“Are you trying to scare me away?” my patient asked as I explained to him the surgical risks involved with his ankle arthroscopy surgery and obtained his consent.
Although we had discussed these risks earlier in my office, I always like to review the plan immediately before surgery, just in case there are any additional questions. He responded that he would rather not think about the potential downsides, although he knew they existed, and we agreed that neither of us would do much flying or driving if we had to participate in an informed consent process. Yet, I persisted in obtaining consent, emphasizing that although catastrophic complications from elective arthroscopy are rare, they are unfortunately more common than airplane crashes, and because he was the only person hopping on this particular flight, he needed to not only agree to the flight plan but also know where the exit rows are in case of a crash landing.
The consent process presents unique challenges to the orthopaedic surgeon because the risks and benefits of surgeries can vary wildly, from clearly beneficial (débridement of an open fracture) to unproven or nonbeneficial (arthroscopy or platelet-rich plasma for end-stage knee osteoarthritis). Unlike many of my colleagues, I do not have a standardized or cookie-cutter consent process for all of my surgical procedures. In fact, I believe a uniform approach is misguided and doesn’t account for the variability of orthopaedic pathologies we treat. Instead, I follow a sliding scale approach to the informed consent process.
Given the confusion surrounding informed consent , it is important to understand that the primary goal of informed consent has nothing to do with obtaining a signature, rather, it is a process designed to ensure that the choices patients make match their values, so that their best interests are supported. Yet, the patient’s best interests are not always clear to the physician. In fact, the practice of informed consent was developed in response to ethical violations in medical research in which patients’ best interests were clearly violated . The practice then evolved into the informed consent process we have today, which focuses on patients’ decisional capacity, as well as their knowledge and understanding of the treatment options .
American philosophy educator, James F. Drane believes we should consider the requirements of capacity and understanding in the context of a sliding scale. Drane argues that, “(r)ather than selecting a single standard of competency, a sliding scale is suggested that requires an increasingly more stringent standard as the consequences of the patient’s decision embody more risk” . (Here, Drane uses “competency” interchangeably with “capacity”, although “capacity” is traditionally a medical ethics term whereas “competency” is a legal term, also called “legal capacity”.) In Drane’s model, the assessment of decisional capacity is based on the gravity of the medical decision being made. He proposed three standards to evaluate competency to provide informed consent [3, 4]:
- The first standard applies for medical decisions that are not considered dangerous and are objectively in patients’ best interests.
- The second standard is used for applicable treatments in which the risk-benefit balance is less clearly tipped toward benefit.
- The third standard is for what Drane termed “dangerous treatments”. Most often, this standard applies when the patient refuses a beneficial, often life-saving, intervention.
Orthopaedic surgeons should use this sliding scale model. Drane developed his model to support physicians in determining the amount of understanding required for a patient to be considered competent and, conversely, how limited a patient’s capacity must be before considered incompetent . The sliding scale model creates a mechanism for weighing and promoting a patient’s best interest, and it is particularly useful for orthopaedic surgeons, because the surgeries performed in a single day can range from life- or limb-saving (hip fracture surgery) to decidedly elective (removal of instrumentation). If a physician is counseling a patient whose treatment is life- or limb-saving, the conversation should focus on the benefits of the surgery, and although risks should be discussed, the recommendation for surgery should be clear. Conversely, when counseling a patient about risks and benefits that less clearly favor intervention, the physician must focus more on the expectations and complications to meet the requirements of both understanding and choice. Drane’s model formalizes these standards, providing philosophical support for a practice that may already be intuitive for many surgeons.
In orthopaedics, the first standard would be analogous to a Grade 2 open trimalleolar ankle fracture/dislocation in a healthy, active patient. In this case, irrigation and débridement with internal fixation is relatively easy, effective, and objectively in the patient’s best interest. In this case, Drane argues that the informed consent competency standard minimally requires awareness and assent, whether it is explicit or implied. Although common practice and hospital bylaws generally prohibit pursuing surgery without a signed consent document (except in life-threatening emergencies), this model is nevertheless useful to an orthopaedic surgeon, because the discussion with the patient should focus less on the risks of surgical intervention and instead on the risks of not having surgery.
The second standard applies when the risk-benefit balance of an intervention is not clearly understood as beneficial. In such instances, Drane suggests that both understanding and the ability to make a choice are required. This second standard applies for most elective orthopaedic surgical procedures. In the case of my patient’s ankle arthroscopy, he needed to show understanding of the risks and outcomes of the different options. Only then could he make a decision based on that understanding. Generally, patients do not want to engage with and discuss the risks of surgery. We have all had the patient who says, “I know you’re a good surgeon, so I won’t get a complication.” In these instances, I respond with the maxim, “The only surgeons without complications are retired,” and reframe the conversation by emphasizing that some complications are unavoidable, even catastrophic complications. If a patient is unable or unwilling to acknowledge the riskiness of surgery, they fail to meet the understanding standard, and any signed document would not meet an informed consent standard. Although I have yet to cancel a surgery for this reason, I would strongly advocate doing so, because it is in both the patient’s and surgeon’s interest. In fact, evidence shows that improved communication can reduce the medical liability exposure .
Drane defines the third standard as a decision that would be considered dangerous; the decision being made is against what most professionals would recommend and what the general public would choose, because another available treatment is effective. Drane defines this competency standard as requiring both appreciation (defined as critical and reflective understanding of illness and treatment) and rational decision (defined as based on relevant implications including articulated beliefs and values) . In orthopaedic surgery, for example, a patient with life-threatening anemia refusing blood products would be considered a dangerous decision. According to this model, the dangerous treatment decision should be respected, provided that the patient satisfies this most stringent standard of capacity. This standard has commonly been upheld for a Jehovah’s witness with life-threatening anemia, particularly when the patient’s family and community supports this decision. In contrast, if a patient with life-threatening anemia were to refuse blood products without appreciation and rational decision (“I want to live, but I will be fine without it”), the decision would not meet this highest of standards and therefore does not need to be respected.
In my practice—as with most orthopaedic surgeons—I rarely encounter Drane’s third standard. Instead, I approach each consent process by considering which of the first two standards is applicable. In cases that meet the first standard—safe and effective treatment is available and refusal of treatment is dangerous—I focus on educating patients on the reasons why surgery supports their best interests. I discuss alternative treatments in the context of emphasizing why I would not recommend them. If a patient is incapacitated, a surrogate decision-maker is unavailable, and a delay in surgical treatment would result in known increased mortality (like in the case of a hip fracture), I would agree with intervention on the basis of the concept of presumed consent .
For elective surgery that meets the second standard, the informed consent process begins at the first office visit when I underscore that nonoperative treatment must be pursued before any elective surgery. I discuss the risks and benefits of surgery in the office before scheduling surgery, and I provide reading material about the intervention to improve the patient’s understanding. I complete the formal signed consent on the day of surgery. I start this final step by asking patients to explain to me in their own words what we are planning to do today and what they know about the risks and benefits, as a mechanism to ensure both full understanding and capacity. After I am confident in the patient’s understanding and capacity and have the signed consent form, then it’s time for takeoff.
1. Bernstein J, LeBrun D, MacCourt D, Ahn J. Presumed consent: licenses and limits inferred from the case of geriatric hip fractures. BMC Medical Ethics. 2017;18:17.
2. Carroll AE. To be sued less, doctors should consider talking to their patients more. Available at: https://www.nytimes.com/2015/06/02/upshot/to-be-sued-less-doctors-should-talk-to-patients-more.html
. Accessed February 4, 2020.
3. Drane JF. Competency to give an informed consent: A model for making clinical assessments. JAMA. 1984;252:925-927.
4. Drane JF. The many faces of competency. The Hastings Center Report. 1985;15:17-21.
5. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York, NY: Oxford University Press. 1986.
6. Jonsen AR. The Birth of Bioethics. New York, NY: Oxford University Press. 2003.
7. Meisel A, Kuczewski M. Legal and ethical myths about informed consent. Arch Intern Med.