Making necessary revisions: Improving informed consent

Radiologic informed consent should not only be revised to include information on incidental findings (IFs), but radiologists should conduct these discussions with patients, contends a commentary published in the November issue of the American Journal of Roentgenology.

Jonathan Kole, MD, of Brown University in Providence, R.I., and Autumn Fiester, PhD, of the University of Pennsylvania in Philadelphia, explained that IFs commonly appear in radiologic examinations. As the frequency of diagnostic scanning increases, it can generate false-positives, very low rates of actual malignancies, and potential financial and emotional strains on patients and the healthcare system. 

“Current radiologic practice rarely includes a thorough informed consent process and has never included information about the possibility and prevalence of IFs,” wrote Kole and Fiester. “Given that IFs often cause patients significant distress, patients should be provided information about the possibility of an IF as part of radiologic informed consent.”

The article’s authors utilized a case example to delineate their arguments surrounding the need to revise informed consent. Tina, a 33 year-old healthy woman, presents to the emergency department with intense abdominal pain, nausea, and bloating. She believed she had bad food at a restaurant the previous evening and though the emergency department provider suspects it is food poisoning, physical exam findings resemble acute appendicitis.

Tina is told she will need to undergo CT of her abdomen and agrees to the exam without being informed of the risks associated with CT or the potential for IFs. While no appendicitis is revealed, a small 1 cm circumscribed lesion was found in her adrenal gland. The provider informs Tina that she is safe to go home but should follow up with her primary care physician about the IF in her adrenal gland.

Distraught and unable to ask the emergency department provider any more questions, Tina is discharged without knowing any important clinical information. She assumes the lesion is malignant and must wait several weeks to see her primary care provider. During her visit she learns that the IF has little chance of being cancerous and undergoes several tests that come back normal.

While informed consent is defined as obtaining legal authorization for a procedure or test, the term has a second meaning as well.

“It invokes an ethical, rather than legal, obligation of the provider to ensure the patient’s or subject’s ‘substantial understanding’ of the intervention, including short- and long-term consequences, alternatives to the proposed intervention, risk-benefit analysis, and provider recommendations,” wrote Kole and Fiester.

Unfortunately, Tina’s experience is the norm, according to the article’s authors. Because informed consent in regard to IFs in research is so heavily backed, Kole and Fiester argue that this should be extended into clinical practice in order to protect patients like Tina who have insufficient knowledge of the numerous potential harms that stem from the discovery of IFs.

However, some objections may be made to this proposal. Patients may opt out of CT altogether even if the study was important to their overall health out of fear of IFs. On the contrary, if every patient agrees to undergoing a CT study even after being properly informed about IFs, then the information does not seem to benefit the patient. Lastly, informed consent for every CT study may create more burdens for providers that already have immense time constraints.

Kole and Fiester additionally believe that radiologists should be responsible for providing patients with the necessary informed consent because they possess the most expertise. Again, some objections may be raised to this idea, as many believe that radiologists should focus their time on reading the studies instead of patient interaction. Radiologists are also often offsite when a patient is scanned.

“We contend that the experience of receiving results including IFs may be greatly improved if radiologists inform patients before scanning about the common and real possibility of an IF,” wrote the authors. “Although change may take time and effort, the duty to our patients’ autonomy will not waver, thus neither will our resolve for improvement.”