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 While radiotherapy has become more precise in recent years, it can
still damage some healthy cells and tissues in addition to
destroying the cancer. Common short-term side effects can include
fatigue as well as skin problems like itching, blistering and
peeling. Lasting side effects depend on the type and location of
radiation therapy and can include more serious problems like new
malignancies elsewhere on the body.
In theory, informed consent is a cornerstone of modern cancer
treatment. But the study results suggest that paperwork patients
receive to explain radiation is falling short of this goal.
"We looked at the readability of these forms and discovered that,
even using the most conservative estimates, they were at far higher
reading levels than most patients understand," said study co-author
Dr. Andrew Einstein of the Columbia University Irving Medical Center
in New York City.
To make medical forms easy for most patients to comprehend, the
American Medical Association recommends the documents be written at
a sixth grade reading level. The National Cancer Institute,
meanwhile, suggests an eighth grade reading level may still be
understandable by many patients.
For the study, researchers asked 89 radiation oncology departments
across the U.S. to answer questions about their consent process and
share copies of consent forms. Overall, 67 departments, or 75
percent, answered questions, and 57 departments provided a total of
113 forms for analysis.
All of the departments reported using written consent forms, and 38
of them, or 57 percent, tailored forms to the location on the body
where patients would get radiation.
But just nine of these forms, or 8 percent, were written at an
eighth grade level. And only 4 forms achieved a sixth grade reading
level.
"Undoubtedly a patient's decision making is informed both by
conversations with healthcare providers and by written materials
provided," Einstein said by email "If a patient signs a consent form
which they don't comprehend in itself, they may or may not
understand their condition, treatment options, and benefits and
risks well enough to make an informed decision, but they haven't
really demonstrated this understanding."
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On average, each consent form contained 7.2 "difficult" words - such
as "oncologist," "intervention" and "recurrent" - that might make it
hard for patients to decipher the risks of treatment.
The study wasn't designed to assess whether the reading levels of
consent forms might directly impact patients' treatment decisions.
It's also possible that doctors explained the risks and benefits of
radiation in language very different than what was used on the
forms.
"We cannot depend on forms to adequately inform patients," said Dr.
Peter Angelos, associate director of the MacLean Center for Clinical
Medical Ethics at the University of Chicago.
"We must depend on doctors to communicate well with patients and
ensure that they have answered questions so that the patient can
make an informed decision," Angelos, who wasn't involved in the
study, said by email.
At the same time, poorly written forms can deprive patients and
families of a valuable tool for understanding the risks and benefits
of radiation, said Dr. Jacqueline Kruser of the Northwestern
University Feinberg School of Medicine in Chicago.
"Although face-to-face discussions with doctors might be the most
important way to help understand treatment options, written
information like informed consent forms and informational websites
are a valuable resource to either prepare questions ahead of time or
to serve as a reminder of what was discussed," Kruser, who wasn't
involved in the study, said by email.
"Even though informed consent documents are not the most important
part of the process, they should be written in a way that supports
the overall goal and serves as a reminder to a patient and their
family about what was discussed and decided," Kruser said.
SOURCE: https://bit.ly/2VokKXO JAMA Oncology, online May 2, 2019.
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