analytic framework for tobacco use, initiation, and cessation 

Implementation 

strategies

 Reminder systems

 Provider education

Population strategies

 Media campaigns

 Restrictions and bans

Marketing 

smokeless 

products

Strategies to 

improve success 

rate

Strategies to 

increase number of 

quitters

Individual 

cessation 

treatment

Increased quit rates

Increased use of 

smokeless

tobacco

Increased use of 

cigarettes

Population

KQ1 – Adolescent, young adults, and diverse populations

KQ2 – Adolescents, young adults, adults, and diverse

 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

Initiation Tobacco 

dependence

 Decreased consumption 

and use

 Increased cessation

Morbidity and 

mortality

Strategies to reduce 

initiation

 Population-based

 Community-based

KQ2 and KQ5

KQ3

KQ1

KQ4

Interventions

Outcomes

Possible association

Adapted from Hopkins et al., 200131
20 

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 
21 

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 
22 

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 
23 

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 tobaccorelated 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. 
24 

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 cooccurring 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. 
25 

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 

design and other criteria) 

Original research studies that provide sufficient detail regarding methods and results to 

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. 
26 

Article selection process. 

Once we had identified articles 

through the electronic database 

search, review articles, and 

bibliographies, we examined 

abstracts and the full text of the 

articles to determine whether 

the studies met our inclusion 

criteria. Two reviewers initially 

evaluated abstracts for 

inclusion or exclusion; only one 

reviewer was needed to include 

an article, but two reviewers 

were required to exclude an 

article. Dr. Ranney, the Study 

Director, reconciled all 

conflicts. As articles appeared 

that met inclusion criteria at the 

abstract review stage, we 

obtained the article’s full text. 

For the full text review, two 

reviewers read each article and 

determined whether it met our 

eligibility criteria. Again, Dr. 

Ranney adjudicated any 

disagreements. Dr. Ranney and 

Dr. Cathy Melvin, our Scientific Director, reviewed articles excluded by the first two reviewers 

and assigned reasons for exclusion or, when appropriate, included them in the pool for 

abstraction. 

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); 

Table 3. Medical subject headings and text words

Medical Subject Headings 

Tobacco use cessation Marketing 

Smoking cessation Social marketing 

Smoking/prevention and control Choice behavior 

Smoking (and as text term) Advertising 

Primary prevention 

 

Community networks Tobacco, smokeless 

Community health services Spit tobacco (text term) 

Community health planning Chewing tobacco (text term) 

Community health aides Dip tobacco (text term) 

Community health nursing Oral tobacco (text term) 

Community health centers 

Community mental health services Comorbidity 

Community medicine Risk-taking 

Community mental health centers Risk factors 

 Depressive disorder 

Randomized controlled trials Depression 

Single-blind method Bipolar disorder 

Double-blind method Attention deficit disorder with 

hyperactivity 

Random allocation Stress disorders, post-traumatic 

 Diabetes mellitus 

Consumer satisfaction Hypertension 

Consumer participation Heart diseases 

Health services needs and demand Asthma 

 Obesity 

Health plan implementation 

Diffusion of Innovation 

Patient education 
27 

• 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. 
28 

• 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.” 
29 

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 

Good 

Good or fair 

Greatest 

Greatest or moderate 

Greatest 

At least 2 studies 

At least 5 studies 

At least 5 studies 

Sufficient Good 

Good or fair 

Good or fair 

Greatest 

Greatest or moderate 

Greatest, moderate, or least 

At least 1 study 

At least 3 studies 

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. 
31 

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.
32 

Figure 3. Tobacco use: prevention, cessation, and control article disposition 

Title and abstracts identified through searches

N = 1,288

Citations excluded

N = 642

Published in abstract form only

N = 2

Full text articles excluded:

N = 298

 1 Foreign language

106 Wrong outcome/off topic

 12 Sample size too small

 3 Outside specified geographic area

 93 Wrong publication type

 22 Wrong study design

 8 Followup too short

 53 Wrong date

Full text articles retrieved

N = 488

Full text articles included in review

N = 102

Marked as background

N = 88

Full text not obtained – overlapped with 

included meta-analysis

N = 156

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, metaanalyses, 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), 
33 

• 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 

Review Type Authors Topic 

Included 

Research 

Cochrane Ebbert JO, Rowland LC, Montori V, Vickers 

KS, Erwin PC, Dale LC, Stead, LF57 Interventions for smokeless tobacco use 

cessation 

1992 to Mar. 

2004 

Cochrane Lancaster T, Stead LF58 Physician Advice for Smoking 

Cessation 

1974 to 2003 

Cochrane Lancaster T, Stead L59 Self-help interventions for smoking 

cessation 

1981 to Apr. 

2005 

Cochrane Lancaster T, Stead LF60 Individual behavioural counseling for 

smoking cessation 

1984 to Feb. 

2005 

Cochrane Lumley J, Oliver SS, Chamberlain C, and 

Oakley L61 Interventions for promoting smoking 

cessation during pregnancy 

1976 to Mar. 

2004 

Cochrane Moher M, Hey K, Lancaster T62 Workplace interventions for smoking 

cessation 

1981 to Feb. 

2005 

Cochrane Rigotti NA, Munafo MR,Murphy MFG, 

Stead LF63 Interventions for smoking cessation in 

hospitalised patients 

1974 to 2002 

Cochrane Secker-Walker RH, Gnich W, Platt S, 

Lancaster T36 Community interventions for reducing 

smoking among adults 

1970 to Jan. 

2002 

Cochrane Sowden A, Arblaster L33 Mass media interventions for preventing 

smoking in young people 

1983 to Aug. 

1998 

Cochrane Sowden A, Stead L64 Community interventions for preventing 

smoking in young people 

1983 to Sept. 

2002 

Cochrane Stead LF, Lancaster T65 Group behaviour therapy programmes 

for smoking cessation 

1981 to Feb. 

2005 

Cochrane Stead LF, Lancaster T, Perera R66 Telephone counseling for smoking 

cessation 

1991 to Oct. 

2002 

Cochrane Thomas R34 School-based programmes for 

preventing smoking 

1980 to Jan. 

2002 

Systematic 

review 

el-Guebaly N, Cathcart J, Currie S, Brown 

D, Gloster S30 Smoking cessation approaches for 

persons with mental illness or addictive 

disorders 

1990 to 2000 

Meta-analysis Fiore MC, Bailey WC, Cohen SF, et al.5 Clinical practice guideline update: 

Treating Tobacco Use and Dependence 

1995 to 1999 

Meta-analysis Prochaska JJ, Delucchi K, Hall SM9 A meta-analysis of smoking cessation 

interventions with individuals in 

substance abuse treatment or recovery 

1991 to 2003 

Systematic 

review 

Lynch BS, Bonnie RJ32 Growing up tobacco free: preventing 

nicotine addiction in children and youths 

1990 to 1993 

Systematic 

review 

Melvin, CL, Gaffney, C37 Treating nicotine use and dependence 

of pregnant and parenting smokers: An 

update 

1994 to 2003 

Systematic 

review 

US Department of Health and Human 

Services 

Reducing tobacco use: a report of the 

Surgeon General 

Not reported 

Systematic 

review 

Zaza S, Briss PA, Harris KW7 The Community Preventive Services 

Guide: Tobacco (Chapter 1) 

1976 to May 

2000 
34 

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. 
35 

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

 
36 

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. 
37 

Table 6. Effective population-based interventions 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Ennett et al., 

200173

United States 

48 contiguous 

states 

RCT 

4 mailings 

over 14 

months 

3 and 12 

months 

G1: Booklets mailed 

to parents followed by 

telephone discussion 

with health educator 

and parents 

C1: Did not receive 

“Family Matters” 

program 

1,316 

adolescentparent pairs 

(adolescents 

ages 12–14 

years) 

Effects present for non- Hispanic 

whites only (n=791) 

Adolescents in the control group 

were more than 1.5 times as 

likely to smoke at the 3-month 

followup than adolescents in the 

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 

Fair 

Thomson et 

al., 200479

United States 

Boston, MA 

Crosssectional 

NA 

NA 

G1: parent 

involvement in 

community-level 

tobacco ordinances 

3,831 youth 

(12–17 years) 

Youth living in towns that ban 

free-standing displays were less 

likely to perceive tobacco as 

easy to purchase (AOR, 0.6; 

95% CI, 0.5-0.9; P = 0.007) 

Increased perceived access was 

associated with being older (P < 

0.0001) and male (P ≤ 0.002) 

Fair 

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 
38 

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 substancespecific 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 neversmoked 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 
39 

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 schoolbased 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 
40 

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 

Never smoker Never smoked a cigarette or even took a puff of a cigarette 

Noncurrent smoker Smoked in the past but not in the past month 

Ausems et al., 

200468

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., 2003 Nonsmoker Never smokers, experimenters that no longer smoke, and quitters 71

Smoker Smokes at least once a week or less than once a week and 

experimenters that continue to smoke 

Perry et al., 2003 Nonsmoker Not specified 75

Current smoker Measured by amount of current tobacco use (response categories not 

specified) 

Unger et al., 2004 Nonsmoker Never smokers 81

Smoker Tried smoking between 6th and 7th grade 

Multiple-School-Year Smoking Prevention Programs 

Never smoker No history of smoking 

Tried once Tried once 

Experimental smoker Smoked less than once a week 

Quit Smoked and quit 

Brown et al., 200270

Regular Smoked weekly 

Ever smoker Lifetime use 

Past-month smoker Frequency of use within past month 

Ellickson et al., 

200372

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 

Nonsmoker Never smoked or former tobacco smokers 

Experimental smoker Smoked less than one pack per week 

Winkelby et al., 

200482

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. 
41 

Table 8. Effective school-based interventions 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Single School Year Interventions 

Ausems et al., 

200468

The 

Netherlands 

Middle and high 

(school level); 

vocational 

schools 

RCT 

5 months 

6, 12, and 18 

months 

G1: In school: 3 

lessons 

G2: Out of school: 3 

tailored letters 

G3: Both 

C1: Control, not 

described 

36 schools 

Number of 

students not 

reported 

At 12 months, the in-school 

intervention prevented more 

students from continuing to 

compared with controls 

(OR = 0.49, 95% CI, 0.29 – 

0.84) 

At 18 months, the tailored 

letters intervention prevented 

more smoking initiation 

compared with the controls 

(OR = 0.42, 95% CI, 0.18 – 

0.96) 

Fair 

Aveyard et al., 

200169

United Kingdom 

Adolescents 

(ages 13 to 24) 

living in West 

Midlands 

RCT 

Up to 6 

sessions over 

an academic 

year 

1 and 2 years 

G1: 3 computerbased program 

lessons with videos 

and 3 classroom 

lessons related to 

Transtheoretic Model 

C1: Standard lessons 

52 schools 

8,352 

students 

At 1- or 2-year followup, no 

evidence of change in stage 

or regular smoking 

Fair 

Crone et al., 

200371

The 

Netherlands 

Lower 

secondary 

schools 

RCT 

8 months 

8 and 20 

months 

G1: 3 classroom 

lessons on 

knowledge, attitudes, 

and social influence 

C1: Usual drug 

prevention program 

26 schools 

2,562 

students 

At 20 months, nonsmokers 

who became smokers 

increased less in intervention 

groups than control group, the 

program successfully 

decreased smoking for regular 

smokers and maintained 

nonsmoking for nonsmokers 

versus control 

Those with perceived social 

pressure were more likely to 

be smokers 

Fair 

Perry et al., 

200375

United States 

Middle and 

junior high 

schools in 

Minneapolis/St. 

Paul, 

Minnesota 

RCT 

8 months 

8 and 20 

months 

G1: D.A.R.E. 

curriculum taught by 

police officers (10 

sessions) 

G2: G1 plus D.A.R.E. 

Plus—peer led, 

parental involvement 

in extracurricular 

activities 

Control: Delayed 

program—D.A.R.E. 

offered in next school 

year 

24 schools 

6,237 

students 

D.A.R.E. Plus significantly 

less likely than D.A.R.E. to 

show an increase in current 

smoking or intentions to use 

tobacco for boys 

No significant differences for 

girls 

Fair 

C1, Control Group; D.A.R.E., Drug Abuse Resistance Education; G1, intervention group; RCT, randomized controlled trial 
42 

Table 8. Effective school-based interventions (continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Unger et al., 

200481

United States 

6th and 7th 

graders in 

Southern 

California 

RCT 

8 weeks over 

an academic 

year 

12 months 

G1: 8 weekly 

classroom sessions 

by health educators 

relating smoking 

issues to several 

cultures 

C1: Without the 

cultural references 

16 schools 

1,970 

students 

Overall, intervention effect 

was not significant 

Hispanic boys in the 

intervention group were less 

likely to report ever smoking 

at 1 year followup than the 

control group 

Fair 

Multiple School Year Interventions 

Brown et al., 

200270

Canada 

High schools 

(9th and 10th 

grades) 

RCT 

Students 

receiving 

tobacco 

prevention in 

elementary 

schools 

recruited for 

intervention in 

9th and 10th 

grade 

At the end of 

each academic 

year 

G1: Extracurricular 

activities, teacherfacilitated 

C1: Usual care 

30 schools, 

2,776 

students 

Male never smokers at 

baseline in the intervention 

group were significantly less 

likely to become “regular” 

smokers in 10th grade than 

controls 

No significant effect for 

females 

Fair 

Ellickson et al., 

200372

United States 

Urban, rural, 

and middle 

schools in 

South Dakota 

RCT 

NR (11 lessons 

in 7th grade 

and 3 lessons 

in 8th grade) 

18 months 

G1: 11 interactive 

teaching lessons in 

7th grade, and 3 

lessons in 8th grade, 

booster lessons in 9th 

and 10th 

G2: Same as G1 but 

no booster sessions 

C1: Regular 

prevention 

curriculums 

55 schools 

4,276 

students 

Treatment results for G1, G2 

combined through 8th grade; 

other results NR 

At 18 months, cigarette 

initiation rates in G1+G2: were 

significantly lower than in the 

controls 

Project ALERT significantly 

reduced proportion of new 

smokers 

Fair 

Josendal et al., 

200574

Norway 

7th to 9th grade 

schools 

RCT 

Minimum class 

and lessons 5 

times per year: 

8 hours in 7th 

grade; 5 hours 

in 8th grade; 6 

hours in 9th 

grade 

End of each 

academic 

year—7th, 8th, 

9th grade 

G1: Classroom (5 

times per year), 

teacher in-service, 

parental involvement 

G2: Same as GI, but 

no teacher in-service 

course 

G3: Same as GI, but 

no parental 

involvement 

C1: Education on 

smoking and health, 

but about half of the 

number of hours as in 

G1 or G2 

99 schools 

4,223 

students 

Full program (G1) had 

significantly fewer smokers 

than controls across all 3 

years 

Intervention without the 

parental involvement or the 

teacher in-service (G2 or G3) 

had significantly fewer 

smokers than the controls 

Odds of becoming a smoker 

(daily, weekly, any) during the 

intervention period were 

significantly lower in the full 

program group (G1) than in 

the controls 

Good 
43 

Table 8. Effective school-based interventions (continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Schofield et al., 

200376

Australia 

7th to 10th 

grades in New 

South Wales 

school district 

RCT 

2 school years 

24 months 

G1: Self-help, group 

counseling, social 

support 

C1: Offered and 

received none of the 

experimental activities

22 schools 

1,852 

students 

Proportion of students who 

smoked in past 7 days did not 

differ significantly by treatment 

condition, intervention not 

effective 

Significantly greater 

improvement in smoking 

knowledge for the intervention 

group compared with the 

control 

Positive attitudes toward 

smoking significantly 

decreased among smokers 

Fair 

Winkelby et al., 

200482

United States 

High Schools 

(11th or 12th 

grades) in San 

Francisco and 

San Jose, 

California 

RCT 

Weekly lessons 

and activities 

over an 

academic 

semester 

At the end of 

each semester 

and 6 months 

after the end of 

the semester 

G1: Three-phase 

advocacy and 

empowerment 

C1: Existing 

substance abuse 

curriculum, not 

specific to tobacco 

10 

continuation 

high 

schools 

813 

students 

Regular smokers had greatest 

statistically significant net 

decrease in tobacco use 

No differences in nonsmokers 

at baseline between 

intervention and control 

groups in uptake of smoking 

at followup 

Fair 

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 computerbased lessons.68,69,71,75,81 Drug Abuse Resistance Education (D.A.R.E.), a well-known, schoolbased 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 
44 

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 inand out-of-school intervention were compared with a control group (not described). The inschool 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 inschool 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-
45 

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 
46 

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 inservice, 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 inservice 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 
47 

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. 
48 

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 diseasefree 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 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Tyc et al., 

200380

United States 

St Jude’s 

Children’s 

Research 

Hospital, 

Memphis, 

Tennessee 

RCT 

Education and 

counseling 

over 3 months 

6 and 12 

months 

G1: Self-help, 

individual counseling, 

health professional 

telephone counseling, 

video 

C1: Brief advice to stop 

smoking or continue 

not smoking 

103 cancer 

survivors (10 to 

18 years of age)

Intervention group had 

higher mean knowledge 

and perceived vulnerability 

scores and lower intentionto-use tobacco scores 

Fair 

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. 
49 

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.
50 

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 metaanalysis 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. 
51 

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 
52 

Table 10. Multicomponent interventions to increase the number of users who quit smoking 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Bauman et al., 

200090

United States 

Populationbased 

RCT 

2 months 

3 and 12 months 

postcompletion 

or dropout 

G1: Mailing of booklets 

and telephone 

counseling 

C1: NR 

85 parentadolescent 

pairs 

No statistically significant 

difference in tobacco use 

between control and 

treatment for baseline 

cigarette users 

Fair 

Etter et al., 

200488

Switzerland, 

Western 

Europe 

Populationbased 

RCT 

12 months 

7 and 24 months 

post-baseline 

G1: Tailored counseling 

letters and booklets 

C1: A single letter 

identifying person as 

part of the control group

2,934 adults At 7 months, significantly 

more people in the 

intervention than in the 

control group were 

abstinent for at least 1 

month (G1: 5.8%; C1: 

2.2%; P ≤ 0.001) 

No difference between 

groups at 24 months. 

Fair 

Lipkus et al., 

200484

United States 

Communitybased 

RCT 

2 months 

4 and 8 months 

post-baseline 

G1: 2 self-help booklets 

in mail; 6-minute video; 

3 telephone counseling 

C1: 2 self-help booklets 

in mail; 6-minute video; 

no telephone 

counseling 

402 

adolescents 

No differences in 

abstinence at 4- or 8-month 

followup or for sustained 

abstinence 

Participants completing 

more counseling calls were 

more likely to report 

cessation at 4 and 8 

months (8-month OR = 

1.54, 95% CI, 1.15-2.07, 

P < 0.007) 

Fair 

McBride et al., 

200287

United States 

Practice/ 

provider 

settings 

RCT 

10 weeks 

6 and 12 months 

G1: Provider advice to 

quit smoking; referral to 

smoking specialist; selfhelp guide; if eligible, 

nicotine patches 

G2: Self-help guide; if 

eligible, nicotine 

patches and refills; 

biomarker feedback 

and tailored booklet 

557 

adults; low 

SES; African 

American 

Significantly more 

participants of G2 than G1 

were not smoking at 6 

months (G1: 10%, G2: 

19%; P = 0.03) and had 

sustained abstinence 

(G1: 5%, G2: 11%; 

P = 0.08) 

Fair 

Murray et al., 

200289

United States, 

Canada 

Practice/ 

provider 

settings 

RCT 

3 months 

11 years 

G1: Ipratropium 

bromide inhaler, 

placebo inhaler 

C1: Usual care 

4,517 adults More participants in G1 

than in C1 had sustained 

abstinence (G1: 21.9%, 

C1: 6.0%; P ≤ 0.001) 

Fair 

ACS, American Cancer Society; C, control group; G, intervention group(s); NR, not reported; OR, odds ratio; RCT, randomized 

controlled trial; SES, socioeconomic status. 
53 

Table 10. Multicomponent interventions to increase the number of users who quit smoking (continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Rabius et al., 

200485

United States 

Populationbased 

RCT 

Varies by quit 

date, up to 5 

followup calls, up 

to 2 weeks 

postquit date 

3 and 6 months 

G1: ACS booklets and 

standard advice plus 

up to 5 sessions of 

proactive telephone 

counseling 

C1: ACS booklets and 

standard advice 

3,522 

young adults, 

adults 

G1 group had higher rates 

of 48-hour abstinence than 

C1 group at 3 months (18–

25 years: G1: 19.6%, 

C1: 9.3%; P < 0.005; over 

25 years: G1: 15.1%, C1: 

9.6%; P < 0.001) 

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) 

Fair 

Smith et al., 

200486

Canada 

Populationbased 

RCT 

3, 6, and 12 

months 

G1: Telephone 

counseling, 2 follow-up 

calls, booklet 

G2: Telephone 

counseling, 2 follow-up 

calls, pamphlet 

G3: Telephone 

counseling, 6 follow-up 

calls, booklet 

G4: Telephone 

counseling, 6 follow-up 

calls, pamphlet 

C1: Print materials only

632 

adults 

Intervention groups 

combined (G1, G2, G3) 

had significantly higher 

continuous abstinence 

rates than control group: 

(G1, 2, 3: 5%, 

C1: 1%; P ≤ 0.05) 

Fair 

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 
54 

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 selfhelp 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. 
55 

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; metaanalysis 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 selfhelp 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 
56 

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 
57 

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 
58 

Table 11. Strategies to improve success rates for quit attempts for general and special populations 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Aveyard et al., 

2003105

United Kingdom 

Practice/ 

Provider Settings 

RCT 

9 months 

12 months 

post baseline 

G1: Pro-Change self-help 

system with workbook and 3 

questionnaires to generate 

tailored feedback 

G2: G1 plus three telephone 

calls 

G3: G1 plus three nurse visits 

C1: 2 standard self-help quit 

guides and 2 tip cards 

2471 

adults 

No statistically 

significant difference in 

quit rates between 

intervention and control 

groups (G1=11%, 

G2=12%, G3=10%, 

C1=10%) in 

biochemically-confirmed 

abstinence for 6-

months sustained 

abstinence and 12-

months point 

prevalence 

Fair 

Bohadana et al., 

200091

France, 

Western Europe 

Practice/provider 

settings 

RCT 

26 weeks 

6 weeks; 3, 6, 

and 12 months 

G1: Nicotine inhaler and nicotine 

patch 

C1: Nicotine inhaler and placebo 

patch 

400 

adults 

Abstinence was greater 

at 3 months for 

intervention group than 

control group (P = 0.02) 

No significant difference 

between groups at 6- 

and 12-month followups 

Fair 

Canga et al., 

2000119 * 

Spain, 

Western Europe 

Practice/provider 

settings 

Hospital 

RCT with 

systematic 

randomization 

6 months 

6 months 

G1: Interview with nurse; selfhelp materials; 3 months of 

transdermal NRT if eligible; 5 

follow-up contacts 

C1: Usual care for diabetic 

smokers established in the 

Navarre diabetes care program 

280 

young 

adults, 

adults 

Those in the 

intervention were 

significantly more likely 

than those in the control 

to quit at 6-month 

followup (validated): 

(P ≤ 0.001) 

Fair 

Carpenter et al., 

200498

United States 

Population-based 

RCT 

24 weeks 

3, 6, 12 and 24 

weeks 

G1: Telephone-based reduction 

counseling and NRT and brief 

advice to quit 

G2: Motivational advice (5Rs) 

and brief advice 

C1: No treatment 

616 

adults 

At 6 months, those 

receiving either 

intervention had greater 

percentages of “24 hour 

quit attempts” (G1: 43% 

and G2: 51%) than 

those who received no 

treatment (C1: 16%) 

(P < 0.01) 

Fair 

Clark et al., 

2004109

United States 

Hospital 

Practice/provider 

settings 

RCT 

Given 

materials at 

time of chest 

CT scan 

1 and 12 

months 

G1: Internet cessation resources 

handout with Web site 

addresses 

C1: Standard self-help 

material—NCI handout, ACS 

booklet 

171 

adults, 

> 50 

years of 

age 

No statistically 

significant differences in 

smoking status found at 

1-month or 1-year 

followup 

Fair 

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 
59 

Table 11. Strategies to improve success rates for quit attempts for general and special populations 

(continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Dalsgareth et al., 

2004106

Denmark 

Hospital 

RCT 

7 weeks 

26 weeks postbaseline 

G1: 2 motivating phone 

calls, 5 clinic visits, and 

sustained-release 

bupropion hydrochloride 

C1: 2 motivating phone 

calls, 5 clinic visits, and 

placebo 

336 adult 

hospital 

employees 

Continuous abstinence 

at 26 weeks: 

G1 = 18% 

C1 = 7% 

P = 0.008 

Fair 

Garvey et al., 

2000107

United States 

Populationbased 

RCT 

2 months 

1, 7, 14, 30 days 

and 2, 3, 6, 9, 

and 12 months 

post-cessation 

All subjects received Self 

help booklet and brief 

behavioral counseling, 

(5-10 minutes per visit, for 

1 year) 

G1: Low dependence 2 mg 

gum 

G2: Low dependence 4 mg 

gum 

G3: High dependence 2 

mg gum 

G4: High dependence 4 

mg gum 

608 adults At 1 year follow-up quit 

rates for low 

dependence were 

Placebo 11.2% 

2 mg gum 19.5% 

4 mg gum 18.4% (NS) 

High dependence 

smokers quit rates at 1 

year 

2 mg gum compared to 

placebo (15.7% vs. 

6.1%, P = 0.02) 

4 mg gum compared to 

placebo (20.7% vs. 

6.1% P = 0.002) 

Fair 

Hall et al., 200497

United States 

Populationbased 

RCT 

Brief: 12 weeks 

Extended: 52 

weeks 

12, 24, 36, 52 

weeks 

G1: Brief nortriptyline: 

nortriptyline for 12 weeks; 

5 counseling sessions and 

NRT patch at week 5 

C1: Brief placebo: placebo 

for 12 weeks; 5 counseling 

sessions and NRT at week 

5 

G2: Extended nortriptyline: 

G1 + extended 

pharmacotherapy and 

counseling (1/month) for 

52 weeks 

C2: Extended placebo: G2 

but used placebo instead 

of nortriptyline 

160 adults At 12 weeks 

nortriptyline was more 

effective than placebo 

(OR = 0.69, 95% CI; 

0.49-0.92, P = 0.02) 

and placebo at 52 

weeks (OR = 0.47; 95% 

CI; 0.30-0.75, P = 

0.001); however 52 

weeks of nortriptyline 

did not differ 

significantly from 

placebo at that same 

time frame 

Fair 
60 

Table 11. Strategies to improve success rates for quit attempts for general and special populations 

(continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Hennrikus et al., 

2005112 * 

United States 

Hospital 

RCT 

6 months 

7 to 18 days, 

12 months 

postdischarge 

G1: 2 smoking cessation 

manuals; community 

resources directory; 

medical record label to cue 

to providers; postdischarge 

letter 

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 

2,095 

adults 

Cotinine corrected 

intention-to-treat 

analysis found 

percentage of 

abstinence at 12-month 

followup (P > 0.05) NS 

Fair 

Hitsman et al., 

1999113

United States 

Populationbased 

RCT 

10 weeks 

1 week, 1, 3, 

and 6 months 

postquit date 

G1: Individual cognitive 

behavioral therapy, 

fluoxetine 30mg for 10 

weeks, fluoxetine 

compliance level set at 

< 150ng/ml 

G2: Same as G1, except 

fluoxetine dose of 60mg 

and fluoxetine compliance 

level set at 300ng/ml 

C1: Individual cognitive 

behavioral therapy plus 

placebo 

253 

adults 

No significant results 

found at 1, 3, and 6 

month followup. 

Individual differences 

that predict cessation 

when fluoxetine is 

combined with CBT 

include higher levels of 

weight concern, degree 

of depression, and 

levels of nicotine 

dependence 

Fair 

Holt et al., 

2005114 * 

New Zealand 

Communitybased 

Populationbased 

RCT 

2 months 

3 and 7 weeks, 

3, 6, 9, and 12 

months 

posttarget quit 

date 

G1: Bupropion; counseling

C1: Placebo and 

counseling 

134 

adolescents; 

young adults; 

adults 

People in the 

intervention group were 

significantly more likely 

than those in the control 

to be continuously 

abstinent at 3 months 

Fair 

Jones et al., 

2001115 * 

United Kingdom 

Hospital 

RCT 

6 months 

8 weeks, 6 

months postICU 

discharge 

G1: Verbal 

encouragement to 

patients to remain 

nonsmokers and for 

immediate family not to 

smoke in the same room 

as the patient, plus selfhelp manual 

C1: G1 without the 

manual 

61 

adults 

Of the smokers pre-ICU 

admission, more 

returned to smoking in 

the control group at 6-

mos followup 

Fair 
61 

Table 11. Strategies to improve success rates for quit attempts for general and special populations 

(continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Jorenby et al., 

1999116

United States 

Communitybased 

RCT 

9 weeks 

10 weeks, 3, 6, 

and 12 months 

post start of 

study 

G1: bupropion and 

nicotine patch 

G2: bupropion and 

placebo patch 

G3: placebo tablets and 

nicotine patch 

C1: placebo tablets and 

placebo patch 

893 

adults 

Those receiving 

buproprion and patch 

were most likely 

(P ≤ 0.001) to be 

abstinent at 6 and 12 

months 

Fair 

Killen et al., 

200099

United States 

Populationbased 

RCT 

17 weeks 

4, 10 and 26 

weeks 

G1: NRT transdermal 

system patch for 8 weeks 

plus 20 mg paroxetine for 

9 weeks 

G2: NRT transdermal 

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 

224 adults No significant 

differences in 

abstinence groups 

found between groups 

at any follow up time 

period 

Good 

Lancaster et al., 

1999121

United Kingdom 

Practice/provider 

settings 

RCT with 

systematic 

randomization 

6 weeks 

3 and 12 months 

postquit date 

G1: Brief advice to quit 

from general practitioner, 

plus: extended counseling 

a nurse; leaflet on 

cessation; fact sheet on 

NRT; invitation to contact 

the research nurse for 

more intensive, tailored 

counseling; NRT if 

necessary 

C1: Brief advice to quit 

from the patients’ general 

practitioners 

497 

adults 

No significant 

differences found 

between groups at 3 

and 12 month followups 

Fair 

Lerman et al., 

2004100

United States 

Populationbased 

RCT 

8 weeks 

8 weeks and 6 

months 

G1: 8 weeks of nicotine 

nasal spray and 7 

sessions of behavioral 

group counseling 

G2: 8 weeks of 

transdermal nicotine 

therapy (i.e., patch) and 7 

sessions of behavioral 

group counseling 

299 adults No statistically 

significant difference 

found between 

treatment groups at 6 

months (G1: 12.2%, 

G2: 15%, NS) 

Smokers who were 

highly dependent, 

obese, or members of 

minority groups 

achieved higher rates of 

abstinence with nasal 

spray 

Fair 
62 

Table 11. Strategies to improve success rates for quit attempts for general and special populations 

(continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

MacLeod et al., 

2003104

Australia 

Populationbased 

RCT 

10 weeks 

1, 2, 3 and 6 

months 

G1: Nicotine Patch and 5 

telephone counseling calls 

C1: Nicotine Patch only 

854 adults Telephone counseling 

improves cessation 

rates when used in 

conjunction with the 

patch 

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 

Good 

McBride et al., 

2004122 † 

United States 

Military Medical 

Center 

RCT 

First trimester 

to delivery and 

12 months 

postpartum 

28 weeks 

pregnant 

Postpartum 

2, 6, and 12 

months 

G1: Usual care plus late 

pregnancy relapse kit, and 6 

counseling calls 

G2: G1 plus the partners 

received telephone 

counseling and support 

guide (partners who smoked 

received cessation aids and 

counseling) 

C1: Usual Care: provider 

583 Pregnant 

women and 

their partners

No statistically 

significant difference 

between groups at any 

follow up point 

In late pregnancy, more 

partners abstinent in G2 

group (15%) than C1 

group (5%) P = 0.02 

Fair 

Peterson 2004120

* 

United States 

Hospital 

RCT 

3 months 

12 months 

G1:Brief physician 

counseling and usual care 

plus nurse managed, 

cognitive behavioral relapse 

prevention intervention given 

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 

277 adults 

women 

No significant 

differences between 

groups at 12 month 

follow ups 

Fair 

Quist-Paulsen et 

al., 2003123 † 

Norway 

Hospital – 

cardiac ward 

RCT 

5 months 

12 months 

G1: Self-help booklet on how 

to quit smoking plus cardiac 

nurse consultation during inpatient days and phone 

consultation for up to 5 

months following discharge 

C1: Group sessions with 

nurses with minor emphasis 

on smoking cessation and no 

further advice or instruction 

on how to quit 

240 adults At one year, the quit 

rate was far greater 

(57%) in the intensive 

nurse intervention 

versus the minimal 

intervention group 

(37%) (absolute risk 

reduction 20%, 95% CI 

6.4-33.0; P = 0.004) 

Good 
63 

Table 11. Strategies to improve success rates for quit attempts for general and special populations 

(continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Ratner et al 

2004124 † 

Western Canada 

Teaching 

hospital 

Randomized 

pretest-posttest 

control group 

experiment 

NR 

6 and 12 

months 

G1: 2 face to face 

counseling sessions and 9 

telephone counseling 

sessions 

C1: Standard hospital 

treatment 

237 surgical 

patients 

Those receiving the 

counseling (73%) were 

more likely to be 

abstinent than the 

controls (53%) (P = 

0.003) at 6 months but 

the difference is not 

significant at 12 months 

after surgery 

Fair 

Reid et al 

2003125 † 

Canada 

Hospital, tertiary 

care cardiac 

facility 

RCT 

8 weeks 

3 months and 1 

year 

G1: Self-help booklet given 

in the hospital, then followup by nurse counselor at 4 

weeks after discharge; if 

patient smoking, nurse 

provides 3 twenty minute 

face to face sessions over 8 

weeks and offered nicotine 

patch therapy 

254 coronary 

artery 

disease 

hospitalized 

patients 

Smoking cessation 

rates increased from 

42% at hospitalization 

to 53% at 3 month 

follow up (P = 0.05), but 

not significant at 1 year 

follow up 

Good 

Simon et al., 

2004101

United States 

Hospital 

RCT 

7 weeks 

7 weeks, 3, 6 

and 12 months 

G1: 7 week course of 

Bupropion, 2 months 

transdermal nicotine 

replacement therapy, 1 visit 

with counselor (30-60 

minute session), and 5 

telephone follow-up calls 

C1: Same as G1 except 

participants received 

placebo instead of 

Bupropion 

244 adults 

(86% male) 

No statistically 

significant differences in 

smoking cessation rates 

at end of medication 3, 

6, and 12 months 

The addition of 7-week 

treatment with 

Bupropion did not 

significantly increase 

quit rates over NRT and 

counseling 

Fair 

Swan et al; 2003 

and 2003102,103 

United States 

Practice/ 

provider 

settings 

RCT 

12 months 

3 and 12 

months 

All participants received 

Bupropion SR for 7 weeks

G1: 150 mg Bupropion SR, 

brief counseling call day 

after quit date, personalized 

intervention materials, and 

access to 24 hour 

automated support line 

G2: G1 except 300 mg 

Bupropion SR 

G3: 150 mg Bupropion SR, 

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 

1524 adults Abstinence significantly 

greater at both 3 

months and 1 year for 

those receiving 

intensive counseling 

and higher dose of 

bupropion (G4) vs (G1, 

G3) and (G3) at higher 

dose with brief 

counseling 

The 300 mg dose was 

associated with more 

adverse events 

Fair 
64 

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 selfreported 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 
65 

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 highdependence 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 
66 

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 
67 

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. 
68 

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 
69 

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
70 

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 longterm 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 latepregnancy 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. 
71 

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 smokefree 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 
72 

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 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Borland et al., 

2003131

Australia 

Population-based 

RCT 

6 months 

3, 6, and 12 

months 

baseline 

G1: Offered self-help “Quit 

Pack”; 3 computergenerated tailored letters 

G2: Offered self-help “Quit 

Pack”; 3 computergenerated tailored letters; 

callback counseling service

C1: Offered printed, selfhelp “Quit Pack” 

528 

adolescents, 

young adults, 

and adults 

No difference in 

smoking prevalence at 

12-month followup 

Good 

Maguire et al., 

2001132

United Kingdom 

Community-based 

RCT 

3 months 

3, 6, 9, and 12 

months 

G1: Initial interview with 

pharmacist; smoking 

cessation contract; NRT 

offered if appropriate; 

leaflet; weekly followup for 

4 weeks, then monthly 

followup for 3 months 

C1: Normal pharmaceutical 

service (including the 

provision of NRT, as 

appropriate) provided by 

pharmacist 

484 adults Significantly more 

participants in G1 had a 

validated (urinary 

cotinine) nonsmoking 

status at 12 months 

(G1: 14.3% 

C1: 2.7%; P ≤ 0.001) 

Fair 

Ronda et al., 

2004133

Netherlands, 

Western 

Europe 

Community-based 

Pretestposttest 

control 

G1: Regional mass Medialed smoking cessation 

campaign; local activities 

organized by local 

interested working groups 

C1: Older mass media-led 

smoking cessation 

campaign, no local 

activities 

8,939 adults No significant 

differences between 

interventions regarding 

smoking status and 

determinants of 

smoking behavior 

Fair 

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 
73 

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 
74 

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-ofpocket 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 
75 

Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider-based 

and health care settings 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Cornuz et al., 

2002134

Switzerland, 

Western Europe 

Practice/provider 

settings 

RCT with cluster 

randomization 

3 months 

1 year 

G1: Active learning 

training program for 

residents; received 

the control training 

4 months later 

C1: Traditional 

didactic training 

program on 

management of 

dyslipidemia; 

received the 

intervention training 

4 months later 

251 young 

adult and 

adult 

patients 

35 residents 

Those patients seen by 

intervention group 

residents more likely to 

be abstinent for at least 1 

week at 1-year followup 

(P = 0.005) 

Fair 

Goldstein et al., 

2003141

United States 

Practice/provider 

settings, 

community-based 

Cross-sectional 

NR 

6, 12, 18, and 24 

months 

G1: Physicians 

provided “4 As” to 

patients 

G2: Smokers 

provided with 

computergenerated, stagetailored cessation 

information at home

G3: Physician 

delivered “4 As” to 

patients, and 

patients received 

computergenerated, stagetailored smoking 

cessation 

information at home

C1: No intervention 

2,346 

adults 

At 2-year followup, 

patients who received the 

“4 As” were significantly 

more likely to quit 

smoking (P = 0.006) 

Fair 

Joseph et al., 

2004143

United States 

Practice/provider 

settings 

RCT 

2 days 

6 and 12 months 

G1: Organizational 

support, 2 day 

training sessions, 

smoking cessation 

medication 

C1: NR 

5,678 adults No effect on change 

scores between groups 

reporting whether their 

physician asked about 

smoking or provided 

counseled 

Fair 

“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 
76 

Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider-based 

and health care settings (continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Katz et al., 2004142

United States 

Practice/provider 

settings 

Community-based 

RCT 

2 months 

Immediate 

G1: Study personnel 

worked with intake 

clinicians to 

implement guideline 

intervention; 

clinicians completed 

survey prior to 

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 

1,221 adult 

patients 

72 clinicians 

Intervention group RNs 

were the most likely to 

ask about smoking, 

assess willingness to 

quit, advise patients to 

quit, and assist patients 

in quitting (P = NR) 

Fair 

Katz et al., 2004144

United States 

Practice/provider 

settings 

RCT 

10.5 months 

2 and 6 months 

G1: Multicomponent 

office based 

intervention 

including a tutorial 

for intake clinicians 

on the AHRQ 

Guideline, 

performance 

feedback, offer of 

free NRT, and 

proactive counseling

C1: Staff received 

general information 

on the AHRQ 

Guideline 

2,163 adult 

patients 

Significantly more 

patients from practices 

who received the 

intervention were more 

likely to be asked by their 

clinician about their 

smoking status, 

willingness to quit, given 

literature about quitting, 

assisted in setting a quit 

date, engaged in a 

discussion about 

pharmacotherapy, or 

remain abstinent 

Good 

Pbert et al., 

2004139

United States 

Practice/provider 

settings 

RCT with cluster 

randomization 

10 months 

End of 

pregnancy, 1, 3, 

and 6 months 

postpartum 

G1: Clients visited 

community health 

centers and WIC 

offices that received 

provider training, an 

office reminder 

system, and 

establishment of 

program boards to 

coordinate the 

transfer of 

documentation 

among clinics 

C1: Usual care 

550 adult 

pregnant 

women 

Women in the 

intervention group more 

likely than those in the 

control to be abstinent at 

the end of pregnancy 

(G1: 26%; C1: 12%; OR: 

2.57; P = 0.05) and 1 

month postpartum 

(G1: 26%; C1: 11%; OR: 

3.01; P = 0.04) 

No effect remained at 3- 

and 6-month followup 

Fair 
77 

Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider-based 

and health care settings (continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Pieterse, 2001140

The Netherlands, 

Western Europe 

Practice/provider 

settings 

RCT with simple 

randomization 

NR 

1 and 12 months 

G1: Brief physician 

counseling; self-help 

manual; follow-up 

sessions 

C1: Usual 

treatment—no 

counseling or advice 

on smoking except 

when initiated by the 

patient or when 

indicated by the 

contact reason 

530 young 

adults, adults

At 12 months, smoking 

abstinence rates were 

greater among those in 

the intervention 

compared with controls 

(G1: 13.4%; C1: 7.3%; 

OR = 1.51, CI: 1.1, 2.1; 

P < 0.05), as were 

consecutive abstinence 

rates (G1: 8.2%; C1: 

3.1%; OR = 3.04, CI: 1.7, 

5.6l; P < 0.001) 

Fair 

Piper et al., 2003145

United States 

Practice/provider 

settings 

RCT 

NR 

12 months 

G1: Smoking added 

to vital sign stamp 

C1: Usual vital sign 

stamp without 

smoking 

1,611 adult 

smokers 

Significant increase 

(31%) in asking behavior 

of physicians in the 

smoking plus vital sign 

clinics (P = 0.0002); no 

difference in abstinence 

rates 

Fair 

Russos et al., 

1999135

United States 

Practice/provider 

settings 

Cross-sectional 

2 years 

2 years 

postbaseline 

G1: Orthodontists 

given antitobacco 

materials, training 

session on tobacco 

prevention, written 

antitobacco 

prescriptions and 

reimbursement for 

distribution, 

quarterly visits and 

calls; office staff 

asked to make 

office tobacco-free 

C1: Orthodontists 

given no training, 

materials, or visits, 

nor asked to change 

their offices or 

practices 

126 adults In a typical week more 

clinicians in G1 vs. C1 

provided prevention 

counseling to patients 

(Mean: 25.4% vs. 3%, 

Mann-Whitney U = 

696.5, z = -7.0, P < 0.01) 

and at least some 

cessation counseling 

(91% vs. 72%, Χ2

 = 8.4, 

P < 0.01) 

Fair 

Slama et al., 

1999136

France, Western 

Europe 

Practice/provider 

settings 

Cross-sectional 

NA 

1 and 12 months 

G1: NA 

C1: NA 

372 adult 

patients 

2,680 

general 

practitioners 

None of the GPs’ 

smoking-related attitudes 

and reported behaviors 

were significantly related 

to their participation in 

the study or to their 

patients’ rates of 

smoking cessation at 1 

or 12 months 

Fair 
78 

Table 13. Strategies to increase implementation of population-level tobacco use cessation: provider -based 

and health care settings (continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Smith et al., 

2002137

United States 

Hospital 

Time series 

3 months 

1 year 

G1: During 

hospitalization: 

physician advice on 

smoking cessation, 

bedside education 

and counseling with 

nurse, take-home 

materials, NRT if 

requested or 

indicated, 4 nurseinitiated 

postdischarge 

phone counseling 

calls 

C1: NA 

1,077 

adults 

Including only those who 

were reached at 12 

months, 49% reported 

being smoke-free for the 

previous 7 days. 

Including the 211 who 

were not reached at 12 

months (intent to treat) 

and counting them as 

smokers, self-reported 

smoking cessation rate 

was 35% 

Fair 

Young et al., 

2002138

Australia 

Practice/provider 

settings 

RCT with cluster 

randomization 

4 months 

6 months 

postbaseline 

G1: Family 

physicians received 

three academic 

detail visits, 

resources for FPs, 

resources for 

practices. and 

resources for 

patients 

C1: Similar 

intervention to G1 in 

terms of intensity 

and format, but 

focused on cervical 

screening 

1,788 adult 

patients 

60 

family 

practitioners 

Improvements between 

baseline and posttest in 

patient recall of FP 

advice about nicotine 

replacement patches and 

gum were significantly 

greater in the 

intervention than the 

control group 

(P = 0.0056 and 

P = 0.0002, respectively) 

Fair 

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 
79 

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 followup 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 
80 

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 
81 

• 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. 
82 

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 
83 

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 
84 

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 lownicotine 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
85 

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 
86 

Table 14. Characteristics and results of studies assessing the effects of smokeless tobacco marketing 

Author 

Year 

Setting Design Survey N Results 

Quality 

Rating 

Choi et al., 

1995146

California 

Populationbased 

Cross-sectional Youth 

Attitudes 

and 

Practice 

Survey 

2,814 

adolescents, 

young adult 

males 

Among adolescent boys, recall of 

smokeless tobacco advertisements was 

associated with smokeless tobacco use: 

OR, 7.5; 95% CI, 3.1-18.1 

Fair 

Tomar et al., 

2003147 

United States 

Populationbased 

Cross-sectional Teenage 

Attitudes 

and 

Practice 

Survey 

(TAPS-I 

and -II) 

3,996 

adolescents, 

young adult 

males 

Significantly more users than nonusers 

of smokeless tobacco became smokers 

during 4 years of followup: 

OR, 3.45; 95% CI, 1.84-6.47 

Fair 

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
87 

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
88 

Table 15. Tobacco cessation interventions for persons with co-occurring morbidities and risk behaviors 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Studies in Psychiatric Populations 

Brown et al., 

2001150

United States 

Population-based 

RCT 

6 weeks 

1, 6, and 12 

months 

G1: Group CBT for 

smoking cessation 

plus additional CBT 

on coping for 

depression 

C1: Group CBT for 

smoking cessation 

alone 

179 formerly 

depressed 

adults 

In the main analysis, 

smoking abstinence 

did not differ when 

CBT tailored for 

depression was added; 

in a secondary 

analysis CBT tailored 

for depression had 

significant interactions 

with both heavy 

smoking and recurrent 

depression 

Fair 

Brown et al., 

2003151

United States 

Psychiatric hospital 

RCT 

Variable, 

dependent 

upon the 

length of stay 

1,3,6,9, and 

12 months 

G1: In-person 

motivational 

interviewing 

sessions, offer of 

nicotine patch, 

postdischarge 

telephone counseling 

(MI) 

C1: Brief in-person 

advice, on cessation, 

pamphlet and shorter 

course of nicotine 

patch (BA) 

191 

hospitalized 

adolescents 

for 

psychiatric 

disorders 

7-day point prevalence 

rates 

At 1 month 

• MI arm: 11% 

• BA arm: 11% 

At 6 months 

• MI arm: 13.3% 

• BA arm: 8.5% 

At 12 months 

• MI arm: 14% 

• BA arm: 9.9% 

P = NS 

Anxiety disorders 

increased odds for quit 

attempts in 

adolescents with 

psychiatric disorders 

(AOR, 1.99; 95% CI, 

1.08-3.71) 

Fair 

Hitsman et al., 

1999113

United States 

Population-based 

RCT 

10 weeks 

1 week; 1, 3, 

and 6 months 

G1: Individual 

behavioral therapy; 

fluoxetine 30mg; quit 

date set, compliance 

level at 150ng/ml 

G2: Same as G1 

except fluoxetine is a 

60mg dose and 

compliance level set 

at 300ng/ml 

C1: Same as G1 

except received 

placebo 

253 adults At 1 and 3 months, for 

treatment-compliant 

patients, fluoxetine had 

a positive association 

with degree of 

depression and 

likelihood of 

abstinence (OR, 1.35; 

95% CI, 1.00-1.81) 

Fair 
89 

Table 15. Tobacco cessation interventions for persons with co-occurring morbidities and risk behaviors 

(continued) 

Author 

Year 

Setting 

Design 

Exposure 

Followup Intervention N Results 

Quality 

Rating 

Studies in Substance-Addicted Populations 

Joseph et al., 

2004149 

United States 

Residential 

substance use 

disorder treatment 

program 

RCT 

10 weeks 

3, 6, 9,12, 

and 18 

months 

G1: Individual 

behavioral therapy; 

recommended 

nicotine patches (21 

mg for 6 weeks, 14 

mg for 2 weeks, and 

7 mg for 2 weeks) for 

smokers; 

combination of 

patches and nicotine 

gum for smokers of 

>20 cigarettes per 

day 

C: Temporary control 

group with treatment 

delayed for 6 months

499 

substance 

use disorder 

adults 

At both 3 and 6 

months, smoking 

abstinence rates were 

significantly greater in 

the treatment groups 

than the temporary 

control group 

(P < 0.000 and 

P = 0.02, respectively) 

Good 

Joseph, 1993152

United States 

Hospital 

Prospective 

cohort study 

3 weeks 

1 year after 

hospitalization 

G1: No specific 

information on 

smoking or 

cessation; smoking 

allowed in 

designated rooms 

and not during group 

sessions 

G2: Upon admission, 

patient signed 

contract to abstain 

from nicotine during 

stay; cessation 

program provided; 

clonidine patches 

available 

706 adults 

enrolled in a 

substance 

abuse 

treatment 

program 

Patients who want to 

quit smoking 

At 3-week followup 

• Prepolicy: 24% 

• Postpolicy: 61% 

(P < 0.001) 

Patients who quit 

smoking 

At 1-year followup 

• Prepolicy: 3% 

• Postpolicy: 8% 

(P < 0.05) 

Fair 

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. 
90 

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. 
91 

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 (Χ2

, 11.4; 

P < 0.001), and expired CO (Χ2

, 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
92 

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 
93 

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). 
95 

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 populationbased 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.
96 

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-tominors laws.79 

Community-based tobacco prevention interventions. Ten studies implemented schoolbased 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 shortterm 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 schoolbased 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 
97 

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 populationbased 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 schoolbased 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 
98 

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 selfhelp 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-toperson 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. 
99 

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. 
100 

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 faceto-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.
101 

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 
102 

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 
103 

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 smokingrelated 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 
104 

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 nonnicotine 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 substanceaddicted 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 
105 

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 
106 

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.
107 

Table 16. Characteristics of studies rated poor quality 

Intervention 

Design* 

Sample Size Reasons for Rating 

Key Question 1 

Group counseling, social support77

RCT 

450 

All methods (e.g., randomization, sampling) not well 

delineated 

No baseline data reported 

analytical methods not well described 

Video, classroom instruction78

RCT 

3,038 

No baseline data reported 

No treatment versus comparison data reported 

Post randomization exclusions 

Key Question 2 

Self-help materials129

RCT 

918 

High attrition rate 

No intention-to-treat analysis 

No power analysis 

Baseline differences 

Self-help, computer-based program, telephone 

counseling, group counseling, social support, media 

campaign, individual counseling by health 

professional111

Quasi-experiment 

538 

Intervention group volunteer sample 

Control group care not reported 

Exposure to intervention low 

Findings not generalizable† 

High attrition 

Self-help, individual counseling by health professional, 

social support118

Cohort study 

110 

Self-selected sampling technique 

Baseline differences regarding motivation to quit 

Incomplete reporting of data 

Self-help, group counseling108

Before/after study 

119 

Self-selection of intervention 

Small group sample sizes 

High attrition rate 

No report of comparison of groups 

Findings not generalizableH 

Individual counseling, 

Acupuncture92

RCT 

141 

High attrition rate 

Completers analysis 

Pharmaceuticals110

RCT 

1,384 

High rate of noncompliance 

High overall rate of attrition 

Pharmacotherapy93

RCT 

134 

Removed study participants perceived not to be motivated 

(similar to a “run-in period”) 

Attrition moderately high 

Limited reporting on adverse events 

Randomization not described 

Pharmacotherapy126

RCT 

245 

Attrition rate not reported 

Allocation to groups predictable 

No adverse events reported 

Poor randomization 

Pharmaceuticals, group counseling117

RCT 

5,887 

Large differences in baseline comparisons between white 

and black participants negate any conclusions from findings 

Pharmacotherapy, cognitive behavioral counseling96

RCT 

150 

Randomization not reported 

No power analysis 

High attrition rate 

No adverse events reported 

Pharmacotherapy, cognitive behavioral counseling127

RCT 

248 

High attrition rate 

Randomization not reported 

No adverse events reported 

No power analysis 
108 

Table 16. Characteristics of studies rated poor quality 

Intervention 

Design* 

Sample Size Reasons for Rating 

Pharmacotherapy, self-help, counseling128

RCT 

137 

High attrition rate 

Lacked power 

Significant baseline differences not reported 

Telephone quit line94

Cohort study 

1594 

High attrition rate 

Confounded by “additional support” 

Baseline data not reported for Proactive Treatment group 

No reliability or validity measures for instruments 

Inclusion/exclusion criteria not reported 

Telephone counseling, group meetings95

RCT 

756 

No true control group 

Randomization not reported 

Population not described 

Inclusion/exclusion criteria not reported 

Intention-to-treat analysis not reported 

Key Question 3 

Video, telephone counseling, individual counseling by 

health professional, group counseling, social support, 

pharmaceuticals155

Before/after study 

299 

Sampling not explained 

No control group 

Limited generalizability†

Self-help, individual counseling by health professional, 

telephone counseling, video156

RCT 

1,173 

Inadequate allocation of concealment and blinding 

Contamination of usual care group 

Attrition not reported 

Key Question 5 

Group counseling, pharmaceuticals153

RCT 

3,976 

Sampling technique not reported 

Study criteria changed after one-third of participants 

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 
109 

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. 
110 

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 welldesigned 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
111 

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. 
112 

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. 

Our review found no evidence for tobacco prevention in populations with co-occurring 

morbidities and risk behaviors. Consistent with other reviews, we found some support for 

pharmacotherapy and/or counseling, but the evidence was insufficient in number and quality to 

draw conclusions about the effectiveness of smoking cessation interventions in comorbid 

populations. Taken as a whole, this clearly illuminates the need for better studies to close these 

gaps. 

We documented numerous gaps in the existing knowledge base and deficiencies in the design 

and conduct of currently available studies and recommend a variety of research initiatives to 

overcome these limitations. 
113 

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117. Murray RP, Connett JE, Buist AS, et al. 

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118. Rowe K, Clark JM. Evaluating the effectiveness 

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122. McBride CM, Baucom DH, Peterson BL et al. 

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132. Maguire TA, McElnay JC, Drummond A. A 

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Appendix A 

Search Strategies by Database 

Appendix A. Search Strategy 

#1 Search "Tobacco Use Cessation"[MeSH] OR "Smoking 

Cessation"[MeSH] OR "Smoking/prevention and control"[MeSH] 

17017

#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, 

Middle Aged: 45-64 years, English, Humans 

7383

#5 Search ("Community Networks"[MeSH] OR "Community Health 

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]) 

345024

#9 Search ("Randomized Controlled Trial"[Publication Type] OR 

"Randomized Controlled Trials"[MeSH]) OR "Single-Blind 

Method"[MeSH] OR "Double-Blind Method"[MeSH] OR "Random 

Allocation"[MeSH] 

310410

#10 Search #4 AND #5 AND #9 402

#11 Search ("Consumer Satisfaction"[MeSH] OR "Consumer 

Participation"[MeSH]) OR "Health Services Needs and 

Demand"[MeSH] 

84543

#12 Search #4 AND #11 129

#13 Search "Health Plan Implementation"[MeSH] OR "Diffusion of 

Innovation"[MeSH] OR "Patient Education"[MeSH] 

52494

#14 Search #4 AND #13 334

#15 Search "Tobacco, Smokeless"[MeSH]OR "spit tobacco" OR "chewing 

tobacco" OR "dip tobacco" OR "oral tobacco" 

1893

#16 Search #4 AND #15 160

#17 Search ("Marketing"[MeSH] OR "Social Marketing"[MeSH]) OR 

"Choice Behavior"[MeSH] OR "Advertising"[MeSH] 

39557

#18 Search #4 AND #17 402

#19 Search "Comorbidity"[MeSH] OR ("Risk-Taking"[MeSH] OR "Risk 

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] 

1406831

#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: 

e next questions are for drug studies only.

18. Non-bias selection? 

Quality Assessment for Adverse Events 

Th

 

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 multlevel 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 

C-3 

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-4 

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-5 

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) 

Χ2 Chi sq 

yr(s) yr(s) 
C-6 

Evidence Table 1. Effective population-based interventions 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Ennett et al., 2001 

Geographic area: 

US 

Funding agency: 

National Institute on Drug 

Abuse 

Study setting: 

Population-based 

Research objective: 

To identify mediators through which the 

Family Matters Program influenced 

adolescent smoking and drinking 

Population: 

• Adolescents 

• 12 to 14 yr olds and their families 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

Families had to have an adolescent age 12 

to 14 yrs old and live in contiguous 48 

states 

Exclusion criteria: 

NR 

Sampling plan: 

• Probability sample of families 

throughout 48 contiguous States of 

US entered into a randomized trial 

• Partcipants identified through 

random-digit dialing 

• Eligible families screened 

• Offered opportunity to participate in 

study and told that they had a 50/50 

chance of receiving Family Matters 

program 

• 1,316 adolescent–parent pairs 

agreed to enrolled in study 

• Pairs completed baseline interviews 

by telephone, matched w/ another 

pair by date and time of completion, 

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-7 

Evidence Table 1. Effective population-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Telephone counseling 

w/ parents 

Intervention: 

G1: Family Matters 

consists of successive 

mailings 4 mailings over 

14 mos of 4 booklets to 

parents of 12- to 14-yr-old 

adolescents and telephone 

discussions b/w parents 

and health educators after 

each mailing 

C1: NR 

Method of assessment: 

3- and 12-month followup 

via telephone interview w/ 

parent/guardian and 

adolescent 

Baseline data: 

Fewer non-Hispanic 

Whites in G1 than in C1 

Statistical analysis: 

• Repeated measures 

logistic regression w/ 

GEE using a one 

sided tail test 

• Mediation analysis 

follows approach 

outlined by Baron and 

Kenny to assess 

whether extent to 

which change in 

behavioral outcomes 

as a result of Family 

Matters program is 

accounted for by 

change in proposed 

mediators 

Data verification: 

Self-report 

Dependent variables: 

• Smoking status 

• Global family 

mediators 

(supervision, support, 

communication and 

involvment) 

• Substance specific 

mediators (expected 

consequences, 

parental attitude, 

parental 

encouragement, 

parent substance use, 

rules about use, 

monitoring, availability, 

nonfamily influences) 

• Adolescents in C more than 

1.5 times likely to smoke at 

follow up than family matters 

group (OR = 1.59, P = 0.008, 

lower bound CI, 1.19) 

• Program parents significantly 

more likely to discuss peer and 

media influences (b = -.76, 

P < 0.01), set rules about 

smoking (b = -0.46, P < 0.01) 

• Non Hispanic white 

participants only, program 

parents significantly more 

likely to encourage their 

children not to smoke 

(b = -0.42, P < 0.01), 

improvements in parent 

involvement 

(b = -0.10, P < 0.05), and 

positive effect on adolescent’s 

intentions to smoke (b = -0.15, 

P ≤ 0.01) 

Mediating effects for full model: 

stricter parent supervision (b = 

0.16, P < 0.01) and decreased 

parental use of tobacco (b = 

0.60, P < 0.01) 

Expected consequences and 

intention to use (b = 1.82, and b 

= 0.85, P < 0.01) decreased 

smoking 

Quality rating: 

Fair 

Comments: 

• No description of 

control 

intervention 

• Sample size for 

G1 and C1 NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

26% 
C-8 

Evidence Table 1. Effective population-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Thomson et al., 2004 

Geographic area: 

US 

Funding agency: 

NCI, Flight Attendant 

Medical Research Institute 

Study setting: 

Population-based 

Research objective: 

To test whether community-level youth 

access ordinances reduce adolescents' 

perceived access to tobacco, purchase 

attempts, and tobacco use 

Population: 

• Adolescents, 12 to 17 yrs 

Study type: 

Cross-sectional 

Describe study design 

• Representative sample of youth from 

across Massachusetts 

Inclusion criteria: 

• Age 12 to 17 

• Resident of Massachusetts 

• Parental consent 

• Youth assent 

Exclusion criteria: 

• Youth report of resident town disagreed 

w/ ZIP code and phone exchange 

indicators 

• Towns having no identified youth 

Sampling plan: 

• University of Massachusetts obtained 

a statewide random sample of 

households by random-digit dialing 

• Interview conducted w/ an adult 

resident to collect demographic data 

• Requested permission to interview all 

youth in household b/w ages 12 to 17 

yrs 

• Screen interviewers completed 66% 

of sample and 6,006 eligible youths 

identified 

Sample size: 

• Total: 3,831 

Definition of smoking: 

Cigarettes 

• Ever smoker: smoked or puffed 

cigarette in lifetime 

• Current smokers: smoked at least 

one cigarette inpast 30 days 
C-9 

Evidence Table 1. Effective population-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Parent involvment 

• Implementation of state 

wide youth tobacco access 

ordinances 

Intervention: 

G1: Community-level 

tobacco ordinances 

C1: NA 

Method of assessment: 

Phone survey 

Statistical analysis: 

X2uare 

GEE 

Data verification: 

Self-report 

Dependent variables: 

• Youth perceived access 

to tobacco 

• Attempts to purchase 

tobacco 

• Tobacco use 

Baseline data: 

White: 78% 

HispaniC1: 9% 

Other: 13% 

• 37% of youth perceived easy 

access to purchase tobacco 

• Less likely to perceive easy to 

purchase w/ ban on free displays 

AOR = 0.6, 95% (CI 0.5-0.9; P = 

0.007) 

• Youth reported easy access in 

towns that required tobacco 

vendors to have a license OR = 

1.3, 95% (CI 1.1 – 1.5, P = 0.009) 

• Increased perceived access 

associated w/ being older (P < 

0.0001) and male, (P ≤ 0.002) 

• 33% of 512 youth who smoked a 

cigarette in past 6 mos reported 

purchasing cigarettes 

• Result associated w/ bans on free 

samples and single cigarette sales 

in unadjusted model only 

• Attempts to purchase cigarettes: 

AOR = NS for all ordinances 

• Tobacco use: NS in adjusted 

model 

Quality rating: 

Fair 

Comments: 

Strengths: accounted 

for clustering in 

analyses 

Limitations: moderate 

participation rate; 

generic data on 

ordinance 

enforcement; crosssectional data 

Adequate 

randomization: 

NR 

Attrition rate: 

76% of eligible youth 

had parental consent 
C-10 

Evidence Table 2. Effective school-based interventions 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Ausems et al., 2004 

Geographic area: 

Western Europe 

Funding agency: 

European Commission and 

the Dutch Cancer 

Foundation 

Study setting: 

School-based 

Research objective: 

To compare effects on smoking prevention 

among Dutch first grade vocational school 

children using a newly developed computertailored (personalized messages/letters) 

out-of-school program, an existing in-school 

program, and a combined approach 

including both in-school and out-of-school 

programs 

Population: 

• Adolescents 

• Vocational school children in the 

Netherlands 

Study type: 

• RCT w/ cluster randomization 

• Six out of 8 area health departments 

agreed to participate, and within these 

areas local vocational schools invited to 

participate 

Inclusion criteria: 

Dutch vocational schools 

Exclusion criteria: 

NR 

Sampling plan: 

• 19 schools already participating in 

Healthy Schools and Stimulant 

Program 

• Randomly assigned within regionally 

defined blocks to in-school and out-of 

school conditions 

• Remaining 17 schools randomlly 

assigned to out-of school or control 

conditions 

Sample size: 

G1: 9 schools 

G2: 8 schools 

G3: 10 schools 

C1: 9 schools 

Definition of smoking: 

Cigarettes 

• Never-smokers: students who have 

never smoked even one cigarette or a 

puff of one 

• Non-current smokers: students who 

have smoked in past, but not during 

past month 

• Current smokers: students who have 

smoked during past month 
C-11 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Computer-based program 

• Classroom instruction 

• Computer generated 

letters 

Intervention: 

G1: In-school intervention: 

• Three lessons, each 

lasting about 50 min, 

student and teacher 

manuals available 

• Each lesson consisted of 

general introduction by 

teacher, reading text in 

workbook, classroom 

discussion, workbook task 

and additional task that 

summarized main points of 

lesson 

• First lesson explained 

ingredients of tobacco, 

and physical and mental 

reactions of smoking, 

while second discussed 

norms concerning 

smoking, and third 

emphasized pressures to 

smoke and skills that are 

helpful in resisting 

cigarettes 

Statistical analysis: 

• All effect analyses done 

separately for posttests 

1–2–3 

• Since running large 

regression models w/ 

MIXOR might cause 

problems, model 

reduction first applied, 

using SPSS 9.0 to 

determine final models 

containing significant 

covariates and 

interaction terms for 

prediction of smoking at 

posttests 1–2–3 

Data verification: 

Self-reports 

Dependent variables: 

Smoking rates, based on 

both smoking initiation 

among never-smokers and 

smoking continuation 

among ever-smokers 

Baseline data: 

• Smoking behavior: 

• Ever smoking: 59.7% 

• Current smoking: 19.5% 

• Mean age (yrs): 13.1 

• Gender (%, male): 52.1 

• Origin (w/ both parents 

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 

• Twelve months after pretest 

(posttest 2), in-school 

intervention successful in 

preventing vocational school 

students from continuing to 

smoke, compared w/ students in 

control condition OR = 0.49; 95% 

CI 0.29–0.84 

• Eighteen months after pretest 

(posttest 3), tailored out-ofschool intervention successful in 

preventing smoking initiation, 

compared w/ students in control 

(OR = 0.42; 95% CI, 0.18–0.96) 

• Effect of combined approach not 

larger than sum of effects of inschool and out-of-school effects. 

Quality rating: 

Fair 

Comments: 

• Refusal rate NR 

• Randomization 

description unclear 

regarding number 

of schools in txt 

groups 

• Out-of-school 

intervention poorly 

implemented (65% 

of personalized 

letters read by 

participants) 

Adequate 

randomization: 

Yes 

Attrition rate: 

School level 

• Posttest 1: 5.6% 

(2 schools) 

• Posttest 2: 8.3% 

(3 schools) 

• Posttest 3: 18.5% 

(NR) 

Student level: 

• Posttest 1: 17.3% 

• Posttest 2: 5.4% 

• Posttest 3: 24.6% 
C-12 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Ausems et al., 2004 

(continued) 

 
C-13 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

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-14 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Aveyard et al., 2001 

Geographic area: 

United Kingdom 

Funding agency: 

NR 

Study setting: 

School-based 

Research objective: 

To re-evaluate whether addition of a TTMbased intervention to existing health 

education school curriculum would protect 

young people from becoming smokers and 

help those who smoked quit compared w/ 

unknown effect of existing health 

educationRe-evaluation employed different 

periods of followup and fully exploring 

effects of using an ITT analytical approach 

Population: 

• Adolescents, ages 13 to 16 

• Living in West Midlands, UK 

Study type: 

RCT w/ cluster randomization 

Inclusion criteria: 

Yr 9 student (age 13 to 14) in participating 

school, assented and parents consented 

Exclusion criteria: 

• Parent or student refusal 

• Smoking status could not be assessed at 

followup(s) 

Sampling plan: 

• Sampling description referenced from 

previous study (Aveyard et. al., 1999) 

• Once schools agreed to participate 

individuals randomly allocated to 

intervention or control 

• Arms balanced by ordering schools 

into five groups based on numbers of 

students in yr 9; allocated each 

school a number b/w 1 and n 

(maximum number in group) 

• Computer program generated n/2 

random numbers b/w 1 and n, and 

schools allocated to intervention 

• One school allocated to intervention 

dropped out after randomisation and 

before baseline questionnaires 

administered 

All Yr 9 students (aged 13 to 14) in 

participating schools invited to 

participate 

Sample size: 

G1: 4,125 

C1: 4,227 

Definition of smoking: 

Cigarettes 

• Regularly smoking at least one 

cigarette per wk 
C-15 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis 

and Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Computer-based program 

• Video 

• Classroom instruction 

Intervention: 

G1: During Yr 9, received 

• Three whole class 

lessons and three 

interactive computer 

sessions (including video 

clips of young people 

discussing their smoking) 

• Followed by 

questionnaires assessing 

stages of change, 

smoking uptake or 

cessation 

• Feedback on results of 

questionnaire, counseling 

about how to move 

forward in stages, and 

feedback on progress 

over time points 

C1: Standard lessons on 

smoking as part of English 

national curriculum, possibly 

up to three additional 

lessons on smoking (already 

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 

Statistical analysis: 

• Random effects 

logistical regression 

• Logistical regression 

• Bivariate analysis, 

• Frequencies 

• Kappa assessment 

• Sensitivity analysis 

Data verification: 

Self-report 

Dependent variables: 

• Movement in stage of 

change 

• Smoking status 

Baseline data: 

• NR, but stated no 

large differences b/w 

groups in these 

predictors of smoking 

at baseline 

• Predictors included: 

smoking status, 

stage of change, and 

potential 

confounders, i.e., risk 

factors for smoking in 

future 

No evidence of change of stage 

at either 1 yr or 2 yr followup: 

G1 vs C1

• 1 yr AOR = 1.13, 95% (CI, 

0.91 - 1.41); 

• 2 yr AOR = 1.25, 95% (CI, 

0.95 - 1.64) 

No change in regular smoking at 

either follow up: 

• G1 vs C1: 

1 yr AOR = 1.14, 

(95% CI, 0.93, 1.39) 

• 2-yr AOR = 1.06, 

(95% CI, 0.86, 1.31) 

Subgroup analysis by initial 

smoking status NS for benefit for 

prevention of smoking or 

smoking cessation 

Quality rating: 

Fair 

Comments: 

40% refusal rate; 

no details on 

baseline data; C 

exposure to other 

prevention 

programs not 

assessed 

Adequate 

randomization: 

Yes 

Attrition rate: 

Yr 1: 

G1: 11% 

C1: 10.7% 

Yr 2: 

G1: 14% 

C1: 16.9% 
C-16 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Brown et al., 2002 

Geographic area: 

Canada 

Funding agency: 

NHLBI 

Study setting: 

School-based 

Research objective: 

To evaluate an extracurricular HS tobacco 

control intervention developed by teachers 

and students 

Population: 

• Adolescents 

• Cohort followed from 7-8th grade through 

9-10th grade 

Study type: 

• RCT w/ cluster randomization and pairedmatching 

• Matched pairs prior to randomization 

• Randomized within pairs to Intervention 

and Cs 

Inclusion criteria: 

• School board participated in prior 

elementary school smoking prevention 

study 

• At least 30 students from elementary 

school cohort projected to attend HS 

Exclusion criteria: 

NR 

Sampling plan: 

30 high schools 

Matched pairs prior to randomization by: 

• Size of school 

• Number of students projected to 

attend who participated in an 

elementary school study 

• Proportion of cohort students from 

elementary school study control 

condition 

Sample size: 

G1: 1,563 

C1: 1,465 

Definition of smoking: 

Cigarettes 

• Experimental smoker: smoked less 

than once a wk 

• Regular smoker: smoked weekly 
C-17 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis 

and Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Extra-curricular activities 

• Mobilization of staff and 

students to involvement in 

anti-smoking activities 

Intervention: 

G1: Extracurricular 

activities: Quit and win 

contests, poster contests, 

displays, health fairs, 

smoking surveys 

• Average of 3.8 

intervention activities in 

9th grade and 3.5 

activities in 10th grade 

• A teacher facilitated 

students, staff, and 

community members in 

planning and 

implementing prevention 

and cessation activities 

tailored to each 

intervention school to 

build committment and 

strengthen not smoking 

as a school social norm 

• 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 $1000 per 

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 

Statistical analysis: 

Cluster-randomized 

designs (as discussed 

in Donner) and applied 

a procedure that uses a 

variance term 

appropriate to 

randomization of 

schools (Liang) 

Data verification: 

• Bogus CO breath 

samples collected to 

enhance validity of 

self-reported 

smoking behavior 

• Data collected from 

absent students by 

mail or phone, but no 

bogus CO samples 

collected 

Dependent variables: 

• Social model risk 

score 

• Elementary school 

risk score 

• Smoking status 

Baseline data: 

Baseline data similar 

except proportion of HS 

students in elementary 

school study 

intervention cohort : 

G1: 84% 

C1: 75% 

(P = 0.10) 

Grade 10 smoking rates for 

never smokers: 

• Male regular smoking rates 

lower 

G1: 9.8% 

C1: 16.4% 

P = 0.02 

Smoking rates despite baseline 

status (NS): 

• Females: 

G1: 28.3% 

C1: 24.8% 

P = NR 

• Males: 

G1: 21.1% 

C1: 26.4% 

P = NR 

• Overall: 

G1: 24.9% 

C1: 25.7% 

P = NR 

Quality rating: 

Fair 

Comments: 

• Randomization 

technique 

incomplete 

• Control schools 

received “usual” 

care but not 

described 

• Some slight 

baseline data 

differences 

• Limited 

generalizability 

Adequate 

randomization: 

Yes 

Attrition rate: 

G1: 5% 

C1: 5% 
C-18 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Crone et al., 2003 

Geographic area: 

Western Europe 

Funding agency: 

None 

Study setting: 

School-based 

Research objective: 

To assess effect of a peer pressure based 

antismoking intervention on adolescents in 

lower secondary (middle) school 

Population: 

• Adolescents 

• 1st grade of lower secondary education in 

the Netherlands (mean age 13) 

Study type: 

RCT w/ stratified randomization 

Inclusion criteria: 

• Adolescents in lower secondary 

education in the Netherlands 

Exclusion criteria: 

• If already participating in another study 

Sampling plan: 

Community Health Sources 

• 48 school identified; 

18 willing to participate; 

8 additional schools recruited 

• Schools stratified by size and use of 

national drug education 

• Randomized to intervention or control 

by toss of coin by independent 

person 

Sample size: 

G1: 14 schools, 1,444 students 

C1: 12 schools, 1,118 students 

Definition of smoking: 

Cigarettes 

• Smoker: all students who experiment 

w/ smoking or who smoke weekly or 

daily 
C-19 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Video 

• Classroom instruction 

• Competition by NIAS 

that reward class w/ 

< 10% smokers 

Intervention: 

G1: Three lessons on 

knowledge, attitudes, and 

social influence, followed 

by a class agreement not 

to start smoking or to stop 

smoking for next 5 months 

• Two extra video lessons 

on smoking and social 

influence were available 

as an optional extra 

during the 5 months 

• A competition 

administered by the 

NIAS that rewarded 

classes that had fewer 

than 10% smokers at 

the end of the 5 month 

period 

• A photography contest 

to pick best photos that 

expressed a nonsmoking class 

C1: Used drug prevention 

program normally given to 

students (which 

intervention schools used 

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 

Statistical analysis: 

• Used multilevel 

techniques to account 

for clustering; 

• Compared intervention 

and Cs in terms of 

proportions of smokers 

before and after 

intervention and 

proportion who started 

smoking, controlling 

for differences at 

baseline 

• Performed ITT 

analysis 

Data verification: 

Self-report 

Dependent variables: 

Smoking status 

• Changes in attitude 

toward smoking 

• Perceived social 

influence 

• Self-efficacy 

• Intention to remain a 

smoker 

Baseline data: 

Males (%): 

G1: 49.5 

C1: 60.9 

P = < 0.001smoker 

Mean age: 13 yrs 

Proportion increase at end of 

intervention: 

• Nonsmokers: 

G1: 9.6% 

C1: 14.2% 

OR 0.61 

(95% CI, 0.41-.90) 

• Smokers: 

G1: 2.6% 

C1: 7.9% 

OR = 0.62 

(95% CI, 0.43 - 0.90) 

Perceived social pressure: 

• More likely to be smokers 

OR = 2.21 

(95% CI, 1.53 - 3.18) 

• Effects at one yr followup: NS 

Quality rating: 

Fair 

Comments: 

• Refusal rate 

(62.5%) 

• Not generalizble 

• Significant 

differences in 

baseline data 

• Very high 

attrition but used 

ITT 

Adequate 

randomization: 

Yes 

Attrition rate: 

Schools: 

Overall attrition: 

11.5% (3/26) 

G1: 7.1% (1/14) 

C1: 16.7% (2/12) 

Student attrition: 

Overall: 63.3% 

(1,621/2,562) 

G1: 61.4% 

(887/1,444) 

C1: 63.9% 

(714/1,118) 
C-20 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Ellickson et al., 2003 

Geographic area: 

US 

Funding agency: 

NIDA, the BEST Foundation 

for a Drug-Free Tomorrow; 

the Conrad N. Hilton 

Foundation 

Study setting: 

School-based 

Research objective: 

To evaluate revised Project ALERT drug 

prevention program across a variety of 

Midwestern schools and communities 

Population: 

• Adolescents, 7th and 8th graders in 

South Dakota (Urban and rural 

communities) 

Study type: 

RCT w/ stratified randomization 

Inclusion criteria: 

• Middle schools in South Dakota 

• Parental consent obtained 

Exclusion criteria: 

NR 

Sampling plan: 

• 48 school clusters (high schools and 

their feeder middle schools) 

• Schools organized in 3 strata by 

community size and type (city, town, 

rural) 

• Blocks of school clusters consisted of 

3 clusters from same stratum located 

in same geographic region of state., 

within each block, 1 school cluster 

randomly assigned to each 

experimental condition 

• Results are combined through 8th 

grade for this study w/ one C 

Sample size: 

G1: 34 middle schools, 2,553 students 

C1: 21 middle schools, 1,723 students 

Definition of smoking: 

Cigarettes 

• Cigarette use: ever, past month, and 

weekly 
C-21 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

Classroom instruction 

Intervention: 

G1: 11 lessons in 7th 

grade and 3 lessons in 8th 

grade that, using 

interactive teaching 

methods, they sought to 

change students' beliefs 

about drug norms and 

social, emotional, and 

physical consequences of 

using drugs, to help 

students identify and resist 

pro-drug pressures from 

parents, peers, media, and 

others, and to build 

resistance self-efficacy; 

followed by booster 

lessons in 9th and 10th 

grades 

G2: 11 lessons in 7th 

grade and 3 lessons in 8th 

grade that, using 

interactive teaching 

methods, they sought to 

change students' beliefs 

about drug norms and 

social, emotional, and 

physical consequences of 

using drugs, to help 

students identify and resist 

pro-drug pressures from 

parents, peers, media, and 

others, and to build 

resistance self-efficacy; 

not followed by any 

booster lessons 

C1: Did not receive 

experimental program; 

schools could continue 

other prevention curricula 

already in place 

Method of assessment: 

Students completed 

surveys at baseline and 18 

months later 

Statistical analysis: 

• Adjusted for multiple 

baseline covariates, 

including covariates 

for school geographic 

location and 

enrollment size to 

account for blocking 

• Used Bayesian model 

to impute missing data 

for covariates; a 

generalized estimating 

equation that assumed 

a linear model for 

natural logarithm of 

the odds of use and 

constant correlation 

among responses 

from students from 

same schools used to 

account for possible 

intraschool correlation 

Data verification: 

Self-reported smoking 

status validated by 

assessing salivary 

cotinine levels for a 

random subsample of 

654 students 

Dependent variables: 

Cigarette, marijuana, and 

alcohol use; beliefs 

about consequences, 

prevalence and 

expectations of use, selfefficacy 

Baseline data: 

• Non-white: 12.5% 

(largely Native 

American) 

• Female: 50% 

• Students in C1 less 

likely to be White and 

more likely to have 

used marijuana than 

students in G1 and G2 

At 18-month followup, cigarette 

use in the past month: 

• Baseline non-users: 

G1+G2:8.6% 

C1: 11.1% 

P = < 0.01 

• Baseline experimenters: 

G1+G2:28.9% 

C1: 36.6% 

P = < 0.05 

• Baseline users: 

G1+G2:56.8% 

C1: 70.8% 

P = < 0.05 

At 18-month followup, weekly 

cigarette use: 

• Baseline non-users: 

G1+G2:4.0% 

C1: 6.6% 

P = < 0.05 

• Experimenters: 

G1+G2:18.0% 

C1: 23.5% 

P = < 0.05 

• Users: 

G1+G2:45.1% 

C1: 56.0% 

P = < 0.10 

Quality rating: 

Fair 

Comments: 

• Slight baseline 

differences but 

controlled for in 

analysis 

• Clear description 

of school 

assignment 

• Possible 

disruption of 

randomization 

process 

Adequate 

randomization: 

Yes 

Attrition rate: 

9% 
C-22 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Josendal et al 2005 

Geographic area: 

Western Europe 

Funding agency: 

Norwegian Cancer Society 

Study setting: 

School-based 

Research objective: 

To evaluate the BEsmokeFREE schoolbased, smoking-prevention program for 

adolescents in Norway 

Population: 

• Adolescents 

• Norwegian 7th, 8th , and 9th grade (mean 

age 13) 

Study type: 

• RCT w/ cluster randomization 

Inclusion criteria: 

After being sampled by technique 

described, the school had to agree to 

participate 

Exclusion criteria: 

NR 

Sampling plan: 

• Nationally representative sample of 

99 secondary schools from a list of all 

secondary schools in Norway 

• Schools sorted by ascending postal 

code number, every 11th school 

included in study; schools allocated to 

groups by investigators choosing a 

random number b/w 1 and 44 

• Starting w/ that number, every 44th 

school selected for C and next three 

schools on list of comparable size (+/- 

10%) allocated to three intervention 

groups 

Sample size: 

G1: 25 schools, 1,125 students 

G2: 25 schools, 933 students 

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-23 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Video 

• Parent involvment 

• Classroom instruction 

Intervention: 

G1: Intervention 

administered by teachers 

and other staff at school 

• Given to students in 

grades 7 and followed 

cohort through 7, 8, 9 

grade 

• Number of hrs of 

intervention: grades 7 thru 

9 were 8, 5 and 6 hrs, 

respectively 

• Classroom instruction 

contained non-traditional 

school activities such as 

video, games, and group 

work 

• During grade 8 

adjustments to intervention 

were requested by 

students and teachers 

• In grade 9, students 

developed and carried out 

and evaluated their own 

campaign to promote a 

smoke free lifestyle among 

the 7th graders 

• Classroom curriculum, 

teacher in-service course, 

and parental involvement 

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 inservice 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. 

Statistical analysis: 

Multilevel, multiple logistic 

regression analyses used 

to examine odds of 

smoking among students in 

intervention groups 

compared w/ students in 

C1, adjusted for gender 

and smoking habits at 

baseline 

Significance tested w/ 

Pearson's Χ2

, corrected for 

design effect; correction 

implies chi sq value 

converted to an F-value w/ 

number of d.f. that may 

deviate from integer values

Data verification: 

Self-report 

Dependent variables: 

• Frequency of smoking 

• Number of cigarette hrs 

• Number of cigarettes 

smoked per wk 

• Use of cannabis 

• Frequency of cannabis 

use 

Baseline data: 

Baseline data reported but 

limited to smoking 

frequencies 

Mean age: 13 yrs 

Proportion of smokers higher in C1 

vs G1 for 3 followup yrs: 

• 1995: F(d.f. = 2.61; 125.49) = 

5.66; P < 0.01 

• 1996: F(2.34; 114.46) = 7.19; 

P < 0.001 

• 1997: F(2.39; 112.42) = 4.05; 

P < 0.05 

In G2 and G3, proportion of 

smokers on all followup occasions 

higher than G1 but lower then C1 

• 1995: F(d.f. = 9.74; 886.65) = 

2.84; P < 0.01 

• 1996: F(7.87; 739.55) = 3.98 

P < .001 

• 1997: F(6.00; 485.98) = 2.46; 

P < .05 

Odds of becoming a smoker during 

intervention period statistically 

lower in G1 compared to C1: 

• Daily smoking (Wald’s 9.81, d.f. 

= 3, P = 0.02) 

• Weekly smoking (Wald’s 15.65, 

d.f. = 3, P = 0.0001) 

• Any smoking (Wald’s 16.54, d.f. 

= 3, P = 0.0001) 

Quality rating: 

Good 

Comments: 

• Study design and 

randomization 

technique clearly 

described 

• Intervention 

theoretically 

anchored; 

description of 

scales reported in 

referenced article 

• Explored attrition 

by surveying drop 

outs 

Adequate 

randomization: 

Yes 

Attrition rate: 

• G1+G2+G3: 11.2%

C1: 5.8% 

• Smokers more 

likely to drop out 

than non-smokers 
C-24 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Perry et al., 2003 

Geographic area: 

US 

Funding agency: 

NIDA 

Study setting: 

School-based 

Research objective: 

To evaluate effect of middle and junior HS 

D.A.R.E. and D.A.R.E. Plus programs on 

drug use and violence 

Population: 

• Adolescents, 7th and 8th grade 

• Junior High Schools and communities in 

Minneapolis-St Paul region, Minnesota 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

Minnesota school district, 7th graders in Fall 

1999 

Exclusion criteria: 

NR 

Sampling plan: 

• Targeted Minnnesota school districts 

w/ schools w/ 7th grade populations 

of at least 200 

• 24 Junior high schools matched on 

SES, drug use and size; schools 

randomly assigned to 1 of 3 

conditions DARE only, DARE Plus, or 

C 

Sample size: 

G1: 8 schools; 2226 students 

G2: 8 schools; 2221 students 

C1: 8 schools; 1790 students 

Definition of smoking: 

NR 
C-25 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Parent involvment 

• Extra-curricular activities 

• Classroom instruction 

• Community-activities 

Intervention: 

G1: D.A.R.E. middle and 

junior HS curriculum 

• 10 sessions taught by 

police officers in 1999-

2001 

G2: D.A.R.E curriculum 

and D.A.R.E. Plus 

program in 1999-2001: 

• Classroom sessions, 

peer led, parent 

involvement 

• Community leader 

involvement program 

consisting of extra 

curricular anti-smoking 

activities in and out of 

school, including 

neighborhood activities 

to address 

neighborhood issues 

related to drug use and 

violent behavior 

C1: Delayed program: 

Schools could receive 

D.A.R.E. Plus programs in 

2001-2002, after final 

followup 

Method of assessment: 

Self-administered 

questionnaire 

Statistical analysis: 

Growth curve analysis; 

3-level linear, randomcoefficients model 

Data verification: 

Self-report 

Dependent variables: 

• Use of cigarettes, 

alcohol, and 

marijuana; multidrug 

use; violent behaviors; 

expectations 

concerning drug use, 

perceived access/offer 

of drugs, parental 

rules and 

communication about 

drugs 

• Outcome expectations 

about tobacco 

Baseline data: 

Male: 51.6% 

White: 67.3% 

African American: 7.5% 

Asian American: 12.7% 

HispaniC1: 3.6% 

American Indian: 4.0% 

Mixed or other: 4.9% 

Using growth curve analysis: 

D.A.R.E. Plus less likely than 

control to show an increase in 

current smoking for boys 

G2: (.28) std = 0.05 

C1: (.31), std = 0.05 

D.A.R.E. Plus less likely than 

D.A.R.E. curriculum alone to 

show an increase in tobacco use 

behavior and intentions. 

G1: (.95), std = 0.11 

G2: (.68), std = 0.11 

C1: (.96), std = 0.12 

NS outcomes for females 

Quality rating: 

Fair 

Comments: 

• Randomization 

and sampling 

technique 

incomplete 

• No baseline 

comparison data 

Adequate 

randomization: 

No, grouprandomization 

method NR; exactly 

8 schools per 

intervention 

Attrition rate: 

• 16% overall 

• Minimal 

differential 

attrition per 

authors 
C-26 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Schofield et al., 2003 

Geographic area: 

Australia 

Funding agency: 

National Health and Medical 

Research Council 

(Australia); Hunter Centre 

for Health Advancement 

Study setting: 

School-based 

Research objective: 

To determine whether HPS intervention 

program led to lower smoking uptake and 

improved knowledge and attitudes among a 

cohort of students, and to examine factors 

independently predicting posttest smoking 

status 

Population: 

• Adolescents 

• 7th -8th grade cohort followed 2 yrs to 

grades 9-10 in New South Wales 

Study type: 

• RCT w/ cluster randomization (cohort 

prepost design) 

• Students followed over two yr period; 

cohort prepost design used to evaluate 

intervention effectiveness 

Inclusion criteria: 

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 

Sampling plan: 

• Intervention randomly allocated to 

selected secondary schools 

• Randomly selected 24 of 31 

secondary schools in Hunter and 

Taree schools districts of New South 

Wales 

• 22 of 24 schools participated, w/ 12 

schools assigned to intervention, 10 

to control 

Sample size: 

G1: 1,007 

C1: 845 

Definition of smoking: 

Cigarettes 

• Smoking status at posttest: having 

smoked any amount of cigarettes 

within past 7 days 
C-27 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Group counseling 

• Social support 

Intervention: 

G1: Each school had 

liaison office responsible 

for introducing minimum 

set of actions and 

facilitating tailoring and 

implementation of the 

following actions: 

• Ensure curriculum 

covers smoking effects, 

distribute parent 

smoking pamphlet, 

implement school 

smoking policy, 

distribute letters to 

tobacco retailers, 

discussion group/survey 

w/ parents, followup 

action from discussion 

group, and training of 

SRC/peer leaders to 

deal w/ smoking issues 

• Schools also 

encouraged to take over 

other additional anti 

smoking activities of 

their choice 

C1: Control schools not 

offered any of the 

resources or actions to 

reduce smoking that 

intervention schools 

received, but if they 

requested assistance, 

project team offered 

support for other healthrelated 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 

Statistical analysis: 

Univariate analysis 

Bivariate analysis 

Multivariate analysis 

Logistic regression 

Data verification: 

Self-report 

Dependent variables: 

• Smoked in last wk 

• Smoking knowledge 

• Smoking attitudes 

towards schools 

Baseline data: 

Large variations in 

baseline smoking rates 

(11-33%) so smoking 

and school controlled for 

in regression (details 

NR) 

At pretest, smokers had: 

• Less positive attitudes 

than nonsmokers 

(mean for smokers: 

4.3; mean for nonsmokers 4.7, mean 

difference = 0.4, 95% 

CI-0.3, 0.5) 

• Fewer perceived 

negatives about 

smoking (smokers' 

mean: 3.6, nonsmoker's mean = 3.9, 

mean difference = 0.2, 

95% CI, 0.1, 0.3) 

Posttest results: 

Smoked in last wk: NS 

G1: 17.5% 

C1: 20.5% 

Crude OR for G1 = 0.82 (0.65, 

1.04) 

Maximum knowledge score: 

G1: 64% 

C1: 60% 

Prepost change: 

G1: 12% 

C1: 7% 

P = 0.001 

Smoking attitudes: 

NS at pre or posttest 

Solely among smokers (from 

combined groups), positive 

attitudes to smoking 

decreased from pretest to 

posttest (P = 0.01), but not 

among non-smokers 

Quality rating: 

Fair 

Comments: 

• Refusal rate: 40% 

• High attrition 

• Intervention not 

consistently 

implemented across 

schools, though 

high fidelity in 

implementing "key 

components" of 

intervention, 

authors mention 

potential 

contamination via 

control schools w/ 

personnel 

supportive of HPS 

intervention 

program, but no 

data to 

support/refute 

• Study properly 

addressed 

clustering issue 

through analytical 

methods 

Adequate 

randomization: 

Yes 

Attrition rate: 

G1: 48% 

C1: 52% 

(Authors mention 

more smokers than 

non-smokers lost to 

follow up) 
C-28 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Share et. al., 2004 

Geographic area: 

Western Europe 

Funding agency: 

Europe Against Cancer 

Programme 

Study setting: 

School-based 

Research objective: 

To evaluate impact of a school-based 

intervention-SFL-which aimed to involve the 

community, increase tobacco knowledge, 

strenghthen refusal skills, and improve 

decision-making ability 

Population: 

• Adolescents, ages 13 to 15 

• Leitrim, Sligo, and Donegal County, 

Ireland students 

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 

Sampling plan: 

SLF program participant cohort 

matched w/ a C located in North 

Western Health Board area (not 

defined) 

Sample size: 

G1: 450 

C1: NR 

Definition of smoking: 

NR 
C-29 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

Classroom instruction 

Intervention: 

G1: Primary school phase: 

materials about smoking, 

healthy lifestyle, and 

growing up provided for 

classroom instruction; 

• Teachers determined 

order/timing of lessons; 

visits from health 

promotion staff,and yr 

end celebration; 

• Postprimary school 

phase: quizzes, 

competition, visits by 

health promotion staff, 

newsletter, website, 

peer education project, 

smoke free school 

buses campaign, and 

annual events day(no 

classroom materials 

provided) 

C1: NR 

Method of assessment: 

Self-report questionnaire 

at study's end 

(administered face to face 

in intervention group and 

11 control schools; 

"posted" (mailed) to other 

control schools) 

Statistical analysis: 

• SPSS 

• Pearsons chi sq 

• Spearman's Rank 

correlation 

Data verification: 

Self-report 

Dependent variables: 

• Smoking 

experimentation 

• Current smoking 

• Smoking knowledge 

• Attitudes about 

smoking 

• Family member 

smoking 

• Reasons for continued 

smoking 

Baseline data: 

Baseline data (i.e: at age 

9 to 10) NR 

Male 

G1: 52% 

C1: 45% 

Age 13: 

G1: 12% 

C1: 14% 

Age 14: 

G1: 72% 

C1: 77% 

Age 15+: 

G1: 16% 

C1: 9% 

Tried smoking: 

G1: 59% 

C1: 55% 

Current smoking: 

G1: 19% 

C1: 24% 

Females in C 2x as likely to 

smoke everyday and 50% more 

likely to currently smoke than 

females in intervention group, (P 

< 0.05) 

Feel grown if smoke: 

G1: 30% 

C1: 43% 

(P < 0.01) 

Don't mind if friends smoke: 

G1: 72% 

C1: 67% 

(P < 0.05) 

Family: correlation b/w student 

smoking experimentation and 

parent/sibiling smoking: 

• Mother (rs = 0.165, P < 0.01) 

• Father (rs = 0.172, P < 0.05) 

• Both parents (rs = 0.346, 

P < 0.01) 

• Brother (rs = 0.162, P < 0.01) 

• Sister (rs 0.277, P < 0.01) 

Quality rating: 

Poor 

Comments: 

• No information 

on selection of 

subjects from 

primary 

intervention 

• Unable make 

inferences from 

original baseline 

data because 

followup 

instrument not 

compatible 

• No reliability 

testing of 

instrument 

• No information 

on 

randomization, 

or C 

• No baseline data 

and analytical 

methods not well 

described 

Adequate 

randomization: 

NR 

Attrition rate: 

G1: 22% 

C1: NR 
C-30 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Simons-Morton et al.,2004 

Geographic area: 

US 

Funding agency: 

NR 

Study setting: 

School-based 

Research objective: 

To examine associations b/w initial and 

continuing peer affiliation and parent 

influences and smoking stage progression 

Population: 

• Adolescents, 6th, 7th, and 8th graders 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

• 6th grader in 1996 or 1997 at one of 7 

schools in un-named Maryland School 

District 

• Consent by parents 

Exclusion criteria: 

Special education students 

Sampling plan: 

• Seven middle schools (in 1 Maryland 

school district) recruited and 

randomized: 

o 3 to txt condition and 4 to control 

• Starting w/ 1996 school yr., 2 

successive cohorts of 6th-grade 

students recruited and followed 

through 9th-grade 

Sample size: 

Total: 3,039 at start, 1,320 final 

C1: NR 

Definition of smoking: 

Cigarettes 

• Never: no smoking in past 30 days or 

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-31 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Video 

• Classroom instruction 

Intervention: 

G1: The Going Places 

Program: parent education 

(materials sent home), 

school media, social skills 

curriculum (to increase 

school engagement and 

prevent multiple problem 

behavior such as 

substance use, 

aggression, and antisocial 

behavior) 

• 18 class sessions in 6th 

grade, 10 in 7th grade, 6 

in 8th grade 

C1: NR 

Method of assessment: 

• Students surveyed at 

beginning and end of 

6th grade, toward end 

7th & 8th grades, and 

beginning of 9th grade 

• Two trained proctors 

collected data; teachers 

not involved w/ survey 

Baseline data: 

NR 

Statistical analysis: 

LGC analysis (Curran, 

2000): structural 

equation modeling + 

hierarchical linear 

modeling 

Data verification: 

Self-report 

Dependent variables: 

• Background variable 

• Smoking 

• Friends w/ problem 

behaviors 

• Parenting practices 

Final sample: 

• White: 66% 

• Black: 25% 

• Other: 9% 

• Variance of intercept factor in 

linear LGC model 2.23 (SE = 

2.05; P < 0.001) indicating 

significant differences in 

tobacco use at beginning of 

6th grade 

• Variance of slope factor 0.289 

(SE = 0.038; P < 0.01) 

indicating significant 

differences in smoking stage 

progression over time 

• Path coefficients: intercept of 

adolescent smoking to slope of 

friends who smoke variable = 

0.31(P < 0.01) indicating 

adolescents at higher initial 

smoking stages had increased 

# of friends smoking over time 

• Path coefficient b/w parent 

involvement and adolescent 

smoking = -0.15, (P < 0.01) 

indicating parent monitoring 

and expectations overtime are 

negatively associated w/ 

smoking stage progression 

• 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 

Quality rating: 

Poor 

Comments: 

• Baseline data 

NR 

• C sample size 

NR 

• No txt vs 

comparison 

group data 

reported 

• 151 special 

education 

students 

excluded after 

assessment 1, 

suggested 

possibility of post 

randomization of 

exclusions 

Adequate 

randomization: 

NR 

Attrition rate: 

36.3% 
C-32 

Evidence Table 2. Effective school-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Unger et al., 2004 

Geographic area: 

US 

Funding agency: 

National Institutes of Health 

and the Calif TobaccoRelated Disease Research 

Program 

Study setting: 

School-based 

Research objective: 

Determine whether a multicultural 

curriculum prevents initiation of smoking 

among middle school children at 1-yr 

followup 

Population: 

• Adolescents 

Study type: 

RCT w/ cluster randomization 

Inclusion criteria: 

Students participated if they and their 

parents provided active written consent 

Exclusion criteria: 

NR 

Sampling plan: 

Sixteen middle schools in Southern 

Calif randomly assigned to receive 

multicultural curriculum or standard 

curriculum (8 schools in each group) 

Sample size: 

G1: 1,040 students, 8 schools 

C1: 930 students, 8 schools 

Definition of smoking: 

Cigarettes 

• Smokers: trying smoking b/w 6th and 

7th grade 
C-33 

Evidence Table 2. Effective school-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

Classroom instruction 

Intervention: 

G1: Project FLAVOR (Fun 

Learning about vitality, 

origins, and respect) 

provided 8 weekly 

classroom sessions 

conducted by health 

educators that addressed 

smoking-related 

psychosocial concepts 

through activities such as 

role-playing, trivia games 

and art projects, relating 

these issues to values of 

several cultures, such as 

Asian Yin-Yang concepts, 

and telenovela (soap 

opera) role play 

C1: 8 weekly classroom 

sessions conducted by 

health educators that 

addressed smokingrelated psychosocial 

concepts through activities 

such as role-playing, trivia 

games and art projects, 

but without cultural 

references 

Method of assessment: 

Surveys at baseline and 1 

yr followup 

Statistical analysis: 

• X2

 and ANOVA 

analyses assessed 

prevention 

equivalence of 2 

groups 

• Logistic regression 

used to examine 

attrition based on 

experimental 

condition, baseline 

smoking, and 

experimental condition 

x baseline smoking 

• Multi-level logistic 

regression w/ school 

as a random effect to 

control for intraclass 

correlation assessed 

effect of intervention 

on smoking initiation 

b/w sixth and seventh 

grades 

Data verification: 

Self-report 

Dependent variables: 

Smoking status 

Baseline data: 

• Groups similar at 

baseline 

• No significant 

differences in 

demographics or 

lifetime smoking 

prevalence b/w 

intervention and Cs 

• HispaniC1: 57% 

• Asian American: 27% 

• Other: 16% 

Initiation among never smokers 

(yr 1 followup): 

G1: 8% 

C1: 11% 

P = NR 

Among male, Hispanic, never 

smokers, OR of smoking 

intitation by 7th grade: OR = 0.49 

(95% CI, 0.27 -.88) 

Overall intervention effect NS: 

OR = 0.75 (95% CI, 0.48, 1.18) 

Quality rating: 

Fair 

Comments: 

• Randomization 

scheme NR 

• No ITT analysis 

Adequate 

randomization: 

NR 

Attrition rate: 

G1: 16.83% 

C1: 16.77% 

Higher among 

baseline ever 

smokers (22%) 

than never 

smokers (16%), 

P = < 0.05 
C-34 

Evidence Table 3. Effective provider-based interventions 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Tyc et al., 2003 

Geographic area: 

US 

Funding agency: 

NCI, ALSAC 

Study setting: 

Practice/provider settings 

Research objective: 

To evaluate efficacy of a tobacco risk 

counseling intervention vs standard care for 

preadolescent and adolescent cancer 

survivors 

Population: 

• Adolescents who were cancer survivors 

age 10 to 18 (treated at St. Jude 

Children's Research Hopital, Memphis, 

TN) 

Study type: 

RCT w/ stratified randomization 

Inclusion criteria: 

• Between 10 to 18 yrs old 

• Survivor of pediatric cancer 

• Currently disease-free 

• At least 1 yr from completion of 

antineoplastic therapy at St. Jude 

Children's Research Hospital (TN) 

Exclusion criteria: 

Patients who had brain tumors (due to 

cognitive, functional impairments that often 

result from txt) 

Sampling plan: 

• Stratified RCT w/ patients who were 

pediatric cancer survivors treated at 

St. Jude Children's Research 

Hospital, Memphis, TN, currently 

receiving txt there 

• Recruited during outpatient visits 

• Asked to participate and told 

participation did not depend on 

smoking status 

• On enrollment patients randomly 

assigned (stratified by age, sex, race, 

and self-reported smoking status) 

• Randomization scheme proposed by 

Zelen (1974) 

Sample size: 

G1: 53 

C1: 50 

Definition of smoking: 

NR 
C-35 

Evidence Table 3. Effective provider-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Telephone counseling 

• Video 

Intervention: 

G1: Administered in single 

session w/ periodic 

reinforcement of tobacco 

goals by telephone 

• Educational video 

discussed short- and 

long-term physical and 

social consequences of 

tobacco use 

• Late effects risk 

counseling focused on 

potential chemotherapy 

and radiation txt related 

toxicities exacerbated by 

tobacco use and 

survivors’ increased 

vulnerability to tobaccorelated health risks 

relative to their healthy 

peers 

• Goal setting involving 

tobacco abstinence or 

cessation depending on 

survivor’s smoking 

status 

• A physician feedback 

letter that reinforced 

antitobacco message 

delivered in intervention 

• Tobacco literature and 

followup telephone 

counseling at 1 and 3 

months after 

intervention 

• Face-to-face counseling 

component of 

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. 

Statistical analysis: 

• Descriptive 

• Multivariate analysis of 

variance, 

• Repeated measures 

• Mixed-model analysis 

of variance and 

regression 

Data verification: 

Self-report 

Dependent variables: 

• Knowledge (of 

adverse 

consequences of 

tobacco use generally 

and for cancer 

survivors) 

• Perceived Vulnerability 

(to tobacco related 

health risks) 

• Intentions (I) (to use 

tobacco) 

• Perceived PPE 

Baseline data: 

Baseline demographic 

and questionnaire data 

collected for both groups 

w/ no significant 

differences b/w groups 

Mean K score: 

G1: 24

C1: 22.7

Mean PV score: 

G1: 35.9

C1: 32.5 

I scores: 

G1: 7.8

C1: 10.0 

P = 0.002 

No significant differences in PPE 

at 12 mos, nor in any of 

dependent variables at 6 months 

Quality rating: 

Fair 

Comments: 

• No psychometric 

validation of 

researcherdesigned scales 

to measure 

knowledge and 

perceived 

positive effects 

of tobacco 

• No verification or 

definition of 

tobacco use 

• Limited 

generalizability 

to primarily white 

cancer patience 

• Possible ceiling 

and floor effects 

on Knowledge 

and intention 

measures makes 

it difficult to 

access 

meaningful 

changes 

Adequate 

randomization: 

Yes 

Attrition rate: 

At 6 months: 

Overall: 30% 

(31/103) 

G1: 32.1% (17/53)

C1: 28% (14/50) 

At 12 months: 

Overall: 21.5% 

(22/103) 

G1: 20.1% (11/53)

C1: 22% (11/50) 
C-36 

Evidence Table 3. Effective provider-based interventions (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Tyc et al., 2003 

(continued) 

 
C-37 

Evidence Table 3. Effective provider-based interventions (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

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-38 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Bauman et al., 2000 

Geographic area: 

US 

Funding agency: 

NIDA Grant 

Study setting: 

Population-based 

Study objective: 

To report effectiveness of a universal familydirected program (Family Matters) for 

reducing/eliminating cigarette and alcohol 

use by adolescent users 

Population: 

Adolescents 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

• In contiguous US state 

• Consent 

• Child age 12 to 14 yrs 

• Completion of baseline interview 

Exclusion criteria: 

NR 

Sampling plan: 

• Eligible parent-adolescent pairs 

matched (by date and time of baseline 

interview) then randomly assigned to 

either Family Matters or C 

• Random digit dialing and basic query 

used to identify families w/ 12- to 14-

yr old children 

Sample size: 

G1: 37 baseline tobacco users 

C1: 48 baseline tobacco users 

Definition of smoking: 

Cigarettes 

• Use on one or more days during past 

30 days 
C-39 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Telephone counseling 

Intervention: 

G1: Family Matters: 

• Successive mailing of 4 

booklets and telephone 

discussion w/ health 

educator 2 wks after each 

mailing 

• Adult family members 

read booklets and do 15 

activities w/ adolescent 

• Booklet topics: (1) 

motivation, (2) family 

characteristics, (3) 

tobacco and alcohol 

variables, 

(4) variables outside 

family 

C1: NR 

Method of assessment: 

Telephone interviews at 3 

and 12 months 

postcompletion or dropout 

Statistical analysis: 

GEE method, one-tailed 

test (alpha 0.05), 

controlled for background 

variables. 

Data verification: 

NR 

Dependent variables: 

Smoking 30 days before 

interview 

Baseline data: 

Groups similar on all 

measures except txt had 

younger and fewer nonHispanic white participants 

Overall: 

12 yrs: 30.6% 

13 yrs: 35.3% 

14 yrs: 34.1% 

Male: 49% 

Non-Hispanic white: 73.4% 

In 2-parent home: 78.8% 

Among smokers: 

• 21.6%, 40.5%, and 

37.8% were 12,13, and 

14 yrs old respectively in 

txt 

• 10.4%, 29.2%, and 

60.4% were 12,13,and 

14 yrs old respectively in 

control 

• 35.1% male (txt) vs 

47.9% male (control); 

• 70.3% vs 95.8% nonHispanic white in txt vs 

control 

• 75.7% vs 68.8% in 2-

parent home in txt vs 

control 

Of 85 baseline smokers, 74 

completed followup at 3 months 

(62.2% still smoked) and 80 

completed followup at 12 months 

(66.3% still smoked) 

No statistically significant 

difference in tobacco use b/w 

control and txt for baseline 

cigarette users (OR = 1.42, lower 

bound CI, 0.57, P = 0.2846). 

Quality rating: 

Fair 

Comments: 

• Include only 

baseline users in 

analyses in order 

to focus on 

cessation 

• Only compare 

entire baseline 

groups to US or 

previous study 

population rather 

than each other 

• Used one-tailed 

tests 

• Attrition high 

among tobacco 

users 

• No biochemical 

measure of use 

• Small sample size 

Adequate 

randomization: 

No 

Groups not similar at 

baseline by age and 

race 

Attrition rate: 

14% overall; 40.5% 

among tobacco 

users in txt 

group(Control NR) 
C-40 

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: 

Etter et al., 2004 

Geographic area: 

Western Europe 

Funding agency: 

Swiss National Science 

Foundation, the Swiss 

Cancer League, the Swiss 

Federal Office of Public 

Health, and the Health 

Authority of the Canton of 

Geneva 

Study setting: 

Population-based 

Study objective: 

To determine whether effects of a computertailored smoking cessation program were 

maintained at 2-yr followup 

Population: 

Adults 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

• 18 to 60 yrs old 

• Resident of French-speaking Switzerland 

• More than an occasional smoker 

• Have a postal address 

Exclusion criteria: 

NR 

Sampling plan: 

• Baseline questionnaire sent to 20,000 

18-60 yr old residents of Frenchspeaking Switzerland, 3,124 agreed 

to participate in study 

• 2,934 randomized to txt or Cs 

Sample size: 

G1: 1,467 

C1: 1,467 

Definition of smoking: 

Cigarettes 

• 1 mo Abstinence: not smoking even a 

puff of a tobacco cigarette, cigar, or 

pipe in last 4 wks 

• 1 wk Abstinence: not smoking even a 

puff of a tobacco cigarette, cigar, or 

pipe in last 7 days 
C-41 

Evidence Table 4. Multi-component interventions to increase number of users who quit smoking (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Self-help 

Intervention: 

G1: After baseline 

questionnaire: 

• Received 8-pg personal 

counseling letters 

written by a computer 

according to answers 

given by participants on 

a 62 item questionnaire 

• Received 2 16-pg 

booklets corresponding 

to their current stage of 

change and next stage 

of change 

• Two, four, and 12 mos 

after entering study, 

participants could 

answer tailoring 

questions again to 

receive new letter 

C1: After completing 

baseline questionnaire, C 

participants received a 

letter telling them that they 

were in C, and not 

contacted again until 6- 

and 23-mo followup 

surveys 

Method of assessment: 

Surveys at 7- and 24-mos 

postbaseline 

Statistical analysis: 

X2

 to compare 

proportions; t-tests to 

compare means 

Data verification: 

NR 

Dependent variables: 

• Demographic 

characteristics 

• Stage of change 

• Level of tobacco 

dependence 

• Perceived drawbacks 

of smoking 

• Self efficacy 

• Use of self help 

strategies 

• Current use 

• Intention to use NRT 

Baseline data: 

Groups similar at 

baseline 

At 7 mo followup: 

1 mo abstinence rates: 

G1: 5.8%

C1: 2.2% 

P = < 0.001 

1 wk abstinence rates: 

G1: 8.0% 

C1: 3.3% 

P = < 0.001 

At 24-mo followup: 

1 mo and 1 wk abstinence 

rates similar for both groups, 

differences NS 

Proportion of those who quit 

for at least 1 mo during study: 

G1: 30.9%

C1: 24.7% 

P = < 0.001 

Proportion of those who used 

> 1 nicotine replacement 

product: 

G1: 24.9%

C1: 20.8% 

P = < 0.008 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

NR 

Attrition rate: 

7-mo followup: 16% 

24-mo followup: 12% 
C-42 

Evidence Table 4. Multi-component interventions to increase number of users who quit smoking (continued) 

Study Characteristics Study Design Sample Design and Definitions 

Author: 

Lipkus et al., 2004 

Geographic area: 

US 

Funding agency: 

NCI grant 

Study setting: 

Community-based 

Study objective: 

To test efficacy of self-help materials w/ or 

without proactive telephone counseling to 

increase cessation among teen smokers. 

Population: 

Adolescents 

Study type: 

RCT w/ simple randomization 

• 2-arm randomized intervention trial 

• 

Inclusion criteria: 

• Age 15 to 18 

• Smoked a cigarette within last wk 

• Gave verbal consent 

• Obtained parental consent if < 18 yr 

Exclusion criteria: 

NR 

Sampling plan: 

• Teen smokers recruited from 11 

shopping malls and 1 amusement 

park in Southeastern US 

• Teens stratified on stage of readiness 

to quit, then randomized to (1)selfhelp materials + video (C) or (2) selfhelp materials + video + telephone 

counselors (experimental group). 

Sample size: 

G1: 193 

G2: 209 

Definition of smoking: 

Cigarettes 

• Smoked 1 or more within last wk 
C-43 

Evidence Table 4. Multi-component interventions to increase number of users who quit smoking (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Telephone counseling 

• Video 

Intervention: 

G1: Two self-help booklets 

by mail and 6 minute video 

and 3 telephone counseling 

sessions 

C1: Two self-help booklets 

by mail , 6 minute video, no 

telephone counseling 

Method of assessment: 

6-item revised Fagerstrom 

Nicotine Tolerance Scale; 

self report (validated by 

saliva cotinine if denied 

smoking in last wk); Shadel 

and Mermelstein's 5-item 

scale 

Statistical analysis: 

ITT; logistic regression 

Data verification: 

Saliva cotinine kit mailed at 

month 4 postbaseline if teen 

denied smoking in last 7 

days; otherwise selfreport. 

Saliva kits retruned by 40% 

of those reporting cessation; 

rates of return did not differ 

by group 

Dependent variables: 

Point-prevalent abstinence 

at 4 and 8 mos 

postbaseline; sustained 

abstinence (proportion 

reporting not smoking at 

both followups) and 

predictors of cessation 

Baseline data: 

No arm differences on 

sample characteristics 

Age 17 or older: 

G1: 55%

C1: 59% 

Male: 

G1: 47%

C1: 51% 

High School: 

G1: 85%

C1: 78% 

82% white, 10% black in 

both groups 

3 (SD 2) mean yrs smoking 

in both groups 

No group differences 

observed in abstinence at 

either time point or for 

sustained abstinence 

G1: Abstinence rates: 16% 

and 21% for 4 and 8 mos, 

respectively 

C1: Abstinence rates: 11% 

and 19% for 4 and 8 mos, 

respectively 

Outcome Measures 

unchanged after adjusting 

for multiple variables 

Sustained abstinence rates 

(C1) 7% and (G1) 9% 

Participants completing 

more counseling calls more 

likely to report cessation at 

4 and 8 mos postbaseline 

w/ ITT: (OR = 1.59, 95% CI, 

1.14-2.22 for 4 mos and OR 

= 1.54, 95% CI, 1.15-2.07 

for 8 mos) and to have 

sustained abstinence (OR = 

2.03, 95% CI, 1.14-2.22 

Intervention group less likely 

to watch some/all of video 

(44% vs 62%, P < 0.05) and 

read some/all of booklet 

(57% vs 78%, P < 0.01) 

Teens completing more 

calls more likely to report 

quitting at 4 and 8 mos (4 

mos: OR = 1.59, 95%CI, 

1.14-2.22, P < 0.007; 8 

mos: OR = 1.54, 95% CI, 

1.15-2.07, P < 0.007) and 

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) 

Quality rating: 

Fair 

Comments: 

• Methods described in 

good detail (except 

randomization scheme) 

• Major limitation is high 

attrition rates 

Adequate randomization: 

NR 

Attrition rate: 

Control: 49% 

Intervention: 66% 

Abstinence rates: 

4 mos: 

G1: 16%

C1: 11% 

8 mos: 

G1: 21% 

C1: 19% 
C-44 

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-45 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

(continued) 

Intervention Details 

Statistical Analysis and 

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-46 

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 

Geographic area: 

US 

Funding agency: 

NCI 

Study setting: 

Practice/provider settings 

Study objective: 

To assess whether a multicomponent 

intervention that included feedback about 

genetic susceptibility to lung cancer 

increased risk perceptions and rates of 

smoking cessation compared w/ a standard 

cessation intervention 

Population: 

• Adults 

• African Americans 

• Low SES 

Study type: 

NR 

Eligible smokers randomized in a 1:2 ratio 

to enhanced usual care group or biomarker 

feedback (that included tailored feedback of 

genetic susceptibility to lung cancer based 

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 

Sampling plan: 

African-American patients (seen in adult 

medicine, dental, urgent care and 

specialty clinics) current smokers, and 

identified by chart abstraction and 

provider referral 

Those eligible and agreed to participate 

called within 7 days of visits to complete 

participant intake assessment 

Sample size: 

G1: 185 

G2: 372 

Definition of smoking: 

Cigarettes 

• Smoking: At least 1 cigarette in past 7 

days 
C-47 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Telephone counseling 

• Pharmaceuticals 

• Genetic susceptibility 

feedback 

Intervention: 

G1: Enhanced Usual Care: 

participants received 

provider advice to quit 

smoking and referred to 

smoking specialist who 

assessed stage of 

readiness to quit and 

appropriateness of NRT 

• Within 2 wks after clinic 

visit, all smokers sent a 

self-help smoking 

cessation guide 

especially designed for 

African-American 

smokers, “Pathways to 

Freedom” 

• If eligible (smoked at 

least five cigarettes/day 

and in preparation stage 

of readiness to quit), a 

14-day supply of 15 mg 

nicotine patches 

• Refill kits included a 7-

day supply of patches 

provided as needed; 

• Participants allowed to 

request up to eight refills 

over study period (for a 

total of 10 wks of 

therapy) 

Statistical analysis: 

• Baseline characteristics 

compared by intervention 

arm w/ Χ2

 statistic for 

discrete variables and ttests for normally 

distributed continuous 

and ordinal variables 

• Wilcoxon test statistic 

used when variables not 

normally distributed 

• Logistic regression used 

for main binary outcomes 

of trial, abstinence from 

smoking in prior 7 days at 

6- and 12-mo followups, 

and continuous 

abstinence (not smoking 

at both 6- and 12-mo 

followups) 

• All analyses done twice, 

first unadjusted and then 

adjusted by adding 

baseline variables that 

differed (P < 0.05) by arm 

and known to be 

associated w/ smoking 

cessation, including 

number of chronic 

illnesses (0 v. 1 or more), 

smoking within 30 min of 

rising (no v. yes), and 

desire to quit (below or 

equal to median v. above 

median) 

Data verification: 

• Salivary cotinine levels 

assessed for self-report of 

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) 

Proportion of participants not 

smoking at 6-mo followup: 

G1: 10%

G2: 19% 

Unadjusted P = 0.006 

Adjusted P = 0.03 

Proportion of participants not 

smoking at 12-mo followup is 

NS: 

G1: 10%

G2: 15% 

Unadjusted P = 0.12 

Adjusted P = 0.34 

Continuous abstinence of 

participants: 

G1: 5%

G2: 11% 

Unadjusted P = 0.02 

Adjusted P = 0.08 

Rates of prevalent and 

sustained abstinence for 

those w/ enzyme missing or 

present did not differ 

significantly at followup: 

• 6 mos, 17 and 23%, 

respectively 

• 12 mos, 18 and 15%; 

sustained, 12 and 12% 

Among those who declined 

test, rates of prevalent 

abstinence at 6 and 12 mos 

and sustained abstinence 

substantially lower (11, 11, 

and 5% for each outcome and 

time point, respectively 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

• 6-month 

followup: 26% 

• 12-month 

followup: 36% 

No difference in 

attrition b/w groups 
C-48 

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-49 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

G2: Biomarker Feedback: 

• Participants offered 

opportunity to have their 

blood tested for GSTM1 

• Within 2 wks after clinic 

visit, participants priority 

mailed an eight-pg test 

result booklet written at 

a fifth grade reading 

level that included test 

result, information about 

chemical constituents of 

tobacco smoke and 

harms of exposure, 

regardless of genetic 

make-up 

• Those who declined test 

were sent an identical 

booklet that included 

same graphical displays 

along w/ a generic 

description of test and a 

question mark in result 

box 

• Within 1 wk after test 

result booklet mailed, 

participants called to 

discuss GSTM1 test and 

their result; counselors 

attempted a total of four 

calls w/ each participant 

over a 12-wk period; b/w 

first and second calls, 

participant sent 

“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 

Data verification: 

Salivary cotinine levels 

assessed for those who 

self-reported not 

smoking at 12-mo 

followup 

Efforts to biochemically 

confirm self-reported 

cessation unsuccessful; 

39% (24 of 61) of those 

who reported abstinence 

and agreed to provide a 

saliva test 

Dependent variables: 

Primary: 

• smoking status 

Secondary: 

• risk perceptions 

• worry 

• depression 

Baseline data: 

Groups similar at 

baseline except: G1 arm 

participants had: 

• more chronic illnesses 

• less desire to quit 

smoking 

• more likely to smoke 

within 30 min of 

waking 

than those in G2 arm 
C-50 

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: 

Murray et al., 2002 

Geographic area: 

US 

Canada 

Funding agency: 

NIH 

Study setting: 

Practice/provider settings 

Study objective: 

To evaluate long-term persistence of effects 

on smoking and quitting on participants in 

the LHS intervention aimed at smoking 

cessation and to describe characteristics 

that distinguish those who quit smoking 

from those continuing to smoke 

Population: 

• Adults 

Study type: 

RCT w/ systematic randomization 

Inclusion criteria: 

• Smokers who had some evidence of lung 

function impairment (at baseline, their 

ratio of FEV to FVC less than 0.70 and 

their FEV b/w 55 and 90% of predicted 

normal for their age, gender, height, and 

race) 

• Willingness to participate in a smoking 

cessation program if randomized to 

smoking intervention 

Exclusion criteria: 

• Serious health conditions likely to affect 

participation in followup visits and lung 

function measurement 

• Use of prescribed medications that might 

alter lung function 

Sampling plan: 

Original LHS recruited, in 10 clinics in 

U.S. and Canada, 5,887 adult volunteer 

smokers w/ some evidence of lung 

function impairment 

Following LHS 1, LCS enrolled 5,008 of 

original cohort, and followed at 6-mo 

intervals w/ telephone interviews to 

ascertain smoking status and morbidity 

Recruits randomized equally to three 

study arms 

Sample size: 

G1: 3,040 

C1: 1,477 

Definition of smoking: 

Sustained abstainers: 

• participants who had been sustained 

quitters in LHS 1 

• gave no report of smoking during 

LCS 

• if not enrolled in LCS, recalled no 

month w/ as much as one cigarette 

per day in interval b/w LHS 1 and 

LHS 3 

• ex-smokers at LHS 3 baseline, 

validated by expired air CO levels 
C-51 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

Pharmaceuticals 

Intervention: 

G1: SI(described in other 

articles) w/ ipratropium 

bromide inhaler and SIwith 

placebo inhaler - both 

groups combined for 

analysis because 

ipratropium bromide 

inhaler had no effect on 

smoking cessation 

C1: usual care (described 

in other articles) 

Method of assessment: 

• Interviews in-person and 

via telephone 

• Expired air CO levels 

Statistical analysis: 

Comparisons b/w groups 

for quantitative variables 

are based on t-tests, 

while those for 

categorical variables are 

based on Χ2

 or Fisher’s 

exact test; Logistic 

regression used to 

analyze multiple 

predictors of LHS 3 

cross-sectional smoking 

status and sustained 

abstinence status 

Data verification: 

Expired air CO levels 

used to validate nonsmoking status 

Dependent variables: 

Smoking status 

Baseline data: 

Groups similar at 

baseline 

Biochemically validated smoking 

status at LHS 3 baseline - 

Percent quit: 

G1: 51.7

C1: 42.9 

P = < 0.001 

Sustained abstinence since LHS 

1 baseline: 

G1: 21.9%

C1: 6.0% 

P = < 0.001 

OR of abstinence in participants 

assigned to G1 as opposed to 

C1 = 4.45 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

16.7% 
C-52 

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: 

Rabius et al., 2004 

Geographic area: 

US 

Funding agency: 

ACS 

Study setting: 

Population-based 

Study objective: 

To examine effects of telephone counseling 

on smoking cessation among smokers 18 to 

25 yrs old and smokers over 25 yrs old 

Population: 

• Young adults 

• Adults 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

Of those who called a toll-free ACS number 

to inquire about cessation, adult current 

daily smokers willing to make a quit attempt 

in next two wks 

Exclusion criteria: 

NR 

Sampling plan: 

• Cessation assistance offered to 

smokers from anywhere in US that 

called ACS' general toll-free number 

for information about cessation 

• Adult current daily smokers willing to 

make a quit attempt in next 2 wks and 

gave consent , interviewed and 

randomized to 2 txt or control 

• All participants received three ACS 

booklets that provide standard advice; 

half of participants randomized to 

receive an offer of telephone 

counseling 

Sample size: 

Total: 3,522 

G1: Half of participants; exact N NR 

C1: Half of participants; exact N NR 

Definition of smoking: 

Cigarettes 

• Current smoking: any smoking within 

last 48 hrs 
C-53 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Telephone counseling 

Intervention: 

G1: Three ACS booklets w/ 

standard advice plus up to 

five sessions of proactive 

telephone counseling 

C1: Three ACS booklets w/ 

standard advice 

Method of assessment: 

Interview at 15 wks after 

enrollment (approximately 3 

mos postquit date); if 

participants reported 

abstinence at 3 mo 

interview, then interviewed 

again at 6 mos postquit date 

Statistical analysis: 

• Logistic regression for 

studies of factors 

predicting study 

retention and quitting 

success, t-tests for 

comparing means 

• Χ2

 for comparing 

proportions 

Data verification: 

NR 

Dependent variables: 

Study retention by 

intervention; abstinence; 

use of NRT or Zyban 

Baseline data: 

Proportion of participants 

in younger age group (18-

25 yrs old): 

12% (n = 420), similar to 

larger population 

Women outnumbered men 

overall 

Proportion of men: 

18-25 yrs: 39% 

Over 25 yrs: 33% 

P = < 0.01 

Proportion of married men: 

18-25 yrs: 19% 

over 25 yrs: 49% 

P = < 0.001 

Frequency of cigarette 

use: 

18-25 yrs: 18 cigarettes 

Over 25 yrs: 24 cigarettes 

P = < 0.001 

Prevalence of reported 48 hr 

abstinence at 3 mo followup 

among 18-25 yr olds: 

G1: 19.6%

C1: 9.3% 

P = < 0.005 

Prevalence of reported 48 hr 

abstinence at 3 mo followup for 

over-25 yr olds: 

G1: 15.1%

C1: 9.6% 

P = < 0.001 

Proportion of 18-25 yr olds 

reporting 48 hr abstinence at both 

3 and 6-mo followups: 

G1: 9.8%

C1: 3.2% 

P = < 0.01 

Proportion of over-25 yr olds 

reporting 48 hr abstinence at both 

3 and 6-mo followups: 

G1: 8.8%

C1: 5.3% 

P = < 0.005 

Estimate of prolonged abstinence 

at 6 mo followup (reported 48 hr 

abstinence plus 5 or fewer 

• Logistic regression analysis 

examining relationships b/w 

demographic variables, smoking 

behavior and history, and txt 

condition found the following: 

among 18-25 yr olds, txt 

condition only significant 

predictor of 48 hr abstinence at 

3-mo followup 

(P = < 0.01) 

• 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) 

Quality rating: 

Fair 

Comments: 

Adequate 

randomization: 

NR 

Attrition rate: 

Overall: 36% 

Attrition at 3-mo 

followup: 

18-25 yr olds: 48% 

Over-25 yr olds: 34%

P = < 0.001 

Attrition among those 

abstinent and eligible 

for followup at 6 mos: 

18-25 yr olds: 36% 

Over-25 yr olds: 15%

P = < 0.001 

Logistic regression 

found that 

successfully followed 

participants more 

likely to be female (P 

= < 0.01) and better 

educated (P = < 

0.01) than those not 

retained in study 
C-54 

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: 

Smith et al.; 2004 

Geographic area: 

Canada 

Funding agency: 

Ontario Ministry of Health; 

Heart and Stroke 

Foundation of Ontario 

Study setting: 

Population-based 

Study objective: 

To examine options for use, efficiency, and 

effectiveness of telephone counseling for 

structuring a population-based telephone 

smoking cessation service 

Population: 

• Adults 

Study type: 

RCT w/ stratified randomization 

Inclusion criteria: 

• Current smokers 

• At least 18 yrs of age 

• Daily smokers 

• Non pregnant 

• Intend to quit within 7-20 days 

• Live in specified geographic recruitment 

areas 

• Consent to participate in study 

Exclusion criteria: 

NR 

Sampling plan: 

Counselors answered incoming toll-free 

calls and determined study eligibility of 

callers; ineligible callers sent cessation 

materials designed to respond to their 

needs (e.g., pregnancy); eligible callers 

randomized (stratified within 

communities) to one of five conditions 

Sample size: 

Total: 632 

Definition of smoking: 

Cigarettes 

• Point abstinence: 7-day abstinence at 

time of followup call 

• Continuous abstinence: 7-day 

abstinence at all followup calls 
C-55 

Evidence Table 4. Multi-component interventions to increase the number of users who quit smoking 

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Telephone counseling 

• Pharmaceuticals 

Intervention: 

G1: Initial 50 minute 

telephone counseling, 2 

five to 10 minute followup 

calls, booklet 

G2: Initial 50 minute 

telephone counseling, 2 

five to 10 minute followup 

calls, pamphlet 

G3: Initial 50 minute 

telephone counseling, 6 

five to 10 minute followup 

calls, booklet 

C1: Print materials only 

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 

Statistical analysis: 

NR 

Data verification: 

No biochemical 

validation of self-reported 

smoking status 

performed 

Dependent variables: 

• Smoking status 

• Participant rating of 

print materials 

• Participant rating of 

telephone counseling 

Baseline data: 

No significant differences 

across the 5 groups at 

baseline 

Point abstinence at 3 mos: 

G1: (1, 2, 3, 4 collapsed) = 15%

C1: 13% 

P = < 0.05 

Point abstinence at 6 mos: 

G1: (1, 2, 3, 4 collapsed) = 15%

C1: 14% 

P = < 0.05 

Point abstinence at 12 mos: 

G1: (1, 2, 3, 4 collapsed) = 17%

C1: 20% 

P = < 0.05 

Continuous abstinence: 

G1: (1, 2, 3, 4 collapsed) = 5%

C1: 1% 

P = < 0.05 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

Attrition: 30.6% 

• Died: 0.003% 

• Withdrew: 7.1% 

• Lost to followup: 

23.2% 
C-56 

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: 

Aveyard et al., 2003 

Geographic area: 

United Kingdom 

Funding agency: 

West Midlands health 

authorities 

Study setting: 

Practice/provider settings 

Research objective: 

To examine the population impact and 

effectiveness of the Pro-Change smoking 

cessation course based on the 

Transtheoretical Model (TTM) compared to 

standard self-help smoking cessation 

literature 

Population: 

Patients of general pracitioners employed at 

65 West Midlands general practices 

Study type: 

RCT 

Inclusion criteria: 

Current smokers 

Exclusion criteria: 

All selected patients were eligible unless 

terminally ill, violent or other unusual 

circumstances pertained 

Sampling plan: 

• 3 wave recruitment process – wanted 

to estimate the proportion of smokers 

that could be recruited from British 

general practice 

• 1st wave: used random sampling. 

West Midlands GP practices were 

selected with probability proportional 

to size and then a fixed number of 

patients (300) were selected for 

invitation 

• From wave 1, became clear that 

insufficient patients would be recruited 

so invited originally recruited practices 

to repeat the process (2nd wave) 

• When 2nd wave failed to reach target 

number, non-randomly selected new 

practices approached to participate. 

• In all waves, potential participants 

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 selfhelp literature), manual intervention 

group (received Pro-Change system), 

the telephone group (received ProChange 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-57 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help quit guides and 

tip cards 

• Workbook and 

questionnaires 

• Telephone counseling 

• Nurse visits 

Intervention: 

G1: Pro-Change self-help 

system with workbook and 3 

questionnaires to generate 

tailored feedback 

G2: G1 plus three telephone 

calls 

G3: G1 plus three nurse 

visits 

C1: 2 standard self-help quit 

guides and 2 tip cards 

Method of assessment: 

Asked the question “are you 

currently a smoker?” at 12 

months post baseline - 

verified by salivary cotinine, 

obtained by visit to 

participant’s house or by 

mail 

Baseline data: 

No significant differences 

b/w any of the groups 

Statistical analysis: 

• Recruitment of new 

practices in wave 3 

where participants only 

allocated to 3 arms (no 

one allocated to G3) 

complicated analysis, 

b/c no guarantee overall 

that participants’ 

characteristics balanced 

b/w arms – therefore, 

analyzed the data as 2 

separate trials – 

calculated the 

percentage quitters in 

each arm and performed 

an overall chi-square 

test to calculate 

differences between 

arms 

• Odds ratios for the risk 

of quitting relative to 

control arm and the 

percentage and OR for 

quitting in 3 intervention 

groups (G1, G2, G3) 

combined vs. control 

arm were calculated 

• To examine if difference 

b/w 4-arm and 3-arm 

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-totreat 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 

No statistically significant 

difference in quit rates between 

intervention and control groups 

(G1=11%, G2=12%, G3=10%, 

C1=10%) in biochemicallyconfirmed abstinence for 6-months 

sustained abstinence and 

12-months point prevalence 

Quality rating: 

Fair 

Comments: 

• Authors conclude 

Pro-Change 

system unlikely to 

provide important 

alternative to 

current network of 

smoking cessation 

clinics and 

prescription of 

NRT 

Adequate 

randomization: 

Yes 

Attrition rate: 

29% 
C-58 

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: 

Bier et al., 2002 

Geographic area: 

NR 

Funding agency: 

Arizona Disease Control 

Research Commission 

Study setting: 

NR 

Research objective: 

To examine the effect of acupuncture alone 

and in combination with education on 

smoking cessation and cigarette 

consumption 

Population: 

Age 18 years or older 

Study type: 

Prospective, quasi factorial design 

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 

Sampling plan: 

Blind random assignment to groups 

Sample size: 

G1: 38

G2: 45

C1: 58

Definition of smoking: 

NR 
C-59 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Individual counseling by 

health professional 

Intervention: 

G1: Acupuncture, 20 

sessions over 4 weeks (5 per 

week) 

G2: Same as GI, but also 

received 5 weeks 

educational smoking 

cessation program 

(multisession, 

multicomponent behavioral 

training, education, social 

support, relapse prevention, 

1.5 hours twice per week for 

first week, then once per 

week for next 4 weeks) 

C1: Sham accupuncture, 20 

sessions over 4 weeks (5 per 

week) plus 5 weeks 

educational smoking 

cessation program 

(multisession, 

multicomponent behavioral 

training, education, social 

support, relapse prevention, 

1.5 hours twice per week for 

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 

Statistical analysis: 

• Power analyses for 

sample size (.05 for power 

of .80) 

• Mixed model with 

repeated measures 

• Covariance between any 

2 periods considered 

autoregressive 

Data verification: 

Self report 

Dependent variables: 

• Beck Depression 

Inventory score 

• Zung Self-Rating Anxiety 

Scale 

• # of cigarettes smoked per 

day 

• Age of initiation 

• # of years smoking 

• Smoking or not smoking 

at visit 

• % decrease in smoking 

• Decrease in # of 

cigarettes smokes 

• VAS Score 

• Pack year history 

Not Smoking (%) at 18 

months 

G1: 20% 

G2: 40% 

C1: 53% 

NS 

Greater the estimated pack 

year history before treatment, 

the greater the decrease in 

total number of cigarettes 

smoked per day following 

treatment 

Quality rating: 

Poor 

Comments: 

• Very high attrition rate 

• Group has a higher pack 

year history than in other 

studies 

Adequate randomization: 

Yes 

Attrition rate: 

At 18 months 

Total: 66% 

G1: 68% 

G2: 65% 

C1: 66% 
C-60 

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: 

Bohadana et al; 2000 

Geographic area: 

Western Europe 

Funding agency: 

Pharmacia and Upjohn 

Consumer Healthcare 

Study setting: 

Practice/provider settings 

Study objective: 

To investigate whether short-term (6-wk) 

addition of a NPto nicotine inhaler txt 

improves early smoking cessation rates, and 

whether this txt combination improves 

likelihood of abstinence at 6 and 12 months 

Population: 

• Adults 

Study type: 

• RCT w/ systematic randomization 

• Double-blind, randomized, placebocontrolled trial 

Inclusion criteria: 

• Aged 18 to 70 yrs 

• Smoked 10 or more cigarettes per day for 

3 or more yrs 

• Expired CO level of 10 ppm or more 

• Made 1 or more previous attempts to quit 

• Personally motivated to stop smoking 

• Fluent in French 

Exclusion criteria: 

• History of myocardial infarction within past 

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 

Sampling plan: 

• Subjects from Nancy, France, and 

surrounding towns recruited by means 

of local newspaper 

• First subject enrolled in March 1996, 

and followup completed in February 

1998 

• Approximately 1,000 people who 

contacted the Centre Hospitalier 

Universitaire de Nancy-Brabois, 462 

underwent a prospective telephone 

screen to enroll 400 subjects who met 

inclusion criteria 

Sample size: 

Total: 400 

Definition of smoking: 

Cigarettes 

• 3-mo cessation rate, rate of 

continuous abstinence at all time 

points: self-reported nonsmoking b/w 

wk 2 and mo 12 and an expired CO 

level less than 10 ppm at each 

followup visit 
C-61 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Individual counseling by 

health professional 

• Pharmaceuticals 

Intervention: 

G1: Nicotine inhaler 

(plastic tube containing a 

perforated plastic plug 

impregnated w/ 10 mg of 

nicotine, approximately 4 

mg of which is available for 

inhalation, and menthol to 

reduce irritant effect of 

nicotine) plus 30-cm2 

NPcontaining 0.83 mg of 

nicotine per square 

centimeter, delivering 15 

mg per 16 hrs 

C1: Nicotine inhaler 

(plastic tube containing a 

perforated plastic plug 

impregnated w/ 10 mg of 

nicotine, approximately 4 

mg of which is available for 

inhalation, and menthol to 

reduce irritant effect of 

nicotine) plus placebo 

patch that contained no 

nicotine 

Method of assessment: 

Baseline assessments 

included patient 

characteristics, vital signs, 

patient weight, smoking 

history, expired CO, blood 

cotinine, psychological 

status, SES, pulmonary 

measures (symptoms and 

function) and medical 

history; during txt and 

followup, weight 

measured, smoking history 

and expired CO assessed, 

blood cotinine measured, 

craving and withdrawal 

symptoms and all adverse 

events; pulmonary 

measures (symptoms and 

function) collected at 12 

mos 

Statistical analysis: 

• Data analyzed on an 

ITT basis (ie, all 

subjects who entered 

study and received 

medication, 

irrespective of 

medication use or 

outcome); Intergroup 

differences in ITT 

abstinence rates at all 

time points calculated 

by Χ2

 (or Fisher exact 

test if necessary) 

• Proportions of 

participants remaining 

abstinent over time 

calculated by 

comparing relapse w/ 

smoking curves of 2 

groups by means of 

log rank test 

• Continuous variables 

compared b/w groups 

by parametric t-tests 

whenever possible, 

and Mann-Whitney 

rank sum test used for 

data non-normally 

distributed 

Data verification: 

Self-reported smoking 

status validated by blood 

cotinine levels and 

expired air CO levels 

Dependent variables: 

3-mo cessation rate, rate 

of continuous abstinence 

at all time points, nicotine 

inhaler use, nicotine 

substitution, incidence of 

withdrawal symptoms, 

adverse events, and 

changes in body weight 

Baseline data: 

No significant differences 

b/w 2 groups except for a 

greater number of 

cigarettes per day in G1 

Percentage of participants 

completely abstinent at 6-wk 

followup: 

G1: 60.5

C1: 47.5 

P = 0.009 

3-mo followup: 

G1: 42.0

C1: 31.0 

P = 0.02 

No significant difference in 

complete abstinence b/w G1 and 

C1 at 6- and 12-mo followups 

Pulmonary findings confirm 

beneficial respiratory effects of 

smoking cessation and that 

slowing down of decline in FEV 

volume in 1 second appears to 

be relatively rapid in those who 

quit smoking 

Mean body weight gain 

significantly higher in C1 than G1 

by wk 2 (0.49 kg v. 0.99 kg) 

(P = 01) 

No significant difference in mean 

body weight gain at 1 yr (4.22 kg 

and 5.06 kg P = 0.14) 

Subjects in C1 reported 

significantly more intense 

withdrawal symptoms at wk 1 (P 

< 0.001) and craving symptoms 

at wk 6 (P = 0.04) than those in 

G1 

Adverse events rare and 

tolerable 

Quality rating: 

Fair 

Comments: 

Attrition rate NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

1 person withdrew 

from study due to a 

serious adverse 

event, but overall 

attrition rate NR 
C-62 

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: 

Canga et al., 2000 

Geographic area: 

Western Europe 

Funding agency: 

NR 

Study setting: 

Hospital 

Practice/provider settings 

Study objective: 

Evaluate effectiveness of a nurse-managed 

smoking cessation intervention aimed at 

helping diabetic smokers quit smoking 

Population: 

• Young adults 

• Adults 

Study type: 

RCT w/ systematic randomization 

Inclusion criteria: 

• Type 1 and 2 diabetic patients registered 

in centers under study who were either 

current smokers or who had quit 

< 1 yr ago 

Exclusion criteria: 

• Had quit smoking for over 1 yr or was 

misclassified in medical record as a 

diabetic smoker 

Sampling plan: 

• Type 1 and 2 diabetics at 2 hospitals 

and 15 primary care clinics 

randomized to receive either usual 

care or a nurse-led, face-to-face 

cessation counseling intervention 

• All clinical records of Type 1 & 2 

diabetics registered at 15 primary 

care clinics and 2 hospitals b/w Dec 

1997 and Dec 1998 reviewed to 

confirm smoking status 

• Smokers contacted through a letter 

and telephone call to participate in a 

general lifestyle study of diabetic 

patients 

• Smokers randomly assigned to 

intervention or C using computergenerated allocation; randomized 

assignment blinded 

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-63 

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

(continued) 

Intervention Details 

Statistical Analysis 

and Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Pharmaceuticals 

Intervention: 

G1: Initial 40 min face-toface interview w/ a research 

nurse that included 

personalized advice about 

benefits of quitting and 

strategies that may be 

useful, based on patient's 

clinical condition, smoking 

history, and personal 

interests; self-help materials 

w/ quitting cues; 3 months of 

transdermal NRT offered to 

those w/ no 

contraindications who 

smoked > 19 cigarettes per 

day and those who had not 

succeeded after trying to 

quit at least once; followup 

program of 5 contacts 

scheduled according to 

negotiated cessation date: 

1) telephone call the day 

before quit date, 2) a 

followup visit 2 wks post quit 

date, 3) a letter 3 wks post 

quit date, 4) a followup visit 

2 months post quit date, and 

5) a final evaluation carried 

out 6 months post quit date 

C1: Usual care for diabetic 

smokers that is routinely 

provided by hospital or 

primary care clinic and is 

established in the Navarre 

diabetes care program, 

including advice to quit 

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 

Statistical analysis: 

• Two-tailed Fisher's 

exact tests used to 

compare proportion 

of quitters b/w both 

groups 

• Two-tailed t-tests 

used to compare 

change in average 

number of cigarettes 

smoked daily 

• Incidence ratio, 

incidence difference, 

and number needed 

to treat w/ their 

respective 95% CIs 

used to estimate 

effect of intervention 

Data verification: 

Urinary cotinine levels 

obtained from selfreported quitters and 

analyzed using method 

developed by Jarvis, et 

al 

Dependent variables: 

• Urinary cotinine 

validated cessation 

• Mean number of 

cigarettes smoked 

daily 

• Stage of change 

according to 

Prochaska's model 

Baseline data: 

Intervention and Cs 

similar at baseline in 

demographic 

characteristics, 

diabetes history, and 

history of tobacco use 

Proportion of smokers who quit 

at 6-month followup (validated): 

G1: 17.0% 

C1: 2.3% 

Difference: 14.7 (CI, 8.2, 21.3) 

P = < 0.001 

6-mo followup, change in mean 

cigarettes per day: 

G1: -4.6 (CI, -3.2, -6.0) 

C1: -1.6 (CI, -0.4, -2.8) 

Difference: -3.0 (CI, -1.1, -4.9) 

P = < 0.001 

6-mo followup, patients in 

precontemplation stage: 

G1: 39.5% 

C1: 56.4% 

Difference: -16.9% 

(CI, -5.3, -28.9) 

P = < 0.001 

6-month followup, patients in 

contemplation stage: 

G1: 9.5% 

C1: 29.3% 

Difference: -19.8% 

(CI, -10.7, -34.1) 

P = < 0.001 

6-mo followup, patients in action 

and maintence stages: 

G1: 17.0% 

C1: 2.3% 

Difference: 14.8% 

(CI, 8.2, 21.3) 

P = < 0.001 

6-mo followup, patients in 

relapse stage: 

G1: 33.3% 

C1: 10.5% 

Difference = 22.8% 

(CI, 13.6, 32.0) 

P = < 0.001 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

Overall = 0.71% 

G1: 0.68% 

C1: 0.75% 
C-64 

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: 

Carpenter et al., 2004 

Geographic area: 

USA 

Funding agency: 

National Institute on Drug 

Abuse 

Study setting: 

Population-based 

Research objective: 

To assess whether a behavioral treatment to 

reduce smoking combined with NRT 

followed by brief advice to quit versus 

motivational advice plus brief advice to quit 

produces a greater incidence of quit 

attempts 

Population: 

NR 

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 

Sampling plan: 

Randomized 

Sample size: 

G1: 212 

G2: 197 

C1: 207 

Definition of smoking: 

Abstinence: greater than or equal to 3 

cigarettes per day 
C-65 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Telephone counseling 

Intervention: 

G1: Telephone based 

reduction counseling and 

NRT and brief advice to quit 

G2: Motivatiiona advide 

(5Rs) and brief advice 

C1: No treatment 

Method of assessment: 

Mailed questionnaire at 

0,3,6,12 and 24 weeks 

Baseline data: 

• 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 

Statistical analysis: 

• Logistic regression 

Data verification: 

Self report 

Dependent variables: 

• # of cigarettes per day 

over previous 7 days 

• Intention to quit in next 1 

to 6 months 

• Stage of change 

• Self-efficacy 

• Quit attempts within past 

24 hours 

• Point prevalence 

abstinence (no smoking 

at all in past 7 days) 

Percentage with “24-hour Quit 

Attempts” over 6 months 

G1: 43% 

G2: 51% 

C1: 16% 

G1 vs G2: NS 

G1 + G2 vs C1: P < 0.01 

Percentage with “24-hour Quit 

Attempts” at 6 weeks (when 

intervention was completed) 

G1: 36% 

G2: 18% 

C1: NR 

Percentage with “24-hour Quit 

Attempts” after 6 weeks (when 

intervention was completed) 

G1: 64% 

G2: 82% 

C1: NR% 

Abstinence Rates 

G1: 18% 

G2: 23% 

C1: 4% 

Seven-day Point Prevalence at 

6 months: 

P<0.01 

Smoking reduction using NRT 

does not undermine cessation 

but rather increases likelihood of 

quitting to a degree similar to 

motivational advice 

Quality rating: 

Fair 

Comments: 

• Source of database 

used to recruit 

people for study is 

unclear 

• No biochemical 

verification 

Adequate 

randomization: 

NR 

Attrition rate:

NR 
C-66 

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: 

Chalmers et al., 2001 

Geographic area: 

Canada 

Funding agency: 

Health Canada, Tobacco 

Programs Unit, Health 

Promotion Directorate and 

the Canadian Lung 

Association 

Study setting: 

Practice/provider settings 

Study objective: 

Smoking reduction and cessation program 

implemented w/ registered nurses 

Population: 

• Adults 

• Women (only) 

Study type: 

Self-selected intervention 

Inclusion criteria: 

• RN 

Exclusion criteria: 

• No other type of nurses 

Sampling plan: 

Advertised study in a variety of medium 

and participants allowed to select 

intervention type 

Sample size: 

G1: 75 

G2: 44 

Definition of smoking: 

Cigarettes 

NR 
C-67 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Group counseling 

Intervention: 

G1: Group participation 

G2: Self-study 

G3: NR

C1: NR

Method of assessment: 

Questionnaires administered 

prior to and at end of 8-wk 

interventions and at 6 and 12 

months postintervention 

Statistical analysis: 

• SAS and Excel used 

• Descriptive statistics 

obtained and t-tests 

used in pre and posttest 

analyses 

• Variance difference 

considered across 4 time 

periods 

• Duncan's Multiple Range 

test implemented for all 

post hoc comparisons 

• Time-study analysis 

techniques used to 

organize data and 

observe and test for 

trends 

Data verification: 

None 

Dependent variables: 

Stage of quiting 

Baseline data: 

No comparisons made 

Statistically significant changes at 8 

wks in nurses' smoking practices 

found on number of nurses 

continuing to smoke, mean number 

of cigarettes smoked, and 

movement in stage of behavioral 

change 

Quality rating: 

Poor 

Comments: 

No ITT, self-selection 

of intervention, no 

comparisons b/w 

groups. 

Adequate 

randomization: 

No 

Not randomised! 

Attrition rate: 

Pretest: 0 (0%) 

8 wks: 27 (23%) 

6 months: 47 (40%) 

12 months: 62(53%) 
C-68 

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 

Geographic area: 

US 

Funding agency: 

NCI 

Study setting: 

Hospital 

Practice/provider settings 

Study objective: 

To examine effectiveness of standard 

written self-help materials for nicotine 

dependence compared to written materials 

consisting of internet-based resources on 

smoking abstinence rates in a lung cancer 

screening population 

Population: 

• Adults 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

• Asymptomatic 

• 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 

Sampling plan: 

Community informed about low-dose 

fast spiral chest CT screening study by 

local and regional television and 

newspaper coverage carrying 

information on general outline of study 

and eligibility requirements, as well as 

funding by NCI 

Sample size: 

Total: 171 

Definition of smoking: 

Cigarettes 

• Abstinence: no cigarettes in last 7 

days 
C-69 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Computer-based 

program 

Intervention: 

G1: Received handout w/ 

a list of 10 Internet sites 

related to stopping 

smoking and a brief 

description of each site; 

Web sites included: the 

American Heart 

Association, ACS, NCI, 

Cancer Information 

Service, CDC Tips, 

Tobacco 

Information/Prevention 

Source, Mayo Clinic 

Nicotine Dependence 

Center, Quit Now! (the 

National Tobacco 

Campaign), the No Smoke 

Caf, Massachusetts 

Quitline, Nicotine 

Anonymous, and the 

American Lung 

Association; these sites 

include information on 

health risks related to 

tobacco use, benefits of 

stopping smoking, specific 

behavioral strategies, 

support for stopping, 

review of stop smoking 

medications, and 

references to local 

resource 

C1: Received a copy of 

Clearing the Air: How to 

Quit Smoking and Quit for 

Keeps (24-pg self-help 

manual describing multiple 

behavioral strategies for 

stopping smoking), a 

publication of the National 

Cancer Institute; 

participants also given the 

American Lung 

Association booklet, Quit 

Smoking Action Plan, 

which provides up to date 

information on available 

pharmacotherapies for 

nicotine dependence 

Statistical analysis: 

Responses from 1-mo 

followup survey, and 

tobacco use variables 

collected at 1-yr 

followup, compared b/w 

txt groups using Χ2

For 1-yr smoking 

abstinence outcome, 

subjects that missed the 

visit or failed to provide 

tobacco use information, 

classified as smoking 

All other analyses 

performed using 

available data w/ no 

imputation of missing 

values 

For biochemically 

confirmed 7-day smoking 

abstinence, exact binary 

confidence intervals 

calculated for each txt 

group and a logistic 

regression analysis 

performed using smoking 

abstinence as dependent 

variable and txt group as 

independent variable 

Logistic regression used 

to assess whether 

screening 

recommendations 

associated w/ 1-yr 

tobacco use outcomes 

In all cases, two-sided 

tests performed w/ Pvalues; < 0.05 used to 

indicate statistical 

significance 

Data verification: 

Self-reported smoking 

status confirmed w/ 

expired air CO levels at 1 

yr followup 

No statistically significant 

differences in smoking status 

found at 1-mo (13 vs 7%, P = 

0.248) or 1-yr followup (5 vs 

10%, P = 0.166, OR = 0.4, 95% 

CI, 0.1-1.4) 

At yr 1 followup more subjects 

receiving internet-based 

resources, compared to C1, 

reported that they had made an 

attempt to stop smoking in last yr 

(68 vs 48%, P = 0.011) 

Recommendation of additional 

followup from chest CT screening 

exam not found to be associated 

w/ abstinence (OR = 0.5, P = 

0.267), making a quit attempt 

(OR = 0.8, P = 0.412) or 

advancement in state of change 

from baseline to 1-yr (OR = 0.6,

P = 0.222) 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

No attrition at 1-yr 

followup (study 

followup coincided 

w/ 1-yr followup for 

lung cancer 

screening) 
C-70 

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-71 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Method of assessment: 

Questionnaire at 1-mo 

followup: 

• Smoking status selfreported 

In-person visit at 1 yr 

followup: 

• Smoking status and 

expired air CO levels 

assessed 

Dependent variables: 

Biochemically-confirmed 

smoking status 

Baseline data: 

Both groups similar at 

baseline 
C-72 

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: 

Covey et al., 2002 

Geographic area: 

US 

Funding agency: 

Pfizer, Inc 

Study setting: 

Population-based 

Research objective: 

To evaluate sertraline as an effective aid to 

smoking cessation for smokers with a 

history of major depression 

Population: 

Adults 

Study type: 

RCT, double blind, placebo control study 

Inclusion criteria: 

• Subjects required to meet DSM-III-R 

criteria for at least one episode of major 

depression, which must have remitted 

more than 6 months befor the start of the 

study 

• Age 18 to 70 

• Daily use of 20 or more cigarettes for at 

least a year 

• One prior attempt to quit 

Exclusion criteria: 

• Serious medical illnesses 

• Use of a psychotropic medication 

• Major depression, alcohol or drug 

dependence, panic disorders, posttramatic 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 

Sampling plan: 

• Respondents were first screened by 

telephone, those who met initial 

criteria were seen at the first clinical 

visit 

• Eligible participants obtained a 1 

week single-blind washout phase of 

one placebo tablet per day 

• Once medically confirmed to meet 

criteria, participants were randomly 

assigned in a double blind fashion to 

receive sertraline (50mg tablet) or 

placebo 

Sample size: 

G1: 68 

C1: 66 

Definition of smoking: 

• Smoking measured by cotinine level, 

non-smokers < 25 ng/ml 
C-73 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Pharmacotherapy 

Intervention: 

G1: Received sertraline for 

11.3 weeks: 1 week placebo 

washout, 3 weeks for 

medication buildup before 

quit day, 6 weeks at full 

dose (200mg), and a 9 day 

taper period. 

C1: Same as G1 but used 

placebo 

Method of assessment: 

7-Day point prevelance selfreport (biochemically verified 

by cotinine levels less than 

25 ng/ml) 

Baseline data: 

Lower nicotine dependence 

scores for participants in G1; 

no other baseline 

differences 

Statistical analysis: 

Chi square and t-tests of 

significants 

Data verification: 

Self-report and cotinine 

tested 

Dependent variables: 

• Abstience 

• Nicotine dependence 

level 

• Depression 

• Withdrawal symptoms 

• Compliance with NRT 

treatment 

At the end of treatment, 

abstience rates were 28.8% 

for C1 and 33.8% for G1, this 

was not significant 

At 6 months, the abstience 

rates were G1=11.8 and 

C1=16.7%, NS 

No modifying effects of 

depressed mood at baseline, 

nicotine dependence level, or 

gender were observed 

Quality rating: 

Poor 

Comments: 

Similar to a run-in periods 

this study participants if not 

motivated to quit after week 

1 (9%) 

Adequate randomization: 

Yes 

Attrition rate: 

25.4% 
C-74 

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: 

Croghan et al; 2003 

Geographic area: 

US 

Funding agency: 

NCI, Public Health Service 

and NCI, DHHS 

Medications provided by 

NcNeil Consumer Products 

Study setting: 

Community-based 

Practice/provider settings 

Study objective: 

To determine whether combined use of NP 

and a NNS would improve smoking 

abstinence rates compared to either therapy 

alone without behavioral counseling; to 

determine frequency and severity of adverse 

events experience 

Population: 

Adults 

Study type: 

RCT w/ stratified randomization 

• Multi-center, randomized, open-label 

clinical trial 

• Txt assignment carried out using a 

dynamic allocation procedure that 

balanced marginal distributions of 

stratification factors among three txt 

groups 

• Stratification factors used gender, number 

of cigarettes smoked per day reported at 

time of study entry (15–39 vs 40 or more 

cigarettes per day), and total yrs of 

smoking (fewer than 5 yrs vs 5–9 yrs vs 

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

Sampling plan: 

After dissemination of a local news 

release (radio and print), interested 

smokers contacted their regional 

NCCTG cancer control site and 

underwent telephone screening 

Brief discussion of study provided, 

informed consent obtained, 

demographic information collected, and 

an interview based on inclusion and 

exclusion criteria conducted over phone 

Study subjects who fulfilled basic study 

entry criteria were invited to attend an 

information meeting, at which time 

details of study were explained and an 

informed consent signed 

Sample size: 

Total: 1,384 

Definition of smoking: 

Cigarettes 

• At least 15 per day over past yr NR 
C-75 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Pharmaceuticals 

Intervention: 

G1: 15 mg transdermal 

NPfor 16 hr a day; new 

patch each morning; initiated 

within 7 days of 

randomization and 

continued for 6 wks 

G2: NNS that delivered 0.5 

mg of nicotine per spray; 

recommended dose one puff 

per nostril as needed to a 

maximum of five doses per 

hr or 40 doses per day; 

initiated within 7 days of 

randomization and 

continued for 6 wks 

G3: 15 mg transdermal 

NPfor 16 hr a day, putting on 

a new patch each morning, 

plus nicotine nasal spray 

that delivered 0.5 mg of 

nicotine per spray, 

recommended dose of one 

puff per nostril as needed to 

a maximum of five doses per 

hr or 40 doses per day; 

initiated within 7 days of 

randomization and 

continued for 6 wks 

C1: NR 

Method of assessment: 

Subjects returned to clinic at 

3 wks, 6 wks, and 6 mos 

postintervention; selfreported smoking rates, 

expired air CO levels, and 

reports of adverse events 

collected Questionnaire 

about smoking history, 

Fagerstrom, Health Status 

Questionnaire 

Statistical analysis: 

Tests of balance in 

baseline characteristics 

across txt arms carried out 

via Χ2

 procedures for 

categorical variables, 

Kruskal-Wallis tests for 

ordinal-level data, and 

ANOVA for interval- and 

continuous-level variables; 

effect of sociodemographic 

variables on abstinence 

rate comparison 

investigated via logistic 

regression modeling 

Standard equality of 

binomial proportions, 

logistic regression 

modeling 

Data verification: 

CO levels of expired air 

collected to verify selfreported smoking status 

Expired CO < 8 ppm 

confirmed smoking 

abstinence 

Dependent variables: 

Smoking status: wk 6 

biochemically confirmed 7-

day point prevalence 

smoking abstinence rate. 

Baseline data: 

No reported differences 

among txt groups, but no 

data given 

Overall, mean age = 42.0 

(+/-10.8); 58% female; 

mean 26.2 (+/-9.8) 

cigarettes per day; mean 

23.2 (+/-10.7) yrs of 

smoking 

CO confirmed 7-day pointprevalence smoking abstinence 

rates at 6-wks after initial quit date: 

G1: 20.7%

G2: 13.6% 

G3: 27.1% 

P = < 0.001 

Differences in CO confirmed 7-day 

point-prevalence smoking 

abstinence rates at 6 mos were NS 

Abstinence rates (6 wks): 

G1: 20.7%

G2: 13.6% 

G3: 27.1% 

P < 0.001 

NNS associated w/ more adverse 

events than NP (P < 0.001): 

burning in nose or throat (63% vs 

12%), watery eyes (48% vs 14%), 

sneezing (49% vs 21%) 

Quality rating: 

Poor 

Comments: 

Attrition quite high at 

6 mos (70%); overall, 

45% of participants 

non-compliant w/ 

study protocols - a 

larger proportion 

than were compliant 

(34%); study may not 

have had enough 

power 

Baseline data not 

given by txt group 

Adequate 

randomization: 

Yes 

Attrition rate: 

6 wks: 47% 

6 mos: 70% 
C-76 

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: 

Croghan et al; 2003 

(continued) 

Exclusion criteria: 

Exclusion criteria included 

• 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-77 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

 
C-78 

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: 

Dalsgareth et al., 2004 

Geographic area: 

Denmark 

Funding agency: 

GlaxoSmithKline, Denmark 

Study setting: 

Hospital 

Research objective: 

To evaluate treatment with buproprion 

hydrochloride sustained release (Zyban) 

compared with placebo as an aid to smoking 

cessation in healthcare workers 

Population: 

Hospital employees from 5 hospitals in 

eastern part Denmark 

Study type: 

RCT – double-blinded 

Inclusion criteria: 

• Age ≥18 yrs old 

• Average use of ≥10 cigarettes per day 

throughout the last year 

• Motivation to quit smoking 

Exclusion criteria: 

• Use of other pharmacological support for 

smoking cessation 

• History of or current major depression 

reported by participant 

• Sever neurological, cardiopulmonary, liver 

or kidney disease 

• Epilepsy, predisposition to or former 

epidsodes of seizures 

• Use of medicine known to lower seizure 

threshold 

• Pregnancy and lack of sufficient 

contraception were additional exclusion 

criteria for fertile women. 

Sampling plan: 

• Employees were informed of study via 

E-mail, notification accompanying 

paychecks, posters and personal 

contact 

• Eligible participants screened 

• Participants underwent detailed 

baseline interview to obtain healthdisease profile and info on smoking 

behavior in general and at work 

• Subjects were given info on 

physiological and harmful effects of 

smoking as well as on the assumed 

mechanism of action and likely sideeffects of buproprion 

• All subjects received behavioral 

counseling aimed at establishing 

rational smoking cessation process 

• Each participant agreed on a target 

quit date of 8-13 days after baseline 

• Participants then randomly assigned 

either to receive buproprion 150 mg or 

placebo 

Sample size: 

G1: 222 

C1: 114 

Definition of smoking: 

Cigarettes 

• User: smoked ≥10 cigarettes daily 

• Continuous smoking abstinence: not 

even a puff 
C-79 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Telephone counseling 

• Clinic visits 

• Buprprion 150 mg over 7-

week period 

Intervention: 

G1: 2 motivating phone 

calls, 5 clinic visits, and 

sustained-release bupropion 

hydrochloride 

C1: 2 motivating phone 

calls, 5 clinic visits, and 

placebo 

Method of assessment: 

Clinic visits at weeks 

3,7,12,23 and 26 (postbaseline) 

Baseline data: 

No significant differences 

b/w G1 and C1 

Statistical analysis: 

• Intent -to-treat analysis, 

in which all randomized 

patients who took ≥1 

dose of study 

medication were 

counted 

• Mantel-Haenszel chisquare test at two-sided 

5% level of significance 

used analysis of 

smoking abstinence 

endpoints 

• Analysis of covariance 

was used for analysis of 

change in weight from 

baseline and nicotine 

dependence; treatment, 

center and baseline 

values were covariates 

• Participants with 

missing cigarette counts 

after 7-week treatment 

phase assumed to be 

treatment failures 

Data verification: 

• Self-report – completion 

of daily diary cards 

• Expired-air carbon 

monoxide 

measurements (<10 

ppm CO was the cutoff) 

Dependent variables: 

• Smoking status 

• Tobacco craving 

• Weight gain 

Twelve months after pretest 

(posttest 2), in-school intervention 

successful in preventing vocational 

school students from continuing to 

smoke, compared w/ students in 

control condition OR = 0.49; 95% 

CI 0.29–0.84 

Eighteen months after pretest 

(posttest 3), tailored out-of-school 

intervention successful in 

preventing smoking initiation, 

compared w/ students in control 

(OR = 0.42; 95% CI, 0.18–0.96) 

Effect of combined approach not 

larger than sum of effects of inschool and out-of-school effects. 

Quality rating: 

Fair 

Comments: 

• Refusal rate NR 

• Randomization 

description unclear 

regarding number 

of schools in txt 

groups 

• Out-of-school 

intervention poorly 

implemented (65% 

of personalized 

letters read by 

participants) 

Adequate 

randomization: 

Yes 

Attrition rate: 

School level 

• Posttest 1: 5.6% 

(2 schools) 

• Posttest 2: 8.3% 

(3 schools) 

• Posttest 3: 18.5% 

(NR) 

Student level: 

• Posttest 1: 17.3% 

• Posttest 2: 5.4% 

• Posttest 3: 24.6% 
C-80 

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: 

Davies et al., 2005 

Geographic area: 

Southeastern US 

Funding agency: 

National Cancer Institute 

Study setting: 

Hospital 

Research objective: 

To evaluate the impact of a stage-matched 

smoking cessation intervention in a sample 

of hospitalized, low-income, African 

American smokers admitted to an indigent 

care hospital 

Population: 

• Low income hospitalized adult African 

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) 

Sampling plan: 

90 % of patients approached agreed to 

participate 

Sample size: 

248 

Definition of smoking: 

NR 
C-81 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• individual counseling 

Intervention: 

G1: Physician-delivered 

stage-specific advice to quit 

smoking; individualized 

counseling based on the 

smokers stage of readiness 

and individual smoking 

pattern; self-help materials 

tailored to the African 

American smokers and their 

support networks; and a 

follow-up booster session in 

the form of a phone call 

following the patient’s 

discharge from the hospital 

(at @6 months) 

C1: usual care (not defined) 

Method of assessment: 

In person and telephone 

survey at about 6 months 

Baseline data: 

Between group differences 

are not reported 

Statistical analysis: 

• Mann-Whitney U used to 

examine intervention 

effects by baseline stage

• Z Test used to compare 

overall differences 

between treatment groups 

(forward movement, 

success in quitting 

smoking) 

• T tests used for 5 

measures (Pros, Cons, 

Confidence, 2 Nicotine 

Dependent measures) 

• Intention to treat analysis 

used only for cessation 

rates 

Data verification: 

Self report 

Dependent variables: 

• Sociodemographic 

characteristics 

• Smoking history 

• Present smoking habit 

• Stage of change 

• Decisional balance 

• Self-efficacy to remain 

abstinent 

• Perceived nicotine 

dependence 

• Perceived health status 

• Presence of chronic 

disease 

Intervention patients more 

likely to advance in stage than 

control patients 

Dependence score increased 

as stage of readiness 

increased 

Intervention had a higher 

proportion of subjects in the 

preparation and action stages 

at follow-up, significantly 

(P < 0.05) for those at 

contemplation stage at 

baseline 

Greater percentage of 

intervention than controls 

progressed at least one stage 

(40% vs 21.7%, 

P < 0.01) 

ITT analysis for cessation nonsignificant (G1:7.9% vs C1:

5.8%) 

Quality rating: 

Poor 

Comments: 

• 60% failed to complete 6 

month follow-up 

• ITT analysis used for 

cessation rates does not 

state that all of those with 

no follow-up data were 

categorized as smokers 

Adequate randomization: 

Not defined, plus there was 

a second adjustment made 

by assigning shared rooms 

to either the intervention or 

control groups 

Attrition rate: 

• 152 of 248 were loss to 

follow-up 

• Reasons: 

- no telephone, 

- telephones 

 disconnected, 

- changed residence, 

- became homeless, 

- went to prison 

- died 

• Several follow-up 

interviews took place well 

after 6 months 
C-82 

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: 

Garvey et al., 2000 

Geographic area: 

United States 

Funding agency: 

National Institute on Drug 

Abuse and the Department 

of Veteran Affairs 

Study setting: 

Community-based 

Research objective: 

To investigate the long-term efficacy of 4-mg 

and 2-mg gum for smokers classified at 

baseline as low or high in dependence on 

nicotine 

Population: 

• Smokers from greater Boston area 

• ≥20 years old 

Study type: 

RCT 

Inclusion criteria: 

• Aged ≥20 years, smoke ≥5 cigarettes per 

day 

• Adequate health 

Exclusion criteria: 

• Cardiologist deemed subjects in 

“inadequate” health based on medical 

tests, including hematology analyses, 

liver-function profiles, urinalyses and if 

over 50 years old, electrocardiograms 

Sampling plan: 

• Recruited smokers from greater 

Boston area via newspaper ads and 

press releases 

• Subjects needed to obtain a letter 

from their doctor stating they had no 

obvious medical conditions that would 

prevent them from entering the study; 

those who didn’t have primary care 

physician required to undergo testing 

at medical lab in Boston 

• Subjects chose a quit-day and 

reported for their baseline visits a 

median of 3 days before their quit 

days – at baseline, they completed 

the Heaviness of Smoking Index and 

a 2-question subset of the Fagerstrom 

Test for Nicotine Dependence. 

Results were used to classify subjects 

as either low-dependence or highdependence 

• 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 postcessation 

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 postcessation that began the regular 

pattern of smoking 
C-83 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self help booklet (all 

groups) 

• Brief behavioral 

counseling (all groups) 

• Nicotine gum – 2mg or 

4mg 

Intervention: 

G1: Low dependence 2 mg 

gum

G2: Low dependence 4 mg 

gum 

G3: High dependence 2 mg 

gum 

G4: High dependence 4 mg 

gum 

C1: Low dependence 

placebo 

C2: High dependence 

placebo 

Method of assessment: 

Follow up visits at 1, 7, 14, 

30 days and 2, 3, 6, 9, and 

12 months post-cessation 

Baseline data: 

Placebo, 2-mg and 4-mg 

gum users were comparable 

on most baseline variables – 

those in 4-mg group had 

higher mean CO values 

(P= 0.01) and heart rates 

(P = 0.02) 

High-dependence smokers 

were more likely to be older 

and less-educated, slightly 

more likely to be males, and 

they had significantly larger 

values on other indices of 

depencence 

Statistical analysis: 

• Wilcoxon rank sum tests 

were used to compare 

percentage baseline 

cotinine replaced by 

each dose of nicotine 

gum 

• Logistic regression 

analysis and pairwise 

dose comparisons were 

used to assess 

differences in 

abstinence rates among 

groups at each postcessation visit. Two 

dummy variables (each 

coded 1 or 0) were used 

to represent the 3 

nicotine-gum doses in 

these analyses 

• Chi-square tests for 

binomial trends were 

used to examine the 

significance of dosage 

effects 

• Effects of nicotine gum 

dose on withdrawal 

symptoms and urges to 

smoke were assessed 

for the 1st 30 days postcessation using 

repeated-measures 

analysis of variance 

• For withdrawal indices, 

changes from baseline 

on various indices of 

withdrawal were 

dependent variables in 

repeated-measures 

analysis; while values 

obtained at 1,7,14,and 

30 were used to 

supplement repeatedmeasures 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 

At 1 year follow-up quit rates for 

low dependence were 

Placebo 11.2% 

2 mg gum 19.5% 

4 mg gum 18.4% (NS) 

High dependence smokers quit 

rates at 1 year 

2 mg gum compared to placebo 

(15.7% vs. 6.1%, P = 0.02) 

4 mg gum compared to placebo 

(20.7% vs. 6.1% P = 0.002) 

No statistical differences between 

2 and 4 mg gum doses. Both 2 

and 4 mg gum users significantly 

(P < 0.008) more likely to abstain 

than placebo at all post-cessation 

assessments, except for day 1 

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 non-smoking 

spouse or significant other 

Quality rating: 

Fair 

Comments: 

• 3 subjects 

withdrew from 

study due to 

adverse effects – 

dizziness, nausea 

and vomiting 

Adequate 

randomization: 

Yes 

Attrition rate: 

Overall attrition not 

reported but 3 left 

due to adverse 

events 
C-84 

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 

Geographic area: 

US 

Funding agency: 

American Legacy 

Foundation 

Study setting: 

Community-based 

Study objective: 

To evaluate impact of a quit and win contest 

on smoking cessation among low-income 

tobacco users 

Population: 

• Adults 

• Low SES 

Study type: 

Two-group, quasi-experimental study 

Inclusion criteria: 

Intervention group: 

• at least 18 yrs old 

• volunteered to participate in a quit-andwin contest 

• registered for contest by September 10, 

2001 

• 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 

Sampling plan: 

Intervention group: sample of volunteer 

registrants in a quit-and-win contest 

C1: participants randomly selected from 

outside media campaign geographic 

area using random digit dialing and 

meeting inclusion criteria 

Sample size: 

Total: 538 

Definition of smoking: 

Cigarettes 

• Quitter: not used any form of tobacco 

in last 7 days 

Smokless tobacco 

• Quitter: not used any form of tobacco 

in last 7 days 
C-85 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Group counseling 

• Telephone counseling 

• Computer-based 

Program 

• Social support 

• Media campaign 

Intervention: 

G1: A community quit date 

requiring participants to 

quit using tobacco for 30 

days to be eligible for a 

large cash prize lottery; 

provider advice on genderspecific cessation 

information to participants 

through weekly mailed 

postcards during 30-day 

contest period; online 

computer registration and 

quit assistance; one-onone telephone quit 

assistance through a tollfree number provided by 

Cancer Information 

Service’s smoking 

cessation call center; a 

media campaign that 

included paid radio and 

television advertisements, 

intensive billboard 

promotions, magazine or 

newspaper registration, 

newspaper features, 

registration brochures, and 

promotional flyers; and 

support from community 

organizations, work sites, 

physicians, health 

professionals, and 

community leaders 

Statistical analysis: 

Group comparisons 

performed using Χ2

 of 

equal proportions for 

nominal variables 

Kruskal– Wallis tests for 

ordinal variables, or twosample t-tests for 

continuous variables 

Repeated measures 

analysis for logistic 

regression based on 

GEE approach used to 

determine predictors of 

quit status over three 

postcontest time periods 

Each model included 

control variables of 

baseline age, gender, 

race (Caucasian v. 

other), education (<HS v. 

>HS), marital status 

(married v. unmarried), 

and stage of change 

status to adjust for 

differences in personal 

characteristics among 

participants 

Data verification: 

All participants who 

reported quitting were 

asked to provide a urine 

sample to test for 

cotinine; cotinine level 

determined by Accutest 

NicoMeter 

Dependent variables: 

Tobacco use status 

Percentage of participants w/ 

self-reported 7-day point 

prevalence abstinence at 3-

month followup: 

G1: 23.3, 

C1: 3.1 

P = < 0.001 

Percentage of participants w/ 

confirmed 7-day point prevalence 

abstinence at 3-month followup: 

G1: 11.3

C1: 0.7 

P = < 0.001 

Percentage of participants w/ 

self-reported 7-day point 

prevalence abstinence at 6-

month followup: 

G1: 21.2

C1: 5.9 

P = < 0.001 

Percentage of participants w/ 

confirmed 7-day point prevalence 

abstinence at 6-month followup: 

G1: 9.3

C1: 0.7 

P = < 0.001 

Percentage of participants w/ 

self-reported 7-day point 

prevalence abstinence at 12-

month followup: 

G1: 23.3 

C1: 8.7 

P = < 0.001 

Percentage of participants w/ 

confirmed 7-day point prevalence 

abstinence at 12-month followup: 

G1: 8.1 

C1: 0.7 

P = < 0.001 

Quality rating: 

Poor 

Comments: 

• High attrition 

• Intervention 

group volunteer 

sample 

• C care NR 

• Exposure to 

intervention low 

• Not 

generalizable 

Adequate 

randomization: 

NR 

Attrition rate: 

Loss to followup by 

12-month followup: 

G1: 41%

C1: 44% 
C-86 

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-87 

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

(continued) 

Intervention Details 

Statistical Analysis 

and Baseline Data Outcome Measures 

Quality 

Comments 

Community organization 

support included 

promoting the contest at 

work sites and in 

community newsletters, 

recruiting participants via 

flyers at physician offices 

and health fairs, and 

coordinating group 

cessation classes to 

coincide w/ the contest. 

C1: NR 

Method of assessment: 

Telephone interviews 

conducted at baseline, 

then 3, 6, and 12 months 

after baseline interview 

Baseline data: 

Participants more likely 

to be married in the 

intervention group than 

in the control 

More than half of 

intervention group had at 

least some college 

education, while only 1/4 

of C had any 

postsecondary 

education; intervention 

group significantly 

younger than control 

(Median age: G1: 35.9, 

C1: 42.3, t = 5.3, 535 df, 

P = < 0.0001); those lost 

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-88 

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: 

Hall et al., 2004 

Geographic area: 

United States 

Funding agency: 

NIDA 

Study setting: 

Population-based 

Research objective: 

To determine the effects of brief versus 

extended treatment with nortriptyline and 

group counseling 

Population: 

General public 

Study type: 

RCT 

Inclusion criteria: 

Smoked >=10 cigarettes per day 

Exclusion criteria: 

• Cardiovascular disease 

• History of seizure 

• Severe allergies 

• Life-threatening disease 

• Bipolar disorder 

• Current major depressive disorder 

• Use of l-dopa 

• Migraine headaches 

• Current use of any psychiatric medication 

including bupropion 

• Suicidal or psychotic symptoms 

• Current use of NRT 

• Previous treatment for cigarettes smoking 

with nortriptyline 

• Treatment for drugs or alcohol within 6 

months 

• Psychiatric hospitalization within 1 year 

• Pregnancy or lactation 

Sampling plan: 

• Subjects were recruited through 

advertising, PSAs, and flyers 

• Interested persons completed a 

telephone screening and orientation 

meeting 

• After informed consent was obtained, 

potential subjects were invited to a 

baseline physical assessment 

• For those who did not have any 

exclusion criteria, 160 subjects 

smoking ≥ 10 cigarettes per day were 

stratified by: 

- baseline number of cigarettes 

- history of nicotine replacement 

 therapy 

- history of major depressive disorder 

• Subjects were then randomized to 

four treatment cells 

Sample size: 

160 subjects 

Definition of smoking: 

Subject must meet all three criteria to be 

considered abstinent: 

• self-report of not having had a 

cigarette in past seven days, not even 

a puff 

• carbon monoxide levels ≤ 10 ppm 

• cotinine levels of ≤ 50 ng/ml 
C-89 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Transdermal nicotine 

patch 

• Group counseling 

• Bupropion 

Intervention: 

G1: Brief Nortriptyline: 

Nortriptyline for 12 weeks; 5 

counseling sessions and 

NRT patch at week 5 

C1: Brief placebo: Placebo 

for 12 weeks; 5 counseling 

sessions and NRT at week 5 

G2: Extended Nortriptyline: 

G1 + extended 

pharmacotherapy and 

counseling (1/month) for 52 

weeks 

C2: Extended placebo: G2 

but used placebo instead of 

Nortriptyline 

Method of assessment: 

• In-person self-report 

• Carbon monoxide 

• Urinary cotinine 

Baseline data: 

No significant differences 

among the intervention 

conditions 

Statistical analysis: 

• Powered at 80% with 

alpha = .05 

• Logistic regression was 

used to test the effect of 

drug/placebo dose and 

treatment duration on 

repeat 7-day abstinence 

• Generalized estimating 

equation was used to test 

hypotheses about point 

prevalence abstinence at 

weeks 24,36,52 

• Compared baseline 

variables among the four 

groups using ANOVA for 

continuous and chisquare for categorical to 

examine if randomization 

had been compromised 

• To identify potential 

covariates, used pointbiserial correlations 

• Differences in weeks of 

medication / placebo 

dispensed were 

determined by a two-way 

ANOVA with individual 

comparisons with the 

Tukey test 

• 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 

A duration by dose by time of 

assessment effect was significant 

(X2 = 11.90, df=3, P = 0.008) 

Brief Nortriptyline vs brief placebo 

(OR = 0.69, 96%CI; 0.49-0.92, 

P = 0.02) 

Brief Nortriptyline vs extended 

placebo (OR = 0.47, 95%CI; 

0.30-0.75, P = 0.001) 

Extended Nortriptyline did not 

differ significantly from extended 

placebo 

Quality rating: 

Fair 

Comments:

NR 

Adequate 

randomization: 

Unknown – did not 

state how they 

randomized 

participants 

Attrition rate: 

• 13% for brief 

nortriptyline 

• 7% for brief 

placebo 

• 10% for extended 

nortriptyline 

• 27% for extended 

placebo 
C-90 

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: 

Hand et al., 2002 

Geographic area: 

UK 

Funding agency: 

Author’s endowment fund 

Study setting: 

Hospital-based 

Research objective: 

To investigate the effectiveness of combined 

NRT (Patch and inhaler) for smoking 

cessation in patients hospitalized for 

smoking related disease. 

Population: 

Adults 

Study type: 

RCT 

Inclusion criteria: 

• Hospitalized inpatients or outpatients with 

smoking related disease referred to 

counselor by hospital doctor 

• Age 18 or older 

Exclusion criteria: 

• Patients with alcoholism, drug dependeny, 

active psychiatric illness, preterminal or 

terminal patients, pregnant women, and 

patients who suffered a myocardial 

infarction during previous month 

Sampling plan: 

• Recruitment began on October 1, 

1998 and all patients recruited during 

this month and in any even month 

over the next 13 months were given 

NRT 

• Those patients recruited in the 

following month and in any odd month 

over the next 12 months were given 

advice and support 

• One extra month of patients were 

randomized to the NRT group 

resulting in unequal groups 

Sample size: 

G1: 136 (NRT and advise and support) 

C1: 109 (advice and support) 

Definition of smoking: 

Abstinence 

• Carbon monoxide levels less than 

10ppm 
C-91 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Pharmacotherapy 

Intervention: 

G1: Received NRT 

(combination of nicotine 

patch and inhalator) for 3 

weeks; dosage determined 

by number of cigarettes 

smoked; plus G2 

C1: Four weekly sessions 

and patient encouraged to 

set quit date (45 to 60 

minutes); followed by 3 

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 

Statistical analysis: 

Chi square test of 

significants 

Data verification: 

Carbon monoxide verified 

Dependent variables: 

• Smoking status 

• Compliance with NRT 

treatment 

At week 1, abstinence rates were 

higher for G1 compared with C1 

(54% vs 33%, P < 0.001) 

At 6 months this significant 

difference disappeared between 

the two groups. 

At year 1, 14% of the total 

sample were verified as abstinent 

(G1=15%, C1=14%, NS) 

30% of G1 used the full supply of 

NRT and 43.9% of these patients 

successfully quit at year 1 

Quality rating: 

Fair 

Comments: 

NA 

Adequate 

randomization: 

No 

Attrition rate: 

0% 
C-92 

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: 

Helgason et al., 2004 

Geographic area: 

Sweden 

Funding agency: 

NR 

Study setting: 

Population-based 

Research objective: 

To assess variables related to 12-months 

abstience using proactive compared to 

reactive telephone quitline smoking 

interventions 

Population: 

Adults 

Study type: 

Cohort study 

Inclusion criteria: 

Contacted toll-free Swedish quitline from 

April to October 1999 

Exclusion criteria: 

NR 

Sampling plan: 

Immediately after the first call all 

patients expressing an interest in beign 

registered as clients received a 

registration from by mail confirming their 

idenity 

Sample size: 

G1: 694 (reactive quitline) 

G2: 900 (proactive quitline) 

Definition of smoking: 

Abstience 

• Not a single puff of smoke during the 

last week 
C-93 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Telephone quitline 

Intervention: 

G1: Tailored materials to the 

patients motivation to quit 

(stage of change) is offered 

free of charge; treatment 

protocal is described as a 

combination of motivational 

interviewing, cognitive 

behavioral therapy, and 

pharmacological counseling 

G2: same as G1 with 4 to 5 

proactive counseling calls 

Method of assessment: 

Self-report at 12 to 13 

months after first contact 

Baseline data: 

NR 

Statistical analysis: 

Logistic regression was used 

to calculate Odds Ratios 

Data verification: 

Self-report 

Dependent variables: 

• Smoking status 

• Stage of change 

• NRT use 

• Exposure to second hand 

smoke 

• Treatment compliance 

• Periods of depressive 

moods 

• Use of additional support 

Additional support (i.e., being 

referred to the quitline by a 

health professional) was 

associated with abstience and 

persisted with the exclusion of 

patients with severe smoking 

related symptoms 

Overall abstience was not 

significantly higher in the 

proactive compared with the 

reactive group (33% vs 28%, 

NS) 

When men and women are 

assessed separately, women 

were signifcantly more likely to 

be abstinent in the procative 

compared with the reactive 

group (34% vs 27%, P.03) 

Quality rating: 

Poor 

Comments: 

NA 

Adequate randomization: 

NA 

Attrition rate: 

30% 
C-94 

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: 

Hennrikus et al., 2005 

Geographic area: 

US 

Funding agency: 

NIH 

Study setting: 

Hospital 

Study objective: 

Evaluation of effectiveness of three smoking 

cessation interventions for a hospital-based 

population 

Population: 

Adults 

Study type: 

RCT w/ systematic randomization 

Inclusion criteria: 

• Patient smoked a cigarette in wk before 

admission and considered themselves a 

regular smoker for at least 1 mo during yr 

before admission 

• Between 18 and 75 yrs old 

• Length of hospital stay of 24 hrs or 

greater 

• Ability to understand consent process 

• Availability for telephone contact 

Exclusion criteria: 

• Pregnancy 

• Chemical dependency or psychiatric 

disturbance as primary reason for 

admission 

• Severe physical or mental distress 

Sampling plan: 

Research assistant obtained list of all 

general admissions from previous day at 

four hospitals and screened patients 

meeting age and admission dz 

requirements for smoking status and 

other eligibility requirements 

Research assistants approached 

patients for informed consent and asked 

consenting patients to complete a 

baseline interview; participants then 

randomized by research assistant by 

looking up next available group 

assignment on a list on which 3 

conditions were randomly ordered within 

blocks of 30 assignments 

Sample size: 

G1: 703 

G2: 696 

C1: 696 

Definition of smoking: 

Cigarettes 

• Regular smoker: smoked more than 

100 cigarettes in lifetime 

• Current smoker: uses cigarettes now 
C-95 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Individual counseling by health 

professional 

• Telephone counseling 

• Referral to community resources, 

clinician reminder 

Intervention: 

G1: Participants given 2 smoking 

cessation manuals designed for 

hospital in-patients, a directory of 

smoking cessation community 

resources, a label in medical record 

to cue doctors and nurses to provide 

brief (60 second) smoking cessation 

advice and document that advice, 

and a letter after discharge 

reiterating that their health care 

providers would like for them to quit 

and to encourage them to read 

manuals provided 

G2: Participants given 2 smoking 

cessation manuals designed for 

hospital in-patients, a directory of 

smoking cessation community 

resources, a label in medical record 

to cue doctors and nurses to provide 

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 

Statistical analysis: 

Using SAS statistical 

package, multivariate 

logistic regression 

conducted to examine the 

outcome variable 

"abstinence from tobacco 

use; " Mantel-Haenszel 

test for homogeneity of 

effects performed for each 

outcome to determine 

whether results from 4 

hospitals could be pooled; 

Χ2

 analyses of 

relationships b/w txt 

condition and outcomes 

also performed 

Data verification: 

Salivary cotinine levels 

assessed for those who 

reported abstinence at 12-

mo followup 

Dependent variables: 

Abstinence; use of NRT 

Baseline data: 

Groups similar at baseline 

Percentage of those selfreporting abstinence at 7-

day followup: 

C1: 26.0%

G1: 24.0%

G2: 25.2% 

P = > 0.05 

Percentage of those selfreporting abstinence at 12-

mo followup: 

C1: 15.0%

G1: 15.2%

G2: 19.8% 

P = < 0.05 

Percentage of those 

abstinent verified by 

salivary cotinine at 12-mo 

followup: 

C1: 8.8%

G1: 10.0%

G2: 9.9% 

P > 0.05 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

• 7-day followup: 

13.5% 

• 12-mo followup: 

24.1% 
C-96 

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: 

Hitsman et al., 1999 

Geographic area: 

US 

Funding agency: 

VA Merit Review award by 

NIDA, and Eli Lilly and 

Company 

Study setting: 

Population-based 

Study objective: 

To identify individual differences that predict 

cessation when fluoxetine is combined w/ 

CBT 

Population: 

• Adults 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

Participants are: 

• 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) 

Sampling plan: 

Specific randomization scheme NR. 

Sample size: 

Total: 253 

Definition of smoking: 

Cigarettes 

• Reported smoking 

• Expired CO greater than 8 ppm 

• Saliva continine value greater than 10 

ng/ml 
C-97 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Individual counseling by 

health professional 

• Pharmaceuticals 

Intervention: 

G1: Nine, 1-hr individual 

CBT sessions + fluoxetine 

30 mg for a total of 10 wks 

• Participants required to 

set a quit date within 2 

wks after drug txt began 

• Participants quit 

smoking at 3rd CBT 

session 

• Medication stopped at 

9th CBT session, at 

which time 6-month 

followup period began 

• CBT not explained 

• Patients w/ fluoxetine 

level less than or equal 

to 150 ng/ml considered 

compliant 

G2: Same as G1:, except 

fluoxetine dose of 60 mg 

and fluoxetine blood level 

less than or equal to 

300ng/ml considered 

compliant 

C1: Same as G1, except 

given placebo 

Method of assessment: 

Self report of smoking, 

expired CO, and saliva 

continine 

Also used depresion scale, 

nicotine dependence, 

weight restraint scale, and 

self-efficacy questionnaire 

Statistical analysis: 

Constructed predictive 

models using logistic 

regression w/ 

hierarchical approach to 

variable selection. 

Models evaluated w/ 

parallel analyses using 

stepwise selection 

procedure 

Data verification: 

Expired CO and saliva 

continine 

Dependent variables: 

Depression, nicotine 

dependence, weight 

concerns, self-efficacy 

about quitting smoking 

Baseline data: 

No significant difference 

b/w txt groups in 

baseline characteristics: 

age, gender, education, 

smoking history, baseline 

level of nicotine 

dependence, depression, 

weight concern, and selfefficacy 

At 1 wk postcessation: higher 

levels of depression predicted 

failure to achieve abstinence (ITT 

analysis); higher levels of 

nicotine dependence and 

depression associated w/ 

decreasing likelihood of 

abstinence (analysis of txtcompliant patients) and likelihood 

of abstinence for participants on 

fluoxetine tended to be higher 

than for those on placebo (P = 

0.06); At 1 month postcessation: 

higher levels of weight concern 

predicted lower abstinence (Χ2

4.8, P = 0.78); patients on 

fluoxetine had positive 

association b/w degree of 

depression and likelihood of 

abstinence (highest quartile 

HRSD = 3, OR = 2, 95% CI, 

0.85-4.70); At 3 months 

postcessation: patients treated w/ 

fluoxetine had positive 

association b/w HRSD scores 

and abstinence likelihood 

(highest quartile HRSD = 3, OR = 

1.44, 95% CI, 0.53-3.91) 

Smoking characteristics 

predicting txt compliance were 

nicotine intake at baseline, saliva 

cotinine (Χ2

 = 11.4, P < 0.001), 

and expired CO ( Χ2

 = 5.3, P < 

0.05) 

Quality rating: 

Fair 

Comments: 

• Authors didn't 

report numbers 

of participants 

per arm of study, 

baseline 

demographic 

characteristics of 

those groups, 

nor 6 month 

followup results 

• Inclusion/ 

exclusion criteria 

are described in 

companion 

article, Borrelli, 

et al. 1997 

Adequate 

randomization: 

NR 

Attrition rate: 

NR 
C-98 

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: 

Holt et al., 2005 

Geographic area: 

New Zealand 

Funding agency: 

GlaxoSmithKline 

Study setting: 

Community-based 

Population-based 

Study objective: 

To determine whether bupropion is effective 

in txt of smoking cessation in indigenous 

Maori population of New Zealand 

Population: 

• Adolescents 

• Young Adults 

• Adults 

Study type: 

• RCT w/ systematic randomization 

• Placebo controlled, double blind, parallel 

group study 

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 

Sampling plan: 

• Self-recruitment from mall 

advertisements 

• Recruited from Maori health networks

• Randomized (by computer generated 

code) 

Sample size: 

G1: 88 

C1: 46 

Definition of smoking: 

Cigarettes 

• Smoke ≥ 10 per day on average over 

last yr 
C-99 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Individual counseling by 

health professional 

• Individual counseling by 

non health professional 

• Telephone counseling 

• Pharmaceuticals 

Intervention: 

G1: Bupropion 150 mg 

once daily for 3 days, then 

150 mg twice daily for 7 

wks; smoking cessation 

counseling 

Clinic visits (to assess 

smoking status, exhaled 

CO, and adverse events) 

at 3 wk, 7 wk, 

3 mo, 6 mo, 9 mo, and 12 

mo after target quit date 

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 

Statistical analysis: 

Primary: normal 

approximation to 

binomial distribution 

Secondary: GEE 

Exploratory: general 

additive model 

Data verification: 

Exhaled CO 

Dependent variables: 

Continued abstinence 

from smoking at 3 and 

12 months (or other time 

points, secondarily) 

Rates of continued abstinence in 

bupropion and placebo groups, 

respectively = 44.3% vs17.4% at 

3 months (RR = 2.54; 95% CI 

1.30-5.00); = 21.6% vs10.9% at 

12 months (RR = 1.99; 95% CI 

0.79-5.00). 

Bupropion group more likely to 

have insomnia (26% vs9% w/ RR 

= 3.0 and 95% CI 1.1-8.2) 

Quality rating: 

Fair 

Comments: 

• No ITT analysis 

• No attrition 

reported 

• Fell just short of 

sample size 

needed 

according to 

power analysis 

• No analysis for 

confounders. 

Adequate 

randomization: 

Yes 

Attrition rate: 

NR 
C-100 

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: 

Jones et al., 2001 

Geographic area: 

United Kingdom 

Funding agency: 

NR 

Study setting: 

Hospital 

Study objective: 

Determine whether ICU patients' smoking 

cessation after critical illness is aided by 

provision of a rehabilitation program 

Population: 

• Adults 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

• Minimum 48 hr ICU admission 

• Had been ventilated 

Exclusion criteria: 

NR 

Sampling plan: 

Recovering ICU patients recruited to 

study 2 wks after ICU discharge, 

randomized to receive either usual care 

followup of unit visits and ICU clinic 

appointments or routine followup plus 

an ICU rehabilitation manual 

Sample size: 

G1: 31 (20 smokers) 

C1: 30 (16 smokers) 

Definition of smoking: 

Cigarettes 

NR 
C-101 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Social support 

Intervention: 

G1: Verbal encouragement 

to remain non-smoking at 

ICU discharge, at 8-wk clinic 

vist, and six month clinic 

visit; patients' immediate 

family instructed not to 

smoke in same room as 

patient; 2 wks postdischarge 

introduction to 6-wk self help 

ICU rehabilitation manual 

read by patient and relative 

that emphasized importance 

of remaining non-smoking 

and provided practical tips 

C1: Verbal encouragement 

to remain non-smoking at 

ICU discharge, at 8-wk clinic 

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

Statistical analysis: 

NR 

Data verification: 

Smoking status verified by 

information from a close 

family member 

Dependent variables: 

• Smoking status 

• Levels of anxiety 

• Depression 

• PTSD-related symptoms

Of smokers preICU admission, 

those returning to smoking at 8-wk 

followup: 

G1: 2 

C1: 5 

RR = 0.24 (CI 0.03-1.84) 

Of smokers preICU admission, 

those returning to smoking at 6-mo 

followup: 

G1: 3 

C1: 10 

RR = 0.11 (CI 0.02-.64) 

No differences in anxiety, 

depression or PTSD-related 

symptoms at 6 mos b/w patients 

who continued to smoke and those 

who had quit (Mann Whitney U, 

HAD anxiety P = 0.51, HAD 

Depression P = 0.74, Impact of 

Events Scale P = 0.50) 

Quality rating: 

Fair 

Comments: 

Very small study; 

due to type of article, 

details about 

randomization and 

sampling NR 

Adequate 

randomization: 

NR 

Attrition rate: 

O% attrition 
C-102 

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: 

Jorenby et al; 1999 

Geographic area: 

US 

Funding agency: 

Glaxo Wellcome 

Study setting: 

Community-based 

Study objective: 

To determine whether buproprion plus NPis 

more effective for smoking cessation than 

either cessation aid alone or a placebo 

Population: 

• Adults 

Study type: 

• RCT w/ systematic randomization 

• Double-blind, placebo-controlled, 

randomized control trial 

Inclusion criteria: 

• At least 18 yrs of age 

• To smoke at least 15 cigarettes per day 

• To weigh at least 45.4 kg (100 lb) 

• To be motivated to quit smoking 

• To speak English 

• Only one smoker per household allowed 

to enroll in study 

Exclusion criteria: 

Subjects excluded for following reasons: 

• Serious or unstable cardiac, renal, 

hypertensive, pulmonary, endocrine, or 

neurologic disorders, as assessed by 

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–nicotinecontaining 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 

Sampling plan: 

• Subjects recruited at four study sites 

by advertisements in the media 

• First subject enrolled in August 1995, 

and followup completed in March 

1997; subjects randomly assigned to 

one of four treatments w/ use of an 

unequal-cell design 

• Randomization not balanced within 

sites 

Sample size: 

G1: 245 

G2: 244 

G3: 244 

C1: 160 

Definition of smoking: 

Cigarettes 

• Abstinent: no smoking since last clinic 

visit and expired air CO 10 ppm or 

less 

• Continuously abstinent: no smoking 

since quit date at expired air CO 10 

ppm or less at every clinic visit over 

12 mos 
C-103 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Pharmaceuticals 

Intervention: 

G1: sustained-release 

bupropion (subjects received 

150 mg of bupropion in 

morning and a placebo 

tablet in evening on days 1, 

2, and 3 of txt; and one 

bupropion tablet in morning 

and one in evening on days 

4 to 63) plus NP(one patch 

per day; patches from wks 2 

to 7 each contained 21 mg 

of nicotine, those used 

during wk 8 each contained 

14 mg, and those used 

during wk 9 each contained 

7 mg) 

G2: sustained-release 

bupropion (subjects received 

150 mg of bupropion in 

morning and a placebo 

tablet in evening on days 1, 

2, and 3 of txt; and one 

bupropion tablet in morning 

and one in evening on days 

4 to 63) plus placebo patch 

G3: NP(one patch per day; 

patches from wks 2 to 7 

each contained 21 mg of 

nicotine, those used during 

wk 8 each contained 14 mg, 

and those used during wk 9 

each contained 7 mg) plus 

placebo pills 2x per day 

C1: placebo pills 2x per day 

plus placebo patch one time 

per day 

Method of assessment: 

Followup at 10 wks, 3 mos, 

6 mos, and 12 mos after 

start of study; assessment 

consisted of self-reported 

smoking status, vital signs, 

measurement of expired air 

CO, and the Beck 

Depression Inventory 

Statistical analysis: 

Χ2

 and ANOVA used to 

test for baseline 

differences in demographic 

and smoking-history 

variables 

All statistical tests twosided and had an alpha 

level of 0.05 

Logistic-regression 

analysis used to determine 

pairwise differences 

among groups in 

abstinence rates 

Kaplan–Meier method 

used to analyze 

differences in rates of 

continuous abstinence; 

homogeneity among 

treatments and pairwise 

differences tested w/ logrank test 

Data verification: 

Expired air CO levels 

assessed to validate selfreported smoking status 

Dependent variables: 

• Primary: smoking status 

• Secondary: withdrawl 

symptoms, body weight, 

and Beck Depression 

Inventory scores 

Baseline data: 

No significant differences 

b/w groups 

Proportion of participants 

abstinent at 6 mo followup: 

G1: 38.8% OR = 2.7 (95% 

CI, 1.7-4.4) P = < 0.001

G2: 34.8% OR = 2.3 (95% 

CI, 1.4-3.7) P = < 0.001 

G3: 21.3% OR = 1.2 (95% 

CI, 0.7-1.9) P = 0.53

C1: 18.8% 

Proportion of participants 

abstinent at 12 mo 

followup: 

G1: 35.5% OR = 3.0 (95% 

CI, 1.8-4.9) P = < 0.001

G2: 30.3% OR = 2.3 (95% 

CI, 1.4-3.9) P = < 0.001 

G3: 16.4% OR = 1.1 (95% 

CI, 0.6-1.8) P = 0.84, 

C1: 15.6% 

All four groups had 

significant increases in 

withdrawal symptoms 

during first wk of txt (P < 

0.001) but changes 

smaller in three active-txt 

groups than in placebo 

group during first six days 

after quitting date and 

during following wks 

No txt effect on Beck 

Depression Inventory 

scores 

Subjects in combinedtherapy group had gained 

significantly less weight 

than those in placebo 

group (P < 0.05) or 

bupriopion group 

(P < 0.05) at wk 7 but no 

significant differences b/w 

groups in mean weight 

changes after wk 7 

Quality rating: 

Fair 

Comments: 

NR 

Adequate randomization: 

Yes 

Attrition rate: 

6 month followup: 30.8% 

12 month followup: 34.6% 

Adverse events: 8.8% 
C-104 

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: 

Killen et al., 2000 

Geographic area: 

US, San Jose, CA 

Funding agency: 

University of California 

Tobacco-Related Disease 

Research Program; 

SmithKline Beechum 

Study setting: 

Population-based 

Research objective: 

To examine efficacy of smoking cessation 

treatment that combined nicotine 

replacement therapy via transdermal system 

with antidepressant paraxetine 

Population: 

Adults 

Study type: 

RCT, double-blind 

Inclusion criteria: 

• Adults over age 18 

Exclusion criteria: 

• Pregnant, or lactating 

• History of severe liver or kidney disease, 

epilepsy, bipolar disorder, schizophrenia, 

• Receiving active treatment for or reported 

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 

Sampling plan: 

• Recruitment from local newspapers, 

then telephone interview screen, then 

initial office visit screen 

• Double blind allocation 

Sample size: 

Total: 224

About 75 in each group 

Definition of smoking: 

• Greater than or equal to 10 cigarettes 

per day 

• Abstinence: nonsmoking not even a 

puff for 7 consecutive days and saliva 

cotinine level below 20ng/ml an a CO 

level below 9ppm 

• Smokers – reported abstinence but 

failed to provide a saliva sample 
C-105 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Individual counseling 

Intervention: 

G1: NRT transdermal 

system patch for 8 weeks 

plus 20 mg paroxetine for 9 

weeks 

G2: NRT transdermal 

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 

Method of assessment: 

• In person interview and 

biomarkers at initial clinic 

visit 

• Telephone interview at 1, 

4, 10 and 26 weeks 

• Via an interactive voice 

response system at 24 

hours, weeks 2 and 6 

Baseline data: 

• Demographics 

• Medical status questions 

• Smoking history 

• Screen for current major 

depression 

• Modified Fagerstrom 

Tolerance Questionnaire 

• Self-reported depression 

symptoms 

• Clinical diagnosis of 

depression 

• BMI 

• Blood pressure and heart 

rate 

Statistical analysis: 

• Intention to Treat analysis

• Logistic regression 

• 75% poser to detect at 

least a 20% increase in 

abstinence 

Data verification: 

• Self report 

• Saliva cotinine 

concentrations 

• Blood level to determine 

paroxetine compliance 

level 

Dependent variables: 

• Craving 

• Adverse events 

• Smoking status 

• Compliance 

• BMI 

• Heart rate 

• Blood Pressure 

• Expired air CO level 

• Depressive symptoms 

Abstinence Rates (NS) 

At 4 weeks 

G1: 48% 

G2: 57% 

C1: 45% 

At 10 weeks 

G1: 33% 

G2: 39% 

C1: 36% 

At 26 weeks 

G1: 21% 

G2: 27% 

C1: 25% 

Chemical Confirmation 

At 4 weeks: 95% 

At 10 weeks 98% 

At 26 weeks 86% 

Subanalysis of Compliant 

Persons 

At 4 weeks 

G1: 64% 

G2: 74% 

C1: 46% 

P < 0.001 

At 10 weeks 

G1: 43% 

G2: 51% 

C1: 35% 

At 26 weeks 

G1: 33% 

G2: 38% 

C1: 24% 

Those who reported greater use 

of nicotine patches and those 

with higher blood levels of 

paroxetine in Week 4 were more 

likely to be abstinent 

Quality rating: 

Good 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

Not clear 
C-106 

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: 

Lancaster et al., 1999 

Geographic area: 

United Kingdom 

Funding agency: 

NR 

Study setting: 

Practice/provider settings 

Study objective: 

To determine whether receiving brief advice 

from a GP plus extended counseling and 

followup from a trained nurse resulted in 

patients' cessation more than brief advice 

from a GP alone 

Population: 

• Adults 

Study type: 

RCT w/ systematic randomization 

Inclusion criteria: 

• Adults ages 18 and over who smoked at 

least one cigarette per day 

Exclusion criteria: 

• NR 

Sampling plan: 

• Opportunistic recruitment of patients 

attending the practice w/ unrelated 

complaints 

• Letters to patients identified as 

smokers by practice records 

• 497 patients from 6 practices 

systematically randomized to receive 

brief advice from a GP or brief advice 

from a GP plus extended counseling 

and followup from a trained practical 

nurse 

Sample size: 

G1: 249 

C1: 248 

Definition of smoking: 

Cigarettes 

• Smoker: At least one cigarette 

smoked per day and/or salivary 

cotinine levels < 113.5 nmol/l 
C-107 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Pharmaceuticals 

Intervention: 

G1: Brief verbal or written 

advice to quit from the 

patients' general 

practitioners, plus: extended 

counseling and followup from 

a trained practing nurse; 

Health Education Authority 

leaflet on cessation; fact 

sheet on NRT; invitation to 

contact research nurse for 

more intensive, tailored 

counseling that included CO 

breath test and a 

personalized message about 

benefits of quitting - 

minimum one 15 min visit 

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 

Statistical analysis: 

• Chi sq used to test for 

differences b/w 

proportions and 95% CI 

calculated 

• ITT analysis 

Data verification: 

Salivary cotinine levels 

obtained to validate selfreported quitters 

Dependent variables: 

• Sustained abstinence at 

3 and 12 mos 

• Biochemically validated 

• Forward movement on 

stage of change 

Baseline data: 

G1 and C1 similar at 

baseline in terms of 

demographics and 

smoking status 

Abstinence at 3 month followup: 

G1: 9.2% 

C1: 8.1%, NS 

Abstinence at 12 month followup: 

G1: 6.8% 

C1: 11.3%, NS 

Sustained abstinence (abstinent at 

both 3- & 12-month followup): 

G1: 3.6 

C1: 4.4 

Difference: -0.8% 

(CI, -4.3%, 2.6%) 

Validated (-3.3 vs4.0) 

Any forward change in stage of 

change: 

G1: 20.9% 

C1: 26.6% 

Difference: -5.7% 

(CI, -13.2%, 1.7%) 

Quality rating: 

Fair 

Comments: 

Adequate 

randomization: 

Yes 

Attrition rate: 

3 mo followup: 19% 

12 mo followup:25% 
C-108 

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: 

Lawrence et al., 2005 

Geographic area: 

West Midlands, UK 

Funding agency: 

Department of Health and 

the West Midland Health 

Authorities 

Study setting: 

Practice/provider settings 

Research objective: 

To evaluate the effect on quitting smoking at 

18 months post partum of smoking 

cessation intervention based on TTM 

delivered in pregnancy compared to current 

standard of care 

Population:

Women patients at of antenatal clinics in 

general practices 

Study type: 

Cluster randomized trial 

Inclusion criteria: 

• At least 16 years of age 

• Still smoking at 12 weeks gestation 

Exclusion criteria: 

NR 

Sampling plan: 

• Recruited 16 of the 19 midwifery 

services for West Midlands 

• 100 general practices randomized into 

trial arms 

• Allocated by computerized 

minimization algorithm 

Sample size: 

G1: 305 

G2: 324 

C1: 289

393 (42%) eligible smokers were 

followed up on 

Definition of smoking: 

• Urine cotinine of 1.5 ug/ml 

• Abstinence: declared nonsmoking and 

no cigarette consumption in last 24 

hours 
C-109 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Self-help 

Intervention: 

G1: TTM-based self help 

manuals 

G2: TTM-based self help 

manuals plus sessions with 

interactive computer 

program giving 

individualized smoking 

cessation advice 

C1: Standard care 

Method of assessment: 

Medical chart abstraction 

and follow-up telephone 

interview 

Baseline data: 

• 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 

Statistical analysis: 

• Cluster randomization 

• Random effects liners 

regression 

Data verification: 

Self report 

Dependent variables: 

• Cotinine saliva 

• Continuous and point 

prevalence abstinence 

since pregnancy 

Continuous abstinence since 10 

days PP: G1+G2 vs C1: 1.20 

(95% CI: 0.29-4.88) 

Point Prevalence for Abstinence: 

G1+G2 vs C1: 1.15 (95% CI: 

0.66-2.03) 

Seven of the 54 (13%) who quit 

at end of pregnancy were still quit 

18 months later 

No evidence that TTM-based 

interventions were superior in 

preventing relapse 

18 of the 54 (33%) of those who 

had quite 10 days PP were still 

quite at 18 months, though 11 of 

these were not continuously 

Quality rating: 

Poor 

Comments: 

NR 

Adequate 

randomization: 

NR 

Attrition rate: 

NR 
C-110 

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: 

Lerman, et al., 2004 

Geographic area: 

United States 

Funding agency: 

National Cancer Institute; 

National Institute on Drug 

Abuse, and Public Health 

Services Research grant 

Study setting: 

Population-based

Research objective: 

To evaluate the comparative efficacy of 

transdermal nicotine and nicotine nasal 

spray and identify predictors of treatment 

outcome 

Population: 

Adults ≥18 years old enrolled at Georgetown 

University and the University of 

Pennsylvania 

Study type: 

RCT 

Inclusion criteria: 

• 18 years of age or older 

• Had smoked 10 or more cigarettes per 

day for the previous 12 months 

Exclusion criteria: 

• 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 nicotinecontaining products other than cigarettes 

Sampling plan: 

• Participants were recruited through: 

- local media ads for free smoking 

 cessation treatment 

- physician referral 

• Eligible participants randomly 

assigned to receive transdermal 

nicotine or nicotine nasal spray 

Sample size: 

299 adults 

Definition of smoking: 

• Prolonged abstinence defined as not 

having smoked for 7 consecutive days 

at any time during the follow-up period

• Point prevalence defined as 7 days of 

continuous abstinence immediately 

before the follow-up point 
C-111 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Nicotine nasal spray 

• Transdermal nicotine 

therapy 

• Standardized behavioral 

group counseling 

Intervention: 

G1: 8 weeks of nicotine 

nasal spray and 7 sessions 

of behavioral group 

counseling 

G2: 8 weeks of transdermal 

nicotine therapy (i.e., patch) 

and 7 sessions of behavioral 

group counseling 

Method of assessment: 

8 weeks and six month 

telephone interviews plus 

biochemical verification for 

point prevalence 

Baseline data: 

Participants at the University 

of Pennsylvania site were 

significantly more likely to be 

non-white, obese, and have 

lower levels of education 

Statistical analysis: 

• Calculated sample size of 

140 per group to detect a 

between-group difference 

in quit rates of 8% or 

greater with 80% power 

(alpha = 0.05) 

• Chi square and Wilcoxon 

rank-sum tests were used 

to examine differences in 

pre-treatment variables 

• Chi square and Wilcoxon 

rank-sum tests were used 

to compare treatment 

groups on abstinence 

outcomes 

• Logistic regression 

analysis was used to 

examine the independent 

effects of treatment group 

assignment, pretreatment 

variables, and their 

interactions on prolonged 

abstinence and verified 

point prevalence 

abstinence 

• Wilcoxon rank-sum tests 

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 

No statistically significant 

difference found between 

treatment groups at 6 months 

(G1: 12.2%, G2: 15%, NS) 

Abstinence rates similar to those 

achieved in other studies 

Smokers who were highly 

dependent, obese, or members 

of minority groups achieved 

higher rates of abstinence with 

nasal spray 

Quality rating: 

Fair 

Comments: 

Authors stated that 

stratification was 

done by study site but 

no mention of what 

was stratified, or how 

or why 

Adequate 

randomization: 

Yes 

Attrition rate: 

18% lost-to-follow-up 
C-112 

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: 

MacLeod et al., 2003 

Geographic area: 

Australia 

Funding agency: 

GlaxoSmithKline 

Study setting: 

Population-based 

Research objective: 

To investigate the effectiveness of telephone 

counseling as an adjunct to nicotine 

replacement therapy (NRT) by transdermal 

patch in smoking cessation 

Population: 

• Smokers from New South Wales 

• ≥18 years old 

Study type: 

RCT 

Inclusion criteria: 

• Aged ≥18 years 

• English-speaking 

• Smoking ≥10 cigarettes per day for the 

previous year 

• Ready to begin a quit attempt within 1 

week 

Exclusion criteria: 

• History of cardiovascular disease, 

diabetes or skin sensitivity 

• Currently breastfeeding, pregnant or 

intending to become pregnant 

• Using contraindicated medications 

Sampling plan: 

• Recruited smokers from New South 

Wales via newspaper ads 

• Consent forms, questionnaires on 

health, smoking history and attitudes 

to quitting were mailed to people who 

responded to the ads. 

• Responses were screened by a 

pharmacist in accordance with the 

approved product information for 

transdermal nicotine patches and 

eligibility criteria for the study 

• Those deemed eligible were randomly 

allocated to either NRT alone or NRT 

plus telephone counseling 

• Participants were contacted by 

telephone data collectors to verify 

their understanding of the study 

(baseline) 

Sample size: 

G1: 412 

C1: 442 

Definition of smoking: 

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-113 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• NRT - patch 

• Telephone counseling 

Intervention: 

G1: Nicotine Patch and 5 

telephone counseling calls, 

scheduled at 1,2,3,6 and 10 

weeks after baseline 

C1: Nicotine Patch only 

Method of assessment: 

Brief (5 minute) follow-up 

telephone questionnaires 

were administered at 1, 2, 3, 

and 6 months post-baseline 

Baseline data: 

No significant differences 

b/w the 2 groups 

Statistical analysis: 

• Intent-to-treat approach 

used, where missing 

values on smoking status 

imputed as smokers with 

0 days abstinence in that 

period, unless continuous 

abstinence between calls 

was subsequently 

reported 

• Statistical significance 

between groups was 

tested by X2 tests and 

logistical regression 

(categorical variables) or 

t tests (continuous 

variables) 

• Logistic regression 

analysis was conducted 

with both treatment group 

and duration of patch use 

included as predictors of 

90-day abstinence 

Data verification: 

• Self-report, bogus 

pipeline technique used, 

with possibility of carbon 

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 

Telephone counseling improves 

cessation rates when used in 

conjunction with the patch 

28-day continuous abstinence 

rates at 6-months: G1 30.6%, C1 

22.4%, P =.01 

90-day continuous abstinence 

rates G1 26.7%, C1 18.6%, 

P = 0.004 

Logistic regression analysis 

revealed the duration of patch 

use and telephone counseling 

made independent contributions 

to prediction of 90-day 

abstinence 

Odds of successful quitting 

increased with each extra week 

of patch use when treatment 

group held constant (OR=1.24, 

P < 0.05) 

When controlling for weeks of 

patch use, the odds of success 

were higher for those in the 

counseling group (OR=1.46, 

P < 0.05) 

Quality rating: 

Good 

Comments: 

No biochemical 

verification of 

abstinence – relied 

solely on self-report 

Adequate 

randomization: 

Yes 

Attrition rate: 

16% 
C-114 

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: 

McBride et al., 2004 

Geographic area: 

United States 

Funding agency: 

National Cancer Institute 

Study setting: 

Military Medical Center 

Research objective: 

• To evaluate whether relative to usual care 

and a previously evaluated woman-only 

intevention, if training in optimal support 

behaviors and giving support to partners 

increased abstinence rates among 

pregnany women during and after 

pregnancy 

• 2nd aims – decrease postpartum relapse 

and increase rates of smoking cessation 

among partners 

Population: 

• Pregnant woman who received prenatal 

care at the Womack Army Medical 

Centers 

• Their live-in partners 

Study type: 

RCT 

Inclusion criteria: 

• Eligible women were ≤20 weeks pregnant 

• Aged ≥18 years 

• Current smokers or recent quitters 

• Living with an intimate partner 

• Willing to have the partner contacted for 

participation in the study 

Exclusion criteria: 

• >20 weeks pregnant 

• Partner not available, or refused partner 

contact 

Sampling plan: 

• Introductory letters describing the 

study were sent on behalf of WAMC 

to all women identified from 

automated appointment logs with a 

scheduled 1st prenatal visit. 

• Women who did not call study’s tollfree number w/in 10 days to decline 

contact were called to complete 

screening survey 

• Eligible women who agreed to 

participate were stratified by smoking 

status (smoker or recent quitter), their 

partner’s smoking status (smoker or 

nonsmoker) and partner’s level of 

willingness (not at all vs somewhat or 

very) 

• Once stratified, participants were then 

randomly assigned to one of 3 

conditions: usual care (UC), woman 

only (WO) or partner assisted (PA) 

• Women and partners completed 

telephone surveys at baseline (about 

11 weeks of pregnancy) 

Sample size: 

G1: (WO): 192 

G2: (PA): 193 

C1: (UC): 198 

Definition of smoking: 

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-115 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Provider advice 

• Self-help quit guides 

• Telephone counseling 

• Pregnancy relapse kit 

• Telephone counseling 

and support guide geared 

towards partners 

Intervention: 

G1: Usual care plus late 

pregnancy relapse kit, and 6 

counseling calls 

G2: G1 plus the partners 

received telephone 

counseling and support 

guide (partners who smoked 

received cessation aids and 

counseling) 

C1: Usual Care: provider 

advice to quit and self-help 

guide 

Method of assessment: 

• Telephone surveys of the 

women and partners at 28 

weeks pregnant, 

postpartum and 2, 6, and 

12 months 

• Self reported smoking 

status assessed at each 

follow up with the 

question “have you 

smoked any cigarettes in 

the past 7 days?” 

• Saliva samples collected 

by mail at 28 weeks 

pregnancy and 12 months 

postpartum from women 

and partners who 

reported not smoking in 

the previous 7 days 

Baseline data: 

No significant differences 

b/w any of the groups 

Statistical analysis: 

• Logistic regression was 

used to compare the 2 

experimental conditions 

to the control condition on 

each outcome measure, 

controlling for baseline 

smoking-specific support 

variables and predictors 

known to be associated 

with smoking cessation 

trials 

• Intent-to-treat approach 

used, where missing 

values on smoking status 

imputed as “smoker” 

• Comparison on the 

experimental conditions 

to the control condition on 

dichotomous secondary 

outcomes, such as 

postpartum relapse and 

partners’ prevalent 

abstinence, were made 

with logistic regression 

• Proportional hazards 

model was used to 

compare conditions on 

time to relapse, where 

time to relapse defined as 

the number of days b/w 

woman’s delivery date 

and the date she 

resumed smoking 

• Differences by condition 

for changes in women’s 

and partner’s smokingspecific support and 

general support across 

time were tested with 

mixed linear-model 

repeated measures 

analysis 

Data verification: 

Self-report, salivary cotinine 

Dependent variables: 

• Abstinence at 28 weeks, 

2, 6 and 12 months 

postpartum 

• Sustained abstinence 

No statistically significant 

difference between groups at any 

follow up point 

No statistically significant 

difference between groups in the 

proportion relapsed at any 

postpartum follow-up 

In late pregnancy (28 weeks), 

more partners abstinent in G2 

group (15%) than C1 group (5%) 

P = 0.02 

Women in all groups consistently 

reported a decline in positive 

partner support from baseline to 

12-month postpartum (F=81.43, 

df=1322, P < 0.001) 

Quality rating: 

Fair 

Comments: 

By only including 

women who agreed to 

involve their partners, 

couples who were 

inclined to support 

each other and 

attentuated treatment 

effects may have 

been overrepresented 

Adequate 

randomization: 

Yes 

Attrition rate: 

19% 
C-116 

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: 

Mermelstein et al., 2003 

Geographic area: 

US 

Funding agency: 

National Heart, Lung and 

Blood Institute and National 

Cancer Institute 

Study setting: 

NR 

Research objective: 

To compare the relative efficacy of two types 

of proactive telephone calls following a 

group cessation program. 

Population: 

Participants completing a group smoking 

cessation program 

Study type: 

RCT 

Inclusion criteria: 

NR 

Exclusion criteria: 

NR 

Sampling plan: 

• Participants recruited primarily 

through paid advertisements, media 

coverage of the program, flyers and 

referrals 

• 905 smokers attended the first group 

meeting 

• 771 smokers completed the group 

program 

• 756 smokers were assessed at least 

once over the follow-up period 

Sample size: 

G1: (basic): 375 

G2: (enhanced): 381 

Definition of smoking: 

Tobacco dependence as measured by 

the Fagerstrom Tolerance Questionnaire
C-117 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Group meetings 

• Telephone counseling 

Intervention: 

G1: Enhanced: Basic 

program (see C1 below) plus 

telephone counseling call 

content varied by 

participants’ smoking status 

(i.e., still smoking, abstinent, 

slipped or relapsed); if still 

smoking or relapsed also 

received a videotape; plus 

abstinent counseling on 

keeping motivation and selfefficacy high using a variety 

of techniques 

C1: BasiC1: 7 week group 

treatment program of 

telephone counseling giving 

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 

Statistical analysis: 

NR 

Data verification: 

Expired air carbon monoxide 

and saliva cotinine used to 

verify abstinence at each 

major assessment point for 

participants reporting 

abstinence 

Dependent variables: 

• Abstinence: no smoking at 

all in the past 7 days 

• Relapse: smoking one 

one or more days of the 

past 7 after achieving an 

initial 7-day period of 

abstinence at the end of 

the group program 

Point Prevalence of 

Abstinence: no significant 

differences by condition at any 

assessment point 

Post-hoc analysis by condition 

by gender at all assessment 

points showed that men 

receiving the enhanced 

condition were more likely to 

abstain while women were 

more likely to abstain when 

participating in the basic 

condition. 

Quality rating: 

Poor 

Comments:

• No true control group (i.e., 

those in group program 

with no telephone followup). So no true 

comparison of whether 

calls had an effect. 

• Random assignment 

method NR 

• Population not described 

• No inclusion/exclusion 

criteria specified 

Adequate randomization: 

NR 

Attrition rate:

6-month: 1% 

15-month: 4% 
C-118 

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: 

Murray et al., 2001 

Geographic area: 

US 

Funding agency: 

Division of Lung Disease of 

the National Heart, Lung, 

and Blood Institute 

Study setting: 

Practice/provider settings 

Study objective: 

To evaluate hypothesis that Black smokers 

will respond differently than Whites to a 

smoking cessation intervention program 

where no adjustments are made in 

recognition of cultural differences 

Population: 

• Adults 

• African Americans 

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 

Sampling plan: 

NR 

Sample size: 

G1: 3,923 

C1: 1,964 

Definition of smoking: 

Cigarettes 

Defined as smoking at any clinic visit 
C-119 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Group counseling 

• Pharmaceuticals 

Intervention: 

G1: SI (12-wk group 

program using a quit day 

in second wk, followed by 

4 consecutive days of 

group meetings) w/ 

bronchodilator therapy 

G2: SI w/ placebo inhalers 

C1: Usual care- annual 

physician visits 

Method of assessment: 

• Interviews at baseline 

and annually for 5 yrs 

• Annual saliva collection 

Statistical analysis: 

Covariate data used to 

explore differences using 

regression t-tests etc. 

Data verification: 

• Salivary cotinine 

annually 

• Expired CO 

throughout 

intervention program 

and subsequently at 

4-mo intervals 

Dependent variables: 

Smoking cessation 

Baseline data: 

Baseline data 

comparisons b/w 2 

groups showed 

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) 

Quitting at 1 yr G1 vs C1:

Blacks: AOR: 1.48 

Whites: AOR: 5.99 

P = 0.002 

Quitting at 5 yrs: 

G1 vs C1 

Blacks: AOR: 1.87 

Whites: AOR: 3.34 

P = 0.06 

Significant txt effect for Blacks 

over 5 yrs of study (OR = 1.95, P 

= 0.04) 

Quality rating: 

Poor 

Comments: 

Large differences 

in baseline 

comparisons b/w 

white and black 

negate any 

differences that 

occur in outcomes, 

small sample size 

Adequate 

randomization: 

No 

Study not designed 

for this comparison 

Attrition rate: 

NR 
C-120 

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: 

Peterson, 2004 

Geographic area: 

US 

Funding agency: 

National Heart, Lung, and 

Blood Institute 

Study setting: 

Hospital 

Study objective: 

To evaluate whether a nurse-managed 

smoking cessation and relapse prevention 

program reduced smoking rates at 12 mos 

in women admitted to hospital w/ CD 

Population: 

• Adults, 

• Women (only) 

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 

Sampling plan: 

NR 

Sample size: 

G1: 142 

C1: 135 

Definition of smoking: 

Cigarettes 

• Abstinent: no smoking in past 7 days 
C-121 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Telephone counseling 

Intervention: 

G1: Brief physician 

counseling and usual care 

plus nurse managed, 

cognitive behavioural, 

relapse prevention 

intervention given before 

discharge, <5 structured 

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 

Statistical analysis: 

NR 

Data verification: 

Self-reported smoking 

status (abstinence in 

past 7 days) verified by 

cotinine levels and 

family/friends 

Dependent variables: 

Smoking status 

Baseline data: 

NR 

At 12-month followup, 7-day 

point prevalence for nonsmoking: 

G1: 48% 

C1: 42% 

RBI: 14% (95% CI, -14 to 51), 

P = NS 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

NR 

Attrition rate: 

11% 
C-122 

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: 

Quist-Paulsen and 

Gallefoss, 2003 

Geographic area: 

Norway 

Funding agency: 

Vest-Agder Council for 

Public Health and the charity 

Sykehuset i vaare hender 

Study setting: 

Cardiac ward of a general 

hospital 

Research objective: 

To determine whether a nurse led smoking 

cessation intervention affects smoking 

cessation rates in patients admitted for 

coronary heart disease 

Population: 

Adults under 76 yrs of age 

Study type: 

RCT 

Inclusion criteria: 

• Patients under the age of 76 admitted for 

myocardial infarction, unstable angina, or 

cardiac bypass surgery who had been 

daily smokers until the start of their 

present coronary symptoms. Patients had 

to be sufficiently recovered to reliably 

receive the intervention and had to live in 

Vest-Agder or Aust-Agder county. 

Exclusion criteria: 

• Patients with serious illness associated 

with short life expectancies, serious 

psychiatric problems, alcoholism, and 

dementia 

Sampling plan: 

• Invited to participate in study all 

patients admitted to Vest-Agder 

Hospital for myocardial infarction, 

unstable angina, or care after 

coronary bypass surgery performed at 

other hospitals 

• 1016 patients assessed for eligibility 

• Nurses recruited patients 2-4 days 

after admission 

• Participants answered baseline 

questionnaire and were randomly 

allocated to usual care (control group) 

or intervention 

• Nurses given serially numbered 

sealed envelopes from secretary 

otherwise uninvolved in study 

• Randomization was in blocks of 

varying sizes 

• 250 patients randomized; 10 were 

later withdrawn 

Sample size: 

G1: 118 

C1: 122 

Definition of smoking: 

• Daily smoker until start of present 

coronary symptoms 
C-123 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Group sessions with cardiac 

nurses, including seeing a 

video and getting info 

booklet 

• Telephone counseling 

• Self-help 

Intervention: 

G1: Cardiac nurse consulted 

patients 1-2 times during 

hospital stay. Intervention 

based on booklet focusing on 

fear arousal and prevention of 

relapse. Booklet emphasized 

health benefits of quitting 

smoking after coronary event, 

including illustrations showing 

mortality differences for those 

who continued smoking after 

coronary condition vs. those 

who quit, information on how to 

prevent relapse, how to stop 

smoking, how to use nicotine 

replacement.; also explained 

how to identify & cope with 

high risk situations for relapse. 

Nurses contacted participants 

by telephone 2 days, 1 week, 3 

weeks, 3 months & 5 months 

after discharge. At 6 weeks 

aoo participants in G1 had 

consultation at outpatient clinic 

with nurse. 

C1: Patients were offered 

group sessions twice/week 

with nurses where importance 

of smoking cessation was 

mentioned; a video was shown 

and booklet distributed giving 

general information on 

coronary heart disease and 

advice on quitting smoking. No 

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 

Statistical analysis: 

• Chi-square test used to 

assess effect of 

intervention 

• NNT calculated with 

confidence intervals 

• Simple and multiple 

logistic regression 

models used to test 

relation between 

baseline characteristics 

and outcome measures 

• SPSS used for all 

analyses 

Data verification: 

Self-report and urine 

analysis 

Dependent variables: 

• Number of days spent in 

ICU 

• Myocardial infarction as 

reason for admission 

• No previous coronary 

heart disease 

• Employment 

Quit rate at 12 months: 

G1: 57% 

C1: 37% (absolute risk 

reduction 20%, 95% CI 6.4 – 

33.0; P = 0.004) 

NNT to get one additional 

person who would quit was 5 

Assuming dropouts relapsed at 

12 months, smoking cessation 

rates were: 

• G1: 50% 

• C1: 37% (absolute risk 

reduction 13%, 95% CI 0% - 

26%) 

Smokers who stated they were 

still smoking were classified as 

smokers 

Those who claimed they had 

quit and had a nicotine 

metabolite concentration in 

urine < 2.0 mmol/mol 

creatinine were classified as 

non-smokers 

G1: average of 1.6 (SD 0.7) 

consultations as inpatients and 

1.6 (SD 1.5) as outpatients; 

also received a mean of 8.5 

(SD 3.2) telephone calls 

Mean total time devoted to 

each patient was 147 minutes 

(SD 50) 

Use of nicotine replacements: 

G1: 36% 

C1: 28% (without a statistically 

significant difference) 

9% of patients who smoked 

while in hospital or at 6 wks 

were abstinent at 12 months 

Quality rating: 

Good 

Comments: 

• Well-reported—

interventions and methods 

fully described 

• Objective outcome 

measure (urine test) 

• Loss-to-follow up treated 

as relapsed smokers 

yielding valid ITT analysis

Adequate randomization: 

Yes 

Attrition rate: 

• 10 post-randomization 

exclusions 

• LTF at 12 months(not 

including postrandomization 

exclusions): 9% (G1:

15.3%, C1: 3.1%) 
C-124 

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: 

Ratner et al., 2004 

Geographic area: 

Western Canada 

Funding agency: 

National Cancer Institute of 

Canada 

Study setting: 

Teaching hospital 

Research objective: 

Test an intervention to help smokers abstain 

(fast) from smoking before surgery, maintain 

abstinence postoperatively, and achieve 

long-term cessation 

Population: 

Patients admitted for presurgical 

assessment from Nov. 1999 to Oct 2001 

Study type: 

Randomized pretest-posttest control group 

experiment 

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 

Sampling plan: 

Elective-surgical patients in 

• Cardiovascular 

• Opthalmology 

• Orthopedics 

• Plastics 

• Urology 

Sample size: 

237 

Definition of smoking: 

• Smoked in 7 days before surgery 
C-125 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Counseling 

• Nicotine replacement 

therapy 

Intervention: 

• 2 face to face counseling 

sessions 

• 9 telephone counseling 

sessions 

Method of assessment: 

• CO measure 

• Cotinine assay 

• Self-report 

Baseline data: 

Similar in both groups 

Statistical analysis: 

• Univariate descriptive 

statistics 

• Hypothesis testing using 

contingency tables and 

chi-square 

• Treatment effect- multistep logistic regression 

Data verification: 

• Cotinine assay 

• CO measure 

Dependent variables: 

• # days until follow-up 

• Age 

• Education 

• Self-efficacy 

• POMS 

• Fagerstrom test 

• Other household 

smokers 

• Smoking stage of 

change 

Treatment group participants 

(73.0%) were more likely to 

fast than were controls 

(53.0%): 2

(1, N = 228) = 8.89, 

P = .003, and more likely to be 

abstinent 6 months after 

surgery (31.2% vs. 20.2%). 

There was no significant 

difference in the abstinence 

rates at 12 months after 

surgery, 2

(1, N = 169) 

< 0.001, P = 1.00. 

Quality rating: 

Fair 

Adequate randomization: 

Yes 

Attrition rate: 

28.7% 
C-126 

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: 

Reid et al., 2003 

Geographic area: 

Ottawa, Canada 

Funding agency: 

NR 

Study setting: 

Tertiary care cardiac facility 

Research objective: 

To determine whether stepped-care 

treatment helped smokers hospitalized with 

CAD to quit smoking over 3-month and 1-

year follow-up periods. 

Population: 

• Patients hospitalized with CAD 

• Age of 18 years or more 

• Motivated to quit smoking 

Study type: 

RCT 

Inclusion criteria: 

• At least 18 years or age

• Hospitalized with coronary artery disease 

Exclusion criteria: 

• 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 

Sampling plan: 

• 8330 patients admitted for coronary 

angiography, PTCA, MI, or CABG 

were screened 

• 1379 (16.6%) were identified as 

cigarette smokers 

• 419 individuals who met all eligibility 

criteria 

• 254 (60.6%) agreed to participate 

Sample size: 

G1: 126 

C1: 128 

Definition of smoking: 

• 5 or more cigarettes a day 

• Did not include users of pipes, cigars 

or smokeless tobacco exclusively 
C-127 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Stepped-care treatment 

Intervention: 

G1: called by a nursecounselor 4 weeks after 

discharge and questioned. If 

not smoking, provided positive 

reinforcement and reminded 

about relapse prevention 

information in the booklet. If 

smoking, nurse counseling was 

begun, 3 - 20 minute face to 

face sessions over 8 weeks 

and nicotine patch therapy was 

made available 

C1: no additional counseling 

after hospital discharge; free to 

seek assistance from 

community or primary care 

physician 

Method of assessment: 

Surveyed by mail 3 months 

and 1 year after hospital 

discharge. If the questionnaire 

was not returned promptly, the 

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 

Statistical analysis: 

• Baseline subject 

characteristics - t tests 

for continuous variables 

and chi-square tests for 

categorical variables. 

• Primary analysis- a 

Fisher’s exact test was 

used to compare 3-

month and 1-year rates 

A secondary analysis 

univariate and 

multivariate logistic 

regression procedures 

Data verification: 

Self-reported with a 

random sample of 25 

tested for CO levels 

Dependent variables: 

• Demographic factors 

• reason for admission 

• smoking history 

• nicotine dependence 

• self-efficacy 

• motivational readiness 

variables 

At 3 months stepped-care 

treatment increased smoking 

cessation rates from 42% to 

53% during a 3-month followup period (P = 0.05) 

1-year follow-up minimal 

intervention group of 36% 

versus 39% for the steppedcare group (P = 0.36) 

Quality rating: 

Good 

Comments: 

• Well-thought out design 

• Well reported 

Adequate randomization: 

Yes 

Attrition rate: 

C1: 19.5% 

G1: 9.5% 
C-128 

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 

Geographic area: 

United Kingdom 

Funding agency: 

NR 

Study setting: 

Worksite 

Study objective: 

To evaluate effectiveness of offering an 

individualized approach to smoking 

cessation to qualified nurses and student 

nurses in Northern Ireland 

Population: 

• Adults 

Study type: 

Cohort study 

Inclusion criteria: 

• Qualified nurse ("nurse") or student nurse

• Smoked at least one cigarette daily 

• Expressed desire to quit smoking 

• Agreed to participate in study as an 

intervention or control participant 

Exclusion criteria: 

Did not meet all inclusion criteria 

Sampling plan: 

• Nurses and student nurses from a 

college of nursing and a large 

hospital trust who self-identified as 

smokers and wanting to quit were 

invited to participate in study 

• Participants could choose to be in 

intervention group or control 

Sample size: 

G1: 22 (nurses) 

G2: 32 (Student nurses) 

C1: 23 (nurses); 33 (student nurses) 

Definition of smoking: 

Cigarettes 

• Unclear, but to enroll, had to report 

smoking at least one cigarette daily 

(also see Dependent Variables 

section) 
C-129 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

Health professional 

• Social support 

Intervention: 

G1: (Qualified nurses): 

received individual 

counseling to: (1) assess 

health beliefs and motivation 

to quit smoking; (2) plan and 

implement strategy for 

quitting (set quit date, 

discuss coping strategies, 

identify social support, keep 

smoking success and failure 

diary) and make subjects 

aware follow up would occur 

at 6 wks, 6 months, 1 yr 

postintervention. 

G2: (Student nurses): Same 

intervention as G1 

C1: (Qualified nurses) and 

C2 (Student nurses) 

received no smoking 

cessation counseling or 

assistance, but were 

followed up at 6 months and 

1 yr postenrollment 

Method of assessment: 

Self-report on 

questionnaires and 

biochemical verification of 

non-smoking status 

Followup conducted at 6 

wks postintervention for 

intervention groups, at 6 

months and 1 yr for both 

intervention and Cs 

Definition of smoking: 

Cigarettes 

• Unclear, but to enroll, had 

to report smoking at least 

one cigarette daily (also 

see Dependent Variables 

section) 

Statistical analysis: 

Frequencies 

Fisher's Exact Test 

Qualitative data 

Data verification: 

Self report of smoking 

status 

For those reporting no 

smoking, verified through 

CO in expressed alveolar 

air (2-10 ppm = nonsmoker; 11-60 ppm = 

smoker) and through 

salivary cotinine 

concentrations (20 ng/ml = 

non-smoker) 

Dependent variables: 

• Verified quit rate 

• Perceptions of smoking 

and health 

• Perceptions of their 

health promotion role 

Baseline data: 

Nurses: G1 and C1 similar 

(age 23-56 yrs; 45% of G1 

and 49% of C1 had 

spouses, partners, or 

parents who smoked; 

95.5% female) 

G1 and C1 similar in 

smoking history (89% 

began smoking before 

nursing, 64% smoked 20 

cigarettes daily; 82% had 

been smoking more than 

10 yrs) 

68% G1 vs100% C1 tried 

to quit smoking previously 

(no test) 

Verified quit rate: 

G1: 22.7% vs 8.6% (C1) 

P < 0.05 

G2: 25% vs 6% in C2 

P < 0.05 

Quality rating: 

Poor 

Comments: 

Participants selfselected to 

intervention and 

comparison group 

status; at 1 yr 

followup, participants 

self-selected whether 

to answer a 

questionnaire for 

smokers or for nonsmokers; motivation 

and determination to 

quit smoking higher 

among intervention 

groups vscomparison 

groups, factors not 

controlled for in 

analyses; not given 

all data regarding 

intervention 

vscomparison groups 

(sometimes %s 

given, but not per 

group status) 

Adequate 

randomization: 

Not a RCT, but 

problematic group 

membership 

because participants 

self-selected into 

intervention or 

comparison group 

per their desire to 

receive smoking 

cessation assistance 

(intervention groups) 

or to try to stop 

smoking on their own 

(comparison group) 

Attrition rate: 

At 1 yr, 5% overall 

(no further attrition 

detail provided and 

unable to determine 

from tables 

presented) 
C-130 

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-131 

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

(continued) 

Intervention Details 

Statistical Analysis and 

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-132 

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: 

Saules, et al., 2004 

Geographic area: 

US 

Funding agency: 

National Institute on Drug 

Abuse and State of 

Michigan 

Study setting: 

Population-based 

Research objective: 

To test effect of fluoxetine on smoking 

cessation in the context of a program that 

includes group cognitive-behavioral therapy 

(6 weeks) and transdermal nicotine patch 

(10 weeks) 

Population: 

Adults 

Study type: 

Randomized, double-blind, placebocontrolled trial 

Inclusion criteria: 

• Adults 21-65 

• Smoking > 15 cigarettes/day 

• Producing CO. 15ppm 

Exclusion criteria: 

• Candidates in acute psychiatric crisis 

• Met criteria for apsychieatric disorder 

within the past six months 

• Were currently taking psychiatric 

medications 

• Clinically significant medical conditions 

• Pregnant 

• Inability to comprehend and respond to 

measures 

Sampling plan: 

• Participants recruited by flyers and 

notics distributed throughout the 

university and through paid 

advertisements in local newspapers 

and radio stations. 

• Telephone screening of all 

respondents. 

• Candidated attended a screening visit 

at which expired CO reading were 

required to be greater ahn or equal to 

15 ppm. 

Sample size: 

G1: 51 

G2: 51 

C1: Placebo 

Note: planned sample size was 168 with 

56 participants per arm 

Definition of smoking: 

Self-reported smoking of any cigarettes 

at all (or even part of one cigarette), CO 

greater than or equal to 10 ppm 
C-133 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Pharmaceuticals: 

fluoxetine and transdermal 

NRT 

• Cognitive-behavioral 

counseling (CBT) 

Intervention: 

G1: Fluoxetine (20mg) 4 

weeks before quit date, 

changed to 40 mg fluoxetine 

after one week, CBT starting 

2 weeks before quit date and 

15 mg NRT patch on 

morning after quit date visit 

G2: Fluoxetine (20mg) 4 

weeks before quit date and 

for 15 weeks total, CBT 

starting 2 weeks before quit 

date and 15 mg NRT patch 

on morning after quit date 

visit 

C1: Placebo and CBT 

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. 

Statistical analysis: 

Chi-square analysis 

Data verification: 

Expired CO of less than 10 

ppm obtained for selfreported quitters 

Dependent variables: 

Documented nonsmoking: 

self-reported abstinence 

combined with CO less than 

10 ppm 

No significant differences 

observed in smoking status at 

end of trial (assuming that end 

of trial was at 12-months post 

quit date although time frame 

is not stated in the article text 

or table for these 

assessments): 

C1: 35.4% 

G1: 43.1% 

G2: 43.1% 

Change in weight was 

significant for treatment group 

(P = 0.010), smoking cessation 

(P = 0.037) and their 

interaction (P = 0.012). 

Withdrawal symptom scores 

were significantly lower in both 

fluoxetine groups as compared 

to the placebo group 

(P = 0.038) 

Quality rating: 

Fair 

Comments: 

Random assignment method 

NR 

Adequate randomization: 

NR 

Attrition rate: 

40%

Drop-out was related to 

smoking status, as 90% of 

the people who did not 

complete the study had 

documented smoking at their 

last assessment whereas 

only 32% of those who 

completed the study had 

documented smoking at the 

last assessment 

(X2(1)=9.94, P = 0.002) 
C-134 

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: 

Simon et al., 2004 

Geographic area: 

United States 

Funding agency: 

California Tobacco-Related 

Disease Research Program 

Study setting: 

Hospital 

Research objective: 

Whether the addition of bupropion to 

transdermal NRT and cognitive-behavioral 

counseling would increase quit rates 

compared with standard therapy using NRT 

and cognitive-behavioral counseling only 

Population: 

Adults 

Study type: 

RCT 

Inclusion criteria: 

• Smoked 20 or more cigarettes during the 

week prior to enrollment 

• Have a telephone and no plans to leave 

the catchment area during the study 

period 

• In the contemplation or preparation stages 

of quitting according to the Prochaska and 

DiClemente Stages of Change model 

• ≥ 20 years of age 

Exclusion criteria: 

• Contraindications to bupropion or NRT 

• Serious psychiatric illness including major 

depression 

• History of alcohol abuse within the past 

three months or consuming more than 3 

alcoholic beverages per day 

Sampling plan: 

Participants were recruited from the 

three following sources: 

• Lists of known smokers from previous 

smoking cessation clinical trials at the 

San Francisco VA Medical Center 

• Hospital-based advertising at major 

teaching hospitals 

• Local Bay Area advertising and PSAs 

Eligible smokers were assessed for their 

readiness to quit smoking 

Subjects in the contemplation or 

preparation stages of quitting were 

randomized to either treatment or 

control arm 

Sample size: 

244 adults 

Definition of smoking: 

Non-smoker 

• Self-report of no smoking for the past 

seven days during each follow-up 

counseling call 

• Follow-up self report of no-smoking in 

the past six months and twelve 

months 

• Among those who reported no 

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 followup 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-135 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods:

• Bupropion 

• Transdermal nicotine 

replacement therapy 

• Cognitive-behavioral 

counseling 

Intervention: 

G1: 7 week course of 

Bupropion, 2 months 

transdermal nicotine 

replacement therapy, 1 visit 

with counselor (30-60 minute 

session), and 5 telephone 

follow-up calls 

C1: Same as G1 except 

participants received placebo 

instead of Bupropion 

Method of assessment: 

Follow-up at 7 weeks (end-of 

treatment), 3 months, 6 

months, and 12 months by 

telephone 

Baseline data: 

No statistically significant 

differences in any of the 

baseline demographic of 

medical characteristics 

between the samples in the 2 

study arms 

Males: 86% 

Statistical analysis:

• 2-sample t tests and 

Wilcoxon rank sum tests 

for continuous variables

• Chi square tests for 

categorical variables 

• Calculated relative risk 

and 95% CIs 

• For multi-variate 

analysis, used backward 

stepwise procedure to 

examine relationship 

between demographic 

and historical variables 

and smoking cessation 

• Variables were retained 

in the model if they 

remained associated 

with quitting at 

P ≤ 0.20 

• All regression models 

were adjusted for 

treatment assignment 

• Hosmer-Lemeshow 

goodness-of-fit test was 

used to assess 

adequacy of the models

• 2-tailed P values < 0.05 

were considered 

significant 

Data verification: 

Self-report plus cotinine 

saliva for those who selfreported quitting at the 12 

month followup 

Dependent variables: 

Quit rates 

No statistically significant 

differences in smoking 

cessation rates at end of 

medication 3, 6, and 12 

months 

The addition of 7-week 

treatment with Bupropion did 

not significantly increase quit 

rates over NRT and counseling

Quality rating: 

Fair 

Comments:

No power analysis 

Adequate randomization: 

Yes 

Attrition rate: 

• 1% lost to followup 

• 2% died 
C-136 

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: 

Swana

, et al., 2003 and 

Swanb

 et al., 2003 

Geographic area: 

US, Seattle 

Funding agency: 

National Cancer Institute 

Bupropion SR provided by 

Group Health Cooperative 

Pharmacy 

Study setting: 

Non-profit consumergoverned health care 

system serving 600,000 

residents of western 

Washington (GHC) 

Research objective: 

Swan:a

 To identify individual characteristics 

predictive of more clinically relevant smoking 

end-points beyond end of treatment in 

smokers prescribed bupropion SR and 

counseling. 

Swan:b

 To determine the differential 

effectiveness of 2 doses of bupropion in 

combination with behavioral interventions of 

minimal to moderate intensity. 

Population: 

• 18 years of age or older 

Study type: 

• Data from a large, randomized 

effectiveness trial 

• Two dosage levels of bupropion SR 

(Zyban, 150 and 300 mg) were crossed 

with two behavioral treatment programs of 

lower or higher intensity to create a fourcell design. 

Inclusion criteria: 

• Individuals at least 18 years of age 

• Smoking an average of 10 or more 

cigarettes per day in the 12 months prior 

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 

Sampling plan: 

• Participants who called the study 

center were screened over the 

telephone. 

• Eligible volunteers were sent a 

pretreatment questionnaire and 

consent form. 

• Participants were randomly assigned 

to 4 treatment arms by a computergenerated number. 

• The computer code calculated 

probabilities of group assignment that 

were dynamically modified based on 

the number of members in each group 

so that final group sizes were equal. 

• No restrictions such as stratification or 

blocking were used in the process. 

Sample size: 

G1: 382 

G2: 381 

G3: 383 

G4: 378 

Definition of smoking: 

• Any smoking within the past 7 days (7 

day point prevalence) 
C-137 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Pharmacologic treatment 

• Tailored mail program (ZAP) 

• Proactive telephone 

counseling program (Free 

and Clear Program) 

Intervention: 

G1: 150 mg bupropion SR and 

proactive telephone counseling 

(Free and Clear Program) 

G2: 150 mg bupropion SR and 

tailored mail ( Zyban 

Advantage Plan - ZAP) 

G3: 300 mg bupropion SR and 

proactive telephone counseling 

(Free and Clear Program) 

G4: 300 mg bupropion SR and 

(ZAP) 

Method of assessment: 

3- and 12-month follow-up 

Baseline data: 

• Reported by gender not 

treatment condition. 

• Men had significantly more 

years of formal schooling, 

smoked more cigarettes per 

day, had higher number of 

previous attempts to quit. 

• Women significantly more 

likely to report perceived 

stress, social support 

depression, ever having 

depression in lifetime or 

percentage of family ever 

depressed. 

Statistical analysis: 

• Intent-to-treat analysis 

• Logistic regression for 

assessing pretreatment 

characteristics for their 

relationship to pointprevalent smoking at 12 

months 

Data verification: 

Self-report 

Dependent variables: 

• Smoking: any smoking 

within the 7 days prior to 

follow-up 

Swan 2003a 

At 12-month follow-up, type of 

behavioral treatment had a 

strong association with pointprevalent smoking (e.g., 

participation in the lessintensive TM program being 

associated with a greater 

likelihood of smoking) whereas 

dose and the dose x treatment 

interaction had little or no 

association with outcome 

OR=1.21 (95% CI, 1.08 - 

1.35). 

Swan 2003b 

• At 3 months: 

300mg G3: 35% vs 150 mg 

G1: 24.4% (P=0.001); 

300mg G3: 35% vs 150mg 

G2: 24.2% (P =0.001); 

300mg 

G3: 35% vs 300mg 

G4= 26.7% (P =0.01) 

 At 12 months: 

300mg G3: 33.2% vs 

150mg G2: 23.6% (P

=0.004) 

300mg G3: 33.2% vs 

300mg G4: 25.7% (P =0.02) 

150 mg G1: 31.4% vs 

150mg G2: 23.6% vs 

(P =0.02) 

Quality rating: 

Fair 

Comments:

• Lack of blinding 

• No biochemical 

confirmation of selfreported smoking status 

• No objective 

measurement of 

adherence to the 

therapeutic regime 

Adequate randomization: 

NR 

Attrition rate: 

• 3-month follow-up: 20.8% 

• 12-month follow-up: 

14.9% 
C-138 

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: 

Wakefield et al., 2004 

Geographic area: 

South Australia 

Funding agency: 

National Health and Medical 

Research Council 

Study setting: 

Hospital-based 

Research objective: 

To determine whether a motivational 

interviewing intervention increased 

successful smoking cessation attempts of 

patients with cancer attending a South 

Australian public hospital, as compared with 

usual care 

Population: 

• Cancer patients at South Australian public 

hospital 

Study type: 

RCT 

Inclusion criteria: 

• Participant must have a cancer diagnosis 

• Smoke tobacco more than weekly 

• Speak English 

• Be cognitively able to consent 

• Have a prognosis exceeding 6 months 

• Live close enough to maximize 

biochemical confirmation at follow-up 

assessment* (changed to include patients 

living remotely to increase participation 

numbers) 

Exclusion criteria: 

See above 

Sampling plan: 

• Patients were screened by doctors 

after scheduled appointments in the 

radiation therapy, medical oncology, 

and hematology departments at Royal 

Adelaide Hospital over 20 month 

period 

• After several months, accrual of 

participants too slow, so patients 

living remotely were approached to 

increase numbers 

• Once patients consented to 

participate, they completed a baseline 

questionnaire 

• 6-month follow up interviews were 

done and those who said had stopped 

smoking were asked to provide either 

a urine sample for cotinine analysis or 

a CO reading using a breath monitor 

Sample size: 

G1: 74 

C1: 63 

Definition of smoking: 

Tobacco 

• Current Smoker – Smoke tobacco at 

least weekly 
C-139 

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

(continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Visit with smoking cessation 

counselor 

• Booklets 

• NRT 

• Family advice to quit 

• In-person or telephone 

follow-up conversation 

Intervention: 

G1: Specific advice and 

booklets about benefits of 

quitting for patients with 

cancer, telephone and inperson counseling using the 

framework of motivational 

counseling, supplemented with 

NRT if patient smoked ≥15 

cigarettes per day

C1: brief advice to quit, widelyavailable quit-smoking 

brochures, and info about wellpromoted state-based 

telephone quit-line service 

Method of assessment: 

In-person follow up visit or 

telephone assessment at 6 

months post-baseline 

Baseline data: 

Patients in intervention group 

were more likely than control 

patients to have ever tried to 

quit (P = 0.04) and to have 

made more quit attempts in the 

past year (P = 0.02) 

Control patients were more 

likely to live remotely (P = 0.04) 

Statistical analysis: 

• Data were analyzed 

using SPSS 

• Fisher’s exact tests and 

chi-square tests were 

used to establish 

whether groups differed 

significantly across 

categorical variables, 

and t-tests were used 

for continuous variables

• An intention to treat 

analysis was used, as 

well as an analysis 

excluding those lost to 

follow-up evaluation 

• Phi coefficients were 

calculated to determine 

the degree of 

association between the 

intervention and control 

groups across variables

• Binary logistic 

regression was used to 

examine predictors of 

smoking cessation 

Data verification: 

Self-report, urine cotinine 

and CO levels 

Dependent variables: 

• Quit rates – 3 month 

period prevalence, 7-

day period prevalence 

Outcome Measures: 

• At 6-month follow up, no 

difference in biochemically 

confirmed 3-month 

prevalence quit rates 

between the intervention 

(5%) and control (6%) 

groups 

• Sensitivity analysis using 

more lenient criteria 

indicated quit rates of 29% 

for intervention group and 

18% for control group 

(P = 0.32) 

• Predictors of smoking 

cessation at 6 months for all 

patients included a smokingrelated cancer site, more 

cessation attempts in the 

year before the enrollment 

study, and no radiation 

therapy 

Quality rating: 

Poor 

Comments: 

Study lacked power, had a 

high attrition rate and there 

were significant differences 

in groups at baseline 

Adequate randomization: 

No 

Attrition rate: 

36% 
C-140 

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: 

Borland et al., 2003 

Geographic area: 

Australia 

Funding agency: 

NHMRC grant, 

supplemented by The 

Cancer Council Victoria; 

callbacks funded by Quit 

Victoria 

Study setting: 

Population-based 

Study objective: 

To assess effectiveness computergenerated tailored advice for callers to 

telephone helpline; to assess if it enhanced 

series of callback telephone counseling 

sessions in aiding smoking cessation. 

Population: 

• Adolescents 

• Young adults 

• Adults 

Study type: 

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 

Sampling plan: 

Recruited eligible callers of Victorian 

Quitline telephone counseling and 

advice service 

Sample size: 

G1: 523 

G2: 528 

C1: 527 

Definition of smoking: 

NR 
C-141 

Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco 

use cessation strategies (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Telephone counseling 

• Computer-based 

program 

Intervention: 

G1: Offered a 'Quit Pack' 

and a series of 3 

computer-generated 

tailored letters 

G2: Offered a 'Quit 

Pack'and a series of 3 

computer-generated 

tailored letters and 

callback counseling 

service 

G3: NR 

C1: Offered a 'Quit Pack', 

printed self-help materials 

consisting of: a 30 pg 

booklet based on stage of 

disease, leaflets promoting 

smoking cessation courses 

and card w/ strategies to 

reduce cravings 

Method of assessment: 

Baseline interview; mailed 

survey at 3, 6, and 12 

months post baseline 

Statistical analysis: 

Data analyzed using SPSS 

ITT analysis 

Data verification: 

NR 

Dependent variables: 

• Self-reported smoking 

status at 3-, 6-,and 12-

month followups, both 

point prevalence and 9 

months' sustained 

absitinece 

• Duration of cessation 

• Use of nicotine 

replacement 

• Extent of participation in 

callback 

Baseline data: 

Smoked average of 22.8 

cigarettes/day: 

Prepartion stage: 45% 

Contemplation stage: 54% 

Groups similar at baseline 

by gender, age, education, 

level of addiction, stage of 

readiness, quit attempts in 

past yr 

Quit attempts w/ 95% CI 

G1: 56% (51.3-60.7) 

G2: 62.8% (58.2-67.4) 

C1: 57.4% (52.5-61.5) 

Smoking point prevalence at 

12-mo followup: 

G1: 22.6% (18.5-26.7) 

G2: 25.6% (21.3-29.9) 

C1: 22.1% (18.1-26.1) 

Chi sq 1.5, P 0.46 

Quality rating: 

Good 

Comments: 

Groups similar at 

baseline in spite of 

suboptimal 

randomziation 

scheme 

Adequate 

randomization: 

Yes 

Attrition rate: 

Overall: 23.4% 

G1: 23.1% 

G2: 25.9% 

C1: 21.1%
C-142 

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: 

Maguire et al., 2001 

Geographic area: 

United Kingdom 

Funding agency: 

Medical Research Council 

and the Northern Ireland 

DHSS 

Study setting: 

Community-based 

Study objective: 

To evaluate whether a structured 

community pharmacy-based smoking 

cessation program would result in a higher 

smoking cessation rate compared to ad hoc 

advice from pharmacists 

Population: 

• Adults 

Study type: 

• RCT w/ systematic randomization 

• Comparing a structured intervention w/ 

usual care 

Inclusion criteria: 

• More than 18 yrs of age 

• Not pregnant 

• Expressing a wish to stop smoking 

Exclusion criteria: 

• NR 

Sampling plan: 

• 100 pharmacists working in 

community pharmacies in N. Ireland 

and 24 in London participated in 

study 

• Each asked to enroll 12 smokers 

Pharmacists promoted study to: 

• People who used pharmacy for nonmedical reasons, using window 

displays, posters in-pharmacy and 

leaflets at cash registers 

• People reporting and asking for 

advice on minor ailments, e.g. chest 

cold, asking them about smoking and 

telling them about program 

• People being dispensed medicines, 

asking them about smoking and 

telling them about program 

Sample size: 

G1: 265 smokers 

C1: 219 smokers 

Definition of smoking: 

NR 
C-143 

Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco 

use cessation strategies (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Media campaign 

• Pharmaceuticals 

Intervention: 

G1: Initial interview lasting 

b/w 10 and 30 minutes; 

smoking cessation 

contract; indication for 

NRT assessed and offered 

if appropriate; leaflet; 

weekly followup for 4 wks, 

then monthly followup for 3 

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 nonsmoking at 12 mos 

• Qualitative assessments 

also conducted using 

semi-structured 

telephone interviews 

and focus groups 

Statistical analysis: 

NR 

Data verification: 

Urinary cotinine 

assessed to validate selfreported non-smoking at 

12 months 

Dependent variables: 

Smoking status 

Baseline data: 

Numbers given but no 

tests for significance 

Self-reported non-smoking status 

at 3-month followup: 

G1: 27.5% 

C1: 11% 

Self-reported non-smoking status 

at 6-month followup: 

G1: 18.5% 

C1: 8.2% 

Self-reported non-smoking status 

validated by urinary cotinine (50 

ng/ml) at 12-month followup: 

G1: 14.3% 

C1: 2.7% 

Χ2

 = 16.2 

P = <.001 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

G1: 10.2% 

C1: 14.2% 
C-144 

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: 

Ronda et al., 2004 

Geographic area: 

Western Europe 

Funding agency: 

Netherlands Heart 

Foundation 

Study setting: 

Community-based 

Study objective: 

To assess whether Hartslag community 

smoking cessation intervention resulted in 

increased smoking cessation in Maastricht 

region as compared to control region 

Population: 

• Adults 

Study type: 

• Cohort Study 

• A pretest–posttest C design w/ two 

posttests 

Inclusion criteria: 

• Over 18 yrs old 

• Living in intervention or control regions 

Exclusion criteria: 

• NR 

Sampling plan: 

A cohort research population of 1,200 

smokers (age 18 and over) recruited in 

each region by taking a stratified 

random sample of 6,500 inhabitants in 

each region from computerized 

telephone registers, based on number 

of inhabitants i n each municipality 

included in region 

Sample size: 

G1: 4,242 (35.4% of whom were 

smokers) 

C1: 4,697 (34% of whom were 

smokers) 

Definition of smoking: 

Cigarettes 

• Smoker: smoked at all in last 7 days 
C-145 

Evidence Table 6. Community strategies to increase the implementation of proven population-level tobacco 

use cessation strategies (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Telephone counseling 

• Media campaign 

Intervention: 

G1: Regional mass medialed smoking cessation 

campaign Proficiat 

(Congratulations) 

implemented in January 

and February 2000 and 

2001, consisting of radio 

commercials, 

advertisements and 

messages in papers, 

billboards along roads, and 

posters and postcards in 

waiting rooms and public 

buildings; local activities 

organised by working 

groups consisting of 

representatives of local 

organizations, such as a 

non-smoking campaign for 

parents of children in 

playgroups 

C1: National mass medialed smoking cessation 

campaign Dat kan ik ook (I 

can do that too) 

implemented around the 

turn of the century, 

consisting of various 

television programmes, an 

info line, non-smoking 

courses, mailings to 

variousorganizations, 

billboards in bus shelters, 

brochures, posters 

Method of assessment: 

Short structured telephone 

interviews 

Statistical analysis: 

• Multiple logistic 

regression analysis 

conducted to identify 

potential dropout bias 

(w/ attendance v. 

dropout as the 

dependent variable 

and baseline values 

for gender, age, 

education, and 

condition as 

independent variables) 

• Multiple logistic 

regression analysis 

used to identify 

potential baseline 

differences b/w G1 

region and control 

region 

• Independent variables 

in this analysis were 

baseline values for 

gender, age and 

education 

• Only respondents who 

completed all surveys 

included 

• Analyses performed 

using SPSS 10.0 

Data verification: 

NR 

Dependent variables: 

Primary: smoking status 

Secondary: intention to 

quit, cessation selfefficacy, perceived social 

support for cessation 

Baseline data: 

Respondents from G1 

region significantly older, 

more often female, and 

more highly educated 

than respondents from 

control region 

Outcome measures: 

No significant differences found 

b/w G1 and control regions 

regarding smoking status and 

determinants of smoking 

behavior 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

NR 

Attrition rate: 

37.9%, net attrition 

after excluding 

unreachable 

respondents from 

T0 to T2 18.7% 
C-146 

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: 

Cornuz et al., 2002 

Geographic area: 

Western Europe 

Funding agency: 

Swiss Federal Office for 

Public Health, Swiss 

Medical Association, Swiss 

Foundation for Health 

Promotion 

Study setting: 

Practice/provider settings 

Study objective: 

To assess efficacy of an educational 

program based on behavioral theory, active 

learning methods and practice w/ 

standardized patients for internal medicine 

residents in helping patients abstain from 

smoking and changing counseling practices 

Population: 

• Young adults 

• Adults 

Study type: 

RCT w/ cluster randomization 

Inclusion criteria: 

• 16 to 75 yrs old 

• Understood French 

• Consulted an outpatient clinic for a 

followup or an emergency visit 

• Had smoked 1 or more cigarettes daily 

during previous wk 

Exclusion criteria: 

• NR 

Sampling plan: 

• 35 residents at 2 general medicine 

clinics randomly assigned by 

computer and stratified by clinic to 

either intervention group trained in 

smoking cessation or C trained in 

dyslipidemia 

• Patients screened for eligibility by 

research assistants 

• Eligibile patients asked for written 

informed consent to participate in a 

study about preventive care 

Sample size: 

G1: 17 residents, 115 patients 

C1: 18 residents, 136 patients 

Definition of smoking: 

Cigarettes 

• 1-wk point prevalence of abstinence: 

no smoking in last wk 
C-147 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

Intervention: 

G1: Intervention training 

program for residents based 

on active learning of 

counseling skills and 

interventions that matched 

patients' readiness to quit; 

after training, residents 

supposed to reach the 

following objectives: 

Systematically identify all 

smoking patients, clearly 

advise smokers to quit, 

assess each smoker's 

readiness to quit, use 

applied counseling 

strategies and offer a 

brochure that matched 

patient's stage of readiness, 

propose an individual 

smoking cessation program, 

follow smokers in short and 

long term, and facilitate 

implementation of smoking 

cessation in routine practice; 

received control training 4 

months later, after 3 month 

patient recruitment period 

had ended 

C1: Traditional diadactic 

training program on 

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; selfreported abstinence 

validated at one clinic by 

measurement of exhaled CO 

by a research assistant 

blinded to group allocation 

Statistical analysis: 

To compare baseline data, 

Χ2

 and Fisher exact tests 

used for categorical data 

and t-test and Wilcoxon 

rank-sum test used for 

continuous data; to 

measure outcomes, 

logistic regression 

performed w/ a 

generalized estimating 

equation to stratify by clinic 

and adjust for clustering by 

resident; all statistical 

analysis performed using 

STATA 

Data verification: 

Self-reported abstinence 

validated at one clinic by 

measurement of exhaled 

CO by a research 

assistant blinded to group 

allocation 

Dependent variables: 

Primary: Smoking status 

Secondary: Counseling 

score, willingness to quit, 

daily cigarette 

consumption 

Baseline data: 

• Both groups of residents 

similar at baseline 

• Both groups of patients 

similar at baseline 

At one-yr followup, 1-wk point 

prevalence of abstinence: 

G1: 13% (95% CI, 7% to 21%) 

C1: 5% (95% CI, 1% to 9%) 

P = 0.005 

OR = 2.8 (95% CI, 1.4 to 5.5) 

Residents who recieved study 

training provided better counseling 

(mean score 4 vs2.7, P = 0.002) 

Smokers willingness to quit higher 

in IG (94% vs80%, P = 0.007) 

No significant trend toward lower 

daily cigarette consumption in G1. 

Quality rating: 

Fair 

Comments: 

No comments 

Adequate 

randomization: 

Yes 

Attrition rate: 

Loss to followup at 1 

yr: 

G1: 33% 

C1: 26.5% 
C-148 

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: 

Goldstein et al., 2003 

Geographic area: 

US 

Funding agency: 

NCI 

Study setting: 

Community-based 

Practice/provider settings 

Study objective: 

To determine effect of a community-based 

academic detailing intervention on quit rates 

of a population-based sample of smokers 

Population: 

• Adults 

Study type: 

• Cross-sectional 

• Community-based, quasi-experimental 

study 

Inclusion criteria: 

• Physicians eligible if they practiced a 

primary care specialty (i.e., family 

medicine, internal medicine, obstetrics 

/gynecology), provided primary care for at 

least 25% of their patients, completed 

postgraduate training, and planned to 

practice in the state for the 3 study yrs 

• Patients recruited through random digit 

dialing 

• Patients must be 18 to 75 yrs old 

• Live in a household w/ a phone 

• Current smokers 

Exclusion criteria: 

• Full-time hospital-based physicians 

excluded 

• Only one smoking patient per household 

included 

Sampling plan: 

• A list of all licensed physicians 

obtained from Rhode Island 

Department of Health, Folio’s Medical 

Directory of Rhode Island, 1990, and 

local health care institutions 

• Physicians received mailed invitations 

followed by postcards, and then 

phone calls from physician recruiters 

• Principal Investigator contacted 

nonresponders to complete 

recruitment process 

• All physicians providing direct care to 

adults in Newport, Washington, and 

Kent counties targeted for 

participation in intervention and 

delayed intervention (control) arms of 

PCS trial 

Sample size: 

G1: 376 patients 

G2: 385 patients 

G3: 332 patients 

C1: 1253 patients 

Definition of smoking: 

Cigarettes 

• Smoker: currently smokes cigarettes 
C-149 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Multi-component officebased intervention 

• Academic detailing 

Intervention: 

G1: Physicians provided 4 

A's to patients 

G2: Smokers provided w/ 

computer-generated, 

stage-tailored information 

about quitting smoking at 

home 

G3: Physician delivered 4 

A's to patients, and 

patients received 

computer-generated, 

stage-tailored smoking 

cessation information at 

home 

C1: No intervention 

Method of assessment: 

Telephone survey at 6, 12, 

18, and 24 mos 

Statistical analysis: 

• Descriptive statistics 

(mean, median, 

proportions) used to 

characterize study 

sample at baseline 

and to examine 

demographic 

differences b/w study 

groups which might 

confound study 

outcomes at 24 

months 

• Multivariate logistic 

regressions done to 

examine differences in 

smoking status at 24 

mos 

Data verification: 

NR 

Dependent variables: 

Self-reported smoking 

status 

Baseline data: 

• Those residing in 

physician intervention 

areas (G1 & G3) less 

likely to be less than 

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 

Percentage of patients who quit 

smoking at 6-month followup: 

G1: 8.4 

G2: 7.6 

G3: 8.9 

C1: 7.1 

P = NR 

Percentage of patients who quit 

smoking at 12-month followup: 

G1: 17.0 

G2: 16.5 

G3: 16.9 

C1: 16.1 

P = NR 

Percentage of patients who quit 

smoking at 18-month followup: 

G1: 25.2 

G2: 24.8 

G3: 19.2 

C1: 20.0 

P = NR 

Percentage of patients who quit 

smoking at 24-month followup: 

G1: 33.3 

G2: 26.3 

G3: 25.7 

C1: 22.6 

P = 0.006 

Quality rating: 

Fair 

Comments: 

Adequate 

randomization: 

NR 

Attrition rate: 

At 24 mos, of 2346 

participants, 35% 

attrition in 

controlled/delayed 

G1, 35% attrition in 

physician only IG, 

35% attrition in 

physician and 

home G1 
C-150 

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: 

Joseph, Arikian, et al., 2004 

Geographic area: 

US 

Funding agency: 

Veterans Administration 

Health Services Research 

and Development Service 

(CPG 97-039) 

Study setting: 

Provider-based 

Research objective: 

To test the effect of modest intensity, 

practical systems change that might 

increase delivery of smoking cessation 

treatment within Veterans Affairs. 

Population: 

• Adults (N = 5,678) 

• 20 Veteran Affairs Medical Centers 

(results from this analysis were not used 

because sample size too small) 

Study type: 

• Cross-sectional design (individual 

analysis) 

• RCT w/ simple randomization 

(organizational analysis) 

Inclusion criteria: 

• Existence of referral-based smoking 

cessation program that treated a minimum 

of 50 patients/year, information resource 

management capacity for data collection, 

institutional review board, and evidence of 

commitment to participation in the project 

Exclusion criteria: 

• Facilities serving predominatly psychiatric 

patients, or displayed communication 

problems. 

Sampling plan: 

• Telephone surveys were conducted 

among 3 cohorts of patients 

• A cross-sectional survey was 

conducted at baseline among a 

sample randomly selected from 

patients who had seen their primary 

care provider within 6 months 

(preintervention) 

• A second cross-sectional survey 

sample was obtained 1 year after the 

intervention using the same sampling 

technique (post intervention) 

• Preintervention smokers at baseline 

were surveyed 1 year after 

intervention 

• Medical records reviewed 6 months 

before intervention and 6 months 

following intervention for all subjects 

who provided consent and smoked 

and a random sample of equal size of 

subjects that did not smoke. 

Sample size: 

Total: 5,678 Adults 

Preintervention 

G1: 2,112 

C1: 2,142 

Post intervention 

G1: 641 

C1:783 

Definition of smoking: 

Cigarettes 

• Current smokers 
C-151 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Multicomponent 

intervention 

Intervention: 

G1: Received 

documentation of tobacco 

use status in medical 

records; delivery of 

intervention to all smokers; 

liberal use of smoking 

cessation medication; 

organizational support; site 

visits; 2 day training 

meeting; an interventionist at 

coordinating site. 

C1: NR 

Method of assessment: 

Medical record review and 

telephone survey 

Baseline data: 

No differences at baseline 

between intervention and 

control group sites. 

Statistical analysis: 

• A McNemar odds on 

change was calculated 

to assess difference in 

change between the 

intervention groups 

• The significance of the 

resulting odds was 

computed by the 

Pearson chi square 

• For continuous variables 

measured at facility level 

a Wilcoxon rank sum 

test was used. 

Data verification: 

Self-report (no biochemical 

verification) and medical 

record review

Dependent variables: 

• Smoking status 

• General health 

• Nicotine dependence 

• Services provided at last 

visit to primary care 

provider 

• Mood 

• Alcohol use 

• Demographics 

G1: 11.4% quit smoking 

C1 13.2% quit smoking, NS 

No effects of the intervention on 

change scores between groups for 

reporting that their provider asked 

about smoking, or being counseled 

to quit at 1 year post intervention 

Intervention had no effect on 

smokers’ report of being counseled 

to quit 

Smokers only group, 30% of 

smokers in G1 were counseled 

before the intervention and 44% 

counseled after the intervention; 

C1 smokers counseled 39.1% 

before intervention and 42.2% post 

intervention. Amomg smokers who 

had a change in counseling before 

and after the intervention, the 

subjects in the intervention group 

had 2 times the odds of being 

counseled relative to controls 

(OR=2.24, 95% CI, 1.17 to 4.28, 

P=.014). 

Medical records: Post intervention 

had a significant effect on smoking 

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 

Quality rating: 

Fair 

Comments: 

• Organizational 

level analysis was 

not used (N = 20) 

Adequate 

randomization: 

Yes for VA hospitals 

only not individual 

subjects 

Attrition rate: 

• Pre-intervention = 

21% 

• Smokers followup 

= 13% 

• Post- intervention 

= 16% 
C-152 

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: 

Katz et al., 2004 

Geographic area: 

US 

Funding agency: 

National Cancer Institute 

and University of Wisconsin 

Comprehensive Cancer 

Center. 

Study setting: 

Community-based 

Practice/provider settings 

Study objective: 

To compare MAs' and LPNs' performance 

of recommended smoking cessation 

activities w/ that of RNs 

Population: 

• Adults 

Study type: 

• Secondary analysis of data from a RCT of 

guideline implementation 

• Intake clinicians (RNs, LPNs, MAs) paired 

w/ primary care physician (PCP) 

• Clinic randomized to receive help 

implementing AHRQ cessation guidelines 

vs control 

• Patients interviewed after clinic visit 

Inclusion criteria: 

• NR 

Exclusion criteria: 

• NR 

Sampling plan: 

NR 

Sample size: 

G1: 724 patients 

By intake clinician: 

RN: 100 

LPN: 154 

MA: 470 

C1: 497 patients 

By intake clinician: 

RN: 153 

LPN: 256 

MA: 88 

Definition of smoking: 

Cigarettes 

• At least one per day on average 
C-153 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Individual counseling by 

non health professional 

• Telephone counseling 

Intervention: 

G1: In original RCT: study 

personnel worked w/ 

intake clinicians to 

implement guideline 

intervention (tutorial w/ 

feedback, real-time 

reminder, self-help 

material, onsite 

pharmacotherapy, and 

proactive telephone 

counseling) 

• Survey administered to 

intake clinicians 

immediately preceeding 

intervention 

• After clinic visit, study 

personnel interviewed 

consecutive adults who 

had routine, nonemergency 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 

Statistical analysis: 

Two-level hierarchical 

logistic regression 

Data verification: 

NR 

Dependent variables: 

Proportion of patients 

receiving guidelinerecommended 

counseling at time of 

scheduled clinic visit 

Baseline data: 

Patients seen by MA 

vsRN at control site = 

57% vs43% male 

(P = 0.01), and 49% 

vs71% w/ regular 

clinician (P = 0.02) 

Patients seen by MA 

vsRN at test site = 57% 

vs75% w/ regular 

clinician (P = 0.001) 

Ask about smoking: 

Control RN/LPN/MA: 

67%/35%/41% vstest site 

RN/LPN/MA: 92%/86%/78%. 

Assess willingness to quit: 

control RN/LPN/MA = 

15%/8%/7% vstest site 

RN/LPN/MA = 85%/75%/60%. 

Advise to quit: control 

RN/LPN/MA = 16%/7%/9% 

vstest site RN/LPN/MA = 

41%/46%/28%. 

Assist in quitting: control 

RN/LPN/MA = 17%/8%/9% 

vstest site RN/LPN/MA = 

73%/69%/51%. 

(Also reported as difference in 

proportion (& 95% CI) b/w RNs 

and other intake clinicians). 

Quality rating: 

Fair 

Comments: 

Secondary 

analysis, so study 

not designed to 

answer this 

question 

Missing important 

info that's reported 

in original study 

Adequate 

randomization: 

NR 

Attrition rate: 

NR 
C-154 

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: 

Katz et al., 2004 

Geographic area: 

US 

Funding agency: 

National Cancer Institute; 

University of Wisconsin; 

GlaxoSmithKline donated 

transdermal nicotine 

patches for use in trial 

Study setting: 

Provider-based 

Research objective: 

To test the effectiveness of a multi-modality 

intervention to implement the AHRQ 

Smoking Cessation Clinical Practice 

Guideline in primary care settings 

Population: 

Adults 

Study type: 

RCT 

Inclusion criteria: 

Adults smoking at least one cigarette per 

day and having an appointment with a 

primary care clinician for routine, nonemergency care and willing to complete a 

brief exit interview immediately after the 

clinic appointment 

Exclusion criteria: 

NR 

Sampling plan: 

• 12 eligible clinics were invited to 

participate; 9 clinics agreed to 

participate; 1 clinic participated only in 

the pilot phase 

• Matched clinic sites (8) by primary 

care discipline and health plan 

affiliation (if any) 

• For each pair of clinics, project 

statistician used a random number 

generator to randomly assign each 

clinic to receive either the intervention 

(test site, n=4) or usual care (control 

site, n=4) 

Sample size: 

G1: 4 clinics, 1141 patients 

C1: 4 clinics, 1022 patients 

Definition of smoking: 

7-day point prevalence 
C-155 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Multicomponent office 

based intervention 

Intervention: 

G1: Tutorial for intake 

clinicians, group and 

individual performance 

feedback for intake 

clinicians, use of a modified 

vital signs stamp, an offer of 

free nicotine replacement 

therapy and proactive 

telephone counseling. 

C1: Staff received only 

general information on the 

AHRQ Guideline 

Method of assessment: 

Self-reported by telephone 

interview at 2- and 6-month 

follow-up 

Baseline data: 

No statistically significant 

differences in smoking 

cessation rates between 

participants at test and 

control sites during the 

baseline period, except in 

educational level 

During the intervention 

period, patients at test sites 

were older, had more years 

of education and smoked 

more cigarettes per day than 

patients at control sites 

No significant differences 

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 

Statistical analysis: 

Hierarchical logistic 

regression models used to 

estimate the odds rations 

for treatment assignment 

after adjustment for patient 

characteristics 

Data verification: 

Self-report and 

confirmatory salivary 

cotinine for self-reported 

quitters 

Dependent variables: 

• Performance of 

recommended smoking 

cessation activities by 

clinic staff 

• Abstinence at 2 and 6 

months after the initial 

clinic visit (7-day point 

prevalence) 

• Continuous abstinence 

at 2 and 6 months (selfreported abstinence at 

both 2 and 6 month 

assessments) 

During the intervention period, 

more patients at test sites were 

asked about their smoking status 

(OR = 3.1; 95%,CI; 1.2 to 8.2; 

P = 0.02) or about their willingness 

to quit smoking (OR = 6.4, 95%, 

CI; 3.7 to 10.8; P < 0.001), were 

given literature about quitting (OR 

= 21, 95%, CI; 8.8to 49; 

P < 0.001), were assisted with 

setting quit date (OR = 33, 95%, 

CI;11 to 100; P < 0.001) or were 

engaged in a discussion about 

pharmacotherapy (OR = 3.9, 95%, 

CI; 2.5 to6.3; P < 0.001). 

Among participants treated during 

the intervention period, those at 

test sites were more likely than 

those at control sites to report 

being abstinent at the 2- month 

(16.4% vs. 5.8%, adjusted OR = 

3.3, 95% CI, 1.9 –5.6, P < 0.001) 

and 6-months (15.4% vs 9.8%; 

adjusted OR = 1.7, (95% CI = 1.2-

2.6), P = 0.009) follow-up 

assessments and to report 

continuous abstinence (10.9% vs 

3.8%, adjusted OR = 3.4 (95% CI, 

1.8-6.3), P < 0.001) 

With biochemically confirmed 

abstinence at 6 months, showed 

no difference between G1 and C1 

Very low response rate for planned 

collection of confirmatory salivary 

cotinine tests of self-report 

cessation 

Quality rating: 

Good 

Comments: 

Failed to reach 

original enrollment 

target resulting in 

slightly lower power 

than originally 

planned to detect 

differences in 

cessation outcomes. 

Adequate 

randomization: 

Yes 

Attrition rate: 

G1: 11% 

C1: 10% 
C-156 

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: 

Pbert et al., 2004 

Geographic area: 

US 

Funding agency: 

NHLBI 

Study setting: 

Practice/provider settings 

Study objective: 

To evaluate effect of a provider counseling 

and office systems intervention in obstetric, 

pediatric, and Special Supplemental 

Nutrition Program for WIC clinics on 

smoking and relapse rates in pregnant and 

postpartum wome 

Population: 

• Adults 

• Women (only) 

• Pregnant women 

Study type: 

RCT w/ cluster randomization 

Inclusion criteria: 

• Women receiving prenatal care and WIC 

services and planning to receive pediatric 

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 

Sampling plan: 

• Five community health centers 

randomized to special intervention or 

usual care 

• Research assistants screened 

women in WIC offices 

Sample size: 

G1: 272 

C1: 278 

Definition of smoking: 

Cigarettes 

• Abstinence: not smoking within last 7 

days 

• Spontaneous quitter: quit smoking 

since learning of pregnancy and not 

smoking for at least 7 days prior to 

baseline 
C-157 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

Individual Counseling by 

non Health Professional 

Intervention: 

G1: Clients visited 

community health centers 

and WIC offices that 

received: provider training 

to deliver a SIbased on 

national clinical practice 

guidelines tailored to 

woman’s stage of change 

and delivered through 

three channels (obstetric, 

pediatric, and WIC 

providers); an office 

practice management 

system to routinely screen 

for smoking status, 

prompt/remind providers to 

intervene, document the 

encounter, distribute 

materials, and arrange 

followup; and 

establishment of program 

boards to coordinate 

transfer of documentation 

among clinics, including 

periodic meetings w/ 

representatives from all 

clinics

C1: Usual care 

Method of assessment: 

Data collected from 

participants at five time 

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 

Statistical analysis: 

• A mixed-effects linear 

modeling used to test 

hypotheses about txt 

conditions controlling 

for clustering of 

respondents within 

each community 

health center 

• Linear logistic 

regression analyses 

computed using 

GLIMMIX macro, 

which uses iteratively 

reweighted likelihoods 

to fit a logistic 

regression 

• PROC MIXED 

procedure in SAS 

used for analysis of 

number of cigarettes 

per day over time 

• Reported P values are 

for two-sided 

alternative hypotheses 

Data verification: 

Salivary cotinine levels 

≤ 20 ng/ml assessed to 

confirm 7 day abstinence 

Dependent variables: 

Smoking status 

Baseline data: 

Groups similar at 

baseline 

30-day abstinence rates at end of 

pregnancy among women who 

did not spontaneously quit upon 

learning of their pregnancy: 

G1: 26% 

C1: 12% 

OR = 2.57 

P = 0.05 

30-day abstinence rates at 1-

month postpartum among 

women who did not 

spontaneously quit upon learning 

of their pregnancy: 

G1: 26% 

C1: 11% 

OR = 3.01 

P = 0.04 

All other effects not statistically 

significant 

No effect remained at 3 and 6 mo 

followup 

Intent to treat at 30 day followup: 

Non-spontaneous quitters: 2.02 

P = 0.09 

Spontaneous quitters 0.95 

P = 0.95 

Quality rating: 

Fair 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

20% 
C-158 

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: 

Pieterse, 2001 

Geographic area: 

Western Europe 

Funding agency: 

Dutch Cancer Society 

Study setting: 

Practice/provider settings 

Study objective: 

To test effectiveness of a minimal contact 

smoking cessation program implemented by 

Dutch general practitioners. 

Population: 

• Young adults 

• Adults 

Study type: 

• RCT w/ simple randomization 

• Randomization occurring within practice 

sites according to a "prestructured 

allocation list" 

Inclusion criteria: 

• 18 to 70 

• Self-reported smoker 

Exclusion criteria: 

• Controls exposed to txt 

• Controls w/ severe tobacco-related health 

problems (thus given intervention) 

Sampling plan: 

Smoking patients 18 to 70 recruited 

from participating Dutch general 

practitioners' clinics 

Only info regarding randomization 

process: 

• Occurred within clinics and used a 

prestructured allocation list 

Sample size: 

G1: 269 

C1: 261 

Definition of smoking: 

Cigarettes 

• Non-smokers at followup defined as 

consistently providing non-smoker 

responses to two questions 1) contact 

name for someone to verify smoking 

status and 2) self-reported smoking 

status 
C-159 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Individual counseling by 

non health professional 

• Telephone counseling 

• Pharmaceuticals 

Intervention: 

G1: Brief (10-minute) 

counseling sessions w/ 

physician; self-help 

manual; followup sessions. 

C1: Usual txt - no 

counseling or advice on 

smoking except when 

initiated by patient or when 

indicated by the contact 

reason, in which case 

counseling limited to a 

straightforward stopsmoking advice and 

possibly a referral to local 

municipal health 

organization 

Method of assessment: 

Self-report by 

questionnaire 

Statistical analysis: 

Logistic regression, 

backward stepwise 

procedures, univariate 

ANOVA, Χ2 tests 

Data verification: 

Self-report. 

No biochemical 

verification 

Dependent variables: 

• Self-reported 

abstinence from 

smoking 

• Point prevalence of 

smoking 

• Consecutive 

abstinence from 

smoking (abstinent at 

both 6- and 12-month 

followups) 

Baseline data: 

Significant difference in 

G1 vsC1 in baseline 

measures of: 

Percent smoking ≤ 10 

cigarettes per day (G1:

13.3, C1: 20.4; F = 4.3, 

P = 0.04) 

Motivation to quit score 

(G1: 14.8, C1: 13.8, F = 

6.7, P = 0.01) 

Otherwise, population 

considered 

representative of 

average Dutch visitor of 

a general practice 

1-month followup smoking 

abstinence rates greater among 

those in intervention compared to 

controls (OR = 2.56; CI, 1.8, 3.8) 

Similarly, 12-month follow up 

smoking abstinence rates were 

13.4% (G1) vs 7.3% (C1), w/ an 

OR = 1.51 (CI, 1.1, 2.1), P < 0.05 

Consecutive abstinence greater 

among intervention group (8.2%) 

than among C (3.1%); OR = 3.04 

(CI, 1.7, 5.6), P < 0.001 

Quality rating: 

Fair 

Comments: 

Not clear about 

randomization 

procedures 

because only 

vague information 

provided 

Important potential 

influence identified 

by authors -- 

implementation of 

national massmedia stopsmoking campaign, 

which started 

shortly before 

second followup 

Adequate 

randomization: 

Yes 

Attrition rate: 

1 month: 

Overall: 26% 

G1: 33% 

C1: 19% 

6 month: 

Overall: 26% (no 

info on each 

group). 

12 month: 

Overall: 19% (no 

info on each 

group). 
C-160 

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: 

Piper et al., 2003 

Geographic area: 

US 

Funding agency: 

National Cancer Institute 

Study setting: 

Provider-based 

Research objective: 

To test effectiveness of expanded vital sign 

stamp to identify smokers and reduce 

smoking rates 

Population: 

Adult smokers attending health care clinics 

Study type: 

Cluster RCT (clinics unit of randomization) 

Inclusion criteria: 

• Any adult smoker (older than 18 years) 

• Attended only one health care clinic 

Exclusion criteria: 

None reported 

Sampling plan: 

• Convenience sample 

• Adults exiting health clinics (n = 5) 

were approached 

• Any adult smoker willing to participate 

was enrolled 

Sample size: 

G1: 5582 

C1: 3857 

Definition of smoking: 

NR 
C-161 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Expanded vital sign stamps 

Intervention: 

G1: smoking status was 

added to the vital sign stamp 

C1: usual vital sign stamp 

without smoking status 

Method of assessment: 

Follow up questionnaire 

after 1 year (method NR) 

Baseline data: 

Similar at baseline 

Statistical analysis: 

Chi square (response 

rates not reported) 

Data verification: 

NR 

Dependent variables: 

• Smoking cessation 

• Identification of smokers

• Rates of smoking 

counseling by 

physicians 

Proportion of all participants asked 

by any clinic staff person about 

smoking before and after 

implementation of vital sign stamp 

revealed an overall increase of 

9.6% in control group and 30.9% in 

intervention clinics 

Mean increase in asking behavior 

of physicians at vital sign clinics 

was statistically greater than that of 

physicians at control clinics 

t = -3.61; P = 0.002) 

No statistically significant 

differences in abstinence rates 

(complete abstinence during past 7 

days) between G1 and C1 after 1 

year (P = 0.27). 

Quality rating: 

Fair 

Comments: 

Response rates to 

follow up 

questionnaire at 1 

year not reported 

Adequate 

randomization: 

NR 

Attrition rate: 

NR 
C-162 

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: 

Russos et al., 1999 

Geographic area: 

US 

Funding agency: 

Cigarette and Tobacco 

Surtax Fund of the State of 

Calif through the TobaccoRelated Disease Research 

Program of the University of 

Calif 

Study setting: 

Practice/provider settings 

Study objective: 

To examine rate and determinants 

(especially as related to social learning 

factors) of tobacco prevention and cessation 

counseling by orthodontists participating in 

a controlled trial to decrease incidence of 

tobacco use among adolescents. 

Population: 

• Adults 

Study type: 

• Cross-sectional 

• Current study based on cross-sectional 

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 

Sampling plan: 

Orthodontists recruited from 154 

participating orthodontic offices within 

various southern Calif counties 

Sample size: 

G1: 63 

C1: 63 

Definition of smoking: 

NR 
C-163 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

non health professional 

• Telephone counseling 

• Video 

• Media campaign 

Intervention: 

G1: Anti-tobacco materials 

(e.g., posters), 1.5 hr 

training session on 

tobacco prevention, written 

anti-tobacco prescriptions, 

reimbursement for antitobacco prescription given 

to patients, quarterly visits 

and calls; office staff asked 

to make office tobaccofree (remove ashtrays, 

distribute anti-tobacco 

materials and prescriptions 

to all youth, to remind 

patients not to begin 

tobacco use) 

C1: No training, materials, 

or visits, nor asked to 

change their offices or 

practices 

Method of assessment: 

Mailed survey requesting 

self-report from 

orthodontists 

Statistical analysis: 

• Nonparametric 

statistics (Kendall, 

Mann-Whitney) used 

in bivariate analyses 

• Multivariate analysis 

Data verification: 

Telephone survey of 

orthodontists 

Dependent variables: 

• Provision of prevention 

and cessation 

counseling to patients 

• Counseling content 

• Counseling 

determinants 

Baseline data: 

No significant differences 

(P > 0.05) found b/w G1 

and C1 in terms of 

demographics, clinical 

practices, office 

characteristics, history of 

tobacco use, nor training 

for tobacco counseling 

Mean age about 51, 

mean yrs in practice 

about 24 yrs, about 230 

adolescent patients, 

mean gross annual 

income 445,000 

Outcome measures: 

In a typical wk more clinicians in 

experimental vsC provided 

prevention counseling to patients 

(Mean: 25.4% v 3%, MannWhitney U = 696.5, z = -7.0, P < 

0.01) and at least some 

cessation counseling (91% vs 

72%, chi sq = 8.4, P < 0.01) 

G1 asked higher % (4.8) of their 

patients whether they use 

tobacco than C1 (2.9), (U = 

1349.0, z = -3.3, P < 0.01) 

G1 more likely to report mostly 

positive reactions from tobacco 

users for cessation counseling 

(chi sq = 7.8, P < 0.05) 

C1 more likely than G1 to say 

they don't provide counseling 

because it's not their job or not 

expected of them (chi sq = 3.7, P

= 0.05) 

G1 more likely to say lack of time 

is significant barrier to giving 

prevention counseling (chi sq = 

4.2, P < 0.05) 

Demographic, office, and clinic 

practice variables not associated 

w/ prevention or cessation 

counseling (P > 0.05) 

Higher rates of prevention and 

cessation counseling associated 

(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 

Quality rating: 

Fair 

Comments: 

Good, 

documentation of 

reasons for attrition 

and distribution of 

non-responders by 

group; things to 

consider when 

trying to improve 

providers' provision 

of tobacco use 

prevention and 

cessation advice 

Similar findings 

from comparison of 

results to other 

studies 

Adequate 

randomization: 

Yes 

Attrition rate: 

Survey: 

G1 and C1: 18% 

each 
C-164 

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: 

Slama et al., 1999 

Geographic area: 

Western Europe 

Funding agency: 

French Ministry of Health; 

European Union "Europe 

Against Cancer 

Programme"; French 

Committee for Health 

Education 

Study setting: 

Practice/provider settings 

Study objective: 

To examine participation and effectiveness 

of GPs in offering a minimal smoking 

cessation intervention according to 

attitudinal and behavior variables 

Population: 

• Adults 

Study type: 

Cross-sectional survey w/ GPs who 

participated in a previous smoking cessation 

intervention 

Inclusion criteria: 

• Participated in previous smoking 

cessation intervention study 

Exclusion criteria: 

• NR 

Sampling plan: 

• 2,860 GPs from France interviewed 

about their attitudes and behaviors 

• From this group, 170 of 371 randomly 

selected smoking GPs and 202 of 

375 randomly selected non-smoking 

GPs participated in survey 

Sample size: 

Smokers: 170 smokers 

Non-smokers: 202 

C1: NA 

Definition of smoking: 

Cigarettes 

• Abstinent: not smoking cigarettes 
C-165 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

Extra-curricular activities 

Intervention: 

G1: NA 

G2: NA 

G3: NA

C1: NA 

Method of assessment: 

For GPs' attitudes and 

reported practices: self 

report obtained by 

telephone survey 

GPs' participation in 

intervention measured by 

patient information GP 

returned per protocol at 1 

and 12 mo followups. 

Patient smoking status: 

self report at 1 and 12 mo 

followups 

Statistical analysis: 

Chi sq tests 

Frequencies 

Proportions 

Data verification: 

Self report 

Dependent variables: 

• Rate of participation in 

cessation trial by GP's 

smoking status 

• Effect of GPs' 

smoking-related 

attitudes and reported 

practices 

Baseline data: 

50% of eligible GPs 

participated (45% 

smoked; 54.1% did not; 

Χ2

 = 5.147, P < 0.05) 

Significant differences 

b/w participating and 

non-participating GPs in 

beliefs about usefulness 

of screening for cervical 

(96.2% vs 91.6%, Χ2

 = 

6.460, P < 0.011) and 

breast cancer (98.1% v 

94.8%, Χ2

 = 5.918, 

P < 0.015) 

Other differences NS 

Doctors who were smokers less 

likely than non-smoking GPs to 

participate in the smoking 

cessation trial, despite having 

originally consented to do so 

(45% vs 54.1%, chi sq: 5.147, 

P < 0.05) 

None of the GPs' smoking 

related attitudes and reported 

behaviors significantly related to 

their participation in the study nor 

to their patients' rates of smoking 

cessation at 1 mo, 12 mos, or 

both 

Conclusion: When minimal 

advice has an effect, it is due 

more to systematic nature of the 

provision of intervention than to 

the attitudes or reported 

practices of practioner giving 

advice 

Quality rating: 

Fair 

Comments: 

Interesting practical 

applications to 

understanding 

factors that might 

influence 

physicians' 

willingness to 

participate in 

interventions to 

address smoking 

cessation w/ 

patients; Limited 

discussion of 

intervention, 

though refers to 

previous article 

description 

Adequate 

randomization: 

NR 

Attrition rate: 

Smoking GPs (%): 

1 wk: 11.8 

2 wks: 8.2 

3 wks: 12.9 

4 wks: 32 

Non-smoking GPs 

(%): 

1 wk: 9.9 

2 wks: 10.3 

3 wks: 15.3 

4 wks: 35.5 
C-166 

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: 

Smith et al., 2002 

Geographic area: 

US 

Funding agency: 

NCI, Canadian Cancer 

Society 

Study setting: 

Hospital 

Study objective: 

To assess effectiveness of a nurse casemanaged smoking cessation program for 

general hospitalized patients, was continued 

for 3 yrs after completion of RCT 

Population: 

• Adults 

Study type: 

• Time series 

• Single group effectiveness study using a 

program put into standard hospital 

practice. 

• No comparison group for this study; 

instead, follows participants over time and 

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 

Sampling plan: 

Patients admitted to Stanford (Calif.) 

Hospital who smoked any amount the 

month before admission were offered a 

smoking cessation program during 

hospitalization 

Sample size: 

12 month sample = 720 

Definition of smoking: 

Cigarettes 

• 7 day point-prevalence as defined by 

NHLBI (not even a puff for a minimum 

of 7 consecutive days prior to 

assessment 
C-167 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Telephone counseling 

• Video 

• Pharmaceuticals 

Intervention: 

G1: Used multiplereinforcement approach 

(multiple providers, 

components, and contacts) 

During hospitalization: 

Physician advice on 

smoking cessation; 

bedside education and 

counseling w/ specially 

trained nurse; take-home 

materials (video, 

workbook, relaxation 

audiotape), NRT if 

requested or indicated, 4 

nurse-initiated 

postdischarge phone 

counseling calls (2,7,21, 

and 90 days 

postdischarge) 

C1: No control or 

comparison group 

Method of assessment: 

In-person survey for 

demographic information, 

and baseline smoking 

history and alcohol 

consumption 

Postdischarge data 

collected by telephone and 

involved self-report 

Statistical analysis: 

• ANOVA 

• Χ2

• Frequencies 

• Intent-to-treat analysis 

Data verification: 

• Self-report by 

telephone No 

biochemical 

assessment 

Dependent variables: 

12 mo quit rate (7 day 

point prevalence at 12 

mos) 

Baseline data: 

Mean age: 52 

Males: 58% 

Race/ethnicity: 

• Caucasian: 79% 

• African American: 5% 

• Asian: 9% 

• HispaniC1: 1% 

• Other race: 6% 

Hospitalization reasons: 

• Cardiovascular: 41% 

• Cancer: 12% 

• Pulmonary: 6% 

• Gynecological: 4% 

• Internal medicine: 19% 

• OrthopediC1: 10% 

• Other: 9% 

Significant (P < 0.001) 

differences in age, sex, 

ethnicity, primary reason 

for hospitalization b/w 

total smokers identified, 

ineligibles, participants, 

wanted to quit on own, 

and did not want to quit 

groups 

Including only those who were 

reached at 12 mos, 49% reported 

being smoke free for previous 7 

days 

Including 211 who were not 

reached at 12 mos (intent to 

treat) and counting them as 

smokers, self-reported smoking 

cessation rate is 35%. 

Quality rating: 

Fair 

Comments: 

Though no 

comparison group 

in this study, it 

provides very good 

and detailed data 

regarding 

continuation of a 

smoking cessation 

program 

implemented 

previously as part 

of a RCT; 

only 52% of eligible 

patients 

participated, but 

this is considered 

fairly high 

acceptance rate for 

the population; 

it also presents 

data both w/ and 

without intent-totreat approach; 

partial reasons for 

high attrition rate at 

12 mos include 

nurse not having 

time to devote to 

trying to make 

follow up calls and 

only 3 attempts 

made to reach 

participants by 

phone. Study also 

addresses practical 

hospital-related 

issues to be 

considered when 

implementing an 

inpatient smoking 

cessation program 

Adequate 

randomization: 

No 

Attrition rate: 

Excluding 42 who 

died before 

assessment, 29% 

attrition rate (not 

reached or dropped 

out)
C-168 

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: 

Soulier-Parmeggiani et al., 

1999 

Geographic area: 

Western Europe 

Funding agency: 

NR 

Study setting: 

Hospital 

Practice/provider settings 

Study objective: 

To evaluate effectiveness of a smoking 

cessation program for outpatients 

Population: 

• Adults 

Study type: 

• Before and after study 

• Patients participated in 1-hr consultation 

groups once a wk for 4 wks; patients 

interviewed at baseline and 3, 6, and 12 

months after intervention 

Inclusion criteria: 

• NR 

Exclusion criteria: 

• NR 

Sampling plan: 

NR 

Sample size: 

G1: 299 

Definition of smoking: 

NR 
C-169 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Individual counseling by 

health professional 

• Group counseling 

• Telephone counseling 

• Social support 

• Video 

• Pharmaceuticals 

Intervention: 

G1: One-hr group 

consultations once per wk 

for 4 wks; followup 

individual consultations by 

telephone at 1, 3, 6, and 

12 mos after intervention; 

prescription of NRT; 

individual strategy for 

cessation discussed w/ a 

provider; family support 

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 

Statistical analysis: 

Proportions of smokers 

calculated at baseline 

and followup intervals 

Data verification: 

Patients' CO levels 

measured at each 

session and followup 

Dependent variables: 

Smoking status 

Baseline data: 

Collected data on 

smoking history, 

addiction level as 

measured by FTQ, and 

motivation and 

confidence to quit 

smoking 

Non-smokers at baseline and 

each followup: 

Baseline: 0% 

End of intervention: 54% 

3-mo followup: 39.4% 

6-mo followup: 25.8% 

12-mo followup: 20.9% 

Quality rating: 

Poor 

Comments: 

Sampling not 

explained, no C, 

limited 

generalizability 

Adequate 

randomization: 

NR 

Attrition rate: 

10.4% 
C-170 

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: 

Stevens et al., 2000 

Geographic area: 

US 

Funding agency: 

NCI 

Study setting: 

Hospital 

Study objective: 

To evaluate implementation and 

effectiveness of hospital-based smoking 

cessation counseling delivered by 

respiratory therapists chosen from among 

hospital staff 

Population: 

• Adults 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

• Between 18 to 70 yrs old 

• Being admitted to one of two participating 

Kaiser Permanente hospitals in Portland, 

OR 

• 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 

Sampling plan: 

• Smokers b/w 18 to 70 yrs old 

identified by questionnaire upon 

hospital admission 

• Eligible smokers assigned to txt or 

usual care by a random digit in their 

HMO member number 

Sample size: 

G1: 541 

C1: 632 

Definition of smoking: 

Cigarettes 

• Abstinence from smoking considered 

as ≥ 6 months 

• Second analysis included pipes or 

cigars 
C-171 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Telephone counseling 

• Video 

Intervention: 

G1: If assigned to 

intervention but did not 

agree to participate, 

received smoking 

cessation brochure only 

If agreed to participate, 

watched 12 minute video 

for hospitalized smokers; 

offered one 20-minute 

counseling session w/ RT; 

choice of written materials 

(e.g., NCI's 

C1: no information 

Method of assessment: 

Mailed questionnaire and 

follow up by phone for 

non-responders 

Statistical analysis: 

Χ2

 tests and one logistic 

regression 

Data verification: 

Relied on self-report of 

smoking status 

Dependent variables: 

6 month abstinence from 

smoking 

Baseline data: 

• 57% women, mean 

age 47 yrs 

• Mean smoking rate 

before hospitalization: 

19 cigarettes per day 

• Similar baseline 

characteristics among 

intervention and Cs 

No statistically significant 

differences b/w groups at 

baseline in terms of 

demographics or 

smoking, but 

race/ethnicity NR) 

NR Quality rating: 

Poor 

Comments: 

NR 

Adequate 

randomization: 

Yes 

Attrition rate: 

NR 
C-172 

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 

Geographic area: 

Australia 

Funding agency: 

CSAHS Tobacco Education 

Team. (NSW Quit 

Campaign supplied free 

"Quit Kits," Pharmacia 

Upjohn donated NRT starter 

packs; NSW Cancer 

Council supplied videos and 

workbooks at cost.) 

Study setting: 

Practice/provider settings 

Study objective: 

To evaluate a multifaceted, practice-based 

intervention involving audit, feedback, and 

academic detailing to improve family 

physicians' smoking cessation advice 

Population: 

• Adults 

Study type: 

• RCT w/ cluster randomization 

• Each family practice, representing a 

cluster, randomly allocated to receive 

either intervention in smoking cessation 

advice (G1) or an intervention of identical 

format and intensity but about cervical 

screening (C1) 

• This constituted a 2 x 2 balanced 

incomplete block design, used to equalize 

nonspecific effects of research 

participation b/w groups and thereby 

minimize Hawthorne effect 

• Data from FPs' patients used to assess 

effectiveness of intervention by 

comparing baseline and posttest 

questionnaires 

Inclusion criteria: 

• Family physicians from practices located 

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 

Sampling plan: 

• All FPs in defined geographical area 

in 1999 were invited to participate 

• Following baseline data collection, 

practices stratified according to 

number of participating FPs at 

practice (1, 2-4, 5+) to ensure 

approximately equal numbers of FPs 

in each study group 

• Within each stratum, practices then 

randomly allocated to intervention or 

C using random numbers generated 

by SAS 

FP patients 18 to 70 recruited 

consecutively and invited to participate 

in a study about health care in a general 

practice. 

Sample size: 

G1: 30 (FPs) in 20 practices 

C1: 30 (FPs) in 19 practices 

Definition of smoking: 

Cigarettes 

• NA 

Smokless tobacco 

• NA 
C-173 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Self-help 

• Individual counseling by 

health professional 

• Video 

• Pharmaceuticals 

Intervention: 

G1: FP received three 

academic detail visits 

which combined audit and 

feedback; resources for 

FPs (skills training video 

and workbook package, 

clinical practice guidelines, 

prompt sheet to assist w/ 

smokers’ excuses and 

self-exceptions); resources 

for practices (patientmediated prompts, 

reminders for medical 

records) and resources for 

patients (patient brochures 

and free starter packs of 

nicotine replacement gum) 

• Sessions 1 and 2 

conducted by a medical 

peer 

• Session 3 conducted by 

a non-medical public 

health academic 

C1: Received similar 

intervention in terms of 

intensity and format, but w/ 

regard to cervical 

screening 

Method of assessment: 

• Baseline: Demographic 

questionnaires 

completed by 

participating FPs 

• Patients at participating 

practices also 

completed baseline and 

posttest questionnaires 

• Medical record audit 

Statistical analysis: 

Frequencies, 

proportions, univariate 

analysis, bivariate 

analysis, Χ2

, Wilcoxon's 

rank sum tests, Fisher's 

exact test, McNemar's 

test for paired 

proportions, Wilcoxon's 

sign rank tests for paired 

ordinal data, logistic 

regression using GEE 

Data verification: 

Self-report of FP 

practices and patient 

recall of them, 

supplemented w/ patient 

medical chart review for 

verification 

Dependent variables: 

• Patient recall of 

smoking cessationrelated interactions w/ 

FP during clinic visit 

• Recall of: question 

from FP about 

smoking status 

• Smokers' recall of 

specific smoking 

cessation advice 

• Discussion of health 

risks of smoking 

• Discussion of passive 

smoking 

• Providing practical 

advice 

• Setting a quit date 

• Providing written 

materials 

• Recommending 

nicotine replacement 

patches 

• Arranging follow up 

appointment; referring 

to a smoking clinic 

Medical record audit of 

patient smoking status 

and cessation advice in 

chart for index 

consultation (for smokers 

only). 

Improvements b/w baseline and 

posttest in patient recall of FP 

advice about nicotine 

replacement patches and gum 

were significantly greater in 

intervention than C (P = 0.0056 

and P = 0.0002, respectively) 

Substantial increases in patient 

recall of assessment of smoking 

status and FP use of quit dates, 

behavioral advice, written 

materials in intervention group, 

but changes not significantly 

greater than those in C 

Medical chart review indicated 

FP notation of smoking cessation 

advice remained suboptimal after 

intervention 

100% of FPs found following 

intervention components 

Quality rating: 

Fair 

Comments: 

• Low consent rate 

among FPs 

(35%), limiting 

generalizability 

of findings 

• Some significant 

differences b/w 

patients in G1 vs 

C1 

• Though many 

comparisons of 

improvements in 

FPs' smoking 

cessation advice 

(G1 v C1) were 

NS, could be due 

to both groups 

being trained to 

be more mindful 

of addressing 

patients' health 

risks, thus 

reducing 

apparent effect 

of intervention 

• High rate of 

attrition in both 

groups and at 

both time points 

Adequate 

randomization: 

Yes 

Attrition rate: 

Baseline follow up: 

G1: 34% 

C1: 27% 

Posttest follow up: 

G1: 37% 

C1: 31% 
C-174 

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-175 

Evidence Table 7. Health care systems strategies to increase implementation of population-level tobacco use 

cessation (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

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 fulltime 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 nonsmokers (57% v 73%, 

chi sq = 35.3, P < 0.001) 

Males (65% v 73%, chisq = 11.8, P < 0.001) 

Those from intervention 

practices (66% v 73% chi 

sq = 11.2, P < 0.001) 
C-176 

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: 

Choi et al., 1995 

Geographic area: 

US 

Funding agency: 

UCSF, Institute for Health 

and Aging 

Study setting: 

Population-based in Calif 

Study objective: 

To assess trends in ST use and to identify 

risk factors that distinguish youths who use 

or who are at risk of using ST 

Population: 

• Adolescent males, ages 12 to 17 

• Young adult males, ages 18 to 24 

Study design: 

• Cross-sectional 

• Telephone survey using random digit 

dialing 

Inclusion criteria: 

Residing in Calif 

Exclusion criteria: 

NR 

Sampling plan: 

Stratified random sample of adults and 

all 12 to 17 yr old adolescents 

Sample size: 

1990: 3,912 

1992: 883 

1993: 2,814 

Definition of smoking: 

Cigarettes 

• Current users: respondents who 

smoked a cigarette within last 30 

days 

Smokeless tobacco 

• Current users: reported use of 

smokeless tobacco within last 30 

days 
C-177 

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

use (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

NA 

Intervention: 

NA 

Method of assessment: 

Telephone survey 

Statistical analysis: 

Multivariate logistic 

regression 

Data verification: 

NR 

Dependent variables: 

• Current use and 

susceptibility to use ST 

• Current cigarette use 

• Exposure to other ST 

users 

• Exposure to ST 

advertisements 

• Rebelliousness 

• Participation in team 

sports 

• Depression 

• Peer Use of drugs or 

alcohol 

• Peer norms 

Baseline data: 

NA 

Ever experimented w/ ST: 

1990: 15.2% (95% CI, 13.7-16.7) 

1992: 12.3% (95% CI, 9.8 - 14.8) 

1993: 13.8% (95% CI, 12.3-15.3) 

Current use of ST (%) 1993: 

• 12 to 13 yrs: 

OR = 0.3 (95% CI, 0.1 -0.05) 

• 14 to 15 yrs: 

OR = 2.6 (95% CI, 1.0 - 4.2) 

• 16 to 17 yrs: 

OR = 6.6 (95% CI, 4.1 - 9.1) 

Susceptibility to use ST (%) in 

1993: 

• 12 to 13 yrs: 

OR = 16.8 (95% CI, 13.7 - 19.9) 

• 14 to 15 yrs: 

OR = 17.3 (95% CI, 14.8 - 19.8) 

• 16-17 yrs: 

OR = 18.8 (95% CI, 14.6 - 23.0) 

Exposure to SLT advertising (%) in 

1993: 

• 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) 

Quality rating: 

Fair 

Comments: 

Cross sectional study 

design; only reported 

analysis on 1993 

data and youth 

subjects; no clear 

explanation of final 

sample size 

Adequate 

randomization: 

Yes 

Attrition rate: 

NR 
C-178 

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: 

Tomar; 2003 

Geographic area: 

US 

Funding agency: 

NR 

Study setting: 

Population-based 

Study objective: 

To assess 4-yr initiation rates of ST use and 

cigarette smoking in relation to each other 

and examine switching b/w products 

Population: 

• Adolescents, ages 11 to 19 

• Young adults 

• Men 

Study design: 

• Cross-sectional 

• Nationally-representative, cross-sectional 

telephone and mail survey 

Inclusion criteria: 

• 11 to 19 yrs of age at baseline 

• Reside in households interviewed for 

National Health Interview Survey 

• Male 

Exclusion criteria: 

NR 

Sampling plan: 

1989 TAPS-I and its 1993 followup 

TAPS-II: TAPS-I sampling frame 

consisted of all teenagers aged 12–18 

yrs on November 1, 1989, who resided 

in households interviewed for the NHIS 

during last two quarters of 1988 and first 

two quarters of 1989 

Sample size: 

Total: 3,996 

Definition of smoking: 

Cigarettes 

• Current smoker: reported smoking at 

least 100 cigarettes in their lifetime 

and smoked at least 1 cigarette in 30 

days preceding interview 

• Former smoker: smoked at least 100 

cigarettes in their lifetime, but smoked 

no cigarettes in last 30 days 

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-179 

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

use (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

NA 

Intervention: 

NA 

Method of assessment: 

• Computer-assisted 

telephone interviews 

• Traditional telephone 

interviews 

• Mailed surveys (TAPS-I 

1989 data and TAPS-II 

1993 data) 

Statistical analysis: 

• Estimates of prevalence 

and initiation rates 

included 95% CI 

• Multiple logistic 

regression modeling 

used to adjust for age 

and race/ethnicity 

• OR estimate interpreted 

as significantly different 

from reference group, at 

95% level of confidence, 

if its 95% CI, excluded 

1.0 

• All analyses of TAPS 

data conducted using 

sampling weights 

developed by National 

Center for Health 

Statistics 

Data verification: 

NR 

Dependent variables: 

• ST use 

• Cigarette use 

Baseline data: 

Prevalence of tobacco use 

at baseline (males only): 

• current smoker: 9% 

• former smoker: 1.6% 

• regular ST user at 

sometime: 6.1% 

• current regular ST user: 

2.7% 

At 4 yr followup: 

• current smokers: 21.2% 

• regular users of ST at sometime: 

11.9% 

• current regular users: 5.7% 

After adjusting for age and race, 

males who had been regular users 

of ST were more than 3 times as 

likely as never users of ST to 

become smokers, 

OR = 3.45 (95% CI, = 1.84 -6.47) 

Current smokers not different from 

never smokers in rate of initiating 

current regular ST use 

OR = 1.45 (95% CI, = .5-4.22) 

NS 

Among males who were regular ST 

users but were not smokers at 

baseline: 

• continued to exclusively use ST 

at followup: 44.8% 

• had switched to smoking at 

followup: 25.5% 

• continued to use ST while also 

smoking at followup: 14.3% 

• no longer using tobacco: 15.2% 

Of smokers at baseline who were 

not ST users: 

• switched to ST exclusively: 8% 

• continued to smoke but also use 

ST: 3.6% 

• quit using tobacco: 16.9% 

Quality rating: 

Fair 

Comments: 

• Self report without 

any biochemical 

verification; 

participants lost at 

followup may have 

been more difficult 

to capture because 

they were more 

likely to progress to 

current smoking or 

regular use of ST 

• Definition of ST 

use relied on 

respondents’ self 

characterization of 

regular use 

Adequate 

randomization: 

NR 

Attrition rate: 

NR 
C-180 

Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk 

behaviors 

Study Characteristics Study design Sample Design and Definition 

Author: 

Brown et al., 2001 

Geographic area: 

US 

Funding agency: 

National Institute on Drug 

Abuse; American Cancer 

Society 

Study setting: 

Population-based 

Research objective: 

To assess the efficacy of a standard, 

cognitive–behavioral smoking cessation 

treatment vs standard cessation treatment 

combined with CBT for depression in 

smokers with a positive history of MDD 

Population: 

• Smokers with a positive history of MDD 

Study type: 

RCT 

Inclusion criteria: 

• Ages of 18 and 70 years 

• Smoked for at least 1 year 

• Currently smoking at least 10 cigarettes 

per day 

• Had a history of MDD according to the 

DSM-III 

Exclusion criteria: 

• DSM–III–R diagnosis of current MDD, 

dysthymia, or other Axis I disorder 

• DSM–III–R diagnosis of psychoactive 

substance abuse or dependence within 

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 

Sampling plan: 

• Potential participants screened by 

telephone prior to an intake interview 

to confirm eligibility 

• Eligible participants required to 

provide a $75 deposit, refunded 

incrementally on completion of followup procedures 

• 358 invited to study center for 

diagnostic interview to confirm 

eligibility; 100 did not show up 

• 258 participants completed informed 

consent and participated in the 

interview; 5 withdrew prior to being 

assigned to a treatment condition; 74 

did not meet inclusion–exclusion 

criteria 

Sample size: 

G1: 86 

C1: 93 

Definition of smoking: 

• Smoked at least 10 cigarettes a day 

for at least 1 year 
C-181 

Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk 

behaviors (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

• Group counseling 

• Tailored cognitive 

behavioral therapy 

Intervention: 

G1: Eight 2-hr sessions over 

6 weeks standard 

comprehensive CBT for 

smoking cessation, plus 

cognitive behavioral coping 

for depression 

C1: Eight 2-hr sessions over 

6 weeks; comprehensive, 

standard CBT for smoking 

cessation 

Method of assessment: 

Assessment battery 

administered at 

pretreatment; questionnaires 

administered at each 

session during treatment; 

follow-up phone interviews 

occurred at 1, 6, and 12 

months posttreatment, and 

self-reported abstinence was 

verified biochemically 

Baseline data: 

Groups were similar 

Statistical analysis: 

• Chi-square analyses 

• Repeated measures 

analyses for categorical 

outcomes using 

generalized estimating 

equation 

Data verification: 

• Self report 

• CO and saliva cotinine 

Dependent variables: 

• Demographic 

characteristics (age, 

gender, marital status, 

and years of education) 

• Nicotine dependence 

severity (FTND score, 

number of years 

smoking, average daily 

smoking rate, and saliva 

cotinine) 

• Depression severity and 

chronicity 

No statistical difference between 

groups were found for 7 day point 

prevalence abstinence rates at 1, 6 

and 12 months for C1 = 30.1%, 

24.7%, 24.7%, respectively; G1 = 

39.5%, 24.4%, 32.5%. 

In the final step of the GEE 

analysis a significant interaction 

was found between treatment and 

heavy smoking (P = 0.02), and 

between treatment and recurrent 

depression (P = 0.02) 

Quality rating: 

Fair 

Adequate 

randomization: 

NR 

Attrition rate: 

• 5% at 1 month 

• 8.9% at 6 months 

• 7.8% at 1 year 
C-182 

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: 

Brown et al., 2003 

Geographic area: 

US 

Funding agency: 

None listed 

Study setting: 

Psychiatric hospital 

Study objective: 

To test hypothesis that among adolescent 

smokers hospitalized for psychiatric and/or 

substance use disorders, MIwould lead to 

more and longer quit attempts, reduced 

smoking, and more abstinence from 

smoking over 12 mo followup 

Population: 

• Adolescents 

• Aged 13 to 17 from Providence, RI 

Study type: 

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 

Sampling plan: 

Consecutive sample of eligible 13 to 17 

yr olds hospitalized for psychiatric 

and/or substance use disorder but not 

psychotic 

Sample size: 

G1: 116 

G2: 75 

Definition of smoking: 

Cigarettes 

• Number of cigarettes smoked per day
C-183 

Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk 

behaviors (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Results Quality Comments 

Intervention methods: 

• Self-help 

• Individual counseling by health 

professional 

• Telephone counseling 

• Pharmaceuticals 

Intervention: 

G1: Two in-person 45-minute MI 

sessions during hospitalization or 

on outpatient basis; self-help 

pamphlet and manual; offer of up 

to two 8-wk courses of free 

transdermal NPtherapy if eligible; 

up to 6 postdischarge phone 

counseling sessions; up to 4 brief 

parent intervention phone 

counseling sessions. 

G2: 5-10 minute in-person advice 

to quit smoking; self-help 

pamphlet; offered one course of 

transdermal NPtxt if eligible 

C1: NA 

Method of assessment: 

Pre and postintervention 

assessment of various outcomes 

at 1, 3, 6, 9, and 12 mo follow ups 

Smoking: 

• Self-report and biochemical 

verification for those claiming 

abstinence 

Nicotine Dependence: 

• Fagerstrom tolerance 

questionnaire 

• Psychopathology dz: 

C-DISC 

• Intent to change: Self-report to 

single item 

• Self-efficacy: SCQ 

Statistical analysis: 

Hierarchical Linear Modeling 

GEE 

Linear and Logistic 

Regression 

Data verification: 

Self-report plus biochemical 

verification (saliva cotinine) for 

those claiming tobacco use 

abstinence 

Dependent variables: 

• Point prevalence abstinence

• Quit attempts 

• Changes in smoking rate 

• Longest quit attempt 

Baseline data: 

• Female: 62.3 

• Mean age: 15.4 

Race/ethnicity 

• White: 94.8 

• HispaniC1: 1.6 

• African American: 0 

• Other Race: 3.6 

Other 

• Mean age at first cigarette: 

10.85 

• Smoked on avg: 91.19% of 

previous 3 mos 

• Mean: 14.48 cigarettes on 

smoking days 

• Daily smokers: 63.9 

• Mean Fagerstrom tolerance 

score: 4.9 

• Met DSM-IV criteria for 

nicotine dependence: 68.6 

• Mean length inpatient stay: 

9.11 days 

• Used NRT during hospital 

stay: 26% 

Mean of anxiety 

disorders: 

G1: 1.1 

G2: 1.3 

P = NS 

Odds for quit attempts 

AOR 1.99 (95% CI, 1.08, 

3.71) 

Longest quit attempt, days: 

G1: 48.2 

G2: 60.9 

P > 0.05 

NS 

Point prevalence 

abstinence at 1, 6 and 12 

mos: 

P > 0.30, NS 

Smoking rate: (b = 0.05, 

SE = 0.16, P = 0.74, NS) 

Higher discharge scores 

on situational confidence 

questionnaire associated 

w/ significantly less 

smoking during followup (b 

= -0.02, SE = 0.007, P = 

0.007) 

Quality rating: 

Fair 

Comments: 

• High refusal rate 

• Due to slow 

participant flow, 

recruitment ended 

before all cohorts 

completed, 

resulting in 

imbalance of 

participants across 

conditions 

• Inconsistent txt 

implementation 

Adequate 

randomization: 

Yes 

Attrition rate: 

20 (9%) 
C-184 

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: 

Hitsman et al., 1999 

Geographic area: 

US 

Funding agency: 

VA Merit Review award by 

NIDA, and Eli Lilly and 

Company 

Study setting: 

Population-based 

Study objective: 

To identify individual differences that predict 

cessation when fluoxetine is combined w/ 

CBT 

Population: 

• Adults 

Study type: 

RCT w/ simple randomization 

Inclusion criteria: 

Participants are: 

• 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) 

Sampling plan: 

Specific randomization scheme NR. 

Sample size: 

Total: 253 

Definition of smoking: 

Cigarettes 

• Reported smoking 

• Expired CO greater than 8 ppm 

• Saliva continine value greater than 10 

ng/ml 
C-185 

Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk 

behaviors (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures 

Quality 

Comments 

Intervention methods: 

• Individual counseling by 

health professional 

• Pharmaceuticals 

Intervention: 

G1: Nine, 1-hr individual 

CBT sessions + fluoxetine 

30 mg for a total of 10 wks 

• Participants required to 

set a quit date within 2 

wks after drug txt began 

• Participants quit 

smoking at 3rd CBT 

session 

• Medication stopped at 

9th CBT session, at 

which time 6-month 

followup period began 

• CBT not explained 

• Patients w/ fluoxetine 

level less than or equal 

to 150 ng/ml considered 

compliant 

G2: Same as G1:, except 

fluoxetine dose of 60 mg 

and fluoxetine blood level 

less than or equal to 

300ng/ml considered 

compliant 

C1: Same as G1, except 

given placebo 

Method of assessment: 

Self report of smoking, 

expired CO, and saliva 

continine 

Also used depresion scale, 

nicotine dependence, 

weight restraint scale, and 

self-efficacy questionnaire 

Statistical analysis: 

Constructed predictive 

models using logistic 

regression w/ 

hierarchical approach to 

variable selection. 

Models evaluated w/ 

parallel analyses using 

stepwise selection 

procedure 

Data verification: 

Expired CO and saliva 

continine 

Dependent variables: 

Depression, nicotine 

dependence, weight 

concerns, self-efficacy 

about quitting smoking 

Baseline data: 

No significant difference 

b/w txt groups in 

baseline characteristics: 

age, gender, education, 

smoking history, baseline 

level of nicotine 

dependence, depression, 

weight concern, and selfefficacy 

At 1 wk postcessation: higher 

levels of depression predicted 

failure to achieve abstinence (ITT 

analysis); higher levels of 

nicotine dependence and 

depression associated w/ 

decreasing likelihood of 

abstinence (analysis of txtcompliant patients) and likelihood 

of abstinence for participants on 

fluoxetine tended to be higher 

than for those on placebo (P = 

0.06); At 1 month postcessation: 

higher levels of weight concern 

predicted lower abstinence (Χ2

4.8, P = 0.78); patients on 

fluoxetine had positive 

association b/w degree of 

depression and likelihood of 

abstinence (highest quartile 

HRSD = 3, OR = 2, 95% CI, 

0.85-4.70); At 3 months 

postcessation: patients treated w/ 

fluoxetine had positive 

association b/w HRSD scores 

and abstinence likelihood 

(highest quartile HRSD = 3, OR = 

1.44, 95% CI, 0.53-3.91) 

Smoking characteristics 

predicting txt compliance were 

nicotine intake at baseline, saliva 

cotinine (Χ2

 = 11.4, P < 0.001), 

and expired CO ( Χ2

 = 5.3, P < 

0.05) 

Quality rating: 

Fair 

Comments: 

• Authors didn't 

report numbers 

of participants 

per arm of study, 

baseline 

demographic 

characteristics of 

those groups, 

nor 6 month 

followup results 

• Inclusion/ 

exclusion criteria 

are described in 

companion 

article, Borrelli, 

et al. 1997 

Adequate 

randomization: 

NR 

Attrition rate: 

NR 
C-186 

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: 

Joseph, 1993 

Geographic area: 

US 

Funding agency: 

NR 

Study setting: 

Hospital 

Study objective: 

To evaluate effect of smoke-free policies in 

in-patient alcohol txt wards and effect of 

these policies on long-term txt outcomes 

Population: 

• Adults 

Study type: 

Prospective cohort study 

Inclusion criteria: 

NR 

Exclusion criteria: 

Excluded patients admitted b/w May and 

July, 1988, because they would have 

overlapped w/ the implementation of smokefree policy 

Sampling plan: 

• Enrolled consecutive patients 

• Admitted to an inpatient substance 

abuse txt program prior to 

implementation of a smoke-free 

policy and those patients admitted 

after smoke-free policy was 

implemented 

Sample size: 

G1: 407 

G2: 299 

Definition of smoking: 

NR 
C-187 

Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk 

behaviors (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Results Quality Comments 

Intervention methods: 

• Group counseling 

• Classroom instruction 

Intervention: 

G1: Patients not given 

specific information about 

smoking or cessation; 

smoking on the ward only 

permitted in 2 designated 

rooms and not allowed 

during group sessions 

G2: Patients required upon 

admission to acknowledge 

the smoke-free policy and 

sign a contract agreeing to 

abstain from nicotine during 

their stay; smoking cessation 

program designed for 

substance abusers delivered 

(didactic lectures on 

pharmacology of nicotine, 

films, and discussion group); 

Clonidine patches available 

but not studied in a 

systematic fashion 

Method of assessment: 

A one-pg, standardized, selfadministered 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 

Statistical analysis: 

NR 

Data verification: 

NR 

Dependent variables: 

Tobacco-use status; 

motivation to quit; use of 

substances other than 

nicotine 

Baseline data: 

Demographic data from 

both groups similar at 

baseline 

Proportion of patients that want to 

quit smoking while in hospital at 

three-wk followup: 

G1: 24% 

G2: = 61% 

P = < 0.001 

Proportion of patients that has 

abstained from smoking for > 1 wk: 

G1: 9%

G2: 41% 

P = < 0.001 

Proportion of patients that cut down 

smoking while in hospital: 

G1: 46% 

G2: 93% 

P = < 0.001 

Quit smoking as reported at 1 yr 

followup interview: 

G1: 3%

G2: 8% 

P < 0.05 quit smoking 

No significant difference found in 1-

yr followup for non-nicotine 

substance use b/w groups 

Quality rating: 

Fair 

Comments: 

• Statistical methods 

NR 

• No biochemical 

verification 

• High attrition 

Adequate 

randomization: 

NR 

Attrition rate: 

Attrition at 1-yr 

followup: 

G1: 61.7% 

G2: 45.5% 
C-188 

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: 

Joseph, Willenbring et al., 

2004 

Geographic area: 

US 

Funding agency: 

National Institute on Alcohol 

Abuse and Alcoholism; 

Health Services Research 

and Development Center for 

Chronic Disease Outcomes 

Research, Veterans Affairs 

Study setting: 

Residential treatment 

program 

Research objective: 

To compare the effects of smoking 

treatment and intensive treatment for alcohol 

dependence, delivered concurrently, with 

treatment delayed by 6 months on smoking 

outcomes and alcohol use 

Population: 

Adult men and women ages 21-75 

Study type: 

RCT Stratified random sampling 

Inclusion criteria: 

• Met criteria for alcohol dependence or 

abuse according to the Diagnostic and 

Statistical Manual of Mental Disorders, 4th 

ed. and who smoked more than 5 

cigarettes per day for more than 1 year 

• Completed first week of alcoholism 

treatment 

Exclusion criteria: 

• No interest in stopping smoking 

• Diagnosis of dementia or schizophrenia 

• Inability to comply with the protocol due to 

severe psychiatric symptoms or cognitive 

deficits 

• Refusal to provide the name of a contact 

or source of collateral information 

• Unwillingness to attend visits as planned 

in the protocol 

Sampling plan: 

• Treatment assignment accomplished 

by stratifying by substance use 

disorder treatment site and blocking 

within site in groups of 10. Computer 

generated random sequence was 

concealed from study personnel 

• Initial screening included questions 

about interest in participating in a 

research study, stage of change and 

potential concerns about participating. 

(Screen A) 

• Patients passing Screen A invited to 

do Screen B, a computerized selfadministered Quick Diagnostic 

Interview Schedule to confirm that 

they met criteria for alcohol 

dependence. 

• 1,943 adults assessed for eligibility 

• 499 adults agreed to participate 

Sample size: 

G1: 251 

G2: 248 

Definition of smoking: 

Any smoking within past 7 days 
C-189 

Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk 

behaviors (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Outcome Measures Quality Comments 

Intervention methods: 

Behavioral counseling and 

pharmacological treatment 

Intervention: 

G1 (concurrent treatment): 

Individual counseling (1-hour 

face-to-face session) and up 

to 3 follow-up sessions 

conducted in person or by 

telephone 

Participants in the action 

stage of change received a 

free prescription for NRT, 

unless they declined or had 

a medical contraindication 

Medication algorithm 

recommended nicotine 

patches (21 mg for 6 weeks, 

14 mg for 2 weeks and 7 mg 

for 2 weeks). A combination 

of patches and nicotine gum 

was offered to participants 

who smoked more than 20 

cigarettes per day. 

Method of assessment: 

• Data collected at 

treatment site, research 

study office or by 

telephone at 6, 12 and 18 

months after study 

enrollment 

• Brief smoking outcome 

data were also collected 

at 3 and 9 months 

Baseline data: 

No baseline group 

differences 

Statistical analysis: 

• Simple likelihood ratio 

chi-square tests 

compared rates of 

tobacco and alcohol 

abstinence 

• Logistic regression 

analyses modeled the 

odds of smoking 

abstinence and 

prolonged alcohol 

abstinence as a function 

of intervention group 

and baseline measures 

that might affect 

smoking and alcohol 

treatment outcomes 

Data verification: 

Self-report abstinence 

Smoking validated by 

expired carbon monoxide; 

alcohol by breath alcohol 

concentration. 

Dependent variables: 

• Smoking: 7 day point 

prevalence 

• Smoking abstinence at 

3, 6 and 12 months 

• Prolonged (6-mo.) 

smoking abstinence at 

18 months 

• Number of quit and 

relapse episodes 

• Participation in 

treatment 

• Alcohol: 6-months 

duration of alcohol 

• 1-months duration of 

alcohol abstinence and 

number of drinking days 

in the past 6 months 

• Relapse to alcohol 

Smoking Cessation Outcomes 

Intention-to-Treat Analysis 

7 day point prevalent smoking 

abstinence rates at 3 months were 

15.5% in the concurrent treatment 

group and 4.4% in the delayed 

group (P < 0.0001); at 6 months, 

10.5% vs. 5.2% ( P = 0.02) (note 

that at 3 and 6 months the delayed 

treatment group had not received 

intervention). At 9,12 and 18 

months there were no significant 

differences between treatment 

groups. 

Alcohol Abstinence Outcomes 

At 6- 12- and 18-month visits, point 

prevalent alcohol abstinence was 

lower in the concurrent treatment 

group than in the delayed 

treatment group (P = 0.004, 

P = 0.11, and P = .001, 

respectively) 

Quality rating: 

Good 

Comments: 

• Very low 

participation rate in 

expired carbon 

monoxide testing, 

34% at 12 months 

and 25% at 18 

months 

• 6.6% failed to 

support selfreported 

abstinence rates 

Adequate 

randomization: 

Yes 

Attrition rate: 

18% at 6 months 

20% at 18 months 
C-190 

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: 

Murray et al., 1995 

Geographic area: 

US 

Canada 

Funding agency: 

Division of Lung Diseases 

of the NHLBI 

Study setting: 

Practice/provider settings 

Study objective: 

Explore relationship b/w alcohol 

consumption and smoking cessation 

Population: 

• Adults 

• Describe: aged 35 to 60 

Study type: 

RCT w/ simple randomization 

Multi-center clinical trial 

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 

Sampling plan: 

NR 

Sample size: 

G1: 2,649 

C1: 1,327 

Definition of smoking: 

Cigarettes 

Defined as smoking at any clinic visit 
C-191 

Evidence Table 9. Tobacco cessation interventions for persons w/ co-occurring morbidities and risk 

behaviors (continued) 

Intervention Details 

Statistical Analysis and 

Baseline Data Results Quality Comments 

Intervention methods: 

• Group counseling 

• Pharmaceuticals 

Intervention: 

G1: Bronchodilator inhaler or 

placebo inhaler and multicomponent counseling and 

nicotine gum; counseling 

intervention included a multicomponent approach w/ 

standard cognitivebehavioral strategies such as 

stimulus control, avoidance, 

role playing, assertiveness 

training, reinforcement, and 

relaxation techniques 

• Following counseling 

program, regular 

maintenance program 

scheduled on at least a 

monthly basis 

• Maintenance programs 

included weight 

management and exercise 

• In addition an extended 

group intervention 

program offered to 

participants who relapsed 

and want to try and quit 

again; NRT available free 

of charge to study 

participants but not 

tracked systematically in 

relationship to quit rates 

C1: Usual care 

Method of assessment: 

• Baseline interviews using 

self-reported alcohol and 

tobacco use 

• Intervention group (only), 

contacted monthly for 1st 

yr then w/ clinic visits 

every 4 mos w/ alcohol 

used assessed at 12 mos 

Statistical analysis: 

Polychotomous ordinal 

logistic regression 

Data verification: 

Self-report on CO in 

expired air 

Dependent variables: 

• Current alcohol use 

• History of alcoholism 

• History and current use 

of tobacco 

• Family smoking 

• Attitudes towards 

smoking and stopping 

smoking 

• Physical dependence on 

nicotine (Fagerstrom) 

Baseline data: 

Similar w/ an exception, 

less female alcoholics in C 

than in txt group (2.8% 

vs5.8%) 

Outcome measures: 

No significant relationship b/w 

amount of alcohol consumed at 

baseline and smoking status after 1 

yr for G1. 

In G2, women baseline drinkers 

more likely not to be smoking after 

1 yr: 

G1:14%

G2: 6.3% 

P = NR 

Currently drinking at end of 

intervention: 

G1:

Smokers: 5.24 drinks/wk 

Nonsmokers: 4.46 drinks/wk 

(t = 1.94, 1,440df, P = 0.05) 

Within smoking cessation 

intervention (G1), those who drank 

eight or more drinks per occasion 

(binge drinkers) more likely to be 

current smokers (i.e., lower 

cessation rate) after 1 yr (men 

binge = 44.8%, no binge = 51%, P

< 0.05) and (women binge = 

27.3%, no binge = 41.8%, 

P < 0.01) 

Within intervention group, binge 

drinkers smoked more cigarettes 

per day than those without a history 

of binge drinking (Men binge = 

12.5, no binge = 10.3, P < 0.05) 

and (women binge = 14.3, no binge 

= 10.7, 

P < 0.01) 

When volume of drinking and 

drinking of eight or more drinks per 

occasion were compared in 

polychotomous ordinal logistic 

regressions, only binge drinking for 

men predicted failure at smoking 

cessation (Chi sq = 4.11, 1 d.f. 

P < 0.05, OR = 0.76) 

Quality rating: 

Poor 

Comments: 

• Changed exclusion 

criteria after 

recruiting 1/3 of 

participants 

• Post randomization 

of subjects 

(excluded 

recovering 

alcoholics) 

• No systematic 

control of NRT use

• No information on 

attrition 

• Within txt group 

analysis 

Adequate 

randomization: 

Yes 

Attrition rate: 

NR 
C-192 

Evidence Table 10. Systematic and meta-analysis reviews 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Ebbert et al., 

2004 

Geographic area 

United Kingdom 

Funding source 

No source of 

support supplied 

Time period 

covered 

Databases 

searched 

systematically 

through March 

2004 

Inclusion criteria 

Randomized trials of behavioral or 

pharmacologicial interventions to help 

users of ST to quit, w/ a followup of at 

least 6 months 

Population 

Users of any tobacco product that is 

placed in mouth and not burned, 

including moist snuff, chewing tobacco 

and betel quid 

Characteristics of studies 

(Interventions) 

Interventions studies could be 

pharmacologicial (NRT or bupropion) or 

behavioral, either directed at individual 

ST users or a groups of users 

Method of review 

• One author examined all titles 

generated from search and obtained 

abstracts 

• Abstracts considerd by two authors for 

full text review 

• Differences of opinion resolved by 

consensus 

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 

Aim of review 

To assess effects of 

behavioral and 

pharmacotherapeutic 

interventions to treat ST 

use 

Main results 

No evidence of ST 

abstinence for trials using 

bupropion, NRT, or 

nicotine gum 

Three trials showed 

significant effects using 

behavioral interventions 

A subgroup of behavioral 

studies that randomized 

individuals showed a 

pooled significant effect 

(OR 1.43, 95% CI, 1.06 

to 1.93); OR higher in 

trials that included an oral 

exam and feedback (OR 

2.41, 95% CI, 1.79 to 

3.24) 

Quality rating 

Good 

Adverse events 

Yes 

All reported adverse 

events associated w/ 

NRT such as skin 

reactions, nausea, 

headache and 

gastro-intestinal 

distress 
C-193 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Author, year Study Characteristics 

Main Results/ 

Aim of Review Quality Rating 

Author, year 

El-Guebaly et al., 

2002 

Geographic area 

Canada 

Funding source 

NR 

Time period 

covered 

Reveiwed the 

following databases 

between 1991 

through 2001: 

Medline, CINAHL, 

PsycINFO, Best 

evidence, 

Healthstar, 

Cochrane 

Database of 

Systematic 

Reviews, Legal 

Trac, Bioethicsline, 

Philosopher’s 

Index, and 

Dissertation 

abstracts 

Inclusion criteria 

Studies that presented data on samples of 

people with diagnoses of specific mental 

illness or addictive disorders , with not 

restrictions as to methodology. Broader 

studies reporting symptomatic sub groups 

in their analysis were excluded 

Population 

People with diagnoses of specific mental 

illness or addictive disorders 

Characteristics of studies 

(interventions) 

Smoking cessation interventions targeted 

at people with diagnoses of specific 

mental illness or addictive disorders 

Method of review 

NR 

Study design 

Qualitative narrative synthesis 

What studies are included in metaanalysis 

NA 

Main results 

Twenty-four studies, 8 

included schizophrenia, 8 

included depression, and 8 

included persons with 

addictive disorders 

Interventins used a 

combination of medication, 

educational and cognitivebehavioral approaches 

Post-treatment quit rates 

for Schizphrenia ranged 

from 35% to 56%, and a 6 

months quit rate of 12% 

Postreatment quit rates for 

depression ranged from 

31% to 72%, and 12 

months quit rates 11.8% to 

46% 

Postreatment quit rates for 

addictive disorders ranged 

from 7% to 60%, and 12 

months quit rates 13% to 

27% 

Aim of review 

To assess the impact of 

smoking cessation 

approaches on individuals 

with mental illness or 

addictive disorders 

Quality rating 

Fair 

Comments 

NR 

Adverse events 

NA 
C-194 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Lancaster et al., 

2005 

Geographic area 

United Kingdom 

Funding source 

Internal: 

Department of 

Primary Health 

Care, University 

of Oxford UK 

External: NHS 

Research and 

Development 

Programme UK 

Time period 

covered 

Databases 

searched 

systematically 

through April 

2005 

Inclusion criteria 

Randomized trials of smoking cessation 

w/ followup of at least six months, where 

at least one arm tested a self-help 

intervention 

Self help defined as a structured 

program of smokers trying to quit without 

intensive contact w/ a therapist 

Population 

Any smoker except pregnant smokers 

and adolescent smokers. 

Characteristics of studies 

(Interventions) 

• Self-help interventions used by 

individual to assist a quit attempt not 

aided by health professionals, 

counsellors and group support 

• Included written materials, audio, 

videotape or computer programs 

Method of review 

• Two authors extracted data 

• Trials categorized according to 

amount of face to face contact 

provided to both txt and comparison 

intervention, and according to whether 

txt group received any written 

materials 

Study design 

Cochrane Systematic Review and meta 

analysis performed where appropriate 

Studies included in meta-analysis 

NR 

Aim of review 

To detemine 

effectiveness of different 

forms of self-help 

materials, compared w/ 

no txt and w/ other 

minimal contact 

strategies; effectiveness 

of adjuncts to self-help, 

such as computer 

generated feedback, 

telephone hotlines, and 

pharmacotherapies 

Main results 

Self-help vs no 

intervention: OR favored 

self-help intevention, 

although C1 narrowly 

excluded 1 (N = 13,773; 

OR 1.24, 95% CI, 1.07 - 

1.45) 

• Two trials excluded 

due to significant 

heterogeneity 

• Where controls 

received an alterative 

form of written 

materials -- no 

evidence of an effect 

(N = 4,807; OR .87, 

95% CI, .68 to 1.12); 

• Failed to find evidence 

of an increased quit 

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) 

Quality rating 

Good 

Adverse events 

No 
C-195 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Lancaster et al., 

2005 

Geographic area 

United Kingdom 

Funding source 

Internal: Oxford 

University of 

Primary Health 

Care UK; 

External: NHS 

Research and 

Development 

Programme UK 

Time period 

covered 

Databases 

systematically 

searched though 

Dec 2004 

Inclusion criteria 

Randomized and quasi-randomized 

trials w/ a least one txt are consisting of 

face to face individual counseling from a 

health care worker not involved in 

routine clinical care and outcome of 

smoking cessation at least 6 months 

after intervention 

Population 

Any smoker except children, 

adolescents, and pregnant women. 

Characteristics of studies 

(Interventions) 

• Face to face encounter b/w a smoking 

patient and a counsellor trained in 

assisting smoking cessation 

• Excludes studies of counseling 

delivered by doctors or nurses 

involved in regular clinical care 

• Also excluded multiple risk factor 

interventions 

Method of review 

• Two authors extracted data 

• Studies summarized 

• Results reported as odds ratios 

• Meta analysis used when appropriate 

Study design 

Cochrane Systematic Review w/ meta 

analysis of pooled studies 

Studies included in meta-analysis 

NR 

Aim of review 

To determine effects of 

individual counseling 

Main results 

• Studies comparing 

counseling w/ minimal 

contact controls 

reported counseling 

significantly increases 

likelihood of cessation 

compared to less 

intense support (OR 

1.56 95% CI, 1.32-

1.84) 

• No evidence of benefit 

from more intensive 

compared to brief 

counseling (OR .98, 

95% CI, .61-1.56); 

• Cessation rates higher 

in trials that used NRT, 

and patients w/ 

coronary artery 

disease 

• No significant 

differences occured 

b/w the comparison of 

counseling approaches 

Quality rating 

Good 

Adverse events 

No 
C-196 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Lancaster et al., 

2004 

Geographic area 

United Kingdom 

Funding source 

NHS Research 

and Development 

Programme UK 

Time period 

covered 

Reviewed the 

following 

databases b/w 

1972 and 2003. 

Tobacco 

Addiction Group 

Register, Medline, 

Embase, Psyclit 

and the Cochrane 

Central Register 

of Controlled 

Trials, 

handsearching of 

specialist 

journals, and 

conference 

proceedings 

Inclusion criteria 

• Randomized trials of smoking 

cessation advice from a medical 

practitioner in which abstinence was 

assessed at least 6 months following 

advice. 

• For inclusion in meta analysis: 1) had 

to have at least 2 txt groups, and 2) 

allocation to groups must use formal 

randomization 

Population 

• Participants were smokers recruited in 

any setting 

• Pregnant smokers excluded 

Characteristics of studies 

(Interventions) 

Studies included physician advice to 

stop smoking vs no advice or comparing 

different levels of physician advice to 

stop smoking 

Method of review 

• Data extracted from published reports 

by 2 people independently 

• Disagreeements resolved by referral 

to a third party 

• Quality assessment performed on all 

studies 

Study design 

Cochrane systematic reivew and meta 

analysis 

Studies included in meta-analysis 

Seventeen trials of brief advice vs no 

advice were pooled 

Aim of review 

To assess effectiveness 

of advice from physicians 

in promoting smoking 

cessation; to compare 

minimal interventions by 

physicians w/ more 

intensive interventions; to 

assess effectiveness of 

various aids to advice in 

prom 

Main results 

Small satistically 

significant increase in 

odds of quiting (OR 1.74, 

95% CI,1.48 to 2.05); 

Intense advice vs no 

advice and minimal 

advice showed a small 

but significant advantage 

to more intense advice 

A subset of 10 trials of 

smoker NOT selected as 

having smoking related 

disease showed a 

marginal significant 

impact for more intensive 

interventions (OR 1.24, 

95% CI, 1.02 to 1.50); 

Studies that included 

followup visits had a 

higher success rate vs no 

advice than those studies 

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 

Quality rating 

Good 

Adverse events 

NA 
C-197 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Lancaster et al., 

2000 

Geographic area 

United Kingdom 

Funding source 

Internal: 

Department of 

Primary Health 

Care, University 

of Oxford UK; 

External: NHS 

Anglia and Oxford 

Region Research 

and Development 

Programme UK; 

NHS Research 

and Dvelopment 

National Cancer 

Programme UK 

Time period 

covered 

Database 

searched 

systematically 

through May 2000 

Inclusion criteria 

• Randomized trials in which the 

intervention was training of health 

care professionals in smoking 

cessation 

• Only used trials w/ outcomes from 

patient smoking rates at least 6 

months after intervention 

Population 

Health care practitioner or health care 

practice 

Characteristics of studies 

(Interventions) 

• Health care professionals trained in 

methods to promote smoking 

cessation among their patients 

• Allocated health care professionals 

into at least 2 groups by a formal 

method of randomization 

• Studies that compared trained 

professionals to C and studies that 

examined effectiveness of adding 

prompts and reminders to training 

Method of review 

• Two reviewers independently 

extracted data from published articles. 

Disagreement resolved by referral to 

another person 

Study design 

Cochrane Systematic Review using a 

narrative approach to synthesising data 

Studies included in meta-analysis 

NR 

Aim of review 

To assess effectiveness 

of training health care 

professionals to deliver 

smoking cessation 

interventions to their 

patients, and to assess 

additional effects of 

prompts and reminders to 

the health professional to 

intervene 

Main results 

• 10 studies met criteria 

• Trained professionals 

about 1.5 to 2.5 times 

more likely to counsel 

patients about smoking 

• One study found a 

significant effect of 

training on sustained 

abstinence at one yr 

(8.8% trained group vs 

6.1% and 4.4% in 

comparison groups P < 

0.001) 

• Prompts increase 

frequency of health 

professions performing 

intervention but only 1 

out of 3 studies 

reported significant 

abstinence rates 

Quality rating 

Good 

Adverse events 

No 
C-198 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Lumley et al., 

2004 

Geographic area 

United Kingdom 

Funding source 

NHS Central R & 

D Programme, 

Dept. of Health 

1995-1996 UK; 

Victorian Health 

Promotion 

Foundation 

Australia; Dept. of 

Health, funding 

for EPI Center, 

London University 

UK; Public Health 

Branch Victoria 

Dept. of Human 

Services 

Australia; La 

Trobe University 

Time period 

covered 

Databases 

searched 

systematically 

though July 2003 

Inclusion criteria 

Randomized and quasi-randomized 

trials of smoking cessation programs 

implemented during pregnancy in 

settings such as hopitals, and 

community clinics 

Population 

Healthy pregnant women, women 

seeking a pre pregnancy consultation, 

and health professionals. 

Characteristics of studies 

(Interventions) 

Interventions include programs providing 

information on risks of smoking to fetus 

and infant, benefits of quitting, 

recommendations to quit, setting quit 

date, feedback about fetus and harmful 

levels of cotinine or CO, teaching 

cognitive behavior strategies, advice 

tailored to stages of change model, 

rewards/incentives, social support or 

peer support, and NRT 

Method of review 

• Two reviewers independently 

extracted data from published reports 

• Quality review of methodology 

assessed 

• Heterogeneity tested In all pooled 

analyses 

Study design 

Cochrane Systematic Review and meta 

analysis 

Studies included in meta-analysis 

NR 

Aim of review 

To assess effects of 

smoking cessation 

programs implemented 

during pregnancy on 

health of fetus, infant, 

mother, and family 

Main results 

• 48 trials revealed a 

significant reduction in 

smoking in late 

pregnancy for 

aintervention groups 

(RR.09, 95% CI, .93 - 

.95) this is an absolute 

difference of 6 out of 

100 women continuing 

smoking 

• With biochemically 

validated studies, 

absolute difference 

was same (RR.94, 

95% CI, .92 - .95) 

• Smoking cessation 

interventions 

signifcantly reduced 

low birth weight, 

preterm birth, and 

increase birth weight 

by 33 g (RR .81, 95% 

CI, .70 - .94), (RR .84, 

95% CI, .72 - .98), and 

(95% CI, 11g - 55g) 

• Intervention strategy 

(reward + social 

support) showed 

significantly greater 

smoking reduction (RR 

.77, 95% CI, .72 - .82) 

• Stages of change and 

relapse showed no 

significant reduction in 

smoking 

Quality rating 

Good 

Adverse events 

No 
C-199 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Author, year Study Characteristics 

Main Results/ 

Aim of Review Quality Rating 

Author, year 

Melvin et al., 2003 

Geographic area 

United States 

Funding source 

The Robert Wood 

Johnson 

Foundation 

Time period 

covered 

Databases 

systematically 

search from 

January 1994 

through March 31 

2002. 

Inclusion criteria: 

Randomized, comparison-controlled 

intervention trials for pregnant smokers at 

the individual level 

Population 

Pregnant smokers 

Characteristics of studies 

(interventions) 

• Brief counseling approach for pregnant 

smokers 

• Improving disclosure of smoking status 

• Spontaneous quitting and eminence of 

cessation 

• Postpartum relapse prevention 

• Adjuncts to brief counseling 

• Exposure to second hand smoke 

around time of pregnancy 

• Disclosure of second hand smoke 

around time of pregnancy 

• Increasing compliance with best 

practice 

Method of review 

Pre-screened published articles for 

relevance, two reviewers assessed 

studies independently for inclusion, data 

extracted by 1 reviewer and checked by a 

second, and used narrative synthese 

Study design 

Systematic review of literature 

What studies are included in metaanalysis 

NA 

Aim of review 

To review the 

recommendations made in 

2000 regarding treatment 

for pregnant and parenting 

Main results 

The 5 A’s approach is still 

the best treatment for light 

and moderate smokers 

Clinicians offering care to 

postpartum women and 

parents should asses 

smoking status and second 

hand smoke exposure 

For parents willing to quit, 

the use of 

pharmacotherapy should 

be used to help 

To assess compliance of 

practice guidelines with 

best practice guide 

evaluation of effectiveness, 

assessment of financial 

incentives, and 

identification of methods is 

needed 

Additional research is 

recommended on ways to 

improve disclosure, safety 

and efficacy of 

pharmacotherapy, use of 

biomarker feedback or 

incentives, partner 

involvement, and 

interventions to reduce 

second hand smoke 

Quality rating 

Good 

Adverse events 

NR 
C-200 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Moher et al., 2005 

Geographic area 

United Kingdom 

Funding source 

Internal: 

Department of 

Primary Health 

Care, Oxford 

University, 

External: NHS 

Research and 

Development 

Program UK 

Time period 

covered 

Databases 

searched 

systematically 

through October 

2004. 

Inclusion criteria 

Interventions categorized into two 

groups: 1)Interventions aimed at 

individual to promote smoking cessation 

in the workplace setting (included 

randomized control trials) 2) 

Interventions aimed at workplace as a 

whole (included controlled trials w/ 

baseline and post interventionoutcomes 

and interrrupted times series studies) 

Population 

Adults, over 18 yrs of age, in 

employment, who smoked. 

Characteristics of studies 

(Interventions) 

• Smoking cessation programs aimed at 

individual in workplace including 

individual and group counseling, self 

help materials, advice from physicians 

and NRT 

• Interventions aimed at workforce 

population to assess a comprehensive 

approach to workers health, including 

smoking cessation 

Method of review 

• Prescreened published articles for 

relevance 

• Two reviewers assessed studies 

independently for inclusion 

• Data extracted by 1 reviewer and 

checked by a second 

• Because of considerable 

heterogeneity studies were combined 

using qualitative narrative synthesis 

Study design 

Cochrane Systematic Review 

Studies included in meta-analysis 

NR 

Aim of review 

To assess extent to 

which different kinds of 

workplace smoking 

programs help smokers 

to reduce or stop 

cigarette consumption. 

Main results 

• Group and individual 

counseling (particularly 

by a physician), and 

NRT significantly 

increased cessation 

rates vs no txt or 

minimal intervention 

controls 

• Self-help interventions 

less effective 

• Tobacco bans aimed at 

workplace as a whole 

decreased cigarette 

consumption at work 

but no evidence that 

total consumption 

decreased 

• Quit rates not 

increased by adding 

social or environmental 

support to workplace 

programs Competitions 

and incentives 

increased attempts to 

quit but less evidence 

for actual quitting 

Quality rating 

Good 

Adverse events 

No 
C-201 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Prochaska et al., 

2004 

Geographic area 

US 

Funding source 

Calif TobaccoRelated Disease 

Research 

Program, and 

National Institute 

on Drug Abuse 

Time period 

covered 

January 1966 

through 

September 2003 

Inclusion criteria 

Randomized controlled designs of 

evaluations of a smoking cessation 

intervention where study participants 

were in addiction txt or recovery 

Studies used quantitative assessment 

Population 

Adults aged 18 yrs and older. 

Characteristics of studies 

(Interventions) 

• Psychosocial smoking cessation 

interventions provided in all but 1 

study and included the following: brief 

advice, educational information, skill 

based, behavioral, cognitive 

behavioral, motivational, or staged 

based interventions 

• Eleven studies provided NRT, one 

evaluated bupropion, and another 

fluoxetine 

Method of review 

• Two reviewers independently 

conducted article abstraction 

• One reviewer blinded to study author, 

institution, artile title, journal, and yr of 

publication 

• Qualilty assessment used a 3 pt scale 

• Discrepancies settled though 

discussion or consulting a third 

reviewer 

Study design 

• Abstinence ratios used to measure 

effect for smoking and substance use 

• Meta Analysis performed using 2X2 

tables for txt and Cs 

• To reduce bias .5 was added to every 

cell in the table containing a zero 

• Abstinence rates expressed as 

relative risk w/ 95% CI; RR > 1.0 

indicated favoring of intervention for 

increased abstinence 

Studies included in meta-analysis 

• 19 studies 

• 12 conducted w/ 1,410 participants in 

addiction txt and 7 studies w/ 638 

participants in recovery 

Aim of review 

To examine outcomes of 

smoking cessastion 

interventions evaluated 

w/ individual in current 

addictions txt or recovery 

Main results 

• Abstinence rates for 

addictions txt were 

12% vs 3% in 

intervention and Cs 

• Abstinence rates for 

recovery were 38% vs 

22% in intervention 

and Cs 

• Summary RR for 

addiction txt 2.03 (95% 

CI, 1.21 - 3.39; 

heterogeneity, P = 

0.519) indicated a 

significant increase in 

likelihood of abstinence 

in intervention group 

• Summary RR for 

recovery 1.77 (95%CI, 

1.37-2.30; 

heterogeneity, P = 

0.878) indicated a 

significant increase in 

likelihood of abstinence 

in intervention group 

• ANOVA comparing 

addiction and recovery 

intervention effects 

were NS 

• Long term follow up no 

significant differences 

in smoking outcomes 

by condition 

• Significant increase of 

drug and alcohol 

abstinence occurred in 

intervention groups RR 

= 1.25 (95% CI, 1.07 – 

1.46, heterogeneity, P

= 0.496) 

• NRT studies revealed 

stronger effects and 

more recently 

published 

Quality rating 

Good 

Adverse events 

No 
C-202 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Author, year Study Characteristics 

Main Results/ 

Aim of Review Quality Rating 

Author, year 

Rigotti et al., 2002 

Geographic area 

United Kingdom 

Funding source 

NHS Research and 

Development 

Programme UK 

and Department of 

Primary Health 

Care, Oxford 

University,UK 

Time period 

covered 

Databases 

systematically 

searched through 

March 2002 

Inclusion criteria: 

• Randomized and quasi-randomized 

trials of behavioral, pharmacological or 

multicomponent interventions to help 

patients to stop smoking conducted with 

hospitalized patients 

• Trials of secondary prevention or 

cardiac rehabilitation that did not recruit 

on the basis of smoking history and 

trials in patients hospitalized for 

psychiatric disorders or substance 

abuse (including inpatient tobacco 

addiction programs) were excluded. 

Population 

Patients who were hospitalized, or about 

to be hospitalized and who were currently 

smoking or had recently quit. 

Characteristics of studies 

(interventions) 

Any intervention to increase motivation to 

quit, to assist a quit attempt or to help 

recent quitters avoid relapse. 

Interventions during the hospital stay were 

categorized according to whether they 

included follow-up after discharge and by 

level of intensity leading to four categories 

of intervention intensity: 

• Single contact in hospital lasting ≤ 15 

minutes, no follow-up support 

• One of more contacts in hospital lasting 

in total > 15 minutes, no follow-up 

support 

• Any hospital contact plus follow-up ≤ 1 

month 

• Any hospital contact plus follow-up ≥ 1 

month 

Method of review 

Pre-screened published articles for 

relevance, three reviewers assessed 

studies independently for inclusion, data 

extracted by 1 reviewer and checked by a 

second, and used statistical methods for 

pooling described by Peto’s group (Yusuf 

1985) 

Study design 

Cochrane Systematic Review 

What studies are included in metaanalysis 

17 trials conducted in the US, the UK, 

Canada and Spain between 1990 and 

2002 

Aim of review 

To determine the 

effectiveness of 

interventions for smoking 

cessation in hospitalized 

patients. 

Main results 

Intensive intervention 

(inpatient contact plus 

follow-up for at least 1 

month) was associated 

with a significantly higher 

quit rate compared to 

control (Peto Odds Ratio = 

1.82 (95% CI, 1.49-2.22, 

six trials). Inteventions with 

less than a month of followup did not show evidence 

of significant benefit (Peto 

Odds Ratio 1.99, (95%CI, 

0.91-1.31, seven trials). 

There was no evidence to 

judge the effect of very 

brief (<20 minutes) 

interventions delivered only 

during rhe hospital stay. 

Longer inteventions 

delivered only during the 

hospital stay were not 

significantly associated 

with a higher quit rate 

(Peto Odds Ratio 1.07 

(95% CI, 0.79-1.44, three 

trials). Although the 

interventions increased quit 

rates irrespective of 

whether nicotine 

replacement therapy (NRT) 

was used, the results for 

NRT were compatible with 

other data indicating that it 

increases quit rates. There 

was no strong evidence 

that clincial diagnosis 

affected the likelihood of 

quitting. 

Quality rating 

Good 

Adverse events 

No 
C-203 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Secker-Walker et 

al., 2002 

Geographic area 

United Kingdom 

Funding source 

No source of 

support supplied 

Time period 

covered 

Databases 

searched 

systematically 

through August, 

2001 

Inclusion criteria 

Controlled trials of community 

interventions for reducing smoking 

prevalence in adult smokers where 

primary outcome measure was smoking 

behavior 

Population 

Adults, 18 yrs and older 

Characteristics of studies 

(Interventions) 

Coordinated, multidimensional programs 

aimed at changing adult smoking 

behavior involving several segments of 

the community and conducted in a 

defined geographical area such as a 

town, city, county, or administrative 

district 

Method of review 

• Prescreened published articles for 

relevance 

• Two reviewers assessed studies 

independently for inclusion 

• Data extracted by 1 reviewer and 

checked by a second 

• Studies combined using qualitative 

narrative synthesis 

Study design 

Cochrane Systematic Review 

Studies included in meta-analysis 

NR 

Aim of review 

To assess effectiveness 

of community 

interventions for reducing 

prevalence of smoking 

Main results 

• Changes in smoking 

prevalence measured 

using cross sectional 

data in 27 studies 

• Net decline ranged 

from -1.0% to 3.0%/yr; 

for women -.2% to 

3.5%/yr; for men -.4% 

to 1.6%/yr 

• Two rigorous studies 

found significant 

results:1) change in 

smoking prevalence 

among light/moderate 

smokers, 2) greater 

quit rates among men 

but community level 

changes not found 

• Projects that address 

smoking alone scarcely 

more effective than 

general health 

prevention projects 

• Longer project, 

projects using 

formative research, 

and projects w/ higher 

levels of participation 

and awareness were 

more effective 

Quality rating 

Good 

Adverse events 

No 
C-204 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Sinclair et al., 

2005 

Geographic area 

United Kingdom 

Funding source 

University of 

Aberdeen UK 

Time period 

covered 

Databases 

systematically 

searched through 

March 2003. 

Inclusion criteria 

Randomized trials which compared 

interventions by community pharmacy 

personnel to promote smoking cessation 

amongst their clients who were smokers 

compared to usual pharmacy support or 

any less intensive program 

Population 

Community pharmacy clients who are 

smokers and wish to stop. 

Characteristics of studies 

(Interventions) 

Any intervention by community 

pharmacy personnel to promote smoking 

cessation amongst their clients 

Pharmaceutical trials which compared 

only NRT w/ a control in the community 

pharmacy setting did not fall within 

scope of this review 

Method of review 

• Studies generated by search strategy 

reviewed by two authors, according to 

inclusion criteria 

• Data extracted by one author and 

checked by a second 

Study design 

Cochrane Systematic Review 

Studies included in meta-analysis 

NR 

Aim of review 

To assess effectiveness 

of interventions by 

community pharmacy 

personnel to assist clients 

to stop smoking 

Main results 

• Two trials met the 

criteria w/ a total of 976 

smokers 

• Both studies involved 

training using stages of 

change model, and 

compared a support 

program of counseling 

and record keeping w/ 

a C who recieved 

normal services 

• Significant result for 

study 1 showed 

cotinine-validated 

continuous abstinence 

at 12 months of 14.3% 

in intervention group 

and 2.7% in C 

• Study 2 did not show a 

statistically significant 

effect at any followup, 

but there was a 

consistent trend toward 

benefits fro intervention 

• Using a random effects 

model to pool results 

showed no evidence of 

significant benefits 

Quality rating 

Good 

Adverse events 

NA 
C-205 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Sowden et al., 

2003 

Geographic area 

United Kingdom 

Funding source 

NHS Center for 

Reviews and 

Dissemination, 

UK 

Time period 

covered 

Databases 

searched 

systematically 

through 

September 2002 

Inclusion criteria 

Randomized and non RCTs that 

assessed effectiveness of multicomponent community (geographical or 

school district) interventions to prevent 

uptake of smoking in young people 

Population 

Young people aged less than 25 yrs 

Characteristics of studies 

(Interventions) 

Interventions targeted at entire or parts 

of entire communities or lage ares w/ 

intention of influencing smoking 

behaviors of young people 

Method of review 

• Prescreened published articles for 

relevance 

• Two reviewers assessed studies 

independently for inclusion 

• Data extracted by 1 reviewer and 

checked by a second, 

• Studies combined using qulitative 

narrative synthesis 

Study design 

Cochrane Systematic Review 

Studies included in meta-analysis 

NR 

Aim of review 

To determine 

effectiveness of 

community interventions 

in preventing initation of 

smoking in young people. 

Main results 

• Community 

interventions vs no 

intervention controls 

reported lower smoking 

prevalence; 

• Community 

interventions vs 

school-based only 

intervention found a 

significant smoking 

prevalence in one 

study 

• Community 

interventions vs 

community w/ schoolbased component 

found no differences in 

smoking cessation 

rates 

• Community 

intervention w/ media 

component vs media 

alone found 

significantly lower rate 

of increased smoking 

in community and 

media intervention 

Quality rating 

Good 

Adverse events 

No 
C-206 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Sowden et al., 

1998 

Geographic area 

United Kingdom 

Funding source 

Internal: NHS 

Centre for 

Reviews and 

Dissemination 

UK; External: 

NHS Research 

and Development 

National Cancer 

Programme, 

England UK 

Time period 

covered 

Databases 

searched 

systematically 

through June 

1998 

Inclusion criteria 

Studies that evaluated effectiveness of 

mass media campaigns influencing 

smoking behaviors in young people 

using the following designs: 1) RCT w/ 

unit of analysis as school, community or 

geographic area, 2) controlled trial w/o 

randomization, 3) time series 

Population 

Young people aged less than 25 yrs. 

Characteristics of studies 

(Interventions) 

• Mass media interventions using 

communication channels such as TV, 

radio, newspapers, bill boards, 

posters, leaflets or booklets intended 

to prevent uptake of smoking in young 

people 

• Also mass media campaigns 

combined w/ school-based programs 

designed to influence smoking 

behaviors were included 

Method of review 

• Stage 1: Reports of evaluations 

prescreened for relevance by at least 

one reviewer 

• Stage 2: Relevant studies assessed 

independently by 2 reviewers 

• Stage 3: Data extracted from included 

studies by one reviewer and checked 

by a second reviewer 

• Stage 4: Studies combined using 

qualitative narrative synthesis 

Study design 

• Cochrane Systematic Review 

• Studies combined using qualitative 

narrative synthesis 

Studies included in meta-analysis 

NR 

Aim of review 

To determine 

effectiveness of mass 

media campaigns in 

preventing uptake of 

smoking in young people. 

Main results 

• Two of these six 

control trial design 

interventions found to 

be associated w/ 

reductions in smoking 

behavior 

• A media campaign 

aimed at girls found 

4% lower smoking 

rates for girls in the 

media county (8.6% vs 

12.4%, P < 0.01); OR 

of being a smoker in 

intervention county 

compared w/ being a 

smoker in control was 

.74 (95% CI, .64 to .86) 

after adjusting for 

baseline and gender 

• A media campaign 

combined w/ a schoolbased program vs 

school based program 

alone found a lower 

risk for weekly smoking 

at 2 yr in communities 

w/ combined 

intervention (OR .62, 

95% CI, .49 to .78) 

• Both studies had 

effective campaigns w/ 

solid theoretical basis, 

used formative 

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 

Quality rating 

Good 

Adverse events 

NA 
C-207 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Stead et al., 2005 

Geographic area 

United Kingdom 

Funding source 

Internal: 

Department of 

Primary Helath 

Care, Oxford 

University UK, 

External: NHS 

Research and 

Development 

National Cancer 

Programme UK 

Time period 

covered 

Database 

searched 

sytematically 

through February 

2005 

Inclusion criteria 

Randomized trials w/ a minimum of two 

group meetings and followup at least 6 

months 

Population 

Smokers of either gender irrespective of 

initial level of nicotine dependency, 

except for pregnant smokers. 

Characteristics of studies 

(Interventions) 

Studies where smokers met for 

scheduled meetings and received some 

form of behavioral therapy delivered 

over at least 2 sessions 

Method of review 

• Studies idenified and reviewed 

independently by 2 authors and 

disagreements referred to a third party 

• If 2 group methods were compared w/ 

another method the groups were 

combined and compared w/ the non 

group method 

Study design 

Cochrane Systematic Review and meta 

analysis performed if appropriate 

Studies included in meta-analysis 

NR 

Aim of review 

To determine effects of 

smoking cessation 

programs delivered in a 

group format compared 

to self-help materials, no 

intervention, individual 

counseling, advice from 

Physician, and NRT 

Main results 

• Group therapy 

significantly increased 

cessation vs self-help 

using same or different 

content (N = 4395, OR 

2.04, 95% CI, 1.60 - 

2.60) 

• Higher quit rates 

comparing group to no 

intervention N = 815, 

OR 2.17, 95% CI, 1.37 

- 3.45); No significant 

difference comparing 

group w/ individual 

therapy and only 

limited evidence that 

group produces extra 

benefits when 

combined w/ physician 

advice and NRT 

Quality rating 

Good 

Adverse events 

No 
C-208 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Stead, 2003 

Geographic area 

United Kingdom 

Funding source 

NHS Research 

and Development 

Programme UK 

Time period 

covered 

Databases 

searched 

systematically 

through 

September 2002 

Inclusion criteria 

Randomized or quasi-RCTs in which 

proactive or reactive telephone 

counseling to assist smoking cessation 

was offered to smokers or recent quitters 

Population 

Smokers or recent quitters 

Characteristics of studies 

(Interventions) 

• Proactive or reactive telephone 

counseling to assist smoking 

cessation to any population 

• Also studies that combined telephone 

counseling w/ self-help materials 

Method of review 

Relevant studies identified by one 

person and checked for inclusion or 

exclusion by a second person 

Data extracted by one author and 

checked by a second 

Study design 

Cochrane Systematic Review and if no 

signficant heterogeneity studies pooled 

for a meta analysis 

Studies included in meta-analysis 

NR 

Aim of review 

To evaluate effect of 

proactive and reactive 

telephone support to help 

smokers quit 

Main results 

• Procative phone 

counseling + minimal 

intervention vs minimal 

intervention only: 

indicted a significant 

benefit from addition of 

phone counseling 

when minimal 

intervention used 

standard self-help 

material (OR 1.56, 

95% CI, 1.38 - 1.77) 

• Proactive phone 

counseling increasec 

quit rates from 4.1% to 

7.5% when compared 

to self-help or reactive 

counseling; Adding 

telephone counseling 

to face to face 

interventions failed to 

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 

Quality rating 

Good 

Adverse events 

No 
C-209 

Evidence Table 10. Systematic and meta-analysis reviews (continued) 

Study 

Demographics Study Characteristics 

Aim of Review 

Main Results Quality Rating 

Author, yr 

Thomas et al., 

2002 

Geographic area 

United Kingdom 

Funding source 

No source of 

support supplied 

Time period 

covered 

Databases 

systematically 

searched through 

January 2002 

Inclusion criteria 

Studies where individual students, 

classes, schools, or school districts were 

randomised to intervention or Cs and 

followed for at least 6 months 

Population 

Children (aged 5 to 12) or adolescents 

(aged 13 to 18) in school settings 

Characteristics of studies 

(Interventions) 

Classroom programs or curricula, 

including those associated w/ family or 

community interventions, intended to 

deter use of tobacco 

Method of review 

• Prescreened published articles for 

relevance 

• Two reviewers assessed studies 

independently for inclusion 

• Data extracted by 1 reviewer and 

checked by a second 

• Because of considerable 

heterogeneity the studies were 

combined using qualitative narrative 

synthesis 

Study design 

Cochrane Systematic Reveiw 

Studies included in meta-analysis 

NR 

Aim of review 

To review all RCTs of 

behavioural interventions 

in schools to prevent 

children and adolescents 

starting smoking 

Main results 

• Information curriculum 

interventions less 

effective or showed no 

difference compared to 

other models of 

delivery 

• SLT (most widely used 

theory) had 8 studies 

w/ positive effects and 

7 w/o positive effects 

and HSPP study had 

no effect 

• SLT lacks evidences 

about effectiveness 

• Limited evidence that 

combining social 

influence models w/ 

other components 

improves effectiveness 

Quality rating 

Good 

Adverse events 

No 
C-210 

References: 

Ausems M, Mesters I, van Breukelen G, De Vries H. 

Effects of in-school and tailored out-of-school 

smoking prevention among Dutch vocational school 

students. Health Educ Res 2004; 19(1):51-63. 

Aveyard P, Griffin C, Lawrence T, Cheng KK. A 

controlled trial of an expert system and self-help 

manual intervention based on the stages of change 

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Appendix D 

List of Excluded Studies 

Exclusion Codes:

X1: Foreign language 

X2: Wrong outcome/off topic 

X3: Sample size too small 

X4: Outside specified geographic area 

X5: Wrong publication type 

X6: Wrong study design 

X7: Follow-up too short 

X8: Wrong date 

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D-29 
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D-34 
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D-35 
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D-36 
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D-37 
Appendix E 

Acknowledgments 

E-1 

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. 

Associate Professor, Department of Health 

Policy & Management, School of Public 

Health, Emory University 

Atlanta, Georgia 

Dianne C. Barker, M.H.S. 

Founder and Principal, Barker BiCoastal 

Health Consultants (BBHC) 

Los Angeles, California

Matthew P. Barry, M.P.A. 

Senior Policy Analyst, Campaign for 

Tobacco-Free Kids 

Washington, D.C.

Cecelia Gaffney, M.Ed. 

Instructor in Family and Community Medicine, 

Norris Cotton Cancer Center, Dartmouth Medical 

School 

White River Junction, New Hampshire 

Harry Lando, Ph.D. 

Professor, Division of Epidemiology, School of 

Public Health 

University of Minnesota, Minneapolis 

Herbert H. Severson, Ph.D. 

Senior Research Scientist, Oregon Research 

Institute 

Eugene, Oregon 
E-2 

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. 

Associate Professor, Department of 

Health Policy & Management, School of 

Public Health, Emory University 

Atlanta, Georgia 

Dianne C. Barker, M.H.S. 

Founder and Principal, 

Barker BiCoastal Health Consultants 

Los Angeles, California 

Matthew P. Barry, M.P.A. 

Senior Policy Analyst 

Campaign for Tobacco-Free Kids 

Washington, D.C. 

Lois Biener, Ph.D. 

Senior Research Fellow 

Center for Survey Research, 

University of Massachusetts 

Boston, Massachusetts 

Brian Flay, Ph.D. 

University Distinguished Professor, 

Department of Public Health 

Oregon State University 

Corvallis, Oregon 

Cecelia Gaffney, M.Ed. 

Instructor in Family and Community 

Medicine, Norris Cotton Cancer Center, 

Dartmouth Medical School 

White River Junction, New Hampshire 

Nancy Kaufman, R.N., M.S. 

Aurora Health Care 

Harry Lando, Ph.D. 

Professor, Division of Epidemiology, 

School of Public Health, 

University of Minnesota 

Minneapolis, Minnesota 

Sharon Phelan, M.D. 

Chair/Professor Obstetrics & Gynecology, 

University of New Mexico 

Albuquerque, NM 
Author Title Year 

Sinclair, HK, C. M. Bond, A. S. 

Lennox, J. Silcock, A. J. Winfield 

and P. T. Donnan 

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controlled trial in Scotland 

1998 

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Hollis, E. Lichtenstein and et al. 

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Ward Jand R. Sanson-Fisher Does a 3-day workshop for family medicine trainees improve 

preventive care? A randomized control trial 

1996 

Wilson, DM, D. W. Taylor, J. R. 

Gilbert, J. A. Best, E. A. Lindsay, D. 

G. Willms and J. Singer 

A randomized trial of a family physician intervention for 

smoking cessation 

1988 

D-38