Informed consent: What you need to know

Editors Note:

Orthopedic surgeons often have many questions about the informed consent process. This article attempts to answer some of the less common questions.

1. Can the informed consent process play a role in patient safety?

Yes. Many misconceptions surround the informed consent process. One misconception is that its only purpose is to advance the legal rights of patients. The reality is that informed consent can play a major role in improving patient safety.

B. Sonny Bal

Lawrence H. Brenner

The informed consent process, and its reason for being, may be better understood if it is compared to the industrial safety model. Industrial safety and risk management embrace three cardinal concepts — hazard, risk and danger. Hazard is defined as a factor or series of factors that can produce an injury. Risk is the statistical likelihood that these hazards will result in injury. Danger is defined as unacceptable risk.

Operating from these definitions, industrial safety engineers have developed a principled, three-step approach to reducing or eliminating industrial injuries:

Principle One	Identify all hazards.
Principle Two	Where feasible (scientifically and economically), eliminate all hazards.
Principle Three	When all hazards cannot be eliminated, warn the ultimate user of the remaining risks.

These industrial principles may be modified and imported into a patient care model as follows:

Principle One	Prior to surgery, identify, insofar as possible, all hazards (pre-existing conditions, unusual anatomy, injuries to nerves or vascular structures, opportunity for infection, etc.)
Principle Two	Where feasible, eliminate surgical hazards.
Principle Three	Inform the patient of the unavoidable risks of surgery and the alternatives to surgical intervention.

2. Are there other ways in which the informed consent process improves patient care quality?

Yes. Studies, particularly by the psychologist Dr. Irving Janus, indicate that patients who are better informed require fewer post-surgical narcotic pain medications and have shorter lengths of stays. The longer that patients stay in the hospital, the more likely an event will occur that harms the patient. Similarly, the more medication a patient receives, the more the chances increase that there will be a medication error.

Accordingly, there is a relationship between informed consent and the reduction in patient injuries and an increase in patient care quality.

3. What risks need to be disclosed to the patient?

The law limits the obligation of the orthopedic surgeon to advise the patient only of the risks that are inherent and material to a procedure.

An inherent risk is a risk that can result in injury, even if the surgery is performed flawlessly.

Materiality is determined by two factors: the likelihood that the injury will occur and the severity of the injury that may be experienced by the patient. Another way to view material risk is to ask whether the risk of the procedure could affect the patient’s decision to undergo the procedure or to choose a less risky alternative.

4. If I fail to disclose these risks, will I automatically be held liable?

No. A patient who brings a lawsuit under the doctrine of informed consent must prove all the elements of his or her case, which include: 1) the existence of a material risk unknown to patient, 2) a failure to disclose the risk on the part of the physician, 3) that disclosure of the risk would have led a reasonable patient in the plaintiff’s position to reject the medical procedure or to choose a different course of treatment; and 4) injury (see Hidding v Williams, 578 So2d 1192, La. App. 5 Cir 1991). This burden of proof requirement imposes upon the patient an obligation to prove much more than inadequate disclosure.

To prove that he or she was damaged, the patient must also prove that had the risk been disclosed, he or she would have rejected the procedure. Obviously, if the risk had been disclosed and the patient still underwent the procedure, then the patient would have failed to establish that he or she was damaged by an inadequate consent process.

Most courts require that this cause-and-effect relationship between the failure to disclose and the injury be proven objectively, meaning that the patient must establish that a reasonable patient in the same or similar circumstances would have rejected the procedure.

5. Can I shield myself from liability from negligence and surgical mistakes by using the informed consent process to tell patients this potential exists?

No. The informed consent process is about advising patients of inherent risks, which are, by definition, unavoidable, non-negligent risks. A physician or surgeon cannot shield him or herself from liability or transfer the risk of loss to a patient by informing the patient of the potential for negligent conduct or mistakes during surgery.

6. Are there any variations on informed consent that are not well-known to orthopedic surgeons?

Yes. There are two that immediately come to mind. In one case, the court held that a woman who refused a pap smear had the right to know what risks were associated with her refusal to consent. When she developed cervical cancer, she filed a lawsuit claiming that had she known the risks of her refusal, she would have consented to the pap smear. The court found in her favor. The result was that there is a doctrine now known as informed refusal. Orthopedic surgeons should consider advising patients not only of the risks of the procedure or treatment plan, but of the risks in a patient’s refusal to undergo diagnostic testing or recommended treatment.

Second, one court held that an orthopedic surgeon was liable for not having disclosed to a patient his history of alcoholism and treatment for depression. The court also found him liable. Fortunately, the courts have not tended to follow these decisions and they represent “outliers,” but may portend more pronounced changes in the informed consent process.

7. How do you envision the future of informed consent?

The New York Times on Jan. 16, 2012 reported that the federal government will require disclosure of any benefits to physicians and surgeons received by drug and or device manufacturers. The future of informed consent may include robustly enforced provisions that the patient be aware of any potential conflict of interest.

It is also becoming increasingly clear that there is much medical uncertainty in orthopedics and other medical specialties. The assumption of the informed consent process is that the physician or surgeon is reasonably certain about the benefits of the procedure. There may be little objective evidence to support the benefit of a procedure notwithstanding the orthopedic surgeon’s well-intentioned belief that such a benefit exists. It is likely that the future of informed consent may result in the physician or surgeon discussing with a patient medical uncertainty. This, in turn, may require a new set of communication skills since a physician or surgeon’s confidence in what he or she is recommending to a patient plays an important therapeutic role in the patient’s outcome.

What do you think?

In the following case examples, what would you say to the patient?

1. A 72-year-old man who has had a revision total hip arthroplasty develops a chronic infection. The patient is fearful of further surgery, but you believe that nonoperative treatment will allow him to return to an independent lifestyle. When you recommend surgery, the patient says, “I’m scared that I’ll never walk again. Are you certain this is the right decision?”

Possible answers:

• Don’t be scared. There’s nothing to be afraid of. I’m certain this is the right decision. I’ll get you back to your old self again.
• It’s completely normal to be apprehensive before surgery. I do believe that this is the right decision, and I’ll do my best to get you back walking.
• I can certainly understand your fear. While I can’t be 100% certain of the decision, our goal is to restore you to your previous level of activity. No matter what the outcome, we’ll work through it together.

2. A 14-year-old girl has 40· thoraco-lumbar scoliosis. You recommend anterior-posterior fusion. The parents have sought other opinions and are worried about surgery of this magnitude. They ask you if you are sure that their daughter will have problems if she does not have surgery. They also ask you what you would do for your own daughter.

Possible answers:

• There’s nothing to worry about. I’ve done dozens of these operations, and I’m confident things will go well. If she doesn’t have the surgery, I’m almost certain she’ll have problems later. I sure wouldn’t wish that on my daughter.
• Surgery of this magnitude is risky, and I’d be concerned if you weren’t worried. Given her age, skeletal immaturity and current curve, I think it’s likely that she could have problems down the road. However, she could stay just as she is now with no intervention. Ultimately, it is your decision, and I’ll be here for you whichever way you choose.
• I understand and respect your concerns. I believe she needs this operation due to the high likelihood of progression and complications later in life. If it were my daughter, I’d think long and hard, as you are doing, but ultimately decide to proceed with surgery.

Join the discussion of these questions at www.OrthoMind.com.

• B. Sonny Bal, MD, JD, MBA, is an associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
• Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California, and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.