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See Inside March 2011

Uninformed Consent: Tech Solutions for Faulty Permissions in Health Care

Technology can help individuals weigh the risks and benefits of an invasive medical procedure, experts say, but only if doctors and patients keep talking



Illustration by Thomas Fuchs

Much of what happens to you in the hospital in the name of diagnosing and healing is invasive. Depending on what ails you, a doctor may need to ream out an artery to get more blood to your heart, or flood your body with a poison to kill cancerous cells, or saw through the bones of your leg to replace a crumbling hip or a worn-out knee. If a stranger came at you with a scalpel or syringe in a back alley, you would consider it assault and battery. But in a hospital most of us willingly schedule an appointment and pay big money to be precision-poked and carved because we trust our doctor’s skill and knowledge and assume the alternatives—illness, incapacity or early death—are surely worse.

But how many patients truly understand the alternatives or the risks and benefits of the test or treatment they are undergoing? One of the guiding principles of modern health care is that, except in an emergency, doctors must get the patient’s permission before the start of any invasive medical procedure. That “informed consent” is supposed to be based on an earlier conversation during which physicians make sure patients understand what the procedure will and will not do, along with its benefits and risks relative to other options.

Unfortunately, what typically happens in hospitals and clinics across the U.S. is far from ideal: On the way into surgery or some test or treatment, a nurse or technician slips the patient a clipboard of legalese to sign. In most cases, that piece of paper is either a vague permission slip acknowledging that the patient has been “informed” about the procedure, or it reads like a legal waiver—a laundry list of every single side effect and rare complication that could possibly go wrong. These badly written, hastily signed forms are meaningless or worse, health literacy experts say. Research consistently confirms that the flawed permission slips do not improve the patient’s understanding or safety. Nor do they protect hospitals or doctors from misguided malpractice suits.

In hopes of filling the gap, a growing number of medical centers are now turning to technology—specifically, interactive computer programs that are designed to get beyond the one-size-fits-no-one consent form. These software solutions vary widely in approach and targeted audience. Some are aimed at doctors, others at patients. Some are meant to be reviewed with a health care provider during an office visit; others can be watched with family members at home. Health researchers still debate each approach’s effectiveness. Rigorous outside testing of them has barely begun. But everyone lauds the goals these new approaches share. First, the programs aim to help make the discussion of the relative pros and cons of every invasive procedure—from angioplasty to tonsillectomy—more meaningful for the patient. Second, they aim to get doctors talking about benefits and risks much earlier in the diagnostic and treatment process so that patients can make truly informed choices about their own health care.

Strong evidence that traditional consent forms fail to inform patients or improve their care has been growing for more than a decade, says Harlan M. Krumholz of Yale University, who studies the ways the system goes wrong. One of the most telling nationwide investigations, he says, was a review published in 2000 of 540 forms collected from 157 randomly selected U.S. hospitals by a public health team led by Melissa M. Bottrell, then at New York University and now with the U.S. Department of Veterans Affairs. Its analysis revealed a haphazard mess: Some forms were short and vague; others were long and confusing. Many contained legalistic language that muddied the decision-making character of the consent process. Only about one in four of the forms went beyond a basic description of the procedure to include common risks, benefits and alternatives.

In nearly 60 percent of the documents studied, protecting “against liability” was the rationale given for using the permission slips, according to the hospitals submitting the forms. Too often, Krumholz says, the informed consent process has deteriorated into “largely a risk management tool for hospitals—a way to try to avoid malpractice suits—instead of a way to promote good decisions. And that seems to me a real shame.”

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