Amy Y. Chen, MD, MPHEmory [email protected] Shindo, MDOregon Health Sciences [email protected] author:Amy Y. Chen, MD, MPHEmory Department of Otolaryngology Head and Neck Surgery550 Peachtree St. MOT 1135Atlanta, GA [email protected] title: Ethics Endocrine Surgery COVID 19Ethical Framework for Head and Neck Endocrine Surgery in the COVID 19 pandemicThe COVID-19 pandemic has halted all elective surgeries, allowing only emergent surgeries, and in some hospitals time-sensitive urgent surgeries to proceed. “Mr. X, This is Dr. I’m calling to discuss with you your previously planned surgery. “ I’ve been having many conversations like this with my patients over the past weeks. Surgeries may be delayed or the patient and his/ her family may need to make a heart wrenching decision whether to proceed with surgery in a hospital filling with COVID patients, risking infection themselves, and without any visitors. Endocrine surgery falls into this valley where it is neither life threatening nor totally benign either. The American Association of Endocrine Surgeons1 as well as the endocrine section of the American Head and Neck Surgery2 have put forth recommendations for thyroid and parathyroid conditions that would be considered urgent time-sensitive surgery. These include 1) high risk thyroid cancers such as those with bulky central and lateral neck disease, concern for tracheal or esophageal involvement, or short doubling time 2) Graves’ disease with thyrotoxicosis that cannot be controlled with anti-thyroid medications, 3) compressive large goiters with dyspnea or significant symptomatic vascular compression, 4) Primary hyperparathyroidism with life-threatening hypercalcemia that cannot be managed medically, 5) endocrine disorders in pregnant patient that are dangerous to the health of the mother or fetus that cannot be controlled medically.Certainly, there has been an international push to observe more well differentiated thyroid cancer; however, what about those “smallish” cancers that are near the isthmus, near the trachea/ esophagus, or with extracapsular extension? Despite their small size, these can become invasive to the degree that could result in the need to perform a more morbid procedure if surgery is delayed, and thus should be considered in the category of “time-sensitive surgery”. What about indeterminate thyroid nodules with adverse molecular markers? If such nodules present with ultrasound findings that are concerning for local invasion, even though the cytologic diagnosis is not “malignant”, such lesions should be treated as high risk cancer, and surgery should not be delayed.If proceeding with surgery, the surgeon has an ethical responsibility to discuss with the patient the potential risk of COVID-19 infection. We as surgeons have a responsibility to reduce risk of infection not only to the patient but the healthcare team who will be caring for the patient. At the minimum COVID-19 testing should be performed preoperatively within 2 days of surgery, and the patient should be educated on the importance of self-isolation and necessary precautions.If potential difficult airway is anticipated communication and planning with anesthesia pre-procedure is important. Despite that fact that the patient may test negative for COVID-19, the false negative rate is not zero, and as such, precautions need to be taken to minimize exposure. A difficult airway may result in manipulation of the airway that could potentially be aerosolizing. Having the appropriate protective gear and all necessary difficult airway equipment is essential in such a situation. If the patient needs fiberoptic laryngoscopy or tracheoscopy, nasal pledgets should be used in lieu of sprays. Surgery should certainly be postponed in Covid-19 positive patients.Scarcity of resources, surge planning, and public health mitigation efforts have all combined in a perfect storm to delay and in some situations, to deny treatment to head and neck surgery patients. Whereas some of our patients may afford a delay in their treatment, others do not have that luxury. It is incumbent upon us, as their clinicians, to integrate competing priorities into an acceptable plan.Justice, or to be just/ fair, must include a lens towards equity. One way to honor this ethical principle is to incorporate both clinical and non-clinical factors in risk assessment. Many papers have reported on the profound effect of sociodemographic factors on patient outcomes. An intersection between higher comorbidity burden and lower socioeconomic status can worsen disparities of who gets treatment. For example, algorithms that incorporate comorbidity are necessary so that resources can be allocated for the “greater good;” however, these guidelines risk heightening disparities and health inequity. Strategies to ameliorate these disparities include flexibility of treatment options, creative discharge planning, and thorough pre-operative conditioning. Flexibility of treatment options include consideration of definitive chemoradiation, induction chemotherapy prior to surgery (to buy time), and resection with delayed reconstruction.Beneficence, or to do good, is a guiding principle of ethics. With limited resources, the “good” of society supersedes the “good’ of the individual. Hence, the cancellation of elective, non-emergent cases is instituted. So is the prioritization of surgical cases that are not likely to need ICU care, blood products, extended inpatient stay, and extensive ancillary laboratory/ radiology testing.However, these cancellations/ delays in treatment/ changes in treatment can cause anxiety for both the clinician and his/ her patient. Many of our patients have been waiting for several weeks for their treatment to start, only to have it be delayed or altered. How do we reassure the patient that the new plan is the best plan, given the restrictions that the COVID 19 pandemic places on systems? How do we, as clinicians, resolve our inner turmoil in delaying/ denying/ altering treatment.Early data already demonstrate that COVID 19 is affecting vulnerable racial minorities at a higher disproportionate rate. To compound the adverse effects, this cohort has more access issues due to transportation, hourly job limitations, and lack of stable insurance. The delay in surgery may result in the patient’s loss of insurance status due to loss of income and/ or being furloughed. As we move into the next phase of easing up restrictions, such factors need to be taken into consideration in prioritizing whom we select for surgery.1. https://www.endocrinesurgery.org/assets/COVID-19/AAES-Elective-Endocrine-Surgery.pdf2. https://www.ahns.info/wp-content/uploads/2020/03/Endocrine-Surgery-during-the-Covid.pdf

INTRODUCTIONWe are quite familiar with the COVID-19 epidemic and its unprecedented implications. It has clearly changed our lives, healthcare, clinical practice, urgency of the health problems, financial implications and mental health. The issues of mental health are applicable both to the patients and healthcare providers. Obviously, we need to pay special attention to the patients suffering from COVID-19 especially those who are symptomatic or having major health crisis such as pulmonary issues and multiorgan failure.As of the 8th of April, globally there have been approximately 1.52 million confirmed cases of COVID-19 of whom 90,000 are dead. In the United States, the confirmed COVID-19 cases are reported to be 435,564 while the reported deaths are 14,829. New York State has faced the major brunt of this pandemic with confirmed cases of 147,037 and death number of 6,220.In spite of this major health crisis patients are always concerned about their own problems in relation to other health issues especially with fear of proven or suspicious cancers. Clearly, some of the cancers are life-threatening and will require urgent attention while other tumors may be monitored or treated at a later date when the COVID-19 issues are relatively settled. In a referral center or a tertiary care cancer center it is fairly common to receive consultations regarding thyroid problems or thyroid tumors.Even though, there are no set guidelines in the management of patients asking for thyroid surgery it would be appropriate to manage these patients based on the risk group analysis and the overall risks of progression to life-threatening issues. We need to explain every patient that thyroid tumors grow slowly and there is no need for active and emergent intervention. It is quite appropriate to wait for 4-6 months.If the patient is extremely anxious a follow up ultrasound may be performed in 3-4 months to document the stability of thyroid tumor. We have divided thyroid cancer patients for almost 50 years into low, intermediate and high-risk groups based on their prognostic features1. We popularly described this as good, bad and ugly tumors. The prognostic factors were described as age, grade of the tumor, size of the tumor, extrathyroidal extension, distant metastases, etc. Other prognostic factors such as multiple lymph node metastases and the molecular analysis should go into the equation of management of these patients. Needless to say, patients are extremely concerned for the fear of any cancer whether it is thyroid or pancreatic cancer. It is our responsibility to explain to the patients the concern about these cancers on their overall prognosis and the best timeline definition for active intervention. The new American Thyroid Association guidelines published in 2015 have done a fantastic job in line with the biology of these tumors and appropriate management 2. As a matter of fact, the ATA endorsed observation as a definitive approach in proven microcarcinomas. This clearly reflects the management of these tumors in relation to their biology and avoiding over treatment. Let the punishment fit the crime or let the treatment not be worse than the disease is quite appropriately applied to thyroid cancer. However, it would be important to define certain indications and road map of active management of some these thyroid cancers. If we use the analogy of management of thyroid cancer during pregnancy and delaying the treatment by 9-10 months, it would be the same philosophy of managing these patients during the COVID-19 pandemic. Clearly, some patients will require urgent or active intervention in a timely fashion. The following summary will describe some of the decision-making issues.Anaplastic Thyroid Cancer – patients with rapidly growing thyroid tumors with proven anaplastic thyroid cancer will obviously require emergent management. The decision regarding surgical intervention should be made based on the extent of the disease and cross-sectional imaging. Appropriate BRAF based therapies and external radiation therapy should be implemented. If the tumor appears to be unresectable there is no reason to bring these patients to the operating room. The definitive diagnosis could easily made with ultrasound guided core biopsy, and appropriate immunohistochemistry. The issue of airway management is always a difficult problem in anaplastic thyroid cancer and more so during COVID-19 pandemic. Obviously, testing the patient for Covid-19 is important since patient may require either active airway intervention or hospitalization with concern of exposing healthcare workers. As mentioned in the first anaplastic thyroid cancer guidelines, elective tracheostomy is best avoided however may be necessary if the patient is having acute airway distress 3. A due consideration should be given to controlled cricothyrotomy.Medullary Thyroid Cancer – Appropriate evaluation of extent of the disease with calcitonin, CEA, ultrasound and cross-sectional imaging is very important before consideration of timely surgical intervention. If the disease appears to be limited and calcitonin levels are not high (under 400) patients can be monitored for a few months without surgical intervention hoping for COVID-19 peak to settle. Generally, medullary carcinoma is a chronic disease and observation with close monitoring would be quite appropriate until the social circumstances get better. Obviously, this will require extensive discussion with the patient and the family which can be easily done even by phone conversations or Facebook. A discussion directly by responsible attending surgeon would give a lot of confidence to the patient and the family. They need to understand that waiting for the best time for surgery is unlikely to hurt them or lead to major progress of the disease. The prognosis essentially would remain the same.Locally Aggressive Thyroid Cancer – These are the patients who will require detailed evaluation of the extent of the disease, its involvement in relation to the central compartment vital organs such as recurrent laryngeal nerve, trachea, esophagus, and major vascular structures. Appropriate cross-sectional imaging will be of great help. If patient does require fiberoptic evaluation it would be best done with the hospital guidelines and appropriate protection to the healthcare staff. Obviously, COVID-19 testing would be important prior to any active intervention. The decisions about surgery in light of COVID-19 pandemic would be quite critical as to how long we can delay the surgical procedure without compromising the total surgical resection and encroachment on vital central compartment structures. The decisions may be slightly different if the preoperative FNA has resulted in poorly differentiated thyroid cancer. It would be quite appropriate to discuss some of these cases with our colleagues in multidisciplinary team since we are able to hold virtual tumor boards. Avoiding surgical compromise is important in these patients however waiting for a reasonable time would not be inappropriate.Patients with Large Primary Tumors and Bulky Nodal Disease – The history of the presence of tumor and the duration of the nodal metastasis would be quite helpful to project the best timing of surgery in these patients. Again, appropriate cross-sectional imaging and approximation of the tumor to the vital structures is critical in making the best decision regarding appropriate timing of surgery in these patients.Low and Intermediate Risk Thyroid Carcinomas – These patients can wait for surgery for a period of time (3-6 months) until we have a better handle on COVID-19, and they are not a risk to the healthcare workers. If the patients need extended period of observation, a repeat imaging with ultrasound in 3-4 months will encourage the patients to delay the surgery further.Microcarcinomas – As reported by a large series of patients from Kobe, Japan; Sloan Kettering, these patients with microcarcinomas can definitely be observed 4,5. Most of these patients can be encouraged not only to delay the surgery but to remain under active surveillance or deferred intervention. Again, appropriate ultrasound will define the exact location of the disease and need of active intervention.Recurrent Thyroid Carcinoma – The majority of the recurrences especially in the central compartment nodes or lateral neck nodes are essentially the persistent diseases. They could be observed for an extended period of time with repeat imaging studies in 4-6 months. The only time one would consider active surgical intervention, if the tumor is plastered against the trachea for the fear of future encroachment into the trachea. Alternate treatment choices such as alcohol injection, radio frequency ablation may be considered for localized nodal recurrences.Indeterminate Thyroid Nodules – most of these patients will be in the group of Bethesda III and IV categories. These patients can be easily monitored and if the tumors are small even if they’re BRAF or TERT positive, could be monitored for a period of time before active surgical intervention. The positivity of the molecular markers and the quantification of the risk of malignancy is not a determinate for emergent surgical intervention.Large Goiters – the majority of the large goiters have generally been there for a long period of time and surgery could be easily avoided even with tracheal deviation and mild compression unless there is a rapid progression, major compression symptoms or impending acute airway issues.Benign Thyroid Conditions – benign thyroid nodules, Hashimoto’s thyroiditis, or Graves’ disease could be managed appropriately as before and probably may not be in-person consultation. The majority of these patients can be easily consulted on telephone, Skype or Facetime which will give patients a sense of confidence and make them feel that the treating physician is actively involved in their care and follow up. The guidelines recommended by ATA for fine needle aspirations of incidental thyroid nodules should be applied vigorously. It would be best to avoid FNA on smaller and non-suspicious thyroid nodules.Moral Dilemma – I am sure there will be many discussion points in above recommendations. These are not written in any of the textbooks or guidelines. These are clinical observations during the early period of COVID-19 pandemic. Hopefully, God willing, the pandemic will be over soon, and we will go back to our regular clinical practices. However, until then, it is our responsibility to manage our patients best, give them a full sense of confidence and avoiding major progression of their tumors and life-threatening issues. We also have a responsibility to the healthcare workers who take the major brunt of exposing themselves to the COVID-19 which may become lethal in a few individuals. This definitely raises a major new dilemma to the healthcare workers. Every profession has certain risks and concerns. For example, a frontline army personnel, a firefighter, or a policeman where both the individuals and their families are aware about the life-threatening risks. However, until the COVID-19 pandemic occurred nobody realized the life-threatening risks to the healthcare workers. This clearly creates a major social and ethical dilemma amongst healthcare workers and their families. Even though the non-essential staff can work from home, the essential staff such as frontline healthcare workers have to be exposed themselves to proven and unproven COVID-19 patients. This may lead to major ethical issues and mental depression amongst healthcare workers. What would be the answer to the 10-year-old child when he tells his father, “Dad, please don’t go to work. I’m afraid you may catch COVID-19 and you are the only one I have.”We don’t have the answers to these questions, however, I would like to salute the frontline healthcare workers who have been actively involved in offering the best medical care to the patients suffering from COVID-19 and offering them and the society a Glimpse of Hope. These are the true Noble Laureates.References:Shaha, AR. Implications of prognostic factors and risk groups in the management of differentiated thyroid cancer. Laryngoscope. 2004, 114; 393-402.Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, et al. 2015 American Thyroid Association – Management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer; the American Thyroid Association Guidelines Task Force on Thyroid nodules and differentiated thyroid cancer. Thyroid. 2016, 26; 1-133.Smallridge RC, Ain KB, Asa SL, Bible KC, Brierley JD, Berman KD et al, American Thyroid Association Guidelines for Management of patients with anaplastic thyroid cancer. Thyroid. 2012, 22; 1104-39.Miyauchi, A. Clinical trials of active surveillance of papillary microcarcinoma of the thyroid. World J Surg. 2016, 40; 516-22.Tuttle, RM, Fagin JA, Minkowitz G, Wong RJ, Roman B, Patel S et al, Natural history and tumor volume kinetics of papillary thyroid cancers during active surveillance. JAMA Otolaryngol Head Neck Surg. 2017, 143; 1015-1020.

BackgroundIn the face of the COVID-19 pandemic, cancer care has had to adapt rapidly given the Centers for Disease Control and Prevention (CDC) and the American College of Surgeons (ACS) issuing recommendations to postpone non-urgent surgeries. MethodsAn institutional multidisciplinary group of Head and Neck Surgical Oncology, Surgical Endocrinology, and Medical Endocrinology devised Surgical Triaging Guidelines for Endocrine Surgery during COVID-19, aligned with phases of care published by the ACS.ResultsPhases of care with examples of corresponding endocrine cases are outlined. Most cases can be safely postponed with active surveillance, including most differentiated and medullary thyroid cancers.  During the most acute phase, all endocrine surgeries are deferred except thyroid tumors requiring acute airway management.ConclusionsThese guidelines provide context for endocrine surgery within the spectrum of surgical oncology, with the goal of optimal individualized multidisciplinary patient care, and the expectation of significant resource diversion to care for COVID-19 patients.