By Lisa Rapaport

(Reuters Health) – Cancer patients usually get written consent forms to sign before radiation that are supposed to clearly spell out the treatment risks, but a new U.S. study suggests these forms are too complex for most patients to easily understand.

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.”

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: JAMA Oncology, online May 2, 2019.