Objective: Obtaining and documenting informed consent is of vital importance to physicians. We developed a procedure-based consent form that facilitates patient discussion and validated this process by surveying the patient regarding elements of the consent process, using an independent evaluator.
Methods: One hundred and twenty consecutive outpatients were evaluated before different neurosurgery procedures. The consent form listed specific diagnoses, procedures, alternatives (eight listed), and risks (22 listed), and each point discussed was checked off by the surgeon. Between 10 and 20 minutes later, each element was questioned by one lay-member of the office staff. A group of patients not at risk for cognitive decline were resurveyed months later.
Results: One hundred and twenty (100%) of 120 of patients answered correctly regarding their diagnosis and the planned procedure. Four hundred and twenty-eight alternative treatments were discussed, and 420 (98.1%) of the 428 were recalled correctly. Of 1207 risks that were discussed, 1176 (97.4%) were recalled correctly. When a subset of the patients were reevaluated at a mean of 4.5 months later, all 20 patients correctly recalled their procedure and diagnosis. Of 79 alternatives discussed with patients before surgery, 73 (92.4%) were subsequently recalled. Of 217 risks discussed before surgery, 199 (91.7%) were recalled. Although the immediate or delayed recall rates were high (> 90%), there was a reduction in the recall rate over time (alternatives, P = .007; risks, P < 0.0001).
Conclusion: A consent process designed for an individual surgeon's practice was validated and showed high rates of patient recall in the postprocedural period. We think that this method to obtain and document informed consent should be considered for use by physicians.