Posted on Oct 13, 2010, 6 a.m.
In an estimated 40% of research subjects who undergo medical imaging, a significant medical finding unrelated to the study, but meaningful to the person’s health may be revealed.
Often, research subjects enrolled in clinical studies are given medical imaging diagnostics, to establish baseline health and monitor progress through the trial. Nicholas M. Orme, from Mayo Clinic (Minnesota, USA), and colleagues evaluated the medical records of 1,426 research participants who underwent an imaging procedure related to a study conducted in 2004. Each image was interpreted by a radiologist the day it was performed, and an expert panel reviewed all incidental findings that resulted in a clinical action during a three-year follow-up period. Of the 1,426 research imaging examinations, an incidental finding occurred in 567 (39.8%), with the risk of an incidental finding increasing with age. Clinical action was taken for 35 (6.2%) of the individuals with an incidental finding, and action resulted in clear medical benefit for six of the 567 patients (1.1%). The team writes that: “Routine evaluation of research images by radiologists may result in identification of [incidental findings] in a high number of cases and subsequent clinical action to address them in a small but significant minority,” concluding that: “Such clinical action can result in medical benefit to a small number of patients.”
Nicholas M. Orme; Joel G. Fletcher; Hassan A. Siddiki; W. Scott Harmsen; Megan M. O’Byrne; John D. Port; William J. Tremaine; Henry C. Pitot; Elizabeth G. McFarland; Marguerite E. Robinson; Barbara A. Koenig; Bernard F. King; Susan M. Wolf. “Incidental Findings in Imaging Research: Evaluating Incidence, Benefit, and Burden.” Arch Intern Med, September 2010; 170: 1525 - 1532.