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Informed consent for refractive surgery: more important than ever
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In a column published in the May 1997 issue of Primary Care Optometry News, contributor Stanley B. Teplick, MD, emphasized that one of the most important tools in successful refractive surgery is informed consent.
“Informed consent is the basis and foundation for proper patient care, and without it, even the most sophisticated surgical technique will be doomed to failure,” he said.
In the ensuing 8 years, the refractive surgery industry has seen the advent of increasingly advanced surgical techniques, equipment and expertise. Breakthroughs such as wavefront technology have raised patient expectations to new levels.
Yet practitioners maintain that no amount of innovation or sophistication will ever negate the need for effective informed consent. In this fifth installment of our 10-Year Anniversary Retrospective Series, PCON talks with practitioners about the continued relevance of informed consent in today’s refractive surgery practice.
More crucial than ever
Eight years after his column was published, Dr. Teplick maintains that informed consent is key to successful refractive surgery outcomes. “I can tell you that in the malpractice arena today, if it’s not the number one complaint, it’s fairly close,” he said in an interview. “When a patient files a problem, it’s almost always based on the fact that he or she was not informed.”
Dr. Teplick said it is the practitioner’s responsibility to ensure that patients are aware of the risk factors as well as the benefits. “The benefits they can hear about anywhere — they’ve spoken to their friends, and they’ve been online,” he said. “What they don’t know is the downside and the parameters that need to be explored to determine if the patient’s downside is outside the standard of care.”
According to Robert M. Grohe, OD, FAAO, a practitioner located in Homewood, Ill., the informed consent document is important for the protection of both practitioner and patient. “One of the difficulties that eye care practitioners face in general is the medicolegal implications of clinical practice,” he told Primary Care Optometry News. “The informed consent document really codifies what we do in the eyes of the court.”
Dr. Grohe said that informed consent is also important in terms of malpractice insurance. “In procedures related to the eye, that document becomes essential, not only in terms of protecting each practitioner, but also in terms of validating the malpractice insurance that each practitioner carries,” he said. “That private practitioner can have all the malpractice insurance in the world, but if these required legal documents are not signed, that can invalidate your insurance coverage.”
More informed patients
Practitioners must also recognize that they are now dealing with a new type of refractive surgery patient — a savvy consumer who is often armed with information from various sources. “In the early days, patients didn’t know anything. They knew there was some miracle involved with a laser, but that was about it,” Dr. Teplick said. “Today, they come in with reams of information. They’re much more knowledgeable.”
Dr. Grohe said that while this knowledge can be helpful in many ways, it is the practitioner’s responsibility to clarify — and sometimes correct — a patient’s preconceived notions. “A large number of unregulated Web sites are available today, providing very good to very poor quality information,” he said. “It becomes very important for the eye care practitioner or comanaging doctor to clarify and establish a common frame of reference.”
This clarification may involve re-educating the patient regarding information gleaned from the Internet, Dr. Grohe said. “To the extent that these Web sites initially serve as a starting point, they can be good, but I have found that many times, especially in chat rooms or blogs, you can find really crucial misunderstandings emerging,” he said. “We all have an obligation to the patient to specifically clarify these issues. After all, it’s not the Internet that will be doing the procedures and providing the care.”
Dr. Grohe said he finds it useful to note in the patient’s chart which Web sites the patient has frequented as sources of information. “Patients tend to refer back to those Web sites, despite being asked not to,” he said. “Should there be any sort of future legal action, it can then be established that the practitioner was aware that the Web site was visited and that he or she subsequently tried to re-educate the patient on that information.”
New technologies, expectations
The sophistication of today’s technologies has also added to the levels of patient expectation, Dr. Grohe said. “A lot of new techniques that are more sophisticated in nature are marketed and cross-promoted to an almost mythological level of treatment,” he said. “And as a result, the patient comes in thinking that it’s a magic treatment that will alleviate all visual problems.”
Dr. Teplick said increased expectations are in part justified by the superior technology. “I think the technology has touted — and in most cases accurately touted — better results,” he said. “Custom vision is a good example. The Food and Drug Administration clinical trial results with custom vision on the platform that we use show that 70% of patients see better than 20/20. That is going to raise expectations.”
Dr. Teplick said the popular advice to “under-promise and over-deliver” is easier said than done. “There is some inherent hype, so it is hard to be an under-promiser,” he said. “You need to be realistic with the promise without the hype of the promise. You have to establish realistic expectations. And then almost universally, you have to deliver more than the patient wanted.”
Dr. Grohe agreed that practitioners must be especially careful with patients with extreme refractive error, as well as those approaching presbyopia. “The presbyopia problem has really begun to surface among baby boomers, and many assume the condition is corrected by Lasik,” he said. “They think they will be able to see the same way they did when they were 18 years old.”
Changing protocols
Many practitioners have, to some extent, changed their informed consent protocols since 1997. “When we first started doing this, we had forms for the patient, and often there was a video,” Dr. Teplick said. “We still have the patients watch a video, but our experience over the years has led us to strongly believe that the majority of the information must be provided by the surgeon himself or herself prior to the surgery.”
Dr. Teplick said it is important for patients to have an opportunity to sit down with their doctor and discuss their specific case. “In the past, we tended to delude ourselves into thinking that if the patient watched a video and signed a form, then all the doctor needed to do was ask if the patient had any more questions,” he said. “We feel strongly that this is not enough anymore.”
Dr. Teplick added that in a live conversation with the patient, a doctor also has the option of skipping outdated informed consent information. “For example, informed consent information that was appropriate to first-generation lasers is antiquated today,” he said. “But it is in the literature in the old informed consent. So there’s more flexibility when the doctor can have an actual conversation with the patient.”
Dr. Grohe said his protocols have primarily changed in that he now makes note of Internet information sources used by patients. “We also spell out specific complications in slightly greater detail, such as describing how a halo might affect vision,” he said. “Another example would be to explain exactly what double-vision is. We do everything we can to provide information and to correct misinformation.”
For Your Information:
- Stanley B. Teplick, MD, practices at Teplick Laser Surgery Centers, 9989 SW Nimbus Ave., Beaverton, OR 97008; (800) 422-7014; fax: (503) 520-0403; e-mail: teplick@europa.com.
- Robert M. Grohe, OD, FAAO, is a Primary Care Optometry News Editorial Board member who practices in Homewood, Ill. He can be reached at 18019 Dixie Highway, Homewood, IL 60430; (708) 799-2020; fax: (708) 799-5999; e-mail: Rmg23eye@aol.com.