In 2010, Harlan M Krumholz wrote a commentary in the Journal of the American Medical Association (JAMA) about the need for true informed consent in patients undergoing elective percutaneous coronary intervention (PCI) in the USA. In this commentary for Cardiovascular News, he reviews what has changed in the past seven years—or rather, what has not changed—and why his arguments still stand.
Seven years ago, I proposed that informed consent for elective PCI was improved as an example of what should be done throughout medicine. Our group had previously published a study that showed that most people undergoing PCI had unrealistic expectations about the benefits of the procedure. Other studies had indicated the failure of informed consent to inform people. People in cardiology are leaders and I felt that improving informed consent for elective PCI was an opportunity for us to show others how to proceed.
I suggested that we start by elevating the informed consent document. I focused on the content of what people need to be truly informed about PCI. I said that the consent should have a short description of the procedure, the potential benefits, the potential harms, the alternatives, the experience and track record of the healthcare team, and the likely out-of-pocket cost for them. I suggested that this information was essential for a truly informed choice.
The situation now is no different than before. Even though interest in empowering and engaging patients is growing, we have yet to institute approaches that seek to ensure that the key choices made by patients are supported not just by recommendations but also by credible information that underlies those recommendations. Moreover, we have yet to ensure that people know the reasonable alternatives that are available to them. Also, we rarely employ mathematical models to ensure that the information we provide is personalised for the individual facing the choice.
In addition, in the JAMA commentary, I argued that we should add information to informed consent that is non-traditionally included. For example, people are entitled to know the track record of the team. People are making a choice about a procedure and a team. How can they be truly informed without such data? They have options about therapeutic strategies and the team. And people are worried about offending their doctors and so rarely ask. It must be provided rather than be available on request.
The cost issue is also key and not traditionally included in the consent process. Financial adverse effects of procedures are real. If people get into debt or worse, then that has severe consequences for them. People deserve to know the financial implications of the choices available to them. These considerations could reasonably influence the decision.
I remain hopeful that we, in cardiology, may take the lead in truly patient-centered consent processes. Our goal should be not to employ informed consent as merely documentation to mitigate the risk of litigation, but as a personal interaction designed to ensure that patients have every chance to understand their options and are treated in accordance with their wishes. We should be there to guide—not dictate—but must ensure they have access to the facts.
Harlan M Krumholz is at Section of Cardiovascular Medicine of the Department of Internal Medicine, Yale School of Medicine; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, USA.