Incidental findings are detected in up to 70% of neuroimaging scans. At the University of New Mexico Health Sciences Center and the Mind Research Network in Albuquerque, these are routinely reported to individuals participating in research studies. However, the terminology used and the complexity of radiology reports can be challenging, confusing, and/or even incomprehensible to the research participant who may overreact or ignore recommendations.
What should be done?
A multidisciplinary team decided to investigate. They conducted a study to identify the extent of health literacy challenges that were created when radiology reports containing information about incidental findings were shared with neuroimaging research participants. The team wanted to determine how much these individuals understood, whether they followed recommendations, and what they ultimately did after they received the report. The researchers also wanted to measure the perceptions of neuroimaging investigators who were conducting the clinical studies about giving these reports to participants.
Co-lead investigator, Deborah L. Helitzer, ScD, dean of the College of Population Health, and colleagues conducted a systematic survey of the perceptions and preferences of former research participants, investigators conducting MRI studies, and members of the university’s Institutional Review Board (IRB). They invited participants and parents of pediatric participants to participate in focus groups. The demographics of participants were balanced with respect to age, sex, and ethnicity. A non-participant group of individuals living in Albuquerque were also recruited and demographically balanced. Primary care and internal medicine physicians affiliated with the university were recruited to participate in separate focus groups. In total, 48 research participants or parents, 29 investigators conducting neuroimaging clinical studies, 17 physicians, 27 IRB members, and 30 “community” members participated in 16 focus group discussions.
The team reviewed 196 radiology reports of participants. Of these, 38% reported no incidental findings, 41% reported incidental findings with the recommendation that no action whatsoever was needed, and 21% recommended that the participant discuss the findings with his/her physician. Of this latter group, more than two-thirds of participants ignored physician referral recommendations. 9% of the subgroup with incidental findings that could be ignored were concerned enough to contact a physician.
Parents of child participants were more health literate. The research team found that they had a high health literacy score of 94.8. By comparison, the “participants” group had mean health literacy scores of 87.3.
Focus group sessions revealed that many recipients of a radiology report of a MRI head scan felt that the medical terminology in the report was difficult if not incomprehensible. They wanted the reports they received to clearly explain the meaning and implications of the incidental findings, preferably in detail that would anticipate such questions as: “Is this something that I should be concerned about in the future?” Others requested references to understandable articles or trusted websites that would provide additional information.
Representative comments included remarks like, “So, what do you want to do with this? I don’t know what it is” and “…well, there’s a bright spot. Is there a light in her head? What’s the deal?”
The neuroimaging investigators, physicians, and IRB members agreed with the participants. They stated that the radiology reports needed to contain explanations that would be understandable to any patient with an 8th-grade reading level and higher. The authors said that a theme unique to the IRB members was the potential ethical dilemma of returning radiology report information that participants cannot understand. Neuroimaging investigators noted that patients could “freak out” and not want to participate in future studies. They said that they were contacted by participants regarding these findings, and that making sure that research participants understood the information in the research radiology report “puts a considerable burden on investigators to communicate that information clearly and accurately.”
Inquiries that were unnecessary also placed an additional burden on physicians who were contacted by their patients.
“Our institution’s experience in disclosing incidental findings has revealed the importance of considering a participant’s ability to understand incidental finding information and make appropriate decisions,” the authors wrote in their article published by BMC Medical Ethics. “Investigators face a complex conundrum: they don’t expect participants to understand the radiology jargon, yet they believe that participants ethically deserve to receive the information. Our research shows that participants report a strong desire to receive all medically relevant incidental findings information.”
The logical conclusion reached by the authors was that language must be developed to supplement a formal radiology report that will explain incidental findings to recipients at a variety of health literacy ability levels. Dr. Helitzer told Applied Radiology that the university is proposing to build a website to address these issues.
She added, “Health literacy is very important for the ethical issues relating to research participation in general. I do not think that most clinical and basic sciences researchers have ever heard about health literacy, and certainly have not made the connection between their work and the health literacy of their subjects. Given the important links between health literacy and health outcomes, it will be important for us to consider how to make health literacy a priority as our use of technology increases.”
Impact of reporting incidental neuroimaging findings to research participants. Appl Radiol.