TY - JOUR
T1 - Ethical and practical considerations in the management of incidental findings in pediatric MRI studies
AU - Kumra, Sanjiv
AU - Ashtari, Manzar
AU - Anderson, Britt
AU - Cervellione, Kelly L.
AU - Kan, Li
PY - 2006/8/1
Y1 - 2006/8/1
N2 - OBJECTIVE: The authors examined the ethical and practical management issues resulting from the detection of incidental abnormal findings on magnetic resonance imaging (MRI) research studies in healthy pediatric volunteers. METHOD: A retrospective examination of the findings from 60 clinical reports of research MRI scans from a cohort of healthy pediatric volunteers (ages 10-21) was conducted. RESULTS: A neuroradiologist noted incidental abnormalities in 8 (13%) of 60 subjects. Of these eight children, three (5%) adolescents were found to have abnormalities (possible tumor, possible vascular malformation, and unidentified bright object in white matter, respectively) that were judged to require further diagnostic workup. In the first two cases, follow-up MRI ruled out the possibility of a tumor or vascular malformation. In the third case, a follow-up MRI 24 months later found that the white matter abnormality remained stable and was thus deemed to be of no clinical significance. CONCLUSIONS: In healthy children who are participating in research MRI protocols, it is ethically difficult to determine whether films should be read clinically. Based on this retrospective analysis, there would have been no risk(s) associated with not reading the films. In contrast, considerable anxiety was generated as a consequence of having the scans clinically read by a neuroradiologist because of the reporting of incidental abnormalities that later turned out to be false positives. Also, the detection of no abnormality on a research-quality scan could imply erroneously to some subjects that no abnormality was present, which may have been falsely reassuring.
AB - OBJECTIVE: The authors examined the ethical and practical management issues resulting from the detection of incidental abnormal findings on magnetic resonance imaging (MRI) research studies in healthy pediatric volunteers. METHOD: A retrospective examination of the findings from 60 clinical reports of research MRI scans from a cohort of healthy pediatric volunteers (ages 10-21) was conducted. RESULTS: A neuroradiologist noted incidental abnormalities in 8 (13%) of 60 subjects. Of these eight children, three (5%) adolescents were found to have abnormalities (possible tumor, possible vascular malformation, and unidentified bright object in white matter, respectively) that were judged to require further diagnostic workup. In the first two cases, follow-up MRI ruled out the possibility of a tumor or vascular malformation. In the third case, a follow-up MRI 24 months later found that the white matter abnormality remained stable and was thus deemed to be of no clinical significance. CONCLUSIONS: In healthy children who are participating in research MRI protocols, it is ethically difficult to determine whether films should be read clinically. Based on this retrospective analysis, there would have been no risk(s) associated with not reading the films. In contrast, considerable anxiety was generated as a consequence of having the scans clinically read by a neuroradiologist because of the reporting of incidental abnormalities that later turned out to be false positives. Also, the detection of no abnormality on a research-quality scan could imply erroneously to some subjects that no abnormality was present, which may have been falsely reassuring.
KW - Children
KW - Healthy volunteers
KW - Incidental findings
KW - Neuroethics
KW - Research protocol
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U2 - 10.1097/01.chi.0000222786.49477.a8
DO - 10.1097/01.chi.0000222786.49477.a8
M3 - Article
C2 - 16865043
AN - SCOPUS:33746394115
VL - 45
SP - 1000
EP - 1006
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
SN - 0890-8567
IS - 8
ER -