A pair of articles in the January issue of Radiology debated whether or not radiology departments need to develop an informed consent process that details the risk of medical radiation. Both groups of experts recognized that informed consent may not be ready for prime time, albeit for different reasons, and acknowledged the value of informed decision making.
Current studies suggest that 95 percent of patients are not informed of any radiation risk prior to a CT exam, according to Richard C. Semelka, MD, of the department of radiology at University of North Carolina, Chapel Hill, and colleagues.
There are several barriers to informed consent regarding the risks of medical imaging with ionizing radiation, according to James A. Brink, MD, from the department of diagnostic radiology at Yale University School of Medicine in New Haven, Conn., and colleagues. “To be entered into a legally binding covenant, the benefits and risks must be clearly stated, unequivocal and easily measured,” they wrote. However, the risks of medical radiation exposure do not meet these criteria.
Brink et al noted that patients face various levels of risks from low levels of medical radiation exposure. Risks vary based on patient age, weight and types of cancer; and in addition, the specific risks of exposure are uncertain. “How would an informed consent process account for these uncertainties?” asked Brink and colleagues.
Another problem with informed consent, according to Brink and colleagues, is the inability to definitively link a patient’s cancer, which affects 40 percent of U.S. citizens, with radiation exposure.
They noted the current inability to easily and accurately measure the amount of medical radiation a patient receives and also detailed the complexity of informed consent documents. Research has demonstrated that many patients do not understand or read consent documents; thus, their educational value is questionable.
Brink and co-authors argued that a relatively new standard—the prudent patient doctrine—should be used instead of informed consent. The doctrine emphasizes the provision of information to the patient to facilitate educated decision making.
“We maintain that informed consent, in its present form, has lost its true intent—that of providing educational value and an opportunity for communication prior to the medical procedure. We must return to the value of education rather than legal documentation,” Brink and colleagues wrote.
They called for the use of decision aids such as booklets, videos and charts to spur meaningful dialogue and noted available existing resources created by the American College of Radiology, the Radiological Society of North America, the American Association of Physicists in Medicine and the American Society of Radiologic Technologists.
Brink et al called for radiologists to embrace a patient-centered, informed decision making approach and concluded, “Informed decision making trumps informed consent.”
Semelka and colleagues advocated for active conveyance of the risks of medical radiation, which includes written material, verbal communication and signed consent.
Like Brink and colleagues, Semelka noted the controversy over the certitude of risks associated with radiation exposure and acknowledged that communication should take into account the dose and risk involved and the individual patient.
Furthermore, they recognized the importance of including the benefits of the exam in the consent or communication process, and wrote, “Description of the benefits of the imaging test and risks of lack of disease detection, if the test is avoided, are also necessary.”
While Semelka and colleagues favored informed consent in theory, they recognized the practical difficulties of the approach. “A reasonable concern for radiologists and the radiology practice is that if every medical radiation procedure requires informed consent, then the time commitment and resultant throughput impediments for healthcare workers and facilities will become prohibitively long.”
Another challenge is that informed consent may induce undue patient anxiety.
Despite these potential challenges, Semelka and colleagues referred to the possibility that U.S. agencies might follow Europe’s lead and impose radiation consent regulations on the radiology community. They suggested the need for “at least verbal informed consent detailing risks … for all procedures of 1 mSv or greater.”
However, they noted that radiologists may