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 basedon your Hemera/Thinkstock.com

recommendationduring a prior visit.

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Was this initial interaction with the patient approached appropriately?

Would you have done anything differently?

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 researchon 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 beensignificantly 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 CapacityComplete Disclosure

UnderstandingAuthorization

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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 ChildressPrinciples 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 standardCommunities accepted practice

2. Reasonable person standard“Material information” for “reasonable person”

3. Subjective standardDifferent individuals want/need different

amounts of information

4.State legal standardsStandards vary from state to state Adapted from Beauchamp and

Childress Principles of Biomedical Ethics, 6th ed.

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Case ConclusionMr. 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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ReferencesBeauchamp 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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