Combination of consent documents may improve subjects' understanding

Participants get more reading simpler version first

When trying to explain a complicated clinical trial to participants, which approach is better: a jam-packed standard-issue informed consent document, or a lower reading level, more interactive model? And which would subjects prefer?

The answers would seem obvious, based on reams of studies that have looked for alternatives to the standard informed consent document. And indeed, as expected, a study by the Feinstein Institute for Medical Research in Manhasset, NY, showed that participants shown a simpler, innovative form were better able to comprehend the study than those shown the hospital's existing informed consent document.

However, the simpler form was not universally popular among the participants, particularly those who were shown it first. The findings may suggest that the best approach for informed consent isn't one document at all, but a combination of documents, says Emmelyn Kim, MA, assistant clinical analyst in Feinstein's Office of Research Compliance.

"When we asked people about it, they were telling us that they were able to understand the standard consent form after initially reading the innovative consent form," Kim says. "We think that maybe using simple brochures or study outlines might be helpful for these trials to help facilitate further understanding.

"Doing that prior to being given this really dense, really difficult consent form actually might help to reinforce the main components of the trial for people."

Kim's group gave a poster presentation about their study at the 2007 Annual Public Responsibility in Medicine & Research (PRIM&R) Human Research Protection Program Conference in Boston, Dec. 1-4, 2007.

Easier, but not shorter

Kim and Kathleen McGill, MPH, manager of research compliance in Feinstein's Office of Research Compliance, say their study of an innovative consent form evolved from a workgroup on informed consent held at their institution.

To test a new type of form, they created a consent form for a Phase 2 study of a fictional cancer drug, first using the standard template. Then, they incorporated suggestions from other studies aimed at improving comprehension of consent in designing their innovative form:

• Simpler language. The institution's standard informed consent template is written at a 12th grade reading level, Kim says. For the innovative form, they were able to bring the language down to an 8th grade level, although the process wasn't an easy one.

"It was actually hard doing that with our standard template," Kim says. "You have to sort of step outside the box and test it with lay people and see if they can understand what you're trying to do.

"It was challenging. But I think it's really crucial, especially for researchers who want to recruit very diverse populations in their research trials who may not be at the 12th grade reading level."

• Enhanced readability. In addition to simpler language, the workgroup changed the format of the document, incorporating more white space, larger fonts, and lots of bullet points.

The headings are written in a question format: "Why is this study being done?" "Why might you want to be in this study?"

An information box in large colorful type warns participants: "Caution! Giving false or incomplete information about your medical history or the use of drugs or alcohol could affect your health while in this study."

The result is actually a longer document than the dense, small-font standard form, but a much more readable one, Kim says.

• Opportunities for participant questions. At the end of each section, a box is provided for participants to write their own questions about the study. In each box is an area for them to check off that the question was answered.

To compare how well the standard and innovative forms aided comprehension, the group recruited 37 volunteers, and split them into two groups.

One group read the standard form first, took a Quality of Informed Consent (QuIC) questionnaire on the information, and then reviewed the innovative form to answer questions about which form they preferred. The second group did the opposite, beginning with the innovative form, taking the QuIC test, and then reviewing the standard form.

Interactive element improves understanding

The results showed that those reviewing the innovative form first scored higher on 11 of 13 knowledge areas within the test. In two key areas — experimental procedures and risks or discomforts — the results were significantly higher for the innovative group.

"I think those are key because they're main elements of the informed consent that people struggle with all the time," Kim says.

When asked which form they preferred, 100% of those randomized to the standard form preferred the innovative version. However, more than 60% of those randomized to the innovative form preferred the standard form.

McGill says that those reading the simpler format first may have been able to take that information into the higher reading level form and enhance their understanding.

In another surprising result, those who first viewed the standard form actually thought they knew more about the study than they did.

Kim and McGill say those who viewed the more complicated form may have missed opportunities to ask questions, even though they didn't understand. They think the use of question boxes in the innovative form may have helped increase understanding by prompting participants to consider whether they really understood the material.

Highly educated subjects

They note there are limitations to the study, due to its small sample size and the generally high education level of the participants — almost 40% had a master's degree, McGill says. The Rapid Estimate of Adult Literacy in Medicine test administered to the participants showed that most scored above the 9th grade level in medical literacy.

Still, McGill says it's worth noting that the group struggled with the consent forms, and had difficulty answering questions even though they were allowed to view the document while taking the QuIC.

"So here you have a very highly educated population, struggling with consent forms," she says.

Looking to continue innovation

The two hope to continue their study of this issue, seeking out a larger and more heterogeneous sample. They hope to accomplish that by getting funding that could allow them to offer incentives to reach a more diverse population.

And they hope others will build on their findings by doing research that involves employing more than one type of consent form to help the information sink in for participants.

"Maybe using patient brochures or simple consent handouts prior to giving them this lengthy consent form [would help improve comprehension]," Kim says.

Since the workgroup began studying this issue, Kim says there's been increased discussion about improving informed consent at Feinstein.

"I had a conversation with our administrator the other day about perhaps having this [innovative consent] template on-line for people to consider using," she says. "We know of one group that's already using a similar type of innovative consent format. I don't know how their participants are responding, but I know people are actively trying to change their forms to increase understanding."

The two say their study reinforces the often-repeated principle that informed consent is not a document, but a process.

"The form is an important part of it, to provide the participants with information," Kim says. "But I also feel it's important to allow a supportive and positive environment for questions to be asked," pointing to the question box that was included in the innovative form.

"That way, participants can come up with questions on their own and not be intimidated. And that might be key to really stimulating discussion about the project itself."