Medicolegal Issues

Patients In the Know


Patient autonomy is one of the core principles of medicine in the U.S. All adult patients of sound mind are entitled to know the risks and benefits of the procedures they undergo—especially when surgery or transfusions are involved.

However, sometimes principles collide with practicalities. Hospitals would grind nearly to a halt if clinicians had to stop and inform patients of the remotest risks associated with even the most benign therapies like potassium supplementation or furosemide.

Read this Research

Find this study (“Patients’ Predilections Regarding Informed Consent for Hospital Treatments”) in the January-February 2008 Journal of Hospital Medicine.

As a result, the vast majority of medical treatments are administered to hospitalized patients with no discussion of risks, benefits, and alternatives. Besides, most patients wouldn’t want to be informed of every single risk associated with those medications if the likelihood of an adverse event were relatively small. Or would they?

A team of investigators at Yale and Bridgeport Hospital in Bridgeport, Conn., led by medical resident Shweta Upadhyay, MD, examined patients’ preferences when it comes to providing informed consent for routine hospital procedures associated with varying degrees of risk.

These researchers submitted questionnaires to 210 patients admitted to the hospital between June and August 2006. The questionnaires described four hypothetical situations of escalating risk:

  • Administration of a diuretic to relieve pulmonary congestion resulting from heart failure;
  • Supplementation to replace mineral loss associated with diuretic use; and
  • Administration of tissue plasminogen activator (TPA) to treat pulmonary emboli, with a 5% or 20% risk of cerebral hemorrhage and stroke.

In each case, patients were asked if they would want their physicians to begin treatment without asking their permission, ask their permission before beginning treatment no matter what, or obtain permission only if time and clinical circumstances permitted.

These data demonstrate that patients’ expectations are high: They want to be fully involved in even the most mundane aspects of their care. I doubt that most physicians realize just how involved their patients want to be.

—Constantine Manthous, MD, associate clinical professor of medicine, Yale and Bridgeport Hospital, Bridgeport, Conn.

“We designed the questionnaire to step up from minimal risk to life-threatening intervention,” says Constantine Manthous, MD, associate clinical professor of medicine at the hospital and senior author of the study.

Surprisingly, the vast majority of patients—85%—wanted to participate in making even the most trivial decisions about their care. Of those answering the question about potassium supplementation, 92% wanted to be informed before receiving a diuretic.

Less surprisingly, 93% and 95% of patients, respectively, wanted their doctors to obtain their permission before administering TPA when the risk of hemorrhage was 5% and 20%. “We did not expect the patients to be interested at all in the mundane things,” Dr. Manthous says.

In general, patients younger than 65 were more likely to want to discuss the risks, but more of the older patients wanted to be informed if time allowed.

“Older patients (>65 years old) were more likely in some questions than younger (<65 years old) patients to allow their physicians to make unilateral decisions regarding their healthcare. This could be explained by the fact that those age 65 and older grew up at a time when physician paternalism was more prevalent in American medicine,” the authors write.

The findings “demonstrate a big change in what it means to be a patient from 30 to 40 years ago,” Dr. Manthous points out. “These data demonstrate that patients’ expectations are high: They want to be fully involved in even the most mundane aspects of their care. I doubt that most physicians realize just how involved their patients want to be.”

Often, the decision to disclose a treatment’s risks boils down to a judgment call, especially when the frequency and severity of those risks are low, John Banja, MD, and Jason Schneider, MD, both of Emory University in Atlanta, wrote in an editorial accompanying the study (“Ethical Challenges in Disclosing Risk”).

The ethical obligation to discuss risks increases when risk severity increases, even if the frequency of those risks remains low. However, hospitals have inconsistent policies for obtaining informed consent.

“Many hospitals, for example, would have staff simply tell patients that they needed diuretics or thrombolytics, even though in certain instances—and especially with thrombolytic agents—the risk of a significant adverse event could well exceed some reasonable disclosure threshold (which is often set at 1%),” Drs. Banja and Schneider write. If a patient is about to undergo a procedure like thrombolysis, in which the risk of cerebral hemorrhage may be as high as 20%, formal informed consent would “most certainly” be required. Failure to get it could be construed as a serious ethical breach.

Like Dr. Manthous, Dr. Schneider, assistant professor of general medicine at Emory University School of Medicine, was startled by the number of patients who took such an interest in even relatively innocuous treatments. “What was most eye-opening for me was the number of people who had so much interest in the intricacies of their medical care,” he says.

Good communication can help doctors strike a balance between fulfilling patients’ wishes for information and working efficiently, Dr. Schneider adds. “Quality can compensate for quantity; with well-tuned communication, you can make up for limited time,” he explains. Unfortunately, although communication has recently been added to the list of core competencies residents should master, “physicians don’t have the interpersonal communication skills they should have. It’s definitely an area where improvement is needed.”

Indeed, doctors could use their newfound expertise in communication to describe to patients the practical implications of listing every risk of every procedure. Right now, “patients probably don’t understand how bothersome and logistically problematic it would be” to make that disclosure, says Dr. Manthous. “I suspect their answers would be different if we explained that care would slow to a crawl.”

Norra MacReady is a medical writer based in California. TH

Norra MacReady is a medical writer based in California.

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