Disclosure of Adverse Outcomes Brings Ethical Challenges for Otolaryngologists

Discussion: It is not an easy matter for a surgeon to inform the patient and family about the occurrence of a surgical complication or mishap. In the mid-20th century, the so-called days of “medical paternalism,” such occurrences were often considered “just one of those things that can happen and not the fault of the surgeon.” Since then, perhaps due to both a rise in the incidence of medical liability lawsuits and a better understanding of patient autonomy and informed consent, surgeons have become increasingly reluctant to take responsibility for surgical complications and mishaps, often at the advice of a personal attorney or the hospital system’s counsel.

A sea change in philosophy has occurred over the past several decades, however, as the philosophy of “compassionate apology” has gained philosophical and statutory traction. In other words, an apology from the surgeon can be considered an ethical and professional responsibility.

The spectrum of surgical complications is broad, ranging from anticipated or potential complication through surgical mishap, regardless of a surgeon’s technical conduct, to surgical mistake caused by an error in judgment or technique by the surgeon. There are also other reasons for complications during surgery, including anesthetic complications, adverse medical events, and a previously undetected physical or anatomical anomaly. This wide range of complications may or may not be the fault of the surgeon, but it falls to him or her to bring the situation to the family initially, and then to the patient, for presentation and discussion.

Such discussions, usually held in a semi-private room in the surgery family waiting area, are fraught with potential difficulties, owing to the anxiety of the family awaiting word of their loved one’s status, the physical/mental/emotional state of the surgeon who has just undergone a traumatic event in his or her career, and the necessity to repeat the discussion when the patient is awake sufficiently to understand what is being conveyed. Handling such a discussion appropriately—ethically, professionally, and compassionately—can be difficult for even the most experienced surgeon.

The surgeon could have several potential “scenarios” or explanations from which to choose in the disclosure of an adverse outcome or event to the family and/or patient: “the anatomy was distorted”; “the tumor was bigger/more involved/more destructive than we thought”; “the nerve wasn’t where it was supposed to be”; or, “during the course of the surgery, the facial nerve was separated.” While we do not know how many times these various explanations have been utilized, we do know there is much more scrutiny these days of what the surgeon does and says, and more interest in the issues of veracity and transparency in reporting adverse events that occur during surgery. With no time following surgery to meet with an attorney to discuss the best way to inform the family and patient, the surgeon must be appropriately trained in the proper ethical approach to disclosing adverse events during surgery.

Ethical and Professional Responsibilities

At least two main aspects should be considered in the approach to disclosing an adverse event: one, the obvious ethical responsibility for veracity, compassion, and understanding; and two, the impact of the manner and content of the disclosure and subsequent discussion on the issue of medical liability.

Concerning the first set of professional duties (deontology), the expectation is stated quite well by the American Medical Association Code of Ethics, Opinion 8.12:

It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care.¹

The professional expectation is for all physicians to be honest with patients in matters of complications—surgical complications in this scenario—or place the sacred trust of the patient-physician relationship at great risk. It is very hard to imagine a situation in which a surgeon would willingly deceive a patient regarding the reason for an adverse event during a surgical procedure. It should not be a valid consideration to lie to a patient.

The counter-argument to full and open disclosure of an adverse event, however, is the concern that such a disclosure, if an error in judgment or a technical mistake was the cause, would compromise a surgeon’s defense in a subsequent medical liability lawsuit. Reluctance by a surgeon to be completely forthcoming might result from the advice of a litigation attorney, or could be a natural reluctance to place oneself in malpractice jeopardy.

Thus, there exists a gap between the ethical and professional responsibilities of a surgeon to be completely honest and forthcoming with a patient regarding an adverse event during a surgical procedure and the potential for placing oneself at increased risk for a medical liability lawsuit.

Efforts have been underway for some time to address this gap by passing apology inadmissibility laws in many, if not most, states. A summary of state legislation regarding these “apology laws” can be obtained from the American Medical Association’s Advocacy Resource Center.² For instance, in the state of Colorado, the following type of apology is inadmissible in a court of law: “Statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.” It is understood that the main impetus behind the apology laws is to promote patient safety by preventing future adverse events through open communication and reporting of errors and other occurrences, discussion and analysis of the causes, and the promotion of professional and systemic improvements.

Increasingly, it appears that a policy of honesty and full disclosure for adverse events has the potential to reduce the medical liability risk for surgeons, in addition to facilitating the proper assistance for the patient who has suffered some negative consequence because of the complication. In some institutions, apology and disclosure are linked with a pathway for financial redress or the off-setting of current and future medical expenses. This model demonstrates both practical and ethical benefits for all parties.

In addition to the primary goal of patient safety, honest disclosure of adverse events and their cause to the patient and family is being viewed from the perspective of how the surgeon presents the information and what is important to the patient and family in the discussion. That is, how can the surgeon appreciate what impact or effect this disclosure has on these individuals, and what is it that they expect the surgeon to provide to them? For the most part, it is very important that the surgeon be sincere and honest in the admission, giving a heartfelt apology—whether it was the surgeon’s fault or an anticipated complication—and indicate what will be done to assist the patient in the recovery process, as well as how the surgeon will work to prevent such an occurrence with another patient in the future. In other words, in addition to the apology, there must also be some positive action that comes out of this unfortunate event.

It must be recognized that very few surgeons are comfortable with disclosing adverse events with the patient and family, let alone giving an apology for a complication or mishap in the operating room. Model approaches and simulated training for surgeons are being developed, based on the premise that apology and disclosure are difficult and must be done well if they are to have the best outcome for both the patient and the surgeon. It is important for the surgeon to understand that the apology/disclosure must be honest and open and conveyed sincerely in both verbal and nonverbal communication. This will be difficult for surgeons whose personalities (read “bedside manner”) are reserved and less than warm, but the capability can be improved through simulation and observation. This capability must also be modeled for physicians in training.

Balance

Considering this specific clinical scenario, a number of aspects bear thoughtful discussion. There is, of course, the issue of balancing patient safety with resident surgical education, which is a constant challenge for those in academic medicine and community preceptorships. In particular, keeping a watchful eye on otologic and facial nerve procedures can be difficult and is a skill that seems to improve with experience.

The timing of disclosure of the adverse event or complication to the family is dependent upon the surgeon’s judgment and the conditions of the surgical procedure. In this scenario, if the surgeon had obtained pre-operative consent for a reparative procedure on the facial nerve in the event of a complication, then it would be acceptable to proceed with the repair/grafting before any discussion with the family.

If, however, a surrogate consent was required for an additional procedure not covered in the original consent, the surgeon would be advised to pause the surgery for a short but honest disclosure to the family to obtain the necessary consent, then return to complete the procedures. Because the latter option can be an emotional one for the surgeon—who then has to return to the operating room to perform delicate nerve anastomoses—it seems it would be more effective to include such a possibility in the pre-operative informed consent.

In effect, the surgeon may be required to present multiple disclosures in the course of the peri-operative period—first family, then patient—and the discussions may need to be repeated in order to answer all of the questions and to discuss the surgeon’s plan to assist the patient in the recovery process. There may be additional discussions between the patient and family and the hospital or surgical center regarding the possibilities of financial redress without the need to proceed through a legal remedy.

A successful outcome from an adverse event, whether it is the surgeon’s direct mistake or not, will include the maintenance of a meaningful patient-physician relationship, the best outcome of a rehabilitation/recovery process, a responsiveness to the needs of the patient and family, the resolution of financial redress without a lawsuit, and a full evaluation/analysis of the adverse event to prevent or decrease the chance of future occurrence. In the broad spectrum of honest and open disclosure of an adverse event, the patient and family are the focus, and the surgeon is the facilitator for the best possible outcome.

Dr. Holt is a professor emeritus in the department of otolaryngology-head and neck surgery at the University of Texas Health Science Center in San Antonio.

References

1. American Medical Association. Code of Medical Ethics. Available at: www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.page. Accessed December 18, 2014.
2. American Medical Association. Advocacy Research Center. Available at: www.ama-assn.org/ama/pub/advocacy/state-advocacy-arc.page? Accessed Accessed December 19, 2014.