J Public Health (2007) 15:353–360 DOI 10.1007/s10389-007-0145-x

ORIGINAL ARTICLE

Development and Implementation of A European Guideline and Training Standards for Diabetes Prevention-The IMAGE project Peter E. H. Schwarz & Ulrike Gruhl & Stefan R. Bornstein & Rüdiger Landgraf & Michael Hall & Jaakko Tuomilehto

Received: 2 May 2007 / Accepted: 20 June 2007 / Published online: 18 August 2007 # Springer-Verlag 2007

Abstract Background The dramatic increase of type 2 diabetes, particularly in younger people, has developed into a major public health concern of the European Union (EU). Several studies have demonstrated that prevention programmes can significantly reduce the risk of developing diabetes. At the EU level, there is a clear consensus that action is needed now to develop targeted prevention management pro-

P. E. H. Schwarz : S. R. Bornstein Department of Internal Medicine III, Clinic for Endocrinology, Diabetes and Metabolism, Technical University Dresden, Medical Faculty Carl Gustav Carus, Fetscherstrasse 74, 01307 Dresden, Germany U. Gruhl : R. Landgraf National Action Forum Diabetes Mellitus, Staffelseestraße 6 (Haus C), 81477 Munich, Germany M. Hall IDF Europe, Avenue Emile De Mot 19, B-1000 Brussels, Belgium J. Tuomilehto Department of Health Promotion and Chronic Disease Prevention, National Public Health Institute, Diabetes Unit, Mannerheimintie 166, FI-00300 Helsinki, Finland P. E. H. Schwarz (*) Division of Endocrinology, Department of Medicine III, Medical Faculty Carl-Gustav-Carus, Technical University Dresden, Dresden 01307, Germany e-mail: [email protected]

grammes for type 2 diabetes. Currently several prevention management concepts exist in various European countries which can be implemented in clinical practice. Nevertheless, EU-wide strategies are still lacking. Therefore, initiated by the Technical University Dresden, the IMAGE project was submitted to the European Commission under the call for proposals 2006 for the programme of community action in the field of public health (2003– 2008) and recommended for co-funding as one of the largest in the public health sector. Methods IMAGE stands for “Development and Implementation of A European Guideline and Training Standards for Diabetes Prevention”. Its general objective is to improve the ability of EU countries to prevent type 2 diabetes in Europe. Within the project, four specific objectives will be developed and implemented into clinical practice: (1) joint European guidelines, (2) a European curriculum for the training of prevention managers, (3) European standards for quality control of diabetes prevention programmes, and (4) a European e-health training portal for prevention managers. Results By now, 32 partners from 13 EU member states plus partners from Serbia-Montenegro, the Ukraine and Israel are involved in the project. The project duration is 3 years, starting in May 2007. The partners who are involved in the IMAGE project, building a consortium of expertise, will work in seven work packages to achieve the project’s objectives. Conclusion The development of competent education programmes, as well as the establishment of quality standards for the primary prevention of type 2 diabetes, will significantly enhance the ability of healthcare professionals to respond swiftly to the drastic increase of type 2 diabetes and its burden to society. Implementing the project achievements will be of major importance in both the prevention of

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diabetes and the promotion of health through addressing health determinants across all policies and activities in Europe. Keywords Type 2 diabetes . Prevention . European guidelines . Prevention managers . Quality standards

Diabetes is a major public health concern in the EU The dramatic increase in newly diagnosed cases of type 2 diabetes has developed into a major public health concern of the EU affecting nearly all populations in developed and developing countries (Valensi et al. 2005). Diabetes and impairment of glucose tolerance are increasingly appearing amongst the elderly and recently in younger people with a most sudden increase in the age group below 30 years (Nestle 2005). This results in an increasing number of people affected by diabetes mellitus in their working age and through this diabetes develops into an economic factor. Recent large meta-analysis shows that more than half of all Europeans will suffer from hyperglycaemia and diabetes during their lifetime (Valensi et al. 2005; Schwarz and Bornstein 2006). This increase in incidence has resulted in dramatically escalating rates of complications of the disease, especially cardiovascular complications and costs due to a longer and intensified medical treatment. After diagnosis of diabetes mellitus there is-up until now-no cure of the disease, only treatment. The real cure of diabetes is the effective primary prevention (Schwarz et al. 2007b).

Diabetes can be prevented Several studies have convincingly demonstrated that prevention of type 2 diabetes is possible. The best method of intervention for preventing diabetes is still not clear, but there is overwhelming evidence that up to 60% of diabetes can be prevented or delayed in high-risk individuals through lifestyle modification and/or pharmacological interventions (Pan et al. 1997; Tuomilehto et al. 2001; Chiasson et al. 2002; Knowler et al. 2002). These studies in the past years have shown that lifestyle intervention, addressing diet and exercise, reduced the risk of progressing from impaired glucose tolerance (IGT) to diabetes by 43% and 58%, whereas the oral hyperglycaemic drug, metformin, reduced risk by 31% (Knowler et al. 2002). The preventive intervention seemed to be more effective in the elderly and obese (Tuomilehto et al. 2001; Knowler et al. 2002). Furthermore it was shown that acarbose (Chiasson et al. 2002), troglitazone (Snitker et al. 2004) and orlistat (Torgerson et al. 2004) significantly decreased progression

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of impaired glucose tolerance to diabetes. These findings were recently confirmed by the Indian Diabetes Prevention Programme (IDPS) (Ramachandran et al. 2006), with a relative risk reduction of 28.5% with lifestyle interventions, 26.4% with metformin and 28.2% with lifestyle interventions and metformin combined. Applying these data to the European population we can expect a 50–60% reduction in diabetes risk-if we are able to implement efficient diabetes prevention programmes (Schwarz et al. 2007b). While these findings offer the evidence base for the development of community-based prevention strategies, it is necessary to learn how the prevention of T2D works in “the real world” (Schwarz et al. 2005).

Joint action and political support are needed There is a clear consensus at the EU level that action is needed now to develop targeted prevention management programmes for type 2 diabetes (Schwarz et al. 2007b). The political support is growing and officially stated (Benterbusch et al. 2007). In 2006 existing prevention management concepts were discussed at the EU Conference on Prevention of Type 2 Diabetes (Women 2006), where the Austrian EU Presidency highlighted the prevention of type 2 diabetes and its complications as the main health topics during their presidency. Experts covering all related areas exchanged views and discussed seminal strategies for the implementation of diabetes prevention and management. The results of the discussions are compiled in the “Vienna Declaration”, which comprises the main findings and recommendations in tackling the burden of diabetes at the EU level as in the Vienna Declaration (Women 2006). In December 2006 a milestone for increasing awareness of the diabetes epidemics was reached by the UN Declaration on diabetes, which acknowledges diabetes as one of the largest threats to worldwide health, next to HIV and malaria. Nevertheless, EU-wide strategies are still lacking. To address those needs, initiated by the Medical Faculty Carl Gustav Carus of the Technical University Dresden, the IMAGE project proposal (logo see Fig. 1) was submitted to the European Commission under the call for proposals 2006 for the programme of community action in the field of public health (2003–2008) and recommended for cofunding as one of the largest in the public health sector. The IMAGE project builds on the results of the EU public health research project DE-PLAN “Diabetes in EuropePrevention using Lifestyle, Physical Activity and Nutritional intervention” which are related to the efficient identification of subjects at high risk of type 2 diabetes in the community and about the feasibility and cost-effectiveness of the translation of the current research knowledge into the existing health care systems.

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Fig. 1 Logo of the IMAGE project

Objectives of the IMAGE project IMAGE stands for “Development and Implementation of A European Guideline and Training Standards for Diabetes Prevention”. Its general objective is to improve the ability to prevent diabetes by establishing best-practice standards and joint quality indicators for diabetes prevention programmes all over Europe. Within the project four specific objectives will be realized by different work packages and working groups (see Fig. 2):

Fig. 2 Overview over project structure and work flow

(1) Development of joint European guidelines The development of joint European guidelines to improve information and knowledge about public health strategies to prevent type 2 diabetes and its co-morbidities can be seen as the basis of the IMAGE project on which the other project achievements are built. To implement this specific objective, within the responsible work package (WP 4) three separate working groups will be established. The focus of working group 1 will be on identification strategies of high-risk individuals, working group 2 will develop recommendations for efficient lifestyle intervention, and working group 3 develops recommendations for pharmaco-intervention of type 2 diabetes. All three working groups will have close interaction among each other, but also with members of other work packages. (2) Development of a European curriculum for the training of prevention managers By the development of a European curriculum for the training of prevention managers, the IMAGE project wants to enhance the ability of healthcare professionals to respond swiftly to the drastic increase of type 2 diabetes and its burden on society. In the work package responsible for this objective (WP 5), also three separate working groups have been established, focusing on (a) nutritional training aspects, (b) aspects of physical activity for the training of prevention managers and (c) behavioural science training aspects. The working groups will cooperate with potential teachers and school leaders to maximize learning achieve-

Steering Committee = Work Package 1 (Coordination of the project) => 7 members = Lead partner of all work packages

WP 2

WP 3

WP 4

WP 5

WP 6

WP 7

Dissemination

Evaluation

Guidelines

Curriculum

Quality Control

E-Health Portal

Working groups

Dissemination and national distribution

Working groups

Project Evaluation

Working groups

Identification of target population

Recommendations for lifestyleintervention

Recommendations for pharmakointervention

Working groups

Nutritional training aspects

Physical activity training aspects

Behavioural science training aspects

General prevention management and certification

Working groups

continuous quality assurance

Set up of EHealth Training Portal

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ments by the potential prevention managers, but also with the other work packages in the project. Expected central results of the curriculum work package will be: – – – – – – –

identifying and responding to training needs defining the required qualifications and admission procedures (e.g., admitted professions) defining the general conditions, content and structure of the curriculum aligning European, national and local training priorities researching and designing contemporary curriculum and pedagogy providing professional training developing an examination regulation/certification for the qualification as prevention manager

(3) Development of European standards for quality control The development of European standards for quality control is necessary in order to monitor and report systematically these both on the national level in the member states and at the EU level using comparative data (Schwarz et al. 2006). The key factors in performing high quality intervention are continuous evaluation and quality control (Roubideaux et al. 2004). The goal of the responsible work package (WP 6) is to develop and implement processes for a Europeanwide continuous evaluation system of primary prevention programmes. This system should work as a quality management tool used to meet implementation challenges (Schwarz et al. 2007b). Implementation issues will be discussed in reference to stakeholder involvement, evaluation design, measurement methods, staff training, data quality control, communication of results, and use of results in decision making. Involving stakeholders in design and implementation can result in increased data quality, datainformed decision making to improve service delivery, and increased public accountability. The aim is to develop a quality management tool and a continuous evaluation system which can address specific needs in a managed care environment. To reach the proposed objective the following steps will be necessary: –

– –

Definition of European-wide accepted and applicable indicators for quality control and evaluation (concerning methods of diabetes prevention, but also cost efficiency of prevention programmes). Dissemination of convenient and cost-efficient instruments for continuous quality control. Establishment of a central data-base for national and European-wide evaluation of the outcomes.

(4) Development of a European e-health training portal for prevention managers

To implement high-quality primary diabetes prevention programmes on a national decentralized basis to improve the availability of evidence-based health information for health care professionals (Schwarz et al. 2007a), innovative techniques for adequate education programmes for health care professionals are needed. The responsible work package (WP 7) will have to realize the technical implementation of the concept developed by the curriculum work package based on an internet platform/multimedia approach (e.g., CD-ROM). The e-health portal follows a specific modular structure. It will be based on a blended learning concept with a minimum of face-to-face instruction and a portfolio of extensive online study material, including interactive case studies, reading material, tools of selfassessment, clear assignments and CSCW functions. Additionally, an internationally accepted credit system will be implemented so that the credits earned in the qualification for the prevention manager can be accredited for CME (continuous medical education). Developing and implementing those project achievements will be of major importance to prevent diabetes and promote health through addressing health determinants across all policies and activities in Europe (Schwarz et al. 2007b).

Project structure-overview Additionally to the above-described work packages responsible for achieving the four specific objectives of the IMAGE project, there are three other work packages focusing on the coordination, communication and evaluation of the project (see Fig. 2), thus guaranteeing a smooth work flow and early detection of problems.

Steering committee-coordination of the project This work package (WP 1) is responsible for coordinating all essential management activities prior to the start of the project, while the project is running and to finish the project. A major part of this work package is the organisation of the steering committee work and of the project conventions. The steering committee consists of the seven lead partners of all the work packages, is responsible for the overall coordination of the project, and functions as a central unit for the internal project communication. Furthermore the steering committee will organize the kick off, follow-up and final convention and will instruct the working groups to elaborate on specific tasks, collect information about the work progress and request a regular report related to the proposed milestones, indicators, and deliverables. It also has to identify problems which constrain the working groups’ progress and assist to solve

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them to allow a smooth work flow and the delivery of project results in time.

Dissemination of the results This work package (WP 2) will be responsible for the communication and dissemination strategy to reach an excellent dissemination level of the project results. Therefore before the first steering committee meeting, a communication plan for internal and external communication will be developed for the whole project. Considering the multifaceted target audience, the dissemination strategy can be divided into two major components: expert information via scientific publications and general information via mass media. The target audiences of these actions will be: (1) Health care professionals/institutions – – – – – – – –

medical doctors nurses nutritional experts/dieticians experts in physical activity (physical therapists, sport therapists, personal trainer) psychologists clinics health resorts schools/teachers

These professions are the most relevant target audience for all of the above results since they are all potential prevention managers. (2) Health insurance companies Health insurance companies are an important target audience since their acceptance is a major prerequisite for possible implementation and refunding of costs for the participation in prevention programmes. (3) Politicians on the international, national, federal, and regional level Politicians on all levels should be informed about the project’s concept and outcomes to convince them of the necessity of implementation into the legal framework of the EU countries to strengthen and underline the importance of diabetes prevention within the European health care systems. The cooperation with the organisations named in 4.2.3. will include stakeholders of the target audience already in the project. (4) International and national organisations (WHO, diabetes associations, professional associations, sports clubs) International and national organisations are important target audiences because of their function as multiplier and distributor to all of their members. Their acceptance will be of

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important help with the nation-wide promotion of the results. (5) Diabetes support groups/patient organisations Individuals with a high diabetes risk, actual patients, and their relatives should also be informed about the prevention manager qualification programme since growing demand by them could stimulate the interest of therapists in the certified training programme and thus further promote dissemination of standardised and quality controlled diabetes prevention programmes.

Evaluation The expected results to be delivered by this work package (WP 3) will be: – – – – –

to develop evaluation tools for process and outcome evaluation to ensure that the working progress of the work packages is within the given time frame of the project timetable to identify delays in working group progress and also the problems causing these delays to intervene in order to allow the compliance with the timetable, for example, by modifying goals/objectives which are not feasible to compose a final evaluation report which outlines the central outcomes

The continuous evaluation of the project is the instrument to ensure the project progress to achieve the proposed objectives. This information is used also for the monthly newsletter and, even more importantly, to identify problems, thus having the chance to intervene at an early stage to ensure continuous project progress.

Methodology A group of specialists including individuals from the relevant professional groups will meet and discuss the objective related issues following a standardized procedure. Decisions are based on a consensus and it is the aim to reach a consensus in the working group. If this is not possible the working group leader proposes a procedure to solve the dissent to the steering committee. Each working group has a chairman who is a member of the steering committee. Each working group defines delegates for each of the other working groups to report about the progress in their groups. The working groups meet and work following their preferences (regular meeting, e-mail, telephone conference) with a minimum of five meetings together with the consortium’s plenary meetings. The steering committee can

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finally decide, but it is suggested in case of a major dissent to state both positions and their rationales in the related project results.

Work flow The project duration is 3 years, beginning in May 2007. During this time, all partners who are involved in the IMAGE project, building a consortium of expertise, will meet three times in plenary meetings: 1. At the project kick off => Definition of the members of the project work packages and assignment to working groups The working groups take up their work and meet following their preferences (regular meeting, e-mail, telephone conference). 2. At the project follow-up => each working group presents its work including problems and achievements to the plenary. This will be discussed by all partners. This meeting will last 3 days to have the time for additional working group sessions and the work plan to finalise the objectives will be coordinated. Between the project follow-up and the final convention the groups are asked to modify and adapt their concepts so that a final version can be distributed to all working groups 6–8 weeks before the final convention. 3. At the final convention => agreement on the project results and achievements following the objectives and to disseminate the results including national certification of the project achievements.

Partners involved in the IMAGE project By now, 32 partners from 13 EU member states plus partners from Serbia-Montenegro, the Ukraine and Israel are involved in the project (see Fig. 3 and Table 1). Potential risks Of course we are aware that in a project of this size also a number of risks have to be identified beforehand to be able to respond to them as quickly and well as possible. In the planning phase the following risks were identified to endanger the success of the IMAGE project, but also strategies to avoid those risks were developed: Risk no. 1 Lack of cooperation between the partners of the project Because many of the partners are recruited from the DEPLAN consortium, the IDF working group Glucoforum and

Fig. 3 Partners from EU member states involved in the IMAGE project

the European working group to establish a United Nations Declaration on Diabetes Mellitus, most of the members know to work in working groups and often know each other. This might ensure a good basis of cooperation and work and will cut down the above-mentioned risk, but of course will not eliminate it. Risk no. 2 Lack of efficient moderation in the discussion of the working groups In this case the steering committee has to take over the responsibility and moderate the working group until a solution for successful work is found. Risk no. 3 Inconsistent participation of the members of the Consortium of expertise To still ensure the achievement of the objectives an alternative way might be the introduction of a “rule of absence”, which states that in case of absence the members have to appoint a substitute who also takes over the voting right for this meeting. This will guarantee more continuity of the work at all levels. Risk no. 4 Ignorance of deadlines To ensure efficient work in the given time frame, the steering committee has to realize an efficient monitoring of the work progress and intervene if there is a delay in progress. In case of a major delay or failure of the working group activity, the steering committee has to take over or newly appoint the duties and responsibilities in the working group. Risk no. 5 Effective dissemination of the project results Here the working group “dissemination” will develop together with the GLUCOFORUM working group from the IDF Europe and business plan for dissemination of results.

J Public Health (2007) 15:353–360 Table 1 List of partner institutions by country

359 Country

Partner institutions

Austria

Karl Landsteiner Institute Vienna St. Johann Hospital Salzburg International Diabetes Federation-European Region* Vlaamse Diabetes Vereniging vzw Primary Care Diabetes Europe ivzw* Alexandrov University Hospital Helsingin yliopisto-Helsinki University Kansanterveyslaitos-Public Health Institute Finnish Diabetes Association Universitée Paris-Nord TU Dresden (main partner) Deutsches Institut für Ernährungsforschung Forschungsinstitut Diabetes Akademie Mergentheim Herz- und Diabeteszentrum NRW Hochschule Niederrhein INSTRUCT AG LMU Munich Nationales Aktionsforum Diabetes mellitus TU Munich Vestische Kinder- und Jugendklinik Datteln National and Kapodistrian University of Athens Family Medicine Department Rappoport Medical School, Technion Doc International SIA Universitetet i Oslo Jagiellonian University Medical College Assiciacao Protectora dos Diabéticos de Portugal University of Belgrade Fundación para la eSalud V.P. Komisarenko Institute of Endocrinology and Metabolism Federation of European Nurses in Diabetes* London School of Hygiene and Tropical Medicine University of Exeter/Peninsula Medical School

Belgium

Bulgaria Finland

France Germany

Greece Israel Latvia Norway Poland Portugal Serbia-Montenegro Spain Ukraine United Kingdom

*Pan-european organisations

Conclusion The dramatic increase in newly diagnosed cases of type 2 diabetes has developed into a major public health concern of the EU. This problem becomes relevant for people affected by diabetes mellitus in their working age, particularly in younger people, but also increasing numbers of middle age and elderly. Furthermore this makes a longer and intensified medical treatment necessary due to the increase in medical standards. All of these increase the economical, medical, and social burden of diabetes mellitus exponentially. After diagnosis of diabetes mellitus there isup until now-no cure of the disease, only treatment. The real cure of diabetes is the effective primary prevention. The IMAGE project addresses this issue. The IMAGE project will develop intervention standards and quality control standards for primary diabetes prevention programmes in Europe especially including needs of children

and adolescents. This is relevant not only for diabetes mellitus, but also for the metabolic syndrome and cardiovascular diseases. The standards set will also address these diseases due to the close link in the pathophysiology of these chronic diseases. Implementing the project results in practice-oriented European guidelines for prevention of type 2 diabetes, a European curriculum for the training of prevention managers, a European strategy for continuous quality assurance and evaluation of programmes for diabetes prevention, and a European e-health training portal for prevention managers thus will develop unique European-wide guidance for the first time in Europe and in a new evolving field of medicine. This can be used as an example for other diseases. Especially implementing the guideline and the quality standards on a daily use basis will be a daily merit of the EU Commission and the IMAGE consortium. Furthermore fulfilling these objectives will realistically help to improve the ability to prevent type 2 diabetes in Europe.

360 Conflict of interest statement The authors are confirming herewith that they have not had any relevant duality of interest with a company whose products or services are directly related to the subject matter of the manuscript in the previous 12 months. This project will be funded by the Commission of the European Communities, Directorate C-Public Health grant agreement no. 2006309.

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