Parents often don’t understand research

Information overload is a problem

Imagine you had a very sick child and were approached about him or her being in a study. In your worry for your son or daughter, how much of the informed consent process would you understand? Would you be clear on what the study entailed? According to several studies published in the last year, maybe not.

The most recent study appeared in the Journal of the American Medical Association and related to parental understanding of randomization in childhood leukemia trials.1 The study found that fully half of the parents didn’t understand randomization despite oral and written explanation of the concept.

The findings of that study are hardly surprising to Mary Jo Kupst, PhD, a professor of pediatrics at the Medical College of Wisconsin in Milwaukee. She has also done studies on the informed consent process in pediatric studies. Her most recent study appeared last October in the Journal of Pediatric Hemoatological Oncology and looked at looked at how well parents involved in cancer studies understood what they had signed their children up for.2 The study did interviews of 20 parents of newly diagnosed pediatric cancer patients. While they were able to recall the diagnosis, treatment plans, and statistic related to survival and cure, the research natures of clinical trials — and particularly of randomization — were not well understood.

Despite this lack of understanding, Kupst and her colleagues found parents generally happy with their informed consent discussions. But it begs the question: Regardless of their satisfaction with the process, if they don’t really understand what is going on, are they truly giving informed consent?

"The pilot had 13 children on randomization protocols, but only five of the parents understood that," says Kupst. "And only half of them knew this was research."

Despite that, she thinks that the process is well explained. "I think there are a couple of issues at play here," says Kupst. "First, they are focusing on treatment and what is it is going to do for their child. Second, these are parents who are under a great deal of stress. There was an overload of information, so they had incomplete recall of what they were told. Their perception was that they got enough information and that they understood what they were told. But I think their emotional distress colors this."

Parents of children with cancer are not focusing on what is in a consent form or what the research is, she continues. "First and foremost, they want to know about the child’s chances of cure and survival. Then they want to know the treatment plan. Then they want to know what the effects of the treatment will be, what side effects there might be, and about the quality of life their child will have under the treatment."

Parents do read the consent form and listen when they are told about it, "but that is not their concern. It is our concern. They are worried about their children’s treatment. And even if they are happy with the process, we have to improve it."

Easy steps to take

There are some simple things that researchers can do to ensure that pediatric studies are done with truly informed consent. Kupst says repeating the consent discussion a couple of times is a good idea. Also, ask the parents outright what their understanding is of what was just said. "Ask them to paraphrase what you said. If they can tell you what it’s all about, then they understand. Don’t limit yourself to asking, Do you understand?’ or Do you have any questions?’"

Parents involved in Kupst’s study were asked what they thought would help them better understand the process. They suggested going slowly and breaking the process down into parts. Doing the entire process and asking about understanding or questions the parents may have requires them to take in too much information at once. Break the discussion down and ask about understanding after each section, she says.

Another suggestion – one that isn’t always possible, particularly with sick children — is giving parents more time to digest the information.

That isn’t possible in many of the anesthesiology and surgical studies that Alan Tait, PhD, an associate professor of anesthesiology at the University of Michigan in Ann Arbor, works on.

Tait and colleagues published a study in Anesthesiology a year ago on the topic of parental consent for children involved in anesthesia and surgery.3 It looked at parental understanding of 11 elements of consent. The findings: Parents thought they understood, but largely overestimated their understanding of the research.

Because a lot of recruiting for surgery and anesthesiology studies occurs on the day of surgery, there is an added element of stress that might impair understanding, says Tait. "They just aren’t assimilating all the information we give them," he says. "Our feeling is that it is not that the information is above their heads, but that there may be different learning styles and that different ways of presenting the information may help."

Tait has an upcoming study in Pediatrics this April that confirms what Kupst has found: Too much information also can have an impact on parental understanding. "Too much information may be as bad as too little," he says.

The work he has done has led Tait to think that presentation is the key to improving understanding. "This is really our problem. The regulations say informed consent documents should be written at the eighth-grade level. But if you actually look at the documents, they are probably at the 11th- or 12th-grade level. Institutional review boards don’t check this."

Reducing the grade level, however, only will go so far. Tait’s most recent work suggests that format of informed consent documents also makes a difference. Making use of bold, underlining, and bullets can help better crystallize the information in the parents’ minds.

The problem is that most institutions have template forms for informed consent. "These are standard forms, and in large institutions, there is a reluctance to change. I think it will be a slow process."

Like Kupst, Tait favors going over the information multiple times and asking parents to repeat it back. "If you do this and they can’t, then you cannot enroll them," he says.

Generally, Tait says, the informed consent process is well done. Certainly most parents think so. "But I think we can do better. We have to look not just at where they are given the information, but whether they truly understand it."

References

1. Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA 2004; 291:470-475.

2. Kupst MJ, Patenaude AF, Walco GA, Sterling C. Clinical trials in pediatric cancer: Parental perspectives on informed consent. J Pediatr Hematol Oncol 2003; 25(10):787-90.

3. Tait AR, Voepel-Lewis T, Malviya S. Do they understand? (Part I): Parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology 2003; 98(3):603-8.