Incidental findings on brain magnetic resonance imaging of children with sickle cell disease.
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ABSTRACT:
SUBMITTER: Jordan LC
PROVIDER: S-EPMC3153884 | biostudies-literature | 2010 Jul
REPOSITORIES: biostudies-literature
Publications
Incidental findings on brain magnetic resonance imaging of children with sickle cell disease.
Jordan Lori C LC McKinstry Robert C RC Kraut Michael A MA Ball William S WS Vendt Bruce A BA Casella James F JF DeBaun Michael R MR Strouse John J JJ
Pediatrics 20100614 1
<h4>Objective</h4>We describe the prevalence and range of incidental intracranial abnormalities identified through MRI of the brain in a large group of children screened for a clinical trial.<h4>Methods</h4>We included 953 children between 5 and 14 years of age who were screened with MRI of the brain for the Silent Infarct Transfusion Trial. All had sickle cell anemia or sickle beta-null thalassemia. MRI scans were interpreted by 3 neuroradiologists. MRI scans reported to have any abnormality we ...[more]
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Project description:Background In the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies. Methods Between 2013 and 2019, 8252 participants (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported. Results Severe structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy. Conclusion The management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies. Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02220582. Supplementary Information The online version contains supplementary material available at 10.1186/s12910-021-00706-3.
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