1 Treating Tobacco Use and Dependence 2008 UPDATE U.S. Public Health Service Clinical Practice Guideline

1

Treating Tobacco Use Treating Tobacco Use and Dependenceand Dependence

2008 UPDATE

U.S. Public Health ServiceU.S. Public Health ServiceClinical Practice GuidelineClinical Practice Guideline

PHS2

2008 PHS Clinical Practice Guideline 2008 PHS Clinical Practice Guideline Update: Treating Tobacco Use and Update: Treating Tobacco Use and DependenceDependence

Brief history and developmental process

Key findings of interest

Getting more information

PHS3



PHS4

2008 PHS Clinical Practice Guideline: 2008 PHS Clinical Practice Guideline: Treating Tobacco Use and Treating Tobacco Use and Dependence UpdateDependence Update

History:

1. 1996—Initial Guideline published;

literature from 1975–1995;

approximately 3,000 articles

2. 2000—Revised Guideline published;


approximately 6,000 articles

3. 2008—Updated Guideline published;


approximately 8,700 total articles

PHS5

Update process started 7-1-06

Scope remains the treatment of tobacco use

and dependence

Update rather than a full rewrite

Used very similar development process

2008 PHS Clinical Practice Guideline: Treating 2008 PHS Clinical Practice Guideline: Treating Tobacco Use and Dependence UpdateTobacco Use and Dependence Update

PHS6

Funded byFunded by

Agency for Healthcare Research and Quality

National Cancer Institute

National Heart, Lung & Blood Institute

National Institute on Drug Abuse

Centers for Disease Control and Prevention

The Robert Wood Johnson Foundation

American Legacy Foundation

University of Wisconsin-Center for Tobacco Research and Intervention

PHS7

Panel MembersPanel MembersMichael C. Fiore, MD, MPH, Chair

Carlos Roberto Jaén, MD, PhD, FAAFP, Vice-Chair

Timothy Baker, PhD, Senior Scientist

William C. Bailey, MD, FACP, FCCP

Neal Benowitz, MD

Susan J. Curry, PhD

Sally Faith Dorfman, MD, MSHSA

Erika S. Froelicher, RN, MA, MPH, PhD

Michael G. Goldstein, MD

Cheryl Healton, DrPH

Patricia Nez Henderson, MD, MPH

Richard B. Heyman, MD

Howard Koh, MD, MPH, FACP

Thomas E. Kottke, MD, MSPH

Harry A. Lando, PhD

Robert Mecklenburg, DDS, MPH

Robin Mermelstein, PhD

Patricia Mullen, Dr PH

C. Tracy Orleans, PhD

Lawrence Robinson, MD, MPH

Maxine Stitzer, PhD

Anthony Tommasello, Pharm BS, PhD

Louise Villejo, MPH, CHES

Mary Ellen Wewers, PhD, RN, MPH

PHS8

PHS LiaisonsPHS Liaisons Ernestine (Tina) Murray, AHRQ (Project Officer)

Christine Williams, AHRQ

Glen Bennett, NHLBI

Stephen Heishman, NIDA

Corrine Husten, CDC

Glen Morgan, NCI

PHS9

Guideline Update Development Guideline Update Development PhasesPhases

1. Identify update topics

2. Meta-analysis of topics

3. Panel/liaisons workgroups

4. Establish recommendations and other content

5. Draft text

6. Peer review/public comment

7. Released – May 7, 2008*

* Full Guideline, including detailed financial disclosure information, available at www.surgeongeneral.gov/tobacco

PHS10

Final Selected TopicsFinal Selected Topics Proactive quitlines

Combining counseling and medication relative to either counseling or medication alone

Varenicline

Various medication combinations

Long-term medication use

Tobacco use interventions for individuals with low socio-economic status/limited formal education

Tobacco use interventions for adolescent smokers

Tobacco use interventions for pregnant smokers

Tobacco use interventions for individuals with psychiatric disorders, including substance abuse disorders

Providing cessation interventions as a health benefit

Systems interventions, including provider training and the combination of training and systems interventions

PHS11

Peer Review/Public CommentPeer Review/Public Comment

Over 90 independent tobacco treatment

experts served as peer reviewers

Federal Register notice announced availability

of guideline for public comment

PHS12

2008 PHS Clinical Practice 2008 PHS Clinical Practice Guideline Update: Treating Tobacco Guideline Update: Treating Tobacco Use and DependenceUse and Dependence



PHS13

Combinations: Medication and Combinations: Medication and CounselingCounseling

Effectiveness of and estimated abstinence rates for the combination of counseling and medication versus medication alone (n = 18 studies)

TreatmentNumber

of arms

Estimate

d

odds

ratio

(95% C.I.)

Estimated

abstinence

rate (95%

C.I.)

Medication

alone8 1.0 21.7

Medication

and

counseling

391.4

(1.2, 1.6)

27.6

(25.0, 30.3)

PHS14

Combinations: Medication and Combinations: Medication and CounselingCounseling

Effectiveness of and estimated abstinence rates for the combination of counseling and medication versus counseling alone (n = 9 studies)

TreatmentNumber

of arms

Estimate

d

odds

ratio

(95% C.I.)

Estimated

abstinence

rate (95%

C.I.)

Counseling

alone11 1.0 14.6

Medication

and

counseling

131.7

(1.3, 2.1)

22.1

(18.1, 26.8)

PHS15

TreatmentTreatment RecommendationsRecommendations –– CounselingCounselingCombining Counseling and Medication

Recommendation: The combination of counseling and medication is more effective for smoking cessation than either medication or counseling alone. Therefore, whenever feasible and appropriate, both counseling and medication should be provided to patients trying to quit smoking. (Strength of Evidence = A).

Recommendation: There is a strong relation between the number of sessions of counseling when it is combined with medication, and the likelihood of successful smoking cessation. Therefore, to the extent possible, clinicians should provide multiple counseling sessions, in addition to medication, to their patients who are trying to quit smoking. (Strength of Evidence = A).

PHS16

Strength of Evidence for Strength of Evidence for RecommendationsRecommendations

Classification Criteria

Strength of

Evidence = A

Multiple well-designed randomized clinical trials, directly

relevant to the recommendation, yielded a consistent

pattern of findings.

Strength of

Evidence = B

Some evidence from randomized clinical trials

supported the recommendation, but the scientific

support was not optimal. For instance, few randomized

trials existed, the trials that did exist were somewhat

inconsistent, or the trials were not directly relevant to

the recommendation.

Strength of

Evidence = C

Reserved for important clinical situations where the

panel achieved consensus on the recommendation in

the absence of relevant randomized controlled trials.

PHS17

Pro-Active QuitlinesPro-Active QuitlinesEffectiveness of and estimated abstinence rates for quitline counseling compared to minimal interventions, self-help or no counseling (n = 9 studies)

InterventionNumber

of arms

Estimated

odds ratio

(95% C.I.)

Estimated

abstinence rate

(95% C.I.)

Minimal or

no counseling

or self-help

11 1.0 8.5

Quitline

counseling 11

1.6

(1.4, 1.8)

12.7

(11.3, 14.2)

PHS18

Effectiveness of and estimated abstinence rates for quitline counseling and medication compared to medication alone (n = 6 studies)

InterventionNumber

of arms

Estimated

odds ratio

(95% C.I.)

Estimated

abstinence rate

(95% C.I.)

Medication alone 6 1.0 23.2

Medication and

quitline counseling 6

1.3

(1.1, 1.6)

28.1

(24.5, 32.0)

Pro-Active QuitlinesPro-Active Quitlines

PHS19

MedicationMedication

Seven first-line medications shown to be effective and recommended for use by the Guideline Panel:

– Bupropion SR – Nicotine Gum– Nicotine Inhaler– Nicotine Lozenge– Nicotine Nasal Spray– Nicotine Patch– Varenicline

PHS20

VareniclineVareniclineEffectiveness and abstinence rates for various medications and medication combinations compared to placebo at 6-months post-quit (n = 86 studies)

MedicationNumber

of arms

Estimated

odds ratio

(95% C. I.)

Estimated

abstinence rate

(95% C. I.)

Placebo 80 1.0 13.8

Varenicline

(2 mg/day)5

3.1

(2.5, 3.8)

33.2

(28.9, 37.8)

PHS21

Nicotine LozengeNicotine Lozenge

Lozenge

Dose

N for active/

N for placebo

Odds Ratio

(95% C.I.)

Continuous abstinence

rates at 6 months

(Active/Placebo)

2 mg 459/4582.0

(1.4, 2.8)24.2/14.4

4 mg 450/4512.8

(1.9, 4.0)23.6/10.2

Effectiveness of the nicotine lozenge: Results from the single randomized controlled trial.

PHS222222

Relative EfficacyRelative Efficacy

MedicationNumber

of arms

Estimated

odds ratio

(95% C. I.)

Nicotine Patch (reference

group)32 1.0

Varenicline (2 mg/day) 51.6

(1.3, 2.0)

Patch (long-term; >14 weeks)

+ NRT (gum or spray)3

1.9

(1.3, 2.7)

Patch + Bupropion SR 31.3

(1.0, 1.8)

PHS23

Medication RecommendationMedication Recommendation

Recommendation: Certain combinations of first-line medications have been shown to be effective smoking cessation treatments. Therefore, clinicians should consider using these combinations of medications with their patients who are willing to quit. Effective combination medications are:

* Long-term (> 14 weeks) nicotine patch + other NRT (gum and spray)

* The nicotine patch + the nicotine inhaler

* The nicotine patch + bupropion SR.

(Strength of Evidence = A)

PHS24

Specific PopulationsSpecific Populations

Children and Adolescent Smokers

Light Smokers

Noncigarette Tobacco Users

Pregnant Smokers

PHS25

Special PopulationsSpecial Populations

HIV-positive smokers

Hospitalized smokers

Lesbian/gay/bisexual/

transgender smokers

Smokers with low

SES/limited formal

education

Smokers with medical

comorbidities

Older smokers

Smokers with

psychiatric disorders

including substance use

disorders

Racial and ethnic

minority smokers

Women smokers

PHS26

Low Socio-Economic Status/Limited Low Socio-Economic Status/Limited Formal EducationFormal Education

InterventionNumber

of arms

Estimated

odds ratio

(95% C. I.)

Estimated

abstinence

rate (95% C. I.)

Usual care or

no counseling6 1.0 13.2

Counseling 51.42

(1.0,1.9)

17.7

(13.7, 22.6)

Effectiveness of and estimated abstinence rates for counseling interventions with low socio-economic status/limited formal education (n = 5 studies)

PHS27

Psychiatric Disorders Including Psychiatric Disorders Including Substance Use DisordersSubstance Use Disorders

InterventionNumber

of arms

Estimated

odds ratio

(95% C. I.)

Estimated

abstinence

rate (95% C. I.)

Placebo 5 1.0 13.2

Bupropion SR or

nortryptyline8

3.4

(1.7, 6.8)

29.9

(17.5, 46.1)

Effectiveness of and estimated abstinence rates for treatment with bupropion and nortryptyline for smokers with a history of depression (n = 4 studies)

PHS28

Specific Populations and Other Specific Populations and Other Topics Topics

Recommendation: The interventions found to be effective in this Guideline have been shown to be effective in a variety of populations. In addition, many of the studies supporting these interventions comprised diverse samples of tobacco users. Therefore, interventions identified as effective in this Guideline are recommended for all individuals who use tobacco except when medication use is contraindicated or with specific populations in which medication has not been shown to be effective (pregnant women, smokeless tobacco users, light smokers and adolescents). (Strength of Evidence = B).

PHS29

Adolescent SmokersAdolescent Smokers

Effectiveness of and estimated abstinence rates for counseling interventions with adolescent smokers (n = 7 studies)

Adolescent

smokers

Number

of arms

Estimated

odds ratio

(95% C.I.)

Estimated

abstinence rate

(95% C.I.)

Usual care 7 1.0 6.7

Counseling 71.8

(1.1, 3.0)

11.6

(7.5, 17.5)

PHS30

Adolescent SmokersAdolescent Smokers

Children and Adolescents:

Recommendation: Clinicians should ask pediatric and adolescent patients about tobacco use and provide a strong message regarding the importance of totally abstaining from tobacco use. (Strength of Evidence = C)

Recommendation: Counseling has been shown to be effective in treatment of adolescent smokers. Therefore, adolescent smokers should be provided with counseling interventions to aid them in quitting smoking. (Strength of Evidence = B)

Recommendation: Second-hand smoke is harmful to children. Cessation counseling delivered in pediatric settings has been shown to be effective in increasing abstinence among parents who smoke. Therefore, in order to protect children from second-hand smoke, clinicians should ask parents about tobacco use and offer them cessation advice and assistance. (Strength of Evidence = B)

PHS31

Pregnant SmokersPregnant Smokers

Effectiveness of and estimated pre-parturition abstinence rates for psychosocial interventions with pregnant smokers (n = 8 studies)

Pregnant

smokers

Number of

arms

Estimated

odds ratio

(95% C.I.)

Estimated

abstinence

rate (95% C.I.)

Usual care 8 1.0 7.6

Psychosocial

intervention

(abstinence

pre-parturition)

91.8

(1.4, 2.3)

13.3

(9.0, 19.4)

PHS32

Pregnant SmokersPregnant Smokers

Recommendation: Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever possible pregnant smokers should be offered person-to-person psychosocial interventions that exceed minimal advice to quit. (Strength of Evidence = A)

Recommendation: Although abstinence early in pregnancy will produce the greatest benefits to the fetus and expectant mother, quitting at any point in pregnancy can yield benefits. Therefore, clinicians should offer effective tobacco dependence interventions to pregnant smokers at the first prenatal visit as well as throughout the course of pregnancy. (Strength of Evidence = B)

PHS33

System RecommendationsSystem Recommendations

Intervention as a covered health care benefit

Clinician training and chart reminders

Tobacco dependence treatment as a part of

assessing health care quality

Cost-effectiveness of tobacco dependence

Interventions

PHS34

Intervention as a Covered Health Intervention as a Covered Health BenefitBenefit

Estimated rates of quit attempts for individuals who received tobacco use interventions as a covered health insurance benefit (n = 3 studies)

TreatmentNumber

of arms

Estimated

odds ratio

(95% C.I.)

Estimated

quit attempt

rate (95% C.I.)

Individuals with no

covered benefit3 1.0 30.5

Individuals with

the benefit 3

1.3

(1.01, 1.5)

36.2

(32.3, 40.2)

PHS35

Intervention as a Covered Health Intervention as a Covered Health BenefitBenefitEstimated abstinence rates for individuals who received tobacco use interventions as a covered benefit (n = 3 studies)

TreatmentNumber

of arms

Estimated

odds ratio

(95% C.I.)

Estimated

abstinence rate

(95% C.I.)

Individuals with

no covered

benefit

3 1.0 6.7

Individuals with

the benefit 3

1.6

(1.2, 2.2)

10.5

(8.1, 13.5)

PHS36

Intervention as a Covered Health Intervention as a Covered Health BenefitBenefit

Recommendation: Providing tobacco dependence treatments (both medication and counseling) as a paid or covered benefit by health insurance plans has been shown to increase the proportion of smokers who use cessation treatment, attempt to quit, and successfully quit. Therefore, treatments shown to be effective in the Guideline should be included as covered services in public and private health benefit plans. (Strength of Evidence = A).

PHS37

Systems Interventions:Systems Interventions:Clinician Training and Chart Clinician Training and Chart RemindersReminders

Effectiveness of clinician training combined with charting on asking about smoking status (“Ask”)(n = 3 studies)

InterventionNumber

of arms

Odds Ratio

(95% C.I.)

Estimated rate

(95% C.I.)

No intervention 3 1.0 58.8

Training and

charting3

2.1

(1.9, 2.4)

75.2

(72.7, 77.6)

PHS38


Effectiveness of training combined with charting on setting a quit date (“Assist”) (n = 2 studies)

InterventionNumber

of arms

Odds Ratio

(95% C.I.)

Estimated rate

(95% C.I.)


Training and

charting2

5.5

(4.1, 7.4)

41.4

(34.4, 48.8)

PHS39


Effectiveness of training combined with charting on arranging for follow-up (“Arrange”) (n = 2 studies)

InterventionNumber

of arms

Odds Ratio

(95% C.I.)

Estimated rate

(95% C.I.)


Training and

charting 2

2.7

(1.9, 3.9)

16.3

(11.8, 22.1)

PHS40

Systems Interventions:Systems Interventions:Clinician Training and Chart RemindersClinician Training and Chart Reminders

Clinician Training and Reminder Systems:

Recommendation: All clinicians and clinicians-in-training should be trained in effective strategies to assist tobacco users willing to make a quit attempt and to motivate those unwilling to quit. Training appears to be more effective when coupled with systems changes. (Strength of Evidence = B).

PHS41

Recommendation: Motivational intervention techniques appear to be effective in increasing a patient’s likelihood of making a future quit attempt. Therefore, clinicians should use motivational techniques to encourage smokers who are not currently willing to quit to consider making a quit attempt in the future. (Strength of Evidence = B).

For Smokers Not Willing To Make a For Smokers Not Willing To Make a Quit Attempt at This TimeQuit Attempt at This Time

PHS42

Ask Ask about tobacco use. Identify and document tobacco use status for every patient at every visit.

AdviseAdvise to quit. In a clear, strong and personalized manner urge every tobacco user to quit.

AssessAssess willingness to make a quit attempt. Is the tobacco user willing to make a quit attempt at this time?

Assist Assist in quit attempt. For the patient willing to make a quit attempt, use counseling or pharmacotherapy to help him or her quit.

ArrangeArrange followup. Schedule followup contact, preferably within the first week after the quit date.

The "5 A's" Model for Treating Tobacco The "5 A's" Model for Treating Tobacco Use and Dependence - 2000Use and Dependence - 2000

PHS43

Ask Ask about tobacco use. Identify and document tobacco use status for every patient

at every visit.

Advise Advise to quit. In a clear, strong and personalized manner urge every tobacco user

to quit.

Assess Assess willingness to make a quit attempt. Is the tobacco user willing to make a

quit attempt at this time?

Assist Assist in quit attempt. For the patient willing to make a quit attempt, offer

medication and provide or refer for counseling or additional treatment to help

the patient quit. For patients unwilling to quit at the time, provide For patients unwilling to quit at the time, provide

interventions designed to increase future quit attempts.interventions designed to increase future quit attempts.

ArrangeArrange followup. For the patient willing to make a quit attempt, arrange for follow-

up contacts, beginning within the first week after the quit date.

For patients unwilling to make a quit attempt at the time, address tobacco For patients unwilling to make a quit attempt at the time, address tobacco

dependence and willingness to quit at next clinic visit.dependence and willingness to quit at next clinic visit.

The "5 A's" Model for Treating Tobacco Use The "5 A's" Model for Treating Tobacco Use and Dependence - 2008and Dependence - 2008

PHS44

The "5 A's" Model for Treating Tobacco Use The "5 A's" Model for Treating Tobacco Use and Dependence - 2008and Dependence - 2008

PHS45

10 Key 10 Key Guideline Guideline RecommendationsRecommendations

PHS46

1. Tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit. However, effective treatments exist that can significantly increase rates of long-term abstinence.

2. It is essential that clinicians and healthcare delivery systems consistently identify and document tobacco use status and treat every tobacco user seen in a healthcare setting.

10 Key Guideline Recommendations10 Key Guideline Recommendations

PHS47

3. Tobacco dependence treatments are effective across a broad range of populations. Clinicians should encourage every patient willing to make a quit attempt to use the counseling treatments and medications recommended in this Guideline.


PHS48

4. Brief tobacco dependence treatment is effective.

Clinicians should offer every patient who uses tobacco at least the brief treatments shown to be effective in this Guideline.

5. Individual, group and telephone counseling are effective, and their effectiveness increases with treatment intensity. Two components of counseling are especially effective and clinicians should use these when counseling patients making a quit attempt.

• Practical counseling (problemsolving/skills training)• Social support delivered as part of treatment


PHS49


6. There are numerous effective medications for tobacco dependence and clinicians should encourage their use by all patients attempting to quit smoking, except when medically contraindicated or with specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers and adolescents).

• Seven first-line medications (5 nicotine and 2 non-nicotine) reliably increase long-term smoking abstinence rates:

Bupropion SR Nicotine nasal spray

Nicotine gum Nicotine patch

Nicotine inhaler Varenicline

Nicotine lozenge

Clinicians should also consider the use of certain combinations of medications identified as

effective in this Guideline.

PHS50

7. Counseling and medication are effective when used by themselves for treating tobacco dependence. However, the combination of counseling and medication is more effective than either alone. Thus, clinicians should encourage all individuals making a quit attempt to use both counseling and medication.

8. Telephone quitline counseling is effective with diverse populations and has broad reach. Therefore, clinicians and healthcare delivery systems should both ensure patient access to quitlines and promote quitline use.


PHS51

9. If a tobacco user is currently unwilling to make a quit attempt, clinicians should use the motivational treatments shown in this Guideline to be effective in increasing future quit attempts.

10. Tobacco dependence treatments are both clinically effective and highly cost-effective relative to interventions for other clinical disorders. Providing coverage for these treatments increases quit rates. Insurers and purchasers should ensure that all insurance plans include the counseling and medication identified as effective in this Guideline as covered benefits.


PHS52




Getting more information

PHS53

Key Guideline Web LinksKey Guideline Web Links

Guideline Materials

http://www.surgeongeneral.gov/tobacco/http://www.surgeongeneral.gov/tobacco/

List of over 55 endorsing organizations at

http://www.ctri.wisc.edu/Researchers/http://www.ctri.wisc.edu/Researchers/researchers_CPGupdate2008_endorse.htmresearchers_CPGupdate2008_endorse.htm

May 7th Webcast

http://www.ctri.wisc.edu/ http://www.ctri.wisc.edu/

then click on View the Webcast

UW-CTRI

www.ctri.wisc.eduwww.ctri.wisc.edu

Documents

1 Treating Tobacco Use and Dependence 2008 UPDATE U.S. Public Health Service Clinical Practice Guideline