Key result
Performing practice transesophageal echocardiography examinations solely for trainee education raises ethical concerns and requires explicit informed consent to maintain patient trust and autonomy.
Why the study?
Is it ethically permissible to allow learners to perform additional TEE examinations, beyond the needs for clinical care, for the sole purpose of practice without explicit patient consent?
Is it ethically permissible to allow learners to perform additional TEE examinations, beyond the needs for clinical care, for the sole purpose of practice without explicit patient consent?
Answers are grounded in this paper and cite their sources.
Performing intraoperative TEEs solely for trainee practice without explicit patient consent raises significant ethical concerns regarding patient autonomy and unnecessary risk exposure.
A patient presents to an academic medical center for mitral valve repair. During her preoperative evaluation, the anesthesiologist informs her that transesophageal echocardiography (TEE) will need to be performed to help guide the surgical repair. The patient consents to this procedure. After induction of anesthesia and central line placement, the attending anesthesiologist performs the standard, comprehensive prebypass TEE examination. Next, the cardiac anesthesiology fellow repeats the TEE examination. Just as this doctor finishes, the cardiac anesthesiology resident on his TEE elective arrives, expecting to perform yet another TEE examination on the patient. Is there anything wrong with this scenario? As attending anesthesiologists, we frequently supervise trainees performing a variety of invasive procedures. It is an accepted norm that experiential learning is the cornerstone of medical education and training of future physicians. Every day, under our watchful eye, we allow our residents and fellows to intubate tracheas, perform nerve blocks, or place central venous catheters. Sometimes, they do it well; sometimes, they cause complications. We condone their attempts because it is a part of medical education. Seasoned experts all begin as novices. When we involve trainees in medical care, invasive procedures in particular, it is like asking our patients to get in the car with a student driver. We justify it because they are aware that the driver is a student and we are sitting beside the student with a foot on the safety break. And while the ride might not be quite as safe as riding with an experienced driver, we rationalize it because we need skilled drivers for the future, and after all, this is how we learned. In any case, the patient needs to go to the destination (ie, have the procedure), and this is the sort of transportation available. What about when a procedure is done solely for the benefit of the learner’s education, and the patient does not stand to benefit at all? Is it ethically permissible to allow learners to perform additional TEE examinations, beyond the needs for clinical care, for the sole purpose of practice? In doing so, do we subject our patients to the risk of the “student driver” when there is no need for the ride? Intraoperative TEE is ubiquitous in cardiac surgery. It is also used during hemodynamic instability or high-risk noncardiac surgeries, and for good reason. Studies have shown that intraoperative TEE frequently impacts surgical decision-making.1 Accordingly, cardiac anesthesiologists are often expected to be proficient in performing and interpreting TEE, training that is now a standard part of American College of Graduate Medical Education–accredited cardiothoracic anesthesiology training programs. Online tutorials, books, simulators, and echo reading sessions supplement the intraoperative learning experience. Ultimately, one must actually perform TEEs to become skilled. As part of the anesthesia care team, the resident or fellow may be the operator for the intraoperative TEE with the expert attending alongside, guiding the examination. This is not unlike the routine for other procedures. A finite number of surgeries or clinical scenarios require a TEE, which limits learning opportunities and may not provide adequate occasions for all trainees, or the accrual of enough experience for certification. Because of limited access, multiple TEEs might be performed on the same patient, by different examiners, all with varying degrees of experience and technical prowess, solely for the purpose of trainee “practice,” rather than enhancing patient care. While these practice examinations most certainly result in learning for the trainee, it is not being done with the intention of patient benefit. For the purpose of this discussion, we define practice as the performance of a procedure that would not otherwise be necessary for clinical care. Like in the student driver example above, a practice TEE refers to an examination that is not otherwise necessary to care for the patient. This prompts important ethical and clinical questions: is it ethical to perform intraoperative, “practice TEEs” solely for educational purposes? If so, do we need the patient’s explicit consent? In this article, we consider some common arguments used to defend intraoperative practice TEEs, explore ethical issues relevant to these (and other) “practice procedures,” and offer guidance on how to ethically proceed when considering incorporating practice TEEs into clinical care. ARGUMENT 1: ”TEE IS SO SAFE, WHAT’S THE BIG DEAL?” The value of any procedure to the patient is defined by the ratio of potential procedural risk to potential patient benefit. The risk of intraoperative TEE is difficult to quantify. Significant injuries such as esophageal perforation and gastric hemorrhage, while fortunately rare, are usually detected.2 However, less obvious complications, such as dysphagia, dysphonia, or hematoma, are often underappreciated, and while not life threatening, can lead to lingering patient discomfort.2 A recent, retrospective review of nearly 8000 intraoperative TEEs performed over an 8-year period revealed a 1.4% incidence of TEE complications.2 The most common complications were dysphagia, ulceration of stomach or duodenum, upper gastrointestinal bleeding, and gastritis. Risk factors for TEE-related complications included age, smaller body mass index, previous stroke, procedure other than coronary bypass grafting, prolonged cardiopulmonary bypass time, and return to the operating room for any reason.2 Less than 1% experienced severe injuries such as Mallory–Weiss tears. Unfortunately, no retrospective review has examined the association between the amount of time spent examining, or in “active” mode, as a potential risk factor for injury. TEE is generally safe, but it is still an invasive procedure. It is well known that there are benefits to intraoperative TEE. In general, an initial, comprehensive TEE evaluation is performed immediately before the procedure as a primary diagnostic tool for surgical planning. The TEE is also used throughout the surgery, as needed, to assess hemodynamic changes, determine the effectiveness of interventions, or detect other physiological insults. Given these potential benefits, the ethical principle of proportionality supports the use of intraoperative TEE because the potential risks are offset by the potential benefit of the information gained from the procedure.3 However, an examination performed only for the purpose of practice is unlikely to provide additional value to the patient, and could potentially cause harm. ARGUMENT 2: “THE PATIENT GAVE INFORMED CONSENT FOR A TEE. THE LENGTH OR FREQUENCY OF THE EXAM ISN’T SPECIFIED.” One might assert that, even with multiple operators, an intraoperative TEE is simply a very long examination, covered under the umbrella of informed consent. For noncardiac surgery practitioners, it should be clarified that a unique element of intraoperative TEE is its use as an ongoing diagnostic tool. The exact needs for TEE examination are dictated by dynamic surgical conditions. As such, the TEE probe remains in place throughout the surgery, ready for use. At times, the TEE will be paused, while other times, it is in active mode, providing ultrasound images. Thus, the amount of time spent manipulating the TEE probe, emitting ultrasonic energy, and obtaining images will vary from case to case. Where clinical care stops and TEE practice begins can be a gray area. We believe that the threshold can be found by asking oneself, “Would I be getting these TEE views if I were working alone?” A baseline examination done under attending supervision, with the resident manipulating the probe, is clearly a part of necessary patient care. Having a resident go from operating room to operating room, performing additional, unnecessary examinations is clearly practice. While there may be a societal benefit in training future practitioners, the practice patient does not stand to gain, unless the practice examination reveals clinically useful information. It must remain a patient’s choice whether or not to allow his/her body to be “practiced upon” in this way. The principle of proportionality supports the request as reasonable because the risk is low, and the educational contribution is significant. It is ethically acceptable to ask for a patient’s consent to participate in education by allowing practice examinations while they are anesthetized. We must, however, ask. ARGUMENT 3: “WHEN A PATIENT COMES TO A TEACHING HOSPITAL, THEY EXPECT TO HAVE TRAINEES WORK ON THEM.” We assume that patients seeking medical care in teaching institutions understand and accept that their physicians will be accompanied by students, residents, and fellows eager for the opportunity to learn from their conditions. While this has not been extensively explored in the anesthesiology literature, we can extrapolate from our colleagues in surgery, by whom this issue has been examined. A survey conducted in a tertiary-level US Army hospital found that nearly all patients (94%) were willing to allow a resident to participate in his or her surgery, although 1 in 5 did not realize that they were coming to a teaching facility until they arrived for their appointment.4 Nevertheless, the majority of patients (91.2%) indicated that they believed their care in the teaching hospital to be equivalent or better than a private hospital.4 Many believed that they stood to benefit from the residents’ involvement (68.3%) and that it would ultimately help other patients (87.4%).4 When specific clinical scenarios were presented to patients, their attitudes seemed to change. Ninety-five percent would consent if there were “no direct resident assistance;” however, this number decreased to 82.7% if a senior resident were to assist, and to only 54.5% if an intern was to be involved in their surgery. When asked if they wanted detailed information about the role of the trainee in their surgical care, nearly everyone (95.7%) preferred disclosure.4 In a separate study of bariatric surgery patients’ attitudes toward training surgeons, the majority (86%) also agreed to have residents or students observe their surgeries.5 When it came to participation, only 56% were willing to have the resident assist, and a mere 14% would consent to the resident operating while the attending surgeon observed.5 The same question of resident involvement was examined in patients having cataract surgery. In spite of the image of a delicate surgery, 83% were “somewhat likely” or “very likely” to allow a resident to assist in the operation, while only half (49%) would allow the resident to actually perform the surgery. However, 74% of patients indicated that they would be “moderately” or “extremely” upset if the resident did the surgery without explicit consent.6 Furthermore, 45% of patients would feel similarly upset if the resident even assisted without permission.6 These studies show us that patients may have a general understanding of trainee involvement, but they still want transparency. PUBLIC PRECEDENT FOR DISCLOSURE OF TRAINEE PARTICIPATION In the study of >4500 medical students, 90% of them who had completed an obstetrics/gynecology clerkship indicated that they had learned to do the internal pelvic examination on anesthetized women.7 The study did not explicitly state whether consent for educational examinations was obtained, but the authors did report that after completing the rotation, only 51% of students thought explicit consent was necessary for the additional examination.7 Another study asked women “what they know about what happens in the operating room” and how they feel about having medical students help with different parts of their surgeries.8 Although this study was conducted in a teaching hospital, and most (64%) of the women had undergone previous gynecological surgery, only 66% assumed that a resident would be in the operating room. The majority expected to meet the resident before surgery (54%). Fewer patients expected to meet the medical student who might attend their surgery (38%), but that might be because 84% thought the student would only be observing. Most participants indicated that they would want to be asked for permission to allow a student to perform a pelvic examination (72%), and 14% said that they would be upset if they found out later that it had happened while they were anesthetized. Several others, including students, have also written about the common practice of teaching pelvic examination on anesthetized women, often without their consent.9 The very personal nature of a genital examination elicits a strong emotional response. Around the time the studies above were published, the practice was heavily scrutinized and even banned in several states. By contrast, others have shown that patients in the emergency departments (EDs) are very willing to have learners involved in their care. Santen et al10 studied 114 ED patients and found that the majority (90%) agreed to have first-year medical students perform procedures on them such as sutures, intravenous access, or splinting, even when told that it was the student’s first time doing the procedure. In fact, when specifically asked, 89% said that they would allow a supervised medical student to perform their first procedure on them.10 This dramatic difference in consent between surgical procedures and ED procedures may be related to the perceived magnitude of the request. Perhaps patients in this study were less afraid of a peripheral than those in previous studies involving surgery. The difference in consent rates may lay in the fact that during surgery, the patient is anesthetized, whereas in the ED, he or she is conscious. Perhaps the variations in attitude toward consent between the 2 locations are an expression of the patients’ fear of what might happen while they are incapacitated by anesthesia. STANDARDS FOR INFORMED CONSENT Since the 1914 landmark case of Schloendorff v. Society of New York Hospital, the performance of any procedure on a patient without their consent or the consent of their agent, except in cases of emergency, has been considered tantamount to battery.11 The 3 essential elements of informed consent include the following: (1) disclosure and the provision of adequate information regarding the nature of the proposed treatment (including risks, benefits, and alternatives); (2) comprehension and assurance that the patient has the capacity to provide informed consent; and (3) voluntariness and the freedom to consent to or refuse the procedure.12 During the past 100 years, medical decision-making has evolved from a paternalistic model to one that prioritizes patient autonomy. The process of informed consent is one way in which physicians promote respect for patients’ autonomy.3 Returning to our fictional clinical case, one might argue that as a necessary part of valvular heart surgery, permission for TEE is implicit in the surgical consent. The American Society of Echocardiography/Society of Cardiac Anesthesiologists has taken a clear position with respect to consent for intraoperative TEE. Current recommendations state that informed consent should be obtained before the examination, and should also be documented in the patient’s chart.13 The importance of obtaining informed consent for all procedures, particularly for those with the potential to cause harm, is self-evident and essential to the preservation of trust between physicians and patients. If we assume that all elements of informed consent were met in the preceding case scenario, are we to infer that the consent extends to the additional TEE examinations performed for the sole intent of learning, and without any direct benefit to the patient? Can a patient be expected to contribute to the educational experience without first providing informed consent? However, the question remains:, how do we ask patients to not only allow trainees to participate in their care but to generously participate in education beyond their clinical needs? OBTAINING INFORMED CONSENT WITHOUT SACRIFICING EDUCATION A valuable lesson keeps reappearing in the medical literature: patients are reasonably willing to contribute to education when asked in an appropriate and transparent way. For example, ophthalmologists compared 3 methods for obtaining consent for resident participation in cataract surgery: (1) a surgeon engaging in a discussion with the patient, and explicitly detailing the resident’s involvement and the provision of attending supervision; (2) the office staff presenting the patient with a separate consent for trainee participation without any additional information (patients may indicate yes or no); or (3) a surgeon stating to patients that residents may assist and having the patient sign a standard hospital form indicating it is a teaching hospital.14 The first method, with a detailed discussion, had a high rate of consent (86%) compared with the form simply requesting a yes/no response regarding trainee participation (21%).14 Like the surgeon above, as anesthesiologists, our priority should similarly be to take the time to speak with each patient and provide transparency and reassurance. We suggest the following guidance for an academic TEE service: First, trainees should meet certain minimal standards before performing TEEs on patients, including completion of basic TEE coursework, and, when available, demonstration of proficiency on a TEE simulator. Second, the resident should never perform a TEE without direct supervision. Part of intraoperative TEE is real-time interpretation, and misinterpretation can be far more dangerous than the physical manipulation of the probe. Cardiac anesthesiology fellowship training represents a specific circumstance in which the achievement of specific milestones may make indirect supervision appropriate. Finally, it should be explicitly explained to the patient that in addition to the TEE that will be performed to guide clinical care, other physicians may manipulate the probe to gain experience. For example, one might say “the TEE probe will be placed into your esophagus at the beginning of the procedure and remain in place throughout the surgery. If time permits, the trainees working with me may also participate by manipulating the probe to obtain additional images of your heart. This additional examination poses minimal if any increased risk to you, will be appropriately supervised at all times, and occasionally does provide additional, helpful information.” Finally, the patient should be reassured that participating in education is a choice, and the decision to not consent will not impact their care. This is a high standard. It takes some extra effort. But consent is absolutely necessary to maintain patient trust as well as our fiduciary responsibility as patient advocates. Patients should expect that we will ask for their permission to participate in education, in particular when the motivation is the trainee education and not the patient medical needs. To optimize patient agreement and minimize disruptions in workflow, academic medical centers should create policies and a process for obtaining such informed consent. CONCLUSIONS As echocardiography becomes commonplace in resident and fellow education, we should not be complacent in our teaching. Repeated examinations, especially those by practitioners not otherwise involved in the care of the patient, cross beyond the patient’s medical needs. Academic anesthesiologists can be both defenders of patient as well as for education. consent is a between and patient. the teaching process and the minimal additional risk will generally This transparency from our patients. if some opportunities to perform practice examinations are we will the standards of and as role for the of some may is an important This and the This the This was
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Ivascu et al. (2017) reported an editorial. Practice transesophageal echocardiography (TEE) was evaluated. Performing practice transesophageal echocardiography examinations solely for trainee education raises ethical concerns and requires explicit informed consent to maintain patient trust and autonomy.
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