Clinical guideline for the treatment of tobacco and nicotine dependence

Tobacco and nicotine dependence must be approached as a disorder requiring medical treatment, using the criteria of evidence-based medicine. In recent years, novel products such as heated tobacco products and electronic devices with or without nicotine (electronic cigarettes) have emerged, increasing the number of users including the dual users (i.e. using both conventional tobacco products and nicotine containing products). Accordingly, tobacco and nicotine-dependent population is increasing due to the variety of products marketing.

In this context, it is of fundamental importance for healthcare professionals to have clinical practice guidelines that allows a rapid transfer of knowledge into daily clinical practice.

The Italian Law Bianco-Gelli no. 24/2017 Disposizioni in materia di sicurezza delle cure e della persona assistita, nonché in materia di responsabilità professionale degli esercenti le professioni sanitarie (Provisions on the safety of care and the assisted person, as well as on the professional liability of health professions), on professional responsibility, has entrusted a fundamental role to the guidelines, giving to ISS, through the National Centre for Clinical excellence, healthcare quality and safety (CNEC), the role of methodological guarantor and national governance of the good quality guidelines production process.

The National Guidelines System (SNLG) is based on the best available evidence of the Italy's health needs according to criteria of relevance and clinical, economic and social impact.

SNLG therefore constitutes the institutional access point to the guidelines for clinical practice or for public health choices developed for the National Health Service (NHS) and for decision-makers, professionals and patients.

The National Centre for Addiction and Doping (CNDD) in collaboration with the Epidemiology Department of the S.S.R. ASL Roma 1 - Lazio Region, and under the supervision of CNEC, as part of the mandate implemented by SNLG, started the project “Clinical guidelines for the treatment of tobacco and nicotine dependence”, with the aim of formulating evidence-based recommendations to promote the cessation of traditional cigarette smoking, heated tobacco products and nicotine-containing products consumption (such as e-cigarettes and other new products) in the Italian population.

These Guidelines are addressed to all health professionals involved in the treatment of tobacco and nicotine dependence, who work in outpatient settings and hospital facilities, and other health professionals such as family doctors, pediatricians, pharmacists, dentists, occupational doctors, etc.

The guideline development group is constituted by the Technical-Scientific Committee (CTS) composed of three ISS directors (CNEC, CNDD, and Bioethics Unit) and the Director of the Epidemiology Department of the S.S.R. ASL Rome 1 - Lazio Region. CTS selected the 25 members of the multidisciplinary panel of independent experts on the subject.

CTS also defined the LG production group (Methodological Chair and Co-Chair, Developer, Evidence Review Team, Economic Analysis Team, Documentalists, Ethics Experts, Scientific and Organizational Secretariat, External Referees). Finally, an explicit mechanism for interests disclosure and managing conflicts of interest is an integral part of a rigorous methodology for producing the guidelines and must involve all participants.

The methodology of the Clinical guidelines is reported in the methodological manual for the production of clinical guidelines, edited by CNEC, available at this link  https://snlg.iss.it/wp-content/uploads/2021/08/MM_v1.3.2_apr_2019.pdf.

Specifically, the need to use the GRADE methodology (Grading of Recommendations, Assessment, Development, and Evaluation, available here http://www.gradeworkinggroup.org) arose from the necessity to standardize and make transparent the process assessing the quality of the available evidence as well as the strength of the recommendations for the guidelines. GRADE transparently evaluates the quality of the evidence related to the individual outcome measures, and therefore is not based only on the quality of the individual studies that consider that outcome.

Guidelines are based on three fundamental requirements: a) multidisciplinarity; b) systematic review of available evidence; c) formulating recommendations based on the best available evidence, even when such evidence is not of high quality.

The SNLG website page dedicated to the Clinical guideline for the treatment of tobacco and nicotine dependence is available at the following link https://snlg.iss.it/?p=4070.

The documents produced so far are the followings: Development Group of the Guideline, the SCOPE of the Guideline, the Preliminary Recommendations of the various PICOs, the Reports of public consultations on Draft Recommendations and good practice statements.

All draft recommendations and good practice statements are subject to public consultations by external stakeholders who can approve, evaluate and suggest changes.

Finally, two external referees, selected on the basis of their specific experience on the topic of the guideline or as methodologists, will evaluate the guideline (the methodological path followed, from scoping to formulating the recommendations).