Risk Management

Informed Consent: A Process, Not Just a Legality

By James F. Holzer, JD

[Argus, March, 1991]

Most ophthalmologists and risk managers agree that a significant number of malpractice claims are precipitated by a patient’s surprise over unexpected adverse outcomes and unfavorable provider-patient rapport. This is particularly true with relatively high volume procedures such as cataracts where some patients may unrealistically expect perfect clinical results. Indeed, over half of all malpractice claims filed against OMIC policyholders related to cataract surgery, according to a survey of 236 cases filed from October 1987 through September 1990.

Unfortunately, busy schedules and time-consuming administrative duties can make it difficult for ophthalmologists to develop the dialogue necessary to minimize unrealistic patient expectations. In response to these issues, a new school of thought has evolved concerning the use of informed consent as a way to improve this dialogue.

Rather than being a purely legal function performed under time-constrained conditions, informed consent should be regarded as a process which begins during the first patient-physician encounter, and continues through the operative and postoperative phases of treatment. Forms and signatures merely become a part of the process, and not the focus of it. Thus, consent becomes an opportunity to establish a “therapeutic alliance” between ophthalmologist and patient, addressing two of the most significant problems in health care risk management today: communication and rapport.

Further, this ongoing dialogue between ophthalmologist and patient in which clinical uncertainty and risk is squarely acknowledged and shared, makes informed consent a powerful tool in dealing with patient surprise and anger over unexpected adverse clinical outcomes and iatrogenic events.

Although consent forms continue to have legal significance, the use of such documentation becomes more meaningful when used as supplemental tools to help educate patients and provide ophthalmologists with what the law calls a “written memorialization” of dialogue. A number of ideas and suggestions for implementing the “process” model of informed consent were discussed by the author in a recent edition of the Bulletin of the American College of Surgeons:

• Office support staff such as nurses, paramedical personnel and administrative assistants should be encouraged to shift their focus from the “paperwork of consent” to the ongoing “process.” Remember, documentation is critically important, but is not the sole objective of this effort.
• When possible, start the consent process 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.
• During the initial or subsequent office visit, explain the purpose of the consent form. Then give the patient a copy! A teaching hospital in the East that specializes in ophthalmic surgery has been providing copies of its risk-specific forms to patients for years without any known adverse medical-legal consequences.
• When possible, make contemporaneous notes in the patient’s record and/or your office records during all phases of the consent process.

By shifting the focus of consent as a single event to consent as an ongoing process of shared information and decision-making, ophthalmologists can collaboratively work with their patients to eliminate many of the factors that trigger a significant percentage of malpractice claims. In the process, the so-called burden of informed consent can become a learning opportunity for both the ophthalmologist and patient.