Templates don't ensure copy is easy to read

Patient ed departments may need to assist

Templates often are created to help make sure patients with low health literacy understand information. The National Cancer Institute published a template for consent documents with an eighth-grade reading level for participants in clinical trials.

To determine how effective these templates were in keeping consent forms understandable, a study assessed these forms once the local institutional review boards (IRBs) at various institutions added specific clinical trial details. The hypothesis was that the local IRB-approved consent forms would have a lower reading ease score, a higher reading grade level score based on Flesch-Kincaid statistics, and be longer than the sample oncology group trial consent. The lead researcher was Shlomo Koyfman, MD, associate staff, departments of radiation oncology and bioethics, Cleveland Clinic Taussig Cancer Institute in Ohio.

Lorianne Classen, MPH, MCHES, senior health education specialist at the Patient Education Office, MD Anderson Cancer Center in Houston, TX, says "Researchers were trying to see the impact the IRB has on the process." Classen and her colleague, Chesley Cheatham, MEd, MCHES, a senior health education specialist, took part in the research project by assessing the clinical trial consent forms from oncology cooperative groups, such as the radiation oncology group, at MD Anderson Cancer Center. The trials were going on at multiple institutions across the United States.

At MD Anderson, a total of 141 consent forms were assessed. The assessment was completed with the aid of a chart and included the page count, reading level, and reading ease of the document. The IRB inserts information in the template such as a description of the medicine and the side effects.

Cheatham says, "There was a large fluctuation between some forms we studied and the NCI templates." Often the text was scientific and difficult to comprehend without any medical background or advanced education, she says.

According to Koyfman, the research study found that the consent forms tended to get longer and less readable when following the additions made by each local IRB. "There are lots of potential reasons for this," he adds. "Part of it is that each local IRB has their sense of what is and is not appropriate language." Also, many do not have skills in making copy easy to read. "It is important for each institution to keep in mind how their modifications impact the length and readability of these forms," says Koyfman.

The Patient Education Office at MD Anderson would like to use the study results to show IRBs or cooperative groups there could be a big difference between consent forms at various institutions participating in the same clinical trials and try to get some consistency. Also, the department would like to assist in the writing of the forms whenever possible within their institution.

Classen says staff with a health education background can provide their expertise as a consultant on clinical trial consent forms.

NCI is revising the template for clinical trial consent forms in an effort to shorten and simplify all consent forms used, says Koyfman.


• Chesley Cheatham, MEd, MCHES, Senior Health Education Specialist, Patient Education Office, MD Anderson Cancer Center, Houston, TX. E-mail: ccheatham@mdanderson.org.

• Lorianne Classen, MPH, MCHES, Senior Health Education Specialist, Patient Education Office, MD Anderson Cancer Center, Houston, TX. E-mail: lclassen@mdanderson.org.

• Shlomo Koyfman, MD, Associate Staff, Departments of Radiation Oncology and Bioethics, Cleveland (OH) Clinic Taussig Cancer Institute. E-mail: koyfmas@ccf.org.

• National Cancer Institute template and process for consent documents. Web: www.cancer.gov/clinicaltrials/patientsafety/simplification-of-informed-consent-docs/page1.