Dr. Aaron Fink Publishes Largest Study Ever Done on Informed Consent

July 2010

Dr. Aaron Fink was co-principal investigator of the most major investigation ever conducted on the surgical informed consent process, the results of which were published in the June issue of the Journal of the American College of Surgeons and the July issue of Annals of Surgery. Informed consent for surgical procedures is a critical part of surgical patient care, ideally enabling the patient to make rational, independent decisions. Unfortunately, numerous prior investigations have shown that the average patient has an inadequate comprehension of the issues related to surgical procedures.

The study led by Dr. Fink and his colleagues involved 575 patients in seven Department of Veterans Affairs (VA) medical centers from August 2006 to June 2008. All informed consent discussions were performed and documented 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. Researchers selected a random sample of patients to participate in a "repeat back" discussion at the time the consent was sought, during which the provider asked the patient to correctly reiterate procedure-specific facts and gave additional information as needed. The comprehension of all patient participants was tested after the informed consent discussion using procedure-specific questionnaires, and each patient's comprehension score was calculated as the percentage of questions that were answered correctly.

"We found that patients with potential cultural or language difficulties from factors such as race, education or age may have more limited informed consent comprehension," said Dr. Fink. "But all patients benefited from what we found to be the strongest influence on patient comprehension — extending the amount of time spent on informed consent discussions and having the patient repeat back their understanding of the proposed procedure."

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.