Pubblichiamo questo importante studio segnalato dal Dott. Vincenzo Provenzano.
Development of the Italian clinical practice guideline on diagnosing and treating obesity in adults: scope and methodological aspects.
Rocco Barazzoni1; Silvio Buscemi2; Luca Busetto3; Paolo Sbraccia4; Simona Bo5; Emanuele Cereda6; Marco Chianelli7; Sonja Chiappetta8; Riccardo Dalle Grave9; Walter de Caro10; Giovanni Docimo11; Giuseppe Galloro12; Primiano Iannone13; Frida Leonetti14; Fabrizia Lisso15; Maria Caterina Manca16; Gerardo Medea17; Manuela Merli18; Anna Maria Moretti19; Giuseppe Navarra20; Uberto Pagotto21; Barbara Paolini22; Giovanni Papa23; Nicola Perrotta24; Andrea Pession25; Vincenzo Pilone26; Vincenzo Provenzano27; Cecilia Ricciardi Rizzo28; Maurizio Santomauro29; Cristina Segura Garcia30; Federico Spandonaro31; Samir Sukkar32; Patrizia Todisco33; Dario Tuccinardi34; Andrea Vania35; Valentina Vanzi36; Riccardo Williams37; Iris Zani38; Benedetta Ragghianti39, Giovanni Antonio Silverii39; Matteo Monami39, and the panel and Evidence Review Team for the Italian Guidelines on Surgical Treatment of Obesity.
Affiliations: 1Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy; 2Department of Promozione della Salute, Materno-Infantile, Medicina Interna e Specialistica di Eccellenza (PROMISE), University of Palermo, Palermo, Italy; 3Department of Medicine, University of Padova, Padova, Italy; 4Department of Systems Medicine University of Rome Tor Vergata, Italy; 5ASO Città della Salute e della Scienza Hospital Department of Medical Sciences, University of Torino, Italy; 6SC Dietetica e Nutrizione Clinica Fondazione IRCCS Policlinico San Matteo Pavia, Italy; 7Regina Apostolorum Hospital Albano, Roma, Italy; 8UOC Chirurgia Generale e Laparoscopica Ospedale Evangelico Betania, Napoli, Italy; 9Department of Eating and Weight Disorders, Villa Garda Hospital, Garda, Italy; 10Sapienza Università di Roma, Roma, Italy; 11University of Campania “Luigi Vanvitelli”, Caserta, Italy; 12Dept. of Clinical Medicine and Surgery Unit of Surgical Endoscopy University of Naples Federico II – School of Medicine, Napoli, Italy; 13UOC Medicina Interna C, Ospedale Maggiore, Bologna, Italy; 14Sapienza University of Rome, SM Goretti Hospital, Latin, Italy; 15Sant’Anna Hospital, Como, Italy; 16UOS Medicina legale centro, Azienda USL di Bologna, Bologna, Italy; 17Medico di Medina Generale ASST Garda, Brescia, Italy; 18Department of translation and precision medicine – Policlinico Universitario Umberto 1- Rome, Italy; 19UOC Pneumologia, Università di Bari, Bari, Italy; 20DU di Patologia Umana DETEV Università di Messina, Italy; 21IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy; 22Dietetica e Nutrizione Clinica, Azienda Ospedaliera Universitaria Senese, Siena, Italy; 23Head of Plastic Surgery Unit and Plastic Reconstructive and Aesthetic Surgery University of Trieste, Italy; 24Azienda Ospedaliera Regionale “San Carlo”, Ospedale di Villa d’Agri, Potenza, Italy; 25Dipartimento di Scienze Mediche e Chirurgiche; Università di Bologna, Bologna, Italy; 26Dipartimento di sanità pubblica, Scuola Medicina e Chirurgia, Università Degli Studi Di Napoli “Federico II”, Napoli, Itlay; 27Istituto e Clinica S Chiara, Partinico, Palermo, Italy; 28Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Italy; 29Department of Advanced Biomedical Sciences, University of Naples Federico II, Napoli, Italy; 30Magna Græcia University of Catanzaro, Catanzaro, Italy; 31Dipartimento di Economia e Istituzioni, University of Rome Tor Vergata, Roma, Italy; 32U.O. Dietetica e Nutrizione Clinica IRCCS Ospedale Policlinico San Martino di Genova, Italy; 33Psychonutritional Center, Verona, Italy; 34Fondazione Policlinico Universitario Campus Bio-Medico, Roma, Italy; 35Independent researcher, Roma, Italy; 36Centro Interdipartimentale per la Ricerca e la Formazione, Università degli Studi di Roma Tor Vergata, Roma, Italy; 37Dipartimento di Psicologia Dinamica e Clinica, Università degli Studi di Roma “Sapienza”, Roma, Italy; 38Amici Obesi onlus, Milano, Italy; 39Diabetology and Metabolic Disease Unit; Careggi Teaching Hospital and University of Florence, Florence, Italy.
Short title: Italian guidelines for the obesity: methodological aspects.
Address for correspondence:
Matteo Monami; Diabetology, Careggi Hospital;
Largo Brambilla 3, 50141 Florence; Italy;
e-mail: matteo.monami@unifi.it
ABSTRACT
Overweight and obesity are substantial, growing public health concerns due to their huge direct and indirect negative impact on health. Obesity-associated complications and comorbid conditions include metabolic, cardiovascular, renal, liver and respiratory diseases, cancers, and functional limitations, leading to higher all-cause and cardiovascular mortality, and incident disability. The development of rigorous guidelines considering and comparing all possible therapeutic strategies is of critical importance, and a relevant tool for improving the quality of care and increasing the appropriateness of therapeutic choices. The Italian National Institute of Health (ISS – Istituto Superiore di Sanità) appointed the Italian Obesity Society (SIO – Società Italiana dell’Obesità) and other key scientific societies with a relevant stakeholder role on the theme issue to design and develop a new Italian guideline for the management of obesity in adult subjects, aimed at assisting healthcare professionals in the consideration of lifestyle, pharmacological, endoscopic, and surgical options for the treatment of overweight and obesity, as well as related conditions. We adopted Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology, strongly endorsed by Istituto Superiore di Sanità to develop trustworthy guidelines to be accepted onto Sistema Nazionale Linee Guida, the reference repository of national clinical practice guidelines for the Servizio Sanitario Nazionale.
INTRODUCTION
Overweight and obesity are growing public health concerns due to their huge direct and indirect negative impact on health. Obesity often begins in childhood or adolescence, although it can also manifest in adulthood. This chronic condition results from an intricate interplay of genetic, environmental, and behavioral factors. Genetic predisposition can influence one’s susceptibility to weight gain, while environmental factors such as sedentary lifestyles and high-calorie diets further exacerbate the risk. Excess in adipose tissues can subsequently contribute to metabolic diseases and several obesity-associated medical conditions which can negatively affect the prognosis of subjects affected by “preclinical” obesity1. Systemic obesity-associated medical conditions affect all organs and include metabolic, cardiovascular, renal, liver, and respiratory diseases, cancer, and functional limitations, leading to higher all-cause and cardiovascular mortality, and incident disability. It has been estimated that half of the excess risk for coronary heart disease and about three-quarters of the excess risk for stroke was mediated through obesity-associated high blood pressure, cholesterol, and glucose concentrations2. Aside from the health impact of excess body weight and fat, the related economic burden represents a major and growing issue for many countries3.
The treatment of overweight and obesity includes lifestyle interventions (LSI), medications, and surgical options; all of them are commonly characterized by limited long-term efficacy and/or few available data on their effectiveness and safety4.
Metabolic bariatric surgery (MBS), which has been developed for achieving a relevant weight loss above 20-25% of initial body weight5, has also been shown to have a therapeutic potential for reducing obesity-related complications, such as hypertension6, type 2 diabetes6,7 and obstructive sleep apnea8. However, the use of surgical approaches has been limited by organizational and economic issues.
Several national and international guidelines promoted by scientific societies, such as the European Association for the Study of Obesity (EASO)9, the European Society for Clinical Nutrition and Metabolism (ESPEN)10, the American Gastroenterological Association (AGA)11, the American Society for Metabolic and Bariatric Surgery (ASMBS)12, the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO)13, the Associazione Medici Endocrinologi (AME)14 and the Italian Society of Bariatric and Metabolic Surgery for Obesity (SICOB)5, have proposed several therapeutic algorithms reflecting their main expertise (i.e. lifestyle10, pharmacological9,11,13, or surgical5,12 approaches, respectively). However, the treatment of obesity often requires a multi-professional and multimodal approach14, not fully adopted by the current guidelines; the development of a GRADE-based guideline considering and comparing all of the possible therapeutic strategies might improve the quality and the appropriateness of care.
For all the above-mentioned reasons, the Italian National Institute of Health (ISS – Istituto Superiore di Sanità), entitled by Italian Law and the Ministry of Health to assess and publish trustworthy guidelines, entrusted the Società Italiana dell’Obesità (SIO) and other key scientific societies to develop a new Italian guideline for the management of obesity in adults. This guideline is aimed at assisting healthcare professionals involved in the management of patients living with overweight/obesity. In the Italian national legal environment15, the inclusion of guidelines in the National Guideline System is possible only after a careful methodological and formal revision by the National Center for Clinical Excellence of the Ministry of Health. In the development of national guidelines, the Center for Clinical Excellence recommends the use of Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology16, which requires the explicit, preliminary identification of clear clinical questions as well as the definition of relevant outcomes for each question. The present paper reports on the steps followed for developing questions and the definition of outcomes for the new Italian guideline for the management of obesity.