Mar. 17, 2010 Parents of children undergoing ear, nose and throat surgery do not appear to remember all of the risks of the procedures explained to them by clinicians, even when detailed surgical risk counseling and data sheets are used, according to a report in the March issue of Archives of Otolaryngology-Head & Neck Surgery, one of the JAMA/Archives journals.
When a child undergoes surgery, a parent or legal guardian must first give informed consent, according to background information in the article. The four key elements of informed consent are disclosure, comprehension, competence and voluntary choice. "To meet these criteria, the physician must openly communicate to the patient a clear description of the procedure and the goals and benefits of that procedures as well as the risks of, and all alternatives to, surgery," the authors write. "In the case of pediatric patients, the parents or legal guardians must be counseled concerning their child's surgery."
Daniel P. Nadeau, M.D., and colleagues at Walter Reed Army Medical Center, Washington, D.C., studied 34 parents whose children underwent a tonsillectomy or placement of ear tubes at one facility. Eighteen of these parents were randomly assigned to received standard informed consent and the other 16 also received detailed information aids. Immediately after counseling and again on the day of the surgery, parents completed questionnaires testing their general knowledge of the procedure and how well they recalled nine specific surgical risks. For tonsillectomy, these included pain, bleeding, and voice changes, and for ear tube installation, perforation of the eardrum, hearing loss and the need for further surgery.
The average time between risk counseling and surgery was 6.3 days. Overall, parents in both groups recalled 5.17 of nine risks (58 percent) immediately after counseling and 5.14 (57 percent) after surgery. Those who received detailed aids scored higher on identifying the nine risks both before and on the day of surgery (average score, 6 vs. 4.44 before surgery and 6.25 vs. 4.17 afterward). In both groups, parents with lower education levels remembered more than parents who were better educated and mothers remembered more than fathers.
"Although formal counseling with detailed data sheets does improve parent surgical risk recall, no parent was able to recall 100 percent (nine of nine) of the intended surgical risks," the authors write. "The overall risk recall rate for this study was 57.5 percent, which is largely disappointing given the effort that was put forth to improve recall."
"Despite our best efforts in this study, patients and parents clearly do not retain and/or understand the full extent of the surgical risks that were discussed during the informed consent process even though this is the number one goal of the informed consent discussion," the authors write. "Clearly, more efforts need to be made by physicians to study this process to better understand the factors that may affect the informed consent process, with the goal of patients and parents being better informed of the basic risks before surgery."
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- Daniel P. Nadeau; Jeremy N. Rich; Scott E. Brietzke. Informed Consent in Pediatric Surgery: Do Parents Understand the Risks? Arch Otolaryngol Head Neck Surg, 2010; 136 (3): 265-269 [link]
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