Ethical Considerations in Informed Consent: Contrasting Inpatient and Outpatient Laryngectomy Counseling

A 63-year-old female presented to the emergency department (ED) with a one-and-a-half-year history of hoarseness and intermittent hemoptysis. She was found to have T4N0M0 supraglottic squamous cell carcinoma after subsequent tracheostomy and direct laryngoscopy with biopsies. Head and neck tumor board discussed and agreed for the patient to stay inpatient and undergo total laryngectomy as she had multiple comorbidities requiring medical management. After discussions with the surgical team and preoperative counseling with speech and language pathology (SLP) while remaining inpatient, the patient agreed to laryngectomy. Her postoperative course was complicated with hematomas, flap failure, and pharyngoesophageal dehiscence requiring multiple takebacks to the operating room for wound revision and bleeding control. Eventually, the patient was stabilized and discharged roughly 1 month after her initial presentation. Given the host of postoperative complications and resulting emotional anguish this patient faced, the fast-tracked inpatient laryngectomy was questioned by the surgical team. Retrospectively, the team considered that maybe these complications and associated emotional burden could have been avoided if the patient had been stabilized with preoperative management and counseling performed in the outpatient setting. Similar scenarios present themselves not uncommonly for head and neck cancer treatment, where logistics (safe discharge options, transportation, and access to healthcare) are used as justification for abbreviating standard informed consent and preoperative counseling. At our own institution, out of a total of 234 laryngectomies done over 10 years, we had 52 laryngectomies done in the inpatient setting. The objective of this paper is to contrast the ethical implications of inpatient expedited cancer treatment with truncated consent and preoperative counseling process versus delaying care in favor of a thorough outpatient preoperative counseling and consent. The laryngectomy procedure is a life-saving treatment for individuals with laryngeal cancer. Many patients present with malnutrition, dyspnea, dysphonia, or significant disfigurement, and deadly progression is inevitable if left untreated. However, the life-altering sequelae of the laryngectomy procedure cannot be overstated. The loss of voice is the most prominent change that laryngectomy patients face; in addition, patients incur lifelong behavioral restrictions related to living with a laryngectomy stoma, such as limitations for showering and swimming. The anticipated lifestyle alterations can place a significant psychological toll on an individual, especially in the setting of a recent cancer diagnosis. For this reason, appropriate and detailed preoperative information and counseling are imperative to prepare the patient for these changes. Historical studies have highlighted significant gaps in preoperative preparation for patients undergoing laryngectomy. Keith et al observed that 13% of patients and 19% of their spouses reported that the loss of voice associated with the procedure had not been explained.1 A more recent study unfortunately showed similar results, with 20% of laryngectomy recipients reporting that they did not know they would lose their voice.2 These results were found despite extensive preoperative attention, which identifies significant gaps in information dissemination during the preoperative period. Currently, there is no standardized preoperative protocol for patients undergoing laryngectomy. However, current literature has highlighted key preoperative interventions that may benefit recovery and rehabilitation. In general, preoperative counseling can reduce hospital length of stay (LOS) after laryngectomy. Preoperative counseling, in the form of a designated visit, in addition to the clinic visit where the patient receives his or her diagnosis, was associated with a 2.5-day decrease in LOS (95% CI: −5.0, −0.05; P = .046).3 Laryngectomees have also identified preoperative visits with SLP as beneficial before surgery.2 Such counseling should include an understanding of the patient's goals, lifestyle, and how they intend to use voice augmentation. The SLP provider is best equipped to set expectations for postoperative rehabilitation. Lastly, patients can benefit from meeting with laryngectomy social groups before their surgery. Though no objective data exist linking patient quality of life to involvement in a laryngectomy social support group, it is well known that support groups have a significant benefit on patients with chronic disease.4 Meeting with other individuals that have undergone a laryngectomy can provide the patient with realistic expectations and increase understanding of life post-laryngectomy. The opportunity for patients to receive appropriate preoperative information and counseling before the laryngectomy procedure should not be understated. An individual undergoing a laryngectomy is subject to life-altering conditions to save his or her life. This trade-off puts significant stress on an individual, which could obscure his or her capacity at the time of consent. Therefore, it is important to provide an adequate outpatient preoperative period to allow time for extensive counseling, sessions with SLP, and connection with social support groups. The ideal components of this preoperative period embody the three pillars of informed consent: information, comprehension, and autonomy (Table 1; Figure 1).5 We argue that an inpatient tracheostomy to secure an airway, followed by an elective laryngectomy, is more ethical than proceeding with an inpatient laryngectomy. Laryngectomy, which may require free-flap reconstruction, is at high risk for complications, and it is essential to maintain shared decision-making for such a life-changing procedure. It is unlikely that preoperative counseling in the inpatient setting is adequate, considering that it may be rushed and not have all components of outpatient counseling. In fact, in otolaryngology medicolegal cases, a perceived lack of informed consent has been noted to be as high as 34% in some studies.6 Curtailing thorough preoperative counseling and adequate informed consent, no matter how well-intentioned it may be, ultimately is a disservice to the patient. Ideally, patients with laryngeal cancer undergo a thorough preoperative counseling process involving a multidisciplinary team to best prepare a patient for life post-laryngectomy. However, in certain scenarios, this lengthy preoperative counseling process must be truncated. It is uncommon, though not unheard of, for a patient to present to the ED with an upper airway obstruction secondary to a laryngeal malignancy, sometimes previously undiagnosed. For patients with an impending airway, the options are limited: tracheostomy (likely done awake) with a delayed laryngectomy or an emergent laryngectomy. There are possible concerns regarding the ethics of an emergent laryngectomy, as these patients may not undergo the thorough preoperative counseling that elective laryngectomy patients may receive. If a patient does not properly understand the implications of their surgery, it can impede upon the shared decision-making process. However, one can argue that an expedited cancer treatment with an abbreviated consent is the most ethical decision in select scenarios. The complexity of shared decision-making and informed consent in urgent scenarios is not unique to Otolaryngology. Surgery regularly proceeds in emergent trauma scenarios without informed consent when there is time-sensitive medical necessity and patient goals cannot be confirmed. In OBGYN, it is not uncommon for a routine scheduled pregnancy to quickly transition to an urgent surgical procedure with limited time given for a thorough consent. Even in the pediatric intensive care unit (PICU), transition to extracorporeal membrane oxygenation (ECMO) can occur with limited shared decision-making due to the urgency of the patient's condition.7 Informed consent in the inpatient setting for an emergent laryngectomy is not necessarily inferior to the consent done outpatient for an elective laryngectomy. Numerous studies have shown that there is limited recall and comprehension in the informed consent process, even under ideal circumstances. One study found that parents of pediatric patients undergoing otolaryngologic procedures were only able to recall one-third of the risks 2 weeks after consent.8 Another study showed that consents are often written with extensive jargon, requiring medical literacy.9 These limitations illustrate the imperfect nature of the consent process and highlight that a consent obtained in the outpatient setting is not necessarily more effective than an inpatient consent. Given this context, shortcutting a lengthy outpatient consent process to avoid a delay in care may be justified if inpatient consent is non-inferior. The importance of multidisciplinary preoperative counseling for laryngectomy due to the morbidity and life-altering qualities of the surgery has been well established. Yet, previous research has shown that less than 80% of patients report being satisfied with the preoperative counseling they received in the outpatient setting.10 To our knowledge, there has been no research done on inpatient preoperative counseling for emergent laryngectomy. At our institution, we can achieve an abbreviated form of counseling, incorporating many of the recommendations established in previous literature. We have inpatient SLP that can meet with the patient and provide thorough counseling for the patient and family. In the inpatient setting, the surgical team has a constant presence, allowing multiple discussions to occur with different team members in a short timeframe, compared to outpatient counseling, where the patient may only meet with the surgical team once. However, compared to outpatient counseling, the patient does not have a prolonged period to decide about surgery and cannot meet with a laryngectomy support group. Emergent laryngectomy may be favorable to tracheostomy with delayed laryngectomy for certain patients. Namely, there is an increased risk of stomal recurrence due to seeding for laryngeal cancer patients who undergo tracheostomy for upper airway obstruction.11 Second, there can be a logistical dilemma for patients who opt for tracheostomy and delayed laryngectomy over emergent laryngectomy. Operating room space may be limited at many hospitals, and opting to change procedure priority from emergent to elective may delay the case for months. With a delay, there is a risk for cancer to spread primarily or through stomal recurrence. Furthermore, there is a risk of the patient being lost to follow-up if laryngectomy is delayed. Patients' insurance may also redirect them to establish care elsewhere, leading to new appointments and new evaluations. The factors that prevented patients with upper airway obstruction secondary to laryngeal cancer from initially seeking treatment may still be at play, whether it be financial limitations, decreased access to care, or low medical literacy. Notably, research has shown that patients with emergent laryngectomy have similar postoperative mortality and survival compared to patients undergoing elective laryngectomy.11 Reviewing medicolegal cases gives insight on the aspects of healthcare that patients find unacceptable. Delays in care/treatment are one of the most common claims in legal cases raised against otolaryngologists.12, 13 This evidence further justifies expedited inpatient cancer treatment at the expense of a thorough preoperative counseling and consent process. With similar outcomes to the outpatient alternative, emergent laryngectomy may be a favorable option for patients presenting to the ED with upper airway obstruction due to advanced laryngeal cancer. Patient autonomy is an essential aspect of providing appropriate healthcare; however, otolaryngologists must assess each situation separately. A self-limited delay in care to ensure a lengthy consent/counseling process may not always be an appropriate action. With increasing weight placed on expedited care by some patients and established inpatient multidisciplinary support, an emergent laryngectomy may be the best course of action for a patient. The ethics for deciding on an inpatient and outpatient laryngectomy will likely never be clear. One must balance the principles of autonomy and beneficence and treat each situation uniquely. The authors have nothing to report. Khwaja H. Ahmed, conceptualization, design, conduct, presentation, writing original draft, review and editing; Traeden Wilson, conceptualization, design, conduct, presentation, writing original draft, review and editing; Arjun Sharma, design, conduct, presentation, writing original draft, review and editing; Nihal Punjabi, design, conduct, presentation, writing original draft, review and editing; Jared C. Inman, conceptualization, design, conduct, presentation, writing original draft, review and editing, supervision. The authors declare no conflicts of interest. None.