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Validating prediction scales of type 2 diabetes mellitus in Spain: the SPREDIA-2 population-based prospective cohort study protocol
  1. Miguel Ángel Salinero-Fort1,
  2. Carmen de Burgos-Lunar2,
  3. José Mostaza Prieto3,
  4. Carlos Lahoz Rallo3,
  5. Juan Carlos Abánades-Herranz4,
  6. Paloma Gómez-Campelo5,
  7. Fernando Laguna Cuesta3,
  8. Eva Estirado De Cabo3,
  9. Francisca García Iglesias3,
  10. Teresa González Alegre3,
  11. Belén Fernández Puntero6,
  12. Luis Montesano Sánchez6,
  13. David Vicent López6,
  14. Víctor Cornejo Del Río6,
  15. Pedro J Fernández García6,
  16. Concesa Sabín Rodríguez6,
  17. Silvia López López6,
  18. Pedro Patrón Barandío6,
  19. the SPREDIA-2 Group
    1. 1Gerencia Adjunta de Planificación y Calidad, Atención Primaria. Servicio Madrileño de Salud, Instituto de Investigación Sanitaria del Hospital Universitario La Paz-IdiPAZ. Red de Investigación en servicios de salud en enfermedades crónicas (REDISSEC), Madrid, Spain
    2. 2Servicio de Medicina Preventiva, Hospital Universitario La Paz, Instituto de Investigación Sanitaria del Hospital Universitario La Paz-IdiPAZ. Red de Investigación en servicios de salud en enfermedades crónicas (REDISSEC), Madrid, Spain
    3. 3Servicio de Medicina Interna, Hospital Carlos III, Madrid, Spain
    4. 4Dirección Técnica de Docencia e Investigación. Gerencia Adjunta de Planificación y Calidad. Atención Primaria, Servicio Madrileño de Salud. Instituto de Investigación Sanitaria del Hospital Universitario La Paz-IdiPaz, Madrid, Spain
    5. 5Plataforma de apoyo al Investigador Novel. Instituto de Investigación Sanitaria del Hospital Universitario La Paz-IdiPAZ, Madrid, Spain
    6. 6Hospital Carlos III, Madrid, Spain
    1. Correspondence to Dr Miguel Ángel Salinero-Fort; miguel.salinero{at}salud.madrid.org

    Abstract

    Introduction The incidence of type 2 diabetes mellitus (T2DM) is increasing worldwide. When diagnosed, many patients already have organ damage or advance subclinical atherosclerosis. An early diagnosis could allow the implementation of lifestyle changes and treatment options aimed at delaying the progression of the disease and to avoid cardiovascular complications. Different scores for identifying undiagnosed diabetes have been reported, however, their performance in populations of southern Europe has not been sufficiently evaluated. The main objectives of our study are: to evaluate the screening performance and cut-off points of the main scores that identify the risk of undiagnosed T2DM and prediabetes in a Spanish population, and to develop and validate our own predictive models of undiagnosed T2DM (screening model), and future T2DM (prediction risk model) after 5-year follow-up. As a secondary objective, we will evaluate the atherosclerotic burden of the population with undiagnosed T2DM.

    Methods and analysis Population-based prospective cohort study with baseline screening, to evaluate the performance of the FINDRISC, DANISH, DESIR, ARIC and QDScore, against the gold standard tests: Fasting plasma glucose, oral glucose tolerance and/or HbA1c. The sample size will include 1352 participants between the ages of 45 and 74 years. Analysis: sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio positive, likelihood ratio negative and receiver operating characteristic curves and area under curve. Binary logistic regression for the first 700 individuals (derivation) and last 652 (validation) will be performed. All analyses will be calculated with their 95% CI; statistical significance will be p<0.05.

    Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of the Carlos III Hospital (Madrid). The score performance and predictive model will be presented in medical conferences, workshops, seminars and round table discussions. Furthermore, the predictive model will be published in a peer-reviewed medical journal to further increase the exposure of the scores.

    • DIABETES & ENDOCRINOLOGY
    • EPIDEMIOLOGY
    • PUBLIC HEALTH

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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