Validity of a method for the self-screening of cardiovascular risk

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.