Let’s Be Reasonable: Surgical Informed Consent in the COVID-19 Era

From the * Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Justin T. Clapp

From the * Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Lee A. Fleisher

From the * Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

From the * Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; and Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.

Reprint: Steven E. Raper, MD, JD, 4 Silverstein Pavilion, 3400 Spruce Street, Philadelphia, PA 19104. E-mail: ude.nnepu.enicidemnnep@repar.nevets.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Abstract

Our perspective on informed consent is that expanding the duty to disclose novel uncertainties (eg, the covid-19 pandemic) stretches the doctrine to almost limitless proportions. Instead, we argue for a more conventional view in which the informed consent process should remain focused on the proposed operation and its ramifications.

INTRODUCTION

The COVID-19 pandemic presents surgeons with novel concerns; informed consent is no exception. A number of authors, both national and international, have made pronouncements about what surgeons are obliged to tell their patients. 1–3 This article responds to these recommendations by introducing the concept of reasonableness into COVID-19 informed consent disclosures. There are essentially 2 legal standards of informed consent, and both rely on the concept of reasonableness. The Reasonable Physician standard arose from the principle of beneficence and requires individual physicians to abide by the customary practices of the professional community. 4 Twenty-six states adhere to the Reasonable Physician standard. 5 The Reasonable Physician standard raises significant concerns, including whether physicians have the expertise necessary to know what information patients want or need and whether a national standard of disclosure truly exists or devolves into local or regional variation. 4 Difficulties in the Reasonable Physician standard led to development of the Reasonable Person standard, which focuses on what risks, benefits, alternatives, and consequences a reasonable person would want to know about an operation. This is the prevailing standard in 23 states. 5 Professional societies such as the American College of Surgeons have articulated elements that when discussed by a surgeon and patient satisfy the reasonableness standard leading to surgical informed consent. The elements of an informed consent conversation should include—among others—the nature of the disease, appropriate details of the proposed operation, the estimated risks of mortality and morbidity, and a discussion of the commonly known complications. Patients should comprehend the risks as well as the benefits of the operative plan. The conversation should include a description of alternative treatments, including nonoperative treatments and what to expect during the perioperative period including recuperative issues. 6

The question then arises: what information should surgeons themselves provide patients about COVID-19 to satisfy a reasonableness standard? The COVID-19 pandemic has created many urgent but currently unanswered questions about SARS-CoV-2. Editors of medical journals may be receiving 20–40 full-length papers on COVID-19 every day. During the past several months, some journals have each received 500–1000 papers on COVID-19. 7 The outpouring of manuscripts written by scientists and clinicians trying urgently to add knowledge about the new virus and its disease manifestations has strained the ability of peer review to identify unsound science. Further, the advent of preprint servers—such as medRχiv—provide data sourced from papers that have not been reviewed by peers. Given the rapid proliferation of information on all aspects of the COVID-19 epidemic, responsible surgeons do well if they can manage the updates provided by their own institutions. Few if any surgeons would pretend to be infectious disease or infection control experts if they are not.

As elective surgery resumes, there is a need to balance the COVID-19-specific risks of an operation—including current evidence of increased mortality if the patient has COVID-19 or of contracting the SARS-CoV-2 virus in the perioperative setting—with the benefits of an operation. 8 This balance will clearly be different if the patient is undergoing an aesthetic versus a cancer operation. 2 One alternative that should be discussed in consultations is the option to postpone surgery to a later time, when COVID-19 disease and hospital or community spread are better understood. The requirement of preoperative testing, the implications of a positive test, and reasons for possible postponement should also be addressed.

While standards of reasonableness would clearly require certain COVID-19-related topics to be addressed, many of the requirements recently proposed by various authors are excessive. Contrary to what has been suggested in the literature, surgeons should not be required to obtain separate “hold harmless” documents from patients. 1,2 It should not be the duty of the surgeon in the consent discussion to inform patients of uncertainties of novel diseases or other information not directly relevant to the planned operation. 3 To expand the duty to inform beyond those elements already set forth by the professional societies would be to expand the scope of consent discussions to unachievable levels. Patients, in need of calming reassurance, should not reasonably be expected to wade through uncertainties only tangentially related to the planned operation. Validated measures to understand patient fears to COVID-19 are only being developed now, and in the absence of such data, patients need reassurance, not uncertainty. 9

Another proposed obligation is that only the surgeon performing the operation should be the only person providing information on a wide variety of COVID-19 related issues. 3 But all patients—not just those undergoing surgery—need to hear a clear, consistent message from their many health care providers. A number of clinical procedures and treatments require health care institution–wide signed informed consent, including anesthesiology, blood transfusion, interventional radiology, gastroenterology procedures, chemotherapy, and radiation therapy. Such procedures are done by a variety of specialists in different departments. To mandate that each of these individual providers cover in the consent discussion all of the uncertainties involved with care during COVID-19 would likely lead to misunderstanding or messaging at odds with that of the institution.

Discussion of family support and ongoing patient care is also important. However, prioritizing the care and comfort provided require institutional solutions and are again generally outside the surgeon’s ambit. 3 Most health care institutions provide audio or videoconferencing when possible. Special considerations are generally given to actively dying patients or when withholding/withdrawing life-sustaining therapies from patients who in their final moments do not want to be alone. Surgeons need not assert that a patient’s care may be compromised as a result of the need to accommodate COVID-19 patients; this devalues the efforts of physician and nursing leadership, the care providers, and the many ancillary services to provide safe, quality care to all patients. Patients who require emergency room evaluation or readmission due to postoperative complications should be assured that care will be available. Surgeons and other health care providers have shown time and again resilience and ingenuity in the face of adversity.

Instead of imposing an expanded duty to inform upon surgeons, a better option for communication of information about the COVID-19 pandemic is to organize a health care organization–wide response. 10 A surgeon is but one of many team members focused on highly reliable patient care. The job of discussing the many aspects of patient care during the COVID-19 pandemic is distributed among all who come in contact with patients, and messages should be standardized to minimize confusion. Surgeons should be aware of—and make available to patients—institutional information regarding COVID-19. At our institution, a series of COVID-19 safety FAQs are sent to patients via email or other preferred platform at the time of appointment scheduling and then again by previsit email: whether an outpatient encounter, nonsurgical procedure, or as part of the preoperative teaching. These FAQs are updated by local subject matter experts (eg, infection control) as new information becomes available from reliable sources (eg, Centers for Disease Control) and are widely disseminated to patients, faculty, and staff. Recognizing the critical need for patients to have friend and family support through the difficult time of surgery, our organization has developed a number of communication tools for wide distribution (Table ​ (Table1). 1 ). Questions not answered by standard educational materials can be addressed by querying experts (Infectious Disease consultation, Infection Control staff).

Table 1.

Institution-Specific Resources for and About Patients and COVID-19 *