ARTICLE IN BRIEF
Neuroethicists comment on a new report from the Presidential Commission for the Study of Bioethical Issues that suggests, among other recommendations, clinicians inform patients before a test or procedure is ordered about the range of possibilities that might be revealed and that they “respect a patient's preference not to know about incidental or secondary findings.”
How should clinicians address “incidental” medical findings that might surface when they are investigating a seemingly unrelated clinical issue? A federal panel has weighed in, offering recommendations in a new report, “Anticipate and Communicate,” released in December.
“Incidental findings — traditionally defined as results that arise that are outside the original purpose for which the test or procedure was conducted — can create a range of practical, legal, and ethical challenges for recipients and practitioners,” wrote the authors of the report by the Presidential Commission for the Study of Bioethical Issues. “Discovering an incidental finding can be lifesaving, but it also can lead to uncertainty and distress without any corresponding improvement in health or wellbeing.”
The recommendations of the Commission — an independent panel of experts that advises the President and his administration on bioethical issues, which address clinical practice, research studies, and direct-to-consumer testing — are meant to educate physicians, patients, researchers, policymakers, professional organizations, and health-related businesses.
The panel recommended, among other suggestions, that clinicians inform patients before a test or procedure is ordered about the range of possibilities that might be revealed.
“Practitioners should inform potential recipients about their plan for disclosing and managing incidental and secondary findings, including what findings will and will not be returned,” said the authors of the report.
In another recommendation, the panel advised that clinicians “should respect a patient's preference not to know about incidental or secondary findings to the extent consistent with the clinician's fiduciary duty.” If doctors aren't comfortable with the patient's wishes regarding the degree to which they want to know testing results, they could choose not to order the test or refer the patient to another practitioner.
In an article published Dec.13 in Science, the commission's chair, Amy Gutmann, PhD, president of the University of Pennsylvania, stressed the importance of shared decision-making between doctors and their patients.
“Clinicians live up to their highest calling when they discuss how they will handle incidental finings with their patients,” she wrote.
James L. Bernat, MD — Louis and Ruth Frank professor of neuroscience and professor of neurology and medicine at the Geisel School of Medicine at Dartmouth — told Neurology Today that he found the report to be “very comprehensive and well thought out.” He said the report's title reflects the overriding take-away message for clinicians when it comes to dealing with incidental findings — to anticipate and communicate.
“No one can anticipate everything,” he said. “But physicians and patients should recognize that when a test is done for one reason that it is possible that other unanticipated findings will be made,” said Dr. Bernat, who serves on the editorial advisory board of Neurology Today and has authored the publication's “Ask the Neuroethicist” column.
That possibility is particularly true when it comes to brain imaging. Dr. Bernat said he is often asked to provide consultations for patients who have had an MRI because of headaches and the scan ends up showing a benign tumor or a lesion in the white matter that had nothing to do with the headache.
“Once there is a discovery, it sets into motion a cascade of further tests to chase down that abnormality and you may end up on a wild goose chase,” he said.
While “watchful waiting” may sound like a good plan when something unusual but not immediately consequential is found, Dr. Bernat said that some patients are very uncomfortable knowing that a scan found something out of the ordinary, even if the anomaly isn't causing them problems. He recalled one patient, whose MRI revealed a benign tumor inside her orbit that was simply being followed, recently telling him, “I am sorry I had that scan.”
“We have scanning technology now that is so ultrasensitive that it may disclose findings and we don't know what they mean,” Dr. Bernat said. “We don't know if they are normal or abnormal.”
But Dr. Bernat said the only instance he could imagine not revealing incidental findings would be in the case of a “patient with such a severe anxiety disorder that merely communicating the finding would induce an anxiety attack. Otherwise it is the best policy to share what we know with patients and simply reassure them that the finding is not serious and will not harm them.”
Some companies and health care systems are promoting “wellness scans,” or whole body scans, as a way to assure patients that everything is OK, or if it isn't, the problem will be caught early when it is treatable. When technology is used more as a fishing expedition rather than for making a specific diagnosis, incidental findings may be more likely to result. Even more targeted scans of the abdomen and pelvis can include images of the kidneys, liver, adrenal glands, and pancreas, the commission's report noted, perhaps offering up more information than what was intended when the scan was ordered.
“The likelihood of encountering incidental findings using imaging techniques is high, even among asymptomatic individuals, but few of these finings have serious or health consequences,” the report said.
Michael J. Schneck, MD, professor of neurology and neurosurgery at Loyola University Medical Center, told Neurology Today that the report by the bioethics commission contained some important points, but he did not agree with everything the commission said. For one, he took exception with the report's characterization of incidental findings as either “anticipatable” or “unanticipatable.” He said that some incidental findings are simply more anticipatable than others. “The bottom line is that most findings are not truly incidental,” he said.
He also took issue with the commission's recommendation that patients be given the option ahead of a test or procedure not to be told about incidental or secondary findings. He said that approach struck him as “reverse paternalism.”
“I think the clinician has the obligation to report bad news and discuss it,” said Dr. Schneck, who chairs the AAN Ethics Section. “You're always better providing the information.”
Part of the discussion, he said, has to involve making a clear distinction between relative risk versus absolute risk. A patient may be at elevated risk because of some finding on the scan, but the risk may actually still be very low.
The report also focused on the question of research. A study that involves examining blood samples might reveal, for instance, that a participant was carrying the trait for sickle cell, even though the study has nothing to do with the disease.
The commission again recommended that potential study participants be informed about the possibility of incidental or secondary findings turning up in the course of the investigation. Part of that discussion should involve what will be done with the findings, such as whether and how the study volunteer will be referred for further consultation. Researchers can decline to include a person in studies if they aren't comfortable that the study volunteer doesn't want to know incidental findings.
“The context in which incidental findings occur makes a considerable difference in how they can and should be handled,” Dr. Gutmann wrote in the Science article. “Clinicians have a primary fiduciary duty to their patients to act in their interests. Research investigators have more limited duties to research participants.”
Genetic testing is opening up a new list of possibilities that clinicians and researchers will likely be routinely dealing with in the years ahead, she wrote. Testing for a single gene, such as whether a patient has a gene for a specific inherited disease is one thing, but large-scale genetic sequencing can turn up multiple genetic variants that may not mean anything, at least by measure of current knowledge.
BETTER GUIDELINES NEEDED
The report also tackled some broader policy issues, including the need to provide clearer guidance regarding screening programs that are targeted at the general population or specific high-risk groups.
“Professional and public health organizations should produce evidence-based proposed screening programs that take into account the likelihood that incidental findings will arise,” it said. “Professional organizations should provide guidance to clinicians on how to manage these incidental findings.”
Dr. Gutmann, in the Science article, acknowledged that just because medical technology is capable of uncovering all sorts of information about a patient, doesn't mean it should be used that way.
“It would be rash — both ethically and practically speaking — to conclude that everything that can be sought should be sought, and reported in all contexts,” she said.