Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

of whether it was documented. Under the law, oral testimony and documentary evidence are theoretically entitled to equal weight. As a practical matter, however, documentation of treatment provided wins out in virtually all instances in which the plaintiff alleges treatment was not provided. Of all the things that can be a disadvantage to a physician who is accused of negligence, failure to adequately document in the patient’s medical record is by far the most commonly damning element. In the face of good documentation in the medical record, the sole argument then left to the complainant is that the record has been altered. Of course, one of the worst things that could ever be done from a medicolegal perspective is alteration of the record. This must never occur. Rather, the record should be well documented contemporaneously. If additional information is necessary and/or appropriate, the further documentation should be clearly labeled as an addendum.

Detailed Patient Questionnaire

To properly treat your patient with uveitis, you must take a full and complete history. A detailed patient questionnaire allows you to learn more about your patient and permits further insightful questioning of the patient at the initial visit and/or subsequently. We have used an extensive questionnaire at the Massachusetts Eye Research and Surgery Institute with special customization for inflammatory disease that I designed many years ago, the use of which, along with follow-up questioning, provides by far the greatest source of diagnostic leads of any of our activities and also demonstrates to the patient our effort in eliciting further significant information.

The more you know of the patient’s medical history and family medical history, the better the position from which you are able to consider various diagnoses and differential diagnoses and the better documented your records are regarding the quality of your patient care efforts. For instance, a family history of certain conditions may place the patient at greater risk for such conditions and require the ophthalmologist to discuss said greater risk when advising the patient of possible diagnoses and/or treatment options. For example, it is now clear that the child with juvenile idiopathic arthritis–associated uveitis has a greater risk of an especially stubborn course of disease if there is a family history of psoriasis. Knowing this, both doctor and parents may be motivated to advance such a child to steroidsparing immunomodulatory therapy sooner rather than later in an effort to induce a steroid-free durable remission and avoid development of cataract or glaucoma or vision loss from retinal damage from recurrent or chronic inflammation.

A detailed questionnaire, history, and initial examination build the foundation on which future treatment rests. Time and effort spent at this stage are not only appropriate and indicated but help to establish the requisite rapport with the patient. While you are evaluating the patient for necessary care, the patient is likewise evaluating you and your manner of caring, noting, for example, that you have reviewed the questionnaire that they completed prior to their encounter with you

and noting that the information there is important to you, stimulating you to inquire further into certain responses on the questionnaire.

Chief Complaint and History of Present Illness

Three things are required at this point in documentation of the chief complaint and the history of the present illness: detail, detail, detail. The time of onset of presenting symptoms as well as any change in symptoms prior to the time of the first visit when the formulation of a diagnosis and treatment plan are developed may all be critical to diagnosis and treatment as well as defense of the critical diagnosis and treatment plan. Whether the signs and symptoms are bilateral and the intensity of the signs and symptoms may also prove determinative in the patient’s care as well as in the courtroom. The presence or lack of nonvisual complaints should also be documented where important to diagnosis or to exclusion of diagnosis. For instance, documentation that the physician inquired about the presence or lack of general malaise or the presence or lack of jaw claudication is important in that these symptoms may be significant to the diagnosis or exclusion of the diagnosis of giant cell arteritis.

Review of Systems: Use of a Questionnaire

The written questionnaire or template is a wonderful starting point. A start, however, is all that it actually is. Questionnaires and templates are a beginning of the thought toward the goals of diagnosis and treatment, which are far down the road from these limited tools. In certain cases, the review of systems may not require questions beyond the routine of the questionnaire. By necessity, the questionnaire and template, however, cannot encompass all aspects of review of systems. Thought must be given on occasion to items not contained on the questionnaire or template. This, as well as the patient rapport building aspect of taking the medical history, is why it is important for the physician to be willing and eager to think beyond and outside the box of the questionnaire and template.

Medications

All of the patient’s medications need to be documented. The patient’s medications may lead to questions regarding history that otherwise may never have been asked. Dosage and frequency must also be recorded. For instance, the adequacy of the medication to accomplish the desired goal can be properly assessed only if the dosage and frequency are known. Interaction of medications must also be considered before a medication can be appropriately prescribed by an ophthalmologist.

Examination: Eye and Otherwise

The record should reflect all aspects of the eyes that are examined. All other aspects of the examination should also be reflected in the records so as to document the findings considered by the ophthalmologist. For example, for the patient with a history of recurrent uveitis with a review of systems questionnaire indicating that the patient has an episodic itchy, scaly rash on leg or scalp or elbow may prompt the ophthalmologist to consider psoriasis as a possible entity associated with the patient’s uveitis. An examination of the patient’s fingernails may disclose tiny punctate pits; these should obviously be documented in the medical record. Even if nail pitting is not detected, documentation of that negative extraocular finding is equally worthy of documentation.

Formulation of a Differential Diagnosis

It is important to document not only the leading diagnosis or impression but also the other diagnoses in the differential. Consideration should always be given to testing and/or follow up for any potential diagnosis that is life, limb, or vision threatening. Be prepared to justify why a test or follow up was not done to rule out these types of potential diagnoses. For instance, it may be that the potential diagnosis was so remote that further testing or examination was not indicated. For example, although the patient with uveitis and associated retinal vasculitis could have Wegener’s granulomatosis as the underlying cause of these findings (and antineutrophil cytoplasmic antibody testing is easy and appropriate to request), chest and sinus computed tomography scanning may represent overreaching defensive medical testing in the absence of any sinus or chest symptoms on review of medical systems in the mind of even the most prudent physician, and so he may choose not to do such testing.

Formulation of a Plan: Laboratory Tests, Referral,

and Treatment

The record needs to reflect what the ophthalmologist considered in formulating a plan. Documentation should reveal the thought process as to laboratory tests, referral, and treatment. If laboratory tests and/or referral were considered but not ordered for the time being, in certain cases it may be appropriate to document the reasons for delay or for not doing such at all. For example, the patient with uveitis with the greatest concentration of cellular activity in the vitreous might be considered potentially to have central nervous system–intraocular large cell lymphoma, with neurology consultation and vitreal biopsy as part of the plan if fluorescein angiography, electroretinography, and HLA-A29 testing do not disclose that the

patient has all of the features that speak more strongly for the diagnosis of birdshot retinochoroidopathy. Thus, the risks and the expense to the patient of the more invasive testing are appropriately deferred until the noninvasive studies have been completed. However, the documentation has clearly demonstrated the physician’s thought processes and in particular that he has considered the possibility of lymphoma and plans to pursue that possibility in the event that the noninvasive studies are negative.

Diagnosis

After consideration of the patient’s history, review of systems, examination, tests, and laboratory results, what is the most likely diagnosis? What are the other possible diagnoses in order of most likely to least likely? What is the worst case scenario? Are additional tests, follow-up examination, or referral indicated to attempt to avoid vision loss or worse? Does the record reflect your thought process? Can you defend your thought process from the record or otherwise? Asking yourself these questions now may avoid your being asked these questions later by the patient or a representative of the patient.

Advice to Patient

In treating patients, the prudent and caring ophthalmologist should advise his patient of the differential diagnoses along with the signs and symptoms of such, particularly when a differential diagnosis may have devastating consequences. For instance, a patient may have what appears to be a comparatively benign condition, such as a retinal tear. The condition, however, may be a precursor to a detached retina. Accordingly, the patient must be fully advised as to the initial signs and symptoms of a detached retina in order that the patient may respond in a timely way to receive the necessary treatment and avoid vision loss.

Discussion of Potential Risks and Complications

Often, the patient is anxious and overwhelmed by the potential diagnoses, treatment options, and possible outcomes. In these circumstances, the patient does not always hear and retain what is being discussed and/or “filters” the discussion in a light most positive for the patient’s prognosis. Given that lack of informed consent provides a separate and distinct basis for recovery against a physician, it is critical to document the treatment options, alternatives, and potential risks and complications.

The Risk of Failure to Diagnose

Failure to diagnose is a matter of major importance in medicolegal actions. Uveitis patients may have an infection that is difficult to diagnose until late in the course of disease (e.g., herpes simplex recurrent uveitis), or they may have cancer as the cause of the “uveitis,” with the highly lethal central nervous system– intraocular large cell lymphoma being the preeminent example of this “masquerade.” Documentation of consideration of such possibilities can go a long way in making clear that the ophthalmologist has not been negligent in his intellectual assessment of the patient. Referral of the patient, of course, sooner rather than later in the case of uveitis that is unusual, stubborn, and particularly chronic, that is recurrent, or that is producing damage that is a threat to vision is the other preferred practice pattern that can provide the patient the best standard of care.

Consideration of Referral to a Specialist

If the diagnosis remains unclear or if it is clear but implicates the need for further specialization, refer the patient sooner rather than later. Seldom is a physician criticized solely for referral. Instead, the criticism comes if the referral has been delayed. Involving a specialist early avoids this potential basis of criticism but, more importantly, provides the patient with more specialized care while you may or may not remain directly involved in the patient’s care. Even if you may no longer see the patient, your continuing to seek or receive reports will avoid any basis for any claim for alleged abandonment that unfortunately can follow an abrupt cessation in care, particularly if the possibility of a poor outcome has been raised. Finally, be complete in the information provided to the specialist, including your potential diagnoses even though you believe the specialist has a greater ability than you to reach the appropriate diagnosis. This will avoid a claim that not all significant information was conveyed to the specialist.

The Risk of Failure to Timely Refer

The risk of allegations of negligence as a consequence of failure to refer a patient with uveitis to a subspecialist who has done additional training in the form of ocular immunology or uveitis fellowship training may be underappreciated. Our experience1 and that of others2–6 indicate a surprising prevalence of referral after irreversible damage from chronic or recurrent intraocular inflammation has occurred, with a shocking onethird of patients blind in at least one eye at the time of the initial referral visit. This is especially disappointing in light of the fact that if the uveitis in these patients is then typically abolished (generally after steroid-sparing immunomodulatory therapy) it indicates the irrefutable fact that the uveitis was treatable and raises the argument that

Table 22.1 Types of uveitis requiring early referral to an ocular immunologist

Juvenile idiopathic arthritis–associated uveitis

Steroid-dependent chronic uveitis

Steroid-resistant uveitis

Posterior uveitis

Retinal vasculitis

within all probability vision in the now blind eye would have been salvaged had the patient been referred to the subspecialist earlier. Therefore, we believe that referral early in the course of the care of patients with the types of uveitis listed in Table 22.1 to an ocular immunologist/uveitis specialist demonstrates the comprehensive ophthalmologist’s high level of knowledge and high level of concern for his patient’s care. It also demonstrates his understanding of current preferred practice patterns, even if such referral means that the patient must travel some distance for what may turn out to simply be a one time consultation visit, following which the primary ophthalmologist can continue to care for the patient, with long distance collaboration with the consultant and possibly with comanagement with a local chemotherapist.

Communications with Other Physicians

In communications with a primary care physician, a specialist, or other physician, it is critical that it is crystal clear what your and the other physician’s responsibilities are or will be. It should be stated without equivocation who is now responsible for each aspect of the patient’s care, including who will follow up on each of the various medical issues of the patient. Such delineation may involve partial responsibility and follow up by a number of physicians with overall responsibility and coordination perhaps resting primarily with one physician whether it is a primary care physician or possibly a specialist, such as an oncologist during a period of cancer treatment.

The Risk of Failing to Treat Properly

Certain disorders have been discovered to have such poor long-term outcomes (eye or otherwise) with corticosteroid monotherapy that two learned uveitis societies, following evidence-based medicine and peer-reviewed literature review exercises, rendered the opinion that those disorders should be treated (or at the very least should be offered treatment) with immunomodulatory therapy.7 Such diseases include uveitis secondary to sympathetic ophthalmia, Vogt-Koyanagi-Harada disease, Adamantiades-Behcet disease with retinal involvement, and uveitis or retinal vasculitis caused by Wegener’s granulomatosis or by polyarteritis nodosa. We agree with these opinions. In fact, in some instances, such as with polyarteritis

nodosa and Wegener’s granulomatosis, failure to offer such therapy is almost guaranteed to ensure the patient’s death from these potentially lethal diseases. Clearly, no doctor wants to be party to such outcomes, nor should he be willing to be party to blindness as an outcome either, when effective therapy, employed early in the course of the stubborn uveitis, is available.

The Risk of Treatment-Associated Complications

Treatment-associated complications may also trigger litigation, with allegations of negligence. The potential side effects of immunomodulatory therapy are well known, and these risks are typically well managed by the ocular immunologist or other chemotherapist who monitors the patient on such therapy through frequent face-to-face encounters and hematologic and serologic monitoring. The ophthalmologist who is not specifically trained in such matters obviously must engage the services of an appropriate expert to manage this aspect of his patient’s care. However, the ophthalmologist himself is exposed to the risk of treatment-associated complications that could result in encounters with the legal system. Complications of topical corticosteroid therapy (cataract and glaucoma), of systemic corticosteroid therapy (osteoporosis, diabetes mellitus, hypertension, psychosis, myopathy, and even morbid obesity include but a few of the myriad and legendary potential and sometimes inescapable side effects of chronic systemic corticosteroid therapy), of intraocular injection therapy (endophthalmitis, retinal detachment, glaucoma, cataract), and of surgical therapy (the legendary complications of surgery on the “complicated” uveitic cataract) are all risk exposures for the ophthalmologist caring for the patient with uveitis.

Most are avoidable with proper strategic planning and therapy choice, but, clearly, documentation of discussions with the patient regarding treatment options and the risk/benefit ratio of each approach is essential in risk management vis-à-vis malpractice litigation. Consider the following example. A patient with chronic, indolent posterior uveitis for many months was referred to a vitreoretinal specialist who found a previously undiagnosed metallic intraocular foreign body. The uveitis was responsive to only oral steroids. After surgical removal of the intraocular foreign body the uveitis persisted and the oral steroids were continued. The patient developed aseptic necrosis of the hip and sued for improper informed consent, claiming he was not advised of the risk of hip necrosis and would not have consented to the oral steroids had he been so advised. At trial the surgeon said that among the warnings he gave to the patient prior to surgery was the possibility of death from the anesthetic, the likelihood of which he felt was approximately 1 in 30,000. The plaintiff’s attorney then showed the jury the Physician’s Desk Reference, which estimated the risk of hip necrosis at 1 in 10,000. He admonished the vitreoretinal surgeon for failing to warn the patient of the risk of hip necrosis, which was three times more likely than anesthetic death. The jury found for the plaintiff and gave him a large award. The verdict was reversed on appeal by a second jury who felt that no reason-

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able patient would have refused the steroid therapy based on the significant risk of permanent severe vision loss and the relatively small risk of hip necrosis.

Documentation After a Poor Outcome

As with the informed consent discussion, physician’s statements following a poor outcome are often misheard and misconstrued. Patients who have had a poor outcome resulting from a recognized complication of a procedure even with the best of care are understandably anxious and upset. Expressions of sorrow that a bad result has occurred can and should be made but with the awareness that this can be misunderstood as admissions of fault. Accordingly, it remains important to document completely what has been said. It is likewise as important to document the response of the patient, particularly when (after the outcome) the patient expresses prior understanding of possible risks, particularly the risk that materialized. A patient’s statement of gratitude for the care given, continued confidence despite the poor outcome, and/or a wish to continue care should also be documented. Unfortunately, such statements may later be denied, particularly if not documented.

Conclusion

Medicine always has been and remains an inexact science. Guarantees cannot reasonably be given because poor outcomes occur unavoidably without negligence. Steps such as those suggested in this chapter can be taken, most importantly to improve patient care and, incidentally, to avoid involvement with the legal system.

References

1.Dana MR, Merayo-Lloves J, Schaumberg DA, et al. Visual outcomes prognosticators in juvenile rheumatoid arthritis associated uveitis. Ophthalmology 1997;104:236–244.

2.Rosenberg KD, Feuer WJ, Davis JL. Ocular complications of pediatric uveitis. Ophthalmology 2004;111:2299–2306.

3.Edelsten C, Reddy MA, Stanford MR, Graham EM. Visual loss associated with pediatric uveitis in English primary and referral centers. Am J Ophthalmol 2003;135:676–680.

4.Ozdal PC, Vianna RNG, Deschenes J. Visual outcomes of juvenile rheumatoid arthritis associated uveitis in adults. Ocular Immunol Inflamm 2005;13:133–138.

5.Kump LI, Cervantes RA, Androudi SN, et al. Visual outcomes in children with juvenile idiopathic arthritis associated uveitis. Ophthalmology 2006;113:1874–1877.

6.Zak M, Fledelhius H, Pedersen FK. Ocular complications and visual outcome in juvenile chronic arthritis: a 25 year follow-up study. Acta Ophthalmol Scand 2003;81:211–215.

7.Jabs D, Rosenbaum JT. Guidelines for the use of immunosuppressive drugs in patients’ ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol 2001;131:679.