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Restarting Orthopaedic Care in a Pandemic: Ethical Framework and Case Examples

Humbyrd, Casey Jo MD, MBE; Dunham, Alexandra M. MD; Xu, Amy L. BS; Rieder, Travis N. PhD

Author Information
Journal of the American Academy of Orthopaedic Surgeons: January 15, 2021 - Volume 29 - Issue 2 - p e72-e78
doi: 10.5435/JAAOS-D-20-00871
  • Free
  • COVID-19

Abstract

Introduction: Restarting Usual Orthopaedic Care Should Also Be Framed as an Ethics Question

tIn light of the ongoing novel coronavirus disease 2019 (COVID-19) pandemic, national medical organizations have issued guidelines for surgical care to prepare for an inundation of patients with COVID-19.1 The American College of Surgeons (ACS) and the Centers for Medicare & Medicaid Services (CMS) have recommended curtailing elective surgical procedures. However, clinicians have struggled to identify which procedures are elective. Although the CMS and ACS guidelines are intended to provide a framework for such decision making, the vagueness of the guidelines has caused confusion and variability in interpretation. National healthcare emergencies necessitate a shift from shared decision making between the patient and the surgeon, which is governed by standard bedside ethics (eg, a principle-based approach), to a less collaborative framework governed by public health ethics.2 The latter approach is designed to maximize the distribution of scarce resources. We believe that resuming orthopaedic care is an ethics question as much as a scientific debate.3 We discuss the shortcomings of the current recommendations for the field of orthopaedic surgery, provide ethical guidelines for resuming orthopaedic care, and describe several case scenarios.

Examination of Current Guidelines: Strengths and Shortcomings of Each

The CMS, ACS, and American Academy of Orthopaedic Surgeons (AAOS) guidelines recommend shifting from the standard patient-physician focus to a public health focus. These guidelines are intended to help clinicians transition to this new framework easily and consistently while allowing them to advocate for surgery for patients whose conditions could fall under multiple categories within a triage system. Here, we examine the advantages and shortcomings of these guidelines.

The CMS recommends delaying nonessential planned surgeries and procedures during COVID-19 using a three-tiered triage system based on low, intermediate, or high treatment acuity.4 The CMS system also includes location of care (ambulatory surgery center [ASC] versus hospital), with examples of services in each tier and a recommended action plan. This system is meant to advise physicians on how best to provide urgent attention to save a life, manage severe disease, or avoid further harm from underlying conditions or disease during a time of variable resource availability. However, the way in which these criteria are applied is left to the discretion of healthcare delivery systems and providers. Surgery is considered specialty care and is not discussed specifically.4

Regarding decisions about curtailing surgical procedures, the ACS states that “patients should receive appropriate and timely surgical care, including operative management, based on sound surgical judgment and availability of resources” and that surgeons should “consider nonoperative management whenever it is clinically appropriate for the patient.”5 The ACS provides a table developed by the University of Pennsylvania to aid the orthopaedic surgeon's decision making to curtail or eliminate practice across each of the adult subspecialties.5 Both the ACS and CMS recommendations are categorized according to the severity of the pandemic: phase II (curtail elective practice) or phase III (eliminate elective practice). (Phase I is least severe and involves minimal surgical restrictions.) Generally, surgeons are encouraged to perform procedures for acute conditions and postpone those for chronic conditions.

The AAOS guidelines consist of four tiers with progressive surgical restrictions to accommodate increasing viral prevalence and shortages of critical resources. The most restrictive tier recommends surgery only for life- or limb-threatening injuries to minimize the need for ventilator support. Local decision making is emphasized, although the hazard of this approach is also discussed. One such hazard was the short-sighted approach enacted during early phases of COVID-19, in which less affected localities conducted business as usual and then experienced rapid depletion of resources.6

We believe that although the current AAOS guidelines are responsive to clinical needs, they do not fully address the moral dilemmas that occur during a pandemic because they do not embody a shift to a public health paradigm. A just allocation of resources for the entire population must supersede the interests of individual patients and healthcare systems during a pandemic. Decisions about which nonemergency procedures will be performed should be made on the basis of recommendations from local, state, or federal governments. Specialists must be good stewards of resources, so they remain available for local use if patient volumes increase or can be sent where they are needed.

The existing guidelines put surgeons in a challenging position. For example, under the guidelines, an acute fracture is considered an emergency, and surgery can be scheduled even when elective procedures are eliminated. Under this guidance, a surgeon could justify offering surgery for a simple clavicle fracture, although long-term functional outcomes after nonsurgical treatment are equivalent.7,8 Moreover, surgeons may decide to perform surgery for reasons that represent a conflict of interest, such as financial incentives.

We support the concept of flexible guidelines; however, the lack of clarity creates a dilemma for physicians, who may value the well-being of their patients over the good of the population. For example, Major League Baseball's New York Mets pitcher Noah Syndergaard sustained an ulnar collateral ligament tear during spring training. Surgery was performed at the Hospital for Special Surgery Florida at the end of March 2020 despite Florida state orders prohibiting any medically unnecessary, nonurgent, or nonemergency procedure. His surgery was deemed essential care. His surgeon defended the choice because Syndergaard's livelihood was at stake.9,10

These scenarios highlight the need for more explicit orthopaedic guidelines. Leaving discretion up to individual providers is insufficient. Structural policies should help physicians make the ethically defensible decisions while promoting patient-centered care. Performing nonessential surgical procedures when resources are scarce is in neither the patient's nor the healthcare system's best interests. For example, the patient may be exposed to the novel coronavirus during surgery,11 while the healthcare system is depleted of critical resources. This depletion undermines the commitment to nonmaleficence from both population- and patient-centered perspectives in favor of prioritizing the immediate, short-term financial bottom line of clinicians and healthcare systems alike. We believe that the current guidelines are too vague to provide a just framework during a national healthcare emergency.

Ethical Guidance for Resumption of Care

Guidance Specific to Orthopaedic Surgery

Orthopaedic conditions range in severity, from life-threatening cancers to sports-related injuries treated with physical therapy. Many surgical procedures are considered quality-of-life procedures; however, the degree to which quality of life can improve after orthopaedic surgery is astounding. One study estimated that the typical improvement in quality of life after hip arthroplasty is greater than that after coronary artery bypass grafting.12 Another study showed that 12% of patients awaiting total knee arthroplasty and 19% of patients awaiting total hip arthroplasty had EuroQol 5-dimension questionnaire scores that represented a medical state that patients would rate worse than death.13 General guidelines, such as those of the CMS and the ACS, may undervalue the benefits of orthopaedic surgery.

In addition, general surgical guidelines that differentiate between emergency, urgent, or elective/schedulable surgery may not fully account for the nuances of orthopaedic care. To a nonorthopaedic surgeon, it may seem reasonable to categorize tendon ruptures as requiring urgent surgical treatment. This may be true for certain tendon injuries (eg, acute quadriceps tendon ruptures), but other tendon ruptures, such as those of the long head of the biceps tendon, are frequently treated without surgery and result in little or no functional deficit. Guidelines specific to orthopaedic surgery would not determine urgency of treatment on the basis of injury type but would rather weigh the anticipated harm if the injury went untreated against the potential benefit of a particular surgical procedure.

Public Health Ethics

Typically, clinical ethics revolves around the best interests and autonomy of the patient. Inherent to a patient-centered, shared decision-making framework is the focus on the individual. In fact, typical clinical ethics requires physicians to consider only their particular patient to avoid unjust bedside rationing.14 Yet, in a time of resource scarcity, usual practices will lead physicians to overuse resources for an individual patient without consideration of the greater population.

During a pandemic, public health ethics takes precedence. This is not to say that we disregard the provider's considerations about an individual patient, but rather that population-level concerns take precedence. The principle of public health ethics asks how we, as a system, institution, or hospital, can serve the needs of the many rather than the needs of the few. This principle has sometimes been viewed as saving as many as possible, with the many measured in life-years saved, number of lives saved, or another metric. This approach represents utilitarianism or maximizing the good. Yet, Powers and Faden15 argued that social justice is the foundation of public health, meaning that any promotion of the good must be balanced by other considerations, such as the inequitable distribution of good health in the population. Inequities in health care have come into stark relief during COVID-19, which has disproportionately affected ethnic and racial minorities.16 Although debate continues about whether utilitarianism or social justice is the foundation of public health ethics, it is clear that public health ethics is concerned with advancing the health of the population, rather than the health of an individual patient, which is the focus of clinical ethics. Implementation of public health ethics clearly requires cessation of elective surgery during a virus surge.

Public health ethics requires the efficient and just allocation of resources. This stewardship of available resources can take many forms. For example, during a pandemic, the scarcity of blood products increases. If two patients require an equally beneficial surgery, but one patient is expected to require a transfusion, it is reasonable to preferentially perform the surgery on the patient who will not require a transfusion, assuming that other resources (eg, ventilator and operating room) are available. The ethics of resource conservation also requires us to consider how we use personal protective equipment, staff, and ventilatory capacity.

Cases of Clinical Equipoise

We typically use a patient-centered, shared decision-making framework to determine the optimal treatment for any one patient. However, during a pandemic, surgery should not be performed for injuries that could be treated as effectively without surgery—regardless of patient preferences. For example, consider a patient with an Achilles tendon rupture. The AAOS Clinical Practice Guidelines state that both surgical and nonsurgical treatments are reasonable.17 In an ideal situation, a surgeon would likely initiate a shared decision-making process in which the risks and benefits of each treatment approach are discussed. In a time of resource scarcity, guidelines would dictate nonsurgical treatment, at least initially, on the basis of clinical equipoise.18

Importantly, this approach to patient care is not bedside rationing, which occurs when a physician rations care for an individual patient. Rather, it represents a hospital, health system, or state-wide framework supporting nonsurgical treatment when equipoise exists. Indeed, an advantage of a policy that proscribes surgery in such cases is that surgeons no longer need to make the decision themselves. They are required to adhere to the policy. Even when the acute phase of the crisis has ended, some degree of scarcity will remain because of the backlog of surgical cases. We advocate that a shared decision-making approach in cases of clinical equipoise should resume only after the crisis has ended and resources are no longer scarce.

Cases of Clear Surgical Benefit

We believe that during a pandemic, a framework based in public health ethics requires nonsurgical treatment in cases of clinical equipoise. Conversely, public health ethics supports the continuation of surgical treatment of life- or limb-threatening conditions. We now consider the surgeries to treat injuries that are not immediately life or limb threatening: schedulable procedures that are in a patient's best interests. During a pandemic, how should we modulate the imposition and lifting of restrictions on surgical care for these patients?

Tier Surgeries on the Basis of Anticipated Harm

As operating room availability increases, we would advocate prioritization according to the anticipated harm to the patient if care is delayed or denied. It would be prudent to proceed with surgery for a patient who needs 4 hours of operating room time and blood products for resection of a Ewing sarcoma rather than for a patient who needs the same operating room time and blood products for treatment of spondylolisthesis with radiculopathy. A delay in surgery is likely to cause much greater harm for the patient with a life-threatening tumor than for the patient with radicular pain. As the COVID-19 emergency abates, the number of permissible surgical procedures will increase until all procedures resume—including in cases of clinical equipoise.

Preserve Scarce Resources

Public health ethics requires responsible stewardship of available resources. Resource conservation can be straightforward, such as extending the use of personal protective equipment or avoiding unnecessary gown changes during surgery. The operating room itself is also a critical, finite resource. An operating room can be used for surgery or converted into an intensive care unit if needed. Ethical stewardship of resources requires thoughtful allocation. The use of operating rooms to care for professional athletes, for example, may limit the resources available to fight a pandemic within the community, disproportionately harming minority and underserved populations.

One strategy is to increase the proportion of procedures performed in ASCs rather than hospitals. This shift frees hospital space for patients who require hospital-based care. In addition, it reduces the likelihood that medically frail patients will be exposed to a surgical patient with asymptomatic infection. Because ASCs can provide care only for relatively healthy patients (because postoperative hospital admission is not an option), they inevitably prohibit care for less healthy patients and more complex surgeries. Although these biases raise justice concerns—especially given how race, socioeconomic status, and geography influence health—we argue that an aggressive expansion of ASC capacity is still ethically permissible because the shift would expand resource availability and reduce resource consumption in the hospital setting. We do not advocate indiscriminate expansion to ASCs; instead, we would continue to advocate for a tiered system designed to minimize patient harm.

Create Flexible Systems

Finally, good ethics requires flexibility. The United States is a large, diverse country without a national healthcare system. We are unlike European and Asian countries, where national leadership dictates the healthcare approach. In the United States, resumption of surgical care must vary locally. For example, in Maryland, major medical systems collaborated with the state government on the cessation and resumption of elective surgical care.

Ideally, states or regions will establish criteria for determining which nonurgent care is allowed to ensure that no hospital or physician unfairly exploits the situation. The local setting can be defined by metropolitan area with adjustments for population size, population density, and access to resources (eg, number of intensive care unit beds and hospital census). Region-specific care will also create a system that can be scaled forward or backward as needed. Inevitably, waves of COVID-19 infections will occur in the form of local outbreaks. A coordinated, region-specific approach will ensure that nonurgent care proceeds only when sufficient regional resources are available. Finally, flexible, region-specific care policies will allow surgeons to recommend surgery in cases that might otherwise be treated nonsurgically when special circumstances warrant surgical treatment. For example, nonsurgical treatment may be reasonable for a patient with an isolated distal radius or ankle fracture, but if the patient has both a distal radius and an ankle fracture, surgery may be appropriate even when resources are scarce.

Application of the Guidelines

We will now apply these public health ethics to several cases (Table 1).

Table 1 - Ethical Guidance According to Surgery Type
Surgery Type Ethical Guidelines
Emergency or urgent (life or limb saving) Proceed with surgery as soon as possible
Schedulable and clinical equipoise Proceed with nonsurgical treatment
Schedulable and clear surgical benefit Tier according to anticipated harm; preserve scarce resources; and build flexible systems

Case 1: Hip/Knee Arthroplasty

Hip and knee arthroplasties are high-value procedures. Many studies have documented major quality-of-life improvements after joint arthroplasty. Yet, joint arthroplasty requires extensive resources, with many patients requiring hospital admission and inpatient or outpatient postoperative care. Some patients require postoperative transfusions, which are an additional resource burden. Therefore, we would argue that during the most acute phase of a pandemic, total joint arthroplasty procedures unrelated to fractures should cease.

As orthopaedic care resumes, which patients should be prioritized? Let us consider two hypothetical patients. The first is a 75-year-old man with hypertension and diet-controlled diabetes with a body mass index value of 32 kg/m2 (obese). The second is a 75-year-old man who has undergone a kidney transplant for sickle cell disease. Both patients have end-stage hip osteoarthritis, although the patient with sickle cell disease reports greater pain, with evidence of avascular collapse of the femoral head. How do we treat these patients as orthopaedic care resumes?

For this comparison, we will assume that both patients have undergone extensive nonsurgical treatment and are prepared to consider surgery. The benefits of hip arthroplasty are well documented. Therefore, this is not a case of clinical equipoise; surgery is preferred when possible. A utilitarian approach to public health ethics would seem to favor providing surgery for the patient with fewer comorbidities because this patient is less likely to require additional resources, such as transfusion or a prolonged hospital stay. However, the burden of sickle cell disease is inequitably distributed in the population, primarily affecting African Americans, and some would argue that social justice requires us to consider this factor. The harm of a delay in treatment slightly favors care of the patient with sickle cell disease, given his greater pain and joint space collapse from osteonecrosis. An argument could be made from a public health ethics perspective to support care of either patient, which leads us to conclude that care of both patients is desirable as soon as feasible.

When we consider a tiered system, the healthier patient may be able to be treated first because his care may be performed on an outpatient basis at an ASC. In addition, it is likely that the patient with sickle cell and renal disease would be better served at a tertiary care center rather than a community hospital. A flexible approach would favor arthroplasty for the healthier patient in an ASC and care for the patient with sickle cell and renal disease at a tertiary care center as soon as the hospital census and blood product availability ensure that the patient can receive appropriate treatment. If both patients were to receive care at a tertiary center, we would favor prioritization of the individual with sickle cell disease on the basis of the principles of social justice and the disproportionate harm caused by both sickle cell disease and COVID-19 in minority communities.

Case 2: Clavicle Fracture

A 45-year-old man is riding his mountain bike when he falls over the handlebars and sustains a midshaft clavicle fracture that is 80% displaced with 1.5 cm of shortening. He works in a seated job. His primary athletic activity is cycling. He is otherwise healthy with no clinically relevant medical history. He consults his orthopaedic sports medicine surgeon who performed his anterior cruciate ligament surgery 15 years earlier after a soccer-related injury. On examination, there is palpable deformity but no tenting of the skin. He is neurovascularly intact.

Under normal circumstances, this injury would be ideally suited to a shared decision-making process, in which the risks and benefits of surgical versus nonsurgical treatment would be discussed. During a pandemic, clinical equipoise would dictate nonsurgical treatment. Although nonunion of clavicle fractures is more common in midshaft injuries treated without surgery,19 this particular fracture is likely to be treated equally effectively with or without surgery. Furthermore, the harm from a nonunion is unlikely to be permanent because surgery could be performed in the future if a painful nonunion develops.

Case 3: Rotator Cuff Tear

A 50-year-old man who is employed as a roofer falls from a ladder while working on his own home. He develops new-onset right shoulder pain after the fall. He reports weakness in the shoulder, and on examination, he has limited active forward elevation of the arm with pain and giving way with resistance. MRI shows an acute, large rotator cuff tear without evidence of chronic changes, such as fatty infiltration.

Another 50-year-old man employed as a roofer begins a new push-up routine. He has had intermittent right shoulder pain for the past 6 months. He reports soreness in the shoulder, and on examination, he has limited active forward elevation of the arm with pain and giving way with resistance. MRI shows an acute-on-chronic moderate rotator cuff tear.

Typically, many orthopaedic surgeons would favor surgery for the patient with an acute tear and nonsurgical treatment for the patient with the acute-on-chronic tear. Would a pandemic change these decisions?

According to a review by Keener et al,20 an acute, large rotator cuff tear is at substantial risk of progression and poor healing. In addition, surgical treatment of these injuries is likely to alter the natural history for the better. Therefore, clinical equipoise is not a major consideration in the first case because the evidence favors intervention, especially for a manual laborer in whom the lack of function could be financially devastating. Conversely, for the patient with an acute-on-chronic tear, nonsurgical treatment is favored on the basis of clinical equipoise, despite identical careers for the two patients.

For the patient with an acute rotator cuff tear, surgery would be reasonable. Ideally, surgery would be performed in an ASC or on an outpatient basis in a hospital (as is the norm for this procedure), provided that the region is not in a severe infection state, in which operating rooms should be used only for emergency and urgent cases. This case could reasonably be tiered to occur within months rather than weeks, and scheduling should be flexible according to local resources.

Case 4: Aggressive Benign Tumor

A 17-year-old girl presents to her orthopaedic surgeon's office after 2 weeks of right knee pain. She is a varsity soccer player who is being scouted to play National Collegiate Athletic Association Division 1 soccer. Radiographs show an aggressive lesion of the distal femur. MRI and biopsy confirm a giant cell tumor. The MRI shows a stress reaction but no fracture at a thin cortical margin of the knee joint. Crutches were recommended for non–weight-bearing ambulation with the goal of preventing fracture through the joint until surgery can be performed.

In this case, surgery is clearly warranted to prevent further morbidity from this locally aggressive, benign tumor. Substantial harms from disease progression are possible, including the potential for pulmonary metastases. In addition, remaining non–weight bearing for an extended period is physically harmful, and if the bone were to fracture through the joint, the defect may become unreconstructable, requiring a prosthesis and an end to her athletic goals. Although a joint-sparing surgery cannot guarantee a return to full activity, curettage and bone grafting has the greatest potential to prevent further morbidity.

Public health ethics clearly supports surgery on a semi-urgent basis. Although this patient should be treated after patients with life-threatening disease, clear harms of nonsurgical treatment are possible. Utilitarian considerations favor prioritization of younger patients, given their anticipated longer life expectancy after treatment. Furthermore, during COVID-19, younger patients are less likely to become infected with the novel coronavirus and to develop severe disease21 and therefore less likely experience harm from potential exposure to patients with COVID-19 in the care setting.

In terms of tier and flexibility, this patient is likely to receive care in the hospital and/or at a tertiary care center. Care may be delayed on the basis of bed availability, although because many children hospitals' census has remained low during COVID-19, a major delay may not occur.

Conclusion: A Way Forward

During a national healthcare emergency, we must shift from prioritizing individual patients to preserving resources for the greater population. We propose ethical guidelines for the resumption of orthopaedic care based on public health ethics, with an emphasis on a tiered system based on anticipated harms, preservation of scarce resources, and flexibility. Our approach highlights the value of staying informed about current treatment recommendations and differences in outcomes. As the state of emergency fades, these guidelines can help surgeons address the backlog of cases that will occur.1

References

Levels of evidence are described in the table of contents. In this article, references 17 and 20 are level I studies. References 1, 12, 20, and 21 are level II studies. References 1, 7, 8, 13, and 21 are level III studies. Reference 13 is a level IV report or expert opinion. References 2-6, 11, 14, 15, and 18, are level V studies.

References printed in bold type are those published within the past 5 years.

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Copyright 2020 by the American Academy of Orthopaedic Surgeons.