Informed Consent and the Disclosure of Surgeon Experience




© Springer International Publishing Switzerland 2015
Barbara G. Jericho (ed.)Ethical Issues in Anesthesiology and Surgery10.1007/978-3-319-15949-2_3


3. Informed Consent and the Disclosure of Surgeon Experience



Logan K. Chastain  and Sabha Ganai 


(1)
Department of Radiology, Southern Illinois University School of Medicine, 315 W. Carpenter St., 19638, Springfield, IL 62794, USA

(2)
Department of Surgery, Southern Illinois University School of Medicine, Simmons Cancer Institute at Southern Illinois University, 315 W. Carpenter St., 19638, Springfield, IL 62794, USA

 



 

Logan K. Chastain (Corresponding author)



 

Sabha Ganai



Abstract

This chapter provides an overview of ethical issues and legal precedent relevant to informed consent for surgical procedures including the disclosure of the surgeon’s experience. The process of informed consent will be examined in a systematic fashion, including methods to improve physician-patient communication and important considerations for documentation of the consent process. Ethical principles including respect for patient autonomy, beneficence, nonmaleficience, distributive justice, and duty to tell the truth will be explored as relevant to the doctrine of informed consent.


Keywords
EthicsInformed ConsentAutonomySurgical Decision MakingDisclosure



Case Presentation

Ms. B. is a 38-year-old obese female with a body mass index of 47 kg/m2. Despite numerous attempts at weight reduction with dietary interventions and exercise, she has failed to maintain her weight loss. She complains of chronic lower back pain and has been recently diagnosed with hypertension, diabetes, and obstructive sleep apnea, all of which her primary care physician attributes to the patient’s morbid obesity. Her primary care physician advised her that weight loss is essential to improve her health and longevity.

Ms. B. meets with a bariatric surgeon to discuss the options of different surgical approaches to address her morbid obesity, including laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. She learns about the risks, benefits, and alternatives of the different surgical procedures, and their relative probabilities of weight regain. She is instructed that she will be required to participate in a yearlong process of psychological and nutritional counseling prior to surgery, will meet with others who have undergone the procedure, and will join a support group of patients who plan to undergo bariatric surgery. As the surgical date approaches, the patient will also meet with the anesthesiologist in the anesthesia clinic. Her surgeon advises her that she can change her mind about having surgery at any time, even the day of surgery. Her surgeon then asks her if she has any questions. The patient asks for the disclosure of the surgeon’s prior surgical experience in bariatric surgery.


Introduction


Informed consent is an essential component in the daily practice of surgeons and anesthesiologists. While the process of informed consent is meant to expand and protect patient autonomy, it gives patients the opportunity to decide what is truly in their best interests and make a decision on whether or not to receive a specific treatment based on their own perception of benefit. The ethical principle of autonomy becomes a fundamental part of discourse relevant to informed consent, and recognizes that patients have an intrinsic right to decide what happens to their body, regardless if others believe they are making the “correct” choice. However, one may still question how many patients are truly informed; understand the risks, benefits, and alternatives of the procedure; and are informed of the surgeon’s experience for a specific procedure. This chapter will explore some of the nuances and complexities relevant to the obtaining of informed consent and the disclosure of surgeon experience.


Informed Consent Principles: Disclosure and Understanding


Informed consent may be incorrectly perceived to be just a signature and just one more task to get marked off on a preoperative checklist. Furthermore, while the disclosure of the indications, risks, benefits, and alternatives of a procedure is given in the process of obtaining informed consent from a competent patient with decision making capacity, it does not assure a patient’s true understanding of the information received by that patient to make an autonomous decision. Moreover, the patient’s signature on a consent form is hardly sufficient as legal protection against litigation regarding informed consent issues. Informed consent should ultimately be a conversation between the patient and physician within the framework of shared decision making with the document only being a record that this discussion took place.


Disclosure of the Risks, Benefits, Alternatives


Canterbury v. Spence established the legal standard of informed consent as an “objective” duty to disclose, otherwise known as the reasonable patient test [1]. In Canterbury v. Spence, Jerry Canterbury sued his physician for negligence after complications ensued, alleging that he was not properly informed of the risks involved with an elective laminectomy performed for back pain [1]. The content of the disclosure of the risks of a procedure to the patient has been approached in terms of subjective, community, and reasonable person standards. “Subjective” standards require the disclosure of what a specific patient would need to know pertinent to the patient’s particular circumstances; “community practice” standards require disclosure of information that other local practitioners in a local community deem appropriate for disclosure; and “reasonable person” standards require the disclosure of what a reasonable patient would want to know under the given circumstances. In Canterbury v. Spence, the court ultimately stated that “full” disclosure was a norm that was prohibitive and unrealistic to demand from physicians, so it was favored to require disclosure of risk as “material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy” [1]. Current legal precedent thus requires the disclosure of information that would be relevant to the ability of a patient to make a decision under given circumstances. This information includes discussion of the risks and benefits, potential alternatives, and expected postoperative course relevant to a procedure or disease process in order for it to be a truly informed decision. Unfortunately, the “objective” legal standard focusing on information that a reasonable person would want to know can still be considered ambiguous and subjective as the content can vary widely among different patients.


Patient Understanding


Once the physician discloses information to the patient, it is essential to confirm that the patient understands this information and the risks, benefits, and alternatives of the procedure. In The Nichomachean Ethics, Aristotle discusses nous (comprehension) as not based only on the acquisition of episteme (knowledge), techne (craft), or phronesis (practical wisdom), but as exercising an opinion in order to render a decision or judgment [2, 3]. Using the framework of Aristotlean virtue ethics, informed consent requires the provision of sufficient information and the confirmation of the patient’s understanding of the provided information that will allow for judgment at a personal level [4]. The process of disclosure of relevant information can be extensive, as this discourse may not only be procedure-specific and disease-specific, but also patient-specific. However, the patient’s understanding of this information is critical to the informed consent process.

In the discussion between Ms. B. and her bariatric surgeon, the surgeon asks if the patient has any questions and thus begins to explore the patient’s level of comprehension and what additional information is relevant for her as a person. While the informed consent process for bariatric surgery may take over a year and may be assisted and supplemented by support groups and teams to ensure that adequate disclosure and understanding has taken place, it can be argued that the majority of surgical procedures and anesthetics cannot be practically undertaken with such liberty to educate the patient.

Despite physicians presenting information to patients in the obtaining of informed consent, the patients’ recall and understanding of this information can be limited. In a study of patients undergoing an open inguinal hernia repair, patient understanding and recall were poor only 4–5 days after informed consent was obtained [5]. In fact, only two-thirds of patients understood that they would have mesh in their groin, and less than 3% of patients were aware of the potential to develop chronic pain [5]. Furthermore, a study of patients with rectal cancer on a multidisciplinary clinical pathway including neoadjuvant therapy followed by a surgical procedure with multiple preoperative visits by the surgical team showed that patients still retained very little of informed consent discussions, and most still did not perceive these decisions surrounding surgery as being reflective of a true choice [6]. However, even with elective surgery, up to 13% of patients did not know the major risks of the procedure or even the procedure being performed (major deficits), and another 33% of patients did not have their values, preferences, or goals assessed [7].

Moreover, it is challenging to know when a patient truly does understand all of the relevant information, even if a patient verbalizes understanding. A recent study showed that while two-thirds of patients felt that they were extremely to moderately well-informed about their procedure, there was no relationship between perceptions of being informed and actual knowledge scores [8]. While these findings may lead to the conclusion that we are doing a poor job of informing our patients, these findings also highlight challenges in the process of the disclosure of information to patients. Interestingly, while surgeons and anesthesiologists are considered important sources of information for the consent process, the majority of patients seeking elective surgery may have already decided on whether they want the procedure done prior to even meeting their surgeon [9].


Informed Consent


The content and methods of informed consent have led both patients and physicians to be dissatisfied with the process of consent [10, 11]. It has been argued that the eras of paternalism and patient autonomy have led to a general dissatisfaction of the physician-patient relationship by both stakeholders, and that the current era of “bureaucratic parsimony”, or “shared decision making,” is appealing because it fosters both autonomy and collegiality in the decision making process [12]. This new paradigm effectively requires clinicians to relinquish their role as a sole authority, but rather than give up their expertise, they must train to become more effective coaches [13]. To further explore the process of informed consent in the context of a shared decision making framework, we will divide this section into two parts: (1) informing the patient, and (2) obtaining consent [11].


Informing the Patient


Informing the patient can be the more challenging of the components of informing the patient and obtaining consent. Informing the patient can be divided into three requirements to be met during the informed consent process: (1) physician disclosure, (2) assessing patient understanding, and (3) shared decision making [14]. In clinical practice, these stages are less distinct, and can happen over time and over multiple patient encounters, but we will examine each of them individually.


Physician Disclosure


Physician disclosure is performed before the informed consent document is actually signed by the physician and patient or patient’s surrogate decision maker. Ideally, the act of disclosing information to the patient or surrogate decision maker should take place as early as possible in the clinical setting. This early disclosure of information to the patient will allow the patient time to reflect on the given information and to formulate and ask pertinent questions. Certainly, this ability to disclose information to the patient may be influenced by the emergent nature of the procedure and the patient’s decision making capacity and competence.

The act of physician disclosure can be challenging, partly because of the breadth and complexity of the information. Whether in an elective or acute setting, it may be impossible to discuss every facet of the procedure and anesthetic with the patient, so the physician should focus on the most important values and interests as determined by the patient and the physician together and what a reasonable patient would want to know under the given circumstances. The discussion should include the diagnosis, an explanation of the procedure and anesthetic, risks and benefits of the procedure and anesthetic, and alternatives including nonsurgical management or non-intervention. Disclosure can also include other topics that could be relevant to the patient, such as prognosis depending on treatment choice, change in functional status after the procedure, side effects, and the expected postoperative course.

The language used during disclosure is important, and if the physician is not thoughtful the physician can unintentionally coerce the patient into making a decision initially not wanted by the patient. The goal is to be as objective as possible while delivering information to the patient, and to try to avoid personal opinions until after disclosure is complete unless the patient specifically asks for recommendations. For example, a physician may only tell a patient “there are risks from this surgery, but your quality of life will be much worse if you don’t have this procedure.” This statement can be construed as manipulative and coercive and can negatively impact the decision making process. However, when the physician states “about a third of people who undergo this procedure have complications, however choosing this surgery ultimately leads to a cure in more patients compared to observation,” this statement may be preferable as it provides information relevant to making an autonomous decision. It is also beneficial to the patient to counteract framing bias by presenting the data in both directions: “one out of five people develop a recurrence after this procedure; that means that four out of five do not.” A physician can make recommendations to the patient, yet must not coerce the patient or manipulate the patient into making a decision. Furthermore, a patient’s decision to not accept a physician’s recommendation for a procedure should be respected in accordance with the ethical principle of patient autonomy.

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Sep 21, 2016 | Posted by in ANESTHESIA | Comments Off on Informed Consent and the Disclosure of Surgeon Experience

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