Case Study
Informed Consent Is More than Just a Signature
Key Lesson
Improved communication of information to patients and families enhances their trust.
Description
Although a patient signed an informed consent for an elective blepharoplasty, they were left dissatisfied after experiencing scarring and needing surgical revision—both known risks of the procedure.
Clinical Sequence
A 57-year-old female elected to have a facelift and upper and lower blepharoplasty (a surgical procedure that corrects or improves the appearance of the eyelids). Prior to the facelift and upper blepharoplasty, the patient reviewed the information sheet as well as the consent form, which listed scarring and need for revision as possible risks of the procedure. The physician documented that the patient “understands risks and recovery time of a facelift.” The procedure was completed without incident.
Two weeks after the initial facelift and upper blepharoplasty was completed, the physician completed the lower blepharoplasty. Again, the patient signed a consent form that listed scarring and the need for revision as possible risks. The physician did not, however, document that the risks were discussed verbally with the patient. The patient alleged these risks were not reviewed or discussed verbally. Per the physician, because of the condition of the patient’s skin, incisions were made lower than is typical. This resulted in prominent scarring below the patient’s eyes and a need for a revision.
Allegation
The patient alleged that the risks of scarring or the need for surgical revision were not clearly or thoroughly reviewed prior to the surgery.
Disposition
The case was settled in the low range.
Clinical Analysis
Ensuring a complete understanding of risks, benefits, and alternatives of a procedure by the patient and/or family is imperative prior to surgery.
Informed consent should be promoted as a process of clear communication between patients and providers and not just a signature on a form. Improved communication of information to patients and families enhances their trust—even in situations where a patient has experienced harm or known complication.
Effective provider communication and shared decision-making have been shown to improve the adequacy of the informed consent process. Some ways to enhance the informed consent process include:
- Limiting the use of medical jargon when explaining the procedure to patients
- Utilizing interactive media or other decision aids to communicate the risks, benefits, and alternatives
- Addressing any language or cultural barriers and ensuring the patient has the appropriate communication resources
- Using the “teach-back” method by having the patient repeat back the understanding of the information provided
(See Reference #1 below for additional information)
Discussion Questions
- What best practices does your organization utilize related to informed consent and shared decision making?
- How are clinicians trained to ensure patient understanding of risks, benefits, and alternatives?
- Is there an opportunity to utilize simulation training for clinicians on how to complete informed consent?
Resources
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