Radiology
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Comparative Study
Aortoiliac and lower extremity arteries assessed with 16-detector row CT angiography: prospective comparison with digital subtraction angiography.
To prospectively compare the accuracy of 16-detector row computed tomographic (CT) angiography with conventional digital subtraction angiography (DSA) as the reference standard in the assessment of aortoiliac and lower extremity arteries in patients with peripheral arterial disease. ⋯ Sixteen-detector row CT angiography is an accurate and reliable noninvasive alternative to conventional DSA in the assessment of aortoiliac and lower extremity arteries in patients with peripheral arterial disease.
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Comparative Study
Dynamic bilateral contrast-enhanced MR imaging of the breast: trade-off between spatial and temporal resolution.
To investigate prospectively the trade-off between temporal and spatial resolution in dynamic contrast material-enhanced bilateral magnetic resonance (MR) imaging of the breast. ⋯ Increased spatial resolution significantly improves diagnostic confidence and accuracy at dynamic MR imaging, even if this improvement occurs at the expense of temporal resolution. Loss of kinetic information regarding enhancement rates proved to be not diagnostically relevant because enhancement rates showed broad overlap between benign and malignant lesions and were therefore of only limited diagnostic use in the individual patient. Kinetic information regarding time course pattern was preserved and confirmed as having high specificity and high positive predictive value.
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The purpose of this series of articles is to explain the ethical and legal basis for responsible conduct of radiology research and the rules that an investigator must follow. In this article (part two of the series), the regulatory requirements to conduct human research are explained. The Food and Drug Administration and Department of Health and Human Services research regulations require two main protections to be in place for the conduct of research involving humans: informed consent and prior review and approval by an institutional review board. ⋯ When investigators do not design their research, they should actively work with the sponsor of the research to improve the design in terms of protection of study participants. Investigators should also know the information that must be disclosed when obtaining informed consent and incorporate those requirements into the informed consent process and the documentation of informed consent. Investigators should know about waiver of informed consent and consent documentation and when these situations might be appropriate for their research.