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    Excerpted from the AAO BCSC Companion Volume, The Profession of Ophthalmology: Practice Management, Ethics, and Advocacy.

    Abstract: The process of informed consent involves the interplay of four elements: 1. disclosure,  2. comprehension, 3. competence, and 4. voluntary choice on the part of the patient.  The following case considers these elements in detail.

    Case Study: Mr. Bluder, a 63-year-old laborer with little education and only a fair command of English, visited Dr. Sampson for an exam. When asked the reason for his visit, he explained to the doctor that over the previous six months he had noted his vision becoming a little less clear at distance, although he had no problem with the little reading he did. Television viewing gave him no problem either, and he reported being able to drive without difficulty.

    Dr. Sampson found the patient’s best corrected visual acuity to be 20/40 in the right eye and 20/30 in the left eye with one line of improvement in each eye with a small change in prescription. He also found bilateral nuclear sclerosis that was consistent with the patient’s vision. The remainder of the examination revealed no other ocular problems.

    Dr. Sampson told the patient he would see much better if the cataracts were removed and mentioned it was a brief, safe procedure (“nothing to worry about”) and that the longer he waited for the surgery, the more difficult and risky it would be. With his limited command of English, the patient didn’t understand some of the terms the doctor was using, but believed the doctor knew what was best for him. He was uneasy questioning the authority of the physician, so he said “yes” when the doctor asked if he would like to proceed.

    Mr. Bluder met with the surgical coordinator, who carried out a consent discussion, during which Mr. Bluder said very little. After that, an office technician performed the biometric studies. The coordinator gave Mr. Bluder some literature and a consent form to take home, read, and sign and asked him to bring the latter to the surgical facility the day of his procedure.

    Discussion: The medical and surgical care of patients with cataracts has become a large part of many ophthalmic practices. With improvements in surgical procedures, many patients with visual complaints from cataract can be treated earlier than in the past, and success rates are high. However, modern cataract surgery still involves risk, and not all cataracts have to be removed.

    In the case presented, the patient did not complain of any disability due to his vision and came in for only minor symptoms. He was able to carry out his activities of daily living well. When and how to suggest surgical or medical remediation should depend on the medical condition and how it affects the patient, and on whether treating it will have some beneficial effect for the patient.

    Physicians are trained to do what they can to make their patients better; ophthalmologists constantly try to improve and retain their patients’ vision. However, when patients see adequately for their needs, the ophthalmologist must consider whether or not to recommend and perform a procedure solely because it might improve vision further.

    The term “informed consent” has been used since the 1950s, when the duty to inform the patient about the procedure became a legal requirement. It is based on the principle that the patient should know what a “reasonable” patient would want to know before proceeding with a treatment.  Informed consent is not merely a document signed by the patient and doctor listing the risks and benefits of a planned procedure. Even a brief explanation that the planned treatment will improve or maintain vision is inadequate; without a discussion of alternatives, risks and benefits, and without certainty that the patient understands the issues involved, the basic requirements of informed consent have not been met.

    Many believe that the surgeon should be the individual to present the basic information needed for informed consent for a procedure. The ophthalmologist must be the one who conducts and evaluates the informed consent discussion, to be certain the patient has received and understood the needed information before deciding whether or not to proceed with treatment.

    Informed consent has informational and consent components. The informational part comprises disclosure and comprehension. Disclosure involves informing the patient of what is to be done, and of the anticipated benefits, possible risks, and reasonable alternatives to what is being suggested. Comprehension refers to the patient’s ability to understand the implications of what has been disclosed.

    Comprehension further involves competence and voluntary choice. Competence relates to the physician’s determination that the patient is able to process the information given well enough to make an informed decision. Without it, the physician must consider involving an appropriate surrogate to aid in the process. The informed consent process is not complete until the patient, on the basis of information given, voluntarily chooses how to proceed.