Model
Definition and problems
Professional model
Disclosure and discussion based on what other physicians would disclose in similar circumstances
Problem: Promotes generalizations and diminishes importance of individual patient values and interests
Reasonable model
Disclosure and discussion based on what a reasonable patient would want to know
Problem: What is reasonable to one patient may be unreasonable to the next
Subjective model
Disclosure and discussion based solely on specific interests, values, and life plan of patient
Problem: Difficult to know every important detail of patient’s life; cumbersome to implement consistently
Balanced model: reasonable and subjective
Disclosure and discussion based on the most important and relevant interests, values, and goals of the patient, as identified by both patient and physician
Although these and many other legal cases highlight the need for good documentation, informed consent is not only based on legal safeguards but also ethical principle. Childers and colleagues suggest three main components for ethical informed consent consisting of disclosure, patient understanding, and patient decision making . Disclosure encompasses the patient and physician discussion regarding the details of a treatment or procedure, the indicated need, and also the attendant risks [9]. As discussed earlier, several models of disclosing risk to a patient exist from the professional model to the reasonable model and some amalgam in between. Patient understanding is gauged by the physician and through communication to assess comprehension [10, 11]. Lastly, patient decision making encompasses shared decision making and incorporating the capacity of the patient to make decisions along with their values and preferences [9]. Indeed, the Declaration of Helsinki and the Nuremburg Trials demonstrate that informed consent is an ethical standard in allowing patients with capacity to make informed decisions about their own care instead of having treatments imposed upon them. This capacity to give consent is based on the ethical principle of patient autonomy. While physicians may scoff at the idea that patients know how best to be autonomous in their decisions, we have an obligation to be open about the risks, benefits, and alternatives of a procedure and guide them in their decision making process [12–14]. At the heart of shared decision making , physicians serve as facilitators of care who disclose information about treatment options but take into account their patient’s preferences to help them come to a conclusion. The decision algorithm for pelvic organ prolapse surgery illustrates this concept. Although quite a prevalent condition, the majority of women with prolapse are not symptomatic [15]. Therefore for a symptomatic patient, no single treatment option serves to be the “right one.” Instead the female pelvic medicine reconstructive surgeon elicits a history to further elucidate her preferences as to whether a reconstructive versus obliterative surgery might serve her better. And again (based on what the patient’s beliefs and preferences are), the reconstructive treatment algorithm further branches out into uterine sparing versus nonuterine sparing and discusses different surgical approaches. Gone are the days of paternalistic surgeon privilege when a one-size-fit-all approach was administered to every patient without any input. This evolution reflects the myriad surgical options we have and also the evidence that one surgical approach is not necessarily superior to another.
Informed Consent in FPMRS
Given the different treatment options for disease processes in female pelvic medicine and reconstructive surgery, it is important for the physician to foster a relationship with the patient. When surgical treatment options are presented, this decision is impacted by the physician and patient relationship. Multiple papers have evaluated the role of the physician’s relationship on impacting patient care [16–18]. Nowhere is that more true than during procedures that effect quality of life. With these elective procedures, it is important that communication be transparent and deliberate [10]. Tamblyn and colleagues found a significant correlation between low clinical skills examination scores (based on physician communication) and prediction of likely complaints against physicians in Ontario and Quebec [18]. The difficulty in establishing this relationship and communicating effectively manifests in today’s medical environment. Quality patient encounters can be hampered by time constraints of the modern doctor’s visit. But, we should consider that given the time to talk, most patients speak for 2 min or less while most physicians interrupt within the first 22 s [19, 20]! While quality of care can be determined by patient-driven opinion-dominated metrics, it becomes increasingly more important for the physician to communicate effectively during the limited time with the patient. Studies have demonstrated that patients respond positively to the doctor who addresses their questions and needs [21–24]. Simple portions of the interview such as allowing the patient uninterrupted time to address their concerns, asking for additional questions, and demonstrating empathy improve the physician–patient relationship. All of this trust built during the relationship culminates in the shared formulation of a treatment plan. Often the treatment plan involves shared decision making on a therapeutic intervention. Intervention takes many forms in female pelvic medicine and reconstructive surgery . A prime example of this is the treatment of overactive bladder. Surgery is just one option among many including behavioral modification and medications. Often, education and behavioral modification are all that are needed to make a meaningful impact in one’s quality of life. Discussion with a patient regarding caffeine intake reduction and fluid intake modification can make a therapeutic difference without surgical intervention. Regardless of the treatment plan, shared decision making between patient and physician is paramount. This involves education regarding the diagnosis, treatment options including the option of no treatment, open dialog between the physician and patient, and lastly mutual decision making on the treatment option that should be pursued. Numerous studies have demonstrated that information presented in multiple modalities can serve to enhance the patient’s knowledge and satisfaction with the shared decision-making experience [25]. Long gone are the paternalistic doctoring models where only one decision was the correct decision. Today’s medicine involves taking into account patient’s and family’s preferences and wishes. Part of the difficulty with informed consent is based on how much risk to divulge to the patient. There is a fine line between giving enough information so the patient can make an informed decision versus overburdening a patient with superfluous details. Already presented with the Canterbury v. Spence case was the model of the reasonable patient. But rather than placing all decisions in a rigid matrix, a combined approach taking into account patient preferences and values in addition to what a reasonable patient would want to know is probably the best method of informed consent. In this regard, the surgeon would discuss the risks for a surgery that a reasonable patient would want to know and also include any additional risks, however low risk they may be, that may be in accordance with a patient’s values. Framed in this context of overactive bladder treatment, a patient may best be served by sacral neuromodulation for overactive bladder if the risk of urinary retention with another treatment is unacceptable to the patient. This model can only be utilized if a physician has spent time elucidating the patient’s preferences and goals through building the physician–patient relationship.
Another difficulty regarding informed consent is the realization that this process happens before any paperwork is signed for surgery. Informed consent as it applies to surgical procedures is typically the piece of paper or document in the medical record that has the patient’s signature. In reality, the signature documents that the discussion took place prior between the physician and patient. It does not replace this discussion. And it is during this discussion that the physician has the ability to impact the patient’s perception of any outcome of a surgery. The informed consent should take place in a non-hurried setting where the physician has a chance to explain the procedure, the patient has the chance to ask questions, and the physician has a chance to answer these questions and check for comprehension and understanding [11]. The documentation itself should not be trivialized because it serves as an objective part of the medical record. Components that should be included in any documentation include a description of the procedure in understandable terms, details of the risks/benefits documentation that the risks/benefits and alternatives were discussed including the option of no surgical intervention, and then an attestation that the patient had a chance to ask questions [9, 10]. With most shared decision in FPMRS cases, we enjoy the luxury of discussing treatment options in our office without emergent need for an operation. For more complex decisions regarding surgical treatment options, it would serve us well to educate our patient so that they can be an integral part of the shared decision making process and be diligent about all steps of the informed consent process. An example of this can be found in subtleties of informed consent in any procedure using synthetic mesh .
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