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(Circulation. 2008;117:2684-2690.)
© 2008 American Heart Association, Inc.

Contemporary Reviews in Cardiovascular Medicine

Methods and Limitations of Assessing New Noninvasive Tests

Part I: Anatomy-Based Validation of Noninvasive Testing

Rory Hachamovitch, MD, MSc; Marcelo F. Di Carli, MD

From the Divisions of Nuclear Medicine/PET and Cardiovascular Imaging, Departments of Radiology and Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Mass (M.D.F.).

Correspondence to Rory Hachamovitch, MD, MSc, 6380 Wilshire Blvd, Suite 1109, Los Angeles, CA 90048. E-mail hach@msn.com

Key Words: epidemiology • heart diseases • imaging • statistics • tests

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
The introduction and dissemination of new technology provide the potential for enhancing and expanding our understanding of disease processes (eg, atherosclerosis, myocardial dysfunction) and extending our treatment options while providing a tool for monitoring therapeutic responses.^1,2 However, the growth of cardiac imaging has profound cost implications that will be exacerbated if newer technology is widely disseminated and used freely³ without appropriate validation. Hence, technology validation has become an important consideration in today’s healthcare reality.³ Our goal is to provide a critical review of the methods and challenges inherent to the validation of existing or emerging noninvasive imaging technologies.

	How Should Noninvasive Testing Be Viewed?

 
Historically, imaging has been considered in the context of anatomic end points. A shift from anatomy-based to outcomes-based assessments of testing has been accepted. More recently, a further shift occurred from imaging for risk identification to imaging for identification of patients’ optimal therapeutic management, ie, identifying a therapeutic approach associated with optimal survival or improved well being after a given test result for a patient. This review focuses on diagnostic approaches; the second part focuses on test validation using risk and benefit end points.

	What Is Technology Assessment for Imaging Modalities?

 
In the context of assessing cardiac imaging, several factors must be considered. First, the assessment of a new modality is not a simple determination of sensitivity and specificity. Rather, it is a stepwise, multifactorial process incorporating diagnostic, prognostic, therapeutic, resource use, cost-effectiveness, and other end points that considers the perspectives of patients, payers, ordering physicians, and the healthcare system.⁴ A series of questions drive this process: Does the . . . [Full Text of this Article]

This article has been cited by other articles:

				R. Hachamovitch and M. F. Di Carli Methods and Limitations of Assessing New Noninvasive Tests: Part II: Outcomes-Based Validation and Reliability Assessment of Noninvasive Testing Circulation, May 27, 2008; 117(21): 2793 - 2801. [Full Text] [PDF]