|
|
PRINCIPLES OF MEDICAL ETHICS AND PROFESSIONALISM IN
ORTHOPAEDIC SURGERY
The following principles of Medical Ethics and
Professionalism in Orthopaedic surgery have been adopted
by the executive committee of the South African
Orthopaedic Association.
They are not laws, but rather standards of conduct that
define the essentials of honourable behavior for the
orthopaedic surgeon.
- PHYSICIAN – PATIENT RELATIONSHIP
- orthopaedic profession exists for the primary
purpose of caring for the patient.
- The physician-patient relationship is the central
focus of all ethical concerns.
- The orthopaedic surgeon should be dedicated to
providing competent medical service with compassion and
respect.
- INTEGRITY
- The orthopaedic surgeon should maintain a reputation
for truth and honesty with patients and colleagues.
- The orthopaedic surgeon should strive to expose
through the appropriate review process those physicians
who are deficient in character or competence or who
engage in fraud and deception.
- LEGALITIES AND HONOUR
- The orthopaedic surgeon must obey the law, uphold the
dignity and honour of the profession and accept the
profession’s self-imposed discipline.
- The orthopaedic surgeon also has the responsibility to
seek changes in legal requirements that are contrary to
the best interest of the patient.
- CONFLICTS OF INTEREST
- The practice of medicine inherently presents potential
conflicts of interest.
- Wherever a conflict of interest arises, it must be
resolved in the best interest of the patient.
- The orthopaedic surgeon should exercise all reasonable
alternatives to ensure that the most appropriate care is
provided to the patient.
- If a conflict of interest cannot be resolved, the
orthopaedic surgeon should notify the patient of his or
her intention to withdraw from the care of the patient.
- CONFIDENTIALITY
- The orthopaedic surgeon should respect the rights of
patients, of colleagues and of other health professions.
- The orthopaedic surgeon must safeguard patient
confidences within the constraints of the law.
- MEDICAL KNOWLEDGE
- The orthopaedic surgeon continually must strive to
maintain and improve medical knowledge.
- The orthopaedic surgeon should make relevant
information available to patients, colleagues and the
public.
- COOPERATION
- Good relationships among physicians, nurses and health
care professionals are essential for good patient care.
- The orthopaedic surgeon should promote the development
of an expert health care team that will work together
harmoniously to provide optimal patient care.
- REMUNERATION
- Remuneration for orthopaedic services should be
commensurate with the services rendered.
- Orthopaedic surgeons should deliver high quality, cost
effective care without discrimination.
- PUBLICITY
- The orthopaedic surgeon should not publicize himself
or herself through any medium or form of public
communication in an untruthful, misleading, or deceptive
manner.
- SOCIETAL RESPONSIBILITY
- The orthopaedic surgeon has a responsibility not only
to the individual patient, to colleagues and orthopaedic
surgeon-in-training, but also to society as a whole.
- Activities that have the purpose of improving the
health and well-being of the patient and/or the
community in a cost effective way deserve the interest,
support and participation of the orthopaedic surgeon.
CODE OF MEDICAL ETHICS AND PROFESSIONALISM FOR
ORTHOPAEDIC SURGEONS
PREAMBLE:
- Concerns for the patient’s welfare and the appropriate
behaviour of the physician are a part of the heritage of
medicine.
- Guidelines for ethical behaviour must address the
demands for contemporary orthopaedic practice.
- The code of medical ethics and professionalism was
developed primarily for the benefit of our patients and
to serve as a guide to conduct in the physician-patient
relationship.
- The document is directed to concerns of specific
interest to orthopaedic surgeons.
- The code of medical ethics will provide standards of
conduct that define the essentials of honourable
behaviour for the orthopaedic surgeon.
- While taking into account the legal requirements of
medical practice, the code will call for and espouse a
standard of behaviour that is higher than that required
by law.
- Orthopaedic surgeons-in-training and other health care
professionals should by their deeds and actions comply
with the code of medical ethics and professionalism.
- THE PHYSICIAN-PATIENT RELATIONSHIP:
A - The orthopaedic profession exists for the primary
purpose of caring for the patient.
- The physician-patient relationship is the central
focus of all ethical concerns.
B - The physician-patient relationship has a
contractual basis and is based on confidentiality, trust
and honesty.
- Both the patient and the orthopaedic surgeon are
free to enter or discontinue the relationship within any
existing constraints of a contract with a third party.
- An orthopaedic surgeon has an obligation to render
care only for those conditions that he or she is
competent to treat.
- The orthopaedic surgeon shall not decline to accept
patients solely on the basis of race, colour, gender,
sexual orientation, religion or national origin or on
any basis that would constitute illegal discrimination.
C - The orthopaedic surgeon should render services to
the best of his or her ability, but may choose whom he
or she will serve.
- Having undertaken the care of a patient, the
orthopaedic surgeon may not neglect that person.
v Unless discharged by the patient, the orthopaedic
surgeon may discontinue service only after giving
adequate notice to the patient so that the patient can
secure alternative care.
- If the enrolment of a physician or patient is
discontinued in a managed care plan, the physician will
have an ethical responsibility to assist the patient in
obtaining follow up care. In this instance the physician
will be responsible to provide medically necessary care
for the patient until appropriate referrals can be
arranged.
D - When obtaining informed consent for treatment, the
orthopaedic surgeon is obligated to present to the
patient or to the person responsible for the patient, in
understandable terms, pertinent medical facts and
recommendations consistent with good medical practice.
- Such information should include alternative modes
of treatment, the objectives, risk and possible
complications and consequences of no treatment.
- PERSONAL CONDUCT
A. - The orthopaedic surgeon should maintain a
reputation for truth and honesty.
- In all professional conduct, the orthopaedic
surgeon is expected to provide competent and
compassionate patient care, exercise appropriate respect
for other health care professionals, and maintain the
patient’s best interest as paramount.
B. - The orthopaedic surgeon should conduct himself or
herself morally and ethically, so as to merit the
confidence of patients entrusted to his or her care.
- The orthopaedic surgeon should render to each
patient a full measure of service and devotion.
C. - The orthopaedic surgeon should obey all laws,
uphold the dignity and honour of the profession, and
accept the profession’s self-imposed discipline.
- Within legal and other constraints, if the
orthopaedic surgeon has a reasonable basis for believing
that a physician or other health care provider has been
involved in any unethical or illegal activity, he or she
should attempt to prevent the continuation of this
activity by communicating with that person and/or
identifying that person to a duly-constituted peer
review authority of the appropriate regulatory agency.
- The orthopaedic surgeon should also cooperate with
peer review and other authorities in their professional
and legal efforts to prevent the continuation of
unethical or illegal conduct.
D.- Because of the orthopaedic surgeon’s
responsibility for the patient’s life and future
welfare, substance abuse is a special threat that must
be recognized and stopped.
- The orthopaedic surgeon must avoid substance abuse
and, when necessary, seek rehabilitation.
- It is ethical for an orthopaedic surgeon to take
actions to encourage colleagues who are chemically
dependent to seek rehabilitation.
- CONFLICTS OF INTEREST:
A. - The practice of medicine inherently presents
potential conflicts of interest.
- When a conflict of interest arises, it must be
resolved in the best interest of the patient.
(iii) The orthopaedic surgeon should exercise all
reasonable alternatives to ensure that the most
appropriate care is provided to the patient.
- If the conflict of interest cannot be resolved, the
orthopaedic surgeon should notify the patient of his or
her intention to withdraw from the relationship.
B. - If the orthopaedic surgeon has a financial
ownership or interest in a durable medical goods
provider, imaging centre, surgery centre or other health
care facility where the orthopaedic surgeon’s financial
interest is not immediately obvious, the orthopaedic
surgeon must disclose this interest to the patient.
- The orthopaedic surgeon has an obligation to know
the applicable laws regarding ownership, compensation
and control of these services and facilities.
C. - When an orthopaedic surgeon receives anything of
significant value from industry, a potential conflict
exists which should be disclosed to the patient.
- When an orthopaedic surgeon receives inventor
royalties from industry, the orthopaedic surgeon should
disclose this fact to the patient if such royalties
relate to the patient’s treatment.
( - It is unethical for an orthopaedic surgeon to
receive compensation of any kind from industry for using
a particular device or medication.
- Reimbursement for reasonable administrative costs
in conducting or participating in a scientifically sound
research clinical trial is acceptable.
D. - An orthopaedic surgeon reporting on clinical
research or experience with a given procedure or device
must disclose any financial interest in that procedure
or device if the orthopaedic surgeon or any institution
with which that orthopaedic surgeon is connected, has
received anything of value from its inventor or
manufacturer.
E. - Except when inconsistent with applicable law,
orthopaedic surgeons have a right to dispense
medication, assistive devices, orthopaedic appliances
and similar related patient-care items, and to provide
facilities and render services as long as their doing so
provides a convenience or an accommodation to the
patient without taking financial advantage of the
patient.
- Ultimately, the patient must have the choice of
accepting the dispensed medication or patient-care items
or obtaining them outside the physician’s office.
- MAINTENANCE OF COMPETENCE
A.- The orthopaedic surgeon continually should strive
to maintain and improve medical knowledge and skill.
- The orthopaedic surgeon should make available to
patients and colleagues the benefits of his or her
professional attainments.
- Each orthopaedic surgeon should participate in
continuing medical educational activities.
- . RELATIONSHIPS WITH ORTHOPAEDIC SURGEON, NURSES AND
ALLIED HEALTH PERSONNEL
A. - Good relationship among physicians, nurses, and
other health care professionals are essential for good
patient care.
- The orthopaedic surgeon should promote the
development of an expert health care team that will work
together harmoniously to provide optimal patient care.
B.- The professional conduct of the orthopaedic
surgeon will be scrutinized by local professional
associations, hospitals, managed care organizations,
peer review committees, and state medical and/or
licensing boards.
- These groups deserve the participation and
cooperation of orthopaedic surgeons.
C. - Orthopaedic surgeons are frequently called upon
to provide expert medical testimony in courts of law.
- In providing testimony, the orthopaedic surgeon
should ensure that the testimony provided is
non-partisan, scientifically correct, and clinically
accurate.
- The orthopaedic surgeon should not testify
concerning matters about which the orthopaedic surgeon
is not knowledgeable.
- It is unethical for an orthopaedic surgeon to
accept compensation that is contingent upon the outcome
of litigation.
- . RELATIONSHIP TO THE PUBLIC
A. - The orthopaedic surgeon should not publicize
himself or herself through any medium or form of public
communication in an untruthful, misleading or deceptive
manner.
- Competition between and among surgeons and other
health care practitioners is ethical and acceptable.
B. - Professional fees should be commensurate with the
services provided.
- It is unethical for orthopaedic surgeons to bill
individually for services that are properly considered a
part of the “global service” package where defined, i.e.
services that are necessary part or the surgical
procedure.
- It is unethical for orthopaedic surgeons to submit
billing codes that reflect higher levels of service or
complexity than those that were actually required.
- It is unethical for orthopaedic surgeons to charge
for services not provided.
C. - Physicians should be encouraged to devote some
time and work to provide care for individuals who have
no means of paying.
- The physician has an obligation to serve as the
patient’s advocate to ensure that the patient’s welfare
remains the paramount concern.
- . GENERAL PRINCIPLES OF CARE
A. - An orthopaedic surgeon should practice only
within the scope of his or her personal education,
training and experience.
- If an orthopaedic surgeon contracts to provide
comprehensive musculoskeletal care, then he or she has
to the obligation to ensure that appropriate care is
provided in areas outside his or her personal
experience.
B. - It is unethical to prescribe, provide or seek
compensation for unnecessary services or not to provide
services that are medically necessary.
- It is unethical to prescribe controlled substances
when they are not medically indicated.
- It is also unethical to prescribe substances for
the sole purpose of enhancing athletic performance.
C. - The orthopaedic surgeon should not perform a
surgical operation under circumstances in which the
responsibility for diagnosis or care of the patient is
delegated to another who is not qualified to undertake
it
D. - When a patient submits a proper request for
records, the patient is entitled to a copy of such
records as they pertain to that patient individually.
- Charges should be commensurate with the services to
reproduce the medical records.
- Certain correspondence from insurance carriers or
attorneys may call for conclusions on the part of the
orthopaedic surgeon as such. A reasonable fee for
professional services is permissible.
- RESEARCH AND ACADEMIC RESPONSIBILITIES
A. - All research and academic activities must be
conducted under conditions of full compliance with
ethical, institutional and government guidelines.
- Patients participating in research programmes must
have given full informed consent and retain the right to
withdraw from the research protocol at any time.
B. - Orthopaedic surgeons should not claim as their
own intellectual property which is not theirs.
- Plagiarism or the use of others’ work without
attribution is unethical.
C. - The principal investigator of a scientific
research project or clinical research project is
responsible for proposing, designing and reporting the
research.
- The principal investigator may delegate portions of
the work to other individuals, but this does not
relieve2 the principal investigator of the
responsibility for work conducted by other individuals.
- The principal investigator or senior author of a
scientific report is responsible for ensuring that
appropriate credit is given for contributions to the
research described.
- COMMUNITY RESPONSIBILITY
A. - The honoured ideals of the medical profession
imply that the responsibility of the orthopaedic surgeon
extends not only to the individual but also to society
as a whole.
- Activities that have the purpose of improving the
health and well being of the patient and/or the
community in a cost-effective way deserve the interest,
support and participation of the orthopaedic surgeon.
MEDICAL PROFESSIONALISM TODAY : A PHYSICIAN CHARTER
PREAMBLE:
Physicians today are experiencing frustrations as
changes in the health care delivery system in virtually
all industrialized countries, threaten the very nature
and values of medical professionalism.
Recently voices from many countries have begun calling
for a reviewed sense of professionalism, one that is
activist in reforming health care systems. Responding to
this challenge a “charter” was developed to encompass a
set of principles to which all medical professionals can
and should aspire. The charter supports physicians’
efforts to ensure that health care systems and the
physicians working in them remain committed both to
patient welfare and the basic tenets to be applicable to
different cultures and political systems.
Professionalism is the basis of medicine’s contract with
society. It demands placing the interests of patients
above those of the physician, setting and maintaining
standards of competence and integrity, and providing
expert advice to society on matters of health. The
principles and responsibilities of medical
professionalism must be clearly understood by both the
profession and society. Essential to this contract is
public trust in physicians, which depend on the
integrity of both individual physicians and the whole
profession.
At present, the medical profession is confronted by an
explosion of technology, changing market forces,
problems in health care delivery, bioterrorism and
globalization. As a result, physicians find it
increasingly difficult to meet their responsibilities to
patients and society. In these circumstances,
reaffirming the fundamental and universal principles and
values of medical professionalism which remain ideals to
be pursued by all physicians, becomes all the more
important.
The medical profession everywhere is embedded in diverse
cultures and national traditions, but its members share
the role of healer. The medical profession must contend
with complicated legal and market forces. Moreover,
there are wide variations in medical delivery and
practice through which any general principles may be
expressed in both complex and subtle ways.
Despite these differences, common themes emerge and form
the basis of the charter in the form of three
fundamental principles and as a set of definitive
professional responsibilities.
FUNDAMENTAL PRINCIPLES
- PRINCIPLE OF PRIMACY OF PATIENT WELFARE
This principle dates from ancient times it is based on a
dedication to serving the interests of the patient.
Altruism contributes to the trust that is central to the
patient-physician relationship. Market forces, societal
pressures and administrative exigencies must not
compromise this principle.
- PRINCIPLES OF PATIENT AUTONOMY
This principle has more recent history. Only in the
latter part of the last century have people begun to
view the physician as an advisor, often one of many, to
an autonomous patient. Physicians must have respect for
patient autonomy. Physicians must be honest with their
patients and empower them to make informed decisions
about their treatment. Patient’s decisions must be
paramount, as long as those decision are in keeping with
ethical practice and do not lead to demands for
inappropriate care.
- PRINCIPLE OF SOCIAL JUSTICE
The medical profession must promote justice in the
health care system, including a fair distribution of
health care resources. Physicians should work actively
to eliminate discrimination in health care, whether
based on race, gender, socioeconomic status, ethnicity,
religion or any other societal category.
PROFESSIONAL RESPONSIBILITIES
- COMMITMENT TO PROFESSIONAL COMPETENCE
Physicians must be committed to lifelong learning and be
responsible for maintaining the medical knowledge and
clinical and team skills necessary for the provision of
quality care.
The profession as a whole must strive to see that all of
its members are competent and must ensure that
appropriate mechanisms are available for physicians to
accomplish his goal.
- COMMITMENT TO HONESTY WITH PATIENTS
Physicians must ensure that patients are completely and
honestly informed before the patient has consented to
treatment and after treatment has occurred. This
expectation does not mean that patients should be
involved in every minute decision about medical care;
rather they must be empowered to decide the course of
the therapy.
Physicians should also acknowledge that in health care,
medical errors that injure patients do sometime occur.
Whenever patients are injured as a consequence of
medical care, the patient should be informed promptly
because failure to do so seriously compromises patient
and societal trust. Reporting and analyzing medical
mistakes provides the basis for appropriate prevention
and improvement strategies and for appropriate
compensation to injured parties.
- COMMITMENT TO PATIENT CONFIDENTIALITY
Earning the trust and confidence of patients requires
that appropriate confidentiality safeguards be applied
to disclosure of patient information. This commitment
extends to discussions with persons acting on behalf of
the patient when obtaining the patient’s own consent is
not feasible.
Fulfilling the commitment to confidentiality is more
pressing now than ever before, given the widespread use
of electronic information systems for compiling
patients’ data and increasing availability of genetic
information.
Physicians recognize however that their commitment to
patient confidentiality must occasionally yield to
overriding considerations in the public interest
(example: when patients endanger others).
- COMMITMENTS TO MAINTAINING APPROPRIATE RELATIONS WITH
PATIENTS
Given the inherent vulnerability and dependency of
patients, certain relationships between physicians and
patients must be avoided. In particular, physicians
should never exploit patients for any sexual advantage,
personal financial gain or other private purpose.
- COMMITMENT TO IMPROVING QUALITY OF CARE
Physicians must be dedicated to continuous improvement
in the quality of health care. This commitment entails
not only maintaining clinical competence but also
working collaboratively with other professionals to
reduce medical error, increasing patient safety,
minimize overuse of health care resources and optimize
the outcomes of care.
Physicians must actively participate in the development
of better measures of quality of care and the
application of quality measures to assess routinely the
performance of all individuals, institutions and systems
responsible for health care delivery. Physicians, both
individually and through their professional
associations, must take responsibility for assisting in
the creation and implementation of mechanism designed to
encourage continuous improvement in the quality of care.
- COMMITMENT TO IMPROVING ACCESS TO CARE
Medical professionalism demands that the objective of
all health care systems be the availability of a uniform
and adequate standard care.
Physicians must individually and collectively strive to
reduce barriers to equitable health care. Within each
system, physicians should work to eliminate barriers to
access based on education, laws, finances, geography and
social discrimination.
A commitment to equity entails the promotion of public
health and preventative medicine, as well as public
advocacy on the part of each physician, without concern
for the self-interest of the physician or the
profession.
- COMMITMENT TO A JUST DISTRIBUTION OF FINITE RESOURCES
While meeting the needs of individual patients,
physicians are required to provide health care that is
based on the wise and cost-effective management of
limited clinical resources. They should be committed to
working with other physicians, hospitals and payer to
develop guidelines for cost-effective care.
The physician’s professional responsibility for
appropriate allocation of resources requires scrupulous
avoidance of superfluous tests and procedures. The
provision of unnecessary services not only exposes ones
patients to avoidable harm and expenses but also
diminishes the resources available to others.
- COMMITMENT TO SCIENTIFIC KNOWLEDGE
Much of medicine’s contract with society is based on the
integrity and appropriate use of scientific knowledge
and technology. Physicians have a duty to uphold
scientific standards, to promote research, and to create
new knowledge and ensures its appropriate use.
The profession is responsible for the integrity of this
knowledge, which is based on scientific knowledge and
physician experience.
- COMMITMENT TO MAINTAINING TRUST BY MANAGING CONFLICTS
OF INTEREST
Medical professionals and their organizations have many
opportunities to compromise their professional
responsibilities by pursuing private gain or personal
advantage.
Such compromises are especially threatening in the
pursuit of personal or organizational interactions with
for-profit industries, including medical equipment
manufacturers, insurance companies and pharmaceutical
firms.
Physicians have the obligation to recognize, disclose to
the general public, and deal with conflicts of interest
that arise in the course of their professional duties
and activities.
Relationships between industry and opinion leaders
should be disclosed, especially when the latter
determine the criteria for conducting and reporting
clinical trials, writing editorials or therapeutic
guidelines, or serving as editors of scientific
journals.
- COMMITMENT TO PROFESSIONAL RESPONSIBILITIES
As members of a profession, physicians are expected to
work collaboratively to maximize patient care, be
respectful of one another, and participate in the
processes of self-regulation, including remediation and
discipline of members who have failed to meet
professional standards.
The profession should also define and organize the
educational and standard-setting process for current and
future members. Physicians have both individual and
collective obligations to participate in these
processes. These obligations include engaging in
internal assessment and accepting external scrutiny of
all aspects of their professional performance.
OPINION ON ETHICS AND PROFESSIONALISM
ADVERTISING BY ORTHOPAEDICF SURGEONS
ISSUES RAISED:
What parameters exist to guide orthopaedic surgeons
regarding advertising?
APPLICABLE PROVISION OF THE PRINCIPLES OF MEDICAL ETHICS
AND PROFESSIONALISM.
IX: The orthopaedic surgeon should not publicize himself
or herself through any medium or form of public
communication in an untruthful, misleading or deceptive
manner.
APPLICABLE PROVISIONS OF THE CODE OF MEDICAL ETHICS AND
PROFESSIONALISM
I.D (i) When obtaining informed consent for treatment,
the orthopaedic surgeon is obliged to present to the
patient or the person responsible for the patient, in
understandable terms, pertinent medical facts and
recommendations consistent with good medical practice.
(ii) Such information should include alternative modes
of treatment, the objectives, risks and possible
complications and consequences of no treatment.
II. A (i) The orthopaedic surgeon should maintain a
reputation for truth and honesty.
(ii) In all professional conduct, the orthopaedic
surgeon is expected to provide competent and
compassionate patient care, exercise appropriate respect
for other health care professionals, and maintain the
patients’ best interests as paramount.
IV. A (i) The orthopaedic surgeon should not publicize
himself or herself through any medium or form of public
communication in an untruthful, misleading or deceptive
manner.
LEGAL ANALYSIS:
• State laws prohibit medical associations like the SAOA
from impeding physicians who use truthful advertising.
The reason for this prohibition is to preserve and
promote a free and open market by enabling physicians to
disseminate information about their services to
patients. It is believed that truthful advertising may
assist patients in making better informed judgements and
choices.
• Although truthful advertising has substantial legal
protections, physician advertising that is not truthful
is not protected. In fact, physician advertising that is
false, deceptive or misleading is illegal.
• Patients who have been injured by false or misleading
physician advertising may be able to sue the physician
involved for damages under consumer protection statutes
or common law fraud claims.
ETHICAL ANALYSIS:
• Orthopaedic surgeon, like all physicians, has an
ethical obligation to present themselves and the
services they provide to patients in a clear and
accurate manner.
• A successful physician-patient relationship is based
on trust. The patient trusts that the physician has the
appropriate training and skills, will listen to the
patient’s complaints and symptoms, and will advise the
patient accurately and objectively about the alternative
courses of treatment. It is essential in this
relationship that the patient has confidence that the
physician is honest and is not manipulating the
information presented for any purpose. Because the
patient is often in a relatively uninformed position,
patients usually assume that the physician is telling
them all they need to know and that what they are told
is accurate.
Consequently, patients are especially at risk for
untruthful, misleading or deceptive advertising. For
this reason false and deceptive advertising by
physicians destroys the trust relationship between the
physician and patient which is essential to quality
medical care. A physician’s misrepresentation may harm
patients by making them less likely to seek out
treatments they need or vulnerable to accepting
treatments that are not essential.
• Four general rules to determine whether physician
advertisements are truthful and not false, deceptive or
misleading have been developed. They are:
- Advertisements should be accurate and not contain
explicit false claims or misrepresentations of material
fact. Generally, a false claim or misrepresentation of
fact would be material if it would be likely to affect
the behaviour or actions of an ordinary and prudent
person regarding a physician or physician service.
- Advertisement should not contain material implied
false claims or implied misrepresentation of material
fact. An advertisement that does not contain direct
false claims or misrepresentations should not by
implication create false or unjustified expectations
about the physician or physician services being
publicized. An implied false claim or misrepresentations
would be material if it would be likely to affect the
behaviour of an ordinary and prudent person towards a
physician or physician service.
- There should be no omissions of material fact from
advertisements. In advertisements, disclosures of
information are necessary where omission would make the
advertisement as a whole misleading to an ordinary and
prudent person or an average member of the audience to
whom it is directed.
- Physicians should be able to substantiate material
claims and personal representations made in the
advertisement
The ultimate question of whether an advertisement is
truthful can be determined by addressing whether all
four of these rules of truthful advertising have been
followed in the development and dissemination of the
advertisement.
SPECIFIC ISSUES:
- ENDORSEMENTS AND PICTURES
Endorsements and pictures are sometimes used to
represent the benefits of specific orthopaedic services,
such as degree of relief, recovery, or other benefits
that may be attained if the services are used.
The primary concern raised by endorsement and pictures,
is whether they communicate benefits of orthopaedic
services that are representative of the benefits
ordinary attained by the average patient. If they
communicate a degree of relief or recovery that is
exceptional or otherwise not representative of the
average patient, they may mislead patients into having
unjustified medical expectations about the orthopaedic
services advertised.
- CLAIMS : “PAINLESS”:
The degree of comfort, ease, or pain involved in the
provision of an orthopaedic service is difficult to
measure by objective standards. How these factors are
experienced by an individual is subjective and varies
from patient to patient.
Therefore, claims or representations about the degree of
comfort, or lack of pain involved in an orthopaedic
service may be difficult to substantiate and may be
misleading if not used with care.
Statements that an orthopaedic procedure does not cause
pain or is painless raise concerns if the services
advertised are invasive. It is highly unlikely that an
invasive orthopaedic procedure will not cause some
degree of pain.
- CLAIMS : “SAFE OR EFFECTIVE”:
General representations about the safety or
effectiveness of specific orthopaedic services should
not be misleading. Such representations may cause a
layperson to lack appreciation for the nature of any
risks or adverse effects associated with the orthopaedic
procedure, even if the likelihood that adverse effects
may occur is low. More specific representation also
causes concerns. For example, a statement that an
orthopaedic surgeon has cured or successfully treated a
large number of cases involving a particular serious
ailment is deceptive if it implies a certainty or result
and creates unjustified and misleading expectations in
prospective patients. Representations about safety and
effectiveness of orthopaedic services should be
substantiated with sound scientific support, such as
peer reviewed publications in medical literature of
other authoritive sources of scientific information.
Simply using a phrase such as “safe” is likely to
deceive prospective clients by implying and absolute
standard, when in fact the “safety” of an orthopaedic
procedure is necessarily a qualified concept. The
failure to qualify the claim is particularly
objectionable since a variety of phrases could easily be
employed to communicate the safety/risk relationship
(eg. “Relatively safe”, “safe for the most patients”.
or, “Among the safer type of orthopaedic surgery.”)
- CLAIMS : “CURE”:
Use of the term “cure” with reference to a problem is
often deceptive. To “cure” a condition means to alter
the circumstances so that the condition no longer exists
and will not recur.
In order not to be misleading, the term “cure” should
almost always be further explained and qualified to give
the patient an accurate understanding of his/her
prospects for improvement.
- CLAIMS : PHYSICIAN QUALIFICATIONS
Orthopaedic surgeon qualifications include education,
training, and other indicators of status and achievement
within the profession. The lay public does not have a
good understanding about what various qualifications
represent.
Most patients will assume that physician qualifications
in an advertisement indicate training, knowledge,
expertise and competence with respect to the services
being advertised. That assumption is likely because
patients will conclude that the qualifications are
listed in an advertisement to substantiate the
orthopaedic surgeon’s ability to perform the service
being advertised.
It is possible for patients to be misled if the
qualifications listed imply a level of education or
training which the orthopaedic surgeon did not receive;
if they imply a degree of scrutiny of the orthopaedic
surgeon’s knowledge, training and competence that did
not occur; if they imply a qualification which the
orthopaedic surgeon does not have; if the qualifications
are inaccurately listed; or if the qualifications do not
indicate education, training, knowledge, or competence
with respect to the services being advertised.
- CLAIMS : “WORLD FAMOUS”, “TOP SURGEON”, “PIONEER”:
Only a small fraction of all orthopaedic surgeons can
justifiably claim to be “world famous.” These may
include some orthopaedic surgeons who are editors of
major journals, who have authored widely used texts, or
who have made major, original contributions to medical
techniques. However, it is the very elusiveness of
measures of “fame” which make invoking them in trying to
lure patients misleading. Merely travelling widely,
presenting addresses at professional meetings or
treating patients from abroad does not mean that an
orthopaedic surgeon is “word-famous.” To so indicate is
to use the inherent impression of the concept fame to
mislead patients. There can be little question that such
claims are employed in order to give patients the
impression that the orthopaedic surgeon meets some
objective, high level of competence, skill or
recognition – which probably does not exist with respect
to the advertiser.
The same is true of advertising oneself as a “top
orthopaedic surgeon.” Saying that one has “pioneered
advances in orthopaedic surgery” is also deceptive. Such
a phrase connotes a major break through, not a minor
alteration or refinement of conventional procedures.
Simply being one of many “investigators” for a type of
orthopaedic prosthesis, using one piece of equipment, or
using a slightly refined surgical procedure does not
justify use of the term “pioneer”. Since all orthopaedic
surgery requires some degree of innovation, an
orthopaedic surgeon cannot meaningfully claim to be an
originator or developer of a technique or product simply
because he or she has modified what existed before in
some minor way.
- CLAIMS : FEES AND COSTS
Orthopaedic surgeons may advertise truthful information
about fees and costs.
However, statements about fee information can be
misleading if they do not fairly inform the public about
the costs likely to be incurred when patronizing the
advertised physician. For example, the description of
any service for which a fee or a range of fees is
advertised must not be deceptive or misleading, and the
statement should also indicate whether there may be
additional fees for related services that are commonly
required when the advertised service is obtained.
THE ORTHOPAEDIC SURGEONS RELATIONSHIP WITH INDUSTRY
ISSUES RAISED:
Under what, if any circumstances are it appropriate for
orthopaedic surgeons to accept gifts or other financial
support from industry, including pharmaceutical,
biomaterial or device manufacturers?
APPLICABLE PROVISIONS OF THE PRINCIPLES OF MEDICAL
ETHICS AND PROFESSIONALISM
I. Physician- patient relationship
• The orthopaedic profession exists for the primary
purpose of caring for the patient.
• The physician-patient relationship is the central
focus of all ethical concerns.
• The orthopaedic surgeon should be dedicated to
providing competent medical service with compassion and
respect.
APPLICABLE PROVISIONS OF THE CODE OF MEDICAL ETHICS AND
PROFESSIONALISM:
I. A. (i) The orthopaedic profession exists for the
primary purpose of caring for the patient.
III. C. (i) When an orthopaedic surgeon receives
anything of significant value from industry, a potential
conflict exists which should be disclosed to the
patient.
(ii) When an orthopaedic surgeon received inventor
royalties from industry, the orthopaedic surgeon should
disclose this fact to the patient if such royalties
relate to the patient’s treatment.
(iii) It is unethical for an orthopaedic surgeon to
receive compensation of any kind from industry for using
a particular device or medication.
(iv) Reimbursement for reasonable administrative costs
in conducting or participating in a scientifically sound
research clinical trial is acceptable.
IV. A. (i) The orthopaedic surgeon continually should
strive to maintain and improve medical knowledge and
skill.
(ii) The orthopaedic surgeon should make available to
patients and colleagues the benefits of his or her
professional attainments.
(iii) Each orthopaedic surgeon should participate in
continuing medical educational activities.
DISCUSSION
Orthopaedic surgeons have long recognized the importance
or continuing medical education in maintaining their
professional skills.
Both orthopaedists-in-training and practicing
orthopaedic surgeons attend and participate in numerous
continuing medical educational programmes and seminars.
Industry, including pharmaceutical, biomaterial and
device manufactures, has generously supported many of
these beneficial programmes.
For several years, there has been concern about industry
making gifts to physicians. Some of these gifts that
reflect customary marketing practices of industry may
not be consistent with basic principles of medical
ethics. The line is sometimes burred between industry’s
providing funds for an actual continuing medical
educational experience and providing funds to promote
the use or purchase of a particular pharmaceutical,
biomaterial or a piece of orthopaedic equipment.
Generally the SAOA believes that it is acceptable for
industry to provide financial and other support to
orthopaedic surgeons if such support has significant
educational value and has the purpose of improving
patient care. All the dealings between orthopaedic
surgeons and industry should benefit the patient and be
able to withstand public scrutiny.
GUIDELINES
To avoid acceptance of inappropriate gifts or other
financial support, the SAOA recommends that orthopaedic
surgeons observe the following guidelines.
- Benefit to patients
The patient’s best interest is paramount. Therefore it
is of utmost importance that any gift or other financial
support accepted by an orthopaedic surgeon should
primarily entail a benefit to his or her patient.
A gift of any kind from industry should in no say
influence the orthopaedic surgeon in determining the
most appropriate treatment for his or her patient.
It is only by strict adherence to this principle that
the orthopaedic surgeon may maintain the patient’s
trust.
- Gifts with condition attached
Orthopaedic surgeon should not accept gifts with
conditions attached.
No gifts (including goods, meals, accommodations,
meeting registration, travel etc to attend educational
meetings or learning new skills under the tutelage of an
expert) should be accepted with the implicit requirement
that the orthopaedic surgeon use the products or
services provided by that particular industry.
- Social functions
Although the SAOA is generally opposed to social events
sponsored by industry, social functions supported by
industry in combination with significant continuing
medical education events are acceptable.
However, social functions supported by industry (e.g.
dinners, tickets to sporting events or theatre, golf
outings etc.) where there is no educational element,
should not be offered to nor accepted by orthopaedic
surgeons.
- Cash Gifts
Cash gifts from industry to orthopaedic surgeons must
not be offered nor accepted.
- Continuing medical education events
A. Subsidies
Subsidies by industry to underwrite the costs of
educational events where CPD credit is provided can
contribute to the improvement of patient care and are
acceptable. A corporate subsidy received by the
conference’s sponsor is appropriate and acceptable so
long as such support is publicly acknowledged and the
location, curriculum, faculty and educational methods of
the conference or meeting are determined solely by the
organization sponsoring the educational course, not
industry.
Industry reimbursement, whether direct or indirect, for
an orthopaedic surgeon to attend an educational event is
not appropriate.
B. Faculty expenses and honoraria for CPD activities
It is appropriate for faculty at educational events
where CPD credits are provided to accept reasonable
honoraria and to accept reimbursement for reasonable
travel, lodging and meal expenses from the conference’s
sponsor.
- Other educational events
Educational; events sponsored by industry may be of
educational value and improve patient care. Orthopaedic
surgeons are responsible for ensuring that decisions to
accept subsidies from industry are in the best interest
of their patients. The SAOA believes that a potential
conflict or interest exists when an orthopaedic surgeon
receives such subsidies.
Special circumstances may arise in which orthopaedic
surgeons may be required, to learn new techniques
demonstrated by an expert in the field or to review new
implants or other devices on-site. On-site education
provides the added benefit of educating a larger number
of attendees per session and offers important insights
into the function of ancillary staff and institutional
protocols. In these circumstances, reimbursement for
expenses may be appropriate.
Reimbursement should be limited to expenses that are
strictly necessary and able to withstand public
scrutiny. In no case should honoraria or reimbursement
for time off to attend the course be offered or
accepted. In addition, attending the course and learning
the technique must not require or imply that the
orthopaedic surgeon must subsequently use that
technique.
- Scholarships for orthopaedic surgeons-in-training
Scholarships or other specific funds from industry to
permit orthopaedic surgeons-in-training to attend
continuing medical education conferences are appropriate
as long as the selection of students, registrars or
fellows who will receive the funds is made by the
orthopedist-in-training’s programme director.
- Consultant expenses and honoraria
It is appropriate for consultants to industry who
provide genuine services as faculty in educational
events to receive reasonable compensation and to accept
reimbursement for reasonable travel, lodging and meal
expenses.
Token consulting or advisory arrangements such as
passive attendance at a meeting or being named to an
advisory board for simply discussing a device without
making any real contribution to product development or
analysis, cannot be used to justify compensating
orthopaedic surgeons for their time, travel, lodging or
other out-of packet expenses.
- Other consulting arrangements
A symbiotic relationship exists between orthopaedic
surgeons and industry. Orthopaedic surgeons are best
qualified to provide innovative ideas and feedback,
conduct research trails, serve on scientific advisory
boards, and to serve as faculty to teach the use of new
technology. Orthopaedic surgeons, in an effort to
improve patient care, rely on industry to bring their
creative ideas to fruition. A collaborative relationship
between orthopaedic surgeons and industry is necessary
to improve patient care but must be carefully
scrutinized to avoid pitfalls or improper inducements,
whether real or perceived.
It is appropriate for consultants to industry that
provides genuine services to receive reasonable
compensation for their services. Such arrangements
should be established in advance and in writing to
include evidence of the following:
a) Documentation of actual need for the service
b) Proof that the service was provided
c) Evidence that physician reimbursement for consulting
services should be equal to fair market value.
Examples of inappropriate relationships between
orthopaedic surgeons and industry include but are not
limited to:
a) Receiving a consultant fee for simply attending a
meeting
b) Receiving remuneration for using a particular implant
c) Receiving consultant fees or other financial
inducement for switching form one manufacturer’s product
to another.
Proper collaborative relationship s between orthopaedic
surgeons and industry are essential for advancement and
improvement in patient care. Such relationships allow
industry to fulfill their goals to improve patient care
and increase patient access to new products and are also
beneficial to orthopaedic surgeons and their patients.
Orthopaedic surgeons must continually strive to improve
patient care through the development of new advances and
methodology.
Orthopaedic surgeons should never lose sight of their
primary ethical responsibility to provide competent,
compassionate patient care, maintaining professionalism
and objectivity at all times.
OPINION ON ETHICS AND PROFESSIONALISM
CONTINUING MEDICAL EDUCATION
ISSUES RAISED:
What are the standards of continuing medical education
to which orthopaedic surgeons should subscribe?
APPLICABLE PROVISION OF THE PRINCIPLES OF MEDICAL ETHICS
AND PROFESSIONALISM.
- * The orthopaedic surgeon continually must strive to
maintain and improve medical knowledge.
* The orthopaedic surgeon should make relevant
information available to patients, colleagues and the
public.
APPLICABLE PROVISION OF THE CODE OF MEDICAL ETHICS AND
PROFESIONALISM
- A (i) The orthopaedic surgeon should continually
strive to maintain and improve medical knowledge and
skill.
(ii) The orthopaedic surgeon should make available to
patients and colleagues the benefits of his or her
professional attainments.
(iii) Each orthopaedic surgeon should participate in
continuing medical educational activities.
BACKGROUND:
Every orthopaedic surgeon has an ethical and
professional obligation to stay abreast of the
developing knowledge in the musculoskeletal sciences.
The contract that exists between surgeon and patient,
and between the profession and society, requires the
acceptance of this obligation. The rate of growth of
scientific knowledge and clinical experience in our
specialty place an extraordinary responsibility on each
orthopaedic surgeon to maintain his or her knowledge
base.
The South African Orthopaedic Association believes that
a lifelong commitment to continuing medical education is
essential for orthopaedic surgeons. This commitment is
essential if orthopaedic surgeons as professionals are
to fulfill their commitments to provide high quality
health care.
The choice of educational methods or experience is the
responsibility of individual orthopaedic surgeons. The
SAOA places no specific requirements on its members in
terms of areas or types of instruction, minimum number
of hours of education during a particular time period,
or preferred providers of education programmes.
RECOMMENDATIONS:
The SAOA believes that each orthopaedic surgeon must
develop hi s or her own approach to knowledge
maintenance in an organized and explicit manner to
assure that it addresses content in all areas in which
care is provided.
To do this requires:
- self generated practice audit to determine the types
of conditions, procedures, complications etc, which
comprise one’s practice experience, and to assess the
results of treatment provided.
- A periodic self-assessment evaluation which addresses
the knowledge and content areas relevant to the
individual practice.
- The development of a personal education plan, to
include study in identified areas of deficiency, and the
subsequent scheduling of educational activities to
fulfill the goals developed in the education plan.
As an association devoted to the education of
orthopaedic surgeons and others the SAOA makes available
current authoritive and evaluative educational materials
to enhance orthopaedic knowledge and to facilitate the
provision of improved patient care.
The SAOA’s commitment to education is enduring and
substantive. Every orthopedist should make a similar
commitment to excellence.
OPINION ON ETHICS AND PROFESSIONALISM
ETHICS IN HEALTH RESEARCH IN ORTHOPAEDIC SURGERY
ISSUE RAISED:
What are the general ethical issues involved in the
conduct of health research in orthopaedic surgery.
APPLICABLE PROVISIONS OF THE PRINCIPLES OF MEDICAL
ETHICS AND PROFESSIONALISM
- INTEGRITY
-
- The orthopaedic surgeon should maintain a reputation
for truth and honesty with patients and colleagues.
- The orthopaedic surgeon should strive to expose
through the appropriate review process those physicians
who are deficient in character or competence or who
engage in fraud and deception.
- MEDICAL KNOWLEGDE
-
The orthopaedic surgeon continually must strive to
maintain and improve medical knowledge.
- The orthopaedic surgeon should make relevant
information available to patients, colleagues and the
public.
APPLICABLE PROVISIONS OF THE CODE OF MEDICAL ETHICS AND
PROFESSIONALISM
- C.
- When an orthopaedic surgeon receives
anything of significant value from industry, a potential
conflict of interest exists which should be disclosed to
the patient.
- When an orthopaedic surgeon receives inventor
royalties from industry, the orthopaedic surgeon should
disclose this fact to the patient if such royalties
relate to the patient’s treatment.
- It is unethical for an orthopaedic surgeon to
receive compensation of any kind from industry for using
a practical device or medication.
- Reimbursement for reasonable administrative costs
in conducting or participating in a scientifically sound
research clinical trial is acceptable.
III. D. - An orthopaedic surgeon reporting on clinical
research or experience with a given procedure or device
must disclose any financial interest in that procedure
or device if the orthopaedic surgeon or any institution
with which that orthopaedic surgeon is connected, has
received anything of value from its inventor or
manufacturer.
IV. A. - The orthopaedic surgeon continually should
strive to maintain and improve medical knowledge and
skill.
- The orthopaedic surgeon should make available to
patients and colleagues the benefits of his or her
professional attainments.
VII. A. - All research and academic activities must be
conducted under conditions of full compliance with
ethical, institutional and government guidelines.
- Patients participating in research programmes must
have given full informed consent and retain the right to
withdraw from research protocol at any time.
B. - Orthopaedic surgeons should not claim as their
own intellectual property which is not theirs.
- Plagiarism or the use of others’ work without
attribution is unethical.
C. - The principle investigator or a scientific
research project or clinical research project is
responsible for proposing, designing and reporting the
research.
- The principal investigator may delegate portions of
the work to other individuals, but this does not relieve
the principal investigator of the responsibility for
work conducted by other individuals.
- The principal investigator or senior author of a
scientific report is responsible for ensuring that
appropriate credit is given for contributions to the
research described.
DEFINITIONS:
Orthopaedic surgeons conduct research in a number of
areas. “Health Research” is considered to be the
universe of research dealing with health care-related
matters. Health care research encompasses various types
of research, including clinical research, outcome
studies research, psychological research and demographic
and economic studies. Clinical research is defined as a
part of a systematic programme competently designed,
under accepted standards of scientific research, to
produce data that are scientifically valid and
significant.
In this opinion, unless otherwise noted, the broad term
“Health Research” will be used.
ETHICAL CONSIDERATIONS:
According to the SAOA’s opinion on ethics and
professionalism regarding continuing medical education,
upon completion of orthopaedic residences, orthopaedic
surgeons assume an ethical and professional obligation
to stay abreast of developing knowledge in the
musculoskeletal sciences. Many orthopaedic surgeons have
chosen to go beyond this basic obligation to assist in
the advancement of musculoskeletal knowledge and its
dissemination.
Orthopaedic surgeons who conduct health research have
special ethical responsibilities. They must accept
responsibility for ethical conduct in their own
scientific work and should help support high standards
of ethical conduct in the scientific community. Failing
to do so may impede or delay progress in learning about
musculoskeletal sciences and will damage the credibility
of all health researchers, thereby harming not only the
research community, but also the greater orthopaedic
community and the patients whose care depends on the
results of research.
The SAOA believes that the tenets described below
constitute reasonable guidelines to assist health
researchers in orthopaedics. These guidelines include
the following:
- The purpose of health research
Health research should be designed and conducted to
develop new or confirmatory knowledge that promotes
health, prevents diseases and injuries and improves
diagnosis and treatment of diseases and injuries. If the
research involves human subjects, it is appropriate only
when potential risks to the patient are reasonable in
relation to the potential benefits to the patient or the
future patients and the importance of the knowledge
which reasonably might be gained.
Examples of unethical conduct:
• Designing and conducting research with the primary
purpose of discerning methods of causing injury, illness
or suffering.
• Designing or conducting research that is repetitious
or redundant with the primary intent of advancing
individuals or specific groups financially or
professionally.
• Designing or conducting research that is not intended
to produce new or confirmatory information that is valid
or significant; and
• Purposefully stating, reporting or misinterpreting
data to arrive at a pre-determined theory or opinion.
- Support or sponsorship of research
Support by industry for biomedical research has risen
sharply in recent years.
For many years health researchers perceived that
commercial support of research was inappropriate because
of the potentially biased results which may occur. This
position has softened significantly since many major
medical developments have resulted from research funded
by private sources. Furthermore, industry support of
health research particularly biotechnology research, has
become substantial in recent years.
There are three parties, with distinct interests,
concerned with the corporate funding of health research:
(1) the individual researcher; (2) the research
institution: (3) the corporation funding the research.
The interrelationships among these groups may vary
substantially.
In the first type of relationship, the funding
corporation develops a request for proposal or presents
a research protocol to the researcher and fund the
researcher for carrying out the protocol. This
essentially creates a fee-for-service arrangement.
Assuming that basic rules for scientific propriety are
followed, this constitutes an appropriate remunerative
relationship. In this relationship, it may be
undesirable for the researcher to deal or negotiate with
the corporation funding the research. Consequently
research institutions or other parties may create a
structure whereby funded research arrangements can be
negotiated in a manner that is satisfactory to all
parties.
A second type of relationship involves the researcher
submitting an unsolicited research proposal directly to
the funding corporation. The researcher would benefit by
obtaining funds for needed equipment and supplies and
the funding corporation would benefit by the possibility
of expanding its market potential for a given product.
This arrangement may also be viewed as ethically
appropriate and mutually beneficial, assuming the proper
conduct of science ensues and full disclosure is
maintained.
A third type of relationship involves truly cooperative
projects. Often, these types of relationships are
enacted in the setting of clinical trials. Numerous
advantages exist for the researcher, the research
institution, and the funding corporation for the
development of cooperative programmes between medicine
and industry. Full disclosure is essential to the
success of this type of venture.
Ethical problems may arise when the researcher or the
research institution have a direct financial interest in
the research programme. For example, researchers may
hold stock or stock options in the funding corporation
that manufacturers the product or they may have other
profit-sharing arrangements with the company. These
financial interests may compromise (or give the
impression of compromising) the objectivity of the
researchers and cause them to downplay or suppress
negative data while exaggerating favourable data. Such
economic incentives may also introduce subtle biases
into the way research is conducted, analysed or
reported.
The SAOA believes that guidelines for circumstances in
which researchers face economic conflicts of interest
may be determined in reference to two ethical
principles:
• A researcher may ethically share the economic rewards
of his or her efforts. If a drug, device or other
product becomes financially remunerative, the researcher
may receive profits that reasonably resulted from his or
her contribution. The code of medical ethics and
professionalism explicitly permits an orthopaedic
surgeon to receive royalties. However, the researcher
ethically may not reap profits that are not justified by
the value of his or her actual efforts.
• Potential sources of bias in research should be
eliminated, particularly where there is a direct
relationship between a researcher’s personal interest
and potential outcomes of the research.
Several conclusions result by applying these two ethical
principles. Once the researcher becomes involved in a
research project for the funding corporation or knows
that he or she might become involved in the research, he
or she should not buy or sell the funding corporation’s
stock until the involvement ends and the results of the
research are publicly disseminated. As long as the
researcher is involved in research on the funding
corporation’s product, he or she has the potential to
derive profits that stem from inside information, rather
than from individual effort.
Researchers may serve as consultants or may be retained
to lecture on behalf of the funding corporation.
However, the researchers’ remuneration ethically must be
commensurate with his or her actual efforts on behalf of
the funding corporation.
Safeguards may be necessary to protect against the
appearance of impropriety, even when ethically
permissible relationships among the researcher, research
institution and the funding corporation exist. Full
disclosure presents the best mechanism to address doubts
about propriety of a research arrangement. Researchers
should disclose all ties to corporations whose products
they are investigating for example, the researcher’s
participation in educational activities supported by the
corporation; participation in other research projects
funded by the corporation; and consulting arrangements
with corporation must be disclosed to the research
institution, to the funding corporation, to audiences
who hear the research results and to journals that
publish the results of research.
Examples of unethical conduct:
• Knowingly negotiating for more funding than is
appropriate to support the project and related
institutional and departmental overhead costs.
• A researcher’s selling or purchasing stock in a
company whose orthopaedic device is being tested by that
orthopaedic surgeon-researcher.
• A researcher’s receiving financial incentives to alter
data.
• A researcher’s receiving excessive remuneration by the
funding corporation for evaluating that corporation’s
products.
• A failure to disclose research or consulting
arrangements with the funding corporation when reporting
about research on devices manufactured by that
corporation.
- Use of research resources
Resources allocated by any agency, industry or
organization for the performance of specific research
should be used only for that purpose unless the granting
agency gives specific permission for reallocation of the
resources.
Example of unethical conduct.
• Using resources provided by any organization for the
direct financial benefit or personal use or the
investigators.
- Use of animals in research
The SAOA believes that the appropriate and humane use of
animals in research is justified to enhance the quality
of life of both humans and animals. Animals should be
used in research only when there are no suitable
alternatives. Research projects should be designed to
use the minimal number of animals possible in a manner
that avoids abuse of animals and maintains appropriate
standards of animal care. Researchers should conduct
animal research only with the approval of the
institution’s ethical committee and in compliance with
applicable regulations and standards.
Examples of unethical conduct:
• Using methods that cause animals unnecessary
discomfort.
• Failing to maintain appropriate standards of animal
care.
• Using excessive numbers of animals to perform
experiments
• Using inappropriate animal models, and
• Using animals when other methods of conducting the
research would be scientifically valid eg. computer
simulations, tissue culture or mathematical models.
- Use of human subjects in research
The progress in medical care through research depends on
informed partnership between patients and physicians in
the development of new drugs and treatment methods It is
recognized that certain advances in the knowledge of
treatment of disease can only be learned by properly
conducted clinical trials during which the result of
varying treatments recommended by individual doctors are
carefully compared.
Human subjects should be used in health research only
when there is no reasonable alternative. Human subjects
should never be exposed to unnecessary risk,
embarrassment or expense and should fully understand the
purpose of the research and if their participation may
benefit them (a therapeutic experiment) or is intended
primarily to benefit future patients (a non-therapeutic
experiment). The selection criteria of human subjects
must be objective and reasonable.
Human subjects should provide voluntary informed consent
before being included in a prospective study and should
be allowed to decline to continue participation in a
research programme at anytime without compromising of
their medical care. To ensure full informed consent,
three elements must exist:
1. The orthopaedic surgeon must explain tot the patient
in terms the patient can understand the proposed
treatment, its likely effect on the patient, and purpose
of the research. Orthopaedic surgeons must provide at
least the degree of information that is required by
applicable law, which will include at minimum
information on the purpose of research, its potential
side effects, alternatives and risks of the proposed
treatment as well as the method, purpose, conditions of
participation and the opportunity to withdraw from the
research protocol without penalty.
2. The patient must understand for what they are
providing consent. The orthopaedic surgeon must believe
reasonably that the patient has understood the basic
information and has engaged in rational decision-making
in deciding to participate in the research: and
3. The patient must consent voluntary. The orthopaedic
surgeon must believe that the patient’s consent is free
from undue or overbearing influences, e.g. fear of loss
of care or medical benefits if the patient declines to
participate.
Human subjects participating in clinical research
programmes should receive the care and treatment that is
in their best interest and be assured that the potential
benefit of the research outweighs the risks. Researchers
should conduct human research only with the approval of
the institution’s ethical committee on research and in
compliance with all applicable regulations and
standards.
Research on population designated as vulnerable
(including children and pregnant women) must be
scrutinized with special care. For research involving
minors, assent (by the minor) may be required in
addition to parental or guardian consent. In addition,
any review of any patient information, including
retrospective chart and X-ray review, for any purpose
other than care of an individual patient or quality
improvement, must be approved by the ethics committee.
Examples of unethical conduct:
• Failing to disclose risks
• Exposing participating patients to unnecessary risks
• Failing to obtain substituted consent of the patient’s
legally authorized representative when the patient lacks
the legal capacity to consent.
• Causing human subjects unnecessary embarrassment.
• Causing human subjects unnecessary expense.
• Manipulating human subjects cohorts with selected
medical problems or results of treatment with the intent
of proving the investigator’s bias or to promote a given
treatment or medical device; and
• Directly or indirectly coercing human subjects to
participate in the research protocol.
- Responsibility of the research institution
The ultimate responsibility for the ethical conduct of
research resides within the institution in which the
health research is conducted and/or with the primary
investigator. Research institutions should assure that
rigorous scientific standards are upheld by each of
their facility, staff and students and should extend
these standards to all reports, publications and
databases produced by the institution. All medical
schools and research institutions should implement
guidelines for a review process for dealing with
allegations of scientific misconduct, which include
appropriate due process protections for these alleged to
have committed scientific misconduct. In addition, the
research institution must be capable of and committed to
implementing effective procedures for examining
allegations of scientific misconduct.
Examples of unethical conduct:
• The research institution’s failing to maintain
guidelines for dealing with allegations of scientific
misconduct or fraud.
• The research institution’s failing to inform and
educate staff and students of institutional guidelines
for dealing with allegations of scientific misconduct or
fraud; and
• The research institution’s failing to implement and
enforce institutional guidelines for dealing with
allegations of scientific misconduct or fraud.
- Responsibilities of the principal investigator (PI)
The principal investigator of a health research project
is responsible for proposing, designing and reporting
the research. In addition the PI may delegate portions
of the work to other individuals, but this does not
relieve the principal investigator of responsibility for
work conducted by other individuals.
Regulations and laws on a person’s privacy also affect
the storage and dissemination of research information.
Personally-identifiable information designed as
protected health information (PHI) must be kept private.
PHI includes any information which might identify an
individual as well as any information in a medical
record, including diagnosis, treatment, health status
and test results. The principal investigator is
responsible for following this rule. The PI must also
determine the minimum of PHI necessary to perform the
research; to obtain consent from all subjects for
obtaining PHI for research and to document how PHI will
be stored, who will have access to the PHI and how
reports including PHI will be disseminated. Failure to
adhere to the requirements of the privacy rule may
result in civil and criminal penalties.
Examples of unethical conduct:
• The principal investigator’s failing to participate in
and supervise the design or conduct of a research
project.
• The principal investigator’s failing to adequately
supervise those conducting the project.
• Failure to maintain confidentially of PHI obtained for
the purposes of research by the principal investigator
or anyone else assisting with the project.
• The principal investigator’s failing to critically
review the results and verify the accuracy of reports.
- Reporting results of research
The results of research should be described in timely,
objective, accurate, complete reports and potential
conflicts of interest should be identified. Specifically
the code of medical ethics and professionalism provides
that when reporting on clinical research or experience
with a given device or procedure, orthopaedic
researchers have an ethical obligation to disclose any
financial interest in that procedure or device if the
researcher or any institution with which the researcher
is connected has received anything of value from its
inventor or manufactures.
Reports may not disclose individual protected health
information without the express permission of the
subject.
Examples of unethical conduct:
• Failing to provide timely, accurate reports
• Failing to report unfavourable results
• Providing reports that do not contain a sufficient and
accurate methodology to replicate the experiments or
references to where such information might be obtained.
• Falsifying reports
• Fabricating results
• Reporting results of uncertain or minimal significance
unless clearly stated as such.
• Preparing multiple partial reports or duplicate
reports of the same work to increase apparent
productivity of the investigators; and
• Failing to identify potential conflicts of interest
including possible financial benefits to the
investigators from research reports.
- Authorship and credit for scientific work
The principal investigator of a research study is
responsible for ensuring that articles describing the
research include appropriate credit for individuals
contributing importantly to the research. The authorship
policy of the JBJS, which is endorsed by the SAOA,
states that each author must have contributed
significantly to one or more aspects of the study; its
design, data acquisition, analysis and interpretation of
data, drafting of the manuscript; critical revision of
the manuscript; statistical analysis; and/or
supervision. In addition, each author should be able to
defend and assume full responsibility for the content of
the manuscript regardless of the specific contributions.
The sources of financial and technical support and
individuals who provide important materials and
information should be acknowledged.
Examples of unethical conduct:
• Failing to credit co-workers; individuals who have
designed the project or who have interpreted the data:
individuals or agents that have provided resources to
fund the project; or individuals or groups that have
previously performed similar research, if such research
is valid and appropriate.
• Failing to credit sources of quotations
• Plagiarizing or using others’ work without attribution
• Failing to review and credit relevant previous
publications; and
• Including as authors individuals who did not make
substantial contributions to the work.
- Copyrights and royalties
Typically, the patent to devices and the copyright to
articles written belong to the principal investigator or
his research institution or funding corporations. The
ownership of patents, the allocation of revenues,
copyright and other intellectual property interests
among principal investigators, the research institution
and the funding corporations and other important issues
should be made clear either in standing policies or in
clear contracts executed before the commercial support
is received. The rewards of commercialization should be
fairly allocated.
It is ethically acceptable for a principal investigator
to receive royalties from a funding corporation for
using a particular device or medication the researcher
has developed. However, it is unethical for an
orthopaedic surgeon-principal investigator to commit to
always use a particular product which he or she
developed and for which the researcher received
royalties, or to fail to disclose to interested parties,
including patients, that royalties are received for the
use of a device or medication.
Example of unethical conduct:
• The principal investigator’s agreeing to always use a
device he or she developed.
- Research records
Accurate and complete records of research data should be
maintained until there has been sufficient time for
critical review. The time will vary with the type of
research, but five years after publication is sufficient
for most work. It may be required from the principal
investigator to specify the length of time that the
records will be stored, who will have access to them,
the location of the records and precautions to prevent
misuse.
Example of unethical conduct:
• Failing to maintain accurate complete records of
research activity so that replication of the work or
verification of the results is difficult or impossible.
- Scientific errors; contradictory results and
inability to replicate results
If errors in the proposal, conduct or reporting of
research are identified, the principal investigator has
an ethical obligation to report such errors. If the
principal investigator or other investigators repeat an
experiment and obtain results that contradict the
initial report or they are unable to replicate the
experiment, the contradictions and inability to
replicate an experiment should be reported. If the
long-term results of a health research project differ
from the initial reported results, the differences
should be reported. Scientific publications have a
responsibility to publish report of scientific errors,
contradictory results and failures to replicate
previously reported research.
Example of unethical conduct:
• Failing to report any significant scientific error
• Failing to report work that contradicts previously
reported date or conclusions
• Failing to report late adverse outcomes for techniques
or devices which were introduced with favourable initial
experiences.
• Failing to report difficulties in replicating or
verifying previous findings; and
• A scientific publication’s failing to publish reports
of scientific errors, contradictory results, and failure
to replicate previously reported research.
- Obligation to report scientific misconduct:
Orthopaedic surgeons have an ethical obligation to
report scientific misconduct if they become aware of it.
A spectrum of activities constitutes scientific
misconduct, ranging from duplicate publication at the
lower end to fraud and plagiarism at the upper end.
Scientific misconduct can broadly be defined to include
research fraud (including plagiarism, deception,
falsification and/or fabrication of scientific data) as
well as other practices that seriously deviate from
those that are commonly accepted within the scientific
community for proposing, conducting and reporting
research.
However, while it is clear that unequivocal scientific
misconduct must be reported, members of the health
research community have a concurrent responsibility to
attempt to distinguish between honest error and
scientific misconduct. Orthopaedic surgeons must also
respect differences in scientific methods and analysis,
interpretation and judgement about data.
Examples of unethical conduct:
• Failing to identify and report unequivocal instances
of scientific misconduct.
• Personally attacking, verbally or in writing, other
investigators, based upon differences in methods,
analysis, interpretation, judgement or opinion.
• Attempting to discredit or intimidate other
investigators because of differences in methods,
investigation or interpretation of data.
• Attempting to restrict funding or research,
publications or presentation of data because of
differences in interpretation; and
• Making accusations of scientific misconduct when
honest error may be as likely.
Recommendation:
The SAOA urges orthopaedic surgeons who participate in
health research to review and adopt these ethical
tenets. These tenets provide a flexible, ethical
framework for the conduct and the publication of
research results.
OPINION ON ETHICS AND PROFESSIONALISM
SECOND OR ADDITIONAL MEDICAL OPINIONS IN ORTHOPAEDIC
SURGERY
ISSUES RAISED:
- What are the ethical oblications involved in
relationships between orthopaedic surgeons with respect
to providing second or additional medical opinions?
- What different types of second or additional medical
opinions exist?
APPLICABLE PROVISION OF THE CODE OF MEDICAL ETHICS AND
PROFESSIONALISM
I B - The physician-patient relationship has a
contractual basis and is based on confidentiality, trust
and honesty.
- Both the patient and the orthopaedic surgeon are
free to enter or discontinue the relationship within any
constraints of a contract with a third party.
I C - The orthopaedic surgeon should render services
to the best of his or her ability, but may choose whom
he or she will serve.
- Having undertaken the care of a patient, the
orthopaedic surgeon may not neglect that person.
- Unless discharged by the patient, the orthopaedic
surgeon may discontinue service only after giving
adequate notice to the patient so that the patient can
secure alternative care.
VII D - When a patient submits a proper request for
records, the patient is entitled to a copy of such
records as they pertain to that patient individually.
VII A - An orthopaedic surgeon should practice only
within the scope of his or her personal education,
training and experience.
BACKGROUND :
Patients ultimately control their own personal health
care decisions. While some patients may choose to limit
their control of choice by enrolling in managed care
organizations, all patients have the option to obtain
health care from whoever they wish. The physician
assumes a contractural obligation in undertaking the
care of the patient. The patient the ultimate purchaser,
owns and has a right to participate in all decisions in
this contract.
Many patients find medical decision-making difficult,
particularly regarding advanced medical technology. For
this reason and economic pressures to contain costs, the
process of seeking a “second opinion” from another
physician has developed. While patients have
independently sought second or additional medical
opinion to confirm medical decisions in the past, the
frequency of seeking additional medical opinions has
skyrocketed in the past decade. Indeed, some patients
now seek the opinions of multiple physicians as a matter
of course. In today’s environment, there is a
undercurrent of skepticism and distrust that encourages
the solicitation of additional medical opinions. To
compound this, confusion exists about the medical
decision-making process in the lay and health care
communities. Second or additional medical opinions
sometimes have produced anxiety, frustration, anger and
intimidation in patients and physicians alike.
Many questions concerning the ethics of seeking and
providing additional medical opinions have been raised.
Some actions have resulted in accusations of impropriety
and unethical behaviour. While unethical behaviour has
occasionally occurred, many times the conflict has
arisen from a lack of proper communication and mutual
respect between the treating physician and the physician
from whom the patient has sought additional information.
This conflict raises the specter of “turf”, greed and
dishonesty and, when aired in the public forum, does
much to discredit the profession.
DEFINITIONS:
Distinct types of interactions exist involving the
gathering of additional medical opinions to which
different ethical rules apply. They include:
- Consultations with a colleague, initiated by the
treating physician, on behalf of and with the implicit
consent of the patient, to gain additional diagnostic
insight or confirmation in order to continue providing
comprehensive treatment plan for the patient.
- Referrals to a colleague, initiated by the treating
physician, on behalf of and with the consent of the
patient, to share the care of the patient in the
performance of a specified service. A referral might be
temporary or permanent; this decision should b e made
between the two physicians at the time of the referral.
- Transfers, initiated by the treating physician, to
transfer all care of the patient to another physician.
There are legal requirements for the treating physician
in transferring a patient. The consent of the patient is
required.
- Withdrawals, initiated by the treating physician, to
discharge a patient from his or her care. There are
legal requirements for the treating physician who is
withdrawing services from a patient. In addition the
SAOA’s code of medical ethics provides that “unless
discharged by the patient, the orthopaedic surgeon may
discontinue services only after giving adequate notice
to the patient so that the patient can secure
alternative care.”
- Second opinions, initiated by a third party payer or
insurance company of the insured prior to giving
authorization to the physician to perform the procedure
in some health insurance contracts. Patients must comply
with this requirement to receive full benefit of their
contract. The choice of which provider will provide the
additional opinion is the sole decision of the insurer.
The patient may seek additional medical opinions by
initiating a consultation with another physician
concerning his or her care plan or by dismissing the
treating physician and transferring all care to another
health care professional. The patient’s course of action
is entirely within the patient’s prerogative.
ETHICAL CONSIDERATIONS:
The patient has the ultimate decision-making authority
in seeking second or additional medical opinions and
referrals. Although the patient may choose to give up a
certain degree of free choice by participating in
managed care plan or by accepting insurance coverage
with certain limitations, the choice of the options
ultimately remains with the patient.
The SAOA recommends that orthopaedic surgeons observe
the following guidelines regarding second or additional
medical opinions and referrals:
- Any illegal action is unethical. For example, it
would be illegal as well as unethical for the
orthopaedic surgeon providing the second or additional
medical opinion to slander the referring physician if
the slanderous information is known or can be proven to
be false.
- In accepting a patient for consultation, it is
ethical for the consulting orthopaedic surgeon to render
an opinion and return the patient to the treating
physician for continuing care. The consulting
orthopaedic surgeon should communicate with patient as
well as the referring physician about the opinion.
It is unethical for the consulting orthopaedic surgeon
to solicit care of the patient. However, at the sole
discretion of the patient, the patient may choose to
terminate his or her relationship with his or her
treating physician and then enter into another treatment
relationship with the consulting orthopaedic surgeon. It
is not unethical for the consulting orthopaedic surgeon
to accept the patient under these circumstances,
although some orthopaedic surgeons may choose not to
accept the patient because of their personal view that a
conflict of interest situation might be created.
- When treating a patient referred by a colleague, the
accepting orthopaedic surgeon ethically should return
the patient to the referring physician after the index
care has been rendered unless prior arrangements have
been made with the consent of both the referring
physician and the patient to transfer the patient’s care
permanently. In a referral, professional courtesy
dictates that some type of direct communication be given
to the referring physician.
- In specific cases where orthopaedic surgeons agree to
render “second” medical opinions for a third party who
then directs patients to them, the assumption of that
patient’s care may be prohibited expressly by the terms
of the physician’s arrangement with the insurance
company. If the patient is independently seeking an
additional medical opinion, the orthopaedic surgeon may
render an opinion and advise the patient of a treatment
plan, provided the contract permits such action. The
physician must be aware of the provisions of his/her
agreement with the third party.
- As an extension of patient autonomy, patients have an
ethical right to prompt and complete access to their
medical record information unless the physician is bound
by a contract with the patient’s third party payer. As a
corollary, orthopaedic surgeons who offer second or
additional medical opinions at the treating physician’s
or the patient’s request also have a right to complete
access to this information. In general, the physician
legally “owns” the patient’s medical records that he or
she maintains. However, this ownership is subject to the
patient’s right of privacy and, in legal proceedings,
the doctor-patient privilege. It is also subject to the
patient’s right to obtain copies of those records or to
have copies transferred to another person.
It is in the patient’s best medical interest for
orthopaedic surgeon to cooperate fully in sharing copies
of a patient’s medical records, including physician’s
notes, prescriptions, charts, reports, laboratory
results, technical information used to assess the
patient’s health condition, letters, photographs,
X-rays, and diagnostic imaging. This is true whether the
patient is referred by one orthopaedic surgeon to
another for a consultation or if the patient elects to
see another orthopaedic surgeon for continuing
treatment.
- The orthopaedic surgeon is bound legally and
ethically to give his or her best medical opinion,
regardless of whether the orthopaedist is the treating
physician or the physician who is asked to render a
second or additional medical opinion. The best interest
of the patient should clearly remain the guiding
principle. Ultimately, patients independently may choose
their treating physician, request transfers of their
care, and dismiss their physician at their own
discretion.
ADVISORY STATEMENT
COMMUNICATING ADVERSE OUTCOMES
The responsibility to inform a patient of his/her family
of an adverse outcome is an inevitable part of the
practice of medicine. Adverse events, or disappointing
outcomes, do not necessarily occur as a result of an
error or negligent care: These results occur for
multiple reasons, including uncorrected “unreasonable”
expectations, complicating biological factors and course
of treatment or surgery that don’t work out as
anticipated.
When such an event happens, a patient often wants
acknowledgement and understanding, an assurance that the
physician will take steps so that the event will not
occur again or risks of a similar occurrence will be
minimized, an apology (if appropriate) and consideration
of the financial impact on the patient.
The SAOA believes that an orthopaedic surgeon should put
the interests of the patient first and communicate
directly with a patient/family member in an honest,
compassionate manner as soon as possible after an
adverse event occurs.
Good communication with patients has always been
essential in orthopaedic practice and is the cornerstone
of the physician-patient relationship. Open honest
communication favourable affects patient behaviour,
health outcomes, patient satisfaction, and often reduces
the incidence of malpractice actions.
After an adverse event occurs, it is the orthopaedic
surgeon’s responsibility to assure the event is
investigated and all the facts are collected. The
patient’s health care need should be addressed as soon
as possible.
When an adverse outcome has occurred, the orthopaedic
surgeon should communicate in an honest, empathic manner
with the patient or his/her family as soon as feasible
after the event. During the course of the discussion,
the orthopaedic surgeon should refrain from commenting
about reasons for the event until a medical
investigation is concluded. Currently understood facts
related to the patient’s condition should be discussed
and follow up with the patient after the investigation
is completed should occur. Blame should not be assigned
and speculation about the fault should be avoided. An
honest disclosure of what happened to the patient will
reduce anger and mistrust, as will an apology that
avoids a suggestion of fault or conjecture, if
appropriate. The orthopaedic surgeon should describe
precautions that will be taken so that the risk of the
same event happening again will be minimized. The
discussion should also include recommendations and steps
for follow-up care and an offer to transfer the
patient’s care to another physician, if appropriate. An
administrator or patient liaison should be present, if
possible, both to serve as a witness and to assist with
the patient’s resulting needs and requests.
If an error is the cause of the adverse event, the
orthopaedic surgeon should co-ordinate with legal
counsel to determine the amount of detail that should be
provided in any discussion. Some information, such as
peer review matters, root cause analysis material,
results of disciplinary actions and legal counsel
communications are privileged and should not be part of
the discussion with the patient. Similarly, if an event
could escalate to a claim, expressions of sympathy
relating to the pain, suffering or death of a patient
made to the patient/family member are not admissible in
court as evidence of an admission of liability, whereas
statements of fault may well be considered admissible
evidence.
The physician-patient relationship is built upon trust
and honesty. The SAOA code of medical ethics and
professionalism reinforces these principles in section
II A which states: “The orthopaedic surgeon should
maintain a reputation for truth and honesty. In all
professional conduct, the orthopaedic surgeon is
expected to provide competent and compassionate patient
care, exercise appropriate respect for other health care
professionals, and maintain the patient’s best interests
as paramount.”
Consistent with these principles, the SAOA urges
orthopaedic surgeon to behave in manner consistent with
these recommendations when communicating about adverse
outcomes with their patients and family mem
ADVISORY STATEMENT
THE IMPORTANCE OF GOOD COMMUNICATION IN THE
PHYSICIAN-PATIENT RELATIONSHIP
Good communication with patients has always been
essential in orthopaedic practice. It is the cornerstone
of the physician-patient relationship. Open, honest
communication builds trust and promotes healing. It
favourably impacts patient behaviour, health outcomes,
patient satisfaction, and often reduces the incidence of
malpractice actions. For physicians, good communication
with patients can also increase professional
satisfaction, enhance community image and provide a
competitive economic advantage for the medical practice.
Increasing demands on orthopaedic surgeons in today’s
healthcare environment often leave less time to provide
care to a greater number of patients. While time
constraints can make it difficult to communicate as
effectively as one would like, the quality of time spent
with the patient remains very important. For this
reason, effective patient-focused communication skills
are essential. They can be applied quickly and
effectively within the normal patient encounter.
THE SAOA URGES ORTHOPAEDIC SURGEONS TO USE
PATIENT-FOCUSED COMMUNICATION SKILLS DURING THEIR DIRECT
PATIENT ENCOUNTERS. THESE INCLUDE:
- SHOWING EMPATHY AND RESPECT
- LISTENING ATTENTIVELY
- ELICITING CONCERNS AND CALMING FEARS
- ANSWERING QUESTIONS HONESTLY
- INFORMING AND EDUCATING PATIENTS ABOUT TREATMENT
OPTIONS AND THE COURSE OF CARE
- INVOLVING PATIENTS IN DECISION CONCERNING THEIR
MEDICAL CARE
- DEMONSTRATING SENSITIVITY TO PATIENTS’ CULTURAL AND
ETHNIC DIVERSITY
When time counts, it is the quality and not necessarily
the quantity of physician-patient communication that is
vital. To the patient, quality is often measured by how
well the physician listens and acknowledges patient
concerns. It is measured by how thoroughly the physician
explains the diagnosis and treatment options, and how
well the physician involves the patient in decisions
concerning his or her care. These factors play an
important part in the way patients perceive, recall and
evaluate their visits with the physician.
THE SAOA BELIEVES THAT ORTHOPAEDIC SURGEONS MUST PLACE
AN EMPHASIS ON GOOD COMMUNICATION WITH PATIENTS AND THE
QUALITY OF THE INTERACTION, ESPECIALLY WHEN TIME IS
LIMITED.
Good communication between the orthopaedic surgeon and
the patient can be an effective risk management tool.
While poor treatment outcome is one of the primary
causes of malpractice actions, poor communication is
also a factor in a majority of cases. Patients who sue
often cite the failure of physician to listen or the
physician’s unwillingness to answer questions. Patients
who are well informed about treatment options, the
course of care, expected outcomes and possible
complications are more satisfied patients, and are less
likely to file malpractice claims.
INFORMED CONSENT:
- COMPONENTS OF INFORMED CONSENT:
The orthopaedic surgeon should follow the process of
obtaining informed consent when he/she communicates with
patients regarding treatment alternative and receives
permission to proceed with treatment. Informed consent
is the autonomous authorization obtained from a patient
after the surgeon explains and describes the:
- Nature of the problem
- Alternative treatments
- Anticipated benefits of treatments
- Risk and side effects of treatments
- Consequences of no treatment
The surgeon is legally bound to disclose any information
which the patient needs to know to make an informed
decision about a recommended course of treatment. As
long as the adult patient has the capacity to understand
the information provided by the surgeon, he/she also has
the right to refuse treatment even if it will save life
or limb.
- DOCUMENTATION:
Documentation of consent is critically important. In
addition to the consent form, which is signed by the
patient or guardian and a witness, the surgeon should
document on the chart that he/she has obtained consent
according to the guidelines listed above, that the
patient or guardian understands the explanation and all
of their questions have been answered, and that they
wish to proceed with the recommended treatment. The SAOA
recommends that the surgeon “sign the site”, or agree
upon and mark the planned surgical site together prior
to surgery.
In some instances the physician is required to obtain
pre-operative consent from the patient for the operating
room attendance of people who are not members of the
Health Care Team. This may include representatives of
Biomaterial or implant device manufacturers or other
observers. The surgeon should be familiar with any
regulations requiring permission for observers in the
operating room. Surgeons should also obtain consent for
intra-operative medical photography for the purpose of
documenting the patient’s condition.
- MINORS:
Minors have greater legal protection than adults, and
cannot legally provide consent for treatment until they
have reached the age of majority. Instead, consent for
minors is provided by their legal guardian, usually the
parents.
This does not, however, mean that minors are ignored
during the process of obtaining informed consent for
elective surgery. Minors fall into three categories
regarding their capacity to participate in the informed
consent process:
- No capacity to participate (infants, toddlers,
children with severe developmental delay)
- Developing capacity (school age children)
- Capable decision makers (older adolescents)
It is suggested that the surgeon obtain written assent
or permission from older adolescents before proceeding
with elective surgery. This assent is not binding, and
is not valid without the guardian’s consent, but
obtaining it shows that the surgeon supports and
respects the adolescent’s decision-making abilities,
thereby fostering their participation and cooperation
with the treatment plan. Children with developing
capacity should be involved in the process of informed
consent to the extent of their desires and capabilities:
for instance they may be allowed to choose the colour of
their cast.
One of the additional protections provided by the law to
minors is their right to receive limb- or life-saving
treatment even when this treatment is refused by the
guardian. Thus the surgeon may provide, for example, a
blood transfusion to the child of parents who refuse
this treatment, if he/she believes that the child’s life
is at risk without the transfusion. The surgeon should
be familiar with the institutional and legal processes
they should follow when providing limb-or life-saving
treatment to a child against the wishes of the child’s
parents.
Under certain circumstances, minors are legally allowed
to provide informed consent for their own treatment. The
most common circumstance encountered by physicians is
when minors have a condition for which they may fail to
seek treatment if parental consent was required such as
pregnancy, sexually transmitted disease, substance or
alcohol abuse or a psychiatric condition. Minors with
these conditions may have concomitant problems,
complicating the issue of their capacity to provide
consent. Because the conditions for which minors are
emancipated vary, the orthopaedic surgeon should
familiarize him/her self which the specific requirements
of the country in which they practice.
The SAOA urges orthopaedic surgeons to provide
information and education to their patients about
treatment alternatives, and the course of care,
especially expectations for surgical outcomes.
Discussing the risks of surgery and possible
complications in a kind and compassionate manner, can
create realistic expectations on the part of the
patient, increase patient satisfaction, and minimize the
risk of malpractice claims.
ADVISORY STATEMENT
ORTHOPAEDIC MEDICAL TESTIMONY
Orthopaedic surgeons are frequently called upon to
provide orthopaedic medical testimony in legal or
administrative proceedings. In some jurisdictions,
criteria for medical witnesses may be inadequate and as
a result, unqualified physicians may testify as
orthopaedic expert witnesses. It is in the public
interest that orthopaedic medical testimony be readily
available and objective.
The code of medical ethics and professionalism of the
SAOA provides that:
“Orthopaedic surgeons are frequently called upon to
provide expert medical testimony in courts of law. In
providing testimony, the orthopaedic surgeon should
ensure that the testimony provided is non-partisan,
scientifically correct and clinically accurate. The
orthopaedic surgeon should not testify concerning
matters about which the orthopaedic surgeon is not
knowledgeable. It is unethical for an orthopaedic
surgeon to accept compensation that is contingent upon
the outcome of litigation.”
The SAOA believes that, consistent with the code of
medical ethics and professionalism and to limit
uninformed and possibly misleading testimony,
individuals providing orthopaedic medical testimony
should be qualified for their role and should follow a
clear and consistent set of ethical guidelines.
ORTHOPAEDIC TREATING PHYSICIANS
As a citizen and a professional with special training
and experience, the treating orthopaedic surgeon has an
ethical and legal obligation to provide reasonably
required factual or administrative testimony. If the
orthopaedic surgeon’s patient has a legal claim and
requests his or her treating physician’s assistance, the
orthopaedic surgeon should furnish medical evidence,
with the patient’s consent, in order to secure the
patient’s legal rights. The orthopaedic treating
physician has an ethical obligation to provide truthful,
scientifically correct and clinically accurate testimony
and is entitled to reasonable compensation for the time
spent to prepare and give testimony. A request for
unreasonable compensation by the treating orthopaedic
surgeon may be a de facto refusal to testify, and may be
considered unethical.
The treating orthopaedic surgeon may become an expert
witness, but is not ethically bound to do so.
ORTHOPAEDIC EXPERT WITNESS : QUALIFICATIONS
- The orthopaedic expert witness should have a current,
valid and unrestricted license to practice orthopaedics.
He/she should be a qualified surgeon registered as such
with the HPCSA.
- The orthopaedic expert witness should be familiar
with the clinical practice, the applicable standard of
care and the relevant facts and history of the case at
the time of the incident.
- The orthopaedic expert witness should be engaged in
the active practice and/or teaching of orthopaedic
surgery or be able to demonstrate familiarity with
present practices.
ORTHOPAEDIST TESTIMONY: GUIDELINES FOR BEHAVIOUR
- The orthopaedist providing opinions and/or factual
testimony should review and testify fairly and
impartially and should not adopt an advocacy or partisan
position.
- The orthopaedic expert witness should be
knowledgeable regarding concepts and practices relevant
to commonly accepted standard of care at the time of the
incident. The attorney for the party who calls the
orthopaedist should be informed of all favourable and
unfavourable information developed in the orthopaedist’s
evaluation of the case.
- The orthopaedic surgeon is obligated to state the
basis of the testimony, to indicate if he or she is
expressing a personal view, to state if this opinion
differs from current commonly-accepted evidence based
practice, and to acknowledge if differing opinions
exists.
- Compensation for providing testimony should be
reasonable and commensurate with the time and effort
required preparing for the deposition and appearing in
court. It is unethical to link compensation to the
outcome of the case.
- The expert witness should be aware that failure to
provide complete and truthful, civil suits for
negligence, and revocation or suspension of his or her
professional license.
|
|
