2012
DOI: 10.1177/1740774512436882
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Design of the Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) trial and the impact of uncertainty on power

Abstract: Background Although observational evidence has suggested that the measurement of CAC may improve risk stratification for cardiovascular events and thus help guide the use of lipid-lowering therapy, this contention has not been evaluated within the context of a randomized trial. The Value of Imaging in Enhancing the Wellness of Your Heart (VIEW) trial is proposed as a randomized study in participants at low intermediate risk of future coronary heart disease (CHD) events to evaluate whether coronary artery calci… Show more

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Cited by 25 publications
(15 citation statements)
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“…The ideal approach to address this study’s hypothesis would be a randomized controlled trial. However, conducting such a trial for a diagnostic screening test in the setting of primary prevention requires a large sample size, long duration, and high cost (39). The 18% CHD reduction for the total sample, the 32% reduction in CHD for men, and 17% reduction in CVD for women are larger benefits than what the recent meta-analyses of aspirin in primary prevention have shown (4,5).…”
Section: Discussionmentioning
confidence: 99%
“…The ideal approach to address this study’s hypothesis would be a randomized controlled trial. However, conducting such a trial for a diagnostic screening test in the setting of primary prevention requires a large sample size, long duration, and high cost (39). The 18% CHD reduction for the total sample, the 32% reduction in CHD for men, and 17% reduction in CVD for women are larger benefits than what the recent meta-analyses of aspirin in primary prevention have shown (4,5).…”
Section: Discussionmentioning
confidence: 99%
“…This degradation might occur if scanning technique and interpretation are lower quality in practice than they have been in research studies, or if research estimates of CAC prediction were otherwise over-optimistic, such as might occur from the lack of blinding to CAC scores that has been common in cohort studies. This sensitivity to assumptions creates a powerful rationale for real-world effectiveness testing with a clinical trial, as has been proposed 43 ; such a trial, however, would be very expensive and would take many years to complete.…”
Section: Discussionmentioning
confidence: 99%
“…The net comparative effectiveness and efficiency (cost-effectiveness) of this approach, however, have not been proven. To do so would require randomized controlled trials of an integrated screening and targeted prevention strategy 31 or careful modeling of expected benefits, harms and costs 32 .…”
Section: Discussionmentioning
confidence: 99%