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Informed consent: More than just a signature

By Thomas B. Fleeter, MD

Take advantage of the opportunity to build a relationship

When asked to define informed consent, many orthopaedic surgeons may instead reply, “I’ll know it when I see it.” Despite the many articles on the issue, widespread misunderstanding of what constitutes informed consent and how to provide it still exists. Although orthopaedic surgeons can all agree about what informed consent is not, the optimal method for fully informing patients about the procedures they are about to undergo and the risks associated with them is not well defined.

Informed consent is an evolving concept. In 1914, Supreme Court Justice Benjamin Cardozo validated the concept of voluntary consent when he noted that every human being has a right to decide what shall be done with his or her body. However, it was not until 1955 that two cases—one in North Carolina and the second in California—specifically held that physicians had a duty to disclose potential surgical risks to patients.

Thus emerged the modern concept of informed consent—requiring that patients freely consent to treatment and that they are fully informed about a procedure’s risks, benefits, and options. Most surgeons are very familiar with this responsibility, but it is the nuts and bolts of providing and obtaining informed consent that can be problematic.

Prove it happened
The first rule of informed consent is: If it isn’t documented it didn’t happen. Although a piece of paper cannot prevent a lawsuit, documented evidence that a conversation between a patient and the physician occurred is critical.

The location where informed consent is obtained is equally important. It may be commonplace to have patients sign the consent form in the holding area before surgery, but significant evidence exists to show that asking patients to review and sign the consent form in the physician’s office before surgery reduces the risk of a subsequent lawsuit. The office progress notes should also document that informed consent occurred.

Although the orthopaedic surgeon is not legally required to be present for the entire session when informed consent is provided, the surgeon should be present for at least a portion of the session. A physician’s assistant, nurse, or resident can legally provide the necessary information; however, there is no substitute for the surgeon being present at some point during the meeting to answer questions.

Most medical liability lawsuits are not about bad medicine; they are about poor communication and strained interpersonal relationships. A strong doctor-patient relationship, exemplified by the physician’s presence to explain the proposed procedure and to answer pertinent questions, can be key in avoiding medical-legal issues.

Make sure the patient understands
Providing the pertinent information in a manner the patient can understand is also very important. As many surgeons know, patients often forget even the most basic information once the possibility of surgery is raised. Numerous studies have documented how quickly patients forget information provided to them in the exam room.

The most effective way to provide informed consent, therefore, is to talk to the patient and give him or her something in writing. The use of diagrams, models, handouts, and language appropriate to the patient’s education or ethnic background can heighten the ability of the patient to understand.

Patients do often feel powerless and vulnerable. As a result, physicians must make it clear to patients that informed consent is about making a decision, not only about signing a form. The process of informed consent is more than a description of risks and complications; it is an invitation for the patient to participate in the process and ask questions about the procedure.

How much information is enough?
As physicians, how do we know that we have provided enough information about a procedure to our patient? Legal precedents as well as the relevant literature provide the following three possibilities:

Reasonable physician standard: How a typical physician would describe the procedure. Because physicians typically do not disclose enough information, this standard is probably not sufficient.

Reasonable patient standard: What an average patient needs to know to make an informed decision.

Subjective standard: What information the patient needs to have and understand to make an informed decision. This standard is the most difficult to meet as it requires customizing the information to meet the educational and cultural background of the patient.

Although there is no one standard for how much information must be provided to the patient to provide informed consent, the information must be sufficient to allow the patient to exercise control of his or her own body. In many states, the courts are clear: The standard is not just what the physician thinks the patient should know about the proposed procedure, but what the patient actually needs to know and understand to make an intelligent and informed decision.

Many lists detail the nature and scope of the information provided to the patient, but clearly the following categories of information must be provided:

  • The risks inherent in a specific treatment
  • The probabilities of success
  • The frequencies of the inherent risks
  • Reasonable alternatives to treatment
  • Conflicts of interest or any other material information that would be needed to make an informed decision

Look at it as an opportunity
Obtaining informed consent has graduated from a legal requirement to an opportunity to build trust between the patient and physician, as well as a chance to broaden the discussion about an impending procedure. According to Timothy Pawlik, MD, professor of surgery at Johns Hopkins University and author of a recent review of informed consent in surgery, “There’s been an incredible sea change [in the relationship between] patients and doctors in the last 40 years. We are treating patients as partners in the process, and our informed consent reflects that. The informed consent process is the main opportunity for patients to participate in their care and to form a relationship with you. Conversations that are one-way, rushed, or paternalistic not only miss an opportunity but also undermine the relationship. That is very difficult to rectify after an operation.”

In summary, informed consent is more than just a signature on a page. It should be an ongoing discussion started well before a surgical procedure. Consent is a shared process between patients and their physicians.

Thomas B. Fleeter, MD, is a member of the AAOS Medical Liability Committee. He can be reached at bonedock@comcast.net

January 2010 Issue