Attachment #9.2 Review of IMAGE Project Guidelines For use in the EAL Title: A European Evidence-Based Guideline for the Prevention of Type 2 Diabetes The Pre-Diabetes workgroup is requesting EBPC consideration to approve the IMAGE Guidelines for the Prevention of Type 2 Diabetes to support the Pre-Diabetes project questions on the EAL. If the IMAGE Guidelines meet the criteria for use in the EAL, they can be adopted and rated using ADA’s Recommendation Rating Scale, if not they will be “consensus” rated recommendations. IMAGE stands for "Development and Implementation of a European Guideline and Training Standards for Diabetes prevention". The general objective of this project is to improve the ability to prevent diabetes in Europe. In addition, to generate guidelines for prevention of type 2 diabetes and to develop a curriculum for the training of prevention managers, one aim of the project is to produce standards for quality management of diabetes prevention programs. A European multidisciplinary consortium systematically reviewed the evidence on the effectiveness of screening and interventions for T2DM prevention using SIGN criteria to create these guidelines. ADA’s criteria and summary of the guideline methodology is below. ADA Criteria for using Guidelines in EAL Produced under appropriate organization type (relevant professional society). Meets Criteria European Multidisciplinary Consortium Guideline methodology IMAGE Quality And Outcome Indicators Working Group: Dr. Ala'a AlKerwi, CRP-Santé/Centre d'Etudes en Santé Luxembourg, Luxembourg Dr. Jose Manuel Boavida Portuguese Diabetes Association, Lisbon Portugal Associate Professor Xavier Cos, Barcelona Spain Stijn Deceukelier Vlaamse Diabetes Vereniging vzw, Gent Belgium Dr. Margalit Goldfracht, Tel-Aviv Israel Professor Hans Hauner TU Munich, Munich Germany Katarzyna Kissimova-Skarbek International Diabetes Federation, Brussels Belgium Dinah Köhler German Diabetes Foundation, Munich Germany Professor Rüdiger Landgraf German Diabetes Foundation, Munich Germany Dr. Jaana Lindström National Institute for Health, Helsinki Finland Ana Christina Mesquita Portuguese Diabetes Association, Lisbon Portugal 1 Attachment #9.2 Includes Systematic Review which involves: Determining the problem and formulating into a question Gathering and selecting relevant evidence Synthesizing and grading the evidence Frederik Muylle Vlaamse Diabetes Vereniging vzw, Gent Belgium Anne Neumann TU Dresden Dresden Germany, Umeå University, Umeå Sweden Dr. Pia Pajunen National Institute for Health, Helsinki Finland Associate Professor Markku Peltonen National Institute for Health, Helsinki Finland Dr. Filipe Raposo Portuguese Diabetes Association, Lisbon Portugal Professor Aila Rissanen Helsinki University Central Hospital, Helsinki Finland Dr. Ulrike Rothe TU Dresden, Dresden Germany Dr. Florian Toti Albanian Diabetes Association, Tirana Albania Christina Valadas Portuguese Diabetes Association, Lisbon Portugal Paulien Vermunt Tilburg University Tilburg, The Netherlands Professor Johan Wens University of Antwerp, Antwerp Belgium The overall objectives of the guideline were developed through consultation with all stakeholders by email, teleconference and a 2-day symposium. By this process, the clinical questions and target population covered by the guideline were defined and separate working groups established to synthesize the evidence under the following headings: definitions of risk and target population; screening tools, diagnosis and detection; prevention of T2DM and its comorbidities; supporting change in lifestyle behavior for adults at risk of T2DM; models of care and economic aspects of T2DM prevention; and recommendations for economic evaluation of T2DM prevention strategies. Evidence identification and review: systematic methods were used to identify relevant evidence using defined search strategies appropriate to the specific topic (described in Methodology sections for each recommendation), use of multiple databases, follow up of cited references, and consultation with experts in the field. Criteria for selecting and evaluating the quality of the evidence were based only on publications in peer-reviewed scientific journals and are described in detail (see Methodology sections). The review examined systematic reviews, published between 1998 and 2008, which focused primarily on populations of adults at risk of developing T2DM and/or CVD. Articles were identified by searching multiple electronic databases of published evidence and other sources. Throughout the guideline, The Scottish Intercollegiate Guidelines Network (SIGN) 2 Attachment #9.2 guidance was used to define the criteria for levels (quality) of evidence and grades of the resulting recommendation http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html. SIGN develops evidence based clinical guidelines for the NHS in Scotland. The key elements of the methodology are (a) that guidelines are developed by multidisciplinary groups; (b) they are based on a systematic review of the scientific evidence; and (c) recommendations are explicitly linked to the supporting evidence and graded according to the strength of that evidence. See Table 13 on page S22 of the guideline for an example of the evidence grading strength. Formulating recommendations using the best available evidence Disseminating the findings The recommendations on this topic are based on a systematic review, which summarized the available scientific evidence on the relationship between increased intervention effectiveness and:(i) theoretical basis, (ii) behavior change techniques used, (iii) mode of delivery, (iv) intervention provider, (v) intervention intensity, (vi) characteristics of the target population (e.g. gender, ethnicity), (vii) setting. Systematic “review of reviews” of the scientific evidence base on dietary and/or physical activity interventions is published separately and is available to download from the IMAGE website (http://www.image-project.eu). Only the key recommendations and a summary of the evidence are presented in guideline document attached to the agenda. The methodological quality of studies was systematically assessed using an established rating system and data were only extracted from reviews meeting a preset quality standard. Selection and data extraction were undertaken independently by two reviewers and any disagreements resolved by discussion. 3856 potentially relevant articles were identified, of which 30 met the quality and selection criteria. Each piece of evidence was rated, using the SIGN evidence rating system, and produced detailed evidence tables. Further discussion of the evidence in workshops of experts in primary care, behavioral science and diabetes prevention (the IMAGE study group) helped to derive the recommendations. Work Package 2 (WP2) is responsible for disseminating and communicating the progress and results of the IMAGE project. A plan for disseminating the guideline to relevant professional groups and persons with increased diabetes risk is in development The responsibilities for WP2 will include coordinating all communications activities for the partner organizations within the IMAGE project and also disseminating information to all others in Europe with an interest in diabetes prevention: about the 3 Attachment #9.2 Most recent version produced. Safeguards to ensure funding did not affect the process. project itself, the training curriculum for prevention managers, the guidelines for prevention, European standards for quality control and the final project results. WP2 will provide all partner organizations with the relevant communications tools to translate and cascade information about the IMAGE project within its own country. Website: www.image-project.eu Yes- copyright April 2010 The guideline is editorially independent from the funding body. Conflicts of interest of guideline development members have been recorded in the Acknowledgements. 4