The process of consent is unique and challenging in pediatrics as the patients themselves are
not able to give their own consent. Instead the consent is given by their caregiver
(parent/guardian). The elements of a good consent include - disclosure, comprehension, and
voluntary choice.1 To achieve this the physician obtaining consent must clearly communicate
and provide the caregivers with the description of the procedures and risks. For the consent
process to be successful, it requires the caregiver to understand the information provided to
them. The posters will provide the same information on the conduct of a general anesthetic
and risks that the anesthesiologist will discuss with the caregivers prior to surgery. The
posters will contain pictures and keywords describing the same information. The post consent
questionnaire will assess the recall and satisfaction of the caregivers to the consent
process.
Various studies have demonstrated the use of visual aids by way of pamphlets, brochures and
posters increased patient understanding of medication adherence and the details of surgical
procedures.2-5 However, there is no recent data on the use of these aids in the anesthesia
consent process, especially in the pediatric population. The investigators aim to develop a
visual aid describing the risks of anesthesia to supplement the pediatric consent process.
The investigators hope to improve the consent process for pediatric patients and their
caregivers and increase caregiver understanding and recall of the risks of general
anesthesia. The investigators will include pediatric patients who are undergoing elective
surgery under general anesthesia and their caregivers.
Caregivers of pediatric patients who are undergoing elective surgical procedures that require
general anesthesia will be recruited to the study and randomized into one of two groups: 1)
Group 1 participants will complete the anesthesia consent process as per standard protocol
without the use of visual aids. This anesthesia consent process will verbally discuss and
explain the type of anesthesia being used, airway management strategies, pain management, and
associated risks. The caregivers will then be asked verbally or through writing to answer
survey questions which includes caregiver age, sex, education level, occupation, relationship
to the patient, and recall of consent process (type of anesthesia, risks involved, etc.). The
survey will be administered in the recovery unit after the surgery before discharge from the
recovery unit.
Group 2 participants will complete the anesthesia consent process as per standard protocol
with the additional use of visual aids (poster that has been attached in Section 2.22). The
visual aid will contain a brief note on general anesthesia for elective pediatric surgery and
its safety. It will also contain a pictorial representation of the common events and risks
involved in receiving a general anesthetic. This anesthesia consent process will verbally and
pictorially discuss and explain the type of anesthesia being used, airway management
strategies, pain management, and associated risks. The caregivers will then be asked verbally
or through writing to answer survey questions which includes caregiver age, sex, education
level, occupation, relationship to the patient, and recall of consent process (type of
anesthesia, risks involved, etc.). The survey will be administered while the caregivers are
in the waiting room during surgery or in the recovery unit after the surgery before discharge
from the recovery unit and is expected to take less than 5 minutes to complete. Completion of
this survey will end the participants' involvement in this study.
The caregivers will be consented to participate in the study after the anesthesia consent
process (but before administration of the caregiver survey) to avoid the risk of recall bias.
They will not be made aware of the different methods of consent being administered at the
time of anesthesia consent. If the caregiver does not provide consent to participate in this
study then the caregiver questionnaire will not be administered and data will not be
collected for the purpose of this study. The addition of the visual aids will only enhance
the consent process and have the potential for this group of caregiver participants to gain
additional information about the anesthesia consent process compared to the standard consent
protocol. Thus, since being randomized to the group that would receive the visual aids would
not produce any detriment as compared to the standard consent protocol, the study team
believes delaying obtaining informed consent to participate in this study until after the
anesthesia consent process has been completed is reasonable for this study design.
All statistical analysis will be completed through R Studio version 3.6.0. Descriptive
statistics will be reported for baseline characteristic using proportions for categorical
variables and means and standard deviations for continuous variables.
If the recall score follows a normal distribution, a two-tailed Student's t-test will be
performed to examine the difference in mean recall score between groups otherwise a
non-parametric Mann-Whitney U test will be performed. A multivariable linear regression
analysis will be performed to estimate correlation coefficients and 95% confidence intervals
between baseline characteristics and recall score as a secondary explorative analysis.