Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

Accordingly, building rapport with the patient is absolutely essential, and it is imperative to carry out extensive presurgical counseling, as well as preand postoperative photography.

As subspecialists, ophthalmic plastic surgeons frequently function as consultants to comprehensive ophthalmologists, specialty ophthalmologists, as well as general practitioners. The role of a consultant has special legal implications. The words and attitudes of the consultant can lead the patient to seek legal counsel against the referring or previous physician if problems were missed or mismanaged. A consultant must maintain a nonjudgmental attitude and avoid inflammatory words. The consultant should carefully define the scope of the evaluation and redirect the patient to the referring physician for ongoing management and care of nonspecialty issues.1 A consultant may be named in a lawsuit primarily involving a patient and the referring physician.

In general, this textbook is designed to familiarize ophthalmologists and subspecialists with the legal implications of practicing ophthalmology. A goal of this endeavor is to prevent legal action against the reader. Accordingly, this chapter is written with this end in mind.

This chapter should serve as a guide for physicians and is not designed to delineate the standard of care in ophthalmic plastic surgery. We practice in a unique academic and university environment. Our approach is not necessarily representative of the community at large and should not be construed as the standard in the community

The Informed Consent: An Opportunity for Dialogue

The process of informed consent is essential in the practice of quality medicine regardless of medical specialty. Informed consent is composed of information provided to and acknowledged by the patient. This process should not be considered solely a legal requirement or a malpractice prophylaxis maneuver but an opportunity to engage the patient in an educational session about the patient’s condition and options for management. One of the most effective tools at building rapport is to walk the patient through the process of informed consent. Although this book features a chapter dedicated to the details of informed consent in ophthalmology (see Chapter 7), there are several aspects of the process that deserve special attention with regard to ophthalmic plastic surgery.

It is imperative that any physician performing ophthalmic plastic surgery procedures understands the following axiom: the more elective the procedure, the more extensive the requirements for a detailed informed consent. This statement is true not only from a legal viewpoint but also from an ethical and humanistic perspective. The process is an opportunity to fully educate the patient before a procedure that has the potential to significantly improve function and appearance but also carries the risk of producing a deterioration of function and perhaps cosmetic disfigurement. It is important to recognize and manage unrealistic expectations, as is

demonstrated by the comment, “Doctor, I know you are a specialist, and so these things won’t happen.” These patients require extra time to be educated and to understand and to grasp the limitations and risks.

When a patient has minimal or no preoperative medical symptoms and undergoes an elective procedure, the disappointment caused by an unsuccessful surgery or complications is all the more bitter. Consider the middle-aged female patient who undergoes elective upper blepharoplasty and experiences severe postoperative new-onset symptoms of dry eyes. Neglecting to discuss this potential postoperative effect prior to performing the surgery would be unfortunate from both a legal and an ethical perspective. Anything told to the patient prior to surgery is accepted as an explanation, whereas anything told to the patient after the surgery can be perceived as an excuse. Often the process of informed consent allows the physician to measure the patient’s expectations and then to help tailor the expectations appropriately. Explanations can be designed to encourage patients to focus on improvement, not perfection. “Ms. Jones, perfection is not possible, but we can certainly do our very best to achieve an improvement here.”

If there are particular maneuvers that are usually performed to avoid complications during surgery, these may suggest potential areas for specific discussion during the informed consent process. For example, during inferior orbit surgery, we specifically identify the inferior oblique muscle to avoid injury, and so we discuss with patients the risks of double vision after surgery. Another example is our application of ointment to the cornea during eyelid surgery to prevent a corneal abrasion, and so we discuss with patients the risks of corneal abrasion or ulceration after surgery.

With any given procedure, there is a distinction between what needs to be discussed during the informed consent process and what is not required by the standard of care. For example, while discussing the potential complications of ptosis surgery, it is prudent and necessary to review the potential need for revision surgery for asymmetry or contour abnormalities. Certainly, the vast majority of ptosis surgeons would discuss these possibilities, and this is what constitutes the standard of care. However, it may not be necessary in the discussion to bring up the possibility that a fire could erupt in the operating room as a result of electrocautery and cause first-degree burns to the facial skin. Although this scenario is a rare possibility, it falls under the category of rare and unusual circumstances that a physician is not required to review in the informed consent. If brought under courtroom scrutiny, the jury would be asked to make a determination of whether there was sufficient disclosure to allow the patient to make an informed consent.2 In fact, it may not be possible or practical to name every conceivable potential complication.

The informed consent process in ophthalmic plastic surgery should always include three general items. First, when discussing surgery involving a skin incision or soft tissue manipulation, the potential for cosmetic disfigurement from unexpected healing should be revealed. Dermal and soft tissue healing varies from individual to individual, and therefore fibrosis outside of the standard deviation can lead to unpredictable results. Second, the rare but possible risk of vision loss, including blindness, should be discussed. In New York state, a plaintiff successfully prosecuted a case of corneal laceration during ptosis surgery; the informed

consent process omitted the discussions of vision-related complications.3 Finally, patients must be informed that, with any surgery, there is the potential need for reoperation. The reasons to return to the operating room may be functional or reconstructive in nature.

Perhaps the most important idea to convey during the informed consent process is the concept of risk. It is preferable to use real-world examples rather than quoting esoteric numbers. In our practice, we have a routine method of simplifying the discussion of surgical risk in order to facilitate understanding. Often the explanation is similar to the following scenario:

Ms. Jones, I want you to know that there are risks of unwanted results and consequences as a result of your entropion surgery. Anything can happen—any question you ask, the answer could be yes. Is it possible that you could lose vision? Yes. Is it possible that you will not be happy with the results of surgery? Yes. Is it possible that you could die on the operating room table? Yes. But let’s talk about the chances that the event will happen. What are the chances that we could have an earthquake during surgery? What are the chances that you could be involved in a car accident the morning of surgery on your way here? What are the chances that you could have an infection after surgery?

As a final point, the process of informed consent is often perceived by the patient as a sobering discussion of potentially negative consequences. From a psychological perspective, a patient who has a positive outlook before surgery is more likely to be satisfied with the results of surgery. The physician should always end the discussion of informed consent on an upbeat but realistic note. “Ms. Jones, I believe that you are a good candidate for this surgery, and we can both look forward to the potential benefits of this surgery with a positive attitude,” or “You are an acceptable candidate for a potential improvement, recognizing that you have asymmetry.” Use of the word potential conveys optimism yet acknowledges that the result is not certain.

The Slippery Slope Concept: Planning for Disappointment Prevents Disappointment

Maintaining the doctor–patient relationship is paramount to minimizing risk, as this relationship is based on mutual trust and understanding. Failing to anticipate events that will derail the doctor–patient relationship can be a physician’s legal Achilles’ heel. In particular, combining functional and cosmetic surgery sets up a delicate and complex set of expectations from the patient. For example, a patient may ask, “Doctor, while you are performing my ptosis surgery, can you remove some of my extra skin?” Alternatively, the physician may suggest, “As we are doing the ptosis surgery anyway, we should address the eyebrows . . . deal with the nevus on the eyelid . . . address the lower eyelids.” Payment for these procedures may involve a combination of insurance and self-pay. Any perceived imperfect result could be a set-up for disappointment. Patients focus on subtle asymmetry after ptosis surgery and blepharoplasty and wonder, “Will there be a need for more surgery? Shouldn’t

reoperation be at no cost to me?” These events can begin a downward spiral of distrust and negativity stemming from disappointment that was not discussed, hence the slippery slope.

The definition of cosmetic surgery should be made quite clear to the patient: cosmetic surgery is surgery that the insurance company deems not medically necessary. For example, dermatochalesis excision “on the side” during ptosis surgery is considered cosmetic surgery. In addition, the patient should be made to understand that all surgery, both medically necessary and cosmetic, is performed on a fee-for- service basis. This concept is self-evident for functional surgery. When explaining the risks of reoperation to a patient who undergoes insurance-covered scleral buckle surgery for retinal detachment, it goes without saying that the insurance company will also be billed if further vitrectomy surgery is required to complete the retinal detachment repair. On the other hand, patients often perceive cosmetic surgery to be in a different category of billing. After all, when a patient goes to a salon for a haircut, if he or she is unhappy with a certain aspect of the style, cannot he or she demand that the hairstylist “fix” the unacceptable area without charge?

In the “slippery slope” model, the doctor–patient relationship breaks down from both sides. The patient is unhappy with the result and does not expect to pay for a “touch up.” The physician is unhappy because she did everything possible, spent an extra hour on the surgery, did her very best, and now the patient wants the physician to pay for the operating room cost and to absorb the cost of revision surgery. When both the patient and the physician become resentful, the “slippery slope” becomes more slippery, and the doctor–patient relationship quickly deteriorates. If there has been no preoperative discussion of how to manage disappointment, the patient proceeds with reoperation surgery full of resentment. If the revision surgery is not successful, the patient will have very little patience and may seek legal counsel.

To anticipate the “slippery slope,” there should be a preoperative agreement, a fee-for-service arrangement, to manage perceived disappointment from cosmetic surgery or the cosmetic portion of a mixed cosmetic–functional surgery. A detailed discussion should take place prior to embarking on surgery regarding the fee-for- service nature of surgery and reoperations. This agreement should be discussed and documented. The essence of the agreement might be, “I will do my very best, and I will not take advantage of you. If we have to revise the surgery, there will be a fee.” If the physician prefers not to enter into detailed conversations with patients regarding financial arrangements, a responsible employee that usually handles financial discussions may perform the agreement.

The practitioner unaccustomed to this concept of a fee-for-service relationship may be shy to discuss such detailed financial agreements regarding further surgery. However, a fee-for-service agreement does not undermine the doctor–patient relationship. In contrast, it strengthens the relationship by rooting the patient in the reality of the risk of complications and undesired results that are possible in all surgical endeavors, including cosmetic surgery. A patient who undergoes cosmetic surgery with a realistic and balanced outlook is much more likely to be satisfied with the results than a patient who is expecting an “extreme makeover” without compromise.

Functional Eyelid Surgery: Risks and Pitfalls for the Busy Practitioner

A major portion of the practice of an ophthalmic plastic surgeon focuses on functional eyelid problems. Frequently, these conditions require surgery. Despite the high frequency and usual straightforward nature of these procedures, several potential legal pitfalls exist in preoperative planning and surgical care for the various categories of procedures.

Several risks are common for any eyelid surgery, and the material risks of harm must be discussed before surgery. During eyelid surgery, all imaginable harm may occur during the injection of anesthetics, as well as the incision and manipulation of eyelid tissue. The protective mechanism of the eyelids for the ocular surface may be negatively affected by surgery. Lagophthalmos, retraction, other types of eyelid malposition, and poor orbicularis function may lead to a compromised ocular surface. Sutures can rub against the eye or conjunctiva and cause irritation. The potential end result may range from dry eye and exposure keratopathy to chemosis and corneal ulceration. While it may not be feasible to name every conceivable complication, acknowledging that vision-threatening problems are rare but possible is highly recommended from a legal as well as an ethical perspective.

One of the most common procedures performed is ptosis surgery. Yet, ptosis surgery perhaps is one of the most complex and unpredictable surgeries in the category of eyelid surgery. From a patient’s perspective, the surgery does not seem complex. After all, how difficult is it to just “lift the droopy eyelids a bit?” Only after lengthy explanations reviewing the contribution of eyebrow compensation, Herring’s law, and the difficulty of interpreting the intraoperative effects of local and intravenous sedation on levator function might a patient begin to understand the complexity of the surgery. Thus patients should be counseled on the potential need for reoperation after ptosis surgery for various reasons. Insufficient eyelid elevation, overelevation, contour abnormalities, and asymmetry are all possible results following ptosis surgery, even in the hands of a very experienced surgeon. We routinely quote a 20% reoperation rate after ptosis surgery for our patients. Prior to surgery, we try to prepare patients mentally for imperfection by openly discussing the possibility of minor asymmetries. When a less-than-perfect result occurs, patients are not surprised, and further management discussions can proceed. On the other hand, an excellent result causes a patient to celebrate.

A delicate subcategory of functional eyelid surgery consists of eyelid neoplasms. Contrary to common belief, patients sue much more frequently from delay in diagnosis in oncology rather than morbidity related to the cancer itself or its treatment.3 A classic illustration of this scenario is the elderly patient with a “chronic chalazion” that does not respond to medical treatment; the underlying sebaceous cell carcinoma can rapidly become systemically malignant if not identified and managed appropriately. Multiple lawsuits have occurred over the misdiagnosis and/or delay in diagnosing eyelid neoplasms. In one analysis, the most common allegation group in malpractice is “failure to diagnose,” and the most common specific allegation is “failure to diagnose cancer.”4

Cancer is a complex legal topic with emotional overtones, and it deserves special attention as any morbidity may cause a patient to seek to blame. When in doubt, perform a biopsy, and inform the patient of the risk of carcinoma upon presentation of the suspicious lesion.

One of the most frequent office-based procedures in ophthalmic plastic surgery is the excisional biopsy of an eyelid lesion. Many surgeons routinely perform several of these procedures a day. The majority of cases carry benign clinical diagnoses: papilloma, inclusion cysts, hydrocystomas, nevi, and so forth. However, occasionally a lesion that may have appeared benign unexpectedly turns out to be a skin cancer. Therefore, a biopsy log should make its way into every ophthalmologist’s practice. Specimens sent for pathologic examination may take several days to be processed and read. Occasionally a patient will miss a follow-up appointment, especially if a small lesion was excised completely from a clinical perspective. Patients have little motivation to return to the biopsy surgeon if they were referred primarily for lesion excision. Occasionally, the pathology laboratory may not notify the physician of biopsy results, even if the final diagnosis is ominous. When both events happen, the results can be disastrous. A biopsy log lists all tissue sent for histopathology, and its regular review is a safety net for preventing diagnosed but unmanaged situations.

Orbit and Lacrimal Surgery: Avoid Management Pitfalls

When faced with orbital and lacrimal disease, the ophthalmic plastic surgeon must navigate a wide differential of possibilities. General categories include neoplasm, inflammation, and infection. The differential may include diagnoses with severe potential morbidity or even mortality. Careful work-up is indicated, including imaging studies, if indicated.

As in eyelid tumors, cases of orbital and lacrimal neoplasms can become legally ominous if not diagnosed promptly and managed appropriately. Orbital neoplasms have the potential to disfigure a patient, cause sensory and motor neuropathy, and produce further morbidity and/or mortality from local and systemic spread. Moreover, the treatments may also be disfiguring and/or cause visual and functional morbidity. Careful adherence to the specific standard of care for managing the individual cancer can prevent suits alleging inappropriate procedure or management. During the informed consent for orbit neoplasm surgery, the specific risk of pupil dysfunction after surgery should be discussed. For example, after a successful dissection and removal of an intraconal hemangioma, damage to the parasympathetic plexus entering the posterior globe can cause an irregular shape or dilation of the pupil. Despite the success in removing the neoplasm, a patient with light irides may have symptoms of glare or photophobia with a dilated pupil. A patient may even scrutinize the cosmetic consequence of asymmetric pupils.

Graves’ disease often causes a significant impact on patients’ long-term quality of life. It is a frustrating and debilitating disease that often requires multiple

stages of medical and surgical management. Patients who are confused, suffering a chronic disease, and experiencing permanent disfigurement and loss of function can become angry and depressed. If a careful doctor–patient relationship has not been nurtured through extensive education and empathy, lawsuits may result. The cornerstone of Graves’ disease management is careful patient education. Detailed discussions of the staged surgical approach to the disease is helpful in preparing the patient for the long road to improvement and the potential need for reoperation at any point.5 In addition, the patient can then accept the idea that orbital surgery may change or cause diplopia, and orbital or muscle surgery might improve or perhaps even worsen eyelid position. The reality that recession of an extraocular muscle may cause relative proptosis should be pointed out. Of course, any disease with the potential for optic neuropathy also requiring multiple surgeries bears the possibility for vision loss at any stage as a complication of management or as a direct effect of the disease process. Careful documentation of patient discussions and clinical evaluations can validate a carefully staged and appropriately explained management plan, even if the final result is not satisfactory to the patient. Preand postoperative photography visually documents the disease and results of surgery.

Orbital and lacrimal infections have the potential to spread rapidly across the face and posteriorly into the cavernous sinus and cranial fossa. These infections can cause significant morbidity and, in rare instances, mortality. The vague nature of the initial clinical presentation and the unpredictability of the disease course require appropriate early evaluation and workup. A delay in management can lead to morbidity that might give a patient reason to seek legal counsel. Significant infections should prompt specialty consultation. Infectious disease specialists can provide valuable assistance in choosing appropriate antibiotics. Otorhinolaryngologists can assist in the management of sinusitis. The comanagement of facial fungal infections with an otorhinolaryngologist is highly recommended, as endoscopic sinus surgery is often indicated early in the evaluation and management of mucormycosis and aspergillosis. The ophthalmologist should maintain a high suspicion for these infections, as they are rapidly progressive and have significant potential for serious harm. Chronic dacryocystitis is usually caused by simple nasolacrimal duct obstruction, but in the back of the clinician’s mind should always remain the suspicion for nasal and lacrimal neoplasms that can masquerade as seemingly more straightforward diagnoses.

Nasolacrimal duct obstruction can be a frustrating problem for patients. Surgery for nasolacrimal duct obstruction involves dissection into the nasal cavity, and bony removal maneuvers have the potential to inadvertently enter sinuses and to cause intranasal scarring and even cerebrospinal fluid leaks. These risks should be discussed with a patient prior to surgery. As in any surgery, complications should be carefully disclosed and monitored, not concealed.

Vigilance and responsive care are of the utmost importance to maximize the care of the patient with orbital or lacrimal disease. The patient who requires surgery should have extensive counseling and education, as orbital and lacrimal diseases are frequently difficult for patients to understand.

Ocular and Facial Trauma: Difficult for Both Patients and Surgeons

In the treatment of a trauma patient, the physician is potentially facing an uphill battle from a legal perspective. Trauma patients are among the most frequent group to initiate legal action against their physicians, and several factors are stacked against the physician. Often a patient requires immediate or semiurgent surgery, and there is little time for the physician to develop rapport with the patient. Furthermore, the trauma often damages delicate periocular structures, and the patient has difficulty in differentiating loss of function from the trauma and saved function from the surgical repair. The patient may require several staged surgeries, perhaps with different subspecialists, which may lead to a protracted recovery. Despite heroic attempts at reconstruction, patients may still be severely disfigured from their perspectives. Several strategies may be helpful in minimizing the chances of a trauma-related legal action.

A rapid and careful workup is required in cases of trauma. There should be a high suspicion for foreign bodies, especially intraocular organic and metallic foreign bodies. A patient with no apparent facial or ocular surface penetration may have an occult self-sealing corneal, limbal, or scleral wound. Intraocular foreign bodies, if missed, have very significant legal ramifications against the physician.6 The visual prognosis of an apparently uninjured eye can rapidly deteriorate in cases of endophthalmitis and/or metal toxicity. Immediate x-ray imaging should be performed in cases of suspected intraocular foreign body, and, if a foreign body is identified, urgent vitreoretinal consultation is needed. Similarly, there should be careful consideration of removing orbital foreign bodies. Imaging studies and the clinical history can help differentiate the two general categories of foreign body composition (organic and inorganic) and two general categories of penetration (stable or unstable). Unstable foreign bodies can affect orbital and globe function and may even penetrate into the cranial vault. Thus consultation with the neurosurgery service should be considered, if necessary. Generally, organic foreign bodies carry a risk of infection and should be removed, whereas inorganic and inert materials need not be removed unless their location is unstable.

Facial fracture repair requires broad surgical exposure. As a result, there is inherent risk of collateral damage to orbital and facial function. Detailed preoperative discussions should include the risk of inducing strabismus and the rare risks of sensory and motor nerve damage.

As is true in all circumstances, but especially in trauma situations, careful documentation is mandatory. Documentation of the accident and the preoperative workup, including radiologic results, should be performed. In the long run, patients have poor recollection of conversations at the time of emergency/urgent care, and so documenting the discussion of risks and alternatives should be performed. An ancillary staff member should witness surgical consents. Photodocumentation of the patient’s clinical examination is highly recommended, as patients immediately posttrauma may not be in a state of mind to digest the realities of the injury, and

photography can capture the extent of the damage. Reviewing the preoperative photos with the patient during the recovery period is helpful in allowing the patient to understand better their preoperative state and to appreciate better their postoperative condition.

A patient with a poor outcome may occasionally seek redress for grievances. Occasionally, the trauma/reconstructive surgeon may be called as a witness when the patient takes another party to trial. The surgeon may be asked to comment on the extent of the injury and on the long-term prognosis. Again, photographs taken by the surgeon at the time of initial evaluation may be quite helpful. Written documentation is crucial. As a pattern, the style of recording information into the chart should be nonbiased and matter of fact. Whatever is written in the chart may be asked to be read out loud to the jury, word for word. Opinions expressed by the patient should be in quotations or, alternatively, should be documented as, “The patient states that.…”

Cosmetic Facial Surgery: Minimize Risk by Managing Expectations

Once a taboo topic, cosmetic surgery is now fashionable. “Honey, this surgery is you! Just let me remove these bags and lift right here—we’re going to make you young again.” Scripted television clip or real life? Reality-based television shows have brought cosmetic surgery to the center stage of modern entertainment and into the homes and minds of society in an unprecedented manner. Patients believe that the “extreme makeover” is not only possible but routine.

Attending to the patients’ expectations of cosmetic surgery is perhaps the most important factor in successfully treating cosmetic patients and minimizing the legal risks involved. It is essential to balance a discussion of the proposed treatments with the potential risks and limitations. The discussion should not be hurried, and an attempt should be made to educate the patient as much as is reasonable with regard to the patient’s specific anatomy and the surgical techniques suggested to achieve a desired outcome. An educated patient is more likely to have realistic expectations. Effort should be made to understand the patient’s psychologic and psychiatric status. Simple direct questioning can uncover patients’ motivations for surgery. When patients expect that cosmetic surgery will transform their lives, save their marriages, or relieve their clinical depression, then the surgery is a setup for disappointment. Patients with body dysmorphic disorder often seek the services of a plastic surgeon, and subjective dysmorphia can extend to the face. Relatively minor facial features can become overly exaggerated in the patient’s mind and lead to obsessive scrutiny of these features. It is the duty of the surgeon to unearth these psychologic states with screening questions. Failure to identify those patients who harbor unrealistic expectations can result in an unsatisfied patient who will be more likely to sink into depression and surface with a lawsuit. Referring the patient for a second opinion by a trusted colleague who can deal with the patient in a friendly