Final Research Plan

Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions

February 18, 2014

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 is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report forms the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from November 7 until December 4, 2013 at 5:00 p.m., ET.

Text Description is shown below.

Text Description.

The figure is the analytic framework that depicts the three Key Questions described in Section II of the Research Plan. It illustrates the overarching questions: whether tobacco cessation interventions in current adult tobacco users, including pregnant women and individuals with mental health conditions, lead to improved health outcomes, tobacco abstinence, or adverse events.


  1. Do tobacco cessation interventions improve mortality, morbidity, and other health outcomes in current adult tobacco users, including pregnant women and individuals with mental health conditions?
  2. Do tobacco cessation interventions achieve tobacco abstinence in current adult tobacco users, including pregnant women and individuals with mental health conditions?
  3. What adverse events are associated with tobacco cessation interventions?

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

  1. What is the efficacy and safety of electronic cigarettes as an aid for smoking cessation in current adult smokers?

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 Report. Criteria are overarching as well as specific to each of the key questions (KQs).

  Included Excluded
Study Design 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

Aim Tobacco cessation in current tobacco users, regardless of readiness to quit
  • Primary prevention of tobacco use
  • Tobacco exposure–reduction strategies
Condition Current use of any tobacco product, including, but not limited to: cigarettes, pipes, cigars, cigarillos, little cigars, bidis, kreteks, tobacco (including chew, snuff [including snus], and dissolvable tobacco in the form of strips, sticks, or lozenges), or smoking tobacco through a hookah or waterpipe  
Population Adults (age ≥18 years) who are current smokers, including pregnant women and individuals with mental health conditions

Includes reviews that focus on specific primary care–relevant subgroups (e.g., young adults; older adults; specific racial/ethnic groups; lesbian, gay, bisexual, and transgender individuals; veterans; low-income; low education; substance users)

Reviews in which >50% of the included studies focus on:
  • Children and adolescents
  • Providers
  • Psychiatric inpatients
  • Other nonmental health comorbid conditions (e.g., chronic obstructive pulmonary disease, cardiovascular conditions, cancer, HIV)
Interventions Primary care–relevant tobacco cessation interventions, including behavioral counseling and/or pharmacotherapy, with or without referral

Examples include:

  • Advice and counseling (including technology- and Web-based services)
  • Self-help materials (including technology- and Web-based services)
  • Referral to quitlines
  • Complementary and alternative therapies (e.g., acupuncture, hypnosis)
  • Exercise interventions
  • Nicotine replacement therapy (gum, inhaler, lozenge, nasal spray, patch)
  • Bupropion (Zyban®)
  • Varenicline tartrate (Chantix®)
  • System-level interventions
  • Broad public health initiatives (e.g., mass media, communitywide)
  • Medications and devices that are not approved by the U.S. Food and Drug Administration as first-line tobacco cessation agents (e.g., clonidine, nortriptyline, selective serotonin reuptake inhibitors, anxiolytics, benzodiazepines, beta-blockers, opioid antagonists/naltrexone, electronic cigarettes)
Setting Any setting applicable to primary care Reviews limited to studies that take place in worksites, specialty care, or other settings not applicable to primary care
  • No intervention
  • Usual care
  • Waitlist
  • Attention control (i.e., similar in format and intensity, but intervention is in a different content area)
  • Minimal intervention (no more than a single brief contact [i.e., <5 minutes] per year or brief written materials, such as pamphlets)
  • 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)
  • Perinatal morbidity/mortality
  • Dental/oral health
  • Quality of life, as measured by validated scales

Other outcomes:

  • Health care utilization

KQ 2: Behavioral outcomes

  • Tobacco cessation/tobacco abstinence (continuous abstinence or point prevalence abstinence)

KQ 3: Adverse events

  • Serious treatment-related harms at any time point after the intervention began
  • Weight gain
  • Emotional distress (e.g., worsening of symptoms such as depression, anxiety, psychosis; loss of associates or friends)
  • Adverse events associated with medications
  • Paradoxical increase in tobacco use
  • Demoralization due to failed quit attempt
Reviews that only report:

  • Smoking/tobacco reduction (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/start of intervention
Study geography Reviews that do not exclusively take place in countries listed as “Very High” on the Human Development Index Reviews in which >50% of included studies take place in countries with a Human Development Index below “Very High”
Publication language English Any language other than English
Publication date 2008 to present Reviews published before 2008
Quality rating Fair or good Poor


The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from November 7, 2013 to December 4, 2013. We received comments from eight commenters and partner organizations. There were no changes made to the Research Plan that changed the scope of the review or the approach to synthesizing the evidence. Minor clarifying text was added as suggested.