Orthopedics: Informed Consent

Robert Morton, CPHRM, CPPS, Assistant Vice President, Department of Patient Safety and Risk Management, and Dana Faber, MS PSL, RN, Senior Patient Safety Risk Manager, Department of Patient Safety and Risk Management

Our closed claims analyses have identified inadequate informed consent communication between the surgeon and the patient or family as a top contributing factor in claims against orthopedists. An effective informed consent discussion requires an open dialogue that affords the patient an opportunity to ask questions and voice concerns. It benefits the patient and the surgeon and can mitigate the risk of a malpractice claim.

Communication Techniques

Good communication considers the patient’s needs and priorities when discussing healthcare options. Implement the following communication techniques to achieve a patient-centered informed consent:

• Consider the patient’s culture, education, lifestyle, and personal preferences.
• Use terminology that the patient can easily understand.
• Use visual aids, such as brochures, anatomical models, and video demonstrations.
• Ask the patient what he or she wants from the treatment as you discuss management strategies. Allow the patient to express concerns.
• Clarify your understanding by restating the patient’s needs. This will also validate the information and help you adapt the treatment plan accordingly.
• Ask the patient to explain his or her understanding of the agreed-upon treatment plan, any procedures, and the expected results.
• Invite the patient’s questions by asking, “What questions do you have?”
• Include the family or support person in the discussion when possible.
• Follow up with a phone call the day before surgery.

Partner for Shared Understanding

It is critical to establish patient understanding to ensure valid disclosure and patient consent:

• Facilitate a dialogue that elicits the patient’s expectations for a good outcome. Ask the patient, “What does a good outcome look like for you?”
• Make sure that expectations—the patient’s and yours—are well aligned. Accomplish this by discussing the expected benefits of a surgical outcome, such as decreased pain and improved mobility, as well as any limitations. For example, even with a good outcome, the patient’s knee might not be able to bend as before. This discussion is in addition to disclosing the procedure’s inherent and material risks, benefits, and alternatives—and the risks of doing nothing (refusal).

Complete Disclosure

Patients may feel betrayed if an unexpected complication or adverse outcome occurs and it was not disclosed or was inadequately addressed. In claims against orthopedists, the most common patient injuries are infection, pain, malunion/nonunion, nerve damage, and death. A complete disclosure informs the patient about these risks (and other risks), how they might occur, and what actions the patient and surgical team can take to reduce risks.

• Make no guarantees. During the informed consent process, it is prudent to discuss the most serious risks of the procedure, even when the likelihood is relatively low. If a complication occurs, the patient and family are less likely to view it as the result of negligence.
• Avoid exaggerating reassurances that a particular complication should or will not occur. If a complication is encountered, a previous complete and honest conversation with the patient/family can be recounted for a shared understanding of the situation.

Use Consent Forms Specific to Your Practice

It is a best practice to document the patient’s record with a detailed note outlining the discussion of the risks, benefits, and alternatives at the time the patient makes the decision to have the procedure. If the patient’s decision is made while in your office, have the patient sign a procedure- and practice-specific consent form printed on your own letterhead.

Check your state requirements and comply with all state laws and regulations. Some states may impose additional informed consent obligations. If the procedure is to be performed in a facility, that facility may require its own form to be completed. Be aware that the facility form might not satisfy state requirements for physicians or your practice protocols.

Although the informed consent doctrine remains dynamic, building a skillset that is patient centered in the orthopedic specialty will enhance the therapeutic relationship while mitigating risk in the informed consent process.

For additional information, see our articles “Informed Consent: Substance and Signature,” “Informed Refusal,” and “Obtaining Informed Consent in Teaching Institutions.” Our patient safety risk managers can also answer questions and provide specific requirements and best practices recommended by each state. Contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.