Draft Recommendation Statement
Prevention and Cessation of Tobacco Use in Children and Adolescents: Primary Care Interventions
This opportunity for public comment expires on July 22, 2019 at 8:00 PM EST
Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.
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.
Draft: Recommendation Summary
|School-aged children and adolescents|
The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use among school-aged children and adolescents.
|School-aged children and adolescents|
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care–feasible interventions for the cessation of tobacco use among school-aged children and adolescents.
See the “Practice Considerations” section for more information on effective interventions to prevent initiation of tobacco use and for suggestions for practice regarding the I statement.
Send Us Your Comments
In an effort to maintain a high level of transparency in our methods, we open our draft Recommendation Statements to a public comment period before we publish the final version.
Tobacco use is the leading cause of preventable death in the United States.1 An estimated 437,000 deaths (approximately 1 in 5 of all deaths) occur annually in current or former smokers that are attributable to tobacco use in adults.1 It is estimated that every day about 2,000 youth younger than age 18 years smoke their first cigarette,2 and that about 5.6 million adolescents alive today will die prematurely from a smoking-related illness.1, 3 Although conventional cigarette use has gradually declined among children in the United States since the late 1990s,4 tobacco use via electronic nicotine delivery systems (ENDS), such as e-cigarettes, is quickly rising and is now more common among youth than cigarette smoking. ENDS entered the U.S. market in the mid-2000s5 and its use in youth has been tracked in the National Youth Tobacco Survey since 2011.1 From 2011 to 2018, current e-cigarette use increased from 1.5% to 20.8% among high school students6 (220,000 to 3.05 million students); in 2018, 8.1% of high school students (1.18 million students) used conventional cigarettes.7 ENDS products frequently contain nicotine, which is addictive, raising concerns about ENDS use and nicotine addiction in children.5 Evidence suggests an association between ENDS use in nonsmoking adolescents and subsequent cigarette smoking in young adults. Ever use of e-cigarettes is associated with increased risk of ever use of combustible tobacco products.8 In addition, as the degree of ENDS use increases, frequency and intensity of smoking cigarettes also increases.8 Exposure to nicotine during adolescence may harm the developing brain, which may have long-term effects on brain function and cognition, attention, and mood.1, 5, 9, 10 For this recommendation, tobacco use includes smoking conventional cigarettes and use of ENDS or “vaping.” See the “Definitions” section for more information on tobacco products and terminology used in this recommendation.
Draft: USPSTF Assessment of Magnitude of Net Benefit
The USPSTF concludes with moderate certainty that primary care–feasible behavioral interventions, including education or brief counseling, to prevent tobacco use in school-aged children and adolescents have a moderate net benefit. The USPSTF found adequate evidence that behavioral counseling interventions, such as face-to-face or telephone interaction with a health care provider, print materials, and computer applications, can have a moderate effect in preventing initiation of tobacco use in school-aged children and adolescents. The USPSTF sought but found no evidence on the harms of behavioral counseling interventions for the prevention or cessation of tobacco use; however, the USPSTF bounds the magnitude of potential harms of behavioral counseling interventions as no greater than small based on the absence of reported harms in the literature and the noninvasive nature of the interventions (Table 1).
The USPSTF concludes that there is insufficient evidence to determine the balance of benefits and harms of primary care interventions for tobacco cessation among school-aged children and adolescents who already smoke, due to a lack of adequately powered studies on behavioral counseling interventions and a lack of studies on medications. The USPSTF found inadequate evidence on the benefit of behavioral counseling interventions for tobacco cessation in school-aged children and adolescents. Sample sizes of studies of behavioral counseling interventions for cessation were small, making it unclear whether the observed lack of effect of interventions was the result of intervention failure or lack of statistical power. Although the USPSTF found no evidence on the harms of behavioral counseling interventions, it bounds the magnitude of potential harms of behavioral counseling interventions as no greater than small based on the absence of reported harms in the literature and the noninvasive nature of the interventions. The USPSTF found inadequate evidence on the benefits and harms of medications for tobacco cessation in children and adolescents primarily because of an inadequate number of studies that have evaluated tobacco cessation medications in this population. Potential harms depend on the specific medication (Table 1).
Draft: Practice Considerations
Patient Population Under Consideration
This recommendation applies to school-aged children and adolescents age 18 years and younger. The USPSTF has issued a separate recommendation statement on interventions for tobacco use cessation in adults older than age 18 years, including pregnant persons.11
“Tobacco use” refers to use of any tobacco product. As defined by the U.S. Food and Drug Administration (FDA), tobacco products include cigarettes, cigars, dissolvables, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless tobacco products (including dip, snuff, snus, and chewing tobacco), vapes, electronic cigarettes, hookah pens, and other ENDS. “Smoking” generally refers to the inhaling and exhaling of smoke produced by combustible tobacco products such as cigarettes, cigars, and pipes. “Vaping” refers to the inhaling and exhaling of aerosols produced by ENDS.12 Vape products usually contain nicotine, which is the addictive ingredient in tobacco. Substances other than tobacco can also be used to smoke or vape. ENDS includes e-cigarettes.
Assessment of Risk
All youth are considered at risk of initiating tobacco use. Interventions to prevent the initiation of tobacco use should be provided to all youth who have not started using tobacco products yet, regardless of the presence or absence of other risk factors. The following risk factors may increase the risk of tobacco use in youth: being male, white race, not college-bound, from a rural area, having parents with lower levels of education, parental smoking, having childhood friends who smoke, being an older adolescent, experiencing highly stressful events, and perceiving tobacco use as low risk.13, 14
Interventions to Prevent Tobacco Use and Implementation Considerations
Various behavioral counseling intervention types are effective in preventing tobacco initiation in children, including face-to-face counseling, telephone counseling, and computer-based and print-based interventions.15
Individual interventions target specific audiences (the child/adolescent, the parent, or both) and a variety of age ranges. For example, in the reviewed studies,15 interventions for children ages 7 to 10 years tended to be print-based materials, whereas face-to-face counseling and telephone- and computer-based interventions typically targeted children older than age 10 years. Interventions targeting parents tended to be print- or telephone-based. The number of contacts made with intervention recipients also varied, ranging from one to eight contacts.15 The intensity of the interventions varied, with the content of the print materials ranging from stickers to informational newsletters or an activity book (for children) or activity guide (for parents). For telephone-based interventions, telephone counseling was usually provided in conjunction with another modality such as print materials or face-to-face counseling. Based on the evidence reviewed,15 no specific component of behavioral counseling interventions (such as intervention modality, target audience, duration of intervention, or intervention setting) appeared to make an intervention more or less effective. Thus, providers have a broad range of effective behavioral counseling interventions from which to choose. For additional information about components of behavioral counseling interventions and how to implement behavioral counseling interventions to prevent tobacco use, see Table 2 and the “Additional Tools and Resources” section.
Most of the evidence on behavioral counseling interventions to prevent tobacco use focused on prevention of cigarette smoking.15 Given the similar contextual and cultural issues currently surrounding the use of ENDS in youth and the inclusion of ENDS as a tobacco product by the FDA, the USPSTF concludes that the evidence on interventions to prevent cigarette smoking could be applied to prevention of ENDS use as well.
Additional Tools and Resources
Primary care clinicians may find the following resources useful in talking with children and adolescents about the harms of tobacco use.
- Center for Disease Control and Prevention’s (CDC’s) “Youth Tobacco Prevention”: https://www.cdc.gov/tobacco/basic_information/youth/index.htm
- CDC’s “Tips from Former Smokers®”: https://www.cdc.gov/tobacco/campaign/tips/resources/index.html
- FDA’s “Think E-Cigs Can’t Harm Teen’s Health?”: https://www.fda.gov/tobacco-products/ctp-newsroom/think-e-cigs-cant-harm-teens-health
- National Cancer Institute’s “Become a Smokefree Teen”: https://teen.smokefree.gov
- National Cancer Institute’s: 1-800-QUIT-NOW
- 2016 Surgeon General’s Report: “E-Cigarette Use Among Youth and Young Adults”: https://www.cdc.gov/tobacco/data_statistics/sgr/e-cigarettes/index.htm
- 2012 Surgeon General’s Report: “Preventing Tobacco Use Among Youth and Young Adults”: https://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm
- CDC’s “Fact Sheet on Youth and Tobacco Use”: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm
Other Related USPSTF Recommendations
The USPSTF has made recommendation on behavioral and pharmacotherapy interventions for tobacco smoking cessation in adults, including pregnant women,11 and primary care behavioral interventions to reduce illicit drug and nonmedical pharmaceutical use in children and adolescents.16
Suggestions for Practice Regarding the I Statement on Cessation
Potential Preventable Burden
Nearly 90% of adult daily smokers smoked their first cigarette by the age of 18 years.1 In 2018, 1.18 million high school students reported current use of conventional cigarettes7 and 3.05 million high school students reported current e-cigarette use.6 Forty-one percent of high school students who used any tobacco product in the past 12 months try to quit;17 however, most fail, and 75% will go on to smoke into adulthood. Immediate adverse health effects in child and adolescent smokers include increased negative respiratory effects such as impaired lung growth, early onset of lung function decline, respiratory and asthma-related symptoms (e.g., coughing and wheezing), and early abdominal aortic atherosclerosis.1, 18 Concerns regarding use of ENDS in adolescence includes its use as a bridge to conventional cigarette smoking, inhalation of carcinogens, nicotine dependence and toxicity, and harm to the developing brain.5
Although the evidence on behavioral counseling interventions to prevent tobacco use in children and adolescents is robust, fewer studies with smaller sample sizes are available that evaluate the effect of behavioral counseling interventions or pharmacotherapy on tobacco cessation.15 The pooled effect of the trials that evaluated behavioral counseling interventions for tobacco cessation in primary care settings did not find a significant reduction in smokers after the intervention.15 However, the study interventions were heterogeneous and most of the studies had fewer than 50 participants per study arm, making it difficult to determine whether interventions were unsuccessful at helping children and adolescents to stop using tobacco, or whether they were underpowered to detect a difference in tobacco cessation.
No medications are currently approved by the FDA for tobacco cessation in children and adolescents. The label for varenicline now states that it is not indicated in children age 16 years and younger because its efficacy in this population has not been demonstrated.19 Few trials have been published on medication use for tobacco cessation in children and adolescents (one trial on nicotine replacement therapy [NRT] and two trials on bupropion sustained-release [SR]). Trials were relatively small and all included behavioral counseling in addition to pharmacotherapy. None found a significant difference in quit rates postintervention.15
The USPSTF found no evidence on harms from behavioral counseling interventions for tobacco cessation;15 however, these harms are likely small to none based on the absence of reported harms in the evidence, the noninvasive nature of the interventions, and the low likelihood of serious harms. The USPSTF found the evidence on harms from medications for tobacco cessation in children and adolescents to be inadequate. None of the published trials reported any serious harms; however, study sizes were relatively small.15 The single trial of NRT found a greater number of headaches, cough, abnormal dreams, muscle pain, and patch-related adverse events with NRT.20 Bupropion carries a boxed warning for increased risk of suicidality in children, adolescents, and young adults, with other concerns for increased risk of seizure, hypertension, mania, visual problems, and unusual thoughts and behaviors.21 Varenicline is not indicated in children age 16 years and younger; therefore, no warnings specific to this age group are included in its label.19 For older populations, labeling includes warnings and precautions for neuropsychiatric adverse events, including suicidality, seizures, interaction with alcohol, cardiovascular events, sleepwalking, angioedema, serious skin reactions, and nausea.19
Approximately one third to one half of children and adolescents who have visited a clinician in the past year were asked about their tobacco use.22, 23 Of those who reported tobacco use in the past 30 days, approximately one quarter were advised to quit.22, 23
Draft: Update of Previous USPSTF Recommendation
When finalized, this recommendation will replace the 2013 USPSTF recommendation on primary care interventions to prevent tobacco use in children and adolescents.24 It is consistent with the 2013 recommendation, which similarly issued a “B” recommendation for primary care clinicians to provide interventions to prevent initiation of tobacco use among children and adolescents. New to the current recommendation is the inclusion of ENDS as a tobacco product. Also new to the current recommendation is the “I” statement on insufficient evidence on interventions for cessation of tobacco use among this population. The USPSTF is calling for more research to identify interventions (behavioral counseling or pharmacotherapy) to help children and adolescents who use tobacco to quit.
Draft: Supporting Evidence
Scope of Review
The USPSTF commissioned a systematic review15 to evaluate the benefits and harms of primary care interventions for tobacco use prevention and cessation in children and adolescents. The current systematic review newly included ENDS as a tobacco product.
Benefits of Primary Care Interventions
Nearly all studies evaluated the effect of interventions on smoking prevention and cessation. As mentioned previously, the USPSTF determined that this evidence could be applied to other forms of tobacco use, including ENDS use.
Fourteen trials (n=25,049) reported on the effects of behavioral counseling interventions to prevent the initiation of smoking.15 Nine of these trials enrolled only children who were nonsmokers at baseline while five trials enrolled both smokers and nonsmokers but reported results by baseline smoking status. The weighted mean age of participants was 12.8 years, although eligible ages ranged from 7 to 19 years across studies.15 Most studies used interventions that targeted the child/adolescent, although some targeted both children and parents/caregivers and a few trials targeted only the parents/caregivers. Intervention content included health education, readiness to act/change, and parenting skills (communication and positive parenting). Delivery settings of interventions varied and included primary care clinics, dental clinics, schools (after hours), and the child’s home. Various types of interventions were used, including print materials, face-to-face counseling, telephone support, and computer-based interventions. About half of the studies used only a single intervention type and half used combinations of various interventions (e.g., telephone counseling plus print materials or face-to-face counseling plus a computer-based intervention). Most studies reported that fewer youth initiated smoking when they received a behavioral counseling intervention (followup was most commonly at 12 months but ranged from 7 to 36 months).15 This finding was not always statistically significant for individual studies; however, this reduction was statistically significant when results from trials were pooled: 7.4% vs. 9.2% of participants initiated smoking in the intervention vs. control group (relative risk, 0.82 [95% CI, 0.73 to 0.92]; 13 studies; n=21,700).15 No effect modification was found by intervention type, setting, or target population (child vs. parent).15
Nine trials (n=2,516) reported on the effects of behavioral counseling interventions on smoking cessation in youth.15 Four trials enrolled only smokers while five trials enrolled both smokers and nonsmokers but reported results by baseline smoking status.15 The weighted mean average age of participants in cessation trials was much older than in the prevention trials (16.6 years [range, 12 to 19 years]).15 Nearly all interventions targeted the child/adolescent and very few targeted parents/caregivers. Intervention content most commonly focused on assessing and facilitating the youth’s readiness to change; a few interventions included health education. The delivery setting of interventions was most commonly a primary care or dental clinic; a few studies delivered interventions at home. Nearly all interventions used combinations of intervention types, most commonly face-to face counseling; telephone- and computer-based interventions and print materials (one intervention) were used less commonly. Two trials reported significant increases in smoking cessation rates in youth receiving interventions.25, 26 One trial used a combination of motivational interviewing supplemented with handouts, a computer program, and telephone calls;25 the other trial used a combination of one face-to-face session supplemented with one telephone call.26 Meta-analysis of all nine trials reported a risk reduction of percent smokers postintervention that was not statistically significant (relative risk, 0.97 [95% CI, 0.93 to 1.01]); 80.6% of participants were still smoking at the end of the study (range, 6 to 18 months) in the intervention group vs. 84.1% in the control group.15 However, given the small study sizes, it was unclear whether this finding was a result of the studies being underpowered to detect a change in smoking behavior. Additional analyses were performed to evaluate if various factors, such as intervention type, setting, target population (child vs. parent) or study duration may modify whether an intervention was effective. No factors were identified that modified the effect of interventions.15
Three trials (n=788) reported on the effect of medications on smoking cessation in youth.15 Two trials evaluated bupropion SR27, 28 and one trial evaluated NRT.29 All trials were relatively small (211 to 312 participants per trial) and all trials also included behavioral counseling interventions in addition to medications. One of the bupropion SR trials also included NRT for all participants.27 None of the trials reported that medications improved cessation rates; smoking rates remained high in both treatment and control groups in all trials. In the bupropion SR trials, 87.5% to 93.8% of participants were still smoking at the 6-month followup;27, 28 95.6% of the NRT group and 93.4% of the control group were still smoking at 12 months in the NRT trial.29 The USPSTF identified one unpublished trial of varenicline for tobacco cessation in adolescents.30 Although study results have not been published in a peer-reviewed journal (and therefore are not included in the USPSTF’s systematic evidence review), information is available from trial registries and other documents indicating that the study did not meet its primary endpoint of increased 4-week continuous abstinence at 12 weeks for varenicline compared with placebo.30, 31
Harms of Primary Care Interventions
The USPSTF evaluated harms of behavioral counseling interventions from the 18 trials that reported on benefits of interventions on smoking prevention and smoking cessation, as well as four additional trials that reported on the effect of behavioral counseling interventions on smoking prevalence irrespective of baseline smoking status.15 None of the 22 trials reported adverse events or harms associated with behavioral counseling interventions.15 Some trials reported higher smoking rates at followup in intervention groups compared with control groups, but this finding was not statistically significant in any of the trials.
The USPSTF evaluated harms of medications for smoking cessation from four trials (n=914);15 the three trials described above (two on bupropion and one on NRT) as well as a fourth trial on bupropion SR that did not meet inclusion criteria for evidence on benefits because its followup was less than 6 months.32 No difference in serious or severe adverse events was reported with bupropion vs. control participants, although two trials reported that 4% of participants withdrew due to adverse events with bupropion.15 Some studies reported more headaches, cough, dream disturbance, insomnia, and irritability with bupropion than controls.15 Although no cases were reported in the studies included in the current review, bupropion carries a boxed warning for increased risk of suicidality in children, adolescents, and young adults, and the insert also includes other concerns for increased risk of seizure, hypertension, mania, visual problems, and unusual thoughts and behaviors.21 In the single trial on NRT, NRT was associated with more headaches, cough, abnormal dreams, muscle pain, and patch-related adverse events than placebo.20
Draft: Research Needs and Gaps
More studies are needed to identify effective interventions to help children and adolescents who use tobacco products to quit.
- Larger, adequately powered studies and studies of new behavioral counseling interventions for cessation are needed.
- These studies should report tobacco cessation outcomes at 6 months or later and should also provide information on components of the behavioral counseling intervention provided in the study (such as intensity of delivery, frequency of contacts, content and type of counseling or materials provided, delivery setting of studies, and training of persons delivering the intervention).
- More studies are needed that evaluate the benefits and harms of medications to help youth with tobacco cessation.
- More research is needed on interventions tailored specifically to prevent initiation of use and promote cessation of ENDS use in youth.
Draft: Recommendations of Others
The American Academy of Pediatrics (AAP) recommends that pediatricians provide brief counseling to all children and adolescents to prevent tobacco use initiation, and that all teenagers be screened for tobacco and nicotine use. For adolescents who want to stop using tobacco, AAP recommends that tobacco dependence treatment, referral, or both be offered, and that tobacco dependence pharmacotherapy can be considered for adolescents who are moderately to severely dependent on tobacco who want to stop smoking. ENDS are not recommended as a treatment for tobacco dependence.33 The AAP also recommends that pediatricians screen children and adolescents, parents, and caregivers for ENDS use, and provide prevention counseling for children and adolescents. Further, it recommends that parents, caregivers, and adolescents who use ENDS should be offered or referred to tobacco cessation counseling and FDA-approved tobacco dependence pharmacotherapy appropriate to their level of addiction and readiness to change and, again, that ENDS is not recommended as a treatment for tobacco dependence.34 In 2016, the U.S. Surgeon General issued a report on e-cigarette use and recommended that health care professionals should warn youth of the health risks of e-cigarettes and other nicotine-containing products.5 The American Academy of Family Physicians supports the 2013 USPSTF recommendation.35
Send Us Your Comments
In an effort to maintain a high level of transparency in our methods, we open our draft Recommendation Statements to a public comment period before we publish the final version.
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48. Cremers HP, Mercken L, Candel M, de Vries H, Oenema A. A Web-based, computer-tailored smoking prevention program to prevent children from starting to smoke after transferring to secondary school: randomized controlled trial. J Med Internet Res. 2015;17(3):e59.
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Draft: Table 1. Summary of USPSTF Rationale
|Benefits of Intervention||Adequate evidence that behavioral counseling interventions can have a moderate effect in preventing initiation of tobacco use in school-aged children and adolescents||Inadequate evidence on behavioral counseling interventions and on medications for cessation of tobacco use in school-aged children and adolescents|
|Harms of Intervention||Adequate evidence to bound harms of behavioral counseling interventions as no greater than small based on the absence of reported harms in the evidence, the noninvasive nature of the interventions, and the low likelihood of serious harms||
|USPSTF Assessment||Moderate certainty that primary care–relevant behavioral interventions to prevent tobacco use in school-aged children and adolescents have a moderate net benefit||Insufficient evidence to determine the balance of benefits and harms of primary care interventions for tobacco cessation in school-aged children and adolescents who already smoke|
Draft: Table 2. Implementation*
|Characteristic||Mode of Intervention Delivery|
|Intervention Recipient||Child (ages 7 to 19 years), parent, or both||Child (ages 11 to 19 years) or both parent and child||Child (ages 9 to 17 years), parent, or both||Child (ages 10 to 17 years)|
|Intervention Intensity||Variable. Included stickers, newsletters, activity books, or activity guides||1 to 8 visits
Main intervention or one part of multimodal intervention
|1 to 4 booster calls
Always provided in conjunction with print material or face-to-face counseling
|1 to 6 sessions
Interactive or Web-based programs
|Examples of Materials Provided for Practice†||Prescriptions with preprinted anti-tobacco messages were given to adolescents covering: tobacco-free office, tobacco advertising, tobacco and sports, smokeless tobacco, nicotine and tobacco addiction, passive smoking, tobacco’s effect on teeth, and negative consequences of tobacco use.36||Use of 5A model: Provider asked about smoking, advised continued abstinence, and referred to peer counselor who continued the model (assess, assist, arrange followup) using motivational interviewing and behavior change counseling.37||Use of 5A model: Provider asked about smoking, advised continued abstinence, and referred to peer counselor who continued the model (assess, assist, arrange followup) using motivational interviewing and behavior change counseling.37||Computer screen shots46|
|Intervention References||25, 36, 38-44||25, 36, 37, 45-47||25, 37, 40, 44, 45||25, 46, 48|
|Practice Settings||Medical care settings (primary care, dental care, or family planning) and nonmedical settings (school setting after school hours)|
|Interventionist||Clinicians or other medical providers, dentists, dental hygienists, health educators, health counselors, peer counselors, study-trained counselor, or study-trained workshop leader|
|Demonstrated Benefit||No difference in effectiveness was seen by intervention recipient, provider, modality or setting. Overall, behavioral interventions had a relative risk reduction for initiation of smoking of 0.82 (95% CI, 0.73 to 0.92).|
* Adapted from Table 7 in reference14 and a modified Template for Intervention Description and Replication (TIDieR) checklist.49
† The USPSTF does not endorse any specific intervention. Materials listed here represent examples of materials that were used in reviewed studies, and are publically available. Other studies may reference practice materials, but either their web sites are no longer active, they use outdated modes of communication (e.g., VHS tape), or the material is in a foreign language.
Internet Citation: Draft Recommendation Statement: Prevention and Cessation of Tobacco Use in Children and Adolescents: Primary Care Interventions. U.S. Preventive Services Task Force. June 2019.