Eyeworld

EW NEWS & OPINION 30 December 2017 a process," Dr. Williams said. "How do we do that? I think it starts with the first encounter with the patient. There should be a statement in the medical record about whatever the recommended therapy is. There should be a verbal or written state- ment that reflects the discussion that the risks, benefits, and alterna- tives to this procedure were reviewed with the patient." Special cases In medicine, including ophthalmol- ogy, there are drugs and materials used and procedures performed that might be off label but that the doc- tor thinks might be superior to other alternatives for various reasons, Dr. Williams said. From an informed consent standpoint, Dr. Williams said patients have the right to a discussion about what constitutes an off-label treatment. "We think patients are enti- tled to full disclosure of what all of their treatment options are. If you are proposing an off-label drug, we think patients should be informed as to why you think this is a good idea … and what the alternatives are," Dr. Williams said. "We think the patient has the right to know whether or not there are alternative treatments and whether or not those alternative treatments are on label." For example, corneal colla- gen crosslinking for treatment of progressive keratoconus and corneal ectasia has U.S. Food and Drug Ad- ministration approval for a specific device and drug, following a specific protocol. There are, however, dif- ferent devices, drugs, and protocols that are being used elsewhere in the world to perform crosslinking. "Any off-label or experimental use of crosslinking should acknowl- edge that there is an FDA-approved crosslinking protocol," Dr. Lee said. "However, there are many legitimate reasons why an ophthalmologist might prefer an alternative, includ- ing ongoing research into the best way to perform crosslinking for different patients." IOL scleral fixation techniques might also get into the realm of off-label procedures. Some surgeons use off-label Gore-Tex sutures for this procedure, while others use sutureless intrascleral haptic fixation of a three-piece IOL, which is also off label. When Dr. Lee uses Gore- Tex for suturing, he tells patients it's an off-label use, but explains why he thinks using it is the best option from a longevity standpoint. "Any time I am doing suture fixation or intrascleral haptic fixa- tion, I tell patients why I think that On the whole, Mr. Bruhn suggested young ophthalmologists seek out specific guidance from their medical malpractice insurance companies on informed consent, how the insurance company recom- mends they obtain and verify it. "Consent is a cornerstone to the defense of a claim alleging negligent care. It can also resolve complaints by patients if they feel a complica- tion they experienced was negligent care," Mr. Bruhn said. Dr. Lee said watching others can help young ophthalmologists learn a lot about the informed consent process—including what not to do. "You don't have to memorize a specific conversation or way of obtaining consent, but you can tell who is good at explaining things in a way that patients understand," Dr. Lee said. "You want to incor- porate those approaches as you develop your own way of obtaining consent." EW References 1. Custer BL, et al. Refractive surgery: malpractice litigation outcomes. Cornea. 2017;36:1243–48. 2. Shinal v. Toms. U.S. Supreme Court of Pennsylvania Middle District. No. 31 MAP 2016, 2017. www.pacourts.us/assets/opin- ions/Supreme/out/J-106-2016mo%20-%20 10314196418694166.pdf?cb=1 3. Tipotsch-Maca SM, et al. Effect of a multi- media-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients. J Cataract Refract Surg. 2016;42:110–6. 4. Zhang Y, et al. Video-assisted informed consent for cataract surgery: a randomized controlled trial. J Ophthalmol. Epub 2017 Jan 16. Editors' note: The sources have no financial interests related to their comments. Contact information Bruhn: hbruhn@omic.com Lee: bryanleevision@gmail.com Williams: George.Williams@beaumont.edu approach is the best for them and also discuss alternative fixation tech- niques, but all of them, other than an ACIOL, are off label. I also let them know that there is always the potential for future IOL dislocation," Dr. Lee said. When it comes to intracameral or intravitreal antibiotic prophylaxis for cataract surgery, Mr. Bruhn said the information conveyed to the pa- tient varies based on the medication the doctor would like to use. He rec- ommends physicians consult with their medical malpractice insurer to determine what needs to be commu- nicated and documented. Use of the femtosecond laser is FDA-approved for making corneal incisions, the anterior capsulot- omy, and nucleus fragmentation in cataract surgery. However, the literature has not necessarily shown any significant benefit of femtosec- ond laser-assisted cataract surgery (FLACS) or reduction in complica- tions compared to traditional phaco surgery. Some surgeons may think, however, that there is a benefit to FLACS in their hands. This, Dr. Williams said, should be explained to the patient. "Patients pay us for our judg- ment every day," Dr. Williams said. "There's nothing wrong with a surgeon saying, 'I think this a better operation for the following rea- sons,' and if the patient were to ask about the evidence, then I think the answer is, 'Both operations are good, and there is no evidence … that the laser is substantially better overall, but in my hands, I think it's a better operation.' That's an entirely valid approach. Again, [this conversation] needs to be documented. For things like the femtosecond laser, it needs to be documented by the physician, not by the person who schedules the surgery." Similarly, Dr. Williams said patients are entitled to be informed about premium options, such as toric or multifocal IOLs, that might be available to them. Bruhn, OMIC senior risk manage- ment specialist, said it's ideal to give patients time to take these forms home, read them, and formulate questions. Dr. Williams said provid- ing patients time to take them home gives family members the opportu- nity to review as well. For elective procedures, same- day consent is not ideal, Mr. Bruhn said. "Patients can allege they felt 'pressured' to give consent, they took time out from work, the staff was waiting on them, etc. Also, if patients have been given mild seda- tion prior to arriving at the surgical facility, they are impaired and can allege they were not in a clear state of mind to give consent," Mr. Bruhn said. Patients might benefit from multimedia presentations, such as videos, explaining surgical risks, benefits, and alternatives. Studies have shown that including multi- media presentations in the informed consent discussion can increase patient satisfaction, comprehension, and retention of information. 3,4 Dr. Lee said his practice has patients view videos using Rendia (Balti- more), a patient engagement pro- gram, while they are dilating. Rendia also allows them to use a touch screen to draw on eye diagrams to help patients who learn visually. "This is an efficient way to introduce them to cataract surgery, but again, the key is the conversation you have with the patient, not materials that they receive passively," he added. Dr. Williams said physicians filming themselves talking about the risks, benefits, and alternatives of various procedures and showing that to patients can provide evidence of standardization of the messages. Attempting to verify that patients understood conversations, paperwork, and other forms of information is important. Mr. Bruhn said having patients "teach back" in- formation can accomplish this goal. There are also consent programs, he said, that are self-guided and test the patient's knowledge. The results are the basis for a question and answer session with the physician. Aspects of the informed consent process should be covered in preop- erative visits, but Dr. Williams noted that patients should be asked again on the day of surgery if they have any questions, signing forms when they have no further questions. Documenting conversations and materials provided is an important part of the informed consent process as well from a legal standpoint. "The real key to informed con- sent is to demonstrate that there was Informed continued from page 28 " The real key to informed consent is to demonstrate that there was a process. How do we do that? I think it starts with the first encounter with the patient. " —George Williams, MD

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