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## Complete Summary

#### GUIDELINE TITLE

Tobacco use prevention and cessation for adults and mature adolescents.

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Tobacco use
prevention and cessation for adults and mature adolescents. Bloomington
(MN): Institute for Clinical Systems Improvement (ICSI); 2004 Jun. 42 p.
\[46 references\]

#### GUIDELINE STATUS

This is the current release of guideline.

It updates a previous version: Institute for Clinical Systems
Improvement (ICSI). Tobacco use prevention and cessation for adults and
mature adolescents. Bloomington (MN): Institute for Clinical Systems
Improvement (ICSI); 2003 Jul. 36 p.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [May 2, 2007, Antidepressant
    drugs](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant):
    Update to the existing black box warning on the prescribing
    information on all antidepressant medications to include warnings
    about the increased risks of suicidal thinking and behavior in young
    adults ages 18 to 24 years old during the first one to two months of
    treatment.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Passive tobacco exposure

-   Tobacco use and addiction

#### GUIDELINE CATEGORY

Counseling\
Prevention\
Treatment

#### CLINICAL SPECIALTY

Cardiology\
Family Practice\
Internal Medicine\
Obstetrics and Gynecology\
Pediatrics\
Preventive Medicine\
Psychology

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Health Care Providers\
Health Plans\
Hospitals\
Nurses\
Physician Assistants\
Physicians\
Psychologists/Non-physician Behavioral Health Clinicians

#### GUIDELINE OBJECTIVE(S)

-   To define the appropriate interventions in the clinic setting for
    identification of tobacco-use status in adults and mature
    adolescents, and provision of counseling and assistance in
    tobacco-use cessation

-   To improve the proportion of patients whose current use of tobacco
    or exposure to tobacco smoke is obvious in the chart at any primary
    care clinic encounter

-   To improve the proportion of tobacco-users whose interest in
    quitting is assessed or who receive cessation advice at any clinic
    encounter

-   To increase the number of tobacco-using patients who quit

-   To improve the proportion of clinic-visiting tobacco users setting a
    quit date who received self-help materials along with telephone
    help-line information

#### TARGET POPULATION

Adults and mature adolescents

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Community intervention, including the establishment of smoke-free
    public spaces, limiting youth access to tobacco, restrictions on
    advertising, counter-advertising, and increasing economic
    disincentives to tobacco use

2.  Tobacco use identification and cessation clinic program, including
    frequent assessment to establish tobacco use, counseling,
    encouragement, self-help material, nonconfrontational motivational
    material, advice on smoking cessation, tobacco cessation consultants
    and classes, social support for cessation, phone line support for
    smoking cessation counseling, skills training/problem-solving, and
    follow-up after quit date

3.  Pharmacotherapy, including Zyban (bupropion) and nicotine
    replacement therapy (nicotine gum, nicotine transdermal patches,
    nicotine lozenges, nicotine inhalers, and nicotine nasal spray)

#### MAJOR OUTCOMES CONSIDERED

-   Success rates of smoking cessation interventions (pharmacotherapy,
    education, counseling) on smoking cessation

-   Safety and adverse effects of pharmacotherapy

-   Recidivism rate for tobacco users who quit

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

No additional description of literature search strategies is available.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Key conclusions (as determined by the work group) are supported by a
conclusion grading worksheet that summarizes the important studies
pertaining to the conclusion. Individual studies are classed according
to the system presented below, and are designated as positive, negative,
or neutral to reflect the study quality.

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of minor doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusion because of inconsistencies among
the results from different studies or because of serious doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the question
addressed.

**Grade Not Assignable**: There is no evidence available that directly
supports or refutes the conclusion.

**Study Quality Designations**:

The quality of the primary research reports and systematic reviews are
designated in the following ways on the conclusion grading worksheets:

**Positive**: indicates that the report or review has clearly addressed
issues of inclusion/exclusion, bias, generalizability, and data
collection and analysis.

**Negative**: indicates that these issues (inclusion/exclusion, bias,
generalizability, and data collection and analysis) have not been
adequately addressed.

**Neutral**: indicates that the report or review is neither
exceptionally strong nor exceptionally weak.

**Not Applicable**: indicates that the report is not a primary reference
or a systematic review and therefore the quality has not been assessed.

**Classes of Research Reports**:

A.  Primary Reports of New Data Collection:

> Class A:

-   Randomized, controlled trial

> Class B:

-   Cohort study

> Class C:

-   Nonrandomized trial with concurrent or historical controls

-   Case-control study

-   Study of sensitivity and specificity of a diagnostic test

-   Population-based descriptive study

> Class D:

-   Cross-sectional study

-   Case series

-   Case report

B.  Reports that Synthesize or Reflect upon Collections of Primary
    Reports:

> Class M:

-   Meta-analysis

-   Systematic review

-   Decision analysis

-   Cost-effectiveness analysis

> Class R:

-   Consensus statement

-   Consensus report

-   Narrative review

> Class X:

-   Medical opinion

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Clinical Validation-Pilot Testing\
Comparison with Guidelines from Other Groups\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

**Institute Partners: System-Wide Review**

The guideline draft, discussion, and measurement specification documents
undergo thorough review. Written comments are solicited from clinical,
measurement, and management experts from within the member medical
groups during an eight-week period of \"Critical Review.\"

Each of the Institute\'s participating medical groups determines its own
process for distributing the guideline and obtaining feedback.
Clinicians are asked to suggest modifications based on their
understanding of the clinical literature coupled with their clinical
expertise. Representatives from all departments involved in
implementation and measurement review the guideline to determine its
operational impact. Measurement specifications for selected measures are
developed by the Institute for Clinical Systems Improvement (ICSI) in
collaboration with participating medical groups following general
implementation of the guideline. The specifications suggest approaches
to operationalizing the measure.

**Guideline Work Group: Second Draft**

Following the completion of the \"Critical Review\" period, the
guideline work group meets 1 to 2 times to review the input received.
The original guideline is revised as necessary, and a written response
is prepared to address each of the suggestions received from medical
groups. Two members of the Preventive Services Steering Committee
carefully review the Critical Review input, the work group responses,
and the revised draft of the guideline. They report to the entire
committee their assessment of two questions: (1) Have the concerns of
the medical groups been adequately addressed? (2) Are the medical groups
willing and able to implement the guideline? The committee then either
approves the guideline for pilot testing as submitted or negotiates
changes with the work group representative present at the meeting.

**Pilot Test**

Medical groups introduce the guideline at pilot sites, providing
training to the clinical staff and incorporating it into the
organization\'s scheduling, computer, and other practice systems.
Evaluation and assessment occur throughout the pilot test phase, which
usually lasts for three months. Comments and suggestions are solicited
in the same manner as used during the \"Critical Review\" phase.

The guideline work group meets to review the pilot sites\' experiences
and makes the necessary revisions to the guideline, and the Preventive
Services Steering Committee reviews the revised guideline and approves
it for implementation.

**Comparison with Guidelines from Other Groups**

Consideration was given to guidelines on smoking cessation from the
following groups: U.S. Preventive Services Task Force, the Agency for
Healthcare Research and Quality (formerly the Agency for Health Care
Policy and Research), the United States Department of Health and Humans
Services, Public Health Service, and the National Cancer Institute.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The recommendations for tobacco use prevention and cessation for adults
and mature adolescents are presented in the form of an algorithm
[Tobacco Use Prevention and Cessation for Adults and Mature
Adolescents](http://www.guideline.gov/algorithm/3731/NGC-3731.html),
with 16 components, accompanied by detailed annotations. Clinical
highlights and selected annotations (numbered to correspond with the
algorithm) follow.

Class of evidence (A-D, M, R, X) and conclusion grade (I-III, Not
Assignable) definitions are provided at the end of the \"Major
Recommendations\" field

**Clinical Highlights**

1.  Ask about tobacco use and secondhand smoke exposure at every
    opportunity. (*Annotations #2 and 2a*)

2.  Advise all tobacco users to stop. (*Annotations #13 and 15*)

3.  Assess tobacco user\'s willingness to make a quit attempt.
    (*Annotations #12 and 14*)

4.  Assist tobacco user\'s efforts to quit. (*Annotations #8 and 9*)

5.  Arrange for follow-up. (*Annotations #9 and 16*)

[**Tobacco Use Prevention and Cessation for Adults and Mature
Adolescents Algorithm
Annotations**](http://www.guideline.gov/algorithm/3731/NGC-3731.html)

1.  **Community Intervention**

> **Key Points**:

-   **Tobacco use is the single most preventable cause of disease and
    death in our society.**

-   **The guideline developers urge Institute for Clinical Systems
    Improvement (ICSI) participating medical groups, clinicians,
    insurance plans and employers to actively intervene within their
    community to reduce tobacco use.**

> Tobacco use is the single most preventable cause of disease and death
> in our society. The Centers for Disease Control recommend that tobacco
> control programs be established that are comprehensive, sustainable,
> and accountable. The goal of a comprehensive tobacco control program
> is to reduce disease, disability, and death related to tobacco use by:

-   preventing the initiation of tobacco use among young people

-   promoting cessation among young people and adults

-   eliminating nonsmokers exposure to secondhand smoke

-   identifying and eliminating the disparities related to tobacco use
    and its effects among different population groups.

> The components of a comprehensive tobacco control program include:

-   community programs to reduce tobacco use

-   chronic disease programs to reduce the burden of tobacco-related
    diseases

-   school programs

-   enforcement

-   statewide programs

-   counter-marketing

-   cessation programs

-   surveillance and evaluation

-   administration and management

> The guideline developers urge ICSI participating medical groups,
> clinicians, insurance plans and employers to actively intervene within
> their community to reduce tobacco use. The establishment of smoke-free
> public spaces, limiting youth access to tobacco, restrictions on
> advertising, counter-advertising, and increasing economic
> disincentives to tobacco use are among the most effective community
> actions to be supported.
>
> ***Evidence supporting this recommendation is of classes: M, R***

2.  **Establish Tobacco Use for All Patients and Reassess Users at Every
    Clinic Visit**

> **Key Points**:

-   **Adults who have not used tobacco for at least 12 months and who
    have an easily visible mark on their chart to that effect should be
    asked about their tobacco use status yearly until abstinent for 5
    years.**

-   **Everyone without a tobacco use mark on the chart or those with a
    mark indicating use within the past 6 months should be asked at
    nearly every visit.**

-   **Adolescents should have usage reassessed at nearly every visit,
    regardless of whether there is a chart notation of nonuse.**

> Everyone without a tobacco use mark on the chart or those with a mark
> indicating use within the past 6 months should be asked at nearly
> every visit about current use and the answer documented for the
> provider. This frequency of use assessment should be established as a
> clinic policy and should be done by a staff person, preferably the one
> who rooms the patient.
>
> The two most common ways to indicate tobacco use status are with an
> appropriate label on the chart or with a vital sign in the progress
> notes.
>
> Adolescents should have usage reassessed at nearly every visit,
> regardless of whether there is a chart notation of non-use, due to the
> risk of beginning tobacco use at any time.
>
> Tobacco cessation is particularly important during pregnancy. For more
> information, see the related National Guideline Clearinghouse (NGC)
> summaries of the Institute for Clinical Systems Improvement\'s
> (ICSI\'s) guidelines: [Management of
> Labor](http://www.guideline.gov/summary/summary.aspx?view_id=1&doc_id=10725&nbr=5587)
> and [Routine Prenatal
> Care](http://www.guideline.gov/summary/summary.aspx?view_id=1&doc_id=11532&nbr=5973).
> The guideline developers recommend that clinics have a particularly
> consistent identification and cessation program for pregnant women and
> preconception visits.
>
> Tobacco cessation is also very important in those individuals with
> heart disease or other risk factors for heart disease. (See the
> related NGC summaries of the ICSI guidelines: [Stable Coronary Artery
> Disease](http://www.guideline.gov/summary/summary.aspx?doc_id=10843&nbr=5658),
> [Hypertension Diagnosis and
> Treatment](http://www.guideline.gov/summary/summary.aspx?view_id=1&doc_id=11285&nbr=5886)).
>
> ***Evidence supporting this recommendation is of classes: A, C, D, M,
> R***

**2a. Establish Secondhand Smoke Exposure for All Patients and Encourage
a Smoke-Free Environment**

**Key Points**:

-   **Inform patients of their increased risk of disease due to
    second-hand smoke exposure. Encourage a smoke-free living and
    working environment.**

Inform patients of their increased risk of disease due to second-hand
smoke exposure. Encourage a smoke-free living and working environment
for patients, and assist the exposed patient to communicate with other
household members about decreasing smoking in the house. Encourage the
patient to support smoking cessation efforts among other household
members who use tobacco.

***Evidence supporting this recommendation is of classes: M, R***

3.  **Document the Tobacco Use Discussion**

> **Key Point**:

-   **All discussions with tobacco users should be documented.**

> All discussions with tobacco-users should be documented, either in the
> progress note or on a special card or flow sheet if a clinic uses that
> approach. This documentation should include the user\'s attitude
> toward treatment and any quitting plans agreed upon. The documentation
> can be very brief. Documentation is necessary to facilitate
> coordination between various providers and support staff, to permit
> follow-up and referral arrangements, and to allow subsequent visits to
> build on discussions started earlier.

5.  **Reinforce Nonuse**

> **Key Point**:

-   **Compliment and reinforce nonuse in former tobacco users.**

> If time permits, it is helpful to compliment former tobacco-users.
> These former users are considered to be in the *Maintenance* stage
> once they have quit for at least 12 months. Although a former user can
> return to tobacco use after years of abstinence, the recidivism rate
> reaches a low level by 12 months. The guideline developers suggest
> monitoring the patient for 12 months.
>
> ***Evidence supporting this recommendation is of class: R***

6.  **When Did the Patient Last Use Tobacco?**

> Although the usual definition of a user is one who uses tobacco daily,
> it would be ideal to classify any individual using tobacco with any
> frequency as a user.

7.  **0 -- 12 Months Ago**

> Those who have quit using tobacco within the last month (particularly
> within the past week) are at a very high risk for resuming usage.
> Reinforcement and follow-up can be crucial for these individuals.
>
> ***Evidence supporting this recommendation is of class: M***

8.  **Wants Extra Help in Remaining Tobacco-Free?**

> A former user who is having some trouble remaining tobacco-free may
> want or need more help than the provider can supply in the 2 to 3
> minutes available to discuss this topic. Common difficulties include
> weight gain, stress, withdrawal symptoms, or
> social/habit/psychological needs.

9.  **Congratulate on Quitting/Encourage In-Office or Referral
    Counseling**

> **Key Points**:

-   **The first 12 months after quitting (especially the first 2 weeks)
    is when one is at the highest risk for relapse.**

-   **Follow-up options include a face-to-face, telephoned or mailed
    (postal or electronic) expression of support and willingness to
    help.**

> Those who have quit using tobacco within the last month (particularly
> within the past week) are at a very high risk for resuming use.
> Reinforcement and follow-up can be crucial during this period.
>
> The first 12 months after quitting are the transition between the
> *Action* and *Maintenance* stages. These months (especially the first
> 2 weeks), when one is at the highest risk for relapse, are the most
> challenging. Encourage the patient to avoid temptations to use tobacco
> again. Smoking cessation often takes 3 to 4 attempts before long-term
> success is achieved.
>
> Counseling can be done by the provider or, preferably, by other staff,
> and should be designed to help patients problem-solve any of the
> difficulties referred to in Annotation #8.
>
> Counseling can also be achieved by referring a user to groups, a
> non-office counselor, or an external tobacco cessation specialist. It
> should be recognized, though, that most patients are unwilling to
> attend such groups, especially if they are separate from the clinic.
> However, any such referrals should not replace clinician advice and
> assistance.
>
> If a practice does not have a way for providers to easily and
> efficiently refer to staff or others when a complex quitting problem
> is brought up, it becomes impossible for the provider to complete the
> tobacco discussion within 1 to 3 minutes. The result will be that
> providers will be understandably reluctant to bring up the topic with
> every user as is needed for success.
>
> Follow-up options include a face-to-face, telephoned, or mailed
> (postal or electronic) expression of support and willingness to help.
> The timing of follow-ups should be discussed with the patient;
> generally, the follow-up should come at the time when it will be most
> needed or wanted. Follow-ups can be expertly performed by office
> staff.
>
> Regardless of the desirability of return visits, the guideline
> developers believe that there is neither time nor likelihood of return
> visits happening very frequently, so other arrangements should be
> made.

12. **Intending to Quit in Next 6 Months?**

> **Key Points**:

-   **The goal should be to discuss tobacco cessation at nearly every
    visit.**

-   **Progress from one stage of readiness to quit to the next is
    valuable.**

> Assessment of interest in quitting and timing of that interest should
> be done after the main reasons for the visit have been addressed, and
> should precede any advice about quitting. This allows a 1 to 3 minute
> tobacco discussion accommodating both the user\'s needs and the
> provider\'s time limits.
>
> It is recognized that this discussion may not be possible or
> appropriate at each visit. The goal should be to discuss tobacco
> cessation at nearly every visit.
>
> Remember that progress from one stage of readiness to quit to the next
> is valuable.
>
> The guideline developers have incorporated the exciting and
> scientifically-based concept of readiness stages for behavior change
> developed by Prochaska and DiClemente, which have been particularly
> tested in tobacco cessation, into this guideline. The guideline
> developers believe that these stages (see Annotations #9-12) can focus
> the physician message and make it more effective and feasible.
> However, it is necessary for the provider to first assess readiness to
> quit by asking if a user would consider quitting and then asking when
> (\> 6, 1-6, or 0-1 months). The strategy taken should then be tailored
> to the individual user\'s readiness stage.
>
> ***Evidence supporting this recommendation is of classes: C, R***

13. **Patients Not Intending to Quit in Next 6 Months**

> **Key Point**:

-   **A \"precontemplator\" benefits from nonconfrontational messages
    about importance of quitting and the awareness that provider help is
    available when ready.**

> A user not ready to consider quitting *within the next 6 months* is
> called a *precontemplator* and is helped most when a provider avoids
> confrontation while conveying both the message that quitting is
> important and the desire to be helpful when the user is ready to
> consider quitting. A simple informational pamphlet about the problems
> attending tobacco use and an expression of the provider\'s desire to
> be helpful are far more productive than an attempt to scare or argue
> unwilling users into quitting.

14. **Intending to Quit in Next Month?**

> See Annotation #12, \"Intending to Quit in Next 6 Months?\"

15. **Patient Not Intending to Quit in Next Month**

> **Key Points**:

-   **A \"contemplator\" is accepting of supportive urging to quit and
    encouragement of a plan.**

-   **Ask a tobacco user who is ready to quit to set his/her own date.**

> The *contemplator* is considering quitting within the next 1 to 6
> months. Contemplators are accepting of supportive and respectful
> urging to quit and encouragement to start thinking about a serious
> plan for doing so. Persuasive written, audio, or video information
> about the pros and cons of quitting may be appropriate for
> contemplators.
>
> Virtually every tobacco-cessation expert and program, including the
> National Cancer Institute program, recommends asking a tobacco user
> who is ready to quit to set his/her own quit date. They also recommend
> some type of follow-up, often a return visit. Because users are
> unlikely to keep the appointment, alternatives such as phone calls are
> usually substituted.
>
> ***Evidence supporting this recommendation is of classes: C, R***

16. **Assist the Patient to Quit**

> **Key Points**:

-   **Ask a tobacco user who is ready to quit to set his/her own quit
    date.**

-   **Three treatment elements are effective for smoking cessation
    intervention: pharmacotherapy, social support for cessation, and
    skills training/problem-solving.**

-   **On average, nicotine replacement therapy (NRT) and Zyban
    (bupropion SR) double the probability of success.**

-   **Combining nicotine patches with other self-administered forms of
    NRT (gum, spray) is more effective than a single form of NRT.**

-   **Minnesotans have high-quality free telephone line counseling for
    smoking cessation.**

-   **Other resources include local tobacco cessation classes, community
    support systems, and self-help brochures and materials from drug
    companies.**

> *Negotiate the Quit Date*
>
> The National Cancer Institute program recommends asking a tobacco-user
> who is ready to quit to set his/her own quit date.
>
> *Counsel to Support Cessation and Build Abstinence Skills*
>
> The Agency for Health Care Policy and Research Smoking Cessation
> Clinical Practice Guideline emphasizes that three treatment elements
> in particular are effective for smoking cessation intervention:
> pharmacotherapy, social support for cessation, and skills
> training/problem-solving. The guideline emphasizes the dose-response
> relationship between the intensity and duration of treatment and its
> effectiveness. In general, the more intense the treatment, the more
> effective it is in producing long-term abstinence from tobacco. These
> principles should be kept in mind when counseling and assisting the
> patient to stop using tobacco.
>
> ***Evidence supporting this recommendation is of classes: A, C, M,***
> R
>
> *Discuss Pharmacotherapy*
>
> On average, nicotine replacement therapy (NRT) and Zyban (bupropion
> SR) double the probability of success. It is most effective if the
> patient agrees to completely stop tobacco use with the start of NRT or
> 1 week after starting Zyban (bupropion), **and** the patient agrees to
> participate in a follow-up program of some type. NRT includes nicotine
> gum, nicotine lozenges, nicotine transdermal patches, nicotine
> inhalers, and nicotine nasal spray.
>
> The nicotine lozenge has proven to be effective in helping patients
> quit smoking. \[*Conclusion Grade I: See Conclusion Grading Worksheet
> -- Appendix A -- Annotation #16 (Nicotine Lozenge) in the original
> guideline document*\].
>
> Nicotine nasal spray has been shown to be effective. It is, however,
> the most addictive of the products and is probably best reserved for
> patients who have failed other forms of NRT, who still desire to use a
> product to become completely tobacco-free.
>
> Bupropion (Zyban) has been found to be efficacious in smoking
> cessation and can be offered to patients who have no history of
> seizures, no history of eating disorders, or who are not taking any
> other form of bupropion (i.e., Wellbutrin) or monoamine oxidase (MAO)
> inhibitors.
>
> Suggestions on the clinical use of nicotine patches can be found in
> the Annotation Appendix A of the original guideline document; nicotine
> gum in Annotation Appendix B; nicotine lozenges in Annotation Appendix
> C; bupropion SR in Annotation Appendix D; nicotine inhalers in
> Annotation Appendix E; and nicotine nasal spray in Annotation Appendix
> F.
>
> ***Evidence supporting this recommendation is of classes: A, R***
>
> *Combination Therapy*
>
> Combining nicotine patches with other self-administered forms of NRT
> (gum, lozenge or spray) may be more effective than a single form of
> NRT. \[*Conclusion Grade I: See Conclusion Grading Worksheet --
> Appendix B -- Annotation #16 (Combination Therapy) in the original
> guideline document*\]
>
> If patients use NRT or Zyban, it is important for them to become
> completely tobacco-free. Ongoing use of tobacco predicts failure
> long-term. One strategy is to encourage patients to make their
> tobacco-free program more intense with each use of tobacco after their
> quit date. They can add an exercise program, call a help line, ask for
> a friend\'s help, read a pamphlet, etc.
>
> Although both pregnancy and cardiovascular disease are described as
> contraindications for the use of NRT, there is evidence of safety in
> these conditions, and NRT is more safe than smoking.
>
> Clinicians should encourage their patients to check with their
> insurance plans, as coverage is sometimes available for NRT.
>
> ***Evidence supporting this recommendation is of classes: A, C, D,
> M***
>
> *Offer Phone Line*
>
> Minnesotans have high quality free telephone line counseling for
> smoking cessation. Clinicians are advised to refer patients to their
> respective health plan quitlines. If a patient does not belong to one
> of the health plans listed in the original guideline document, s/he
> should refer to the QUITPLAN Helpline: 1-888-354-PLAN. They are also
> planning to offer face-to-face counseling soon. It is helpful to
> provide a handout with tobacco quitline numbers when referring to a
> quitline. These handouts are available from Blue Cross Blue Shield of
> Minnesota.
>
> An important message to convey to smokers is that quitline counselors
> provide expert advice **in a friendly and supportive manner**.

-   Smokers can consult quitlines for assistance about any issue related
    to tobacco cessation.

-   Quitline counselors can answer brief questions or provide
    counseling, depending on the needs of the smoker.

-   Quitlines can help smokers who are not quite ready to quit as well
    as those who have set a quit date.

-   Smokers who are not quite ready to quit can receive assistance in
    figuring out the next steps.

-   Quitlines can also help smokers who have quit but are having
    difficulty maintaining cessation.

-   Quitlines can send written self-help materials and may provide free
    NRT.

-   The quitlines also can help those who want to know how to support
    someone who is trying to quit.

> ***Evidence supporting this recommendation is of class: A***
>
> *Other Resources*
>
> Consideration may also be given to making a referral to a tobacco
> cessation consultant or a center with programs in tobacco cessation.
> Other resources include local tobacco cessation classes, community
> support systems, and self help brochures and materials from drug
> companies.
>
> ***Evidence supporting this recommendation is of class: A***
>
> *Encourage Follow-up*
>
> Encourage the patient to arrange for a follow-up soon after the quit
> date.
>
> ***Evidence supporting this recommendation is of class: R***

**Definitions**:

**Classes of Research Reports**:

A.  Primary Reports of New Data Collection:

> Class A:

-   Randomized, controlled trial

> Class B:

-   Cohort study

> Class C:

-   Nonrandomized trial with concurrent or historical controls

-   Case-control study

-   Study of sensitivity and specificity of a diagnostic test

-   Population-based descriptive study

> Class D:

-   Cross-sectional study

-   Case series

-   Case report

B.  Reports that Synthesize or Reflect upon Collections of Primary
    Reports:

> Class M:

-   Meta-analysis

-   Systematic review

-   Decision analysis

-   Cost-effectiveness analysis

> Class R:

-   Consensus statement

-   Consensus report

-   Narrative review

> Class X:

-   Medical opinion

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of minor doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusion because of inconsistencies among
the results from different studies or because of serious doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the question
addressed.

**Grade Not Assignable**: There is no evidence available that directly
supports or refutes the conclusion.

#### CLINICAL ALGORITHM(S)

A detailed and annotated clinical algorithm is provided for [Tobacco Use
Prevention and Cessation for Adults and Mature
Adolescents](http://www.guideline.gov/algorithm/3731/NGC-3731.html).

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The guideline contains an annotated bibliography and discussion of the
evidence supporting each recommendation. The type of supporting evidence
is classified for selected recommendations (see \"Major
Recommendations\").

In addition, key conclusions contained in the Work Group\'s algorithm
are supported by a grading worksheet that summarizes the important
studies pertaining to the conclusion. The type and quality of the
evidence supporting these key recommendations (i.e., choice among
alternative therapeutic approaches) is graded for each study.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

**Overall Benefits**

A comprehensive tobacco control program may reduce disease, disability
and death related to tobacco use.

**Specific Benefits**

Use of appropriate interventions in the clinic setting for
identification of tobacco-use status in adults and mature adolescents,
and provision of counseling and assistance in tobacco-use cessation

**Subgroups Most Likely to Benefit**

-   Tobacco cessation is particularly important for pregnant individuals
    and in those individuals with heart disease or other risk factors
    for heart disease.

-   Nicotine replacement therapy (NRT) and Zyban (bupropion) are most
    effective in patients who agree to completely stop tobacco use with
    the start of nicotine replacement therapy or 1 week after starting
    Zyban, and who agree to participate in a follow-up program of some
    type.

#### POTENTIAL HARMS

**Adverse Effects of Medication**

**Nicotine**

-   *Patch*. Up to 50% of patients using the nicotine patch will have a
    local skin reaction. Skin reactions are usually mild and
    self-limiting, but may worsen over the course of therapy. Local
    treatment with hydrocortisone cream (1%) or triamcinolone cream
    (0.1%) and rotating patch sites may ameliorate such local reactions.
    In less than 5% of patients, such reactions require the
    discontinuation of nicotine patch treatment. Another side effect of
    the nicotine patch is insomnia.

-   *Gum*. Common side effects of nicotine chewing gum include mouth
    soreness, hiccups, dyspepsia, and jaw ache. These effects are
    generally mild and transient, and often can be alleviated by
    correcting the patient\'s chewing technique.

-   *Lozenge*. Common side effects include mouth or throat irritation,
    headaches, nausea, hiccups, upset stomach, or dizziness.

-   *Inhaler*. Local irritation in the mouth and throat was observed in
    40% of patients using the nicotine inhaler. Coughing (32%) and
    rhinitis (23%) also were common. Severity was generally rated as
    mild, and the frequency of such symptoms declined with continued
    use.

-   *Nasal spray*. Some 94% of users report moderate to severe nasal
    irritation in the first 2 days of use; 81% still reported nasal
    irritation after 3 weeks, although rated severity was mild to
    moderate. Nasal congestion and transient changes in sense of smell
    and taste also were reported. Nicotine nasal spray has a dependence
    potential intermediate between other nicotine-based therapies and
    cigarettes. About 15 to 20% of patients report using the active
    spray for longer periods than recommended (6 to 12 months), and 5%
    used the spray at a higher dose than recommended.

**Bupropion SR**

The most common side effects reported by bupropion SR users were
insomnia (35 to 40%) and dry mouth (10%).

**Subgroups Most Likely to be Harmed**

**Precautions**

*Nicotine Patch, Gum, Lozenge, Inhaler, and Nasal Spray*

-   [Pregnancy]{.underline}. Pregnant smokers should be encouraged to
    quit first without pharmacologic treatment. The nicotine patch, gum,
    lozenge, inhaler or nasal spray should be used during pregnancy only
    if the increased likelihood of smoking abstinence, with its
    potential benefits, outweighs the risk of nicotine replacement and
    potential concomitant smoking. Similar factors should be considered
    in lactating women.

-   [Cardiovascular diseases]{.underline}. Nicotine replacement therapy
    (NRT) should be used with caution among particular cardiovascular
    patient groups: those in the immediate (within 2 weeks) post
    myocardial infarction period, those with serious arrhythmias, and
    those with serious or worsening angina pectoris.

*Bupropion SR*

-   [Pregnancy]{.underline}. Bupropion SR should be used during
    pregnancy only if the increased likelihood of smoking abstinence,
    with its potential benefits, outweighs the risk of bupropion SR
    treatment and potential concomitant smoking. Similar factors should
    be considered in lactating women.

-   [Cardiovascular diseases]{.underline}. Generally well tolerated;
    infrequent reports of hypertension.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

-   Although both pregnancy and cardiovascular disease are described as
    contraindications for the use of nicotine replacement therapy (NRT),
    there is evidence of safety in these conditions, and NRT is more
    safe than smoking.

-   Nicotine nasal spray should not be used in persons with severe
    reactive airway disease.

-   Bupropion SR is contraindicated in individuals with a history of
    seizure disorder, a history of an eating disorder, who are using
    another form of bupropion (Wellbutrin or Wellbutrin SR), or who are
    using or have used a monoamine oxidase (MAO) inhibitor in the past
    14 days.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These clinical guidelines are designed to assist clinicians by
    providing an analytical framework for the evaluation and treatment
    of patients, and are not intended either to replace a clinician\'s
    judgment or to establish a protocol for all patients with a
    particular condition. A guideline will rarely establish the only
    approach to a problem.

-   This clinical guideline should not be construed as medical advice or
    medical opinion related to any specific facts or circumstances.
    Patients are urged to consult a health care professional regarding
    their own situation and any specific medical questions they may
    have.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Once a guideline is approved for general implementation, a medical group
can choose to concentrate on the implementation of that guideline. When
four or more groups choose the same guideline to implement and they wish
to collaborate with others, they may form an action group.

In the action group, each medical group sets specific goals they plan to
achieve in improving patient care based on the particular guideline(s).
Each medical group shares its experiences and supporting measurement
results within the action group. This sharing facilitates a
collaborative learning environment. Action group learnings are also
documented and shared with interested medical groups within the
collaborative.

Currently, action groups may focus on one guideline or a set of
guidelines such as hypertension, lipid treatment, and tobacco cessation.

Detailed measurement strategies are presented in the original guideline
document to help close the gap between clinical practice and the
guideline recommendations. Summaries of the measures are provided in the
National Quality Measures Clearinghouse (NQMC).

**Key Implementation Recommendations**

1.  Establish a system whereby the tobacco use of each patient is
    identified.

2.  Establish a system to remind providers to assess attitudes of each
    tobacco user toward quitting and to provide cessation advice.

3.  Establish a system to make it easy for a provider to give a tobacco
    user self-help quit books, to arrange for quit counseling and to
    arrange for follow-up after the planned quit date.

4.  Establish a system to collect data at least every three months on
    the success of these interventions and to provide the data to
    providers and clinic staff to assess implementation success.

#### IMPLEMENTATION TOOLS

Clinical Algorithm\
Patient Resources\
Pocket Guide/Reference Cards\
Quality Measures

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

#### RELATED NQMC MEASURES

-   [Tobacco use prevention and cessation for adults and mature
    adolescents: percentage of patients\' charts that either show that
    there is no tobacco use/exposure or (if a user) that the current use
    was documented at the most recent clinician
    visit.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=5485)

-   [Tobacco use prevention and cessation for adults and mature
    adolescents: percentage of patients with documented tobacco use or
    exposure at the latest visit who also have documentation that their
    cessation interest was assessed or that they received advice to
    quit.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=5486)

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Tobacco use
prevention and cessation for adults and mature adolescents. Bloomington
(MN): Institute for Clinical Systems Improvement (ICSI); 2004 Jun. 42 p.
\[46 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1994 May (revised 2004 Jun)

#### GUIDELINE DEVELOPER(S)

Institute for Clinical Systems Improvement - Private Nonprofit
Organization

#### GUIDELINE DEVELOPER COMMENT

Organizations participating in the Institute for Clinical Systems
Improvement (ICSI): Affiliated Community Medical Centers, Allina Medical
Clinic, Altru Health System, Aspen Medical Group, Avera Health,
CentraCare, Columbia Park Medical Group, Community-University Health
Care Center, Dakota Clinic, ENT SpecialtyCare, Fairview Health Services,
Family HealthServices Minnesota, Family Practice Medical Center, Gateway
Family Health Clinic, Gillette Children\'s Specialty Healthcare, Grand
Itasca Clinic and Hospital, Hamm Clinic, HealthEast Care System,
HealthPartners Central Minnesota Clinics, HealthPartners Medical Group
and Clinics, Hennepin Faculty Associates, Hutchinson Area Health Care,
Hutchinson Medical Center, Lakeview Clinic, Mayo Clinic, Mercy Hospital
and Health Care Center, MeritCare, Minnesota Gastroenterology,
Montevideo Clinic, North Clinic, North Memorial Health Care, North
Suburban Family Physicians, NorthPoint Health &: Wellness Center,
Northwest Family Physicians, Olmsted Medical Center, Park Nicollet
Health Services, Quello Clinic, Ridgeview Medical Center, River Falls
Medical Clinic, St. Mary\'s/Duluth Clinic Health System, St. Paul Heart
Clinic, Sioux Valley Hospitals and Health System, Southside Community
Health Services, Stillwater Medical Group, SuperiorHealth Medical Group,
University of Minnesota Physicians, Winona Clinic, Winona Health

ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425;
telephone, (952) 814-7060; fax, (952) 858-9675; e-mail:
<icsi.info@icsi.org>; Web site: [www.icsi.org](http://www.icsi.org/).

#### SOURCE(S) OF FUNDING

The following Minnesota health plans provide direct financial support:
Blue Cross and Blue Shield of Minnesota, HealthPartners, Medica,
Metropolitan Health Plan, PreferredOne, and UCare Minnesota. In-kind
support is provided by the Institute for Clinical Systems Improvement\'s
(ICSI) members.

#### GUIDELINE COMMITTEE

Preventive Services Steering Committee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Work Group Members*: David Klevan, MD (Work Group Leader)
(HealthPartners Medical Group) (Internal Medicine); Thomas E. Kottke, MD
(Mayo Clinic) (Cardiology); Donald A. Pine, MD (Park Nicollet Health
Services) (Family Practice); Michael Schoenleber, MD (HealthPartners
Medical Group) (Family Practice); David Rossmiller, MD (Family
HealthServices Minnesota) (Family Practice); Renee Compo, RN, CNP
(HealthPartners Medical Group) (Obstetrics/Gynecology Nurse
Practitioner); Janice Taramelli (Methodist Hospital/Park Nicollet
Institute) (Health Educator); Penny Carson (Institute for Clinical
Systems Improvement) (Measurement/Implementation Advisor); Peter Lynch,
MPH (Evidence Analyst) (Institute for Clinical Systems Improvement); Pam
Pietruszewski, MA (Institute for Clinical Systems Improvement)
(Facilitator)

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

In the interest of full disclosure, Institute for Clinical Systems
Improvement (ICSI) has adopted the policy of revealing relationships
work group members have with companies that sell products or services
that are relevant to this guideline topic. The reader should not assume
that these financial interests will have an adverse impact on the
content of the guideline, but they are noted here to fully inform users.
Readers of the guideline may assume that only work group members listed
below have potential conflicts of interest to disclose.

Thomas E. Kottke, M.D. receives grant support from Merck, and is a
consultant for Bayer and AstraZeneca.

No other work group members have potential conflicts of interest to
disclose.

ICSI\'s conflict of interest policy and procedures are available for
review on ICSI\'s website at [www.icsi.org](http://www.icsi.org/).

#### GUIDELINE STATUS

This is the current release of guideline.

It updates a previous version: Institute for Clinical Systems
Improvement (ICSI). Tobacco use prevention and cessation for adults and
mature adolescents. Bloomington (MN): Institute for Clinical Systems
Improvement (ICSI); 2003 Jul. 36 p.

#### GUIDELINE AVAILABILITY

Electronic copies of the updated guideline: Available from the
[Institute for Clinical Systems Improvement (ICSI) Web
site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/).

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   ICSI pocket guidelines. April 2004 edition. Bloomington (MN):
    Institute for Clinical Systems Improvement, 2004. 404 p.

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### PATIENT RESOURCES

The following is available:

-   Tobacco use prevention and cessation for adults. Bloomington (MN):
    Institute for Clinical Systems Improvement, 2005 Jan.

Electronic copies: Available in Portable Document Format (PDF) from the
[Institute for Clinical Systems Improvement (ICSI) Web
site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/for_patients_families/).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This summary was updated by ECRI on April 30, 1999. The information was
verified by the guideline developer as of April 30, 1999. This summary
was updated by ECRI on May 15, 2000, December 20, 2001, December 24,
2002, March 25, 2004, and September 24, 2004. This summary was updated
by ECRI Institute on November 6, 2007, following the U.S. Food and Drug
Administration advisory on Antidepressant drugs.

#### COPYRIGHT STATEMENT

This NGC summary (abstracted Institute for Clinical Systems Improvement
\[ICSI\] Guideline) is based on the original guideline, which is subject
to the guideline developer\'s copyright restrictions.

The abstracted ICSI Guidelines contained in this Web site may be
downloaded by any individual or organization. If the abstracted ICSI
Guidelines are downloaded by an individual, the individual may not
distribute copies to third parties.

If the abstracted ICSI Guidelines are downloaded by an organization,
copies may be distributed to the organization\'s employees but may not
be distributed outside of the organization without the prior written
consent of the Institute for Clinical Systems Improvement, Inc.

All other copyright rights in the abstracted ICSI Guidelines are
reserved by the Institute for Clinical Systems Improvement, Inc. The
Institute for Clinical Systems Improvement, Inc. assumes no liability
for any adaptations or revisions or modifications made to the abstracts
of the ICSI Guidelines.

### DISCLAIMER

#### NGC DISCLAIMER

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Date Modified: 11/3/2008