title: Outcomes-Based CV Imaging Research Endpoints and Trial Design: From Pixels to Patient Satisfaction.
abstract: The categories and quality of evidence documenting the value of noninvasive cardiovascular imaging have evolved substantially over the last several decades. From an initial emphasis on the diagnostic accuracy of various imaging modalities, cardiovascular imaging has matured into an outcomes-based field that now provides evidence on adverse events, safety, cost, and patient quality-of-life endpoints, and does so in the setting of large randomized trials. This review aims to highlight types of outcomes endpoints, including updating the hierarchy of evidence for diagnostic imaging as first proposed by Fryback and Thornbury, and critically reviewing their application in the current cardiovascular imaging evidence base. We describe the range of data categories generated to date for the various imaging modalities, and indicate how this provides insights into contemporary study design and future directions in cardiovascular imaging outcomes research.
authors.affiliation: Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: cfordyce@mail.ubc.ca.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Fordyce
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
mesh_terms: D057791:Cardiac Imaging Techniques / Q000191:economics / Q000592:standards; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging* / Q000191:economics / Q000628:therapy; D002986:Clinical Trials as Topic / Q000379:methods*; D003362:Cost-Benefit Analysis; D023381:Endpoint Determination; D019317:Evidence-Based Medicine; D017048:Health Care Costs; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D017060:Patient Satisfaction; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D012107:Research Design
keywords: angina pectoris; coronary artery disease; noninvasive cardiac imaging; patient selection