Focusing on Outcomes in Circulation: Cardiovascular Quality and Outcomes

Outcomes research is distinct in its focus on the patient's experience. Ideally, our research should illuminate key determinants of successful prevention, diagnosis, or treatment of disease, with an emphasis on outcomes that patients will recognize as important.Some of the studies in our pages, however, use biomarkers or surrogate end points. These measures reflect biological processes that are related to risk of meaningful patient outcomes. For example, low-density lipoprotein (LDL) is a marker of risk and the outcome for many studies that assume that lowering LDL is equivalent to reducing risk.1 Other studies with similar assumptions have used glucose control as an outcome2; even the Food and Drug Administration has approved drugs using the assumption that change in a marker of adverse outcomes is also associated with changes in outcome.In fact, these markers are not equivalent to patient outcomes. Although they may be good predictors of outcomes and even play a role in the pathophysiological processes that increase risk, their modification by intervention does not always change patient risk …