D ESCRIPCIÓN DETALLADA DE LOS CASOS DE USO DEL SISTEMA

Part of "Chapter 4 - Professional Liability and Risk Management for the Gynecologic Surgeon"

Informed consent is a legal doctrine that requires physicians to obtain consent for treatment, whether it is diagnostic or therapeutic, medical or surgical, invasive, or noninvasive. Without informed consent the physician can be held liable for violating the patient's rights regardless of whether the treatment was appropriate and rendered within the standard of care. Although failure to provide informed consent is seldom the primary charge in a malpractice claim, it has been found to be a secondary issue in almost one third of malpractice claims. Informed consent is an ongoing process that includes the exchange of

information and the development of choices. Informed consent is a process of ongoing-shared information. It provides for the development of choices and requires active participation from both the patient and the physician. It involves respect for the patient's bodily integrity and right to self-determination;

thus, it respects the patient's autonomy. Informed consent should never be confused with the mere signing of a consent sheet. Without informed consent, a physician may be held liable of violating the patient's rights even if the treatment was appropriate and administered within the standards of care. Failure to obtain informed consent can result in the physician being accused of “battery” under common law.

Since the 1947 Nuremberg Code, valid consent has consistently been described as having four characteristics: voluntary, competent, informed, and understanding. The American College of Obstetricians and Gynecologists, in its statement of May 1992 on “Ethical Dimensions of Informed Consent” explores the concept of voluntary or free consent and understanding or comprehension.

The concept of freedom implies both an ability to choose as well as an ability to refuse treatment.

Freedom also implies a lack of coercion, manipulation, or infringement on the patient's decision-making process. Recognition of different values, preferences, and alternatives is important in the process of free consent.

Courts have recognized and states have adopted three different degrees of disclosure in informed consent. The first, the professional or reasonable physician standard, was prevalent prior to the 1970s.

This degree of disclosure was based on the type and amount of information that a reasonable physician would tell the patient about the risks and benefits of a particular treatment. This paternalistic approach began to give way in the 1970s to the second type of disclosure, The materiality or reasonable patient viewpoint standard. This gave patients more input into the decision-making process. Under this standard, the physician had to disclose what a “reasonable person” would want to know under similar circumstances concerning the risks and benefits of a particular treatment. This concept is based on the patient's need rather than the professional perception of what the patient should know.

The third, but not widely held, disclosure is the subjective patient viewpoint. Under this disclosure, physicians must disclose varying amounts of information based on the individual's personal needs and peculiar requirements. This form renders a standard extremely difficult for physicians to understand and apply.

The need for informed consent can be suspended in an emergency situation, but specific criteria must be met for a situation to be declared an emergency. The patient must be unconscious or incapacitated and suffering from a life-threatening or serious health-threatening condition requiring immediate medical treatment. It is important in these situations for the physician to document the following: a description of the patient's condition at the time of the emergency, the reason the emergency existed, and an

explanation for the need for immediate attention.

Patients have the right to refuse treatment after receiving informed consent. Under these circumstances, for legal protection, the physician should document the reason the patient gave for refusal of the proposed treatment, the reason that the physician felt that the proposed treatment was indicated, and the possible jeopardy to the future health and well-being of the patient that might occur from the refusal of the treatment. It would be prudent to have the patient sign a statement acknowledging

the refusal for treatment and listing the potential adverse consequences that might occur.

The office setting provides the best environment for providing informed consent for several reasons. In this setting, the time for adequate consideration and adequate discussion is provided. Family members

who have a definite influence on the patient's decision can attend or be encouraged to attend. If the physician lacks the ability or time to provide the necessary adequate informed consent, the physician can delegate this responsibility to a nurse practitioner or physician assistant who has been previously trained to provide informed consent and is able to answer the patient's questions. Pamphlets, audiovisual, and even interactive visuals can greatly assist in this process. Because people rarely retain more than 30% of verbal communications, the average patient leaves the physician's office having forgotten or not

understanding most of what was shown and explained. Thus, the more the patient receives in writing or by audiovisual instruction, the better is her understanding.

Once the process of informed consent is complete, the physician can document the record to reflect when it took place, what was disclosed, that the patient had time to ask questions and have her questions answered to her satisfaction, and that the patient then requested the proposed treatment. Well-informed patients are more likely to overlook less than desirable outcomes and accept that medicine is still an art and not an exact science. Less-well informed patients are more likely to have unrealistic expectations and sue when these expectations are not met. Therefore, the best protection to a malpractice claim may come from taking full advantage of the legal doctrine of informed consent.

The degree of disclosure in informed consent varies from state to state. Some states require elaborate consent, others much less. When a complication develops that was disclosed in the informed consent;

however, there is no cause for legal action so long as the complication did not arise from a negligent act.

There is almost universal agreement that informed consent should encompass the following six areas:

Diagnosis

Nature and purpose of the procedure Risks of the procedure

Likelihood of success Reasonable alternatives

Prognosis if the treatment is refused

Figure 4.1 is a general surgical informed consent meeting these requirements. There are several points to note regarding this particular form. First, throughout the form, the words “I request” or “request for surgery”

are included. These words are used to place greater emphasis on the patient's responsibility for her choice in selecting the proposed procedure. Next, a list of the “general risks of surgery” is provided. This list covers those risks that can arise from any surgical procedure as well as anesthesia. In describing the risks and complications of the procedures, the words “may include but are not limited to such

complications as” have been added and are used to indicate that the physician did not attempt to list every potential complication but rather those that a reasonable patient would expect to know before making a decision. In the section on alternative forms of treatment, the words “such as” indicate that only those alternatives considered to be appropriate need to be listed. Finally, space is provided to list any additional materials that the patient was given or might have reviewed in making her decision. If a claim arises, the physician can then explain to a jury the situation surrounding the alleged act of negligence and use the same material in his or her defense to show that a reasonable person was properly informed.

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FIGURE 4.1. Informed consent and request for surgery.

Figures 4.2, Figures 4.3, Figures 4.4, Figures 4.5 and Figures 4.6 are informed consents covering the five most common gynecologic operative procedures. These forms describe each procedure in words that a patient can comprehend easily. A reading specialist has reviewed each of these forms, as well as the general surgery consent form described in the preceding. The language used has been placed at the level of an individual with a sixth-grade education, which is generally that used by daily newspapers. Each of these forms covers the risks and complications as well as alternatives that apply to the specific procedure along with the “general risks of surgery.”

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FIGURE 4.2. Informed consent and request for dilation and curettage, hysteroscopy, or cervical biopsy.

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FIGURE 4.3. Informed consent and request for hysterectomy.

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FIGURE 4.4. Informed consent and request for sterilization.

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FIGURE 4.5. Informed consent and request for laparoscopy.

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FIGURE 4.6. Informed consent and request for repair of relaxation of pelvic organs and/or correction of urinary incontinence.

Figure 4.2, the informed consent and request for dilatation and curettage, cervical biopsy, and

hysteroscopy, lists the most common complication seen, namely perforation of the uterus. It also notes that the procedure can have an adverse impact on subsequent pregnancies.

Figure 4.3, the informed consent and request for hysterectomy, covers complications seen, including injuries to the genitourinary tract, the most frequently seen complication. It also discusses the risk associated with blood transfusion.

Figure 4.4, the informed consent and request for sterilization, clearly states that the procedure is not designed to be reversible. Many patients have a sterilization procedure performed in their twenties and in this age of divorce and remarriage, later request that the sterilization be reversed. When the procedure cannot be reversed, patients may sue with a claim of “lost opportunities.” This statement in the informed

consent is designed to cover that particular area. Ectopic pregnancy, one of the known and accepted risks of any sterilization procedure, is clearly spelled out.

Figure 4.5, the informed consent and request for diagnostic and therapeutic laparoscopy, reviews the more commonly seen complications of injury to the gastrointestinal, or genitourinary tracts and vascular injury. The form also notes the risk of exploratory laparotomy. This provides an opportunity for the physician to discuss this potential extension of a laparoscopy procedure so that the physician is not hesitant to proceed with laparotomy when the findings require this procedure.

Figure 4.6, the informed consent for repair of relaxation of pelvic organs and/or the correction of urinary incontinence problems, notes that recurrence of urinary incontinence is a potential complication. This is designed so that false expectations from the surgical procedure are not created.

These procedure-specific informed consent forms are detailed but have been found to be accepted by patients. They also have made the defense of surgical complications much easier, especially when there is no negligence.

The legal requirements of informed consent vary from state to state and jurisdiction to jurisdiction. The surgeon should be aware of the degree of disclosure required as well as any specific laws on informed consent that exist in his or her state. County or state medical societies are usually able to assist in providing this necessary information.