TY - JOUR
T1 - A practical approach to incidental findings in neuroimaging research
AU - Shoemaker, J. M.
AU - Holdsworth, M. T.
AU - Aine, C.
AU - Calhoun, V. D.
AU - De La Garza, R.
AU - Feldstein Ewing, S. W.
AU - Hayek, R.
AU - Mayer, A. R.
AU - Kiehl, K. A.
AU - Petree, L. E.
AU - Sanjuan, P.
AU - Scott, A.
AU - Stephen, J.
AU - Phillips, J. P.
N1 - Funding Information:
J.M. Shoemaker has received research support from the US Department of Energy and the Suzie Poole Foundation. Dr. Holdsworth reports no disclosures. Dr. Aine serves on the editorial boards of Neuroinformatics, Open Neuroimaging Journal, and Open Medical Imaging Journal; has received research support from the NIH and UNM SOM, CTSC Pilot Project Grant Award. Dr. Calhoun has received research support from the NIH (NIMH, NIBIB, NCRR), National Science Foundation, and the US Department of Energy. R. de La Garza reports no disclosures. Dr. Feldstein Ewing has served as a consultant for DiClemente Research Group (UGA). Dr. Hayek reports no disclosures. Dr. Mayer serves as a consultant for Visionquest and has received research support from the NIH and the US Department of Energy. Dr. Kiehl has received research support from the NIH and the US Department of Energy. L.E. Petree reports no disclosures. Dr. Sanjuan receives research support from the NIH (NIAAA, NIDA) and the US Department of Energy. A. Scott reports no disclosures. Dr. Stephen receives research support from NIH. Dr. Phillips serves on the editorial board of the journal Pediatric Neurology; has received research support from the NIH and the Delle Foundation; and has given expert testimony in medico-legal cases.
Funding Information:
This study was not industry-sponsored; however, data presented from industry-sponsored studies were included in the analysis. This material is based on work supported by NIH, NCCR, the Department of Energy, Defense Advanced Research Projects Agency, Delle Foundation, John Templeton Foundation, University of New Mexico, CTSC, National Multiple Sclerosis Society, Office of Naval Research, Sandia University Research Program, and Swiss NSF under award numbers DE-FG02-08ER64581, CTSC001-1, 1-KL2-RR31976-1, 1-UL1-RR031977, 1-R01-AG029495-03, 1-UL1-RR031977, 1-R21-MH080141-02, 1-R01-AG020302-05, R01-AA017390, 5-P20-RR021938, DE-FG02-08ER64581, 1-R03-DA027892-01, R01-MH072681, R01-MH070539, 1-R01-MH085010-01A1, R01-MH071896, R01-DA020870, 1-R01-DA026505-01A1, 5-P20-AA017068, DE-FG02-08ER64581, 1-R03-DA022435-01A1, R24-HD050836, R21-NS064464-01A1, 5-R21-HD041237-02, 5-M01-RR00997, 5-M01-RR000997-35, 1-R01-HD059856-01A2, 1-R01-EB002618-01, 1-R21-DA027149-A1, 1-R21-DA029464, 1-R41-NS062474-01, DE-FG02-99ER62764, 1-R01-DA14178-01, R01-HL04722-A5, 3-R01-NS052305, 1-R21-DA027149-01, P20-AA017068, 5-U24-AA014811-06, 1-R21-DA025135, PA001-113097, NBCHC070103, NBCHC090055, 5-R01-AA012238, 5-R01-AA014886, and 1-R01-DA025074.
PY - 2011/12/13
Y1 - 2011/12/13
N2 - Objective: We describe the systematic approach to incidental findings (IFs) used at the Mind Research Network (MRN) where all MRI scans receive neuroradiologist interpretation and participants are provided results. Methods: From 2004 to 2011, 8,545 MRI scans were acquired by 45 researchers. As mandated by MRN's external institutional review board, all structural sequences were evaluated by a clinica neuroradiologist who generated a report that included recommendations for referral if indicated. Investigators received a copy of their participants' reports, which were also mailed to participants unless they specifically declined. To better understand the impact of the radiology review process, a financial analysis was completed in addition to a follow-up phone survey to characterize participant perceptions regarding receiving their MRI scan results. Results: The radiologist identified IFs in 34% of the 4,447 participants. Of those with IFs (n = 1,518), the radiologist recommended urgent or immediate referral for 2.5% and routine referra for 17%. For 80.5%, no referral was recommended. Estimated annual cost for this approach ncluding support for the neuroradiologist, medical director, and ancillary staff is approximately $60,000 or $24/scan. The results of the retrospective phone survey showed that 92% of particpants appreciated receiving their MRI report, and the majority stated it increased their likelihood of volunteering for future studies. Conclusions: Addressing IFs in a cost-effective and consistent manner is possible by adopting a policy that provides neuroradiology interpretation and offers participant assistance with clinica follow-up when necessary. Our experience suggests that an ethical, institution-wide approach to IFs can be implemented with minimal investigator burden.
AB - Objective: We describe the systematic approach to incidental findings (IFs) used at the Mind Research Network (MRN) where all MRI scans receive neuroradiologist interpretation and participants are provided results. Methods: From 2004 to 2011, 8,545 MRI scans were acquired by 45 researchers. As mandated by MRN's external institutional review board, all structural sequences were evaluated by a clinica neuroradiologist who generated a report that included recommendations for referral if indicated. Investigators received a copy of their participants' reports, which were also mailed to participants unless they specifically declined. To better understand the impact of the radiology review process, a financial analysis was completed in addition to a follow-up phone survey to characterize participant perceptions regarding receiving their MRI scan results. Results: The radiologist identified IFs in 34% of the 4,447 participants. Of those with IFs (n = 1,518), the radiologist recommended urgent or immediate referral for 2.5% and routine referra for 17%. For 80.5%, no referral was recommended. Estimated annual cost for this approach ncluding support for the neuroradiologist, medical director, and ancillary staff is approximately $60,000 or $24/scan. The results of the retrospective phone survey showed that 92% of particpants appreciated receiving their MRI report, and the majority stated it increased their likelihood of volunteering for future studies. Conclusions: Addressing IFs in a cost-effective and consistent manner is possible by adopting a policy that provides neuroradiology interpretation and offers participant assistance with clinica follow-up when necessary. Our experience suggests that an ethical, institution-wide approach to IFs can be implemented with minimal investigator burden.
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U2 - 10.1212/WNL.0b013e31823d7687
DO - 10.1212/WNL.0b013e31823d7687
M3 - Article
C2 - 22131543
AN - SCOPUS:84856194914
SN - 0028-3878
VL - 77
SP - 2123
EP - 2127
JO - Neurology
JF - Neurology
IS - 24
ER -