Cues prove helpful to schizophrenia patients
Multiple-choice questions aid comprehension
Obtaining informed consent from people with schizophrenia is a process fraught with difficulty, as the condition can impair a potential research subject’s ability to recall the consent information he or she is given. But an Oklahoma researcher says he’s found evidence that a simple, inexpensive method of testing informed consent can greatly improve schizophrenia patients’ understanding of the facts of a study. In fact, even control subjects who didn’t have the disease did better when tested on the facts of the study using the method.
The key is providing cues to the participant in the form of multiple-choice questions, rather than asking open-ended questions that require the participant to recall the information in whole.
Dennis Combs, PhD, assistant professor of psychology at the University of Tulsa (OK), says he began studying ways to improve informed consent for patients with schizophrenia at the request of his IRB at Louisiana State University, where he was pursuing his doctorate.
"That seems to be the direction that the IRBs I work with are moving in," he says. "They really want to make sure the person understands it. The methods that this project developed, we’re using now in our research."
Previous research has shown that people with schizophrenia have deficits in their ability to understand consent form information.
"There are so many cognitive problems there," Combs points out. "They may not be attending to it, they may not remember it. So anything that can help them do that is beneficial."
He says methods of obtaining informed consent usually have been based on research in the general population, which could prove risky to schizophrenia patients.
Some projects have attempted to boost recall of consent form information by using methods such as videotaped presentations and interactive approaches. Combs’ group instead tested a lower-tech approach of creating multiple-choice questions about the study to be administered to participants.
"When you put it in the form of a [multiple-choice] question, they seem to remember it better than if you just ask them to tell you what they remember," Combs says, "because it has context to it. They can remember reading that section and they can identify the correct answer."
His team studied the ability of two groups — one of patients with schizophrenia and one of college students — to recall information from a consent form in two different ways.1
Each group first was asked eight questions about the consent form — information such as the name of the principal investigator, the purpose of the study, the risks and benefits, and the consequences of withdrawing from the study. No cues were given. A point was given for each correct answer, but no information was given to the participant about how well he or she did.
Each participant then was given the cued test, with the same information presented in a multiple-choice format.
Patients with schizophrenia did significantly worse on the first, uncued test than the control group. When the cued responses were provided, there was no difference in recognition scores between the two groups.
Finally, both groups demonstrated significantly higher recognition scores on the cued test than on the uncued one.
"The recognition stuff is always generally better than free recall, where you just answer questions," Combs explains.
He says while many studies working with patients with schizophrenia employ technology to improve understanding, "this is a cheap, easy way to do informed consent. It’s not expensive to come up with some items to test."
Thanks to the success of this study, Combs now employs a version of it in all of his schizophrenia research. He asks patients focused questions about the study with multiple-choice answers.
"We go back over the ones that they miss and make sure they get that information," he says. "We want to make sure they understand every part of the consent form."
In addition to working with schizophrenia patients, Combs says a colleague is testing the cued method in informed consent with multiple sclerosis patients.
"I think it can be applied to any population that has cognitive impairment — that this might be a way to do it better," he says.
In addition to changing informed consent testing for schizophrenia patients, Combs also suggests working with the informed consent document itself to improve readability.
"We’re trying to get them at about a sixth-grade reading level, and that seems to help a lot," he says.
- Combs DR, Adams SD, Wood TD, et al. Informed consent in schizophrenia: The use of cues in the assessment of understanding. Schizophr Res 2005 Sep 1; 77(1):59-63.