The informed consent process is an excellent time to engage patients. Ideally, an informed consent to treatment is the end result of a shared decision making process between a clinician and patient. This process, when executed appropriately, can have many benefits. It can decrease liability exposure, increase patient adherence, protect the patient’s right to self-determination and increase patient satisfaction.1
During shared decision making (SDM), the patient weighs the risks, benefits, and alternatives against their preferences and values in collaboration with the clinician. The process is frequently facilitated by the use of decision aids, which are designed to help the patient understand the risks, benefits, and alternatives (RBA) of the proposed treatment.1 In SDM, the physician is responsible for aligning the risks, benefits, and alternatives with the patient’s values and preferences.2 Because SDM strengthens the therapeutic alliance, it can also help the surgeon and patient work through treatment complications.1
Unfortunately, many surgeons (and other physicians) regard the informed consent process as one of many administrative tasks — an authorization to perform surgery. For these clinicians, informed consent is completed with little or no input from the patient and little effort to determine whether the patient has understood or retained any of the risks, benefits, or alternatives.3 When informed consent is only an authorization for treatment, it does not satisfy legal and ethical informed consent requirements4 and does little to engage the patient in their healthcare, which is unfortunate, because the period leading up to the patient’s consent to undergo surgery is ideal for rapport building.
Patients and surgeons can fall victim to overly optimistic expectations.5 Frequently, patients undergoing surgical procedures have a difficult time understanding that adverse outcomes are not necessarily the result of negligence. It is the surgeon’s job to help the patient understand that uncertain outcomes are an inherent aspect of surgery. When a patient doesn’t adequately understand the degree of risk and weigh the possibility of an unexpected outcome against the benefits of undergoing a proposed surgery, an unexpected adverse outcome is more likely to result in anger and frustration, which is more likely to prompt litigation.
The following case involves a patient who was desperate for relief of chronic pain. Consider how her response to the unsuccessful outcome might have been different if she had truly understood that pain relief was not a guaranteed outcome of surgery. Consider also how the defense of the surgeon might have been facilitated by appropriately documented shared decision making.
Because the surgeon failed to address the potential for chronic pain following surgery, the patient did not give an informed consent.
More Information About Patient Engagement Along the Continuum of Care
- Overview: Patient Engagement Along the Continuum of Care: Case Studies and Best Practices
- Closed Claim Case Study: Poor Patient Activation Leads to Claim of Inadequate Discharge Instructions
- Closed Claim Case Study: Poor Patient Activation Leads to Claim of Negligent Disease Management
A 45-year-old woman was referred to a general surgeon for the repair of a small inguinal hernia with surgical mesh. The patient had been suffering from long-term chronic pelvic pain. Hernia repair was proposed for pain relief. The surgeon presented the risks, benefits, and alternatives of the procedure as three options:
- Doing nothing
- Doing a laparoscopic hernia repair
- Doing an open procedure
He explained that an open procedure had a lower hernia recurrence rate, but a longer recovery period, a higher infection rate, and greater postoperative pain potential than a laparoscopic procedure. For these reasons, the patient chose the laparoscopic option. The surgeon did not document the discussion with the patient in the medical record other than to note “RBA discussed.” He did not use an informed consent form.
The hernia repair was completed with no apparent complications. However, the patient’s pain gradually became worse than it had been before the hernia repair. The mesh was eventually removed, but the patient’s pain continued at the same level. The patient filed a malpractice lawsuit against the surgeon, which included a claim for lack of informed consent.
Defense experts believed there was no surgical malpractice. They believed the patient was one of a small percentage of patients who develop chronic post-hernia surgery pain. The plaintiff’s experts had various criticisms of the surgery, including the use of mesh, the mesh weight and position, method of attachment and apparent lack of consideration for the surrounding nerves. They questioned whether the surgery was necessary, as the hernia was small and possibly unrelated to the patient’s chronic pelvic pain. The plaintiff’s experts also believed the patient should have been informed of the potential for chronic pain and should have been offered a non-mesh surgical alternative.
Although the defense team felt the technical aspects of the surgery were defensible, they believed defending the lack of informed consent claim would be complicated by a number of issues. For example, the patient convincingly testified in deposition that she was not informed of the risk of increased pain, particularly because of her preexisting chronic pelvic pain. She denied receiving any information about the materials (e.g., mesh and tacks) that would be used in her surgery. She was encouraged by the surgeon’s description of the laparoscopic procedure as “simple” and further by his assertion that her recovery would take three to five days. She claimed she would have forgone surgery if she had known it might result in worse pain.
Unfortunately, the surgeon had no memory of the patient. Because his documentation of the informed consent process was very limited, his testimony was limited to what his general practice was for obtaining an informed consent for hernia repair. The surgeon’s limited proof of an informed consent process was expected to be used against him at trial.
Medical Liability Risk Management Recommendations
The following recommendations include the U.S. Department of Health & Human Services Agency for Healthcare Research and Quality (AHRQ) Essential Steps of Shared Decision Making, known as the SHARE Approach. An expanded discussion of the SHARE Approach, including conversation starters, is available on the AHRQ website, as is a shorter “Quick Reference Guide.” Specialty society websites also offer disease-specific patient education materials and consent information.
Consider using the following strategies during the informed consent process:1,5,6,7
- Include shared decision making strategies in your informed consent policies and procedures. Emphasize the importance of the patient’s participation in decision making.
- Help your patient express what matters most to them (e.g., recovery time, cost, pain relief, functionality level, etc.)
- Patients with very low patient activation levels may find shared decision making difficult or impossible. These patients may need extra help to prepare for shared decision making.
- Help your patient express what matters most to them (e.g., recovery time, cost, pain relief, functionality level, etc.)
- Acknowledge and agree on what is important to your patient.
- Tell the patient about the options.
- Assess what your patient already knows about the options.
- Inform the patient about the benefits and risks of non-surgical options and surgical options utilizing different techniques and materials and the likely success of these alternatives.
- Write down the options for the patient and describe them in plain language.
- Be supportive, but present risks realistically. Inform the patient about how unintended outcomes can affect quality of life.
- Utilize evidence-based educational materials to facilitate patient comprehension of the risks, benefits and alternatives to proposed treatment.
- Provide materials written at about a sixth-grade level.
- Present numbers in an understandable way by using graphs, charts and pictographs.
- Create your own educational materials. For example, sketch the surgery with simple notes of the various risks, benefits, and alternatives; scan the page into the electronic record and give the sketch to the patient. Not only does this personalize the consent process, it can help patients explain their upcoming surgery to family members.
- Review educational materials with patients.
- Circle or highlight the most important points as you talk about them.
- Personalize the material by adding the patient’s name, medications, and specific care instructions as appropriate.
- When a patient appears to be having difficulty grasping concepts during the informed consent process:
- Slow down. Speaking more slowly can give a struggling patient a greater opportunity to understand not only the words, but also the implications of what is being said.
- Use meaningful language. For example, instead of describing a procedure as “complex and challenging,” describe what makes it so – scar tissue, previous surgeries, anatomy that may be different from the norm, the extent of the patient’s disease, etc.
- Cluster related concepts. After presenting a cluster, pause, interact, and confirm patient understanding.
- See Patient Engagement Along the Continuum of Care: Case Studies and Best Practices for a discussion of this “teach-back” method.
- Use examples that put things into the context of everyday life. For example, explain how nerve damage could affect driving a car, exercising, or work-related activities.
- Use pictures and models, particularly if a patient struggles with reading comprehension.
- Include the patient’s family or caregivers in the informed consent process when appropriate.
- Give patients a copy of the consent form, pictures, diagrams, and educational written materials to take home.
- Emphasize the importance of the materials by referring to them during follow-up.
Informed Consent Documentation
Informed consent litigation usually pits the memory of the patient against the documentation of the clinician. Clinicians often cannot recall informed consent details and must prove that an appropriate informed consent occurred based on a generic informed consent form in the patient’s record and testimony about their standard practice. Additional documentation in the medical record increases the defensibility of the claim.
Consider including the following in the patient’s record in addition to the consent form:
- Confirmation that the informed consent discussion took place and that the patient either consented or did not consent to the procedure.
- A patient’s refusal of any treatment should be documented in the medical record, and the patient should be asked to sign a refusal of treatment form.
- Notation of the specific questions the patient had about the procedure, how the questions were answered, and any other issues that received special emphasis during the shared decision making process.
- Copies of written material given to the patient, including educational handouts and information sheets.
- Educational materials, even if no longer in use, can be a valuable defense tool in the event of litigation.
- Descriptions of DVDs, websites, and other electronic materials used during the educational process.
- Notation of the patient’s language, if not English, and the name and relationship of the translator or other steps taken to facilitate communication, if applicable.
Documentation of the informed consent process, including shared decision making and efforts to ensure patient comprehension can also be used as a guide for providers in post-surgical discussions about an unintended outcome. For example, the informed consent notes in the medical record can be used as a reference in a discussion with a patient that might start, “Do you remember when we discussed that a risk of ACL reconstruction is nerve damage? Unfortunately, during the procedure it happened. This is what we need to do...”
If an appropriate shared decision making process had been documented in the foregoing case, the surgeon could have gone back to the informed consent documentation to gently remind the patient that she was informed of the risk of post-surgical chronic pain and she was willing to take that risk.
1. Page AE. “Safety in Surgery: The Role of Shared Decision-Making.” Patient Safety in Surgery. 2015; 9:24. (accessed 9/18/2018)
2. Julia James. “Health Policy Brief: Patient Engagement.” Health Affairs. February 14, 2013. (accessed 9/18/2018)
3. Durand MA, Moulton B, Cockle E, Mann M, Elwyn G. “Can Shared Decision-Making Reduce Medical Malpractice Litigation? A Systematic Review.” BMC Health Services Research. 2015;15:167. (accessed 9/18/2018)
4. Eyal N. “Informed Consent.” The Stanford Encyclopedia of Philosophy. Fall 2012. Edward N. Zalta (ed.). (accessed 9/18/2018)
5. Hostetter M, Klein S. “Helping Patients Make Better Treatment Choices with Decision Aids.” Oct/Nov 2012. Quality Matters. (accessed 9/18/2018)
6. Agency for Healthcare Research and Quality (AHRQ). “The SHARE Approach—Essential Steps of Shared Decision Making: Expanded Reference Guide with Sample Conversation Starters.” July 2014. (accessed 9/18/2018)
7. Grady CC. “Enduring and Emerging Challenges of Informed Consent.” NEJM. 2015; 372(9):855-862. (accessed 9/18/2018)
Agency for Healthcare Research and Quality (AHRQ). “The SHARE Approach—Essential Steps of Shared Decisionmaking: Quick Reference Guide.” July 2014. (accessed 9/18/2018)