Risk Management



Informed Consent for Refractive Surgery

By Richard L. Abbott, MD

[Refractive Eyecare for Ophthalmologists, May/June 1998]

We often talk about “the” informed consent as if it were a single document that patients sign prior to undergoing a procedure like refractive surgery. A much more valuable way to envision informed consent is as a process that begins when the patient receives any kind of information about the procedure from the physician’s office. Whatever patients subsequently learn from the practice becomes part of the process of informed consent.

The actual form that the patient signs is just the final step in the process. Most courts will find that all those other pieces of information that patients receive including marketing materials, videos, and patient information brochures are admissible as evidence as part of the informed consent.

The Informed Consent Document

The actual informed consent document that patients sign must cover four basic elements:

  • Risks associated with the procedure
  • The benefits of the procedure
  • The complications of the procedure
  • Alternative treatments

In addition, the informed consent should have some background information on the procedure and explain what happens in the procedure. These should all be presented in language that the layperson can reasonably be assumed to understand.

The informed consent document for refractive surgery should include a discussion of the advantages of one procedure vs. another (e.g., laser in situ keratomileusis [LASIK] vs. photorefractive keratectomy [PRK]). Important subsidiary issues like bilateral simultaneous surgery vs. sequential surgery also have to be aired. In each case, the advantages and disadvantages to the patient need to be spelled out clearly. The document should present the kind of factual information that will allow the patient to make as informed a decision as possible.

Risks

In refractive surgery, the greatest risk to the patient is that the results of the surgery will not meet his expectations. The procedure isn’t perfect, and wound healing isn’t perfectly predictable. Therefore, patients must be clearly advised that there is some uncertainty as to the outcome of any refractive surgery.

Even if a high percentage of patients are 20/20 following a procedure, there is no assurance that a given patient will obtain that (or any other) result. Patients must know and accept that outcomes are not guaranteed.

Failure to achieve an expected outcome is the greatest risk of refractive surgery. Some of the other relatively common risks that must be covered in an informed consent document are: undercorrection, overcorrection, fluctuating vision, glare, astigmatism, halos, and loss of perceived contrast in low light. These are all fairly common risks that must be explained.

More devastating outcomes, including loss of vision from infection or scarring, are very rare. It is not necessary to present these relatively unlikely possibilities in a frightening way; but patients do need to be informed that – just as they can be hit by a truck when crossing a street – there is a small, but not zero, chance of serious side effect or bad outcome.

LASIK adds some additional risks – tearing the flap, microkeratome failure, infections under the flap, epithelial ingrowth, etc. These are well known risks that can simply be listed, if the patient is to undergo LASIK.

“Off Label” Procedures

As of this writing, LASIK is still an “off label” procedure, and the patient needs to know that. Usually it is sufficient to include a simple statement to the effect that the doctor believes it is in the best interest of the patients to perform LASIK and that LASIK is allowed although it wasn’t specifically approved in the initial FDA review of the laser. This is not a major issue, but the patient should be made aware of it.

Like LASIK, simultaneous bilateral PRK has not received specific FDA approval. This fact should be made known to PRK patients considering a bilateral procedure. For bilateral PRK patients (and for bilateral LASIK patients as well), the informed consent should cover the advantages and risks of simultaneous bilateral surgery vs. waiting for the first eye to heal before operating on the second eye.

Support for Informed Consent

The informed consent document offers the surgeon some protection, even if it is the only thing that he can muster to show that there was a process of informed consent. But the protection will be greater if there is supporting evidence of a process that went beyond the single document, e.g., notes in the chart documenting a discussion between doctor and patient, or the results of a test taken after watching a video.

The protection offered by the informed consent document can be undermined, sometimes greatly, if the practice’s marketing or patient information materials don’t support it. Marketing materials that are very aggressive, that make claims that can’t be substantiated with facts, detract from the informed consent document. Even if the informed consent document is letter perfect and signed by the patient, its value will be diminished if other materials from the practice seem to contradict it. The refractive surgeon’s best protection is to pay attention to all steps of the process.

Timing

Patients need adequate time to consider the informed consent document. Handing the informed consent document to the patient a few minutes before the surgery isn’t enough. The patient should be able to take the document home, read it, perhaps share it with a spouse or friend, and then have an opportunity to ask the doctor questions about it prior to signing.

Giving the informed consent to an unprepared patient on the day of surgery doesn’t give the layperson time enough to grasp its contents. If there is an unsatisfactory result and the patient sues, the hurried circumstances under which the informed consent document was signed will come out in testimony, undercutting the value of the document.

Simply signing the document on the day of surgery is acceptable, if the patient has been given the document for review ahead of time (and this is documented). If the patient is to sign the document on the day of surgery, be sure that the patient is not sedated or dilated until after signing. In general, the patient should not be in any way impaired at the time of signing.

The Surgeon’s Role

Since one wants to be able to rely on it in court, the informed consent document should not be underplayed for the patient. Having a staff person hand the informed consent to the patient with words to the effect of “Please sign this document, it’s just a formality,” will diminish its value. If the risks were glossed over, or if the patient wasn’t given a chance to consider them, the patient may be able to make a credible case that she didn’t know before surgery that her unsatisfactory outcome was possible.

The doctor’s rejoinder that those risks were stated in the informed consent won’t carry much weight if the circumstances in which the document was given to the patient made it seem trivial. Again, informed consent is a process, every step of which should be attended to.

In the last analysis, informed consent is the responsibility of the surgeon. Videotapes, true/false tests, refractive surgery coordinators, and the like can all be important parts of the patient education process. But ultimately there needs to be a face-to-face meeting with the surgeon – even if it’s for a very short period of time. At this meeting the surgeon can ask: “Are there any questions that I can answer?”

Although it may be brief, the patient-surgeon meeting should be a real meeting in which an unsedated patient is free to ask questions. The face-to-face meeting should be documented. A first meeting in the surgery suite with the surgeon peering over the microscope to introduce himself and ask if there are any questions will not bolster the surgeon’s case in court.

Making Your Case

Most of the time nothing goes wrong, and most patients are happy with their result; but it takes just one incident to create a protracted period of difficulty for the refractive surgeon. Since the day-to-day reality is that little goes wrong, it is easy to let one’s defenses down. An ongoing process of informed consent, with clear documentation, should be built into the office routine. Good documentation of an adequate informed consent process makes defense of court cases much easier.

A surgeon’s case will get a strong boost if the chart has notes in the surgeon’s handwriting documenting his part in the informed consent process. This need not be elaborate. All that is required is a few brief sentences such as: “Reviewed informed consent document with patient. Patient understands. All questions were answered to patient’s satisfaction.” That plus a signature provides very useful documentation. If the discussion was more than cursory, a little note on how much time was spent will help, e.g., “15 minutes spent answering questions.”

What Can Weaken a Case?

Just as good documentation will support a case, overly aggressive marketing materials can torpedo it. It is hard to demonstrate that the patient should have been prepared for a less-than-desired result when the practice distributes literature that says things like: “You can throw away your glasses,” or “Guaranteed success.”

It is far easier to mount a good defense when the marketing material is straightforward, honest, and informative, and there is evidence of an educational process that took place over an adequate period of time. The absolute minimum time is probably 2 days. A 2-day process will give the patient at least one night to absorb the material and discuss it with a spouse or a friend. If on the next day the patient has an opportunity to ask questions of the surgeon prior to surgery, and if all this is carefully documented, the process is probably adequate.

Problems happen when the patient feels railroaded through the process with no real chance to understand the surgery or its risks. Unless there is a comanager handling the case, it is especially important that the patient have a chance to meet the surgeon and ask questions prior to the day of surgery.

A poor informed consent process is no liability when the surgical result meets the patient’s expectations. But when a patient’s expectations aren’t met, and the patient feels that there was no real communication with the surgeon, anger and lawsuits can happen. The rule is simple: poor communication leads to anger when there’s a bad outcome.

Comanagement

There are several important points about the comanagement situation. First of all, the patient must understand in advance how care will be divided. The comanaging ophthalmologist (or optometrist) must provide the pre- and postoperative care, but the refractive surgeon will be responsible for the actual procedure. The informed consent documents must clearly identify the participants and delineate their roles.

Although the refractive surgeon bears the ultimate responsibility for the surgery, both the surgeon and the comanaging ophthalmologist should have their own informed consent documents. The comanaging ophthalmologist’s document can be less elaborate than the refractive surgeon’s. The comanager’s document can just state his recommendation for the patient, his role in the process, what the procedure entails, and that the patient understands and accepts it.

The refractive surgeon’s document should detail the surgical procedure – including all the basic elements noted above – as well as describe her role and the role of the comanager. The informed consent process can be a joint effort between the refractive surgeon and the comanager. But each should have an informed consent document, and the patient should sign one document in each doctor’s office.

Even in a comanagement situation, the refractive surgeon needs to have a face-to-face meeting with the patient prior to their coming together in the surgery suite. At this meeting, the surgeon can introduce herself, be assured that the patient is adequately prepared, and ask if the patient has any additional questions. This meeting should take place prior to sedation or dilation. The informed consent can be signed at the end of the meeting.

Even though much of the informed consent process took place in the comanaging ophthalmologist’s office, the meeting between the patient and the refractive surgeon is important. The patient has to feel totally at ease with the surgeon, and the surgeon has to know that the informed consent done at the comanager’s office was thorough and well presented.

Conclusion

Informed consent is a very important piece of protection for refractive surgeons and comanaging ophthalmologists. But it is more than that. From an ethical and good practice point of view, as well as from a purely defensive standpoint, it’s important that patients be educated and understand what they are choosing.

A patient who has been brought into the decision process knows the risks and is less likely to believe he has reason to sue. The patients who sue are often the ones who feel abused by an uncaring surgeon who kept them in the dark. The very process of talking to the patients, of taking their concerns seriously, changes the atmosphere and reduces the chance of legal action.

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