CHICAGO (July 7, 2010) Surgical patients who participate in longer- to 30-minute discussions prior to having an operation (known as the informed consent process) better understand the proposed operation, according to new research published in the June issue of the Journal of the American College of Surgeons. In addition, researchers found that asking the patient to "repeat back" their understanding of the procedure was effective in enhancing patient comprehension of informed consent issues. This is the largest study ever conducted on the surgical informed consent process.
Informed consent for surgical procedures is a critical part of surgical patient care. When effective, the informed consent process enables the patient to make rational, independent decisions. Unfortunately, numerous studies demonstrate that the average patient has an inadequate comprehension of the issues related to surgical procedures including a recent literature survey of over 700 patients that found the average patient understood less than half of the relevant informed consent issues related to the recommended surgical procedure.
"In our study, we found that patients with potential cultural or language difficulties from factors such as race, education or age may limit informed consent comprehension," said Aaron S. Fink, MD, FACS, attending surgeon at the Atlanta Veterans Affairs Medical Center and chief surgical consultant for VA Network 7, and professor of surgery at Emory University School of Medicine, Atlanta. "But all patients benefitted from what we found was the strongest influence on patient comprehension extending the amount of time spent on informed consent discussions, as well as having the patient repeat back their understanding of the proposed procedure."
Researchers identified 575 patients in seven Department of Veterans Affairs (VA) medical centers from August 2006 to June 2008. Patients were enrolled in the study if they were scheduled for one of four elective surgical procedures: total hip arthroplasty (hip replacement), carotid endarterectomy (surgical correction of the narrowing of the carotid artery), laparoscopic cholecystectomy (gallbladder removal), or radical prostatectomy (removal of the prostate gland and some of the tissue around it). All informed consent discussions were performed using iMedConsent, the VA's computerized informed consent platform that standardizes risk information and provides a structured, computer-based interview to create an informed consent document. Within iMedConsent, researchers utilized a unique module to select a random sample of patients to participate in a "repeat back" discussion at the time the consent was sought. During the "repeat back," the provider would ask the patient to correctly reiterate procedure-specific facts and would provide additional information as needed.
The comprehension of all patient participants was tested after the informed consent discussion using procedure-specific questionnaires. Each patient's comprehension score was calculated as the percentage of questions that were answered correctly. Time spent completing the informed consent process was measured using time stamps within iMedConsent.
While time for consent (that is, the time spent explaining the consent process) had the strongest impact on patient comprehension (p< 0.0001), other independent factors associated with improved comprehension included race (p< 0.01), ethnicity (p< 0.05), age (p< 0.02), and type of surgical procedure (p< 0.01). Some of these independent factors might suggest language and education barriers, highlighting the need for modified approaches to consent. The "repeat back" method of discussion was associated with an improvement in comprehension (p< 0.05), but the impact was weaker in the analysis that included consent time.
Study limitations included the predominance of male patients in the study (93 percent), the predominance of Caucasians in the study (74 percent), and the focus on four specific surgical procedures. Further study is needed to extrapolate results to a larger population. Additional findings from this study will be published in an upcoming issue of Annals of Surgery.
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