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INFORMED CONSENT
INFORMED CONSENT
Obtaining informed consent is one of the most important steps in the preoperative period. It establishes realistic patient expectations and creates a protective legal framework for the physician to operate within. Failure to inform patients adequately of the potential associated risks and expectations can be viewed as negligence, and performing a procedure on a patient without their express consent can be considered battery in a court of law, although witnessed verbal consent may be acceptable in some situations. The patient must be provided the information to adequately evaluate a procedure before agreeing to that procedure or surgery. The Joint Commission defines informed consent as agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent.1
Before consent can be obtained, the physician must determine whether or not the patient has decision-making capacity. The patient must be over the age of 18 and mentally able to grasp the concepts presented. It is necessary to obtain consent from the health care proxy or guardian of mentally incompetent patients. There are many other potential barriers to patient understanding, including ineffective provider communication; lack of patientโprovider shared decision making; lack of health literacy; and cultural issues. The surgeon must be alert to signs of inadequate patient understanding. Simplification of the content, length, and language may help reduce these communication barriers. A qualified medical interpreter may be utilized for patients with hearing or visual impairments or limited English fluency, though other technologybased communication approaches may be used as well. Asking the patient to summarize the discussion and their decision can also help to highlight those who have failed to understand, and it is up to the physician to uncover the barrier to effective communication and correct it before the procedure is initiated.
Once the surgeon has established the patientโs competence, they may move on to detail the critical components of informed consent. These include an explanation of the proposed procedure in lay terms, an explanation of the reasonable standard of care, indications for the procedure, common adverse outcomes, unexpected adverse effects, and treatment alternatives, including the expected consequences of no treatment.
Risks to be discussed should include those that either a reasonable physician would disclose or a reasonable patient would think necessary to make an intelligent decision. This means that extremely rare risks need not be discussed, though these standards leave
much ambiguity. The surgeon should review the likelihood of those risks based on available clinical evidence and their judgment. Risks addressed should include common adverse events (which may be mild), as well as those that are unlikely but severe. The patient should have the opportunity to refuse the procedure if they deem any of those risks intolerable.
For cases in which residents or fellows in training are participating, the attending physician should explain who will be performing the procedure. Patients should be informed that physicians in training will be performing portions of the procedure commensurate with the ability of the resident or fellow, and will be under the supervision of the teaching physician. Whether or not the supervising physician will be present during all portions of the procedure should be explained, as this may vary based on the level of competence of the trainee.
While a written signature is required, the real goal of the consent process is effective communication. Inadequate communication was found to be the root cause of the majority of unmet expectations and/or complaints reported to the Joint Commission.1 Technically, informed consent does not need to be written, but without written documentation, it is difficult to prove the patientโs agreement in a court of law. It is generally agreed that a written consent form should be placed into the patientโs medical record prior to the procedure. The one exception to this practice would be in an emergent life-threatening condition requiring immediate surgery, in which the principle of implied consent is invoked.
In 2007, the Centers for Medicare and Medicaid Services proposed updated guidelines for participating practitioners obtaining consent.2 Under these guidelines, consent must be a written document in the patientโs medical record and must include additional details, such as the name of the surgeon and a reference to the risks, benefits, and alternatives.
CONCLUSIONS
Patient preparation and the informed consent process is a critical part of the surgical procedure. Without adequate preparation, even mild and expected outcomes, such as edema and ecchymoses, can be a cause for significant concern. Working as a team with the patient, and appreciating that the patient is indeed the most important person in the room, helps guide appropriate decision making. A full discussion of benefits and risks improves mutual trust and respect between the physician and patient, and ultimately improves patient satisfaction.