Outcomes Research in Cardiovascular Imaging: Report of a Workshop Sponsored by the National Heart, Lung, and Blood Institute

Division of Cardiovascular Medicine, Duke University Medical Center, Durham, NC, USA.
Circulation Cardiovascular Imaging (Impact Factor: 5.32). 07/2009; 2(4):339-48. DOI: 10.1161/CIRCIMAGING.108.123999
Source: PubMed


In July of 2008, the National Heart, Lung, and Blood Institute convened experts in noninvasive cardiovascular imaging, outcomes research, statistics, and clinical trials to develop recommendations for future randomized controlled trials of the use of imaging in: 1) screening the asymptomatic patient for coronary artery disease; 2) assessment of patients with stable angina; 3) identification of acute coronary syndromes in the emergency room; and 4) assessment of heart failure patients with chronic coronary artery disease with reduced left ventricular ejection fraction. This study highlights several possible trial designs for each clinical situation.

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Available from: Robert Bonow, Jun 15, 2014
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    • "The majority of clinical trials evaluating the performance of an imaging test have examined diagnostic accuracy. Linking an imaging test, subsequent therapy, and outcome can be difficult even within the context of a carefully conducted trial, owing to individual patient and provider behaviors [24]. Imaging tests can only capture a snapshot of cardiac structure or physiology, and provide an estimation of the natural progression of the disease of interest. "
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    ABSTRACT: With the need for healthcare cost-containment, scrutiny will be increasingly placed on new medical therapeutic or diagnostic technologies. Several challenges exist for a new diagnostic test to demonstrate cost-effectiveness. New diagnostic tests differ from therapeutic procedures due to the fact that diagnostic tests do not generally directly affect long-term patient outcomes. Instead, the results of diagnostic tests can influence the decision for certain management plans of patients and by this route, diagnostic tests indirectly affect long-term outcomes. The benefits from a specific diagnostic technology depend therefore not only on its performance characteristics, but also on other factors such as prevalence of disease, and effectiveness of existing treatments for the disease of interests. We review the concepts and theories of cost-effectiveness analyses (CEA) as they apply to diagnostic tests in general. The limitations of CEA across different study designs and geographic regions are discussed, and we also examine the strengths and weakness of the existing publications where CMR was the focus of CEA compared to other diagnostic options.
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