INFORMED CONSENT FOR PERCUTANEOUS LUNG-BIOPSY - COMPARISON OF 2 CONSENT PROTOCOLS BASED ON PATIENT RECALL AFTER THE PROCEDURE

OBJECTIVE. Informed consent is now required for the majority of radiol ogic procedures, but few studies have evaluated the efficacy of inform ed consent protocols. We compared our standard consent protocol of obt aining consent prior to percutaneous lung biopsy with a modified proto col by using patients' recall of procedure risks after the biopsy as a n indicator of patients' comprehension. SUBJECTS AND METHODS. The stud y sample consisted of 50 patients who underwent percutaneous lung biop sy between December 1992 and June 1994. Twenty-seven patients received our standard informed consent procedure in which four important proce dure risks were described briefly using our standard method. Twenty-th ree patients underwent a consent procedure that had the following modi fication. After the four procedure risks were described, the patient w as tested verbally until all risks could be recited to the physician. This change required 5 additional min at most. In both protocols, effi cacy of the procedure was evaluated by testing patient recall 4 hr aft er consent was obtained. We also assessed any effect that might have b een introduced by differences between the groups, age, sex, time betwe en consent and recall, and complications during the procedure. RESULTS . Patients' recall was significantly better in the modified consent gr oup than in the standard group (p=.005). This result could not be attr ibuted to differences in age, sex, or time between consent and recall. There was a trend for improved recall in patients with complications. This trend did not appear to influence our principal finding. CONCLUS ION. The standard consent procedure for lung biopsy appears inadequate when patients' recall of procedure risks later is used as a measure o f the patients' comprehension. Based on this study, the informed conse nt process may be improved substantially by teaching patients to recit e the procedure risks to the physician as part of the informed consent protocol.