Final Research Plan
Final Research Plan for Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions
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.
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.
Key Questions to be Systematically Reviewed
- 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?
- Do tobacco cessation interventions achieve tobacco abstinence in current adult tobacco users, including pregnant women and individuals with mental health conditions?
- What adverse events are associated with tobacco cessation interventions?
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).
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||
|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|
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:
Primary care–relevant tobacco cessation interventions, including behavioral counseling and/or pharmacotherapy, with or without referral
|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|
|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)|
KQ 1: Health and other outcomes
KQ 2: Behavioral outcomes
KQ 3: Adverse events
Reviews that only report:
|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|
Response to Public Comment
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.
Internet Citation: Final Research Plan: Tobacco Smoking Cessation in Adults, Including Pregnant Women: Behavioral and Pharmacotherapy Interventions. U.S. Preventive Services Task Force. October 2014.