CardioExchange Archive

In an article recently published in Annals of Thoracic Surgery, investigators describe results of a randomized comparison of two different instruments for providing informed consent to 240 patients scheduled for elective cardiac catheterization with possible PCI: a scripted verbal or written presentation and a commercially available, web-based, audiovisual presentation (provided for free by the developer). They found that although both instruments significantly increased patient understanding in two of three key domains (risks and alternatives), the audiovisual instrument outperformed the verbal or written instrument only in the identification of alternative treatments, and neither instrument significantly increased patient understanding of the benefits of the procedure.

CardioExchange Editor-in-Chief Harlan Krumholz discusses the findings with the paper’s senior author, Todd Rosengart, MD.

Harlan Krumholz: The paper is quite interesting. What surprised you most about your findings?

Todd Rosengart: We were amazed that so many patients still heard and believed what they were most hopeful for, such as that PCI would “cure their disease,” especially when corrective counter-information was provided. We were surprised, despite some improvements provided by the audiovisual consent process, that the outcomes were not even better. It taught us that the information provided in the consent tool needs to be carefully thought through to deliver the intended message.

Krumholz: Why didn’t you enroll more patients?

Rosengart: Timing issues led to our termination of the study earlier than expected. Given that there were no discernable trends toward an improvement in comprehension with the audiovisual device in most categories beyond those already identified, in part because of the issues noted above, we concluded that outcomes would have remained largely unchanged even with larger enrollment numbers.

Krumholz: Why did you publish this paper in a surgical journal, since the topic was PCI and cath?

Rosengart: Surgeons as well as cardiologist and PCPs have harbored great concerns regarding the success of current PCI consenting processes in adequately informing patients about the risks and benefits of PCI, as well as alternatives to PCI such as surgery. This study was designed to inform the surgical as well as the medical community as to the adequacy of current processes and the availability of potential improvements, such as the tested audiovisual consenting tool.

Krumholz: What do you believe are the main reasons that patients have misperceptions? We published a paper on this a decade ago; in 2010, Rothberg and colleagues repeated it and found the same results. Both were single-center studies, but the results were the same — decades apart. Why is this so?

Rosengart: As you know, this has been the subject of much investigation — including psychological analyses. It is interesting that aspirational goals (“this will make me better”) are less well-conceptualized (overestimated) than potential risks, which were relatively well understood. As noted in the paper, this seems to correlate well with physicians’ own well-documented inflated perceptions of procedural benefits as well as with the psychology of wanting to feel and be “better.” All of the above underline the need for diligent, objective transfer of information.

Krumholz: Why didn’t this intervention work? What did it make you think of the product that is being sold?

Rosengart: As noted above, our data highlighted the need for further improvements and expansion of information conveyed in such products, which we believe can be effective if so enhanced.

Krumholz: What are the next steps?

Rosengart: Further improvements in the informational content of the audiovisual tool have been recommended. We look forward to further testing of such tools.