title: Validating prediction scales of type 2 diabetes mellitus in Spain: the SPREDIA-2 population-based prospective cohort study protocol.
abstract: BACKGROUND
  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
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: Gerencia 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.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Salinero-Fort
authors.affiliation: Servicio 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.
authors.forename: Carmen
authors.initials: C
authors.lastname: de Burgos-Lunar
authors.affiliation: Servicio de Medicina Interna, Hospital Carlos III, Madrid, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Mostaza Prieto
authors.affiliation: Servicio de Medicina Interna, Hospital Carlos III, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Lahoz Rallo
authors.affiliation: Dirección 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.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Abánades-Herranz
authors.affiliation: Plataforma de apoyo al Investigador Novel. Instituto de Investigación Sanitaria del Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.
authors.forename: Paloma
authors.initials: P
authors.lastname: Gómez-Campelo
authors.affiliation: Servicio de Medicina Interna, Hospital Carlos III, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Laguna Cuesta
authors.affiliation: Servicio de Medicina Interna, Hospital Carlos III, Madrid, Spain.
authors.forename: Eva
authors.initials: E
authors.lastname: Estirado De Cabo
authors.affiliation: Servicio de Medicina Interna, Hospital Carlos III, Madrid, Spain.
authors.forename: Francisca
authors.initials: F
authors.lastname: García Iglesias
authors.affiliation: Servicio de Medicina Interna, Hospital Carlos III, Madrid, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: González Alegre
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Fernández Puntero
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Montesano Sánchez
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Vicent López
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: Víctor
authors.initials: V
authors.lastname: Cornejo Del Río
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: Pedro J
authors.initials: PJ
authors.lastname: Fernández García
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: Concesa
authors.initials: C
authors.lastname: Sabín Rodríguez
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: López López
authors.affiliation: Hospital Carlos III, Madrid, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Patrón Barandío
mesh_terms: D000368:Aged; D015982:Bias; D001786:Blood Glucose / Q000032:analysis*; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis* / Q000453:epidemiology*; D042241:Early Diagnosis; D005260:Female; D005951:Glucose Tolerance Test / Q000379:methods*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D011236:Prediabetic State / Q000175:diagnosis*; D011446:Prospective Studies; D012372:ROC Curve; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology
chemical_list: D001786:Blood Glucose
keywords: DIABETES & ENDOCRINOLOGY; EPIDEMIOLOGY; PUBLIC HEALTH