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Informed consent procedures for cardiac patients may need improvement
Scripted verbal and audio-visual informed consent improved comprehension for patients undergoing cardiac catheterization or PCI, but important misperceptions regarding outcomes and alternatives persist, according to a new report.
For the pilot study, researchers randomly assigned 102 patients undergoing first-time, elective outpatient cardiac catheterization and possible PCI at Stony Brook University Hospital in New York. One group (n=48) was assigned a scripted verbal or written consent process and the other group (n=54) was assigned a Web-based audio-visual presentation (Emmi, Emmi Solutions LLC).
Patients were administered preconsent and postconsent questionnaires to evaluate changes in self-reported understanding of standard consent elements. The primary outcome was successful identification of all PCI-related risks. “Success” was defined as an increase in correct survey responses without an increase in erroneous risk responses from preconsent questionnaire to postconsent questionnaire, or maintenance of a 100% correct score.
The researchers found no difference between the groups in success rate for comprehension of risk (P=.12), benefit (P=.782) or overall comprehension (P=.521). However, the audio-visual group demonstrated a better success rate for comprehension of alternative treatments compared with the verbal or written group (80% vs. 60%; P=.028). According to the researchers, this was likely a function of more extensive treatment in the audio-visual tool compared with the scripted consent tool.
Among all study participants, correct identification of all risks and alternatives increased after the consent process (P<.05), with four of five queried risks correctly identified by more than 90% of respondents.
However, misperceptions of benefits continued after the consent process. Increased survival was incorrectly identified as a PCI-related benefit by 83% of patients and prevention of future MI was incorrectly identified as a PCI-related benefit by 46%, the researchers found.
“Both educational approaches were somewhat effective, but considerable challenges remain in effectively educating patients about contemplated medical procedures,” the researchers wrote. “The data reported in this pilot study show that significant gaps in patient comprehension persist after informed consent as currently practiced, particularly regarding perceived PCI benefits, which correspondingly were not well delineated in the consenting tools tested in this study.”
However, good performance in comprehending elements well-covered in the consent tools, such as procedural risks, “suggests that comprehension may be enhanced with further improvements in consenting instruments,” they wrote.
Disclosure: Emmi Solutions LLC provided materials for free. The researchers report no relevant financial disclosures.