Parents find value in children's health surveys
Study shows surveys may have some benefit
IRBs frequently worry that questioning subjects who have undergone physical or emotional trauma can cause distress, but research has shown that such questions do not tend to cause additional damage to subjects.
In fact, studies with such groups as victims of child abuse or sexual assault have found that while questioning people under these circumstances can cause pain, it also has the potential to provide benefit to subjects.
A recent study, published in the Journal of Palliative Medicine, involved a group of parents whose children have cancer. As part of a larger study about how their children's prognoses were communicated to them by their physicians, parents were asked whether the survey itself caused them distress.
Jennifer Mack, MD, PhD, a pediatric cancer specialist at Dana-Farber Cancer Institute in Boston, says the question grew out of the researchers' experience with IRBs, as well as their own concerns.
"We definitely had experience with the IRB being concerned about these questions — in this study and in other studies that we've done," she says. "We were worried about that, too. We didn't want to be causing a lot of distress to parents, since they were nice enough to participate in the study."
Initially, the researchers intended to ask only about how distressing parents found the experience of participating in the survey, so that they could refer parents for support if necessary. But Mack says one collaborator thought the question didn't go far enough.
"Our collaborator said, 'Why don't you ask them if they found it helpful to participate and see what kind of information you get about that, as sort of a second piece of looking at this?'" she says. "And so we added that brief question as a way to understand their experience in a little more complete way."
The results mirrored other studies of distress among participants in research. Of 194 parents surveyed at Dana-Farber in the first year after their children's cancer diagnosis, only 1% reported being "very" distressed by their research participation. Most parents (62%) said that they were "not at all" distressed by the questionnaire, with the remaining 37% reporting that they were either "a little" or "somewhat" distressed by the questions.
Furthermore, 69% of parents also reported that the survey was useful to them personally — 39% said "a little useful," 25% "somewhat useful" and 5% "very useful."
In looking at both distress and utility, 54% of participants gauged the usefulness of the questions to be greater than the distress they caused, with 27% finding the two to be roughly equal and 18% reporting the distress to be greater than the usefulness of the questions.
Mack believes that one reason the results turned out as they did was that parents who had the potential to be greatly distressed by the questions may simply have chosen not to participate.
"I felt that the process of self-selection actually worked pretty well," she says. "We asked parents to participate, but they didn't have to and parents could choose which of the two parents wanted to participate.
"Using that technique, we only had 1% of parents who considered it very distressing and that suggested that either it really wasn't that distressing, or the process worked pretty well, in terms of parents figuring out who was going to participate and choosing not to if they couldn't."
Experience, not prognosis
There were some factors that contributed to a less distressing experience: Parents who participated more than 100 days after their child's diagnosis and parents who had a "sense of peace of mind" about their child's illness were less likely to report being distressed. On the other hand, parents who found prognostic information distressing and those who had wanted information beyond what their physician had told them were more likely to report distress with the survey questions.
"We found it really wasn't the prognosis itself, it was how it affected them that was really a predictor of distress with the survey," Mack says. "There are lots of reasons why parents might find this kind of study distressing. But it's not always about the research itself — sometimes it's about the situation, or asking them to reflect on aspects of clinical care that they don't feel as good about."
Mack says that the reporting of benefits associated with participating help balance the total picture of how subjects were affected.
"I think that this is human life — that some experiences are hard, talking about them is hard, but it's also how we process them, it's how we come to terms with them, find meaning in them when that's possible," she says. "Parents feel like they're helping parents of the future or helping to change the way physicians take care of kids in the future. I think that can bring some real value to this experience."
She says that while she believes the regulations in place to protect subjects are appropriate and necessary, IRBs shouldn't lose sight of both sides of that balance. She says the small number of parents left very distressed by this research experience suggests that parents did a good job of deciding whether they should participate.
"These things are complicated," Mack says. "If a parent is truly informed about what this means, then it may be reasonable to let them make a decision about whether they should participate and to trust them to do that."
Olcese ME, Mack JW. Research Participation Experiences of Parents of Children with Cancer Who Were Asked about their Child's Prognosis. J Palliat Med 2012 Mar;15(3):269-73.