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Draft Research Plan

Draft Research Plan for Tobacco and Nicotine Use Prevention in Children and Adolescents: Primary Care Interventions

This opportunity for public comment expired on July 19, 2017 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be 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.

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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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

 

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.

Draft: Proposed Key Questions to Be Systematically Reviewed

  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?

Draft: Proposed Contextual Questions

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?

Draft: Proposed Research Approach

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
Current as of: June 2017

Internet Citation: Draft Research Plan: Tobacco and Nicotine Use Prevention in Children and Adolescents: Primary Care Interventions. U.S. Preventive Services Task Force. June 2017.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions

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