What are the ethical and practical issues of performing live surgery and what is the ophthalmologist's responsibility to safeguard patient autonomy, privacy, and confidentiality when performing live surgery?
Rule 1. Competence
Rule 2. Informed Consent
Rule 6. Pretreatment Assessment
Rule 7. Delegation of Services
Rule 8. Postoperative Care
Rule 9. Medical and Surgical Procedures
Rule 11. Commercial Relationships
Rule 13. Communications to the Public
Rule 15. Conflicts of Interest
Rule 17. Confidentiality
“Live surgery” is defined for the purposes of this Advisory Opinion as any surgical procedure used as an educational activity to contribute to generalizable knowledge and skill of ophthalmologists that is recorded or broadcast in real time using any medium (e.g., online streaming, video) to professional medical audiences and accompanied or not by interactive communication. This definition includes teaching surgical techniques by live surgery observation in the surgeon’s own operating room and small meetings where live surgeries are followed by discussion of surgical procedures. The ethical issues involved in ophthalmologists traveling internationally to perform live surgery on individuals from the local population and broadcasts of the surgery to large audiences at professional meetings are addressed in subsections of this Advisory Opinion due to the unique complexities of those arrangements.
Ethical concerns related to the performance of live surgery include the ophthalmologist’s competence to perform the procedure, appropriate informed consent, patient selection, preoperative assessment of the patient, the responsibilities for postoperative care and appropriate delegation of care when necessary, the appropriateness of the location for the surgery, commercial relationships that might impact the decision to perform the surgery, marketing, conflicts of interest that might affect clinical judgment, and patient confidentiality. Proper care of the patient must be foremost in any consideration of a live surgical demonstration including maintaining safeguards to preserve patient safety, autonomy, privacy, and confidentiality. Performing surgery that is not in the best interests of the patient by virtue of scheduling, candidacy, or because of potential conflicts of interest is unethical.
Incorporating new techniques or technology into one's practice by way of observing a live surgery performance is a time-honored tradition in the history of medicine and medical education. The benefit of observing a skilled mentor cannot be overstated. Live surgical performances offer a unique educational experience for ophthalmologists to enhance their surgical skills and disseminate information. In a live surgical performance, it is more appropriate to show how a procedure is performed, i.e., for generalizable knowledge, rather than to show that it can be performed.
Appropriate patient selection is a particularly important factor. Patient personality and their anticipated level of cooperation with the expected technical difficulty of the procedure should be considered, as well as determining whether the patient is an appropriate candidate for the procedure when the live surgery is scheduled. If the performance is scheduled for a future date, the possibility exists for the patient to have an unnecessary delay in treatment. Conversely, if an appropriate patient has not been selected in advance of the surgery, one might be chosen to fit the scheduled date of the surgery rather than because they are a good candidate.
The ophthalmologist should determine whether the additional stress of a live surgical broadcast might be disruptive to his or her cognitive process and ability to respond to unexpected occurrences. Inherent distractions in the performance of live surgery include the potential for frequent interruptions from the audience as questions are asked and clarification requested as the procedure progresses. Another potential detractor from the surgeon’s attention is the fact that he or she may be operating with staff other than their own and may be using instruments or devices that are not part of his or her routine armamentarium. Even if using the surgeon’s own staff, the surgeon will want to brief the team on the live performance aspects. Consequently, the ophthalmologist should consider a pre-surgery meeting with the medical team and the recording team to discuss the procedure, patient safety, and confidentiality.
When determining whether a live surgery performance is in the patient’s and his or her professional interests, the ophthalmologist should query his or her professional liability carrier as the performance may increase liability exposure.
Traveling Internationally to Perform Live Surgery on Local Populations
The ethical issues inherent in traveling internationally to perform live surgery on individuals from the local population includes all those noted above plus the additional, unique issues noted below.
The ophthalmologist who travels internationally to perform live surgery as an educational activity to contribute to generalizable knowledge and skill of ophthalmologists should:
- Carefully assess his or her motivations to assure that participation in the live surgical event is for purely educational purposes and is not influenced by a commercial or industry relationship, the potential for increased professional reputation/recognition or surgical acumen, or the potential for publication following the trip.
- Determine what credentialing is required prior to traveling to the country where the surgery will be performed. All required documentation should be provided and approval obtained prior to the performance of surgery in the country.
- Consult with his or her liability carrier to determine whether liability coverage will be provided.
- Carefully familiarize him or herself with the surgical site in advance of the event. In international settings the surgical suite, staff, instrumentation, sterilization, lighting, voltage, and even the size of the surgical gloves available will likely be different than that with which he or she is comfortable – these elements may complicate the surgical plan.
- Evaluate the patient, or review another health care provider’s evaluation, to confirm accuracy in the documentation of findings and recommended treatment plan.
- Obtain a fully informed consent from the patient. In an international setting where language and customs will be different than those in the U.S., obtaining a fully informed consent may prove difficult. Particular attention must be paid to: 1) An assessment of patient’s competence to decide; 2) The disclosure of relevant information in a manner appropriate to the customs and culture of the country; 3) A realistic assessment of the patient’s comprehension of the discussion; and 4) Obtaining consent from the patient or a surrogate. It should be emphasized that an element of coercion may be present in this setting, where the patient may believe or have been led to believe that he or she will be the recipient of this care only by virtue of agreeing to the live surgery.
- Include the postoperative care plan as part of the informed consent process and assure it is understood and agreed to by the patient. The operating surgeon is responsible for the postoperative care of the patient. Portions of the postoperative care may be delegated to other appropriately trained individuals that the operating surgeon knows to be competent to perform the delegated tasks.
Live Surgery for Large Audiences at Professional Meetings
The ethical issues inherent in the performance of live surgery for large audiences at professional meetings includes all those noted above plus the additional, unique issues noted below.
The ophthalmologist who intends to perform live surgery as an educational activity to contribute to generalizable knowledge and skill of ophthalmologists should:
- Carefully assess his or her motivations to assure that participation in the live surgical event is for purely educational purposes and is not influenced by economic interest in, commitment to, or benefit from a commercial or industry relationship.
- Ask whether his or her professional judgment concerning the well-being of the patient has a reasonable chance of being influenced by other interests, such as those listed above, and including professional reputation/recognition, surgical acumen, and the potential for publication following the event.
- Assure the scheduling is appropriate. The format of large meetings may impose inflexible scheduling of the surgical event, which may affect surgical outcomes. Performing live surgery in a time-restricted setting is not recommended.
- Provide the patient’s informed consent and include information about the size of the audience and the greater potential for breaches of confidentiality.
- Assess whether the size of the larger meeting may inherently offer less educational value than smaller meetings due to impaired visualization of the surgical procedure and minimal possibilities for individual interaction with the surgeon.
- Evaluate the patient to accurately document the findings and treatment plan, perform the informed consent including arrangements for postoperative care of the patient, and perform those aspects of the postoperative care within his or her unique competence.
The following recommendations for the performance of live surgery, based on the Rules of the Academy’s Code of Ethics, are made to educate the ophthalmologist and to protect patients. Ultimately, it is the responsibility of the ophthalmologist to act in the best interest of the patient, regardless of where the surgery is performed.
Rule 1. Competence. The ophthalmologist should be competent to perform the intended procedure. Live surgery, outside of the ophthalmologists’ own surgical suite where the primary purpose of the event is the education of residents and others learning new techniques, is not appropriate for those on any point of the learning curve.
Rule 2. Informed Consent. Of special consideration is the process of providing appropriate informed consent. Appropriate informed consent is an ethical requirement in all surgery. Ophthalmologists should recognize the special nature of live surgery and the potential ramifications for the patient in this alternative care setting. The informed consent should include, but not be limited to, the voluntary nature of the live surgery, the intended purpose and audience of the surgery, the potential risks, benefits and alternatives to the live surgery, including the possibility of added risk because of physician and patient distraction during the surgery, the possibility of breaches of confidentiality and the security of private health information . A surrogate’s informed consent may not be appropriate in this situation.
The patient should be made aware of the role of all members of the surgical team, and there should be clarification of the legal liabilities of -both the surgeon and the facility where the live surgery will be performed.
Coercion of the patient must be avoided. The possibility of having a renowned surgeon perform his or her surgery might place undue pressure on the patient to consent. A patient’s decision to withdraw prior consent must be respected.
Rule 6. Pretreatment Assessment. The ophthalmologist should carefully consider whether the patient chosen for the performance is appropriate for the both the procedure and the experience. An evaluation of the patient to assure accuracy of the documented findings and recommendation for treatment is essential.
Rule 7. Postoperative Care. Postoperative care of the patient who undergoes live surgery should not vary from the postoperative care provided to a patient in the ophthalmologist’s routine practice. If delegation is intended, the patient and the person to whom the care is delegated must agree to the delegation in advance of the procedure. The alternative care provider must be adequately trained, supervised, and able to perform the delegated procedures by virtue of state laws, per Rules 7 and 8 of the Code of Ethics.
Rule 9. Medical and Surgical Procedures. The ophthalmologist should not misrepresent the procedure that is to be performed or the charges that will be made for the procedure, if any. The ophthalmologist should assure that the procedure is performed in an appropriate location and have emergency equipment available in case of need.
Rule 11. Commercial Relationships. The decision to perform live surgery should be based on the ophthalmologist's clinical judgment and desire to contribute to generalizable knowledge and should not be influenced by economic interest in, commitment to, or benefit from professionally-related commercial enterprises. Ophthalmologists should not perform live surgery if the purpose of the performance is self or facility-aggrandizement.
Rule 13. Communications to the Public. As in all professional advertising, promotions for a live surgery performance should not be false, deceptive or misleading, and ophthalmologists should not participate in any live surgery course that is promoted in a false, deceptive or misleading manner, including information about the participating ophthalmologist’s skills, training, experience, or results.
Rule 15. Conflict of Interest. If a physician is compensated differently for the live surgery performance than for routine surgical patient care, that fact should be disclosed to the patient in advance. A conflict of interest exists when professional judgment concerning the well-being of the patient has a reasonable chance of being influenced by other interests of the provider. Disclosure of a conflict of interest is required in communications to patients, the public, and colleagues.
Rule 17. Confidentiality. Special consideration should be taken in the performance of live surgery to respect the confidential physician-patient relationship and the safeguarding of confidential health information consistent with the law. The audience should be reminded of the special nature of the live surgery demonstration, including their need to maintain confidentially and to protect patient privacy. Liability carriers may require an informed consent and/or confidentiality addendum to the forms routinely used for these purposes.
"Rule 1. Competence. An ophthalmologist is a physician who is educated and trained to provide medical and surgical care of the eyes and related structures. An ophthalmologist should perform only those procedures in which the ophthalmologist is competent by virtue of specific training or experience or is assisted by one who is. An ophthalmologist must not misrepresent credentials, training, experience, ability or results."
"Rule 2. Informed Consent. The performance of medical or surgical procedures shall be preceded by appropriate informed consent."
"Rule 6. Pretreatment Assessment. Treatment shall be recommended only after a careful consideration of the patient's physical, social, emotional and occupational needs. The ophthalmologist must evaluate the patient and assure that the evaluation accurately documents the ophthalmic findings and the indications for treatment. Recommendation of unnecessary treatment or withholding of necessary treatment is unethical."
"Rule 7. Delegation of Services. Delegation is the use of auxiliary health care personnel to provide eye care services for which the ophthalmologist is responsible. An ophthalmologist must not delegate to an auxiliary those aspects of eye care within the unique competence of the ophthalmologist (which do not include those permitted by law to be performed by auxiliaries). When other aspects of eye care for which the ophthalmologist is responsible are delegated to an auxiliary, the auxiliary must be qualified and adequately supervised. An ophthalmologist may make different arrangements for the delegation of eye care in special circumstances, so long as the patient's welfare and rights are the primary considerations."
"Rule 8. Postoperative Care. The providing of postoperative eye care until the patient has recovered is integral to patient management. The operating ophthalmologist should provide those aspects of postoperative eye care within the unique competence of the ophthalmologist (which do not include those permitted by law to be performed by auxiliaries). Otherwise, the operating ophthalmologist must make arrangements before surgery for referral of the patient to another ophthalmologist, with the patient's approval and that of the other ophthalmologist. The operating ophthalmologist may make different arrangements for the provision of those aspects of postoperative eye care within the unique competence of the ophthalmologist in special circumstances, such as emergencies or when no ophthalmologist is available, so long as the patient's welfare and rights are the primary considerations. Fees should reflect postoperative eye care arrangements with advance disclosure to the patient."
"Rule 9. Medical and Surgical Procedures. An ophthalmologist must not misrepresent the service that is performed or the charges made for that service. An ophthalmologist must not inappropriately alter the medical record."
"Rule 11. Commercial Relationships. An ophthalmologist's clinical judgment and practice must not be affected by economic interest in, commitment to, or benefit from professionally-related commercial enterprises."
"Rule 13. Communications to the Public. Communications to the public must be accurate. They must not convey false, untrue, deceptive, or misleading information through statements, testimonials, photographs, graphics or other means. They must not omit material information without which the communications would be deceptive. Communications must not appeal to an individual's anxiety in an excessive or unfair way; and they must not create unjustified expectations of results. If communications refer to benefits or other attributes of ophthalmic procedures that involve significant risks, realistic assessments of their safety and efficacy must also be included, as well as the availability of alternatives and, where necessary to avoid deception, descriptions and/or assessments of the benefits or other attributes of those alternatives. Communications must not misrepresent an ophthalmologist's credentials, training, experience or ability, and must not contain material claims of superiority that cannot be substantiated. If a communication results from payment by an ophthalmologist, this must be disclosed unless the nature, format or medium makes it apparent."
"Rule 15. Conflict of Interest. A conflict of interest exists when professional judgment concerning the well-being of the patient has a reasonable chance of being influenced by other interests of the provider. Disclosure of a conflict of interest is required in communications to patients, the public, and colleagues."
"Rule 17. Confidentiality. An ophthalmologist shall respect the confidential physician-patient relationship and safeguard confidential information consistent with the law."
"Principle 1. Ethics in Ophthalmology. Ethics are moral values. An issue of ethics in ophthalmology is resolved by the determination that the best interest of the patient is served."
"Principle 7. An Ophthalmologist's Responsibility. It is the responsibility of the ophthalmologist to act in the best interest of the patient."
"Rule 3. Research and Innovation. Research and innovation shall be approved by appropriate review mechanisms to protect patients from being subjected to or potentially affected by inappropriate, ill-considered, or fraudulent basic science or patient-oriented research. Basic science and clinical research are conducted to develop adequate information on which to base prognostic or therapeutic decisions or to determine etiology or pathogenesis, in circumstances in which insufficient information exists. Appropriate informed consent for research and innovative procedures must recognize their special nature and ramifications. In emerging areas of ophthalmic treatment where recognized guidelines do not exist, the ophthalmologist should exercise careful judgment and take appropriate precautions to safeguard patient welfare."
American Academy of Ophthalmology Advisory Opinions of the Code of Ethics, Research and Innovation in Clinical Practice, Informed Consent, and Appropriate Examination and Treatment Procedures, Delegated Services, Postoperative Care, and Disclosure of Professionally Related Commercial Interests.
American Academy of Ophthalmology Policy Statements, An Ophthalmologist's Duties Concerning Postoperative Care, and Preoperative Assessment: Responsibilities of the Ophthalmologist.
American Academy of Ophthalmology Information Statement, Unique Competence of the Ophthalmologist.
American Medical Association, Council on Ethical and Judicial Affairs Opinion E-5.046 Filming Patients for the Education of Health Professionals, Issued December 2003 based on the report "Filming Patients for Educational Purposes," adopted June 2003.
Smith, A. Urological Surgical Live Surgery, BJU International. 110: 299-300. April 10, 2012.
Kallmes, F. et al. Live case demonstrations: patient safety, ethics, consent and conflicts. www.thelancet.com. Vol 337, April 30, 2011.
Dehmer, G. J. MD, Douglas, J.S. JR, MD, et al. Expert Consensus Document : Statement on the Use of Live Case Demonstrations at Cardiology Meetings . J Amer Coll of Cardiology. 2010;56(15).
Interventional Cardiology Live Case Presentations: Regulatory Considerations.J Amer Coll of Cardiology. 2010;56(15):1283-1285.
Approved by: Board of Trustees, February 2015
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