Taking the time to answer a patient’s questions and making sure the patient understands the procedure are important tasks that the orthopaedic surgeon should perform.

AAOS Now

Published 9/1/2007
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William J. Holt, MD

Informed consent: A process, not a piece of paper

Today, every surgeon has at least some familiarity with the concept of informed consent, and malpractice lawsuits based solely on lack of informed consent are relatively rare. Aspects of informed consent, however, may still cause confusion, so it is worthwhile revisiting this topic.

Part of the problem is the term “consent,” which makes it sound like surgeons go out, drag people into their offices, and ask them for permission to perform surgery on them, to which they agree. The reality is that patients come to orthopaedic surgeons with their problems, and the surgeons (after conducting an examination, coming to a diagnosis, and considering the various treatment options) recommend a surgical procedure as a—or the best—solution to the problem. The patient then agrees and asks us to perform the surgery. It might make more sense if we spoke about “informed requests” for surgery.

Historically, society assumed that patients were unable to appreciate the issues involved in medical decision making and that doctors always acted in the patients’ best interests. During the 1950s, however, instances occurred that showed, unfortunately, that this was not always the case, and a more patient-centered, less paternalistic model of the doctor-patient interaction was introduced. Central to this model is the belief that patients have the right to determine what is done to them, and it is incumbent upon surgeons to give patients the information needed to make that decision.

How much is too much?
This concept points up one of the problems with “informed” consent. Because most patients haven’t attended medical school or completed a surgical residency, there’s no way that they can have all the information that surgeons have at their disposal when they recommend surgery.

A second problem is determining how much information is sufficient. Obviously, this will vary, based on the patient and the clinical situation. Some patients say they don’t want to know anything bad (Don’t rely on that!), while others come with a seemingly endless list of questions or Internet-supplied misinformation. Surgeons don’t need to spend the same amount of time with a patient discussing a trigger finger release as they do for an instrumented lumbar fusion.

How much is legally required? There’s no single answer to that. As with any legal question, surgeons should be aware of their state’s requirements. Surgeons should also be aware that informed consent applies to all treatment courses, not just surgery.

Some states have the “reasonable patient rule”—the surgeon is required to impart that amount of information that a “reasonable” patient would need to make the decision about treatment. Other states turn that around and apply the “reasonable physician rule”—surgeons need only give that information that a typical, appropriately trained physician would give in the same circumstance. Telling the patient what you, as a physician, would want to know if you were a patient facing the same operation probably meets both standards.

Generally, the patient needs the following information:

  • the nature of the problem
  • the proposed treatment plan
  • the most likely or most significant risks associated with treatment
  • the anticipated benefits of treatment (usually obvious)
  • reasonable alternatives to the proposed treatment, including the alternative of not proceeding with the proposed treatment

A discussion of alternative treatments doesn’t mean you have to talk about homeopathic cures—just treatments that are considered reasonable alternatives by similarly trained physicians.

Dealing with risks
Discussions about risks probably cause the greatest uncertainty. It’s not necessary to talk about every possible complication or adverse outcome, nor is it necessary to tell every carpal tunnel patient that he or she might die. Common complications and serious but rare complications specific to the case should be covered.

If specific precautions are taken to prevent a common complication, both the complication and the precautions should be discussed. Although these discussions are no guarantee against being sued, preventing a lawsuit shouldn’t be the point. The point should be that “informed consent” is a process, not a piece of paper.

That being said, lots of paper is associated with the process! In today’s legal climate, everyone wants to have something in writing, which requires that surgeons document that the process occurred.

A hospital “consent form” signed by a premedicated patient will have no value in a court of law without something to prove that the informed consent process took place. The best supporting documentation is a statement in your office notes or in the health and physical notes or in both. The statement should indicate the following:

  • that an appropriate informed consent discussion took place
  • that the patient has been advised of relevant risks, realistic alternatives, and expected outcomes for the procedure
  • that the patient has been given a chance to ask questions and that those questions were answered

Such documentation of the process is far more important than a “consent,” whether signed in the office or at the hospital, especially when—years later—the patient denies having been told of a possible risk. Although a nurse-practitioner or other associate may impart most of the information, the surgeon must take the time to be sure that the patient understands the procedure and is truly “informed.” Remember, the surgeon is the one who’ll be sued, not the nurse!

“Informed refusal”
A recent addition to the law on informed consent can be called “informed refusal”—the obligation to be sure that a patient’s decision NOT to proceed with treatment is an informed one. In most elective cases, the results of not proceeding with a recommended surgery are obvious and unimportant; the consequence of not having a ganglion removed is still having a ganglion. If, however, the patient might suffer adverse consequences by foregoing treatment, the physician must document that this was part of the information conveyed.

For example, a patient with significant carpal tunnel disease should be told of the possibility of irreversible nerve damage if the condition isn’t addressed. A patient with a rotator cuff tear needs to be warned of possible progression to an unrepairable state. This is not the same as trying to scare someone into surgery, but surgeons should realize that they can now be sued for a lost opportunity for healing.

Don’t count on the computer
In addition to chart documentation of the informed consent process, physicians may use computer or Internet-based programs that not only educate but also test patients on their knowledge and document that the patients viewed the material. These systems are new and have not yet been tested in court, so we don’t know how much protection they actually offer the surgeon. Regardless, computer programs, like information pamphlets, don’t excuse the surgeon from the responsibility to be involved in the “informed consent” process.

William J. Holt, MD, is a member of the Medical Liability Committee. This article is not intended as legal advice; please consult your attorney with specific questions.