Draft Research Plan

Tobacco Use in Children and Adolescents: Primary Care Interventions

June 22, 2017

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Figure 1 is an analytic framework that depicts the pathway children and adolescents age 18 years or younger may go through to prevent or stop tobacco or nicotine use. Children and adolescents are assessed for tobacco or nicotine use, may undergo prevention and cessation interventions, which may lead to prevention or cessation of tobacco or nicotine use and secondary health outcomes (improved respiratory health and dental/oral health) and reduced adult smoking or nicotine use. Interventions may also lead to harms.

Text Description

Figure 1 is an analytic framework that depicts the pathway children and adolescents age 18 years or younger may go through to prevent or stop tobacco or nicotine use. Children and adolescents are assessed for tobacco or nicotine use, may undergo prevention and cessation interventions, which may lead to prevention or cessation of tobacco or nicotine use and secondary health outcomes (improved respiratory health and dental/oral health) and reduced adult smoking or nicotine use. Interventions may also lead to harms.

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

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

  1. What is the relationship between use of electronic nicotine delivery systems (ENDS) and use of conventional tobacco products?
  2. Does adjunctive use of nicotine replacement therapy or pharmacotherapy (i.e., bupropion and varenicline tartrate) reduce tobacco use in children and adolescents?

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
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)
  • More than 50% of study participants must be age ≤18 years or the subgroup of participants age ≤18 years must be analyzed and reported separately from adults
  • Adults (age >18 years), unless subgroup results for adolescents are reported separately from adults
  • Trials limited to children or adolescents with cognitive, substance abuse, mental health, or other health issues that would limit generalizability to general primary care patients
  • Pregnant adolescents
Condition
  • Use of tobacco, including cigarettes, smokeless tobacco, cigars, pipes, and ENDS (including electronic cigarettes)
  • A standard definition of tobacco use in adolescents is any use in the past 30 days; however, we will accept different definitions in included trials, such as any use in the past 7 days or daily users
  • Categories of users include never users (never used tobacco at all), former users, experimental or episodic users, and regular users
 Use of marijuana
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
  • Interventions targeting parents or caregivers as a means to prevent or reduce tobacco or nicotine use in children and adolescents
  • Complementary and alternative medicine treatments, such as acupuncture and hypnosis
  • Broad public health or policy interventions
  • Adjunctive use of nicotine replacement therapy or pharmacotherapy (bupropion or varenicline tartrate)
  • Use of ENDS 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
  • Dental/oral health
  • Rate, incidence, or prevalence of adult tobacco or nicotine use
KQ 2:
  • Rate, incidence, or prevalence of tobacco or nicotine use
  • Tobacco or nicotine use cessation
KQ 3:
  • Paradoxical increase in tobacco or nicotine use
  • Demoralization due to failed quit attempt
  • Depression
  • Any adverse effect occurring after the intervention
 Attitudes or knowledge about tobacco
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