Validating prediction scales of type 2 diabetes mellitus in Spain: the SPREDIA-2 population-based prospective cohort study protocol

Abstract

IntroductionThe 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 analysisPopulation-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 disseminationThe 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.

Performance of the Finnish Diabetes Risk Score and a Simplified Finnish Diabetes Risk Score in a Community-Based, Cross-Sectional Programme for Screening of Undiagnosed Type 2 Diabetes Mellitus and Dysglycaemia in Madrid, Spain: The SPREDIA-2 Study

“…This study was conducted as part of a broader project, the S creening PRE -diabetes and type 2 DIA betes (SPREDIA-2) study, which has been described in detail elsewhere [ 16 ]. SPREDIA-2 is a population-based prospective cohort study in which baseline screening was performed from July 2010 to March 2014 according to Standards for Reporting of Diagnostic Accuracy criteria [ 17 ].…”

Prevalence of peripheral artery disease (PAD) and factors associated: An epidemiological analysis from the population-based Screening PRE-diabetes and type 2 DIAbetes (SPREDIA-2) study

“…This study was conducted as part of a broader project, the S creening PRE -diabetes and type 2 DIA betes (SPREDIA-2) study, which has been described in detail elsewhere [ 23 ]. SPREDIA-2 is a population-based prospective cohort study in which baseline screening was performed from July 2010 to March 2014.…”

“…However, subjects in the participants group had a significantly greater family history of DM, hypertension and dyslipidemia compared with the non-participants group ( S1 Table ). The study procedure has been described in detail elsewhere [ 23 ]. Briefly, recruitment was divided into three phases.…”

Screening for diabetes in dental settings

“…age over 45 years, history of gestational diabetes, family history of diabetes or obesity). Salinero-Fort and colleagues reported that there was no consensus on the selection of the optimal high-risk subgroups or on how regularly these screens should be performed (Salinero-Fort et al, 2015). As a consequence, risk scores have been developed in order to better identify high risk participants.…”