The World Health Organization lists ischemic heart disease and stroke as the top 2 leading causes of death worldwide in 2011, responsible for 7 million and 6.2 million deaths, respectively.1 The concept of risk factors for atherosclerotic cardiovascular disease (CVD) was introduced in 1961, based on epidemiologic observations from the Framingham Heart Study. Hypertension and abnormal blood lipid levels were key risk factors shown to be associated with an increased risk of angina pectoris, myocardial infarction, and sudden cardiac death; later, stroke was identified as an important outcome as well, especially in women and racial/ethnic subgroups. Accordingly, clinicians want to provide their patients with the best possible advice with respect to the management of cardiovascular risk, often implementing evidence-based clinical practice guidelines designed to improve health outcomes.
The biologic continuum of disease progresses from ideal health through the development of risk factors (eg, hypertension, hypercholesterolemia) and the transition to disease (eg, atherosclerosis) with development of outcome events (eg, myocardial infarction, stroke). Three categories (A, B, C) of RCTs illustrate the available evidence reviewed by committees for clinical practice guidelines. In epidemiologic observational studies, patients enter the study cohort at different stages along the continuum and vary in the duration they are at risk for an outcome event. The proposed solution to the limitations of the current evidence base is to embed randomized trials in large free-living cohorts of patients who enter the trial and are randomized at different stages throughout the biologic continuum. See text.
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JAMA: 2014-03-26, Vol. 311, No. 12, Author Reading
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