Derivation of Patient-Defined Adverse Cardiovascular and Noncardiovascular Events Through a Modified Delphi Process

Abstract

Therapeutic decisions are challenging for patients with advanced cardiovascular disease, because there is a paucity of evidence to support patient-centered outcomes in this group.^1,2 Traditional cardiovascular trials have sometimes been termed tombstone trials³ because of their focus on major adverse cardiac events and death. However, a prior survey² of cardiovascular patients found that important outcomes identified by patients were very different from those used in traditional trials. Because patients with advanced cardiovascular disease are likely to be elderly with substantial comorbidities, they are more often concerned with how treatment might impact their ability to lead an independent life with less impairment and outside of chronic care institutions. Our group previously explored the concept of disability-free survival as a patient-defined outcome after coronary revascularization.² We conducted the present study to refine this outcome by integrating the perspectives of patients and their caregivers, with input from expert clinicians. We term this outcome patient-defined adverse cardiovascular and noncardiovascular events (PACE).