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40% Of Research Scans Show Extra Findings

September 28, 2010
Written by: , Filed in: Abdominal Imaging, Chest Radiology, Medical Ethics, Neuroradiology
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Want to get a general radiological checkup? Participate in medical research. A new study reports that in almost 40 percent of research subjects who undergo medical imaging, the radiologist finds something unrelated to the research that may affect the individual’s health.

Researchers from Mayo Clinic in Rochester, Minnesota, checked the medical records of 1,426 participants in studies conducted in 2004. Each had undergone imaging as part of the study. A radiologist interpreted each image the day it was created, and an expert panel reviewed all “incidental findings” that resulted in a clinical action during a three-year follow-up period.

The 1,426 imaging examinations turned up incidental findings in 567 subjects (39.8 percent). The older the subject, the greater the chance of an incidental finding. CT scans of the abdomen and pelvis generated the most incidental findings, followed by CT of the chest and MRI of the head.

Almost all of the incidental findings turned out to be no big deal. In only 35 of the 567 incidental-findings subjects (6.2 percent) was clinical action taken. In most cases (26 of the 567, or 4.6 percent), the clinical action led to no clear medical benefit or burden. Clear medical benefit resulted for 6 of the 567 patients (1.1 percent), and a clear medical burden (harm or excessive cost resulting from treatment) resulted for 3 of the 567 (0.5 percent).

And therein lies the problem. “This study demonstrates that research imaging incidental findings are common in certain types of imaging examinations,” the researchers write, “potentially offering an early opportunity to diagnose asymptomatic life-threatening disease, as well as a potential invitation to invasive, costly and ultimately unnecessary interventions for benign processes.”

The study was published Monday in Archives of Internal Medicine. An accompanying editorial by Bernard Lo, MD, notes, “Such incidental findings present ethical dilemmas. Although they may offer the possibility of substantial personal benefit to the participant, more commonly they are false-positive findings that lead to a cascade of further testing that presents additional risks and burdens. While these dilemmas also arise when incidental findings are detected on studies ordered in clinical care, the special role of researchers complicates the situation.”

Dr. Lo is professor of medicine and director of the program in medical ethics at the University of California, San Francisco. He suggests that a plan for responding to incidental findings, including guidelines about what to disclose to participants, should be part of the overall plan for any study: “The possibility of incidental findings, and their ramifications, should be part of the informed consent process.”

Related seminar: Head To Toe Imaging

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