Date post: | 29-Dec-2015 |
Category: |
Documents |
Upload: | cory-blake-mcdonald |
View: | 214 times |
Download: | 0 times |
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
Brief history and developmental process
2008 PHS Clinical Practice Guideline 2008 PHS Clinical Practice Guideline Update: Treating Tobacco Use and Update: Treating Tobacco Use and DependenceDependence
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;
literature from 1995–1999;
approximately 6,000 articles
3. 2008—Updated Guideline published;
literature from 1999–2007;
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
Brief history and developmental process
Key findings of interest
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
Systems Interventions:Systems Interventions:Clinician Training and Chart Clinician Training and Chart RemindersReminders
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.)
No intervention 2 1.0 11.4
Training and
charting2
5.5
(4.1, 7.4)
41.4
(34.4, 48.8)
PHS39
Systems Interventions:Systems Interventions:Clinician Training and Chart Clinician Training and Chart RemindersReminders
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.)
No intervention 2 1.0 6.7
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
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.
10 Key Guideline Recommendations10 Key Guideline Recommendations
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
10 Key Guideline Recommendations10 Key Guideline Recommendations
PHS49
10 Key Guideline Recommendations10 Key Guideline Recommendations
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.
10 Key Guideline Recommendations10 Key Guideline Recommendations
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.
10 Key Guideline Recommendations10 Key Guideline Recommendations
PHS52
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
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