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Draft Research Plan

Behavioral Counseling and Pharmacotherapy Interventions for Tobacco Cessation in Adults, Including Pregnant Women

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

This draft Research Plan was available for comment from November 7 until December 4, 2013 at 5:00 p.m., ET.

I. Proposed Analytic Framework

Select Text Description below for details.

[D] Select for Text Description.

II. Proposed Key Questions to Be Systematically Reviewed

  1. Do tobacco cessation interventions improve mortality, morbidity, and other health and social outcomes in current adult tobacco users, including pregnant women and individuals with mental health conditions?
  2. Do tobacco cessation interventions achieve tobacco abstinence in current adult tobacco users, including pregnant women and individuals with mental health conditions?
  3. What adverse events are associated with tobacco cessation interventions?

III. Proposed Contextual Question

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

  1. What is the efficacy and safety of electronic cigarettes as an aid for smoking cessation in current adult smokers?

IV. 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 Report. Criteria are overarching as well as specific to each of the key questions (KQs).

  Included Excluded
Study Design 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

Aim Tobacco cessation in current tobacco users
  • Primary prevention of tobacco use
  • Tobacco exposure–reduction strategies
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  
Population Adults (age ≥18 years), including pregnant women, who are current smokers

Includes reviews that focus on specific primary care–relevant subgroups (e.g., young adults; specific racial/ethnic groups; lesbian, gay, bisexual, and transgender individuals; veterans)

Reviews in which >50% of the included studies focus on:
  • Children and adolescents
  • Partners
  • Providers
  • Psychiatric inpatients
  • Other nonmental health comorbid conditions (e.g., chronic obstructive pulmonary disease, cardiovascular conditions, cancer, HIV)
Interventions Primary care–relevant tobacco cessation interventions, including behavioral counseling and/or pharmacotherapy, with or without referral

Examples include:

  • Advice and counseling (including technology-based programs)
  • Self-help materials (including technology-based programs)
  • Referral to quitlines
  • Complementary and alternative therapies (e.g., acupuncture, hypnosis)
  • Exercise interventions
  • Nicotine replacement therapy (gum, inhaler, lozenge, nasal spray, patch)
  • Bupropion (Zyban®)
  • Varenicline tartrate (Chantix®)
  • System-level interventions
  • Broad public health initiatives (e.g., mass media, community-wide)
  • 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, specialty care, or other settings not applicable to primary care
  • No intervention
  • Usual care
  • Wait-list
  • Attention control (e.g., similar in format and intensity, but intervention 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, social, and other outcomes

Health outcomes:

  • All-cause mortality
  • Tobacco-related mortality
  • Tobacco-related morbidity (including, but not limited to: cancer, asthma, chronic bronchitis, or other respiratory disorders)
  • Infant morbidity/mortality
  • Dental/oral health
  • Quality of life

Other outcomes:

  • Health care utilization

KQ 2: Behavioral outcomes

  • Tobacco cessation/tobacco abstinence (continuous abstinence or point prevalence abstinence)

KQ 3: Adverse events

  • Serious treatment-related harms at any time point after the intervention began
  • Weight gain
  • Emotional stress
  • Adverse events associated with medications
  • Paradoxical increase in tobacco use
  • Demoralization due to failed quit attempt
Reviews that only report:
  • Smoking/tobacco reduction (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 geography Reviews that do not exclusively take place in nondeveloped countries (http://hdr.undp.org/en/statistics) Reviews in which >50% of included studies take place in countries with a Human Development Index below “Very High”
Publication language English Any language other than English
Publication date 2008 to present Reviews published before 2008
Quality rating Fair or good Poor

AHRQ Publication No. 14-05200-EF-5
Current as of December 2013

Internet Citation:

U.S. Preventive Services Task Force. Behavioral Counseling and Pharmacotherapy Interventions for Tobacco Cessation in Adults, Including Pregnant Women: Draft Research Plan. AHRQ Publication No. 14-05200-EF-5. http://www.uspreventiveservicestaskforce.org/uspstf14/tobacadult/tobacdraftresplan.htm

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