It is rare for written consent forms used for cancer treatment with radiotherapy to meet recommended readability levels for patient materials, according to the authors of a recent analysis.1

“We wanted to better understand how the process of informed consent occurs for cancer patients who undergo radiotherapy and how difficult it may be for patients to understand the information communicated to them,” says Andrew J. Einstein, MD, PhD, one of the study’s senior authors.

Only nine of 113 forms met the recommended eighth grade readability level, and four forms met a sixth grade level. “Appropriately designed informed consent is critical to ensure patient autonomy and shared decision-making,” says Einstein, associate professor of medicine and director of cardiac CT research at Columbia University Medical Center.

Researchers were surprised at the high reading level required to understand consent forms and how many difficult words appear in informed consent documents. “Ethically, it is important to patients to understand the options available to them,” says Nancy E. Kass, ScD, deputy director for public health at Johns Hopkins Berman Institute of Bioethics. This is particularly important when treatments carry difficult risk/benefit tradeoffs, or when options carry different risks and benefits (e.g., surgery vs. physical therapy for back pain).

Often, patients consider only what their doctors recommend. They do not always understand even the basics of possible side effects or risks, how likely they are to benefit, or how to increase or decrease the chance of the risks or benefits. “This is a missed opportunity to help patients and a missed opportunity to avoid significant problems or disappointments,” Kass says.

Written forms should serve as documentation of a conversation that should have happened between a physician and patient. “There is significant data showing that conversation leads to far better understanding than reading a form,” Kass notes.

Shorter, simplified forms are ideal but still do not replace a quality discussion. “Looking someone in the eye, getting a sense of whether they’re with you, and even asking them to repeat back what they understand is the most likely strategy to achieve a meaningful understanding,” Kass offers.

Forms Insufficient

Patients cannot make informed judgments if they do not comprehend the information pertinent to the clinical situation at hand, says Aaron S. Fink, MD, FACS, chief medical officer at Taylor Healthcare in Atlanta.2,3 Informed consent is a much more complex process than just a form read and signed by a patient.

“Indeed, many consent forms offer insufficient or no information about the proposed intervention,” Fink explains. Often, there is insufficient time or an appropriate environment to allow a patient to comprehend the necessary information. Even legible and complete informed consent documents are written at a reading level that prevents comprehension.

“Focusing solely on the informed consent document is insufficient to ensure an acceptable informed consent process,” Fink says. Still, ensuring appropriate reading levels “is one of the many issues that need to be addressed in seeking improvement of this vital healthcare process,” he adds.

Critical Ethics Role

Legal and administrative directives often seek different goals for informed consent. “Medical ethicists can help seek balance between these various competing directives,” Fink says.

Ethicists can partner with clinicians to ensure informed consent is understandable to patients, ensuring patient autonomy. “Ethical principles are not theoretical ideals but guidelines for action that should be implemented in practice,” Einstein says.

Ethicists can work to make them reality. One way is to engage physician leaders. “Ensure that consent forms and all other aspects of the informed consent process are comprehensible, meaningful, and educational for patients and ultimately lead to truly informed consent,” Einstein says.

REFERENCES

  1. Perni S, Rooney MK, Horowitz DP, et al. Assessment of use, specificity, and readability of written clinical informed consent forms for patients with cancer undergoing radiotherapy. JAMA Oncol 2019; May 2:e190260. doi: 10.1001/jamaoncol.2019.0260. [Epub ahead of print].
  2. Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ 2012;184:533-540.
  3. Hersh L, Salzman B, Snyderman D. Health literacy in primary care practice. Am Fam Physician 2015;92:118-124.