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Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: an Evidence Update for the U.S

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Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: an Evidence Update for the U.S Evidence Synthesis Number 196 Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: An Evidence Update for the U.S. Preventive Services Task Force Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. HHSA-290-2015-00007-I-EPC5, Task Order No. 5 Prepared by: Kaiser Permanente Research Affiliates Evidence-based Practice Center Kaiser Permanente Center for Health Research Portland, OR Investigators: Carrie D. Patnode, PhD, MPH Jillian T. Henderson, PhD, MPH Joy Melnikow, MD, MPH Erin L. Coppola, MPH Shauna Durbin, MPH Rachel Thomas, MPH AHRQ Publication No. 20-05264-EF-1 June 2020 This report is based on research conducted by the Kaiser Permanente Research Affiliates Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-00007-I-EPC5, Task Order No. 5). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decision makers—patients and clinicians, health system leaders, and policymakers, among others—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. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients). The final 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. Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Tina Fan, MD, MPH, at the Agency for Healthcare Research and Quality; current and former members of the U.S. Preventive Services Task Force who contributed to topic deliberations; Brian King, PhD, MPH, Janet Wright, MD, Nicola Lindson, MSc, CPsychol, PhD, Stephen Fortmann, MD, Nancy Rigotti, MD, and Michele Levine, PhD, who provided expert review of the draft report; Brandy Peaker, MD, MPH, on behalf of the Office of Smoking Health, Division of Reproductive Health, and the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, A. Gretchen Buckler, MD, MPH, and Elena Gorodetsky, MD, PhD, with the Office of Research on Women’s Health at the National Institutes of Health, Kevin Walton, PhD, with the National Institute on Drug Abuse, and Holly Nicastro, PhD, MPH, with the National Heart, Lung, and Blood Institute for providing federal review of our draft report, and Corinne Husten, MD, MPH, with the Food and Drug Administration, Center for Tobacco Products; and Todd Hannon, MLS, and Katherine Essick, BS, at the Kaiser Permanente Center for Health Research for technical and editorial assistance. Tobacco Cessation in Adults ii Kaiser Permanente Research Affiliates EPC Structured Abstract Objective: We undertook this systematic review to support the U.S. Preventive Services Task Force in updating its 2015 recommendation on tobacco cessation interventions for adults, including pregnant women. Our review addressed the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation. Data Sources: We conducted an overview of reviews for evidence related to pharmacotherapy and behavioral interventions among the general adult population and for behavioral interventions among pregnant women. We searched the following databases and organizations’ websites to identify existing reviews through April 2018: PubMed, PsycInfo, the Database of Abstracts of Reviews of Effects, the Cochrane Database of Systematic Reviews, the Centre for Reviews and Dissemination Health Technology Assessment, the Agency of Healthcare Research and Quality, the Canadian Agency for Drugs and Technologies in Health, Center for Disease Control and Prevention’s Guide to Community Preventive Services, the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine (formerly the Institute of Medicine), the National Health Service Health Technology Assessment Programme, and the Surgeon General. We conducted a search for primary evidence related to the effectiveness and safety of electronic cigarettes (through April 2019) and pharmacotherapy among pregnant women (through April 2019) and did not rely on existing systematic reviews for this evidence. We conducted ongoing surveillance for relevant literature through January 23, 2020. Study Selection: For the overview of reviews, we included reviews with or without meta- analysis that were published in the English language that systematically reported the effects of tobacco cessation interventions on health, cessation, or adverse outcomes. We excluded nonsystematic meta-analyses and narrative reviews. For primary evidence related to the effectiveness and safety of electronic cigarettes among adults and pharmacotherapy among pregnant women, we included randomized controlled trials and large observational studies that reported health or cessation outcomes at 6 months or more followup or adverse events at any time point. For all evidence, we conducted critical appraisal of all provisionally included reviews and excluded reviews rated as having “critically low” credibility according to AMSTAR-2 criteria and individual studies rated as “poor” quality according to study design-specific risk-of- bias criteria. Data were abstracted by one reviewer and confirmed by another. Data Analysis: We grouped reviews based on population and intervention and identified one or more reviews within each population and intervention subgroup that represented the most current and applicable evidence to serve as the basis for the main findings (“primary” reviews) and discussed complementary and discordant findings from other included reviews as necessary. We did not reanalyze any of the individual study evidence but presented pooled analyses and existing point estimates from included reviews. We narratively synthesized the primary evidence for electronic cigarettes among adults and pregnant women and medications for smoking cessation among pregnant women and where appropriate, conducted random-effects meta-analyses to pool study results. Results: We included 67 systematic reviews, 33 of which served as the basis for the primary findings. While this review was broadly scoped to include abstinence of all tobacco products, the Tobacco Cessation in Adults iii Kaiser Permanente Research Affiliates EPC primary outcome in all cases was abstinence from combustible cigarette smoking. Among adults, combined pharmacotherapy and behavioral interventions significantly increased smoking abstinence by 83 percent versus usual care or minimal support control groups not using medication (risk ratio [RR] 1.83 [95% confidence interval [CI], 1.68 to 1.98]). Furthermore, all seven FDA-approved medications for smoking cessation were found to be effective in increasing smoking quit rates compared with placebo or nondrug arms at 6 or more months followup. The pooled RR for abstinence for nicotine replacement therapy (NRT, all forms) was 1.55 (95% CI, 1.49 to 1.61), for bupropion, 1.62 (95% CI, 1.49 to 1.76), and for varenicline, 2.24 (95% CI, 2.06 to 2.43). Combined NRT versus a single form of NRT showed a statistically significantly greater cessation effect (RR 1.25 [95% CI, 1.15 to 1.36]). Pooled analysis of trials directly comparing NRT and bupropion did not suggest a difference between the two types of pharmacotherapy; however, varenicline has been shown to be superior to both NRT and bupropion in achieving abstinence at 6 months or greater, although there are fewer trials testing these differences. Although less evidence is available, certain medications such as nortriptyline and cytisine used for tobacco cessation have shown potential benefits. None of the drugs were associated with serious adverse events, including major cardiovascular adverse events or neuropsychiatric events. Compared with various controls, behavioral interventions such as in-person advice and support from clinicians including physician advice, nurse advice, individual counseling with a cessation specialist, and group behavioral interventions telephone counseling, mobile phone-based interventions, interactive and tailored internet-based interventions, and the use of incentives had modest but significantly increased relative smoking cessation at 6 or more months (15% to 88% range in relative effects). For example, the pooled RR of physician advice versus no advice was 1.76 (95% CI, 1.58 to 1.96) for smoking cessation at 6 or more months’ followup. There was a lack of clear benefit of motivational interviewing, decision aids, print-based, nontailored self- help materials, real-time video counseling, biofeedback (feedback on smoking exposure,
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