Parents of ill babies make tough choices
Informed decisions amid immense stress
The stress of dealing with a critically ill newborn did not prevent parents from making informed decisions about enrolling their child in research, according to a study conducted using a common competence assessment tool.
The findings counter previous studies that had raised concerns about the ability of parents to make informed decisions under such difficulty and time pressure.1
This study also marks a novel use of the MacArthur competence assessment tool for clinical research (MacCAT-CR), which is more commonly used to assess the competence of prospective participants with Alzheimer's disease, schizophrenia and other medical conditions that affect decision-making capacity.
"I think ours is the first study to use it looking at parents in a stressful situation," says Sarah Hoehn, MD, a pediatric critical care physician at St. Christopher's Hospital for Children in Philadelphia and a co-author of the study. "Our hope is that this is a tool people could use a lot more often moving forward in terms of looking at the validity of informed consent."
Newborns in cardiac studies
The 35 parents assessed all had children who were undergoing open-heart surgery for critical congenital heart problems. All had made a decision in the 10 days prior to their assessment either for or against their child's participation in at least one of three studies:
- A study looking at the genetic origins of congenital heart disease, which required DNA analysis of a blood sample from the baby and blood samples and echocardiograms and/or electrocardiograms from the parents.
- A heart rate variability study, which required a continuous 24-hour electrocardiogram recording of the baby at three different points before surgery, before discharge and at three months in addition to medical and laboratory chart reviews.
- An MRI study looking for structural brain abnormalities and also investigating how inhaled carbon dioxide affected cerebral blood flow. This study was described as the most complex of the three.
The MacCAT-CR uses details from a study's informed consent document to assess four components of decision-making: Understanding of the study; appreciation of the voluntariness of participation and of the difference between research and clinical care; reasoning ability; and the ability to make a choice. Scores are assessed for each component and also totaled.
Hoehn says the hypothesis was that parents of critically ill newborns would score similarly with healthy adults who did not face similar stress.
"It was based on my prior experience with parents in this particular situation," Hoehn says. "Certainly from their perspective, they feel as though they are able to make good decisions. They might not understand the intricacies of every single part of a study or part of a procedure but they certainly feel as though they understand the risks and benefits and that they're making an informed decision for their children, whether it's for surgery or for a research study."
And in fact, the overall scores for the parents were generally comparable to those of adult control groups in previous studies using the MacCAT-CR, with a few exceptions.
This appears to run contrary to previous studies that had found 70% of parents having difficulty with at least one of the criteria for consent, such as competence, information, understanding or choice. Another recent study reported that 12% of parents who made decisions about participation in a trial didn't recall 18 months later making that decision.
Hoehn says she thinks the results from this study were different because her group spoke to parents within 10 days after the decision, while other studies didn't talk to parents until months afterward.
"I think that's one of the strengths of our study," she says. "I think if you ask people what they remember 18 months later, you're not going to get a very good recollection."
The challenge of complexity
Of the three studies parents were asked about, the MRI study had the lowest mean scores, including in the area of understanding. Hoehn and co-author Aruna Nathan, MD, an anesthesiologist at The Children's Hospital of Philadelphia, attribute that to the complexity of the MRI study.
"They all understood that their child was getting an MRI and getting something inhaled, but in terms of what the specific effects of the inhaled carbon dioxide were and what effect it could have on the brain, I think they didn't necessarily understand it to the level of detail that we were asking the question," Hoehn says.
Nathan says that in her clinical experience with parents, they often see a gain to having their child undergo an MRI, since brain abnormalities are associated with this population of newborns.
"So I think even if they probably didn't fully understand the risks it is a very complex study they did perceive a certain gain to participation," Nathan says.
Despite these scores, Hoehn says it's still important for IRBs to ask rigorous questions about studies that involve informed consent from parents under great stress.
"They need to really query the investigators to be sure that the parents understand," she says. "And I certainly think whether people use the MacArthur or some other tool maybe asking parents to repeat certain parts back to them the onus is on investigators to make sure that parents understand what they're signing their sick newborn up for, especially for greater than minimal risk studies."
Reference
- Nathan AT, Hoehn KS, Ittenbach RF et al. Assessment of parental decision-making in neonatal cardiac research: A pilot study. J Med Ethics 2010 Feb;36(2):106-10.
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