INFORMED CONSENT

AAOS ETHICS COMMITTEE

Paul Levin, MD

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 Objectives
• Define informed consent
• Identify the informed consent
process
• Define patient understanding
of informed consent
• Define options if surgical
indications are questionable
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 Informed Consent
• Accepted ethical and legal
standard in the United States

• Individuals are entitled to all

the available medical
information and are allowed
to make “autonomous”
decisions related to their
health care
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 Case
Dr. Smith has been
in practice for five
years and has a very
busy and successful
general orthopaedic
practice. He normally
performs 6-8 THAs Comstock/Thinkstock.com

per year.

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He is having a typical, busy,
overbooked office hour session.
He is also waiting for operating
room availability to
repair a hip fracture.
His medical assistant
directs him into the
next exam room where
Mr. Chin is meeting with Jupiterimages/Thinkstock.com

the doctor for a pre-operative

discussion for a THA.
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Dr. Smith knocks on the
door, enters the room,
and shakes hands.
Mr. Chin is sitting on the
exam table, and Dr. Smith
begins their conversation
while standing in front
of the patient. Comstock/Thinkstock.com

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Mr. Chin is a healthy 63 year-old
gentleman. He is physically active
and has no medical
co-morbidities. He has
been Dr. Smith’s
patient for the past
three years for
treatment of
symptoms secondary
to OA of the hip.
.
iStockphoto/Thinkstock.com

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The symptoms are getting worse,
and Mr. Chin reports his quality of
life is being compromised. Mr. Chin
has elected to undergo a THA
because he can no longer play
tennis or go out for his morning
run. His ability to work as a
financial advisor has not been
affected.

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He has no problems sleeping or with
ADLs and is still able
to spend one hour
per day on the
elliptical exerciser.
He has decided to
have a THA based
on your Hemera/Thinkstock.com

recommendation
during a prior visit.
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Was this initial interaction with
the patient approached
appropriately?

Would you have done anything

differently?

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Does this case present any
ethical dilemmas?

How should you proceed?

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Is the patient an appropriate
candidate for a THA?

Should you advise the patient that

you believe it is premature to
perform a THA?

Should you decline to perform the

surgery?

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Dr. Smith explains to Mr. Chin that
he had recommended a THA
because Mr. Chin had described a
significant compromise in his
lifestyle. Dr. Smith expresses his
concern that Mr. Chin may be too
physically active after his surgery.
He is worried that this level of
physical activity will increase the
risk of early complications leading
to the necessity of revision
surgery.
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Mr. Chin reports that he has
done extensive research
on the web, and he fully
understands the risks.
He requests a standard
implant. Mr. Chin has made
a compelling argument
that his life style has been
significantly compromised. iStockphoto/Thinkstock.com

He has always been physically active

and his inability to run leaves him
feeling depressed. Despite Dr. Smith’s
initial reservations he agrees to proceed
with the planned surgery.
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Dr. Smith continues with his discussion
of the risks of the procedure including
advising Mr. Chin of the possibility of:

• DVT and PE
• Blood loss requiring a blood transfusion
• Instability of the hip
• Leg length inequalities
• Injury to the sciatic nerve
• An infection requiring additional surgery

The patient again reminds you that he

has a full understanding and requests
that you proceed with his hip
replacement surgery.
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Was this an acceptable discussion
with the patient?

Would you approach the process

differently?

Are there any issues not included in

the consent discussion which you
believe should have been discussed?

Are there any issues which should

have been discussed in more detail?
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Components of an Acceptable
Informed Consent

Decision-Making Capacity
Complete Disclosure
Understanding
Authorization

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 Informed Consent
• Comprehensive discussion between the
patient and treating physician
– Why is the procedure being recommended
– What are the alternative treatments available
– What are the benefits, risks and complications
of the different treatment options
• Complete documentation of the discussion in
the medical record
• Consent form is not the appropriate document
to fully describe the consent process
• Should not be delegated to most junior
member of the team
Adapted from Beauchamp and Childress
Principles of Biomedical Ethics, 6th ed.
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 Capacity to Consent
• Often called “decision-making capacity”
• Many consider “capacity” as the medical
terminology and “competence” as the
legal terminology
• Patient has the ability to understand the
problem, options of treatment, and
risks/benefits of each approach
• Patient can understand and select an
approach
• Cannot be under duress, no fear of
abandonment
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 CONSENT REQUIRES
A COMPLETE
UNDERSTANDING

CONSENT ≠ DISCLOSURE
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 How Much to Inform?
Four standards
1. Professional practice standard
Communities accepted practice
2. Reasonable person standard
“Material information” for “reasonable
person”
3. Subjective standard
Different individuals want/need different
amounts of information
4. State legal standards
 Standards vary from state to state
Adapted from Beauchamp and Childress
Principles of Biomedical Ethics, 6th ed.
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 Case Conclusion
Mr. Chin undergoes a successful
standard THA and is discharged to
home on POD #2. He returns to Dr.
Smith’s office on POD #12. He has
been having fevers, increasing pain
and drainage. He undergoes an I&D
that evening, and a multifloral
infection is diagnosed. Multiple
attempts to save the implant have
failed. Dr. Smith recommends
removal of the implant and placement
of an antibiotic spacer.
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Mr. Chin is now very angry. He says
that you never told him that an
infection could require the removal
of the implant. He
tells you that he never
would have considered
the operation if he had
known that this could iStockphoto/Thinkstock.com

happen. He has lost faith

in you and tells you he is leaving
the hospital and going to be treated
by a total joint specialist.
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Informed Consent Process

The process of informed

consent is designed to ensure
that the patient has a
complete understanding.

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Does the outcome in this case
change how you believe the
process should be
approached?

Can any patient be “fully

informed” and gain a
“complete understanding”?

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Should the orthopaedic
surgeon inform the patient if
he does not think the
procedure is indicated or
reasonable?

Should the orthopaedic

surgeon refer the patient for
an alternative opinion?

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 Recommendations
• Include all complications that may
have a significant effect on outcome
and explain what treatment may be
necessary

• Try to avoid being told “I didn’t

understand”, or “you never told me
this could happen”.

• Fully review the planned procedure,

even if the patient has read your
handouts or has searched the Web.
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 References
Beauchamp T and Childress J: Principles of
Biomedical Ethics, ed 6. New York, NY,
Oxford University Press, 2009.
Lo B: Resolving Ethical Dilemmas, A Guide
for Clinicians, ed 4. Philadelphia, PA,
Lippincott Williams & Wilkins, 2009.
Pellegrino E and Thomasma D: The Virtues
in Medical Practice. New York, NY, Oxford
University Press, 1993.
Ganzini L, Volicer L, Nelson W, Fox E, Derse
A: Ten Myths about decision-making
capacity. J AM Med Dir Assoc. 2005;6
(3 Suppl):s100-4.

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Council on Ethical and Judicial Affairs: Code
of Medical Ethics, Opinion 8.08. Chicago, IL,
American Medical Association, ed 2010–2011.

American Academy of Orthopaedic Surgeons:

Code of Medical Ethics and Professionalism
for Orthopaedic Surgeons, I.F. Adopted
1988, revised 2011.
http://www.aaos.org/about/papers/ethics/code.asp

American Academy of Orthopaedic Surgeons:

Standards of Professionalism on Providing
Musculoskeletal Services to Patients,
Mandatory Standard 4. Adopted April 2005,
amended April 2008.
http://www3.aaos.org/member/profcomp/provmuscserv.pdf

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American Academy of Orthopaedic Surgeons:
Patient-Physician Communication,
Information Statement 1017. Adopted 2000,
revised 2011.
http://www3aaos.org/about/papers/advistmt/1017.asp

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