key: cord-0754683-ob3u1cuh
authors: de Cássio Zequi, Stênio; Franca Silva, Ivan Leonardo Avelino; Duprat, João Pedreira; Coimbra, Felipe José Fernandez; Gross, Jefferson L.; Vartanian, Jose Guilherme; Makdissi, Fabiana Baroni Alves; Leite, Fernanda Perez M.; da Costa, Walter Henriques; Yazbek, Guilherme; Joaquim, Eduardo Henrique Giroud; Bussolotti, Raquel Marcondes; Caruso, Pedro; de Ávila Lima, Marcon Censoni; Nakagawa, Suely Akiko; Aguiar, Samuel; Baiocchi, Glauco; Lopes, Ademar; Kowalski, Luiz Paulo
title: Informed consent and a risk‐based approach to oncologic surgery in a cancer center during the COVID‐19 pandemic
date: 2021-03-08
journal: J Surg Oncol
DOI: 10.1002/jso.26452
sha: 2d6c2ec8400737a7d018b4d893c8dd41e58678fd
doc_id: 754683
cord_uid: ob3u1cuh

BACKGROUND: Cancer patients configure a risk group for complications or death by COVID‐19. For many of them, postponing or replacing their surgical treatments is not recommended. During this pandemic, surgeons must discuss the risks and benefits of treatment, and patients should sign a specific comprehensive Informed consent (IC). OBJECTIVES: To report an IC and an algorithm developed for oncologic surgery during the COVID‐19 outbreak. METHODS: We developed an IC and a process flowchart containing a preoperative symptoms questionnaire and a PCR SARS‐CoV‐2 test and described all perioperative steps of this program. RESULTS: Patients with negative questionnaires and tests go to surgery, those with positive ones must wait 21 days and undergo a second test before surgery is scheduled. The IC focused both on risks and benefits inherent each surgery and on the risks of perioperative SARS‐CoV‐2 infections or related complications. Also, the IC discusses the possibility of sudden replacement of medical staff member(s) due to the pandemic; the possibility of unexpected complications demanding emergency procedures that cannot be specifically discussed in advance is addressed. CONCLUSIONS: During the pandemic, specific tools must be developed to ensure safe experiences for surgical patients and prevent them from having misunderstandings concerning their care.

Since the end of January 2020, when the World Health Organization (WHO) declared the novel coronavirus outbreak a public health emergency of international concern, 1,2 a profound global transformation in health care has been promoted. The worldwide concern increased in March, when the WHO declared that COVID-19 was a pandemic disease. 3, 4 The majority of health care infrastructure, materials, and personnel resources have been diverted in favor of facing this pandemic and to provide personal protective equipment to health professionals. 2,4,5 One of the most important population recommendations has been social distancing, which is effective in reducing the transmission of SARS-CoV-2. 6 This sanitary policy is considered fundamental, but some adverse effects have been verified in patients with chronic non-communicable diseases, such as cardiovascular disorders and cancer. There are reports of increased numbers of fatal acute cardiovascular events at home, because patients are avoiding going to hospitals or emergency rooms out of fear of becoming infected during hospital admission. [7] [8] [9] In this scenario, the treatment of cancer remains a great challenge. The main risk factors for cancer (older age, obesity, diabetes, arterial hypertension, smoking, respiratory diseases, metabolic syndromes) are also competing risk factors for infection by and its potentially lethal complications. 10, 11 Small series studied in the first countries to be affected suggest that cancer patients are almost twice as likely to become infected 12 and present more severe events in comparison with nononcologic patients (39% vs. 8%, respectively; p = 0.0003; odds ratio, 4.7 [95% CI, 1.23-13.43]; p = 0.02). 11, 12 A recent report of an international cohort study showed a high risk of pulmonary complications and mortality among 1128 SARS-CoV-2-infected patients who underwent surgery. 13 Despite the fact that oncologic surgery is one of the pillars of the treatment of solid tumors, its indication constitutes a dilemma in this pandemic period: if all patients undergo invasive procedures, many of them would be at risk of becoming infected and developing severe complications. 11, 14, 15 Conversely, for many patients with aggressive or life-threatening tumors, when surgery is postponed (or changed for alternative therapies), the odds of being cured or of adequate cancer control are lessened. 15 Regarding surgical staff, many surgical or anesthetic teams may be reduced in number, due to the work impediment for groups such as older colleagues or groups at risk of infection, as well as young colleagues who contract the infection or who have been displaced from their teams to attend to the front lines of infection. 5 Thus, it is important to optimize the management of human and material resources for surgical treatment of cancer at this moment. Reports of infected colleagues and nursing teams must also be taken into account to ensure a safe surgical environment and to respect the recommendations to avoid virus dissemination through intraoperative aerosols or secretions to the surgical room. [15] [16] [17] [18] [19] [20] [21] [22] To reach the best and safest decisions, it is necessary to base them on the natural history of each specific tumor and the patient's health status. For indolent and less aggressive tumors, postponement of surgery and active surveillance protocols might be the best option. For aggressive malignancies, prompt surgery could be indicated. Between these two extreme scenarios, there are intermediate situations which could be managed by alternative measures, such as short-term postponement (60-90 days, with re-evaluation of imaging studies), outpatient thermal ablative procedures, or a nonsurgical approach, such as radiotherapy and/or systemic treatments (such as hormonal therapy, chemotherapy, targeted therapy, and/or immunotherapy). 15, 22 In addition, other characteristics must be taken into account when deciding on the timing of surgical treatment during the pandemic, such as maintenance of a protected cancer flow within the hospital, the hospital occupancy rate, the intensive care unit (ICU) occupancy rate, the availability of hospital supplies including personal protective equipment (PPE), and patient anxiety regarding possible postponement of surgical treatment.

To support surgeons in their therapeutic decisions, many medical specialty societies have published adapted guidelines and recommendations. 15, 22 Although following such guidelines is to be recommended, many statements are based on specialists' opinions and it is impossible to guarantee the effectiveness of these measures for all cases. On the other hand, some patients are absolutely refractory or for personal reasons do not follow medical recommendations and demand prompt surgery.

Historically, high-volume and highly specialized cancer centers have achieved their best results in treating several kinds of solid tumors, in comparison with low-volume or non-specialized centers. 23, 24 Oncologic referral teams must establish the best conditions in which to offer the best multidisciplinary personalized approach for each The aim of this study is to report our IC model and our proposed management algorithm.

We searched the English, Portuguese, Italian, and Spanish literature using the Mesh terms informed consent, COVID-19, SARS-Cov-2, pandemic, and oncologic surgery. We wrote a description of the institution-specific IC and algorithm for surgery during the COVID-19 pandemic that have been in use at the ACCCC since May 5, 2020.

The IC is shown in Figure 1 . The form is divided into two sections:

the first section provides information regarding disease and the procedure: clinical condition; proposed procedure, objectives and justifications; benefits, and risks and eventual consequences. This section is completed by the surgeon. The second section is not limited to discussing the risks and benefits of the surgery during this pandemic. It advises the patient about medical staff exposure risks, mentioning that team members could be infected or put under quarantine during the patient's treatment. In these situations, they will be replaced by other colleagues. Finally, the IC clarifies that unexpected complications can occur and can require new urgent procedures, and it reinforces recommendations that patients maintain social distancing after the surgery.

The surgical treatment algorithm was developed by a task force composed of surgeons, anesthesiologists, infectologists, ICU professionals, nurses, diagnosticians, laboratory teams, lawyers, hospital managers, and institutional stakeholders, and it was based on the recommendations proposed by SBCO 18 and publications about best practices for safe surgery during the COVID 19 pandemic ( Figure 2 ). [15] [16] [17] [19] [20] [21] [22] [28] [29] [30] [31] [32] [33] [34] In summary, 5 days before an elective surgery, patients are ad- It is critical that patients and their relatives or caregivers are comprehensively informed about all benefits and risks involved in the surgical treatment. There is no guarantee that the results will be similar to those achieved before the pandemic. [11] [12] [13] [14] The use of IC forms is well established in surgical routine, 37, 38 being globally recommended by medical and legal authorities. The application of the IC together with an enlightening and realistic conversation, in a welcoming environment, can reduce the risk of future legal disputes between patients, relatives, doctors, and health care institutions.

From this harmonious conversation, a shared therapeutic decision must be achieved. The actual conjunction of uncertainties generated by the cancer diagnosis, the need for surgery, and the risk of COVID-19 must be taken into account and carefully described in the IC specifically adapted to this unique scenario. Surprisingly, in the searched literature, we found only a few papers on the use of IC regarding trials of drugs for COVID-19, or about its use in general surgeries, intubation, and mechanical respiration, [25] [26] [27] [32] [33] [34] 39 and there were few on studies proposing IC documents focused on oncologic surgery during these exceptional times. 19, 40 Motivated by this situation, physicians and institutional legal teams developed a comprehensive IC, which can be applied by all the oncological surgeons at our center. We took care to prepare a wide list of problems, both expected and unexpected, which could affect patients as well as health professionals. This instrument can also offer the patient a broader view of the surgical treatment process. It is a very dynamic situation and new information regarding COVID-19 is produced continuously, and thus continuous revisions or amendments of our IC might be necessary at any time. This IC includes a section which the patients must fill in by themselves, informing the hospital whether or not they have any doubts regarding the procedure. This reinforces the patients were reasonably informed.

The IC also addresses the fact that, despite all the cautions in the algorithm, it is not possible to avoid all the risks of perioperative COVID-19 infection or its complications. The IC informs the patient of the possibility of immunological changes secondary to surgical trauma or anesthesiology. 35, 36 It also clarifies that respiratory complications can occur after major surgeries and are not necessarily synonymous with COVID-19.

Two points related to legal risk were also addressed in advance: unexpected acute situations demanding emergency procedures without discussion with the patient or family; and the sudden absence or substitution of health professionals without prior notice.

The IC by itself does not guarantee that successful therapeutic choices will be made and without legal questioning. Oncologic practices. 41, 42 Besides the risks of patient infection before, during, or after hospitalization, it is also important to clarify to the family the risks involved with the surgical team and even the possibility that part or all of the group will be suddenly substituted with another one due to risk of COVID-19 infection. Another important role of an extensive preoperative conversation is the need to make it clear to the family or accompanying person that they should follow the same pre-and post-operative protective steps as the patients do, to guarantee a completely safe environment for all.

In our early results, among 540 asymptomatic patients candidates to elective surgeries, we found 41 (7.6%) presenting positive tests for SARS-CoV-2, which had postponed operations. None of them were readmitted due COVID-19 in their postoperative periods. 43 Probably, some deaths were avoided, since mortality rates may reach 19.1% up 27.1%, in surgeries performed for COVID-19 positive patients. 13 Between 2020 April and July, we compared surgical outcomes of 49 asymptomatic RT-PCR positive patients that had their surgeries delayed versus 1:2 matched controls (negatives) who had originally scheduled surgeries. There were no significant differences among the groups regarding general complications; Grade 3-4 or pulmonary complications; and SARS-CoV-2 related infections (p > 0.05, for all) 44 F I G U R E 3 Clinical and epidemiological A. C. Camargo Cancer Center screening questionnaire for suspicion of COVID-19 symptoms or contact with infected people This paper has some limitations. The literature in this area is scarce, and the available papers are based on retrospective studies of limited case series or the opinions of specialists. The accuracy of available SARS-Cov-2 tests is limited, and they can produce falsepositive or false-negative results. 45 Initial reports of test results in pregnant women admitted for delivery in New York City found 13.7% SARS-CoV-2 positivity by PCR. 46 The rate of positivity in the Brazilian cancer patient population is not known, since they are on average significantly older than pregnant women and probably present more comorbidities and possibly some immunodeficiency. Additionally, we do not know what the best day to test patients is, because asymptomatic patients can develop infection between the test and surgery. Beyond these uncertainties, it may be logistically impossible to test every patient. Regarding the questionnaire, some patients anxious for treatment for their malignancies will omit some relevant information.

We hypothesize that the majority of the population is now concerned about COVID-19 risks and are in solidarity in contributing to minimize them as best as they can. But this understanding can rapidly change in the face of an incurable, progressing tumor. Good communication and understanding are mandatory, and all decisions must be jointly taken by physicians, patients, and family members, and registered in medical charts. 19, [40] [41] [42] This new model IC dedicated to the surgical treatment of cancer patients during the COVID-19 pandemic and the new multidisciplinary comprehensive algorithm are tools that can improve safety for patients, health professionals, and institutions.

Surgical treatment for cancer patients during the COVID-19 pandemic is a remarkable challenge. Cancer patients are at risk for developing the new coronavirus infection and its life-threatening complications. Meanwhile, numerous patients demand prompt surgeries to treat rapidly growing tumors. In these cases, postponing surgical treatment could jeopardize the chance for cancer control and increase the risk of cancer-related death. Skilled health professionals must individualize treatment, indicating surgery for patients with high-risk tumors and delaying or offering alternative treatment for insidious cases or for patients without medical conditions for surgery. The best risk-based therapeutic decision will result from a thorough risk-benefit discussion and shared decisions, documented using a specific and comprehensive informed consent.

We confirm the absence of shared data in this manuscript.

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Informed consent and a risk-based approach to oncologic surgery in a cancer center during the COVID-19 pandemic