Reading level is not key factor in readability
Reading level is not key factor in readability
Participants persistently misunderstand study benefits
An investigator with experience in writing informed consent documents studied how well potential participants understood documents written at the sixth grade level versus those written at the 10th grade level, and she found no difference.
"The words were changed to meet the reading level, but the white space, paragraphs, page numbers, and appearance were identical," says Kris Walters, MS, PhD, clinical research program coordinator at the University of North Carolina - Wilmington in Wilmington, NC. Walters has spoken about her study, which was conducted as part of her doctoral dissertation, at a national research conference.
"The reading level made no difference," Walters says.
To select participants who represented the general population, Walters used a jury pool, enrolling 317 people.
"Every study has limitations, and this study's limitations were that a non-voting population wasn't in there, so people without driver's licenses weren't in there," Walters says.
The study's findings do not suggest that researchers might as well write informed consent documents at higher grade levels, but they do mean that a document's reading level isn't the most important factor in determining the informed consent's readability, Walters says.
"Just advising people to write at a lower level is not enough," she says. "If you run your document through a reading level program [to seek a lower reading level], it will not mean it will make sense and people now can understand it."
Walters determined subjects' comprehension through a validated questionnaire that she developed for the study.
She created the 15 question tool for the purpose of ensuring that elements of consent were in the consent form and well understood by participants.
"I listed some of the risks and said, 'The consent form stated this...,' and they had to choose the correct risks," Walters says. "The participants had to choose the correct risks."
The tool was administered immediately after they read the consent form, so it doesn't address long-term retention and consent knowledge, she notes.
To be considered well-informed, participants had to get at least 11 of the 15 questions correct, Walters says.
One of the questions most commonly missed involved the potential benefits of research, Walters says.
"Some people circled, 'I will get better medical treatment if I participate in this clinical trial,' which was wrong, and some circled, 'If I do not participate in this clinical trial, my physician will not want to treat me anymore, and he will refer me to another clinician.'" Walters says. "These were not people sitting in a doctor's office, so we should be cognizant that some people really believe this."
Investigators should work harder at assuring potential participants that they will not be treated differently if they do not participate in a clinical trial, Walters adds.
Research subjects who believe incorrectly that they are being coerced or who believe they are participating for the purpose of receiving better medical treatment might not comply with their treatment regimen as well as is necessary for a clinical trial, Walters suggests.
The study began with 317 randomized subjects, but 17 withdrew primarily because they didn't want to spend time reading a five-page consent form, Walters says.
"I modeled the form off of an allergy study, which tend to be short," she says. "The participants had just read another three-page consent form, and some didn't want to do that again."
The questionnaire she created was written at a fifth-grade reading level, Walters says.
Walters became interested in this area of study because existing research has shown conflicting results.
"What I was finding was there still is some conflicting information on what works and what doesn't work in improving readability," Walters says. "I decided to look only at the reading level, although there are many other factors that go into it."
For example, a readable informed consent document also must have an adequate amount of white space, a more readable style, etc., she says.
"For 15 years, I've been writing informed consent forms, so I wanted to try and get a document that was as clean as possible," Walters says.
"I wrote it not using many of the typical mistakes because of my experience in clinical trial compliance," Walters says. "I recalled everything I've seen that should not be repeated, cleaned it up, and wrote it as one of the best examples I've seen at the sixth grade and 10th grade reading levels."
Also, she modeled it after a prior trial in which she had been involved.
"If you have someone who has never written an informed consent form writing one at the 10th grade reading level, then it may not look anything like mine," Walters notes.
The reading level was determined by the Flesch-Kincaid scale, which is in MS Word documents.
"I used it because it's very common and is used in many different industries," Walters says.
An investigator with experience in writing informed consent documents studied how well potential participants understood documents written at the sixth grade level versus those written at the 10th grade level, and she found no difference.Subscribe Now for Access
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