Ethical Considerations


Informed Consent

  1. Principles
    • surgeons are expected to have an open discussion about diagnosis and treatment with the patient
    • “Every human of adult years and sound mind has a right to determine what shall be done with his or her body”
    • risks and benefits of available treatment options, type and frequency of potential complications, and overall prognosis should be disclosed

  2. Basic Elements of Informed Consent
    • the patient (or surrogate) must have the capacity to make a medical decision
    • the diagnosis and treatment options must be discussed sufficiently for the patient to make an informed decision
    • the patient must demonstrate understanding of the diagnosis and treatment options
    • treatment plans should be recommended without undue influence

    1. Patient Competency
      • in order for consent to be valid, the patient must be competent
      • competency means that the patient has the mental ability to understand problems and make decisions about accepting or rejecting treatments
      • competence is always presumed unless there are obvious clinical reasons to doubt competency
      • incompetency may only be temporary; a physician is obligated to reassess competency to consent over time
      • in cases of patients with severe mental illness, psychiatric consultation may be required to determine competency
      • living wills and durable powers of attorney, if present, will help to direct the care of the incompetent patient
      • if there is no durable power of attorney, the courts may have to appoint a guardian to make medical decisions on behalf of an incompetent patient

    2. Diagnosis and Treatment Options
      • all facts relevant to decision-making must be disclosed to the patient: diagnosis; proposed treatment or procedure; alternative treatment options; risks and benefits of the proposed treatment, as well as alternative treatments; and the risks of refusing treatment
      • the physician must decide what facts about a procedure should be presented and how detailed the discussion with the patient should be
      • there are no hard and fast rules about percentage of risk or degrees of harm that require discussion
      • every state has its own regulations about risk disclosure
      • a useful rule of thumb: “If I were is this patient’s situation, what would I want to know.”

    3. Physician Disclosures
      1. Experience and Results
        • physicians must answer truthfully if a patients asks about the number of similar procedures they have performed and their success rates
        • failure to answer honestly may lead to fraud claims, which are not covered by malpractice insurance
        • a surgeon should also disclose the availability of high-volume specialty centers in the area if there is a known difference in the quality or types of care delivered there

      2. Financial Conflicts of Interest
        • the law presumes that financial conflicts of interest can unduly influence a physician’s medical judgment
        • ownership stakes in a laboratory, surgery center, hospital, or imaging center must be disclosed
        • patients must be given the opportunity to go to an independent facility
        • physicians must also disclose if they have a financial interest in the use of a specific device or technique

      3. Personal Health
        • in general, patients do not have a right to know private details about a physician’s health or life
        • however, every state has its own rules
        • some states have mandated disclosure of alcohol abuse or HIV status, but other states consider this an unwarranted invasion of a physician’s privacy

    4. Additional Disclosures
      1. Personnel
        • surgeons should advise patients of all the people who will be participating in their procedure, including residents, students, and equipment representatives
        • patients should know if residents will be performing parts of the procedure
        • patients have the right to refuse participation by residents and students
        • surgeons also have the right to refuse elective care to patients who will not allow residents to participate

      2. Additional Procedures
        • it is prudent to inform patients of any additional procedures that may be predictably necessary
        • examples might include resection of adjacent organs in a cancer operation, stoma creation, incidental cholecystectomy for gallstones, or splenectomy
        • it is wise to inform family of unexpected findings that require a change of procedure

  3. Effective Communication
    1. Comprehensible Language
      • physicians should communicate in language and terms that patients and their families can understand
      • informed consent does not mean giving patients an exhaustive list of everything that could conceivably go wrong
      • only truly relevant information needs to be presented
      • “If I were in this patient’s shoes, what would I want to know?”

    2. Interpreters
      • necessary for non-English speakers
      • a translator skilled in medical terminology is ideal, whether in person or by phone or videoconference
      • translation should not be left to family members, who may not be familiar with medical terms or who may withhold information from the patient in order to protect him or her from bad news
      • in such cases, the patient may receive incomplete information and the physician may not realize that the information was not completely communicated

  4. Documentation
    1. Who Can Document Informed Consent?
      • only a physician can document the content of informed consent discussions
      • ideally, the informed consent discussion and documentation should be done by the surgeon who will be doing the procedure
      • in many jurisdictions, a surgeon can delegate the informed consent discussion to another surgeon (usually a resident)
      • however, the operating surgeon retains liability for the content and effectiveness of the consent session

    2. What Should be Documented?
      • the date and time of the consent discussion should be documented, as well as who was present
      • the generic statement “all risks and benefits were discussed” is not sufficient
      • specific details of the diagnosis, proposed treatment with its risks and benefits, and alternative treatments with their risks and benefits should be recorded
      • the surgeon should also document that the patient and family had an opportunity to ask questions, and that these questions were fully answered and understood
      • standard hospital surgical consent forms are essentially meaningless
      • informed consent occurs in the office, ER, or hospital room and should be documented in those settings
      • one-on-one consent discussions in the office or at bedside do not require a witness
      • if a patient refuses treatment, the physician must carefully document that the specific risks associated with delay or refusal were discussed
      • in emergency situations when informed consent cannot be obtained, the surgeon should document the facts that led him or her to determine that the patient was incapable of making a reasonable decision

  5. Challenges to Informed Consent
    1. Surgical Emergencies
      • emergency decisions are often made with incomplete information
      • surgeons are empowered by law and ethics to act promptly in the best interests of their patients according to the surgeon’s judgment
      • in an emergency, even if the patient or surrogate cannot give permission, a surgeon is legally justified in providing whatever treatment he or she deems necessary to preserve life and health

    2. Pediatric Patients
      • children and adolescents lack the cognitive and emotional maturity to participate fully in informed consent decisions
      • children also may not have the legal standing to participate independent of their parents
      • nevertheless, children should receive age-appropriate information about their diagnosis and proposed treatment

      1. Parents Refusing Lifesaving Treatment for Their Child
        • most commonly occurs when parents refuse life-saving blood transfusions for their child because of religious beliefs
        • legally, parents may not place their children at mortal risk
        • hospitals and surgeons may provide all necessary lifesaving care without fear of legal retribution
        • the hospital medicolegal team and ethics committee will also need to get involved in the case
        • if necessary, a court can name a temporary guardian to make medical decisions for the child

    3. Organ Donation
      • historically, the transplant physician or the treating physician would approach the potential donor family for permission
      • this practice could raise the possibility of conflicts of interest
      • now, responsibility for approaching the donor family is vested in trained professionals who do not have a clinical relationship with the donor or donor family
      • this allows the family to decide in a neutral, less pressured environment

  6. Failure to Obtain Consent
    • failure to obtain informed consent can lead to two different legal actions: battery or negligent nondisclosure

    1. Battery
      • battery is a ‘touching’ to which the patient does not agree to
      • in some jurisdictions, inadequate disclosure of risks can be construed as no consent at all, leading to a battery claim
      • battery actions are infrequent in the medical arena

    2. Negligent Nondisclosure of Risk
      • typically there is a signed consent form, but the patient alleges that they were not adequately made aware of the indication or risks of the procedure
      • in these cases, the patient asserts that he or she would not have undergone the procedure had they known the true nature of the risks

Withdrawing and Withholding Care

  1. Ethical Considerations
    • general consensus that there is no difference between withdrawing (stopping) and withholding (not starting) treatments that are no longer beneficial
    • any, and all, treatments can be withdrawn
    • certain treatments have symbolic and emotional value (nutrition, water), even if their palliative value is questionable

    1. Karen Ann Quinlan Case
      • established that a patient or their surrogate may withdraw ‘extraordinary’ lifesaving care (mechanical ventilation)
      • Quinlan lapsed into a persistent vegetative state after mixing alcohol and Valium
      • her parents, once it was clear that she would never improve, wished to disconnect their daughter from the ventilator
      • her parents believed that mechanical ventilation was an extraordinary means of prolonging life, and that it caused her pain
      • her doctors refused this request after being threatened with homicide charges
      • after a protracted legal battle, she was disconnected from the ventilator
      • somewhat surprisingly, she was able to breathe spontaneously, and she ultimately died nine years later
      • during this time she was fed through a feeding tube, which her parents did not consider an extraordinary measure

    2. Nancy Cruzan Case
      • in 1983, the Cruzan case established that ‘ordinary’ care (tube feeds) may be withdrawn by a patient or their surrogate
      • was the first ‘right to die’ case heard by the Supreme Court
      • Nancy Cruzan was a 25 year old woman who lapsed into a persistent vegetative state after a car accident in 1983
      • in 1988, her parents asked that her feeding tube be removed
      • the hospital refused to do this without a court order, since removing the tube would cause her death
      • the initial court sided with the parents, but this was reversed by the Missouri Supreme Court
      • the legal question was whether there was clear and convincing evidence that Nancy Cruzan would have wanted the feeding tube removed
      • On appeal to the U.S. Supreme Court, in a 5-4 decision, the court sided with the state of Missouri that clear and convincing evidence was required before terminating life-supporting treatment
      • ultimately, the parents were able to demonstrate that their daughter would have wanted the feeding tube removed, and the courts agreed
      • the feeding tube was removed, and she died 12 days later in December 1990

      1. Legal Issues
        • the courts agreed that competent individuals have the right to refuse medical treatment
        • however, with incompetent individuals, there must be a higher standard for evidence of what the patient would want if they were able to make their own decisions
        • surrogates may not always make decisions that the incompetent person would have agreed with, and those decisions may lead to irreversible actions

      2. Legal Precedents
        • the right to die is not a right guaranteed by the Constitution
        • the courts set out rules for what was required for a third party to refuse treatment on behalf of an incompetent person
        • the case established that absent a living will or clear and convincing evidence of what the incompetent person would have wanted, the state's interests in preserving life outweighs the individual's rights to refuse treatment
        • it was left to the states to determine their own right-to-die standards, rather than creating a uniform national standard

      3. Aftermath
        • the case generated an enormous interest in living wills and advanced directives
        • also increased support for the federal Patient Self-Determination Act, which became effective about one year after Nancy Cruzan’s death

    3. ‘Double Effect’ Principle
      • ethical justification for withholding or withdrawing treatment
      • the intent of withholding treatment must be to relieve suffering, not to hasten the death of the patient, even if the death of the patient is a predictable outcome

    4. Medical Futility
      • a physician may recommend to a patient or surrogate to withhold or withdraw medically futile therapy
      • if the patient or surrogate does not agree, then the physician should recommend a second opinion
      • no physician is ethically obligated to provide treatment that he or she believes is futile
      • however, the physician cannot abandon the patient, and must continue to provide care until another physician can be found to take over the care of the patient

Advance Directives

  1. Advance Care Planning
    • goal is to ensure that people receive medical care that is consistent with their goals, values, and preferences
    • requires communication between patients, their family, and their doctors
    • one outcome of advance care planning is the completion of written documents (living wills, durable powers of attorney, DNR orders) that will be used to direct care in case the patient loses the capacity to make decisions

  2. Patient Self-Determination Act
    • became law in 1990
    • all hospitals, nursing homes, and hospices are required to inform patients of their right to have advanced directives
    • patients also have the right to direct their own health care decisions and to refuse medical or surgical treatment
    • these directives must be documented in the chart at the time of admission

  3. Living Wills
    • written to anticipate treatment options and choices in the event that a patient is unable to exercise their autonomy regarding medical decisions
    • patients indicate which treatments they wish to permit or prohibit, generally in the setting of a terminal illness
    • possible treatments addressed include CPR, mechanical ventilation, dialysis, artificial nutrition, transfusions, or antibiotics
    • living wills are often too vague to offer concrete guidance in complex clinical situations that are not terminal: advanced dementia, persistent vegetative states

  4. Durable Power of Attorney
    • signed legal document that authorizes another person to make medical decisions on the patient’s behalf in the event that the patient loses decisional capacity
    • addresses the fact that living wills are limited in the range of decisions that they can cover
    • the hope is that the surrogate will make decisions that reflect the decisions that the patient would make if able
    • however, studies show that surrogates predicted patient treatment preferences with only 68% accuracy
    • surrogates do not necessarily have privileged insight into the autonomous preferences of patients

  5. DNR/DNI Orders
    • confusing to patients, families, (and doctors)
    • if a patient does not want CPR under any circumstances, the physician is obligated to write a DNR order in the chart as soon as possible
    • CPR can only be withheld if a DNR order is on the chart – advanced directives are insufficient to prevent a patient from being resuscitated
    • DNR, however, does not mean ‘do not treat’
    • palliative procedures, including surgery, may be performed on DNR patients
    • DNI orders will need to be temporarily suspended while in the OR or recovery room







References

  1. Schwartz, 10th ed., pgs 1941 - 1946
  2. UpToDate. Informed Procedural Consent. Marsha Ryan, MD, JD, FACS, Michael S. Sinha, MD, JD, MPH. Aug 24, 2020. Pgs 1 – 15
  3. Wikipedia.org/wiki/Karen_Ann_Quinlan
  4. Wikipedia.org/wiki/ Cruzan_v._Director,_Missouri_Department_of_Health
  5. UpToDate. Advance Care Planning and Advance Directives. Maria A. Silveira, MD, MA, MPH. Mar 31, 2020. Pgs 1 – 32