Final Research Plan

Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions

July 12, 2018

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from March 14 until April 11, 2018 at 5:00 p.m., ET.

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

The 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 (KQs).

  Included Excluded
Aim Tobacco cessation in adults who currently use tobacco, regardless of readiness to quit
  • Primary prevention of tobacco use
  • Tobacco harm–reduction strategies
Condition Current use of any tobacco product, including but not limited to: cigarettes, e-cigarettes and other electronic nicotine delivery systems (ENDS), cigars, cigarillos and filtered cigars, smokeless tobacco (including snus pouches), pipe tobacco, dissolvable tobacco in the form of strips, sticks, or lozenges, or smoking tobacco through a hookah or waterpipe  
Population Adults (age ≥18 years), including pregnant women who currently smoke Reviews limited to:
  • Children and adolescents
  • Persons with other comorbid health conditions (e.g., chronic obstructive pulmonary disease, cardiovascular conditions, cancer, 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 pharmacotherapy, behavioral interventions, and e-cigarettes or ENDS, alone or in combination Broad public health initiatives (e.g., mass media, communitywide campaigns)
Setting Any setting applicable to primary care, including interventions that take place in settings that can be referred to from primary care Reviews limited to studies that take place in worksites, churches, or other settings where participants have existing social connections
  • 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)
Outcome assessment 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 and other outcomes)

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

Other outcomes:

  • Health care utilization

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

Reviews that only report:
  • Reduction in smoking/tobacco (based on frequency/quantity only)
  • 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/start of intervention

KQ 3: Harms reported at any point after quit date

<6-month followup after quit date or start of intervention
Study design Pharmacotherapy and behavioral interventions in adults and behavioral interventions in pregnant women (review-of-reviews):

All KQs: Systematic reviews, including review-of-reviews, with or without meta-analysis. A review will be considered “systematic” if it: 1) includes a clear statement of the purpose of the review; 2) describes the search strategy; 3) indicates the criteria used to select studies for inclusion; and 4) presents the findings relevant to the main purpose of the review, including those that did not favor the intervention. Systematic reviews that include experimental and/or observational study designs will be included.

Pharmacotherapy in pregnant women; e-cigarette or ENDS interventions

All KQs: Randomized and nonrandomized controlled trials

KQ 3: The above, plus observational cohort studies (n≥1,000)
Study geography Reviews and primary studies that primarily take place in countries categorized as “Very High” on the 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
Publication language English Any language other than English
Quality rating Fair or good-quality studies Poor-quality studies

A draft research plan was posted on the USPSTF Web site for public comment from March 14 through April 11, 2018. In response, the USPSTF made the following changes to the research plan. First, reviews focused on relapse prevention interventions will now be included. Second, the USPSTF clarified that the target condition includes use of any tobacco product, as regulated by the U.S. Food and Drug Administration, including cigarettes, roll-your-own tobacco, smokeless tobacco, cigars, pipe tobacco, dissolvables, smoking tobacco through a hookah or waterpipe, and e-cigarettes and other ENDS. Reviews limited to or including cessation of any of these tobacco products will be included. Third, reviews limited to specific subpopulations of adults with high prevalence of tobacco use or at risk of tobacco use–related morbidity will be included, as will results from credible subgroup analyses. Lastly, reviews of medications that are not approved as first-line tobacco cessation medications but are used off-label and are available in the United States will be included. The USPSTF made other minor modifications and clarifications as appropriate, including clarifying that any intervention that takes place in primary care or that can feasibly be referred to from primary care will be included. Several comments related to the conduct of the review (e.g., exploring components of effective interventions) or important discussion points that are not reflected in the research plan but will be addressed in the full evidence review.