The Italian Clinical Practice Guideline for the treatment of tobacco and nicotine dependence
The Italian “Clinical Practice Guideline for the treatment of tobacco and nicotine dependence” , developed by the National Centre on Addiction and Doping and the National Centre for Clinical Excellence of the Istituto Superiore di Sanità, is an update of the previous Guidelines for smoking cessation (published in 2002, and subsequently updated in 2008).
This new Clinical Practice Guideline (CPG) includes both the treatment of conventional tobacco dependence and the treatment of nicotine dependence, induced by the new products containing tobacco and/or nicotine (e.g. heated tobacco products, electronic cigarettes or other new and emerging products containing tobacco and/or nicotine), recently appeared on the market.
Currently in Italy, it has been shown that these new products mainly lead to dual use or poly-use of tobacco and nicotine. Therefore, the target population of the interventions analyzed in the CPG was identified as not only consumers of conventional tobacco cigarettes, but also consumers of heated tobacco products, smokeless tobacco, electronic cigarette and other new and emerging products containing tobacco and/or nicotine.
The National Centre on Addiction and Doping of the Istituto Superiore di Sanità defined the objectives and scope of this CPG.
A multidisciplinary panel of 25 clinical experts (i.e. oncologists, pulmonologists, epidemiologists, psychologists, pharmacologists, toxicologists, statisticians, clinical methodologists, patient representatives), together with experts in systematic literature review (the Evidence Review Team of the Department of Epidemiology of the Regional Health Service, ASL Roma 1), identified 9 clinical questions related to the treatment of tobacco and nicotine dependence, based on criteria of priority, feasibility, and available resources.
The applied process was consistent with the Methodological Manual for the production of CPGs (by the National Centre for Clinical excellence, National Guidelines System, ISS). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations. The reporting of the guideline was prepared in accordance with the AGREE Reporting Checklist (Appraisal of Guidelines for Research and Evaluation).
As above reported, the guideline included 9 clinical questions, 4 of which related to behavioral interventions (including brief advice, counselling and digital interventions), 4 related to pharmacological interventions (including pharmacological interventions alone or in association with behavioral support), and one related to the training of healthcare professionals (Table 1).
The novelty of these CPG, compared to the previous version, is that three new clinical questions were included: one clinical question on the electronic cigarette for smoking cessation, one clinical question on digital interventions for tobacco and nicotine cessation and one on the university training of healthcare professionals related to treatment of tobacco and nicotine dependence.
Systematic reviews were conducted for each question and results were discussed with the multidisciplinary panel using the GRADE Evidence to Decision (EtD) Framework. The main purpose of EtD frameworks is to help panels use evidence in a systematic and transparent way to inform decisions for the following criteria: magnitude of desirable and undesirable effects of interventions, overall quality of evidence, resources use, acceptability and feasibility of the intervention, impact on equity. All EtD for each clinical question and related material (literature search strategy, study selection process, summary and characteristics of included studies, forest plot, GRADE tables, economic evaluation) were published in the Appendix “Supplementary Material” . Overall, 29 recommendations for clinical practice, 1 recommendation for further research and 8 Good Practice Statements (GPS), were issued.
GPS are important actionable statements about interventions that would substantially work well that causing as harm or vice versa, but which cannot be subjected to a formal assessment of the quality of the evidence as expected by the GRADE method for formulating recommendations. Some literature should exist to support the formulation of a GPS [3-5].
GPS to tackle nicotine dependence may be formulated in the (frequent) case that other types of tobacco and nicotine products (such as electronic cigarettes, heated tobacco products or other new and emerging products containing tobacco and/or nicotine with an addictive potential) users are not considered in the studies’ population. The interventions proposed in the GPS are indeed evidence-based interventions for smoking cessation (such as pharmacotherapy, counselling and digital interventions).
All the Draft recommendations and GPS were submitted to public consultation on the National Guideline System dedicated platform, where stakeholders could register in and provide judgments and comments. Moreover, two external independent reviewers revised the draft recommendations and GPS, and assessed the quality of reporting (AGREE reporting checklist) and the correctness of the methodology (AGREE II).
To our knowledge, this is the first CPG that includes the treatment of nicotine dependence as well as the treatment of conventional tobacco dependence. The formulation of evidence-based recommendations and GPS were produced according to a standardized and internationally recognized methodology.
Figures and tables
|INTERVENTION CATEGORY||SPECIFIC INTERVENTION||CLINICAL QUESTIONS|
|BEHAVIORAL INTERVENTIONS||Brief advice||In the treatment of tobacco and nicotine dependence, what is the effectiveness of minimal/brief advice versus no intervention or usual care?|
|Counselling||In the treatment of tobacco and nicotine dependence, what is the effectiveness of offering counselling (either individual or group counselling) versus medical information alone?|
|In the treatment of tobacco and nicotine dependence, which modality (face to face meetings, toll-free telephone, remote telephone contacts or video calls) and intensity (number and duration) of the counselling sessions is more effective?|
|Digital interventions||In the treatment of tobacco and nicotine dependence, what is the effectiveness of digital interventions compared to each other, compared to a standard treatment, or to no treatment?|
|PHARMACOLOGICAL INTERVENTIONS||Pharmacological intervention||In the treatment of tobacco and nicotine dependence, what is the effectiveness of pharmacotherapies (nicotine replacement therapy-NRT, bupropion, varenicline, cytisine, nortriptyline) versus placebo, compared to each other or to other non-pharmacological treatments (such as counselling, acupuncture and hypnosis)?|
|In the treatment of tobacco and nicotine dependence, what is the effectiveness of monotherapy (NRT, bupropion, varenicline, cytisine, nortriptyline) compared to a combined pharmacotherapy?|
|In the treatment of tobacco and nicotine dependence, what is the effectiveness of the electronic cigarette compared to pharmacotherapy or counselling or no treatment?|
|Pharmacological intervention with behavioural support||In the treatment of tobacco and nicotine dependence, what is the effectiveness of pharmacotherapy (monotherapy or combined pharmacotherapy) in combination with a counselling intervention (either individual or group counselling) compared to pharmacotherapy alone or counselling alone?|
|TRAINING FOR HEALTHCARE PROFESSIONALS||Training on tobacco and nicotine dependence||In the treatment of tobacco and nicotine dependence, is specific training (university and post-graduate) for GPs and other health professionals more effective than the current generic information on smoking that is received in nursing, medicine or psychology degree courses?|
- Linea guida per il trattamento della dipendenza da tabacco e da nicotina.Publisher Full Text
- Materiali Supplementari della Linea guida per il trattamento della dipendenza da tabacco e da nicotina.Publisher Full Text
- Guyatt GH, Alonso-Coello P, Schünemann HJ, Djulbegovic B, Nothacker M, Lange S. Guideline panels should seldom make good practice statements: guidance from the GRADE Working Group. J Clin Epidemiol. 2016; 80:3-7. DOI
- Lotfi T, Hajizadeh A, Moja L, Akl EA, Piggott T, Kredo T. A taxonomy and framework for identifying and developing actionable statements in guidelines suggests avoiding informal recommendations. J Clin Epidemiol. 2022; 141:161-171. DOI
- Dewidar O, Lotfi T, Langendam M, Parmelli E, Saz Parkinson Z, Solo K, eCOVID-19 recommendations map collaborators. Which actionable statements qualify as good practice statements In Covid-19 guidelines? A systematic appraisal. BMJ Evid Based Med. 2022. DOI
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