181108 - ETHICAL ISSUES: TREATMENT CONSENT / REFUSAL OF TREATMENT: PATIENT AUTONOMY

Presentation at a “Residents’ Ethics Training Program” held in Madinah al Munawwarah on November 8, 2018 by Professor Dr. Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City

 

 

LEARNING OBJECTIVES FOR CONSENT TO TREATMENT:

By the end of this lecture, the student will be able to:

1. Define the concept of autonomy and appreciate that it is the basis for consent OR Recognize the importance of patient autonomy in the decision-making process.

2. Define the informed consent and list its components.

3. Describe the scope of consent in terms of coverage and time and what to do in an emergency situation necessitating life-saving procedures beyond the original consent.

4. Understand how consent protects the interests of both the patient and the physician.

5. Describe in detail the process of obtaining consent from a patient.

6. Define the concepts of competence / capacity and how it is assessed in the patient OR Describe the concept of “rational adult” in the context of patient autonomy and treatment refusal.

7. Describe the consent process for the incompetent using proxy / substitute decision makers and advance directives.

8. Describe ethico-legal procedures in consenting for children, the mentally impaired, and the unconscious.

9. Describe consent procedures in emergency situations in which it is not possible to get consent from the patient and there are no substitute decision makers.

 

LEARNING OBJECTIVES REFUSAL OF CONSENT:

· Predict situations where a patient or family is likely to decline prescribed treatment.

· Analyze key ethical, moral, and regulatory dilemmas in treatment refusal.

  

AUTONOMY:

· Autonomy is the innate human right of a patient to control access to his body and what is done to him or her.

· It involves the right to choose who treats him, where he is treated, and what treatment to use.

· It also involved authorization of the treatment.

· It is not enough for the patient to consent to a course of treatment, he must actually authorize the physician to go ahead with the chosen treatment.

 

CONSENT:

· Consent is a decision of a competent patient to accept the medical procedures proposed.

· The patient has a right to refuse the treatment proposed.

· Both consent and refusal must be informed i.e based on full disclosure of the details of the proposed treatment including its benefits and risks.

· Children with some degree of competence can assent to treatment which signifies their agreement with what their parents, the legal decision makers, have decided.

· Parents may assent to the decision of a fully competent post pubertal child who is below the age of majority, currently 18 years in Saudi Arabia.

· Consent protects both the patient and the physician.

 

AGE OF MAJORITY:

· The age of majority is when an age above which a patient is individual is responsible for all medical decisions if fully competent.

· According to existing regulations in Saudi Arabia this age is 18 years for both males and females.

· The age 7 is considered the age of discrimination, sinn al tamyiiz, after which a child can make some decisions.

· At puberty a person becomes mukallaf being fully responsible for fulfilling all religious obligations.

 

COMPETENCE:

· Competence, ahliyyat, is intellectual capacity to understand, analyze, and judge information.

· The main component or competence is intellectual competence but other factors such as the emotional and psychological factors have their contribution.

· Children and adults have attain capacity at different ages and some never become fully competent intellectually. A consensus was therefore reached about the average age at which most people should be considered competent.

· At the beginning attaining puberty was used as a mark of competence. Later it was realized that many post pubertal children were not competent decision makers and the age of 18 was adopted.

· Another term used for competence is capacity.

 

PATERNALISM:

· Paternalism is a negative attitude that was common among physicians and has now almost disappeared.

· The paternalistic physician assumes that he knows what is best for the patient and should make treatment decisions without reference to the patient.

· Paternalism is violation of the patient’s autonomy rights.

 

MEDICAL DECISION-MAKING:

· Medical decision making is a joint process involving the physicians and the patient regarding treatment choice.

· It should be a rational process based on consideration of facts but in the end the final word is with the patient.

· The patient’s decision will stand even if it is considered irrational by the physicians.

 

ADVANCE TREATMENT DIRECTIVES:

· Advance treatment directives are instructions on treatment or its withdrawal made by a competent patient to be applied when competence is lost.

· Such directives are best made in writing and with witnesses.

 

SUBSTITUTE/PROXY DECISION MAKER:

· Substitute/proxy decision maker is the person who is authorized to make decisions on behalf of a patient who does not have the intellectual competence to decide for him or herself.

· Best interest standard is the criterion used to judge decisions by physicians and decisions of substitute decision makers. These decisions must be in the best interests of the patient.

 

SCOPE & LIMITATIONS OF CONSENT:

· A patient has a right to make autonomous decisions regarding any medical procedures on his or her body. This includes decisions to allow health professionals to take history, to carry out physical examinations, and to undertake any curative or preventive medical procedures.

· Permission to undertake medical procedures has to specify the part of the body and the type of procedure to be carried out and within a specified time period. The medical professional can go beyond these limits only by getting new permission from the patient.

· In addition it is part of the patient’s autonomous rights to decide which profession can treat him. The patient has a right to reject any professional and procedure without having to give a reason. The patient also retains the right to withdraw the permission at any time and without being required to explain why.

· Consent is limited in time. Consent given in one admission will have to be repeated on re-admission.

· If a long time elapses, consent needs to be repeated because circumstances might have changed.

 

THE PROCESS OF INFORMED CONSENT:

· Informed consent is one following full disclosure of all medical facts related to the disease and the intervention such that the patient makes a decision based on full understanding of all the facts.

· The disclosure should include explanation of the diagnosis as much is possible to a lay patient, explanation of the intended procedure in non-technical terms, disclosure of all known side effects and benefits of the procedure.

· To enable the patient make an informed decision, alternative procedures and treatments with their benefits and side effects should also be disclosed.

· The financial cost of the procedure should also be disclosed but preferably at a later stage because it could unduly influence patient decision.

 

CAPACITY/COMPETENCE TO CONSENT:

· For informed consent to be legally valid, the patient making the decision must be judged to be legally competent in other words to have the capacity for decision making.

· Competence is judged by intellectual ability to understand, retain, and judge information. Children below the age of majority are considered not competent.

· A normal adult is judged legally competent unless there is reason to suspect otherwise. If there is such a suspicion or of the nature if the disease affects mental ability specific tests if competence should be carried out.

· In simple cases a physician caring for the patient can test for competence by asking simple questions about the name and address, orientation in time and place, understanding and retaining information, and making judgments.

· In more complicated cases, a clinical psychologist may be invited to test for competence in a formal way.

· The testing for competence should be recorded clearly in the patient’s chart. The record should preferably include the items used for testing.

 

PROXY CONSENT / SUBSTITUTE DECISION-MAKER:

· A patient judged legally incompetent cannot make decisions regarding his or her treatment. A proxy or substitute decision maker must be found.

· The proxy or substitute is usually a member of the family. If family members are not available other proxies may be used.

· Problems arise when there is disagreement among family members and the physicians do not know who to listen to. If the patient had indicated at the time of admission which family member would represent him then we follow the patient’s wishes.

· If the patient did not indicate the father according to Saudi custom has the right to decide. In some cases the father will be the decision maker even if the patient had designated someone else.

 

CONSENT AND REFUSAL OF TREATMENT FOR COMPETENT ADULTS - 1:

· The patient must be free and capable of giving informed consent.

· Informed consent requires disclosure by the physician, understanding by the patient, voluntariness of the decision, legal competence of the patient, explanation of all alternatives, recommendation of the physician on the best course of action, decision by the patient, and authorization by the patient to carry out the procedures.

· Consent is limited to what was explained to the patient except in an emergency.

· Physician assisted suicide, active euthanasia, and voluntary euthanasia are illegal even if the patient consented.

 

CONSENT AND REFUSAL OF TREATMENT FOR COMPETENT ADULTS - 2:

· Refusal to consent must be an informed refusal (patient understands what he is doing).

· Refusal to consent by a competent adult even if irrational is conclusive and treatment can only be given by permission of the court.

· Doubts about consent are resolved in favor of preserving life.

 

CONSENT OR REFUSAL FOR MENTAL PATIENT:

· Mental patients cannot consent to treatment, research, or sterilization because of their intellectual incompetence.

· They are admitted, detained, and treated voluntarily or involuntarily for their own benefit, in emergencies, for purposes of assessment, if they are a danger to themselves, or on a court order.

· Suicidal patients tend to refuse treatment because they want to die.

 

CONSENT AND REFUSAL FOR UNCONSCIOUS:

· For patients in coma, proxy consent by family members can be resorted to.

· If no family members are available, the physician does what he as a professional thinks is in the best interest of the patient.

· There are many disputes about withdrawing nutrition, hydration, and treatment in a persistent vegetative state since the chance of recovery is low.

· There is no moral difference between withholding and withdrawing futile treatment.

 

CONSENT AND REFUSAL IN OBSTETRICS:

· Labor and delivery are emergencies that require immediate decisions but the woman may not be competent and proxies are used.

· Forced medical intervention and cesarean section may be ordered in the fetal interest.

· Birth plans can be treated as an advance directive.

 

DISCUSSION SCENARIOS ON CONSENT TO TREATMENT - 1:

· A bed-ridden patient with limited movements and sensation communicated by sign language and limited speech. She could recognize letters and could write sentences by nodding when the right letter was touched. She indicated that she did not want physiotherapy, wanted to divorce her spouse, and wanted to give the family home to the kind doctor taking care of her. She wanted to disinherit her sons for not sitting around her bed and caring for her daily. She wanted to return to her home and leave the nursing home.

 

DISCUSSION SCENARIOS ON CONSENT TO TREATMENT - 2:

· A patient with a benign prostatic enlargement and mild urinary retention asked the urologist for prostatectomy. The urologist refused after examination revealed no complications and a normal PSA level. Because there was only one urologist in the government hospital, the patient sued the hospital in the High Court to force them to carry out the operation. Due to delays in scheduling a hearing the patient went overseas and had the operation done. Histological examination showed low grade prostate carcinoma confined within the prostatic capsule.

 

DISCUSSION SCENARIOS ON CONSENT TO TREATMENT - 3:

· A patient was brought to the emergency room by the police after attempting to kill himself by hanging. He was unconscious when first brought in and had a signed suicide note in his shirt pocket saying that he wanted to die. The doctors ignored the note and started resuscitation measures. The patient became conscious after 30 minutes and protested at the medical treatment arguing that he wanted to die. The doctor was thinking of stopping resuscitation measures when the patient’s father and wife arrived and instructed the doctor to continue resuscitation.

 

DISCUSSION SCENARIOS ON REFUSAL OF TREATMENT - 1:

· A 40-year old theater nurse refused to accept the diagnosis of breast cancer and refused surgery. The tumor grew larger, broke through the skin and became foul smelling because of bacterial infection. The hospital director put her on unpaid leave.

· A 40-year old policeman refused surgery to drain a pyomyositis abscess. He still refused surgery after the abscess burst spontaneously. The surgeons sedated him and carried out the surgery without his consent.

 

DISCUSSION SCENARIOS ON REFUSAL OF TREATMENT - 2:

· A 30-year old soldier with a history of schizophrenia refused a chest X-ray for a severe cough lasting 2 months. His commanding officer authorized using force to take the X-ray and to treat him accordingly. The army doctors were not sure what to do but being army officers they obeyed orders of the commanding officer.

· A 42-year old actress pregnant for the first time refused an elective caesarean section. She continued to refuse the procedure when labor became obstructed and signs of fetal distress appeared. The obstetrician went ahead to operate on the basis of consent by the husband. The baby was delivered alive and well.

 

DISCUSSION SCENARIOS ON REFUSAL OF TREATMENT - 3:

· A 14-year old patient refused admission because he hated the physicians on the pediatric ward.  The father agreed with the patient but the mother disagreed. Both parents agreed with the patient’s refusal of any blood transfusion which the doctors considered necessary since the hemoglobin level had fallen to a dangerous level.

· A 60-year old retired nurse refused HRT after a diagnosis of osteoporosis was made. She argued that HRT was anticipating and contradicting Allah’s pre-determination, takdir.