1. 0 Ethics Lecture Essentials of Informed Consent

2. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Disclosures  The speaker has no financial interest in the subject matter of this presentation and is not representing the Ethics Committee of the American Academy of Ophthalmology with this presentation  For questions about the material contained herein or about the Academy’s ethics program in general, please contact the ethics program manager, Mara Pearse Burke at ethics@aao.orgethics@aao.org

3. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Why is this Topic Important?  Obligation to be Truthful  Engenders Patient Trust  Develops Patient Autonomy  Integrity of the Profession

4. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Code of Ethics, Rule 2 Informed Consent. The performance of medical or surgical procedures shall be preceded by appropriate informed consent.

5. 0 Essentials of Informed Consent Case Study 1 Bait and Switch?

6. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Preop and Surgery  Dr. A, a radiologist, consults a well-known, high-profile ophthalmologist Drawn to his stellar reputation Website advertises care with a personal touch  Signs consent for cataract surgery Includes language “ Dr. X or his designees… ”  The surgical outcome is disappointing Capsule phimosis, retained cortex, misaligned toric lens

7. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Really?  Contrary to expectation, Dr. A discovers: Dr. X only removed the nucleus and placed the toric IOL A Physician ’ s Assistant performed all the other steps of the surgery.

8. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY A Little Background Info  Dr. A’s wife, an experienced ophthalmology-OR nurse, asked to observe the surgery.  When she saw the PA begin to cut, she objected and was pulled out of the OR by Dr. X’s staff.  She and her husband believed something funny was going on.  Ultimately, they filed a FCA in federal court alleging that Dr. X billed for services provided by others and for unnecessary procedures.

9. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY What Do You Think?  Is this legal? In the state in which the surgery took place, state law allows the surgeon to delegate any aspect of care within the surgeon’s purview to another individual that he/she feels is adequately trained and competent.  Did Dr. X violate the Code of Ethics? The working of the informed consent (Dr. X or his designees… ” ) may have been misleading to the patient. Dr. X’s advertising of his “personal” care may have been misleading as well.

10. 0 Essentials of Informed Consent Case Study 2 Informed Consent for Refractive Procedure

11. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Informed Consent – Case Study  Dr. X examined a 45 y/o man for refractive surgery -7D myope with K’s 45D, normal topography, pachy 530, pupils 6mm, TBUT 10secs.  A detailed discussion of LASIK surgery took place (including risks, poor outcomes and significant complications) was performed on three occasions: at 1 st consultation after wavescan analysis (3 wks later) and day of surgery (2 wks later)  The patient signed an informed consent form at the 1 st consultation and asked and had answered questions at the other two preoperative visits. After asking questions, the patient decided to proceed with surgery A “Consent for LASIK Surgery” was signed.

12. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Surgery and Postop Day 1  The surgery was uncomplicated.  Postop day 1: patient had mild grade 2 DLK, treated aggressively with corticosteroids, patient asked to return in 2 days when DLK was noted as resolved.

13. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY Patient Complaints  Mr. B claims “loss of contrast sensitivity, extreme dry eyes, sinister glare, annoying floaters, vision changing almost everyday for months, inability to work as PA, need for psychiatric care”.  Mr. B alleges that he was inadequately informed and never told of these side-effects.  Patient claims Dr. D runs a “laser surgery mill”, and that he emphasizes “quantity” (20/20 or 20/15) rather than “quality” of postop vision.

14. WWW.AAO.ORGAMERICAN ACADEMY OF OPHTHALMOLOGY What Do You think?  Did Dr. D provide adequate informed consent in compliance with Rule 2 of the Code of Ethics?  There could have been non-medical, underlying issues that affected the patient’s outcome that were revealed, postoperatively, by his complaints of “sinister glare”, “inability to work”, and “need for psychiatric care”.  Is there a way to preoperatively assess for such issues?