in progress

Draft Research Plan

Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons

March 15, 2018

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Figure 1 is an analytic framework for the key questions of this research plan that depicts the effect of tobacco cessation interventions on tobacco cessation, morbidity, and mortality (and subsequent harms) for adults who currently use tobacco.

  1. Do tobacco cessation interventions improve mortality, morbidity, and other health outcomes in adults, including pregnant women, who currently use tobacco?
  2. Do tobacco cessation interventions achieve tobacco abstinence in adults, including pregnant women, who currently use tobacco?
  3. 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).

  Included Excluded
Aim Tobacco cessation in adults who currently use tobacco, regardless of readiness to quit
  • Primary prevention of tobacco use
  • Tobacco exposure–reduction strategies
  • Relapse prevention interventions
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:
  • Children and adolescents
  • Subpopulations based on age, race/ethnicity, or other sociodemographic factors
  • Persons with other comorbid health conditions (e.g., chronic obstructive pulmonary disease, cardiovascular conditions, cancer, HIV)
Interventions Primary care–relevant tobacco cessation interventions, including pharmacotherapy, behavioral interventions, and electronic nicotine delivery systems (ENDS); examples include:
  • Nicotine replacement therapy
  • Bupropion sustained release
  • Varenicline tartrate
  • Advice and counseling (including technology- and Web-based services)
  • Self-help materials (including technology- and Web-based services)
  • Referral to quit lines
  • Complementary and alternative therapies (e.g., acupuncture, hypnosis)
  • Exercise interventions
  • ENDS or electronic cigarettes
  • Health system–level interventions (e.g., electronic medical record prompts)
  • Broad public health initiatives (e.g., mass media, communitywide campaigns)
  • Medications 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)
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
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 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 tools

Other outcomes:

  • Health care utilization

KQ 2 (behavioral outcomes): Tobacco cessation/tobacco abstinence (continuous 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:
  • 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/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 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