Nicholas Orme, Presenter: Nothing to Disclose

Joel Garland Fletcher MD, Abstract Co-Author: Research grant, Siemens AG Grant, E-Z-EM, Inc License agreement, General Electric Company

Hassan Siddiki MD, Abstract Co-Author: Nothing to Disclose

Barbara Koenig PhD, Abstract Co-Author: Nothing to Disclose

John DeWitt Port MD, PhD, Abstract Co-Author: Nothing to Disclose

William Tremaine MD, Abstract Co-Author: Nothing to Disclose

Henry C. Pitot MD, Abstract Co-Author: Nothing to Disclose

Marguerite Strobel, Abstract Co-Author: Nothing to Disclose

Elizabeth Gerard McFarland MD, Abstract Co-Author: Medical Advisory Board, Vital Images, Inc Medical Advisory Board, Medicsight, Inc

Bernard F. King MD, Abstract Co-Author: Nothing to Disclose

Susan Wolf JD, Abstract Co-Author: Nothing to Disclose

et al, Abstract Co-Author: Nothing to Disclose

et al, Abstract Co-Author: Nothing to Disclose

Incidental findings (IF’s) are discovered during imaging research, and are beyond the scope of research hypotheses. Our purpose is to assess the frequency and patterns of IF’s in imaging research, and retrospectively determine if net medical benefit or burden arises from reviewing research exams for IF’s.

Our department reviews imaging research studies for IF’s and issues a report to the patient’s physician. We retrospectively examined these reports from 1/04 - 3/04, recording modality, body region, and all IF’s, extracting from the medical record all decisions and clinical outcomes relating to these IF’s. Outcome data from patients who underwent clinical action consequent to their IF was presented to a panel consisting of MD’s and bioethicists to determine net medical benefit or burden using a predetermined scale. MD’s ranked the gravity of disease associated with each IF (1=trivial to 5=life-threatening).

1570 research exams were reviewed. 1090 IF’s were reported in 599 exams, with frequency of IF’s varying widely depending upon modality and body region (range 0-7/exam). Some research exams (e.g., chest CT) generated large numbers of IF’s. 36/1570 (2.3%) patients had at least one imaging study (n=33) or referral (n=32) on the basis of an IF. 9 patients (0.6%) had medical or surgical intervention. While consensus on all cases has not yet been established, all MD’s independently agreed that 4 patients (3-unknown CA’s resected, 1-osteo) had clear medical benefit as a result of intervention, while one had clear medical burden (laparoscopy for benign dz). Mean gravity score of all IF’s generating clinical action was 2.4, compared to 4 for those patients receiving net benefit.

1. IF’s frequently arise in imaging research, but few require medical surveillance, consultation or intervention (2.3%). 2. Review of imaging research IF’s rarely causes net medical burden, but may result in clear medical benefit to research subjects.

Timely review of incidental findings in imaging research will benefit a small number of research subjects while rarely causing harm.

Orme, N, Fletcher, J, Siddiki, H, Koenig, B, Port, J, Tremaine, W, Pitot, H, Strobel, M, McFarland, E, King, B, Wolf, S, et al, , et al, , Incidental Findings (IF’s) in Radiology Research: Are We Benefiting or Harming the Patient by Disclosing Incidental Research Findings?.  Radiological Society of North America 2007 Scientific Assembly and Annual Meeting, November 25 - November 30, 2007 ,Chicago IL. http://archive.rsna.org/2007/5005980.html