Capacity is a threshold criterium for informed consent [1]. The informed consent process cannot take place unless the patient has the ability to make autonomous, cogent decisions about her healthcare. Traditionally, this has been most commonly described as competence, a concept with different definitions and criteria dependent upon the medical or legal context in which it is used. In the legal context, the competence of an individual is determined by a judge, who considers the evidence presented, including clinical assessments, and makes a global determination regarding an individual’s ability to make decisions and to care for him- or herself. Generally, a patient deemed incompetent by a legal authority legally lacks medical decision-making capacity for all medical decisions. However, in the routine clinical setting, capacity is most often used interchangeably with the concept of decision-making capacity, a term that has a greater applicability in the clinical practice of outpatient gynecologic practice. This concept entails the ability for the patient to acquire and understand information about her condition and medical options, weigh the risks and benefits of different options in a rational fashion, communicate a preference for options, and provide authorization to initiate a plan of care [6].

In the clinical setting, decision-making capacity most often is determined by a clinical judgment rather than a formal psychiatric assessment and is assessed in the context of the specific decision at hand. In other words, a clinician may determine that a patient has the capacity to make medical decisions. A patient’s decision-making capacity is presumed to be intact unless there is an evident reason to suspect otherwise by a member of the healthcare team. In some cases, there may be a transient impairment of decision-making abilities, such as an acute illness, the effects of a pharmaceutical agent, or substance abuse. While most patients with the former will rarely be undergoing an outpatient procedure, the latter may be more common in this setting, where the administration of medications for analgesia or anxiety may influence decision-making. In other cases, there may be a chronic condition affecting decision-making ability, such as in the case of severe psychiatric disease, impaired cognitive development, or dementia. If a physician has any reason to believe that a patient does not have full decision-making capacity, then the procedure should be deferred until a more complete assessment can be performed.

When a patient does not have adequate decision-making capacity, she cannot provide authorization for a procedure. In such cases, advanced directives can help care planning, driven by the underlying ethical principle of respecting and preserving the autonomy of the patient. Advanced directives can take the form of a document outlining treatment preferences, such as an advanced directive or a living will. Most often, in the outpatient gynecologic setting, decision-making would include an individual designated by the patient in a previously completed written healthcare power of attorney or other formal mechanism to make decisions on behalf of the patient [1]. This surrogate decision-maker is known as a healthcare proxy or an attorney-in-fact for healthcare. When this has not been formally established at the time a procedure is indicated, another individual is assigned this responsibility to make decisions on behalf of the patient, as based upon his or her knowledge of the patient’s wishes. State laws and/or institutional policies may provide guidance as to who this individual may be. In most cases, this is a family member, such as a spouse or a member of the immediate family. In the case of surrogate decision-making, the authorizing agent must be familiar with the patient’s wishes so that he or she can make decisions consistent with the patient’s values and preferences. While the patient may not have decision-making capacity, the wishes of the individual should be included in the decision-making process, and care planning should reflect the values and preferences of the patient. Physicians should be aware of their institutional and state policies and procedures regarding surrogate decision-making, as these may vary in different practice settings.

As part of the informed component of the consent process, a patient must have adequate information pertinent to her medical condition and the proposed medical options in order to select a course of management that is consistent with her healthcare, personal needs, and values and belief system. The process of disclosure can present one of the greatest challenges to physicians in terms of determining the amount and detail of information to be conveyed, given that the process is individualized for each patient.

There are several different aspects of the treatment plan that should be presented to the patient as part of the consent process. Disclosure of information material to the procedure includes discussing the patient’s medical condition and the procedure recommended to manage it. This begins with a discussion of the indication of the procedure and how it is performed. Once this has been established, then a discussion about the risks and benefits of the procedure can be initiated. In general, when discussing risks or benefits, a key aspect of a patient’s decision-making is to be able to place these considerations in the context of her immediate and long-term health. This discussion includes not only the nature of those outcomes but also the likelihood of them occurring and the management of any adverse events. The patient should also be educated about the risk of procedure failure, including the chance that the procedure may not be able to take place as initially planned or that it may not resolve the clinical condition. Included in the disclosure process is a discussion of alternatives to the proposed intervention, including other medical options and courses of action if the patient elects against the recommended procedure or elects against any procedure at all. The risk of delay and/or not acting should also be discussed. Finally, she must also be aware of the fact that there is a choice to be made to accept or decline the procedure as part of the informed consent process.

The unique nature of office-based procedures requires additional considerations in structuring the informed consent process (Table 3.2). Specific to outpatient gynecologic procedures, physicians should also discuss aspects of the procedure that may be altered when performed in the clinical setting compared to the operating room. Some of the benefits of an office-based procedure include the avoidance of general anesthesia, and a reduction in the time required for the procedure. However, outpatient procedures are associated with risks that would not be encountered if the patient were under general anesthesia and in the operating room. As the patient will be awake, there are considerations specific to her response during the procedure. Patient discomfort, anxiety, or individual anatomical variation may play a role in the ability to safely and adequately perform the procedure. If complications are encountered, possible transfer for management to another facility may have an effect on the impact of those risks for the patient.