AAOS Comprehensive Orthopaedic Review
Section 2 - General Knowledge
Chapter 14. Medical Ethics
A. Professionalism is a neglected curriculum area in orthopaedic education. It is currently taught by role models, review processes, rewards, and regulations.
B. Categories of unprofessional behavior
1. Criminal behavior
2. Substance abuse
4. Sexual misconduct
5. Inappropriate billing
6. Inadequate medical records
7. Incomplete disclosure
8. Failure to meet the minimum standard of care
II. Informed Consent
A. Information presented to the patient
1. Clear identification of the medical condition
2. Recommended treatment(s)
3. Alternative treatment(s)
4. Risks and benefits of treatment(s) or lack thereof
B. Means of assessing comprehension of the information
1. Educating the patient—Use of discussion, written and visual aids, and referral to other health care providers or patients who have a similar condition and who have undergone the recommended treatment.
2. Answering all questions—Development of an adequately familiar and comfortable rapport that encourages a dialog between patient and physician.
3. Using simplified language—During direct discussion and in written form, both on paper and electronically.
4. Avoiding jargon—Minimize or eliminate abbreviations and technical terms on the consent form and in educational materials.
C. Voluntariness—Follows the "reasonable volunteer" standard.
1. Patient can decline recommendations or withdraw from intervention at any time.
2. Patient has adequate time for making decisions, including during the office interview and at follow-up visit(s), to allow assimilation and gathering of further information.
III. Relationships With Industry
A. Three principal interests—Patient, physician, and third party such as insurers or hospitals.
1. Patient interests must take priority when conflict arises.
2. Any alternative—and even the appearance of such—evokes suspicion of the physician's recommendations and erodes patient trust.
B. There are two principal settings for delivery of health care, each with unique financial incentives.
1. Managed care plans
a. Physicians may serve as gatekeepers and are held accountable for cost per capita.
b. Goal is to improve efficiency and reduce waste.
c. Perceived disadvantage is delay or rationing or withholding of care solely for financial reasons.
2. Fee-for-service plans
a. When reward is based on use, there is an incentive for the physician to consume greater resources, including facilities (such as laboratory work and imaging studies) and devices (as when the physician receives royalties or kick-backs for implants).
b. Financial incentives may be neutralized or elevated to acceptable ethical standards by ensuring that the patient's interests are the priority.
C. Industry sponsorship of professional and educational activities—US Food and Drug Administration (FDA) and the Accreditation Council for Continuing Medical Education (ACCME) stipulations for physicians working with industry.
1. Physicians may not accept gifts from industry valued greater than $100.
2. Industry may subsidize the costs of continuing medical education (CME) courses, but not for physician travel, lodging, recreational activities, or personal expenses.
3. Courses that do not award CME are considered commercial and subject to regulation.
IV. Stark II Regulations
A. Stark II prohibits self-referrals of Medicare patients.
B. See chapter 1, Medicolegal Issues, for details.
V. Peer Review and Medical Errors
A. Purposes of peer review
1. Quality control—To improve outcomes, reduce errors, and enhance patient safety.
2. Forms one basis of certification.
3. Grants respectability to and inspires confidence in the medical profession.
4. Facilitates consumer selection.
B. Challenges of current peer review systems
1. Current systems are largely voluntary and poor at detecting and reducing errors, with data lacking regarding true error rate and number of encounters to generate error.
2. No centralized or standardized system for reporting errors.
3. Focus on negative feedback (culpability) rather than positive feedback (learning to improve processes).
4. Threat of legal ramifications deters reporting of errors.
5. Expensive to develop, with no direct reward for participants.
C. Recommendations for peer review
1. Shift in focus
a. Focus on patient safety, not risk management.
b. Deemphasize blame because legal liability and/or professional discipline have not prevented avoidable errors. Also, avoiding blame will improve communication with colleagues and other organizations and institutions, providing the opportunity to build a knowledge base, learn from others, and devise solutions.
c. Shift from a retrospective review system to a proactive process designed to avoid errors, recognize them before they impact a patient, and identify them when they occur.
d. Shift from individual review to systems and process review.
e. Use a wide variety of tools and consult with other health care professionals when necessary, given the complex and varied nature of medical errors.
f. Include noninstitutional care in peer review.
i. Institutional care, especially in hospital, has been the traditional focus.
ii. Noninstitutional care settings such as the office setting lack the advantages of scale and resources but may provide greater reward on investment, despite the perception that they are less complicated systems with patients who are less ill.
2. Change reporting requirements.
a. Require strict confidentiality in reporting to encourage/increase voluntary reporting.
b. Report "near misses," which are more readily discussed and equally informative.
3. Encourage legal reform.
a. Work for tort reform to end open-ended legal damage awards.
i. Set limits, or caps, for legal damage awards.
ii. Develop a sliding scale proportionate to loss.
b. Shift the burden of liability from the individual to the organization (exclusive enterprise liability).
i. Removing personal liability may eliminate one significant barrier to error reporting.
ii. Shift does not eliminate sanctions from professional partners or organizations.
4. Facilitate patient selection.
a. Make information on outcomes readily available to the consumer.
b. Make patients partners in the process so that they can help improve safety through their health care dollar. This would represent part of a change from penalties for poor outcomes to support for improved outcomes.
VI. End-of-Life Issues
A. Do Not Resuscitate (DNR) orders
1. Cardiopulmonary resuscitation (CPR) is initiated in a patient who experiences a cardiopulmonary arrest unless a DNR order is on record.
2. A DNR order is appropriate if the patient or surrogate requests one or if CPR would be futile.
3. DNR orders and the reasons for them must be documented in the medical record.
4. "Slow" or "show" codes that merely appear to provide CPR in the absence of DNR orders are deceptive and therefore unacceptable.
5. A DNR order signifies that only CPR will be withheld, but the reasons that justify the DNR order may lead to a reconsideration of other plans for care.
B. Advance directives
1. Advance directives are statements by competent patients to direct care if they lose decision-making capacity. They may specify which interventions are acceptable to the patient and who serves as surrogate on behalf of the patient.
2. Types of advance directives
a. Oral conversations—These are the most common format but can be disputed due to lack of clarity and completeness.
b. Living wills—These direct physicians to forgo or provide life-sustaining interventions if the patient develops a terminal condition or persistent vegetative state.
c. Health care proxy (In some states, this process is called executing a durable power of attorney for health care.)
i. Makes decisions if the patient loses such capacity
ii. Most flexible and comprehensive
iii. More comprehensive than the living will, applying whenever the patient is unable to make decisions
3. Patients generally may refuse only interventions that "merely prolong the process of dying."
4. Federal Patient Self-Determination Act requires hospitals and Health Maintenance Organizations (HMOs) to inform patients of their right to make health care decisions and to provide advance directives.
5. Substituted judgment
a. In the absence of clear advance directives, surrogates and physicians substitute their judgment for that of the patient when making decisions that respect what the patient would wish and the patient's best interests.
b. In the event of disagreement, several resources may be accessed:
i. Another physician, who may provide a "second opinion" that is unprejudiced.
ii. The hospital ethics committee, which has experience in resolving such disputes.
iii. A court of law, which should be viewed as the last resort.
A. The importance of confidentiality is widely accepted by the medical profession. Aspects of patient confidentiality are codified in Health Insurance Portability and Accountability (HIPAA) regulations (see chapter 1, Medicolegal Issues).
B. Breaches of confidentiality are justified in circumstances where society regards the benefits to others as outweighing the benefits to the patient:
1. When a patient is at risk (eg, when evidence arises that a treatment has unexpected or unacceptable risk).
2. When a third party is at risk (eg, in communicable disease).
3. When there is a legal obligation to do so (eg, in cases of abuse).
VIII. Institutional Review Boards
A. The modern history of the protection of human subjects began with the Nuremberg Code of Medical Ethics, which was developed by the Nuremberg Military Tribunal after the investigation of Nazi physicians (1946-1947).
1. The code was quickly adopted by the World Medical Association (1948).
2. The Department of Health, Education and Welfare (DHEW) instituted regulations protecting human subjects on May 30, 1974.
3. This was followed in July of the same year by establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report (Belmont Conference Center at the Smithsonian Institute) defining the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
B. The Belmont Report—Elements of this 1978 report form the basis for human research in the United States.
1. Respect for individuals—Emphasizes dignity and autonomy, and encompasses informed consent (quid vide).
2. Beneficence—Emphasizes the need to maximize benefit and minimize risk, including for both the individual and society.
a. Risk should be minimized, with an initial goal of avoiding the use of using human subjects if at all possible.
b. Risk and benefit are determined by assessing information provided by the investigator and all other relevant information available in the literature.
3. Justice—Requires fair selection of subjects and distribution of the benefits and burdens of research. The subject must be considered not only as an individual but also as a member of a social, racial, sexual, or cultural group in an effort to avoid bias.
C. Specific protections were added for vulnerable populations.
1. Fetuses and pregnant women (1978)
2. Prisoners (1978)
3. Children (1991)—Specified need to obtain assent of child and consent of parent.
IX. Care of the Uninsured
A. Obligation to provide care
1. No national public policy in the United States establishes a patient's right to medical care.
2. The physician has an ethical obligation, however, to provide care consistent with the fundamental principles of the medical profession to provide care to a patient in need, regardless of ability to pay and in the absence of a legal or governmental mandate to do so. The physician must advocate for the patient in such circumstances, but not "by any means necessary," that is, not by lying, misrepresentation, or withholding necessary information, because this behavior undermines the very ethical principles that the physician wishes to uphold.
B. Allocation of health care resources
1. Directed allocation, or rationing, is unavoidable because resources are limited.
2. Ideally, allocation decisions should be a matter of public policy with physician input, and not made in the clinical setting.
3. In the clinical setting, the physician should act as a patient advocate within constraints set by society, reasonable insurance coverage, and evidence-based practice.
4. Ad hoc rationing in the clinical setting is ethically problematic because physicians may be inconsistent, unqualified, unfair, and/or ineffective.
X. Culturally Competent Care
A. Factors to be considered when tailoring health care to individual patient needs:
3. Cultural competence
B. Culturally competent care
1. Enhanced by an awareness of and willingness to challenge the following features of North American medical culture:
a. Dominance of time
b. Individual needs over the group or society
c. The shrinking family
d. Undisputed belief in science
e. Primacy of Western medicine
g. Action/goal/work/future orientation
m. Practicality and efficiency
n. Secularism over religion
2. Components of culturally competent care
a. Values—Perceptions of "quality" of treatment and what is regarded as "acceptable" benefit and risk.
d. Nonverbal interactions and behaviors
e. Institutions, including religious
3. Benefits of culturally competent care
a. Improved accuracy of care—In its simplest form, this includes language.
b. Improved consistency in the delivery of care—The informed patient who can negotiate efficiently the medical system and is able to comply with proposed treatment(s).
c. Wider access to care—Surmounting barriers that may shut cultural minorities out of certain parts of the health care system.
d. Reduced cost of care—Elimination of misunderstanding and adoption of preventive measures.
e. Improved outcomes
f. Higher patient satisfaction
4. Misconceptions about culturally competent care include that it is a euphemism for segregated care, that it relies on racial quotas, that it is guided by racial stereotypes, and that it is fulfilled simply by provision of an interpreter.
Top Testing Facts
1. Breaches of medical professionalism include inappropriate billing, failure to maintain adequate medical records, and incomplete disclosure.
2. The three elements essential to informed consent are information, comprehension, and voluntariness.
3. Physicians may not accept gifts from industry valued greater than $100.
4. Physicians attending continuing medical education courses may not accept subsidies for travel, lodging, recreational activities, or personal expenses.
5. Stark II regulations prohibit a physician from referring a Medicare patient for certain designated health services to an entity with which the physician or immediate family member has a direct or indirect financial relationship.
6. Essential components to improvement of peer review and the rate or reporting of medical errors include emphasis on the patient over the practitioner; systems over the individual; proaction over retrospection; and maintenance of confidentiality.
7. Advance directives may be established through oral conversations, living wills, or the appointment of a health care proxy.
8. Patient confidentiality may be breached justifiably when a patient is at risk, when a third party is at risk, or when there is a legal obligation to do so.
9. The three essential components of the Belmont Report are respect for persons, beneficence in maximizing benefit and minimizing risk, and justice of distribution of benefits of human research.
10. Cultural competence will improve accuracy of, delivery of, and access to health care, thereby improving patient outcomes and satisfaction.
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