Consent and Capacity

Curricular Objectives

1. To know the ethical, legal and policy justifications for consent, and the elements of consent
2. To be able to negotiatie a refusal of life-sustaining treatment

Summary of Case

Albert Whiteside is a 70 year old retired journeyman electrician suffering from gangrene in the right foot and lower leg. The patient originally agreed to amputation of the leg, but on the morning scheduled for the operation he refused to give consent. He was discharged and went to stay with his daughter; three days later he has returned to the hospital. The surgery resident has spoken to Mr. Whiteside, explaining the diagnosis, prognosis with and without intervention, and the risks and benefits of surgery. The patient seems to understand, but continues to refuse to have the operation even though this decision will in all likelihood lead shortly to his death.

Mr. Whiteside's wife died 2 years ago. He has 4 children, a daughter aged 43, and 3 sons aged 41, 38, and 34. He has been somewhat depressed since his wife's death, and his relationship with his children is marked by a considerable degree of conflict. Until 6 months ago he lived independently in his own bungalow.

Three years ago an infected toe on his right foot became gangrenous and was amputated; at that time he was diagnosed as diabetic. Last year, a bruise on his right leg developed into gangrene and a portion of his right foot was amputated; an arterial bypass was done to decrease the likelihood that gangrene would recur. The following 5 months were spent in a rehabilitation centre. Last week gangrene was found in the remainder of the foot, and he returned to the hospital.

Mr. Whiteside does not wish to be a burden to his children or to live as an invalid in a nursing home. He believes that the operation will not cure him, and that death is preferable to losing his leg and his independence.

Lesson Plan

Points that should be covered include: * Why the patient does not want the operation

• The patient's mental/emotional state (Is he depressed or suicidal?)
• Accurate information about the leg problem and the planned treatment
• Information about prosthetic limbs following surgery
• Ascertain that the patient clearly understands the consequences of his decision (he may die without amputation)
• The views of other involved persons (e.g., family) should be explored
  The patient's decision should be respected and the patient's right to make the decision should be affirmed. The issue of other life sustaining therapies, for example, antibiotics, CPR, should be discussed. The patient should be told that he can change his mind but only up to a point after which the decision becomes irreversible.

Answer:
The patient definitely has a right to refuse treatment grounded in autonomy and codified in the Charter of Rights. Take a pedagogic vote. Does the patient have a right to refuse? Yes, No, Don't know. Do we have an obligation to treat despite the patient's refusal if he is incapable? Yes, No, Don't know. Is this a real world situation? Do you face similar situations? Give examples. This offers an opportunity for residents to talk about variations on this problem they face.

Answer:
This question offers an opportunity to discuss what actually happens in the practice of a resident surgeon. Is the consent negotiated by the staff and merely certified by the residents? What is their sense of the ethical transaction they participate in when they bring in the consent form to the patient's bedside? How should it be done?

Answer:

1. Capacity: The patient must be able to understand the benefits and burdens of the proposed treatment and the effects of not treating.
2. Voluntariness: The patient must not be coerced (the examples: discuss residents as research subjects, living related donors and the coercive force of all the residents and staff who are trying to get this patient to accept amputation in this exercise).
3. Disclosure: To be informed enough to give consent.

Answer:
Most patients who agree with the treatments recommended by doctors are judged to be capable. It is only when they refuse treatment that the psychiatrist is called. A remarkable number of patients have reduced or inadequate capacity to consent to treatments. A very short, simple series of questions is reliable for determining capacity. "Tell me, in your own words, what you decided and why" is the shortest form of this interview. A more accurate way to ascertain capacity is to ask: * What is the main problem?

• What is the treatment offered?
• What are the risks of treatment and non-treatment?
• What are the benefits of treatment and non-treatment?
• What have you decided and why?

Following completion of this exchange, the physician should write a note in the chart stating "the patient has explained that he does not want surgery because..."

Bioethics Bottom Line

CONSENT TO TREATMENT OF CAPABLE PERSONS

Physicians should seek consent before providing diagnostic tests or treatment because capable adults have the right to choose or refuse diagnostic tests or treatment. This right is grounded in the ethical principle of respect for patient autonomy and the legal doctrine of informed consent. It includes the right to forego (not start or stop) life-sustaining treatments such as cardiopulmonary resuscitation, mechanical ventilation, dialysis, antibiotics, and artificial nutrition and hydration, even if this decision results in the patient's death. The elements of consent include (1) disclosure, (2) capacity, and (3) voluntariness. Disclosure is discussed separately in the next module.

Capacity: Capacity can be defined as the ability to understand and appreciate the consequences of a particular decision or lack of decision. Unfortunately, there are no widely available clinical measures to assess patient capacity in practice. A proposed set of questions physicians can use to assess patient capacity follow:

• What is your main medical problem right now?
• What treatment/diagnostic test has been proposed?
• What are the risks of having this treatment/diagnostic test?
• What have you decided about whether or not to have this treatment/diagnostic test, and why have you made this decision?

If there is doubt about the assessment, consultation from a psychiatrist, hospital attorney, or ethicist may be helpful. In cases of conflict, the ultimate judge of a patient's capacity is court. If the patient is incapable, the physician should seek consent from the appropriate substitute decision maker.

Voluntariness: Patients should be able to make treatment choices without undue external coercion. Sources of coercion might be the patient's family in situations requiring a patient to participate in donation of an organ to a relative, genetic testing in a family study, or in tests or treatments related to employment, military service or status as a resident or student.

CONSENT TO TREATMENT OF INCAPABLE PERSONS

In theory, incompetent patients have the same right to consent to diagnostic tests or treatment as competent patients. In practice, however, incompetent patients cannot exercise this right. To address this paradox, policy makers, judges and legislators have developed a system known as substitute decision making to permit others to exercise the incompetent person's right to consent on his/her behalf. Substitute decision making poses two main Questions: Who should make the decision for the incompetent person and how should the decision be made? The appropriate Answer to these Questions varies from one jurisdiction to another and physicians are encouraged to gain familiarity with the legal standards in their place of practice. However, the overall goal of substitute decision making is to approximate the decision the patient would make if he/she were competent to do so.

With regard to who should make decisions, the most appropriate person is someone appointed by the patient him/herself, while competent, through a proxy advance directive. Other substitute decision makers, in their usual order of priority, include a court-appointed guardian, spouse, child or parent, brother or sister, any other relative or concerned friend. In some jurisdictions, a public official will serve as substitute decision maker for a patient who has no substitute decision maker available.

The standards for how the decision should be made, in decreasing order of priority, are wishes, values and beliefs, and best interests. Wishes are prior expressions by the patient, while competent, that seem to apply to the actual decision that needs to be made. Sometimes patients will have recorded their wishes in an instruction advance directive. Values and beliefs are less specific than wishes but they allow the substitute decision maker to impute what the patient would have decided based on other choices the patient made in his/her life and the patient's approach to life in general. Best interests are "objective" estimates of the benefits and burdens of treatment to the patient.

The preferred answer to both the "who" and "how" questions of substitute decision making is advance directive. An advance directive is a written document containing a person's wishes about life-sustaining treatment. The person makes the advance directive when competent, and the directive takes effect if the person becomes incompetent. The two types of advance directives are proxy directives, which state who a person wants to make treatment decisions on his/her behalf, and instruction directives, which state what treatments the person would and would not want in various situations. Ideally, proxy and instruction advance directives should be combined. At present, there is legislation supporting advance directive in British Columbia, Manitoba, Nova Scotia, Ontario and Quebec. Many different advance directive forms are available. The development and evaluation of advance directives is an area of active empirical research.

CONSENT IN EMERGENCIES

A true emergency is an exception to the usual requirement to obtain informed consent. The rationale for this exception is that a reasonable person would normally consent to the treatment and that the delay necessary to obtain consent would have adverse consequences for the patient. This justification is grounded in the ethical principle of beneficence.

In some jurisdictions, the limits of the emergency exception to informed consent have been recently articulated. If the physician knows that a particular patient would not want treatment in the situation that has arisen, for example, because the patient has stated this in an advance directive, then the physician should not provide treatment. The justification for this limit to the emergency exception to the usual requirement for informed consent is that the particular patient does not hold the same views as the mythical "reasonable person". Examples might include a limit on the acceptance of blood transfusion or ventilation.

References

Etchells E, Sharpe G, Walsh P, Williams J, Singer PA. Bioethics for clinicians: 1. Consent. CMAJ 1996; 155: 177-80.

Etchells E, Sharpe G, Elliott C, Singer PA. Bioethics for clinicians: 3. Capacity. CMAJ 1996; 155: 657-64.

Etchells E, Sharpe G, Dykman MJ, Meslin E, Singer PA. Bioethics for clinicians: 4. Voluntariness. CMAJ 1996; 155: 1083-6.

Teaching Aid: Standardized Patient Case

The case is presented and a negotiation is initiated by the designated resident. It is helpful to take "timeouts" to allow other residents to come forward and talk to the patient. Always have them do this "in character" as the negotiating resident.

Instructions to resident
You are about to see Albert Whiteside. Mr. Whiteside was diagnosed as a diabetic 3 years ago. He is suffering from gangrene in the right foot and lower leg. A week ago it was recommended that his leg be amputated (below the knee) without delay. At first Mr. Whiteside agreed to the amputation. On the morning scheduled for the operation, he refused to give consent. He left the hospital to stay with his daughter for a few days, but now he is back in hospital.

Earlier today, the intern spoke to Mr. Whiteside and fully explained the diagnosis, prognosis with and without intervention, and the risks and benefits of operating and the patient seemed to understand. However, he refused to consent to the operation even though that decision will in all likelihood lead shortly to his death.

You are the resident currently in charge of his care. Your staff person has asked you to speak to Mr. Whiteside about having the operation.

Instructions to Standardized Patient
Your name is Albert Whiteside. You are a 70 year old widower. Your wife of 44 years died 2 years ago. You have 3 sons aged 34, 38, 41, and a daughter aged 43. You are a retired journeyman electrician. You lived in your own bungalow in East York until 6 months ago. You have been depressed and unhappy since your wife died. Your relationship with your children is marked by a considerable degree of conflict.

You are currently hospitalized with gangrene in your right foot and lower leg. Problems with your foot started three years ago, when you had an infection in a toe on your right foot which became gangrenous. It was discovered at that time that you were diabetic. The toe was amputated. Last year, you bruised your right leg while getting into a bus. The bruise developed into gangrene which resulted in an operation 6 months ago I which a portion of your right foot was amputated. At that time, an arterial bypass was done to decrease the likelihood that gangrene would recur. You went from the hospital to a rehabilitation centre, where you remained for 5 months. It was found that you had gangrene in the remainder of the foot and you were returned to the hospital last week.

You originally agreed to amputation of the leg, but you withdrew you consent on the morning scheduled for the operation. You were discharged and went to your daughter's home. After 3 days, you returned to the hospital.

You have discussed with some people the reasons for your decision: you have been unhappy since the death of your wife; you do not wish to be a burden to your children; you do not believe that the operation will cure; you do not wish to live as an invalid or in a nursing home; you do not fear death (but welcome it as better than losing your leg and your independence).

You are discouraged by the failure of the earlier operation to stop the advance of the gangrene. You want to get well but are also resigned to death and are adamantly against the operation. Although a quiet and somewhat stoic person, you tend to be stubborn and somewhat irascible (especially when pressured). You are hostile to certain doctors. You are on occasion defensive and sometimes combative in your responses to questioning.

You are lucid on some matters and confused on others. Your train of thought sometimes wanders. Your conception of time is distorted. You do however exhibit a high degree of awareness and acuity when responding to questions concerning the proposed operation. You have made it clear that you do not wish to have the operation even though that decision will in all likelihood lead shortly to your death. You face the prospect of death with a despairing resignation as preferable to living as an invalid or in a nursing home.

You do not want to give the impression that you are deeply depressed. If asked, you might say: "There's nothing wrong with my spirits."

Timeline of events:

Prompts are used to standardize the scenario and give all candidates an opportunity to address relevant issues.

PROMPT 1 (immediately)
"What do you want?"

PROMPT 2 (by 1-2 minutes)
"I don't want any operation."

PROMPT 3 (by 3-4 minutes)
"It's my decision isn't it? Can you do anything without my consent?"

PROMPT 4 (by 5-6 minutes)
"Are you going to do the surgery?"

PROMPT 5 (by 7-8 minutes)
"What's going to happen to me?"