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Outcomes Research in Cardiovascular Imaging: Report of a Workshop sponsored by the National Heart Lung and Blood Institute
The "value" of imaging in terms of improved health or reduced cardiovascular events is subjective, with limited evidence, often generated with flawed research methodology, that any of the commonly used cardiovascular imaging techniques improve patient outcomes or general public health. There are concerns that imaging can cause harm, that there are few rigorous regulatory controls, and that utilization is at least in part driven by self referral and, in some cases, even direct-to-consumer advertising.
The National Heart, Lung, and Blood Institute recently released its Strategic Plan for “Shaping the Future of Research.” The importance of optimizing diagnostic tests for improving outcomes is explicitly recognized in the Plan, which states that “research is needed to evaluate the extent to which risk stratification and application of personalized approaches can improve effectiveness,” (Challenge 3.1.a), that “studies are needed to reduce the inappropriate used of diagnostic tests and treatments,” (Challenge 3.1.c), and that there is a need to “evaluate the risks, benefits, and costs of diagnostic tests and treatments in representative populations and settings.” (Challenge 3.2.a)
On July 21-22, 2008, the National Heart, Lung, and Blood Institute (NHLBI) convened an expert panel from the fields of non-invasive cardiovascular imaging, outcomes research, statistics, and clinical trials to develop a vision of imaging research that transcends current reliance on diagnostic and prognostic endpoints to a new paradigm that focuses on preventive and therapeutic value, where value implies an improved clinical outcome, and costs. The panel was specifically charged to briefly review current evidence and guidelines for cardiovascular imaging of patients in specific clinical settings and to develop a set of recommendations for future analyses and research for NHLBI, including drafting trial designs for four pre-defined clinical scenarios commonly encountered in clinical practice. The panel was asked to identify need, assess feasibility, and determine ideal trial designs and measured outcomes in each case. The four scenarios included (1) screening the asymptomatic patient for coronary artery disease, (2) assessment of 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 LV ejection fraction.
The panel drafted trial designs for these four scenarios, based on the principle that studies provide useful information about the value of imaging based on clinical outcomes and costs. The panel recommends that consideration be given to these or similar types of studies in determining the true value of cardiovascular imaging.
The full report has been published.