Draft Research Plan
Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons
March 15, 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.
- Do tobacco cessation interventions improve mortality, morbidity, and other health outcomes in adults, including pregnant women, who currently use tobacco?
- Do tobacco cessation interventions achieve tobacco abstinence in adults, including pregnant women, who currently use tobacco?
- What harms are associated with tobacco cessation interventions in adults, including pregnant women?
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 (KQs).
|Aim||Tobacco cessation in adults who currently use tobacco, 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||Reviews limited to persons who use nonconventional cigarettes (e.g., smokeless tobacco, hookah)|
|Population||Adults (age ≥18 years), including pregnant women who currently smoke||Reviews limited to:
|Interventions||Primary care–relevant tobacco cessation interventions, including pharmacotherapy, behavioral interventions, and electronic nicotine delivery systems (ENDS); examples include:
|Setting||Any setting applicable to primary care||Reviews limited to studies that take place in worksites, churches, or other settings where participants have existing social connections|
|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):
KQ 2 (behavioral outcomes): Tobacco cessation/tobacco abstinence (continuous or point prevalence abstinence)
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 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; ENDS interventions:
All KQs: Randomized and nonrandomized controlled trialsKQ 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|