Abstract
BACKGROUND: The validity of a cardiovascular risk self-screening method was assessed. The results obtained for self-measurement of blood pressure, a point-of-care system's assessment of lipid profile and glycated hemoglobin, and a self-administered questionnaire (sex, age, diabetes, tobacco consumption) were compared with the standard screening (gold standard) conducted by a health professional. METHODS: Crossover clinical trial on a population-based sample from Girona (north-eastern Spain), aged 35-74, with no cardiovascular disease at recruitment. Participants were randomized to one of the two risk assessment sequences (standard screening followed by self-screening or vice versa). Cardiovascular risk was estimated with the Framingham-REGICOR function. Concordance between methods was estimated with the intraclass correlation coefficient (ICC). Sensitivity, specificity, and positive and negative predictive values were estimated, considering 5% cardiovascular risk as the cutoff point. ClinicalTrials.gov Registration #NCT02373319. Clinical Research Ethic Committee of the Parc de Salut Mar Registration #2014/5815/I. RESULTS: The median cardiovascular risk in men was 2.56 (interquartile range: 1.42-4.35) estimated by standard methods and 2.25 (1.28-4.07) by self-screening with ICC=0.92 (95% CI: 0.90-0.93). In women, the cardiovascular risk was 1.14 (0.61-2.10) by standard methods and 1.10 (0.56-2.00) by self-screening, with ICC=0.89 (0.87-0.90). The sensitivity, specificity, and positive and negative predictive values for the self-screening method were 0.74 (0.63-0.82), 0.97 (0.95-0.99), 0.86 (0.77-0.93), and 0.94 (0.91-0.96), respectively, in men. In women, these values were 0.50 (0.30-0.70), 0.99 (0.98-1), 0.81 (0.54-0.96), and 0.97 (0.95-0.99), respectively. CONCLUSION: The self-screening method for assessing cardiovascular risk provided similar results to the standard method. Self-screening had high clinical performance to rule out intermediate or high cardiovascular risk.