Background: Multiple formats have been used to deliver information needed for informed consent before a medical procedure, but data comparing formats are conflicting.
Methods: Sixty-three patients (45 men, age 61 ± 16 years) undergoing an initial diagnostic cardiac electrophysiology study were randomly assigned to 1 of 3 groups: oral, written, or video informed consent using a standardized text for all 3 formats. Anxiety levels were assessed with the Spielberger State-Trait Anxiety Inventory (STAI), and questionnaires were used to assess patient comprehension and satisfaction with the informed consent process. Physician time needed to obtain informed consent was also measured. The effect of informed consent format on anxiety state was evaluated by comparing STAI before and after consent. Multivariable analysis was performed to assess the effects of baseline characteristics on the state anxiety scores.
Results: For the oral, written, and video formats, the mean anxiety trait scores were 39 ± 9, 34 ± 8, and 31 ± 7, respectively (P = .005), and baseline anxiety state scores were 49 ± 12, 37 ± 12, and 36 ± 11, respectively (P = .0006). None of the formats had a significant effect on patient anxiety state after consent was obtained. After the procedure, anxiety state declined (P < .0001). There were no differences among the comprehension scores, and patient satisfaction was equivalent among formats. The oral format required the longest physician time (P = .06).
Conclusion: For electrophysiologic testing, all 3 formats have similar effects on anxiety and produce equivalent patient comprehension. The oral format requires more physician time. Given the standardization achievable with a written or video format, physicians may consider these options to facilitate obtaining informed consent.
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