Informed Consent and Informed Decision-Making in High-Risk Surgery: A Quantitative Analysis.

BACKGROUND: Informed consent is an ethical and legal requirement that differs from informed decision-making-a collaborative process that fosters participation and provides information to help patients reach treatment decisions. The objective of this study was to measure informed consent and informed decision-making before major surgery.

STUDY DESIGN: We audio-recorded 90 preoperative patient-surgeon conversations before major cardiothoracic, vascular, oncologic, and neurosurgical procedures at 3 centers in the US and Canada. Transcripts were scored for 11 elements of informed consent based on the American College of Surgeons' definition and 9 elements of informed decision-making using Braddock's validated scale. Uni- and bivariate analyses tested associations between decision outcomes as well as patient, consultation, and surgeon characteristics.

RESULTS: Overall, surgeons discussed more elements of informed consent than informed decision-making. They most frequently described the nature of the illness, the operation, and potential complications, but were less likely to assess patient understanding. When a final treatment decision was deferred, surgeons were more likely to discuss elements of informed decision-making focusing on uncertainty (50% vs 15%, p = 0.006) and treatment alternatives (63% vs 27%, p = 0.02). Conversely, when surgery was scheduled, surgeons completed more elements of informed consent. These results were not associated with the presence of family, history of previous surgery, location, or surgeon specialty.

CONCLUSIONS: Surgeons routinely discuss components of informed consent with patients before high-risk surgery. However, surgeons often fail to review elements unique to informed decision-making, such as the patients' role in the decision, their daily life, uncertainty, understanding, or patient preference.