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.
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NEJM Journal Watch — Recent Cardiology Articles
Congratulations on an important study. Having not seen the video, I will assume that it went through rigorous development, with feedback from clinicians and patients, and that it is quite decent. So I am not really convinced that the next step should be educational tool improvement. What do you think would be different the next time around, and should better knowledge scores be the goal? Have we advanced the patient’s health, experience, outcomes?
“Doctor House vs Robocop”
Thank you for this nice study and well conducted discussion.
This makes me think that we are only human beings, sharing emotion with our patients.
This is well summarized in the remark of Dr Rosengart “physicians’ perception of procedural benefits” it explains why most of the patients (fortunately) keep in mind the positive of the procedure when explain them on an emphatic way (because we believe it is the good one!) .
A robot without any emotional participation (uniform sight, monochord speech, unchanging gestures…) will probably collect different informed consents.
This can be the subject of a following study.” Informed consent signed in front of Robocop”
In my experience most of the people use a thinking process very different from the one we use after years of study and experience. A great deal of people base their decision on their own experience, advice from family and friends and of course from Internet, not necessarily from scientific evidence, and who can blame them this days you can find scientific evidence in any directions in a lot of subject. Most of the people is susceptible to advertising that’s why is a well known profession. Many people go to the doctor complaining of pain, so nobody likes pain and discomfort so everybody prefer comfortable procedures. At the end for a lot of people their medical decision are and act of faith, they prepare for the worst and hope for the best.