questions: “In this clinical research study, how will it be decided
which treatment your child will receive?” and “If your child enrolled
in this clinical research study, will you be able to choose the treat-
ment option you want?” Findings demonstrated that 50% of the 137
parents in the study did not understand the concept of randomiza-
tion. This represents significantly lower understanding of the term
“randomization” than one might intuit.
While studies have identified a need to improve parental under-
standing in pediatric anesthesia,
it must be considered that this need
is significantly understated based on the use of subjective reports of
understanding. Moreover, subjective measures of the effectiveness of
interventions to improve understanding may not be reliable.
We suggest that future research on informed consent employ
more objective strategies to assess parental and/or pediatric patient
understanding. The use of indirect questions, such as those
employed by Kodish et al, represent 1 possible method. For example,
in the context of anesthesia informed consent, questions to assess
understanding may include:
To address the anesthesia plan: “What does anesthesia involve?”
To address risks: “What are the possible things that can go
wrong because of anesthesia?”
To address likelihood of risks: “How likely is it that these things
This style of questioning could readily be adapted from concepts
already employed in the teach-back method for patient education,
which has been shown to be effective in promoting patient under-
standing of health information.
Importantly, investigators and practi-
tioners should take care to frame questions in such a way as to
avoid evoking feelings of embarrassment in patients who do not
demonstrate an understanding of the elements of informed consent.
While Kodish et al
audio-taped and analyzed conversations for
content, questions aimed at assessing understanding could feasibly be
asked and analyzed in real-time. They could be posed by a practitioner,
researcher, or presented on computer- or paper-based questionnaires
for convenience or cost-reduction purposes. In turn, these strategies
to assess understanding may themselves become practical interven-
tions for providers to use during the informed consent process.
We conclude that future research in understanding of pediatric
informed consent should employ methodologies that eliminate bias
inherent to subjective reporting that is commonly used in this line of
CONFLICT OF INTEREST
The authors report no conflict of interest.
Max M. Feinstein
Max M. Feinstein
School of Medicine, Case Western Reserve University, Cleveland, OH, USA
Department of Pediatric Hematology Oncology and Blood and Marrow
Transplantation, Cleveland Clinic, Cleveland, OH, USA
1. Gentry KR, Lepere K, Opel DJ. Informed consent in pediatric anesthe-
siology. Pediatr Anesth. 2017;27:1253-1260.
2. Tait AR, Voepel-Lewis T, Gauger V. Parental recall of anesthesia infor-
mation: informing the practice of informed consent. Anesth Analg.
3. Kodish E, Eder M, Noll RB, et al. Communication of randomization in
childhood leukemia trials. JAMA. 2004;291:470-475.
4. White M, Garbez R, Carroll M, Brinker E, Howie-Esquivel J. Is,
“teach-back” associated with knowledge retention and hospital read-
mission in hospitalized heart failure patients? J Cardiovasc Nurs. 2013;28:
Core temperature measurement through the gastric channel
of the i-gel
Sir—Standard monitoring of patients during anesthesia should include
temperature measurement for procedures exceeding 30 minutes.
contrast to skin temperature, which varies with ambient temperature
and vasomotor tone, core temperature is very reliable and tightly
regulated. However, core temperature measurement often cannot be
achieved when the use of supraglottic airway devices prevents the
insertion of nasopharyngeal or esophageal temperature probes.
Failure to monitor temperature during anesthesia has been high-
lighted in a recent mortality review from the registry of the Malig-
nant Hyperthermia Association of the United States (MHAUS).
report showed a 30% mortality with no temperature monitoring; the
risk was reduced to 21% and 2% with skin temperature and core
temperature monitoring, respectively. In addition, the mortality rate
from malignant hyperthermia (MH) in this report has increased to