Final Research Plan

Tobacco Use in Children and Adolescents: Primary Care Interventions

October 12, 2017

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.

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Panel 1

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 Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from June 22 to July 19, 2017.

Figure 1 is an analytic framework that depicts the pathway children and adolescents may go through to prevent and/or stop tobacco and/or nicotine use. Children and adolescents are assessed for tobacco and/or nicotine use and may undergo prevention and/or cessation interventions that may lead to prevention and/or cessation of tobacco or nicotine use, secondary health outcomes (respiratory health, dental/oral health, and cardiovascular health), and adult tobacco or nicotine use. Interventions may also lead to harms.

  1. Do primary care interventions to prevent tobacco and nicotine use or improve tobacco and nicotine cessation rates in children and adolescents improve health outcomes (i.e., respiratory, dental, cardiovascular, and oral health) and reduce the likelihood of tobacco and nicotine use in adulthood?
  2. Do primary care interventions prevent tobacco and nicotine use or improve tobacco and nicotine cessation rates in children and adolescents?
  3. What adverse effects are associated with primary care interventions to prevent tobacco and nicotine use or improve tobacco and nicotine cessation rates in children and adolescents?

The contextual question will not be systematically reviewed and is not shown in the Analytic Framework.

  1. What is the relationship between use of electronic nicotine delivery systems (ENDS) and use of tobacco products?

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
Setting Primary care, other health care, research clinic/office, dental clinic, or school-based health clinic
  • Schools (other than health clinics delivering primary care)
  • Inpatient settings
  • Institutional/residential facilities
Populations
  • Adolescents (ages 13–18 years) and children (age <13 years) for cessation; children and adolescents (age ≤25 years) for prevention
  • More than 50% of study participants must be in included age group
  • Pregnant adolescents
  • Adults (age >18 years for cessation and age >25 years for prevention), unless subgroup results for adolescents are reported separately from adults
  • Trials limited to children or adolescents with health issues that would limit generalizability to general primary care patients
Condition Tobacco use, nicotine use, or both, including cigarettes, smokeless tobacco, cigars, pipes, and ENDS (including electronic cigarettes) Studies that target marijuana use only
Interventions
  • Primary care–relevant behavioral counseling interventions, including individual, group, phone, or technology-based sessions; telephone quit lines; apps; and health care system–level interventions
  • Adjunctive use of pharmacotherapy (nicotine replacement therapy, bupropion, or varenicline tartrate)
  • Interventions targeting parents or caregivers as a means to prevent or reduce tobacco and nicotine use in children and adolescents
  • Complementary and alternative medicine treatments, such as acupuncture and hypnosis
  • Broad public health or policy interventions
  • ENDS use as a cessation or prevention intervention
  • Trials in which participants are highly likely to know one another (i.e., closed social groups, peer counseling) and participant interaction is likely
Comparisons
  • Usual care
  • Minimal care (no more than one single brief contact per year or brief written materials, such as pamphlets)
  • No intervention
  • Attention control
  • Wait list
 Active intervention (more intensive than a single, brief contact per year or brief written materials)
Outcomes KQ 1:
  • Prevalence or severity of asthma, chronic bronchitis, or other respiratory disorders; health care utilization for respiratory disorders
  • Dental/oral health outcomes
  • Cardiovascular health outcomes
  • Rate, incidence, or prevalence of adult tobacco and nicotine use
KQ 2:
  • Cessation of tobacco use, nicotine use, or both
  • Frequency or quantity of alcohol use or other substance use
KQ 3: Any adverse effect occurring after initiation of the intervention  (e.g., paradoxical increase in tobacco and nicotine use, mental health issues)		 Attitudes or knowledge about tobacco; intentions to quit
Study Design KQs 1, 2:
  • Randomized and nonrandomized, controlled trials; systematic reviews
  • Trials with a minimum of 6 months (or 24 weeks) of followup postbaseline

KQ 3:

  • Randomized and nonrandomized, controlled trials; comparative observational designs; systematic reviews
  • No minimum followup required
 KQs 1–3: All other study designs

KQs 1, 2: Studies with less than 6 months (or 24 weeks) of followup postbaseline
Study Quality Fair- or good-quality studies Poor-quality studies

The draft Research Plan was posted on the USPSTF Web site from June 22 to July 19, 2017. In response to comments, the USPSTF made the following changes to the Research Plan. The USPSTF added pregnant adolescents as an included population, as well as studies in subgroups of adolescents with health problems common to primary care, such as depression and asthma. The USPSTF increased the upper age limit to 25 years for tobacco and nicotine use prevention (young adults ages 18 to 25 years are already included in a separate USPSTF recommendation statement advising behavioral and pharmacological intervention for tobacco cessation in adults). The USPSTF changed pharmacotherapy use for tobacco and nicotine cessation in children and adolescents from a contextual question to an included intervention (i.e., bupropion, varenicline tartrate, and nicotine replacement therapy) that will be reviewed systematically as part of the KQs. The USPSTF also included cardiovascular outcomes in addition to respiratory and oral/dental health outcomes.