Practical Approaches to Informed Consent in Ophthalmic Practice

By James F. Holzer, JD

[Digest, Summer, 1992]

Almost 90% of the ophthalmic malpractice claims closed by OMIC during the past five years were terminated in favor of the ophthalmologist without any indemnity payment made on behalf of the insured. Although these preliminary statistics bode well for ophthalmologists in general, there remains the nagging question: Why were such actions filed in the first place if there were insufficient legal grounds for plaintiffs to succeed?

Assumptions that most patients are motivated by personal greed, hungry lawyers, or both, are unproved at best and “anti-patient” at worst. The simple fact is that many patients sue, regardless of negligence, because they are surprised by the clinical outcome and angry with the provider they believed to have caused it.

Recent literature continues to suggest that most patients and their families who file malpractice claims believe physicians did not warn them about the potential medical problems following a treatment or procedure or that doctors tried to mislead them.¹ Oftentimes, the decision to sue or not comes down to whether the patient believed the physician cared about them personally. A study of patients who experienced adverse clinical outcomes indicated that patients who chose to file a malpractice claim perceived their physicians as uncaring compared to those patients who elected not to sue.²

The best constructed legal consent form in such situations is virtually powerless to forestall litigation triggered by such emotional factors. Yet, a consent form, coupled with the patient’s perception that important clinical information was personally conveyed by a caring physician, could very likely prevent many unexpected medical outcomes from ever developing into formal claims.

Conveying Caring Attitudes with Information

As some authors suggest, a physician who expressly acknowledges clinical uncertainty and empathizes with a patient’s wish for certainty paradoxically forms a type of therapeutic alliance or bond which many patients will perceive as a caring and personal attitude.³ Such interaction prevents informed consent activities from becoming mere episodic “events” which occur only when someone signs a consent form.⁴ Instead, consent activities take place during a “process” that begins with the first patient encounter and continues through the operative and postoperative treatment phase of care. Forms and signatures become merely an end-stage culmination of the process, not the focus of it.⁵

Integrating Process and Form

Since informed consent is still regarded in many ophthalmic practices as a discrete legal event rather than an interactive process, it is important to change the mind-set of the entire patient care team while at the same time altering procedure. Suggestions on how this might be done have been discussed by this author and others in recent editions of ARGUS, the Bulletin of the American College of Surgeons and other periodicals: ^{6, 7, 8}

Office support staff such as nurses, paramedical personnel and administrative assistants must first be encouraged to shift their focus from the “paperwork of consent” to the ongoing “process.” Documentation is important, but not the sole objective during this phase of the process.
When possible, start the consent process (the sharing of pertinent information) as early in the continuum of care as possible. This doesn’t necessarily mean an immediate recitation of the risks, benefits and alternatives to treatment, but rather an interactive exchange of relevant information designed to mutually explore expectations and understanding of pertinent clinical issues. In studies cited earlier in this article, almost a third of the patient families involved in the survey perceived that their doctors would not talk or answer questions. Many believed no one was listening.⁹
In appropriate situations, try to make arrangements to have family members present and included when discussing the patient’s disease process, planned medical treatment or surgery.
During the initial or subsequent office visit, introduce the consent form and explain its purpose. Clarify for the patient that the form is intended to help assure both patient and ophthalmologist that important facts which matter to the patient have been discussed and are understood.
Be frank and honest about clinical uncertainties, but don’t overcompensate by avoiding the potential benefits of treatment either.
Next, give the patient a copy of the form or documentation, either before or after it is signed. Contrary to the belief of many ophthalmologists, an adversarial note is intoned not as the form is being signed, but when a copy is not made available or graciously offered to the patient. This is important since some studies suggest that patients believe doctors cover up or downplay important information. Fear about giving patients a copy of the consent form is usually worse than the reality. A major teaching hospital specializing in ophthalmic surgery has been providing copies of its risk-specific forms to patients for over seven years without any known adverse medicolegal consequences.
If patients appear troubled over the risks and uncertainties of treatment, empathize with their wish for a good result without making any unrealistic assurances. Accept their ultimate decision, even if it doesn’t agree with yours. In most situations, this is their right under the law. If the consent “process” was properly handled as described earlier, there should be no animosity.
When possible, make contemporaneous notes in the patient’s record and/or your office records during all phases of the consent process, even if a form is used.

The Legal Face of Consent

Ironically, very few medical malpractice cases lost by physicians are solely related to the legal doctrine of informed consent. Yet, it is these legal components and the language of consent forms that dominate risk management seminars and instructional advice from professional liability insurance carriers. Clearly, more malpractice cases with consent issues are lost for reasons related to defective process and communication rather than defective forms or legal requirements.

As a starting point, however, it is still necessary for ophthalmologists to understand some of the basic legal fundamentals behind consent case law. As a general rule, most states are adopting what some experts call the “patient viewpoint” standard in that the type of information disclosed should be based on what a reasonable person in the patient’s position would want to know in similar circumstances. This is contrasted with the less popular “reasonable physician” standard which defines disclosure based on what a reasonable practitioner in the medical community would customarily disclose under the same or like circumstances.¹⁰

Although the law may vary from state to state, ophthalmologists have a non-delegable duty to disclose and discuss with patients:^{11, 12, 13}

The ophthalmologist’s diagnosis;
The nature and purpose of the proposed treatment or procedure;
The risks and benefits of the proposed treatment or procedure;
Alternative methods of treatment and the risks and benefits of such alternatives;
The risks and benefits of no treatment.

The best way to document such information and, more importantly, to record that the consent process took place, is still through the use of a pre-established form. Recognizing that this statement is as welcome to ophthalmologists as another reimbursement law, it is incumbent on all members of the practice management team to regard such documentation not as just another form to complete, but as an important informational tool to recognize and confirm the existence of a strong therapeutic alliance between ophthalmologist and patient. (See pages B-9, B-10)

A so called “short-form entry” in the medical record which simply states that “the risks, benefits and alternatives have been explained to the patient” cannot effectively convey the care and attention that has been paid to the consent process. Until handwritten entries can be improved to the level where their evidentiary value consistently exceeds that of a properly developed preestablished document, the use of a consent form for most operative procedures is still the best way for ophthalmologists to document the process.

Model Forms

There is no one right or wrong answer in designing an ophthalmic consent form. Like all parts of the medical record, the consent form must represent that the ophthalmologist made a reasonable effort to effectively carry out this important duty as part of the patient’s ongoing care.

A number of ophthalmic-specific forms, which have been used as attachments to general forms, are reprinted with this article (see page B-7) and can serve as a model for ophthalmologists seeking to develop specialized documents for their practice. In reviewing model forms, practitioners should recognize that no single form can be designed to meet the peculiar legal requirements of each state. Physicians should consult with their legal advisor to determine if there are particular aspects of state law that ought to be addressed in the documentation. However, these reprinted forms do contain the general elements necessary to document the consent process and address legal requirements as well.

Additional sample consent forms used in ophthalmology have been distributed as part of OMIC’s series of risk management educational seminars. Copies of the educational handouts on consent are available without charge to OMIC insureds and for $6.00 to non-insureds by writing the OMIC executive office at 655 Beach Street, San Francisco, CA 94109-1336.

By effectively integrating the consent process and form, ophthalmologists can begin to address the important risk management goals of enhancing patient communication while potentially reducing the growing number of time-consuming and costly malpractice claims precipitated by patient surprise and bad feelings.

Click here to view sample consent forms and other documents for the ophthalmic practice.

Notes:

Hickson GB, Clayton EW, Githens PB, et al. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA. 1992;267:1359-63.
May ML, Stengel DB. Who sues their doctors? How patients handle medical grievances. Law Society Review. 1990;24:105-20.
Gutheil TG, Burszatjn H, Brodsky A. Malpractice prevention through the sharing of uncertainty. N Engl J Med. 1984;311:49-51.
Lidz CW, Appelbaum PS, Miesel A. Two models of implementing informed consent. Arch Intern Med. 1988;148:1385-89.
Holzer JF. The process of informed consent. Bull Am Coll Surgeons.
See note above.
Holzer JF. Informed consent: A process, not just a legality. ARGUS. March 1991:20.
Redmond MR. Patient’s anger could land you in court. ARGUS. July 1991:15.
See note 1 above.
Risk Management Principles & Commentaries for the Medical Office. American Medical Association/Specialty Society Medical Liability Project, Chicago. 1990:2.01-2.06.
See note 10 above.
Rozovsky FA. Informed Consent. Risk Management for Healthcare Facilities. American Society for Healthcare Risk Management and the American Hospital Association, Chicago. 1990:179.
Campion FX. Grand Rounds on Medical Malpractice. American Medical Association, Chicago. 1990:112.