1. INFORMED CONSENT AAOS ETHICS COMMITTEE Paul Levin, MD 1

2. Objectives Define informed consent Identify the informed consent process Define patient understanding of informed consent Define options if surgical indications are questionable 2

3. 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 3

4. 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. 4

5. 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. 5

6. 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 6

7. 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. 7

8. 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. 8

9. 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. 9

10. 10 Was this initial interaction with the patient approached appropriately? Would you have done anything differently?

11. Does this case present any ethical dilemmas? How should you proceed? 11

12. 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? 12

13. 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. 13

14. 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. 14

15. 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. 15

16. 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? 16

17. Components of an Acceptable Informed Consent Decision-Making Capacity Complete Disclosure Understanding Authorization 17

18. 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, 6 th ed. 18

19. 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 19

20. CONSENT REQUIRES A COMPLETE UNDERSTANDING CONSENT ≠ DISCLOSURE 20

21. 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, 6 th ed. 21

22. 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. 22

23. 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. 23

24. Informed Consent Process The process of informed consent is designed to ensure that the patient has a complete understanding. 24

25. 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”? 25

26. 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? 26

27. 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. 27

28. 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. 28

29. 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 29

30. American Academy of Orthopaedic Surgeons: Patient-Physician Communication, Information Statement 1017. Adopted 2000, revised 2011. http://www3aaos.org/about/papers/advistmt/1017.asp 30