Informed Consent Access to Databases Helps Calculate Cardiac Risk

An Internet-based program helps to determine an individual's risk of death, bleeding, or restenosis, using data collected from a U.S. national cardiovascular database in a groundbreaking pilot for a new informed consent form.

First implemented at Saint Luke's Hospital (Kansas City, MO, USA), Integris Heart Hospital (Oklahoma City, OK, USA) and eight other hospital across the United States, the Patient Refined Expectations for Deciding Invasive Cardiac Treatments (PREDICT) system allows physicians to access information from the American College of Cardiology (ACC) national cardiovascular data registry, which contains more than 10 million catheter-laboratory patient records. Using this data, and taking into account a patient's age, comorbidities, and other factors, PREDICT then estimates the individual's risk profile. The system also alerts cardiologists about alternative medical and procedural interventions that might reduce the patient's risks during angioplasties.

However, the PREDICT programs is also part of a pilot informed-consent process for patients undergoing nonemergency cardiac catheterization and potential angioplasty. The progress of the PREDICT pilot study was published in the May 24, 2010, issue of American Medical News.

"It is well-known from the medical literature that informed consent is neither informed nor consensual,” said lead author John Spertus, M.D., M.P.H., clinical director of outcomes at Saint Luke's Hospital. "Most patients do not read or understand forms about informed consent. Largely, it is a legalese document that risk managers have crafted that doesn't communicate well and is vague and uninformative.”

"PREDICT represents a major effort to simplify and give far more information about what the angioplasty is doing and gives realistic estimates about the risks and benefits for the patients undergoing this procedure,” added Dr. Spertus. "The new form represents a major effort to simplify and give far more information about what the angioplasty is doing and gives realistic estimates about the risks and benefits for the patients undergoing this procedure. ... It represents a paradigmatic shift in the practice of medicine.”

"This is the most innovative informed-consent tool in, literally, a decade,” commented Glenn McGee, Ph.D., editor-in-chief of the American Journal of Bioethics. "There is no question that this will be rapidly followed in many fields, because the problem in informed consent right now is that it is the most impersonalized medicine there is. These forms are usually in 7-point font, 14 pages long, doctors haven't read them, they are handed out, and we are not even sure whether they're a legal shield.”

Related Links:
Saint Luke's Hospital
Integris Heart Hospital