Background
Type-2 diabetes (DM2) has become one of the main causes of morbidity and early mortality in most countries, associated especially with a higher risk of cardiovascular diseases. Further, it is expected that the prevalence of DM2 will double by 2030 and that this condition will become the seventh cause of death worldwide [
1]. Cardiovascular morbidity and mortality in individuals with DM2 is much higher than in the general population. The mortality rate associated with diabetes ranges between 13 and 30 deaths per 100,000 people per year, the main cause of death being coronary disease [
2]. It has also been estimated that half of the population of Europe will have hyperglycaemia or diabetes during their lives [
3], these conditions becoming more prevalent among both elderly and young people, with a sudden increase in those below 30 years of age [
4]. This dramatic increase in the recently diagnosed cases of DM2 and its complications have become an important public health problem and affect almost all populations in both developed and developing countries [
1,
5].
In recent years, several clinical trials have demonstrated that is possible to prevent DM2 through educational interventions to change lifestyles. Specifically, in high risk subjects, the risk of developing DM2 can be reduced by around 60% after 3 years of these types of intervention [
6‐
8]. Additionally, the effects of interventions focused on changing lifestyles seem to last in the long-term [
9,
10]. The findings of these studies are revealing. However, the evidence has been obtained from large controlled clinical trials, with well-developed infrastructure and considerable resources. It is not clear whether more realistic interventions, feasible under normal working conditions in health systems, would lead to results similar to those in the aforementioned large trials [
11,
12]. Therefore, the key question is: can the efficacy demonstrated in clinical trials be replicated in normal clinical working conditions, with much lower resources for the implementation of these types of programmes and interventions?
The step after testing the efficacy of a new experimental intervention, with phase III clinical trials, is the assessment of its effectiveness, efficiency and long-term sustainability under real conditions, with phase IV trials [
13]. Unfortunately this step is not at all easy. The widespread adoption of this type of health intervention does not automatically follow from research proving its efficacy, let alone in the specific context of primary health care, characterised by work overload, with shortages of time and training. In recent years, there have been several initiatives assessing the transfer of interventions related to the promotion of healthy lifestyles for the prevention of DM2 to the real context of primary healthcare [
14‐
20]. Some of these have indicated that it is feasible to reduce the risk of developing DM2 in several routine clinical settings. In most cases, however, the studies were not based on group comparisons, were not set up and implemented under real-world conditions in primary care settings or relied in additional resources, and/or did not include the reduction in the incidence of DM2 among the outcome variables. Despite evidence from experimental trials, the translation of lifestyle interventions into routine practice appears to have no effect on diabetes risk reduction [
21].
Recently,
The Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional Intervention project (DE-PLAN), has been launched within the Spanish National Health Service [
22]. This is a public health study focused on evaluating the implementation of a programme developed and implemented in the primary care setting involving: 1) a screening programme for identifying individuals at high risk of developing DM2; 2) an integrated programme with various different intensive interventions for changing lifestyles among high risk individuals; 3) an ongoing intervention programme for maintaining the motivation of participants; and 4) a programme for assessing the feasibility and cost-effectiveness of the aforementioned screening and intervention programmes, in different European primary care systems. The only results published so far concerning the DE-PLAN study conducted in Madrid are exclusively related to the participants in the intervention group, with no comparison group, so that the results obtained cannot be attributed to the programme [
23]. One year after the intervention, about 7% of patients in the intervention group developed clinical features of DM2, similar to the figures reported for the control groups in two large DM2 prevention trials [
6,
7]. More recently, the researchers of the DE-PLAN project in Catalonia [
24] have demonstrated that an intensive intervention for the promotion of healthy lifestyles is feasible in the context of primary care and does significantly reduce the prevalence of DM2 among high risk individuals. After a mean follow-up of 4.2 years, the incidence of DM2 was 7.2 and 4.6 cases per 100 people per year, for usual care and intensive intervention groups, respectively (equivalent to a 36.5% reduction in relative risk). In this study, patients were randomly selected previously to inclusion and centres were asked to assign subjects who agreed to take part in the programme consecutively to comparison groups if feasible. The fact that it is an observational study limits its ability to confirm the effectiveness of the programme in real-world primary care settings.
In short, the methodological limitations and mixed results of studies evaluating the effects of primary DM2 prevention programmes in primary care raise doubts as to whether the implementation of these programmes in normal working conditions in health centres would achieve the results observed in experimental trials. Accordingly, prior to widespread implementation, the transfer to real-word settings should be evaluated with a scientifically valid design. The transfer of effective and sustainable interventions to routine clinical practice remains one of the greatest challenges in scientific research in the field of DM2 prevention [
12].
The “Prevention of Diabetes in Euskadi” project (PreDE) aims to perform an experimental evaluation of the implementation of a programme for the primary prevention of DM2, through the promotion of healthy lifestyles in patients at high risk of developing the disease, under normal working conditions in primary care. The project is based on the DE-PLAN programme and its methodology, though it has been adapted to the OSAKIDETZA centres. The primary objective is to assess the effectiveness and feasibility of the programme in the routine clinical practice of the centres and health professionals using an experimental a phase IV clinical trial design.
Discussion
This study is to be an independent assessment of the results of the implementation of a prevention programme for DM2 in high-risk populations seen in 14 primary care centres in the Basque Health Service, Osakidetza, commissioned by the Department of Health of the Government of the Basque Country. The scientific evidence provided by this study may be unique internationally as it has not, so far, been demonstrated that a programme for preventing DM2, implemented under real conditions in primary health care centres, is able to prevent the development of DM2 in high-risk patients.
Despite the promising results of the studies of DM2 prevention in routine clinical setting available to date [
14‐
18,
21], transferring effective, sustainable and acceptable interventions to routine clinical practice in primary care remains a challenge. The transfer and application of research to clinical practice is a complex process [
29] that requires planning at individual and organisational levels [
30]. On the other hand, health professionals work in specific organisational and structural contexts within a system and there are a wide range of factors that may facilitate or impede change [
31‐
33].
Despite the Basque Health System having already entered into a period of change due to new health policies focused on addressing the issues associated with chronicity [
26], the implementation of any new programme in routine clinical conditions is an extra challenge that requires those involved to adapt and barriers to change to be overcome [
32,
33]. The strategy for the implementation of the present programme for preventing diabetes in routine practice has mainly involved the training of nurses. Additionally, materials and resources for data management have been provided and health professionals have been encouraged to optimise the way they work together. It remains to be seen whether these passive strategies are enough to enable the successful implementation of the programme, and ensure that it is sustainable over time by the health centres, has sufficient reach in the target population, and is effective in terms of patient health. Specifically, in the light of results of other studies, various difficulties can be envisaged that would influence the implementation of the programme and potentially its results: these relate to the degree of adoption among primary care health professionals, patient recruitment during routine clinical practice in the intervention centres, including a lack of willness of patients to participate, problems in the organisation of educational groups, and losses to follow-up, as well as the many external barriers to change with regards to lifestyle habits [
12,
21].
The present study is intended to generate valid scientific data concerning the effectiveness of a programme promoting healthy lifestyles for the prevention of type 2 diabetes in the real world of primary care. It also sets out to assess the feasibility of the programme in terms of reach, adoption and implementation in the routine clinical context and provide data on the many strategies used in the course of its implementation. The results obtained, if positive, will be used to facilitate the process of rolling out the programme to all the primary care centres of the Osakidetza as a new approach to preventing DM2.
Acknowledgements
The PreDE Group:
Llodio Health Centre: Fernando Fernández, Begoña Gutiérrez, Begoña Huguet, Itziar Menéndez, Juan Carlos Antón, Pedro Urigoitioa, Ana Iruarrizaga, Ana María Astobiza, Begoña Díaz, María Isabel Torroba; Galdakao Health Centre: Marta Pérez, Mónica Prieto, Pilar Calvo, Pilar Echevarria, Yolanda Valdivielso, Agurtzane Paskual, María del Camino Alegre, María Dolores Delgado, Marta Hierro, Marta Pérez, Juan Ignacio Salgado; San Vicente Health Center: Amaya García, Ana Pereda, Carmen Sanchez, Encarnación Santamaría, María Jesús Aragón, Mercedes García, Adelina García, Tomas Larrazábal, Elba García, María Begoña, María Teresa López, María Del Castañar Sanchez, Pedro Ángel Martínez; Zuazo Health Centre: María Jesús Galarza, Floreal Crespo, Florencia Martin, Karmele Nagore Benito, Leire Zubiaga, María Luisa Rodríguez, María Cruz Muñoz, María Felisa Loyola, María Teresa Rodeño, María Gracia Díaz-Rada, Miryam Pozas, Ana Cristina Fernández, Begoña Ayerdi, Josune López, María Begoña Arias, María Consuelo Verdes, María Elena Resines, Araceli Benito, María Yolanda Villalba, maría Isabel Lázaro, Nieves Ortego; Legazpi Health Centre: María José Lopetegui, Jon Amilibia, Juan Miguel Urrutia, Ana Belén Pinilla, María Del Carmen Balmaseda, Mercedes Alba Latorre, Asunción García, Izaskun Fernández, Lourdes Zubeldia, Izaskun Bengoa, María Olatz Laxalt, María Teresa Murua, Miren Idoia Garmendia, Olatz Olarte, Ramón Areizaga; Azpeitia Health Center: María Jesús Arratibel, Arantxa Azcune, Elena Lizaso, Janire Iparraguirre, Lourdes Goenaga, Ana Errasti, María Luisa García, Miren Elixabet Loyola, Amaia Arruti, Ascensión Benítez, Imanol Domínguez, José Luis Badiola, María Jesús Bernaras, Pedro Vidaror; Dunboa Health Centre: Benedicta Rodríguez, Luis Ignacio Unzueta, María Isabel Roca, Maite Monge, Carmen López Itxaso Idoiaga, Lourdes De Juan, Juana María Álava, Ana Isabel Cabrerizo, María Ochoteco; Aranbizkarra 1 Health Centre: Nerea Gutiérrez, Adela Soto, Ainhoa González, Emma De Felipe, Isabel González, María Concepción Isasmendi, María Mercedes Torrecilla, María Soledad Areta, Javier García; San Martín Health Centre: María Asunción Fernández, Aranzazu De Garay, Arrate Ruiz De Escudero, Gemma Ayesa, Izaskun Antúnez, Manuela Vila, María Ángeles Sedano, Anunciación Fernández, María Esther San Martin, María Isabel Fernández, Ana Luisa Arrieta, Aurora Alcalde, Beatriz Barrios, Félix María Ricarte, Inmaculada López De Viñaspre, Iñaki Aguirrezabal, Jesús María Ordoño, Lucia Pereda, María Jesús Serna, María Teresa Amiano, Micaela Morales, Rosa Esquisabel Martinez, María Teresa Gómez; Iztieta Health Centre: María Ángeles Sola, Rosa Salaverria, Mercedes Álvarez, Ana María Guinea, Araceli De Gracia, Belinda Zulueta, Eider Alberdi, Gemma Díaz, Igone Roteta, Laura Balague, María Ángeles Ganzarain, Fernando Aguilera, Nuria Gañan, Olatz Elizazu, Onintza Aranzadi, Remedios Oyarzun, Rosa María Espina, Soledad Asenjo, Mikel Bagues.
Amara Berri Health Centre: Carmen Mendinueta, Carmen Maturana, María Lierni Linacisoro, María Pilar Sáenz, José Miguel Rengel, María José Salazar, Ángeles Asenjo, Coro Semperena, Esperanza Garde, María Asunción Aguirre, María Míguez, Mercedes Coloma, Nora Bergera; Bolueta Health Centre: Judit Orive, María Ángeles López, Idoia Herrero, Julia Huerta, Iñigo Alquiza, Félix Menéndez, Lorena Zarrandikoetxea, Zorione Lartitegui, Garbiñe Gómez, Nagore Arce, Alberto López, Francisco Javier Pérez De Nanclares, Esperanza Diez; Txurdinaga Health Centre: Teresa Rodríguez, Concepción Arizaga, Esther Echegaray, Estibaliz Alonso, Fernando Javier Orbegozo, José Ángel Fernández, Iratxe Gancedo, Arrate Oribe, Beatriz Navascues, Belén Sangroniz, María Jesús Manso, María Belén Elezcano, Miren Iosu Polo, Purificación Cos, Eugenia Barrenengoa, Pilar Ruiz, Victoria Marina Ruiz, Carmen Abalo.
The project was supported by the Basque Government Department of Health (EXP: 2010111039), Kronikgune Research Institute (EXP: KRONIK 11/033), and by the Carlos III Institute of Health of the Spanish Ministry of Health, and co-financed by European Union’s ERDF (FIS 2012/00495; RETICS G03/170 and RD06/0018/0018; CAI08/01/0065).
Authors’ contributions
GG and AS conceived the idea and are the study guarantors. They are primarily responsible for the study design and planning, obtained funding, and will be responsible for project coordination and supervision, analysis and interpretation of results and manuscript preparation. CS and RS collaborated in the study design, obtained funding, and will be responsible for study coordination, interpretation of results and manuscript preparation. AS, GG and CS will be responsible for the analysis of results and critically reviewed the manuscript. All contributors approved this version submitted for publication to BMC Public Health. All authors read and approved the final manuscript.