Scientific Sessions 2011
ORLANDO — Patients who received personalized consent forms before
angioplasty or stent implantation better understood the procedure, potential
risks of treatment and were more engaged in the decision-making process with
their physicians, according to research presented here.
For the study, patients undergoing PCI were given a personalized consent form generated by the Patient Risk Information Services Manager (PRISM; n=527) or standard consent form (n=590) before undergoing the procedure. The PRISM form, generated
through a web-based tool, allows physicians to input patients’ specific
health information and to execute complex prediction models to generate each
patient’s individualized risks and benefits of treatment. The personalized
consent form was deemed easy to understand, as it was written on an 8th- or 9th
grade reading level and included educational pictures of the procedure, which
was different from standard consent forms that are typically written in legal
Of the patients who received the PRISM form, 72% reported reading and
52% understanding it. In contrast, 45% of patients who received a standard
consent form read it and 31% comprehended the information within. Those who
read the consent forms were asked if treatment descriptions and complication
information was clear. Forty-nine percent of patients who received the PRISM
form said treatment descriptions were clear and 50% thought information about
potential complications was clear. For patients who received the standard
consent form, one-quarter felt that the descriptions and explanation of
complications were clear.
Overall, more patients who received the PRISM consent form were aware of
risks associated with PCI:
- 66.6% vs. 36% reported understanding the potential risks for death.
- 61% vs. 31% were aware of risks for bleeding.
- 77% vs. 61% reported feeling less nervous about undergoing the
Personalized consent forms also opened discussions about stent types between patients and physicians. After using PRISM, almost two-thirds (63%) of patients discussed with their physician whether to use a bare metal or drug-eluting stent, as compared with about one-third (35%) of those who received the standard consent form. Half of the patients exposed to the PRISM consents were also much less likely to feel that the doctor alone made the decision about stent type as compared with traditional consent forms (72%).
John Spertus, MD, MPH, director of Cardiovascular Education and
Outcomes Research of the Mid America Heart Institute at the University of
Missouri-Kansas City, and the PRISM researchers concluded that it is feasible
to implement evidence-based decision aids within the routine flow of patient
care. In this study, personalized, evidence-based consents supported an improved
informed consent process, better knowledge transfer and more engagement in
shared decision making. However, the researchers noted marked variability in
benefits observed across sites, and added that the consent form is only one
component of the consent process.
In the future, the researchers are looking to define the impact of
individualized, personalized consent forms on treatment and outcomes of
“I think this paradigm is extensible to many other
conditions,” Spertus said at a press conference. “Within cardiology,
we can extend it upstream to think about whether patients with stable coronary
disease even would want angioplasty in the first place, as compared with bypass
surgery or medical therapy alone. Second, it could extend well beyond
cardiology.Orthopedics for back pain and knee surgery or oncology for breast cancer treatments are all ripe areas for the delivery of personalized, evidence-based medicine. Using consents like this is one small step in that direction.”
– by Casey Murphy
For more information:
Disclosure: Dr. Spertus is a founder of the Health Outcomes
Sciences, which disseminates and supports the PRISM tool. He reports equity interest in Health Outcomes Sciences, which sells and supports the PRISM technology.
The informed consent process currently is a process of informing our
patients on the potential risks and benefits prior to medical therapy or
procedure. This is often done on a general population or institutional basis to
give them information. In general, the treatment course has also usually been
decided. It’s important to remember that during the catheterization
process this often occurs in the US and around the world in an ad-hoc fashion,
where the patient is undergoing a cardiac catheterization without the anatomy
Manesh R. Patel, MD
Assistant professor of
Duke University School of Medicine
Disclosure: Dr. Patel reports no relevant financial disclosures.