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Cardiologist Blasts Patient Informed Consent Process

By cclark@healthleadersmedia.com  
   March 12, 2015

With no requirement that hospitals and clinicians be candid with patients about risks and costs, informed consent is "a complete sham," says Harlan Krumholz, MD, speaking at the Lown Institute conference this week.

The healthcare system only gives "lip service" to the informed consent routine, says cardiologist Harlan Krumholz, MD, SM. "What if patient-centered informed consent actually meant something?" he asked clinicians and patient advocates attending a Lown Institute conference in San Diego this week.


Harlan Krumholz, MD, SM

Krumholz, director of the Center for Outcome Research and Evaluation at Yale University School of Medicine, wants to know what would happen if the consent process included a period of time when a patient could consider all of the risks and benefits of a treatment whether they would be appropriate, and whether there were alternatives with lower risks but similar outcomes.

"There's a structural moment in time when people sign something that says yes, [the doctor] can proceed [with the treatment]... But it's a complete sham. It's a complete sham."

Krumholz's words appeared to strike a chord with the attendees, not just because he is an influential member of numerous policy-making boards such as the Patient Centered Outcomes Research Institute (PCORI). At Yale, the center he directs has a contract with the Centers for Medicare & Medicaid Services to develop a portfolio of measures for hospital pay for performance programs.

Unfortunately, he continued, there is no expectation or requirement that hospitals and clinicians be candid with patients about the downside risks and costs of procedures, or whether there are cheaper options.

Krumholz gave an example: Researchers looked at patients who had signed informed consent forms before undergoing elective percutaneous coronary intervention and found that "about 75% believed that PCI would prevent a future heart attack and 71% thought it would prolong their life, even though there was no evidence that either was true."

"We have people undergoing procedures under assumptions of benefit that do not exist," Krumholz said.

He appeared to be preaching to the choir. The fledgling Lown Institute is a Boston-based organization founded by Bernard Lown, MD, the cardiologist who developed the direct current defibrillator, but who now questions the necessity for some 50% of interventional cardiology procedures and many other medical interventions.

The institute's unofficial motto: "Do as much as possible FOR the patient and as little as possible TO the patient."

The three-day conference hosted only about 300 attendees, but featured some big names in the informed patient movement, including: Diane E. Meier, MD, Director, Center to Advance Palliative Care Professor of Geriatrics and Palliative Medicine at Mount Sinai in New York; Michael Fine, MD, Director, Rhode Island Department of Health; and Steven Nissen, MD, Department Chair, Cleveland Clinic Cardiovascular Medicine.

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