Ethics of Clinical Practice in Orthopaedic Surgery
Christian A. Pean, MD, MS
Arthur L. Caplan, PhD
Neither of the following authors nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this chapter: Dr. Pean and Dr. Caplan.
Keywords: ethics; healthcare disparities; orthopaedic surgery; shared-decision making; value-based care
INTRODUCTION
Ethical principles are ideas upon which norms, rules, and behavior are based.1 The rigorous application of ethics is imperative for the clinical practice of orthopaedic surgery and an essential component of the medical profession. The repeated ethical transgressions by members of the medical profession throughout history are evidence of the need to continuously acknowledge and reinforce the role of morality in providing just and beneficent medical care.2 This is increasingly apparent as advances in research and clinical surgery have changed the practice of orthopaedic surgery drastically and sparked the emergence of new challenging subjects such as value-based care, robotic surgery, and the use of biologics. Beyond the application of ethical principles during individual patient encounters, orthopaedic surgeons should also be cognizant of the ethical challenges that may present to them at a systems level and be conscientious practitioners of preventive ethics. Ethical dilemmas present frequently in the clinical practice of orthopaedic surgery, and the ability to anticipate and prevent ethical challenges is a critical skill orthopaedic surgeons should develop to provide the highest standard of care to their patients. This chapter will highlight the application of ethics to orthopaedic surgery from individual patient encounters to considerations at the broader level of the healthcare system and provide guidelines for orthopaedic surgeons to consider in providing ethical surgical care.
PRINCIPLES AND A BRIEF HISTORY OF SURGICAL ETHICS
HISTORICAL CONTEXT
Surgeons and medical practitioners throughout history and across cultures have utilized ethical codes and moral guidelines to govern their profession. The origins of the ethics of clinical practice in orthopaedic surgery are varied in nature and have evolved gradually over time. Most physicians and surgeons will hearken to the Hippocratic Oath established in the fifth century BCE in their recall of the ethical principles that guide the medical profession.3 The philosophical aspects of the Hippocratic Oath often cited in reference to the modern code of medical ethics derive from the famous doctrine of primum non nocere: “first, do no harm.” The role of the surgeon is paradoxical to this oft-quoted maxim of nonmaleficence in that a surgical intervention must in some degree cause harm or pain to the patient via surgical instrumentation in an effort to ultimately cure or alleviate suffering. This aspect of the surgical profession creates a unique paradigm for the patient-physician relationship. The present-day healthcare system prioritizes evidence-based, informed, uncoerced treatment that places primacy on the patient’s well-being and autonomy and frowns upon paternalism. However, ethical norms of the medical profession have changed substantially over the course of recent history.
Just how drastically ethics of patient care have changed is illustrated by a quote attributed to Henri de Mondeville, a French surgeon in medieval times who said, “If the patient is defiant, seldom will the result be successful.”4
The expectation of patient docility and the theme of paternalism are far removed from the modern emphasis on patient autonomy in clinical care. Codes of conduct for surgeons in Western medicine are traced back to 1745 when the Company of Surgeons was established. Until this time in Western society, the surgical vocation was seldom recognized in the same professional vein as other medical disciplines. As surgeons organized into a more regulated profession, individuals emerged who would begin to define the ethical foundations of modern surgery.5 Scottish physician John Gregory (1724-1773) implored physicians and surgeons to develop sympathy defined as the “sensibility of heart which makes us feel for the distresses of our fellow-creatures…” He further believed that the physician’s relationship to the patient required patients to be capable of understanding a physician’s treatment recommendations and able to comply with them. These early notions of patient autonomy were more akin to the modern standard of informed consent in surgical ethics.
The expectation of patient docility and the theme of paternalism are far removed from the modern emphasis on patient autonomy in clinical care. Codes of conduct for surgeons in Western medicine are traced back to 1745 when the Company of Surgeons was established. Until this time in Western society, the surgical vocation was seldom recognized in the same professional vein as other medical disciplines. As surgeons organized into a more regulated profession, individuals emerged who would begin to define the ethical foundations of modern surgery.5 Scottish physician John Gregory (1724-1773) implored physicians and surgeons to develop sympathy defined as the “sensibility of heart which makes us feel for the distresses of our fellow-creatures…” He further believed that the physician’s relationship to the patient required patients to be capable of understanding a physician’s treatment recommendations and able to comply with them. These early notions of patient autonomy were more akin to the modern standard of informed consent in surgical ethics.
The American Medical Association (AMA) Code of Ethics was established in 1847 based on the idea of professional responsibility toward patients; however, surgery is mentioned in this code only in prohibiting physicians from holding patents for surgical instruments and mentioning “unusual fatigue” of the surgical cases.6 The American College of Surgeons (ACS) was founded later in 1913. The Fellowship Pledge of the ACS was established the same year and contained elements of a foundation for a surgical ethical framework. The pledge exalted the merits of teaching and the patient’s welfare above all else. Furthermore, the pledge emphasized the surgeon’s obligation to scrupulous and honest financial dealings with respect to their craft, binding the surgeon to “shun dishonest money-seeking and commercialism as disgraceful to our profession.”4
Ethical guidelines more specific to the orthopaedic surgeon were established by the American Academy of Orthopaedic Surgeons (AAOS). The AAOS was established in 1933 and is the largest medical association of musculoskeletal specialists. The AAOS established a code of professionalism and ethics specifically geared toward orthopaedic surgeons that continues to aid in the recommended behavior of those in the profession.
ETHICAL PRINCIPLES
Recently, surgeon and bioethicist Mile Little more clearly delineated the unique aspects of the surgeon-patient relationship.7 He proposed five characteristics that made the patient-surgeon relationship distinct from other medical specialties:
1. The surgeon’s power to rescue patients;
2. The intimate proximity of surgeons and their patients, especially in the operating room;
3. The ordeal that patients endure before, during, and after surgery;
4. The aftermath, both physical and emotional, of surgery; and
5. The patient’s desire for the surgeon’s presence throughout the experience.
As this chapter will demonstrate, it is indeed such characteristics of the surgical profession—and of orthopaedic surgery in particular—that necessitate special ethical consideration.
There are four basic principles of ethics that have prevailed in modern medicine and surgery.1 They are listed and briefly defined below:
1. Justice: Prioritizes distributive fairness to produce societal good and emphasizes equal patient rights as well as adequate patient access at a population level.
2. Autonomy: Responsibility of the surgeon to elevate the patient’s right to make well-informed decisions for themselves consistent with their own values.
3. Beneficence: Physician obligation to promote the greatest good for the patient.
4. Nonmaleficence: Often equated with primum non nocere: “first do no harm.” Physician responsibility to inflict the least harm in working toward a positive clinical outcome.
THE SURGEON-PATIENT RELATIONSHIP
SHARED DECISION-MAKING
The foundation of orthopaedic surgical ethics begins and ends with the therapeutic relationship between the surgeon and the patient. In this regard, the ethical doctrines that govern orthopaedic surgeons are quite similar to those applicable in general medical ethics. General principles such as the necessity to disclose conflicts of interest to patients, placing the patient’s benefit above other considerations in treatment, and abiding by the principle of nonmaleficence remain steadfast components of the orthopaedic surgeon’s ethical framework. Romantic relationships with patients are regarded as unethical due to the asymmetric power relationship between a physician and their patient and should be avoided. As in other medical fields, confidentiality is an integral component of the relationship between a patient and their orthopaedic surgeon. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established clear guidelines and legal stipulations to protect confidentiality.8
Orthopaedic surgeons are tasked with using surgical means to correct physical form, facilitate function, and improve mobility. Furthermore, orthopaedic procedures are undertaken to elevate a patient’s quality of life but require rehabilitation on the part of the patient to ensure a positive outcome. The ultimate success or failure of many orthopaedic surgical interventions is contingent upon a patient’s willingness and ability to engage in rehabilitation properly after surgery.
This aspect of orthopaedic surgery requires added effort on the part of the surgeon to properly explicate the risks and benefits of proposed treatment and describe the expected patient effort in the postoperative period. This understanding ought to be part and parcel of informed consent, an ethical principle requiring patients comprehend the risks, benefits, and alternative options to treatment proposed before moving forward with given procedure.9 A patient may indeed have debilitating and painful knee osteoarthritis, but if they also have serious medical comorbidities that confer unreasonable surgical risk or portend a low likelihood of being able to recover after surgery, a total knee arthroplasty may not be an ethically sound course of action. The orthopaedic surgeon must be able to accurately judge when surgery is not the best option and also help a patient understand why this is the case. Ensuring a commitment to compliance and availability for follow-up are core elements in the initial consent as well.
This overall emphasis on autonomy and informed consent has led to an increased prevalence of the “shared decision-making” model of patient care in medicine.10 The elective nature of many orthopaedic procedures dictates that this approach has considerable merit to ensure patient satisfaction with the decision to undergo surgery or elect instead for nonsurgical management. Regional variation in surgical procedure volume for total knee and total hip arthroplasty is significant, with some areas seeing up to a tenfold difference in rates of surgical procedure from demographically similar regions.11,12 These figures suggest shared decision-making model may not be sufficiently utilized by orthopaedic surgeons.
Shared decision-making (SDM) has been defined as “an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve informed preferences.”13 Over 80 randomized trials have demonstrated patients using SDM had increased involvement in treatment decisions, more confidence in decisions, and a tendency to elect for more treatment options.14 One study indicated that introducing standardized patient decision aid tools consistent with SDM was associated with 26% fewer hip replacement surgeries and 38% fewer total knee replacements during the same period of time.15
Shared decision-making is a linear fluid process. It consists of “choice talk” explicitly making the patient aware of agency in the decision-making process, “option talk” narrowing discussion to available treatments for the patient to choose from, and moving to “decision talk” in which the patient and physician elect the most suitable course of action (Figure 1). This method of engagement with patients is useful for orthopaedic surgeons and should be used to encourage fulfillment of the principles of informed consent and patient autonomy.
DISCLOSURE OF SURGICAL ERRORS
Imagine a scenario in which during surgical fixation of a proximal humerus fracture an orthopaedic surgeon injures the axillary nerve resulting in a deltoid palsy. The patient will undoubtedly notice the new weakness and inquire about the deficit. The ethical surgeon must disclose the complication and would be hard-pressed not to do so in the face of the obvious sequelae. However, consider an alternate scenario in which the orthopaedic surgeon inadvertently injures a portion of the axillary artery during the same surgery. Though more bleeding than expected occurs, a vascular repair is completed without further complication and there are no significant sequelae from the error. Is disclosure required in both circumstances?
A “medical error” is defined by the Institute of Medicine as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.16 The process for disclosure of a surgical error begins before the surgery itself, during the process of informed consent. A surgeon must make their patient aware of “all” risks of the procedure explicitly. The temptation to make promises of a complication-free procedure or painless postoperative course to temporarily comfort an anxious patient should be avoided. Furthermore, when errors that result from a series of mistakes or systemic missteps happen, disclosure for all members of the healthcare team contributing to the harm is the most ethical course of action. Disclosure demonstrates respect for persons and supports patient autonomy by allowing patients to make educated decisions regarding further care after a medical error.17
There are multiple barriers that may impede honest and transparent disclosure of surgical errors. Fear of instigating grounds for litigation can complicate a surgeon’s effort to discuss an error with a patient. The malpractice environment in the United States has created difficulties for surgeons wishing to apologize to patients. The relationship between errors and medical malpractice claims is mismatched and “lopsided” leading to a particular vulnerability for surgeons in the face of otherwise high-quality care. Fear of litigation, professional loyalty, hierarchy, and fear of retaliation have also been reported as strong deterrent to surgeons disclosing problems in care to patients. Future legislative and policy solutions to accommodate the ethical and honest disclosure of medical and surgical errors may include explicit allowances for apologies that are not admissible in court, similar to legislation passed in California and other states.18
Ultimately, disclosure of errors is an emotionally challenging and logistically onerous component of a surgical career. However, it is also a necessary skill for an orthopaedic surgeon to develop and practice. In one study, a communication and resolution program in which a structured response to adverse events was formulated yielded a decreased trend of new claims and legal defense costs, but no changes in other outcomes.19 This strategy consisted of the physician and healthcare institution communicating with patients about adverse events; investigating and explaining what happened; and, when appropriate, allowing for an apology, taking responsibility, and proactively offering compensation. Another team-based model includes a “disclosure timeout” in which all involved healthcare workers collaboratively plan for communication with the patient. This occurs during a brief period set aside in the operating room after an adverse event. This permits for discrepancies about the event to be reconciled, facilitated accountability, and encourages system-wide corrective change.20 The recommended time for communication with the patient or family is after the timeout as well as consultation with risk management or a disclosure coach. Such strategies uphold the principles of informed consent, professionalism, as well as nonmaleficence, given that undisclosed errors may lead to future individual and systemic dangers for patients.
CONSIDERATIONS OF COST AND JUSTICE
Cost considerations have not traditionally been an integral component of the patient-physician relationship. However, in the face of increasingly burdensome healthcare costs in the United States, a surgeon should consider the financial implications of their treatment for their individual patients as well as society at large. There is potential for conflict between the principles of beneficence for the individual patient and justice for the sake of society. Judgments are often made in the healthcare system that sacrifice marginal benefit for an individual patient to benefit the broader community. It may benefit a patient to spend a full uninterrupted hour with their orthopaedic surgeon in the clinic; however, this hinders the surgeon’s ability to see more patients and provide access to care for a larger group of people.
According to the American College of Physicians Ethics Manual, “Physicians have a responsibility to practice effective and efficient healthcare and to use healthcare resources responsibly.”21 This is also consistent with John Stuart Mills’22 theory of utilitarianism—espousing actions that should promote the greatest happiness for the overall benefits of society. There are many individual choices surgeons make daily that have implications for the cost burden healthcare expenditures.
Judicious use of radiologic studies is one manner of addressing costs in the field of orthopaedic surgery. Patients may demand expensive and unnecessary tests. Suppose a patient presents to the clinic with an obvious simple contusion or hematoma to the elbow, no fracture on radiographs, and no signs of instability or deformity on examination. They adamantly request an MRI study. The orthopaedic surgeon will use his clinical judgment to discern that an MRI will not yield any clinically significant findings or change in treatment, but it can be challenging to appease a demanding patient fixated on a particular test or treatment. It is the responsibility of the surgeon to explain the lack of benefit for such procedures and forge a therapeutic alliance with the patient to best move forward. Close follow-up and reevaluation at a time in the near future should be offered as an alternative to redundant imaging or unnecessary invasive procedures.