The minimum criteria for informed consent (IC) are being met in pediatric anesthesia, but more can be done to obtain explicit agreement from patients’ parents, according to a prospective, cross-sectional study conducted at Seattle Children’s Hospital, in Washington.
The findings come from analyses of recorded and transcribed conversations between parents of surgical patients aged 1 month to 6 years and pediatric anesthesiologists, surveys given to parents about their experiences and descriptions of population demographics.
A total of 97 discussions were included in the final analysis, with a median duration of nine minutes and 40 seconds. Of seven IC elements (description of plan, description of alternatives, discussion of risks, discussion of benefits, discussion of uncertainties, comprehension and solicitation of decision), the discussions included a median of five elements (Figure 1). The investigators found that 70% of discussions (n=68) included the three minimum IC elements: description of plan, description of risks and description of benefits.
Bivariate analyses revealed a significant association between discussions that included the three minimum IC elements and parental recall of those elements (75% vs. 34%; P<0.001) (Figure 2), but no association between presentation of the three elements and perceived parental understanding (84% vs. 74%; P=0.27). The association between the three minimum IC elements and parental recall remained significant in a multivariable analysis, the investigators noted.
“When informed consent has been studied in other clinical environments, oftentimes it’s been incomplete. Providers rarely include very many elements of informed consent, and so our results were actually more positive than I was expecting,” said Katherine Gentry, MD, MA, assistant professor in anesthesiology and pain medicine at Seattle Children’s. “So that’s good news for our department and our field.” She presented the findings at the 2017 meeting of the Society for Pediatric Anesthesia/American Academy of Pediatrics Section on Anesthesiology and Pain Medicine (abstract OT-97).
However, Dr. Gentry added, the results warrant cautious interpretation due to the limitations of the study. “I’m hoping that I may be able to do a follow-up study that involves more institutions and also involves a more diverse patient population, because I do suspect that the results on the parent end, in terms of parent recall and understanding, would be very different in a population that was not primarily English-speaking and perhaps had a lower socioeconomic status in general.”
Dr. Gentry also expressed concern about the finding that only 18% of discussions solicited a decision or statement of agreement from the parents. “This was startling given that a main purpose of the pre-op discussion is to obtain ‘consent,’ but I also know from my own practice that I rarely have stopped to ask parents if they actually agree with the plan I’ve laid out. Soliciting a decision or statement of agreement is ethically important, as it transforms the discussion from one that is merely informative to one that achieves the goal of obtaining authorization to proceed.
“I would encourage anesthesiologists to consider if they explicitly solicit agreement from their patients before proceeding with the plan and explore ways to incorporate this element into their discussions,” she said.
Muhammad Rafique, MD, associate professor in the Department of Anesthesiology at the John P. and Kathrine G. McGovern Medical School at UTHealth, in Houston, said the study was well conducted, albeit with a small sample size, and the findings reflect his own experience at his institution. “If you look at this and reflect on what we do every day, there is a lot of room for improvement for providers to discuss informed consent with the parents, and definitely there is room for improvement in having more inclusive decisions with the parents on how to provide and care for the child.”
Echoing Dr. Gentry’s concerns about the demographic limitations of the study, Dr. Rafique noted that the population of whites in the study was high compared with that in his institution. “We see a lot of Hispanic and other population demographics, and a lot of times population is a big barrier—not everything gets translated when you are using a translator. So when there’s a language barrier, it becomes a bit more difficult, actually.”
While noting that more work remains to be done, Dr. Gentry said the findings are encouraging in showing that parents are paying attention and listening on the day of surgery. “We have a real opportunity to inform parents about what’s going to happen and involve them in the decision. But we still need to investigate how well we communicate with non-English speakers.”