The schism between health care and informed consent

2715599454_ca105ab726_bThe form hospitals typically use to garner “informed consent” from patients weighing major health care procedures seems almost as complicated as the procedure itself. Tiny font spells out incomprehensible health care risks across tens of pages; by the time patients read the form their eyes are glazed over and the need for surgical anesthesia, it seems, has been reduced. Concerned that the typical form leads to neither information nor consent, a concerned doctor is seeking to change the way patients agree to undergo certain health care procedures – and is giving patients a more individualized sense of their own risk in the process.

The idea: use Web-based databases that list actual patient outcomes in order to help patients understand true risks before consenting to a procedure. Nine health care centers around the country, including the Mayo Clinic in Rochester, Minn., and the Henry Ford Hospital in Detroit, are testing an informed-consent process for patients undergoing cardiac catheterization and angioplasty, according to the American Medical Association. The Web-based program draws on a national cardiovascular database to predict individualized risks of death, bleeding or blood vessel complications.

"It is well-known from the medical literature that informed consent is neither informed nor consensual," Dr. John Spertus told the AMA’s amednews. According to that publication, Spertus developed the informed-consent health care process being pilot-tested with $5.6 million in grants from the American Heart Association and the National Institutes of Health. About the old, multi-page form Spertus said: "Largely, it is a legalese document that risk managers have crafted that doesn't communicate well and is vague and uninformative. (The pilot program process) 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."

Spertus has called his pilot program Patient Refined Expectations for Deciding Invasive Cardiac Treatments, or PREDICT. The program gives physicians access to health care information from the American College of Cardiology's huge National Cardiovascular Data Registry, which holds more than 10 million patient records. According to amednews, PREDICT considers a patient's age, additional illnesses or health care conditions plus other characteristics to estimate an individual's risk profile, given how similar patients have fared. The risks are presented in a reader-friendly bar chart. The system also gives doctors tips to consider before performing the health care procedure, given individual patient risk.

This is an important issue. According to a 2005 National Quality Forum Report, a majority of patients – anywhere from 60 percent to 70 percent – do not read or do not understand informed consent papers before they agree to a undergo a health care procedure. Having an easy-to-read document placed in your hands prior to receiving a serious health care procedure not only preserves the medical ethics of informed consent in a meaningful way, it can help ease anxieties surrounding the procedure itself. And that, hopefully, can lead to better outcomes and quicker healing.

Photo Credit: Ed Yourdon

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