S3 Guideline “Screening, Diagnostics, and Treatment of Harmful and Addictive Tobacco Use”

Method

The Tobacco Guideline initiated by the German Society for Psychiatry, Psychotherapy, Psychosomatic, and Neurology (DGPPN) as well as the German Society for Addiction Research and Addiction Therapy (DG-Sucht) was developed by 19 authors. A total of 50 persons were involved in the production process of the text over 4 years, for the most part via voluntary work. For the costs incurred between October 2010 (start of design) and October 2014 (presentation of guideline to the AWMF), only interest-free donations (e. g., financial contributions of the DG-Sucht and the DGPPN) as well as contributions in form of personal support from the Central Institute of Mental Health in Mannheim and the Section of Addiction Research and Addiction Medicine in Tübingen) were applied. No third-party funds from private companies were accepted.

The Tobacco Guideline was developed in a methodological process guided by a Steering Committee consisting of prestigious addiction researchers, scientifically supported by the AWMF together with a further S3 guideline for substance-associated disorders: the Alcohol Guideline. The constituent teleconference of this steering group took place on January 10, 2011. During a systematic overview, one or more scientists can elaborate on the state of research and can use their position for the interpretation of the derivation of guidelines, whereas the recommendations of an S3 guideline are negotiated in a much more complicated methodological process. This was also true for the Tobacco Guideline, whre clinical issues were defined in a consensus process and relevant information from systematically researched basic guidelines as well as systematic reviews of the Cochrane Tobacco Addiction Group were obtained. The responsible work groups applied the Scientific Guideline Manager of the Institute for Lung Research as technical tool for this systematic literature review.

The basic aim of the guideline process was to formulate treatment recommendations: What should or can generally be offered smokers specifically as motivation or support in smoking cessation? Additionally, questions were answered concerning screening, diagnostics, and documentation as well as adequate settings. Recommendations furthermore address problematic offers that should not be adopted.

The level of evidence (LoE) assigned to the recommendations also inform about the quality and reliability of the scientific information in the respective recommendation. Recommendation levels (A = strong recommendation, corresponding to “is to be”, B to “should”, O to “can”) stem from a complex consideration of the LoE regarding the clinical relevance, the benefit-risk profile, patient preferences, implementability into the treatment, and where applicable other relevant variables. If no systematic literature research has been carried out, recommendations considered necessary could also be formulated as “clinical consensus issues” (CCI).

All recommendations based on background texts, recommendation levels, and evaluations of evidence levels were presented to the attending experts during the “consensus conferences.” During these days-long conferences, moderated by a representative of the AWMF and attended by a representative group of up to 35 delegates of expert societies, professional associations, and representatives of patients and relatives, the suggestions for recommendations were discussed intensively and if necessary modified, until they could either be accepted or refused. The potential influence of conflicts of interests were considered in all votes: Existing declarations of all delegates on potential or actual conflicts of interests were used by an independent third party in order to decide whether delegates were allowed to take part in votes concerning scientific areas in which potential conflicts of interests had been determined.

All 78 recommendations of this Guideline and the three clinical algorithms employed to visualize the treatment process according to the Guideline received the approval of at least 75 % (on average 95.2 %) of the delegates of a consensus conference (see Table 1). A detailed description of the methodology may be found in the guideline report of the extended version of the Guideline. ( http://www.awmf.org/uploads/tx_szleitlinien/076-006m_S3_Tabak_2015-02.pdf)

Table 1 Overview of recommendations of the Tobacco Guideline

Partial chapter	Recommendation level						Number ofrecommendations	Mean consent
A(+)	B(+)	0	B(–)	A(–)	CCI
Note. The recommendation levels are A (strong recommendation, “are to be offered”), B (recommendation, “should be offered”) 0 (unclear recommendation, “can be offered”). (+) is the recommendation to offer something, (–) the recommendation, not to offer something. CCI is a decision of the clinical consent (clinical consensus issue), i. e., not on the basis of a systematic review. Consent rule: > 75 % = consent; > 95 % = strong consent.
Diagnostics and documentation	2	–	–	–	–	1	3	(=) 95 %
Motivation treatment and brief interventions	2	5	–	–	–	–	7	96 %
Harm reduction	-	1	–	–	–	1	2	91 %
Psychotherapeutic interventions	2	–	3	1	–	1	7	(>) 95 %
Medication	7	–	5	4	1	–	17	89 %
Somatic therapy approaches	–	–	1	1	–	–	2	87 %
Women	1	1	2	–	–	1	5	98 %
Pregnant women	2	–	1	1	–	2	6	99 %
Adolescents	2	2	–	–	1	1	6	98 %
Older people	3	1	–	–	–	1	5	100 %
Somatic comorbidity	4	1	–	–	–	1	6	98 %
Mental comorbidity	3	3	–	–	–	3	9	98 %
Setting, treatment situation	–	–	–	–	–	3	3	98 %
Total:	28	14	12	7	2	15	78	(>) 95 %(95.2)

Table 1 Overview of recommendations of the Tobacco Guideline

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Results and Discussion

When people contact the health system as patients, their cigarette smoking status is systematically queried. This information is also included in the patient’s documentation. If the severity of the tobacco dependence needs to be assessed in a further diagnostic process, this is done via the Fagerström Test for Tobacco Dependence (FTCD). Smokers who are willing to quit but require external support initially receive offers for low-threshold approaches, especially brief counseling, motivational therapy, and telephone counseling. If more intensive treatment is required, behavioral single or group therapy, possibly combined with medications, can be suggested. In cases involving distinct withdrawal symptoms, medications should be recommended. If a nicotine replacement therapy or a combination of nicotine replacement therapies proves ineffective, varenicline or bupropion should be offered after determining the indications or contraindications. Children, adolescents, and pregnant women should not be prescribed medication for withdrawal treatments.

The recommendations of the present Guideline largely comply with other more recent national and international guidelines for smoking cessation. The German Tobacco Guideline, however, puts more emphasis than other international guidelines on the assessment of potential risks and contraindications concerning the pharmacological interventions.

Diagnostics: Categorical and Dimensional

Table 2

Table 2

	Recommendation statements	Recommendation level
1.1	Fagerström Test for CigaretteDependence (FTCD) The Fagerström Test is to be applied for further diagnostics to estimate severity of cigarette dependence.	CCI
1.2	Systematic screening All patients are to be asked for their tobacco use.	A

Table 2

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Documentation

Table 3

Table 3

	Recommendation statements	Recommendation level
1.3	Assessment in documentation system Systematic assessment for tobacco use in the patient documentation improves the intervention rates. Tobacco use is to be assessed consecutively in the patient documentation.	A

Table 3

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Motivational Treatment and Brief Interventions

Table 4

Table 4

	Recommendation statements	Recommendation level
2.1	Brief counseling In medical and psychosocial healthcare offer brief counseling for smokers to achieve smoking cessation.	A
2.2	Brief counseling (contents) Brief counseling for smokers willing to quit should include a reference to further supportive offers such as single or group therapy or telephone counseling.	B
2.3	Motivational Interviewing Motivational Interviewing should be offered to smokers with low motivation for smoking cessation.	B
2.4	Telephone counseling In medical and psychosocial healthcare, offer telephone counseling to achieve smoking cessation.	A
2.5	Internet-based self-help programs To support achieving smoking cessation, offer internet-based self-help programs.	B
2.6	Mobile self-help programs To support achieving smoking cessation, offer mobile self-help programs.	B
2.7	Self-help materials In medical and psychosocial healthcare, make classical self-help materials available to achieve smoking cessation.	B

Table 4

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Harm Reduction

Table 5

Table 5

	Recommendation statements	Recommendation level
3.1	Electronic cigarette (E-cigarette) E-cigarettes should not be recommended, before having been examined under the conditions of the drug safety testing concerning their efficacy and tolerability for harm reduction and smoking cessation.	CCI
3.2	Programs for reduction of tobacco use If smokers are unable or unwilling to quit or reduce their tobacco consumption, offer support for reduction of use (NET, counseling, behavioral therapy).	B

Table 5

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Psychotherapeutic Interventions

Table 6

Table 6

	Recommendation statements	Recommendation level
4.1	Behavioral group interventions Behavioral group interventions to achieve tobacco abstinence are effective. They are to be offered in medical and psychosocial healthcare.	A
4.2	Behavioral single interventions Behavioral single interventions to achieve smoking cessation are effective. They are to be offered in medical and psychosocial health care.	A
4.3	Psychodynamic therapy No evidence for the efficacy for psychodynamic therapy to achieve smoking cessation. Therefore, no recommendation either for or against psychodynamic therapy approaches can be given.
4.4	Hypnotherapy The available data on the efficacy of hypnotherapy to achieve tobacco abstinence are inconsistent and require further attention. Hypnotherapy can be offered.	0
4.5	Aversion therapy Studies on the efficacy of aversion therapies as monotherapy are out of date, but the efficacy appears to be questionable, and potential risks exist. Aversion therapy should not be offered.	B
4.6	Relevance of single componentsfor effectivity Insufficient data are available concerning the relevance of single components for the efficacy of behavioral treatment approaches. Behavioral treatment approaches should contain several components. The following are especially recommended: • psychoeducation • motivation enhancement • measures for short-term relapse prevention • interventions to reinforce self-efficacy • counseling, suitable for daily practice with concrete behavioral instructions and practical behavioral coping strategies (problem solving and skills training, stress management).	CCI
4.7	Minimal and optimal duration ofpsychosocial treatments There are no indications for a strong dose-effect relationship of psychotherapeutic interventions. Because of missing data, no recommendation for duration and frequency of sessions can be given.

Table 6

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Medications for Withdrawal Treatment and Relapse Prevention (e. g., Nicotine Replacement Therapy, Bupropion, Varenicline, Other Antidepressants and Substance Groups Not to Be Considered)

Table 7

Table 7

	Recommendation statements	Recommendation level
5.1	Nicotine replacement therapy Offer the application of nicotine replacement therapies (nicotine gum, nicotine inhaler, nicotine lozenges, nicotine spray and nicotine patches).	A
5.1.1	Dosage of nicotine gums for strongsmokers For strong smokers 4 mg nicotine gums should be given rather than 2 mg gum.	A
5.1.2	Nicotine replacement therapy,compoundcombination for strong smokers For strong smokers, offer a twofold combination of patch and gum, lozenge, spray or inhaler.	A
5.1.3	Nicotine replacement therapy,combination with bupropion If a guideline-based, implemented pharmaceutical treatment failed to show sufficient effects in strong smokers, offer bupropion under consideration of and after informing about possible risks in combination with a long-term nicotine replacement therapy (patch).	0
5.1.4	Nicotine replacement therapy forrelapseprevention Nicotine replacement therapy can be offered for relapse prevention.	0
5.1.5	Nicotine replacement therapy for use of smokeless tobacco products Nicotine replacement therapy should not be offered for withdrawal from smokeless tobacco products.	B
5.2.1	Antidepressants: bupropion If a guideline-based, implemented pharmaceutical treatment with nicotine replacement therapy failed to show sufficient effects, offer bupropion as pharmacological monotherapy for smoking cessation under consideration of and after informing about possible risks.	A
5.2.2	Antidepressant: nortriptyline Nortriptyline can be offered for smoking cessation under consideration of possible risks, if approved therapy approaches were unsuccessful. In Germany, however, nortriptyline is not approved for this indication (see Appendix, criteria for off-label use).	0
5.2.3	Antidepressants: Others Offer other antidepressants for smoking cessation.	A
5.3.1	Partial nicotine receptor agonists:varenicline If a guideline-based, implemented pharmaceutical treatment with nicotine replacement therapy failed to be effective, offer varenicline for smoking cessation under consideration of and after informing about possible risks.	A
5.3.2	Partial nicotine receptor agonists:cytisine Cytisine can be offered. In Germany, however, it is not approved for this indication (see Appendix, criteria for off-label use).	0
5.3.3	Partial nicotine receptor agonists:Others Other partial nicotine receptor agonists should not be offered.	B
5.4	Clonidine A therapy attempt with clonidine can be offered for smoking cessation under consideration of and after informing about possible risks, if guideline-based therapy approaches fail to show any success. In Germany, however, clonidine is not approved for this indication (see Appendix, criteria for off-label-use).	0
5.5	All other medications All other substances should not be offered because of a lack of evidence of efficacy and/or adverse benefit-risk profile.	B
5.6	Duration of pharmaceutical relapseprevention If continuation of ongoing pharmaceutical treatment for relapse prevention is being considered, nicotine replacement therapy can be offered for 16 – 24 weeks, varenicline for 24 weeks, and bupropion for 16 – 45 weeks.	0
5.7	Combination of counseling andmedication Smokers who want to quit tobacco use and who are offered medication for smoking cessation treatment are to receive concomitant counseling to support smoking cessation.	A
5.8	Behavioral therapy resp. intensive counseling and nicotine replacement therapy If available and appropriate, a combination of medication with behavioral therapy for smoking cessation treatment is to be offered.	A

Table 7

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Somatic Therapy Approaches (e. g., Acupuncture, Magnetic Stimulation, Electronic Cigarette)

Table 8

Table 8

	Recommendation statements	Recommendation level
6.1	Acupuncture Acupuncture does not have any specific effect on long-term tobacco abstinence. Acupuncture cannot be recommended.	0
6.2	Electronic cigarette The data on safety and efficacy of electronic cigarettes for smoking cessation are insufficient. The electronic cigarette should not be offered for smoking cessation.	B

Table 8

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Sex and Age Aspects (e. g., Women, Pregnancy, Adolescents)

Adolescents

Table 9

Table 9

	Recommendation statements	Recommendation level
7.1.1	Adolescents are to be offered a combination of age-appropriate psychoeducation, motivational enhancement (motivational enhancement, self-efficacy) and behavioral therapies.	A
7.1.2	Low-threshold interventions (brief counseling, self-help material, smoker’s handbook, quick guides, information material, skills communication) should be offered to adolescents as recommended in Section 4.1.	B
7.1.3	In certain exceptional cases, nicotine patches can be offered to adolescents, if other recommended interventions were not successful, within the scope of the smoking-cessation treatment under careful consideration of the benefit-risk profile as off-label prescription (see Appendix 1). Other application forms of the nicotine replacement therapy are not to be applied for this age group.	CCI
7.1.4	Further medications for smoking cessation treatment (e. g., bupropion and varenicline; see Section 4.4) are not to be offered to adolescents.	A
7.1.5	Smoking cessation programs with a focus on behavioral therapy, motivational intervention, and enhancement of perceived self-efficacy are to be offered to adolescents.	A
7.1.6	Computer-, internet-, and smartphone-based programs for smoking cessation should be offered to adolescents.	B

Table 9

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Women

Table 10

Table 10

	Recommendation statements	Recommendation level
8.2.1	Women are to be offered the complete spectrum of the smoking cessation interventions, recommended in Sections 4.1 – 4.5.	A
8.2.2	Additional gender-specific procedures for smoking cessation (e. g., weight control, coping with fears about weight gain, mood management, coordination of smoking cessation to menstrual cycle) can be offered to women.	0
8.2.3	Special low-threshold offers can be offered to women.	0
8.2.4	Nicotine replacement compounds, varenicline, and bupropion should be offered to women under consideration of and after informing about possible risks.	B
8.2.5	Psychotherapeutic procedures and counseling are to be offered to women as noted in Section 4.3.	CCI

Table 10

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Pregnant Women

Table 11

Table 11

	Recommendation statements	Recommendation level
8.3.1	Special procedures for smoking cessation are to be offered to pregnant women.	CCI
8.3.2	Low-threshold offers (self-help manuals, information material, quick-guides) can be offered to pregnant women.	CCI
8.3.3	Because of the evidence of reduced efficacy and concurrently increased risk for adverse effects, medications for smoking cessation should not be offered to pregnant women [B]. In certain exceptional cases and under careful evaluation of benefit-risk, nicotine patches, inhalers, tablets, or nicotine gum can be considered (CCI).	B
8.3.4	Psychotherapeutic procedures and counseling, as recommended in the Section on “Psychotherapy,” are to be offered to pregnant women.	A
8.3.5	Pregnant women are especially to be offered intensive counseling, behavioral modification, and motivational enhancement.	A
8.3.6	Pregnancy-specific interventions (state-specific motivation acc. to TTM[please define!], feedback of health status and pollution load of fetus, reinforcement and reward) can be offered.	0

Table 11

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Older People

Table 12

Table 12

	Recommendation statements	Recommendation level
8.4.1	Older people (50+) are to be offered the complete spectrum of the smoking-cessation interventions, as mentioned in Sections 4.1 – 4.6.	A
8.4.2	In this age group more intensive treatment approaches for tobacco dependence (combined methods incl. psychological counseling, medication, and long-term guidance) should be offered.	B
8.4.3	Low-threshold approaches can be offered for this age group.	CCI
8.4.4	The complete spectrum of pharmacological therapies under consideration of and after informing about possible risks is to be offered, as mentioned in Section 4.4.	A
8.4.5	Psychotherapeutic procedures and counseling are to be offered to older persons, as mentioned in Section 4.3.	A

Table 12

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Somatic Comorbidity

Table 13

Table 13

	Recommendation statements	Recommendation level
9.1	For patients with physical disorders, tobacco use is to be assessed.	A
9.2	Patients who smoke and are in hospital because of tobacco-associated disorders are to be offered smoking-cessation programs resp. are to be helped in smoking cessation. Smoking cessation is to be started in the hospital, and patients should receive supportive contact over at least 1 month.	A
9.3	Patients who smoke and for whom an operation is scheduled should be offered smoking-cessation programs with pharmaceutical components.	B
9.4	All COPD-patients who smoke are to be offered smoking-cessation programs with pharmaceutical and psychosocial support.	A
9.5	All patients with cardiovascular diseases are to be advised about smoking cessation without restriction and should avoid all exposure to tobacco, if possible.	A
9.6	Patients who smoke and have tobacco-associated diseases are to be offered smoking cessation with pharmaceutical and psychosocial support.	CCI

Table 13

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Mental Comorbidity

General Key Recommendations

Table 14

Table 14

	Recommendation statements	Recommendation level
10.1.1	Tobacco use is to be assessed among patients with mental disorders – presently or in the past.	CCI
10.1.2	Patients with mental disorders who smoke – presently or in the past – are to be offered smoking cessation.	CCI
10.1.3	Under consideration of the acuteness and the particularities of the mental disorder, patients with tobacco dependence and additional mental disorder – presently or in the past – are generally to be offered the same psychotherapeutic and pharmaceutical measures as for smokers without additional mental disorders.	CCI

Table 14

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Special Recommendations for Comorbid Depressive Disorders

Table 15

Table 15

	Recommendation statements	Recommendation level
10.2.1	Depressive patients who smoke or smokers with depression on their record are to be offered treatment for smoking cessation with components related to the depressive symptomatic (e. g., mood management).	A
10.2.2	Depressive patients who smoke or smokers with depression on their record are to be offered bupropion or varenicline under consideration of and after informing about possible risks (see Sections 4.4.5.2 and 4.4.5.3).	B
10.2.3	Depressive patients who smoke or patients with depression on their record are to be offered treatment with nicotine replacement therapy.	A

Table 15

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Special Recommendations for Comorbid Schizophrenic Disorders

Table 16

Table 16

	Recommendation statements	Recommendation level
10.3.1	Patients who smoke and have stable schizophrenia should be offered bupropion or varenicline under consideration of and after informing about possible risks (see Sections 4.4.5.2 and 4.4.5.3).	B
10.3.2	Schizophrenic patients who smoke are to be offered treatment with nicotine replacement therapy.	CCI
10.3.3	Behavioral (reinforcement-oriented) therapy approaches should be offered to schizophrenic patients for smoking cessation.	B

Table 16

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Setting, Medical Treatment Situation and Aspects of Financing

Table 17

Table 17

	Recommendation statements	Recommendation level
Note:1The implementation “trained” in recommendation 4.9.3.2 was editorially inserted after termination of the consensus conference and was not voted on.
11.1	Setting:counseling approaches(face-to-face, via phone) Counseling for smoking cessation should be systematically offered by medical/psychotherapeutic professionals as well as by other trained professional groups in the healthcare system.	CCI
11.2	Setting:therapeutic interventions(with and without pharmacotherapy) Behavioral-orientated single or group therapy for the promotion of smoking cessation or for withdrawal treatment are to be offered by trained medical/psychotherapeutic1 or qualified staff in the healthcare system.	CCI
11.3	Setting:professionalization ofintervention Counseling approaches for the promotion of smoking cessation as well as therapeutic interventions for withdrawal treatment are to be integrated increasingly into the training and advanced training of healthcare professionals.	CCI

Table 17

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Conflicts of interests

Andreas: Pfizer

Bartsch: keine Interessenskonflikte

Batra: Kath. Fachhochschule, Bezirksärztekammer, Südwürttemberg, Ärztekammer Westfalen‐Lippe, Dtsch. Psychologenakademie, Wissenstransfer Uni Tübingen, Thieme, Kohlhammer, Alkermes, Pfizer, Parexel

Hoch: Dozententätigkeit Rhein‐Ruhr Universität Bochum, FU Berlin, Deutsche Psychologenakademie, BMG, EMCDDA, Deutscher Ärzteverlag, Desitin

Gohlke: keine Interessenskonflikte

Jähne: Daiichi Sankyo, Bristol-Myers Squibb, Johnson & Johnson, Lundbeck, Pfizer, Sanofi, Volkshochschulen, Akademie für ärztliche Fort- und Weiterbildung Südbaden, Ärztekammer Nordrhein, Deutsche Krebshilfe, Institut für Hausärztliche Fortbildung, Ministerium für Arbeit und Sozialordnung, Familie, Frauen und Senioren des Landes Baden-Württemberg.

Kröger: Pfizer, BMG

Lindinger: Krankenkassen, Berufsgenossenschaften, Bundesamt für Gesundheit (Schweiz), Arbeitsgemeinschaft Tabakprävention (Schweiz,) Bundeszentrale für Gesundheitliche Aufklärung (BZgA), Deutsches netz Rauchfreier Krankenhäuser und Gesundheitseinrichtungen (DNRFK), Universität Tübingen, Deutsches Krebsforschungszentrum (DKFZ), Deutsche Psychologenakademie

Mann: Lundbeck, Pfizer, Novartis

Mühlig: Mühlig: Vortragstätigkeit bei Pfizer, Mundipharma, Dozententätigkeit in Psychotherapeutenausbildung, bei Psychotherapeuten- und Ärztekammer und Weiterbildungsakademie (TUCed); Forschungsaufträge: AOKplus, Bundesregierung; Versorgung: Leiter Raucherambulanz Chemnitz, Tabakentwöhnungskurse, Psychotherapie

Neumann: Dozent für Ärztekammer Brandenburg, Thieme‐Verlag, Südd. Verlagsgruppe, MIC Kongressoprganisation.

Petersen: keine Interessenskonflikte

Pötschke-Langer: keine Interessenskonflikte

Ratje: Berlin‐Chemie AG, Publikation in „Der Allgemeinarzt“, Programmschulung für DGNTF e.V.

Rüther: Pfizer, Johnson & Johnson

Schweizer: DGH, MEG

Thürauf: Alberti‐Konzept‐Gesundheit, Hanns‐Seidel‐Stiftung, Janssen‐Cilag, Klinik Barmelweid

Ulbricht: keine Interessenskonflikte