Abstract
Background: The current paradigm for primary cardiovascular disease (CVD) prevention emphasizes absolute risk assessment to guide decision-making. Although considerable attention has been given to the derivation and validation of multivariable CVD risk scores, their effect on clinical outcomes is uncertain. Objective: To evaluate the effect of multivariable CVD risk scores on cardiovascular outcomes in primary CVD prevention. Search Methods: We searched the Cochrane Library, MEDLINE, EMBASE, and Conference Proceedings Citation Index - Science from their inception to January 2015 and imposed no language restriction. We also searched clinical trial registers and hand-searched reference lists of primary studies. Selection Criteria: We included RCTs and quasi-RCTs that compared the delivery of multivariable CVD risk scores to usual care among adults (≥ 18 years) free from clinical CVD. Data Collection and Analysis: We screened titles, selected studies for inclusion, and extracted data, including risk of bias, in duplicate. Our outcomes included: fatal and nonfatal CVD events, changes in CVD risk factor levels, adverse events, medication prescriptions in high-risk individuals, medication adherence, health-related quality of life, health-related behaviors, and costs. Main Results: From a total of 5,442 reports, we identified 38 studies (N=220,122 participants). Interventions ranged from simple CVD risk score presentation to multifaceted interventions incorporating multiple risk messages, clinical decision support tools, electronic reminders, patient activation material, audit and feedback, and nurse-led counseling sessions. We assessed the majority (n=32) of studies as having high or unclear risk of bias in the domains of selection, performance, detection, attrition, and reporting bias. Due to substantial heterogeneity, we were not able to perform meta-analysis for quantitative synthesis. We found no strong evidence that systematic implementation of CVD risk scores reduced fatal or nonfatal CVD events but the 2 studies reporting this endpoint were both underpowered. There were 14 studies that demonstrated improvements in CVD risk factor levels, health behaviors, or prescriptions in high-risk individuals but effect sizes were small and variable between studies. Interventions that were integrated into the electronic health record or provided “heart age” estimates tended to be most effective. There were no reported adverse effects of CVD risk scores. Effects on medication adherence, health-related quality of life, and cost were poorly reported. Conclusions: We found no strong evidence that CVD risk scores improve clinical outcomes. Newer models of implementing risk scores should be developed, implemented, and evaluated in adequately powered studies to improve primary CVD prevention.
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