In clinical trials that include an imaging element, 40 percent of volunteers will have undiagnosed medical conditions that have no bearing on the trial, but that nonetheless reveal themselves in the images. New research shows that these incidental findings lead to some kind of clinical action in about 6 percent of those volunteers. That action proved beneficial in 1 percent; it proved a medical burden in 0.5 percent.
Such findings present ethical dilemmas, says Bernard Lo of the University of California, San Francisco. He writes in an Archives of Internal Medicine editorial that they are "false-positive findings," and says they lead to testing that results in "additional risks and burdens."
Those who conducted the study offer a balanced view: They see incidental findings as potentially a means for early detection of life-threatening disease, but also "an invitation to invasive, costly and ultimately unnecessary interventions for benign processes."
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