iscussions of informed consent always begin by pointing out the sea change that has occurred over the past 40 years in medical decision-making. Previous generations of physicians often made decisions for patients based upon their own perception of the patient’s best interests, often with little involvement from the patients themselves. Physicians did not regard this behavior as unethical; indeed, they felt that it would be unethical to place too much of the burden of decision-making upon the patient and family. Consistent with this approach, patients and families also were often “protected” from the harsh realities of unfavorable diagnoses and prognoses.

In the 1960s came a rebellion against authority and a renewed emphasis upon the rights and freedoms of the individual. From the civil rights movement to student protests to consumer activism, citizens demanded greater involvement and control in decisions that affected them. The patient-physician relationship was not immune from this revolution. Respect for patients’ autonomy became a defining issue for the bioethics movement and the most dominant principle in the landmark work on bioethics by Beauchamp and Childress.¹

It is beyond the scope of this essay to review the case law associated with informed consent; it suffices to say that from the late 1950s forward, courts in the United States have steadily moved toward the view that the locus of decision-making authority must reside with the patient.² There are a number of conditions that must be satisfied in order to ensure that informed consent has taken place. Essential elements of informed consent include:³

1. The nature and purpose of the diagnostic test or procedure.

2. The most significant risks of the diagnostic test or procedure.

3. The benefits of the intervention, including the chances for success, if pertinent.

4. The probable outcome of the intervention or refusal of the proposed plan.

5. Any possible alternatives to the diagnostic test or procedure.

6. The patient must be free from coercion.*

To properly satisfy these conditions, it is required that the patient have the appropriate decision-making capacity. This capacity is not of an all-or-none quality. Patients often have the capacity to consent to some things and not to others. The best example of this may be a child whom we would allow to decide whether to have an I.V. or mask induction but not whether to have a tumor resected.

When there are questions about capacity, who can decide whether the patient can give his or her own consent? Actually anesthesiologists make decisions about patients’ decisional capacities daily, though they are not always aware that they are doing it. Even though there are experts such as psychologists and neurologists who can help us, they are not usually necessary, and it is important to note that they do not necessarily possess any magical ability to determine health care decisional capacity.

There are many tools and templates that have been published to help us determine capacity — but to be helpful, a tool should allow us to assess several abilities. These abilities include:⁴

1. The ability to understand the proposed treatment and options.

2. The ability to appreciate how that information applies to the patient’s own situation.

3. The ability to reason in a manner that is supported by the facts and the patient’s own values.

4. The ability to communicate and express a choice clearly.

The easiest tool to use comes from a paper published by Annas and Densberger in 1984. They suggest asking the patient the following or similar questions:⁵

1. What is your present condition?

2. What is the treatment that is being recommended to you?

3. What do you and your surgeon think might happen to you if you decide to accept the treatment?

4. What do you and your surgeon think might happen to you if you decide not to accept the treatment?

5. What are the alternatives available (including no treatment)?

If a patient can answer these or similar questions appropriately, then he/she likely has the capacity to make his/her own decisions about surgery and anesthesia. Also of considerable value may be a discussion with the patient’s primary physician. A primary physician will probably know the patient better than you or the surgeon and can often add much to the discussion, including information about the patient’s value system.

In 2004, Ganzini, Derse, et al. reported on “Ten Myths About Decision-Making Capacity.”⁶ I refer the reader to this paper for an excellent discussion of misconceptions surrounding a patient’s capacity to decide. I would like to propose an 11th myth that is rarely, if ever, discussed in the literature: “Any patient who has just received pain medication cannot give informed consent.”

Certainly any type of medication that can affect the sensorium has the potential to adversely affect one of the essential elements of informed consent. There are, however, inconsistencies in our behavior surrounding this myth. We may allow a patient who is on a patient-controlled anesthesia pump to give consent but not allow a patient who has received a single shot of narcotics in the emergency room to give similar consent. In addition, sometimes we or the nursing staff seem to think that withholding pain medications from patients until they give consent or sign the permit will result in a more valid consent than relieving the pain first so that the risks, benefits and alternatives may be more calmly considered.

If a patient 1) can answer each of the aforementioned questions appropriately, 2) does not slur his or her speech, 3) appears to be making a decision consistent with his or her value system as best as you are able to determine and 4) agrees that the treatment is in his or her best interests, then that patient has a better capacity to consent than any surrogate who may be available. It may be unethical and coercive to withhold needed pain medication until a patient agrees to surgery rather than administer the medication first. When pain medication does not impair patients’ ability to consider their options and express their choices, it does not impair their medical decisional capacity.

What if the patient is too stuporous from medication to give appropriate consent? Who can and should be the surrogate decision maker? Incapacitation by narcotics is a very temporary situation; therefore, if the surgery is not emergent or too urgent, it is appropriate to wait until the patient is awake enough to make his or her own decision. If the surgery should not wait, then absent a durable power of attorney for health care or prior designation of a surrogate, the next of kin is usually the most appropriate person to give consent. Most states now have laws that spell out who the proper surrogate can be. In most cases, it will be a spouse, adult child or significant other. What if the surrogate is not present or it is a late-night case? Often the surgery has already been explained to the patient/surrogate and consent has been given for the surgery. General consent for anesthesia care has already been given, but still lacking is specific informed consent for the anesthetic care. In these cases, proper documentation that the surgeon has obtained general consent for anesthesia care can be referenced in a chart note written by the anesthesiologist who states that he or she is now proceeding with anesthesia care in the patient’s best interest. Of course in a true life-or-death emergency, consent to anesthesia care can always be presumed.

We all have the potential to fall prey to time constraints and production pressure on the day of surgery. Except in emergencies, taking the time necessary to help your patients develop an informed consent to their anesthetic procedures is an ethical duty of all anesthesiologists. This may motivate anesthesiologists to initiate the informed consent process with information about anesthesia care, which can be distributed at the hospital, surgeon’s office, included with a preadmission information packet that is sent to patients, on a Web site or during a patient visit on a day before the actual surgery is scheduled. ASA materials are available to support anesthesiologists for these purposes.

Patients will appreciate your efforts to respectfully inform them of appropriate anesthetic choices and prepare them for their anesthetic care. Patients will recognize that their anesthesiologist is an ethical physician who cares about them personally and is not just a hospital-based technician who performs procedures.

References:
1. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 5th ed. Oxford University Press; 2001.
2. Syllabus on Ethics. American Society of Anesthesiologists; 1999. www.ASAhq.org/publicationsAndServices/EthicsSyllabus.pdf.
3. Miller S, Marin D. Psychiatric emergencies: Assessing capacity. Emerg Med Clin North Am. 2000; 18(2):233-242.
4. Tunzi M. Can the patient decide? Evaluating patient capacity in practice. Am Fam Physician. 2001; 64(2):299-306.
5. Annas GJ, Densberger JE. Competence to refuse medical treatment: Autonomy vs. paternalism. Toledo Law Rev. 1984; 15:561-592.
6. Ganzini L, Derse AR, et al. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2004; 5(4):263-267.

James M. West, M.D., M.A., is Assistant Clinical Professor of Human Values and Ethics and Assistant Professor of Anesthesiology, University of Tennessee Health Science Center, and Staff Anesthesiologist, Methodist LeBonheur Healthcare and St. Jude Children’s Research Hospital, Medical Anesthesia Group, Memphis, Tennessee.

Susan K. Palmer, M.D., is Medical Director of Anesthesia Services, McKenzie-Willamette Medical Center, Oregon Anesthesiology Group, Springfield, Oregon.