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Draft Research Plan

Tobacco Cessation in Adults: Interventions

February 27, 2025

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Figure 1 is an analytic framework that depicts the three Key Questions (KQs) to be addressed in the systematic review. Specifically, it illustrates the following questions: whether tobacco cessation interventions in adults, including pregnant adults, lead to improved health outcomes (KQ1); whether tobacco cessation interventions in adults, including pregnant adults, lead to increased abstinence from tobacco (KQ2); and whether there are harms associated with tobacco cessation interventions in adults, including pregnant adults (KQ3).

*Tobacco use includes the use of cigarettes, cigars, dissolvables, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless tobacco products including dip, snuff, snus, and chewing tobacco, and e-cigarettes, vapes, and other electronic nicotine delivery systems (ENDS).

  1. Do tobacco cessation interventions improve health outcomes in adults who currently use tobacco, including those who are pregnant?
  2. Do tobacco cessation interventions increase tobacco abstinence in adults who currently use tobacco, including those who are pregnant?
  3. What harms are associated with tobacco cessation interventions in adults, including those who are pregnant?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the evidence on novel tobacco cessation interventions (e.g., transcranial magnetic stimulation, psilocybin, and glucagon-like peptide-1 receptor agonists)?
  2. What factors are associated with disparities in access to and utilization of tobacco cessation interventions?
  3. What strategies and programs facilitate access to or utilization of tobacco cessation interventions?

For key questions, we will describe the population characteristics of the included studies to assess the degree to which the evidence is representative across populations. We will also examine selected subgroup analyses reported in the included studies to explore the extent to which the benefits or harms may vary by population. Finally, we will include contextual questions that address the differences in access to and utilization of tobacco cessation interventions.

The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.

Category Include Exclude
Aim Tobacco cessation in adults who currently use tobacco, regardless of readiness to quit, including relapse prevention
  • Primary prevention of tobacco use
  • Tobacco harm-reduction strategies
Condition Current use of any tobacco product, including but not limited to cigarettes, cigars, dissolvables, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless tobacco products including dip, snuff, snus, and chewing tobacco, and e-cigarettes, vapes, and other electronic nicotine delivery systems (ENDS)*  
Population Adults (age ≥18 years), including those who are pregnant, and persons with serious mental illnesses who currently use tobacco Reviews and studies in which >50% of participants are:
  • Children and adolescents
  • Persons with other comorbid health conditions (e.g., chronic obstructive pulmonary disease, cardiovascular conditions, cancer, and HIV)
Interventions Primary care–relevant tobacco cessation interventions that can be provided in primary care or are feasible to refer to from primary care, including FDA-approved pharmacotherapy (i.e., nicotine replacement therapy, bupropion, and varenicline) or pharmacotherapy in process for FDA approval for tobacco cessation in adults (i.e., cytisine), behavioral interventions, and e-cigarettes or ENDS, alone or in combination. Broad public health initiatives (e.g., mass media, community-wide campaigns), inpatient programs
Setting Any setting applicable to primary care, including interventions that take place in settings that can be referred to from primary care Reviews and studies limited to interventions that take place in worksites, churches, or other settings where participants have existing social connections
Comparators
  • No intervention
  • Usual care
  • Waitlist
  • Attention control (e.g., intervention is similar in format and intensity but on a different content area)
  • Minimal intervention (no more than a single brief contact [i.e., <5 minutes] per year, brief written materials, such as pamphlets, or self-help materials)
  • Active intervention (i.e., more than a single brief contact per year or brief written materials, or another cessation medication)
  
Outcome assessment Tobacco use based on self-report or biochemically validated reports (e.g., expired carbon monoxide; cotinine measured in saliva, urine, or blood; cotinine–creatinine ratio; thiocyanate) Population-based smoking rates (i.e., not based on study sample but on underlying population)
Outcomes KQ 1 (health outcomes):
  • All-cause mortality
  • Tobacco-related mortality
  • Tobacco-related morbidity (including but not limited to cancer, asthma, cardiovascular disease, chronic bronchitis, or other respiratory disorders)
  • Maternal and perinatal morbidity/mortality
  • Dental/oral health
  • Quality of life

KQ 2 (behavioral outcomes): Tobacco cessation/tobacco abstinence (continuous or point prevalence abstinence)

KQ 3 (harms): Serious treatment-related harms at any time point after the intervention began
  • Reduction in withdrawal symptoms
  • Attitudes, knowledge, or beliefs related to tobacco use
  • Intentions to change behavior
  • Intervention participation/compliance
Outcome assessment timing KQs 1, 2: ≥6-month followup after quit date or start of intervention

KQ 3: Harms reported at any point after quit date		 <6-month followup after quit date or start of intervention
Study designs Pharmacotherapy and behavioral interventions in adults:
  • Existing 2024 syntheses conducted by the WHO and CTFPHC1,2
  • Existing Cochrane Collaboration systematic reviews that report evidence on additional tobacco cessation interventions, populations, or subgroup analyses that were not included in the syntheses conducted for the WHO and CTFPHC but otherwise meet criteria within this table
  • Randomized clinical trials of cytisine

Behavioral interventions in pregnant adults: 

  • Systematic reviews, including reviews-of-reviews, with or without meta-analysis

Pharmacotherapy in pregnant adults:

  • Randomized clinical trials
  • Nonrandomized studies of interventions (with concurrent control group) and observational cohort studies (n≥1,000) (KQ 3 only)

e-Cigarette or ENDS interventions in adults, including pregnant adults:

  • Randomized clinical trials
  • Nonrandomized studies of interventions (with concurrent control group) and observational cohort studies (n≥1,000) (KQ 3 only)
  
Study geography Reviews and primary studies that primarily take place in countries categorized as “Very High” on the 2022 Human Development Index (as defined by the United Nations Development Programme) Reviews in which >50% of included studies take place in countries not categorized as “Very High” on the Human Development Index
Countries Studies conducted in countries categorized as “Very High” on the Human Development Index (as defined by the United Nations Development Program) Studies conducted in countries that are not categorized as “Very High” on the Human Development Index
Publication Language English Non-English
Quality rating Reviews: High-, moderate-, and low-credibility existing systematic reviews

Primary studies: Fair- and good-quality studies		 Reviews: Very low-credibility existing systematic reviews

Primary studies: Poor-quality studies

Abbreviations: CTFPHC = Canadian Task Force on Preventive Health Care; ENDS = electronic nicotine delivery systems; FDA = U.S. Food and Drug Administration; HIV = human immunodeficiency virus; KQ = key question; WHO = World Health Organization.

*Includes products that include naturally occurring nicotine (nicotine derived from tobacco plants) and non-tobacco nicotine (“synthetic” nicotine).

1 Hersi M, Beck A, Hamel C, et al. Effectiveness of smoking cessation interventions among adults: an overview of systematic reviews. Syst Rev. 2024;13(1):179.
2 World Health Organization. WHO Clinical Treatment Guideline for Tobacco Cessation in Adults.  Accessed January 6, 2025. https://www.who.int/publications/i/item/9789240096431