Medicolegal Issues

Malpractice risk management: Be thorough—and involved—in obtaining informed consent

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Do not draw conclusions or speak cryptically. Never make assumptions about the patient’s knowledge or understanding of a proposed operation or its alternatives. Instead, invite the patient to ask questions. Be receptive and thoughtful when those questions are posed.

The patient should receive a clear, concise explanation of his or her condition or diagnosis and how that might affect the outcome. For example, discuss proposed surgery for pelvic prolapse in the context of the patient’s presentation.

There’s more to do afterward

The process does not necessarily end after you’ve answered all the patient’s questions and she has given informed consent (or has declined to consent). For selected treatments or operations, some states require a presentation of risks, benefits, and alternatives more specific than the “reasonable person” communication.

In many states, for example, a patient who grants consent for a hysterectomy or sterilization must be told specific points or complete a form. Some states apply similar protocols for breast cancer surgery or chemotherapy.

Handouts and videos are no substitute!

More and more, physicians are using videotapes, CDs, Web-based sources, and handouts to help patients understand procedures. But these resources cannot supplant the role of even a very busy physician. Such materials can supplement a focused discussion between physician and patient, but do not legally serve the purpose of obtaining informed consent.

A nurse or other nonphysician provider can convey some information or provide materials to the patient about the treatment or procedure toward the goal of obtaining informed consent, but, again, it is you who must then come in and complete the discussion. Whether a court accepts this system depends on the quality of the materials.

An informative handout (or video, etc.) can have a big impact on a jury’s impression of whether the patient was informed adequately. However, sometimes a busy physician relies too heavily on nonmedical staff and fails to participate sufficiently in deciding what the staff hands out. Furthermore, the physician is responsible for any information that a staff member provides to a patient.

Must you disclose a lack of experience?

You don’t need to volunteer information that you’ve done a certain procedure only a few times. If the patient or a family member asks this question, however, answer honestly. Even the most aggressive plaintiff’s experts acknowledge that physicians do not have to provide a tabulation of procedures they’ve performed.

Full disclosure needed

Often, in a university hospital or large medical center, a surgeon who discusses a procedure with the patient is not the one who is scheduled to perform it. That situation should be included in the informed consent: “I will be the second assistant surgeon, but it’s Dr. Smith who will perform your operation.”

When a proposed therapy or procedure will involve off-label use of a drug or medical device, tell that to the patient, too, and document the discussion in the chart.

At the end of the informed-consent process, you must be satisfied that you’ve complied with the court’s mandate to meet the patient’s protected interest in autonomous decision making.

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