Behavioral Counseling and Pharmacotherapy Interventions for Tobacco Cessation in Adults, Including Pregnant Women: A Review of Reviews for the U.S. Preventive Services Task Force

Cigarette smoking and exposure to smoke result in more than 480000 premature deaths in the United States every year, along with substantial illness (1, 2). Despite considerable progress in tobacco control over the past 50 years, in 2013, an estimated 17.8% of U.S. adults (3) and 15.9% of pregnant women aged 15 to 44 years were current cigarette smokers (4). Many tools are available to help smokers quit, including counseling by health care providers, telephone- and print-based interventions, computer and text-messaging interventions, and pharmacologic agents (that is, nicotine replacement therapy [NRT], bupropion hydrochloride sustained release [bupropion], and varenicline). In 2009, the U.S. Preventive Services Task Force (USPSTF) reaffirmed its 2003 recommendation that clinicians ask all adults about tobacco use and provide interventions for cessation for those who use tobacco products (grade A recommendation) (5). The original USPSTF recommendation (2003) and reaffirmation (2009) were based on the Public Health Service's clinical practice guidelines on treating tobacco use and dependence (6, 7). Because there were no plans to update the Public Health Service report, we undertook the current review to assess the benefits and harms of behavioral and pharmacologic interventions for tobacco cessation in adults, including pregnant women, to assist the USPSTF in updating its 2009 recommendation. Because of the rapid increase in the use of electronic nicotine delivery systems (ENDS) and the vigorous debate about the public health effect of these devices and their role in smoking cessation (813), our review also synthesized the primary trial evidence on the efficacy and safety related to this technology as a means for quitting conventional smoking. Methods We relied primarily on a review of reviews method for this update. We did not replicate quality rating or data abstraction for original studies or replicate review-specific analyses. However, we decided a priori to conduct a de novo search for primary evidence related to the effectiveness and safety of ENDS. In addition, we did a bridge search for evidence related to pharmacotherapy interventions among pregnant women because of the limited number of studies included in the available systematic reviews and the length of time that had elapsed since their last search dates. We developed an analytic framework and 3 key questions with input from the USPSTF (Appendix Figure 1). The final version of the framework and key questions reflects both USPSTF and public input. The full report provides detailed methods (14). Appendix Figure 1. Analytic framework. KQ = key question. Data Sources and Searches We searched the following databases for relevant reviews from January 2009 to 1 August 2014: PubMed, PsycInfo, Cochrane Database of Systematic Reviews, Health Technology Assessment database, and Database of Abstracts of Reviews of Effects of the Centre for Reviews and Dissemination. We also searched the following organizational Web sites: the Agency for Healthcare Research and Quality, the British Medical Journal Clinical Evidence (through 7 August 2013), the Canadian Agency for Drugs and Technologies in Health, Guide to Community Preventive Services, the Institute of Medicine, the National Institute for Health and Clinical Excellence, the National Health Service Health Technology Assessment Programme, and the Surgeon General. We supplemented our searches with suggestions from experts. We searched PubMed for primary evidence related to ENDS through 1 March 2015 and for pharmacotherapy interventions among pregnant women through 15 August 2014 (the full report outlines the search strategies for these 2 searches [14]). Study Selection Two investigators independently reviewed all identified abstracts and dually reviewed full-text articles against prespecified eligibility criteria (14). We resolved disagreements through discussion. We included systematic reviewswith or without meta-analysisthat examined the effectiveness of interventions for tobacco cessation for adults, including pregnant women, and were linked to primary care or took place in a general adult population. We excluded nonsystematic meta-analyses and narrative reviews. We also excluded reviews that focused on reduction of tobacco harms, interventions for relapse prevention, or cessation medications that were not approved by the U.S. Food and Drug Administration as first-line medications for cessation (such as nortriptyline). We included only the most recent version of updated reviews. We outlined separate selection criteria when considering primary evidence related to ENDS and pharmacotherapy among pregnant women, as described in the full report (14). Data Extraction and Quality Assessment At least 2 independent reviewers rated the quality of all included systematic reviews using a slightly modified version of the Assessment of Multiple Systematic Reviews tool (15, 16) (see the full report for modifications and methods for determining the overall quality rating of individual reviews [14]). We excluded all poor-quality studies (17). One reviewer completed primary data abstraction, and a secondary reviewer checked all data for accuracy and completeness. Data Synthesis and Analysis When we found several fair- and good-quality reviews that met the inclusion criteria in a given population and intervention subgroup, we applied criteria (Appendix Table 1) to identify 1 or more reviews that represented the most current and applicable evidence to serve as the basis for the main findings (called primary reviews). We reviewed the remaining reviews for complementary or discordant findings. When we encountered discordant bodies of evidence, we sought explanations for these differences by examining the eligibility criteria and included studies within each review. Appendix Table 1. Criteria for Choosing the Primary Existing Systematic Reviews We used the pooled point estimates presented in the included reviews when appropriate. We did not reanalyze any of the individual study evidence. We evaluated the appropriateness of meta-analytic procedures and used our technical judgment to interpret pooled analyses accounting for limitations or concerns around heterogeneity, statistical approaches (18, 19), and other factors. Role of the Funding Source This review was funded by the Agency for Healthcare Research and Quality. Agency staff provided technical oversight for the project. Liaisons from the USPSTF helped resolve issues around the review's scope but were not involved in its conduct. Results We reviewed 638 abstracts and 114 full-text reviews for possible inclusion (Appendix Figure 2). We identified 54 systematic reviews that met our eligibility criteria (2073), and 22 of these served as the basis for the primary findings (Table 1). In general, results across all included reviews were consistent within each population and intervention grouping. Our results are organized by outcomes and subcategories by population and interventions. Eleven of the 54 included reviews synthesized evidence on interventions among specific subpopulations of adults (such as persons with depression and young adults) that are not included here but appear in detail in the full report (14). Appendix Figure 2. Summary of evidence search and selection. * 2 studies included both adults and pregnant women. Reviews can be counted in multiple intervention areas. Table 1. Characteristics of Included Systematic Reviews (n =54), by Population, Intervention, and Last Search Date Behavioral Interventions Among Adults Eleven reviews served as primary reviews examining the effects of behavioral interventions for smoking cessation among the general adult population (Table 1) (21, 22, 31, 37, 55, 58, 60, 61, 67, 71, 78). Health and Cessation Outcomes Data on health outcomes after behavioral interventions were limited to 1 study (79) that was reported in 1 review (58) (Table 2). This study reported no statistically significant differences in rates of total mortality, coronary disease mortality, and lung cancer incidence and mortality at 20-year follow-up among men at high risk for cardiorespiratory disease (n=1445) (80). However, at 33-year follow-up, there were significantly fewer deaths from respiratory illnesses among participants who received an intervention than control participants (58). Table 2. Summary of Evidence for the General Adult Population Several behavioral interventions increased smoking cessation at 6 months or more, including physician- (58) and nurse-delivered (55) counseling interventions, tailored self-help print materials (37), and telephone counseling (60), when compared with minimal intervention or usual care (Table 2 and Appendix Table 2). Smokers who were offered cessation advice by a physician, for example, were 76% more likely to have quit at 6 months or more than those who received no advice or usual care (risk ratio [RR], 1.76 [95% CI, 1.58 to 1.96]; I 2=40%; 28 trials; n=22239) (58). Both minimal and intensive advice (>20 minutes, additional materials beyond a brochure, or >1 follow-up visit) showed statistically significant increases in cessation rates when compared with control participants who did not receive advice. Direct comparisons between intensive and minimal advice in 15 trials suggested that more intensive advice offered a significant advantage (RR, 1.37 [CI, 1.20 to 1.56]; I 2=32%; 15 trials; n=9775) (58). Appendix Table 2. Summary of Smoking Abstinence Results From Reviews of Behavioral Counseling and Pharmacotherapy Interventions for Smoking Cessation Among Adults, by Type of Intervention A separate meta-analysis of 38 randomized, controlled trials (RCTs) done among more than 15000 smokers found a small relative benefit of adjunctive behavioral support to pharmacotherapy when compared with pharmacotherapy alone (RR, 1.16 [CI, 1.09 to 1.24]) (61). Cessation rates were relatively high in both the intervention (21.4%) and control (18