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Confronting Medical Errors in Oncology and Disclosing Them to Cancer Patients

European School of Oncology, Milan, Italy, and Departments of Medicine and Oncology, New York University School of Medicine, New York, NY

Michael Rowe

Department of Psychiatry, Yale University School of Medicine, New Haven, CT

Thomas H. Gallagher

Departments of Medicine and Medical History and Ethics, University of Washington School of Medicine, Seattle, WA

Medical errors are common,^1-3 and physicians face increasing pressure to fully disclose unanticipated outcomes and medical errors to patients.^4,5 From an ethical perspective, disclosure is the right thing to do and is wholly consistent with the fiduciary model of the asymmetric physician-patient relationship, in which the patient, vulnerable due to illness, places trust in the expertise and person of the physician.^6-8 When medical errors occur, the physician-patient relationship is fundamentally tested, and when physicians fail to offer an apology or explanation, patients often perceive a violation not only of their safety, but also of their trust.^9-11

The issue of which events merit disclosure is still under debate. The most widely disseminated disclosure standard, from the Joint Commission on Accreditation of Healthcare Organizations, requires that patients be informed about all outcomes of care including "unanticipated outcomes," as defined in the current terminology (Table 1). ^1,12

Although most physicians agree on the importance of telling the truth to their patients when a harmful error has occurred, recent studies reveal a gap between patients’ expectations that errors will be disclosed to them and actual clinical practice.^9,16-18 Moreover, many unanswered questions remain about how to disclose errors and how disclosure affects liability, patient satisfaction, and other outcomes.¹⁹ In general, oncologists are accustomed to communicating bad news about prognosis and risks in the context of the physical and psychological suffering of cancer patients. This experience makes them natural leaders in the medical profession's efforts to improve the disclosure of harmful medical errors to patients.

This article reviews recent professional approaches to patient safety and the disclosure of medical errors, and addresses some critical aspects of patients’ and physicians’ responses to harmful errors in oncology. We explore different dimensions of disclosure and suggest possible future research, policy, and clinical interventions.

BACKGROUND

The emerging patient safety movement has sought to change the way the medical profession thinks about the causes of and appropriate responses to medical errors.^13,20,21 Its proponents have advocated for a shift from the historical culture of blame and shame—one in which health care workers keep information about their errors to themselves, thereby losing opportunities to learn from them—to a culture of transparency that recognizes the role of systems breakdowns in health care injury and encourages health care workers to be more open with each other and to disclose errors with patients.^22-26

Many states have adopted legislation to promote disclosure by providing legal protection for physician expressions of regret after errors. National organizations such as Sorry Works! have been established in the United States to encourage disclosure and apology.²⁷ Support for disclosure is also building in other countries. In the United Kingdom, the National Patient Safety Agency has launched the Being Open policy, which requires that physicians give patients a full explanation and apology after harmful errors, and Australia has developed an Open Disclosure program.^28,29

Disclosure affects not only patients, but also physicians, who experience considerable emotional distress after errors.^30-32 Coping with emotional distress can be especially challenging for oncologists, who experience high rates of burnout syndromes because they care for sick patients over time, with mortality always in the forefront.^33,34 Such distress may lead oncologists to inadvertently minimize the importance of an error that has occurred in a patient with advanced cancer, or experience a heightened sense of personal responsibility for increasing the suffering of their patients.^31,35 Support resources to help health care professionals address these needs are often lacking, and physicians may be unaware of their availability or may hesitate to use them.

DISCLOSURE GAP

Despite increasing support for disclosure, most harmful medical errors are still not being disclosed. In a recent national survey, only 30% of US physicians who reported experiencing harmful errors in their own health care said the error was disclosed to them.¹⁶ New research also suggests that physicians may be less likely to disclose errors that patients would otherwise be unaware of in the absence of disclosure.¹⁷ Physicians are uncertain about the impact of disclosure on key outcomes, especially the likelihood of litigation. Although risk managers traditionally have counseled physicians that full disclosure of harmful errors is undesirable because it increases legal liability, evidence is emerging that disclosure may actually reduce the likelihood of lawsuits and positively influence the outcome of lawsuits already filed.^36-41 In response, many health care institutions and malpractice insurers in the United States have adopted full disclosure policies and instituted early resolution programs.^23,42 Most studies of the effect of disclosure on malpractice lawsuits, however, involve patients’ or family members’ retrospective assessments that they would have been less likely to sue if the physician provided full disclosure.^39,41 Some legal scholars argue that disclosure could alert patients or families that an error had caused injury, thereby precipitating a lawsuit.⁴³

DISCLOSURE OF MEDICAL ERRORS IN ONCOLOGY

Most current disclosure guidelines deal with clear-cut harmful errors. However, in oncology practice multiple active and latent errors may occur at individual and system levels, making it difficult to apply existing disclosure guidelines.⁴ Oncologists thus face several decisions about which events to disclose, the goals of disclosure, the extent of disclosure, and the patient's understanding and experience of medical error and adverse events. In addition, oncologists must confront special challenges regarding errors in clinical research.

Decisions About Which Events to Disclose
Decisions about whether and how to disclose oncology errors are inextricably linked to the clinical context in which these errors occur. The relationship between cancer patients and their oncologists can be especially complex and fragile because of the patient's physical, physiological, and existential suffering, and the fact that oncologists work with patients under conditions of high uncertainty.⁴⁴ As a result, disclosure decisions in oncology can be extremely challenging.

Consider the case of a lung cancer patient whose life expectancy is less than 2 weeks. Should the oncologist, on realizing that an incorrect dose of antibiotic had been administered for the last 10 days, likely contributing to the patient's persistent fever, inform the patient and his wife of such an error? Some might argue that disclosure in this setting would accomplish little and could actually hurt both patient and spouse and lead to the bitter end of a close patient-physician relationship, perhaps culminating in a lawsuit. Yet even in difficult cases such as this one, oncologists should always consider the ethical value of full disclosure and avoid the temptation to rationalize partial or nondisclosure. Should the oncologist choose nondisclosure and the patient or his family discover the error through other means, the negative impact on the physician-patient relationship would likely be much worse than had the error been disclosed skillfully and empathically and a sincere apology offered. Furthermore, focusing during disclosure on the lessons that have been learned by health care professionals can help bring positive meaning to the affected patients, who will apprecieate that the likelihood of similar events in the future will be reduced also for other patients.

Goals of Disclosure
Many reasons, some conflicting, have been brought forward to support full disclosure of harmful errors to patients. Research in Western countries has demonstrated that patients want to be told about harmful medical errors, even when the harm is minor.^9,39,41,45 Bioethicists endorse fully informing patients about harmful errors because disclosure demonstrates respect for patients’ autonomy, promotes patient-informed decision making, upholds physicians’ professional obligation to tell the truth, and may serve the goals of justice and fairness by enhancing patients’ access to compensation for medical harms.^46-48 Disclosure also fosters healing and forgiveness, and reinforces trust between cancer patients and their oncologists.^31,35,49

Ethical arguments for disclosure, however, do not provide guidance about the specific information that physicians should disclose to patients after a medical error. Truth-telling in general requires that physicians encourage patients’ autonomy and active participation in their own care by giving them accurate information while not overwhelming them with medical details.⁵⁰ In addition, many cultures do not share the Western emphasis on patient autonomy and the imperative of providing information that will promote informed decision making.^51,52 In the above vignette, the decision to disclose an error at the end of life would be complicated further if the patient belonged to a culture or generation that eschews truth-telling to cancer patients. Enhancing disclosure in multicultural settings will require that oncologists deepen their knowledge of cross-cultural variables related to patients’ understanding of their autonomy; expectations of patient-physician relationships, needs, and preferences regarding medical information; and family members’ involvement in decision making.^53,54

The Extent of Disclosure
Although current Joint Commission on Accreditation of Healthcare Organizations standards are silent regarding the extent of disclosure, the Harvard Full Disclosure Working Group suggests that patients be told what happened, how it happened, why it happened, and that disclosure should include taking responsibility for the event.⁵⁵ When the adverse event was due to an error, the working group recommends an apology and an explanation of what will be done to prevent future events. In addition, the National Quality Forum recently has adopted a new Safe Practice on disclosure that also provides detailed recommendations for how disclosure should take place.⁵⁶ Even within these more expansive guidelines, however, oncologists may still wonder how much information they should give to their patients, how to frame the discussion of the error—including whether it was the result of poor judgment or a technical lapse—and other elements of nuance, fact, and detail that may shape the discussion and patients’ perception of the disclosure.

Oncologists must also consider the medical uncertainty that still surrounds cancer prognosis and treatment efficacy, which may extend to whether a medical error occurred. In light of their experience dealing with patient-physician communication in complex, uncertain, and life-threatening clinical situations, oncologists can and should bring specific contributions to developing guidelines for disclosure of medical errors to patients.

Patients’ Understanding of Medical Errors
Physicians’ concerns about the impact of disclosure on them personally should not overshadow their concern about how these events affect patients and their loved ones.^57,58 Patients define medical errors more broadly than physicians (eg, sometimes viewing physicians’ failure to communicate effectively with them as medical error).^9,15 In addition, physicians’ or institutions’ arrogance has been described by patients as contributing to their perception of medical errors and to the challenge of repairing a breach in trust.^59,60 In addition, physicians must not lose sight of the stigma of debilitating conditions that harmful errors may cause to patients. Lack of physician empathy and honesty in the aftermath of harmful medical error can exacerbate the suffering of the patient. Finally, hindsight bias may lead to a cancer patient's perception of medical error. A breast cancer patient who learns that a lesion was visible on an early x-ray may conclude that the radiologists erred in reading the film, although this may not be the case. Oncologists must thus be prepared to explain the distinction between prospective and retrospective diagnosis in relation to medical error.

Role of Health Care Teams
Although an error may be traced to an individual practitioner, a team, or a system of care, most current clinical literature describes the disclosure process as an individual physician-patient conversation, for which many institutions provide basic background training augmented with just-in-time coaching before an actual disclosure.⁶¹ In clinical practice, however, medical errors often take place in the context of interdisciplinary care, and some institutions are shifting the responsibility for disclosure away from the health care team involved in the error to critical event response teams that can analyze the event quickly and conduct the disclosure.

When patients experience a harmful error, oncologists must be prepared to accept individual responsibility when appropriate.⁶² In addition, the team must seek consensus about what happened, how to disclose the error, and who should disclose what to the patient. Such interprofessional discussions can be complex, however, given the power differentials between oncologists and nonphysician team members, the natural tendency to affix individual blame for errors, and the pressures on young team members who may feel unsafe in discussing their own mistakes or pointing out those of senior physicians.⁶¹ In addition, the team must address both the degree to which consensus is to be sought among all team members before the attending physician, presumably, makes a final decision, and consider the attending physician's role and responsibility in the case of disclosing nursing errors.

Adverse Events and Errors in Clinical Research
Clinical trials in oncology use treatment protocols that have undergone careful expert review and institutional approval, and yet they are not immune from the same types of errors that occur in standard care. Moreover, adverse events may be more likely with experimental treatments, and it may be difficult for oncologists to distinguish between adverse events and errors.

As in clinical care, transparent communication about adverse events and errors during clinical trials may be inhibited by physicians' fear of lawsuits, embarrassment and shame, inadequate communication skills, or lack of consistency in categorizing and ranking adverse events and errors.^63,64 In addition, clinical trials pose additional unique barriers to open disclosure. One such barrier is whether investigators genuinely anticipated the type and severity of the adverse event that occurred and thus may have or should have alerted the patient in advance. Another barrier is whether investigators can distinguish among the effects of the medication administered as part of the clinical trial, the care the patient was receiving outside the trial, and the patient's underlying disease. A third barrier is whether investigators can determine that the adverse event was due to an error or protocol violation. When they cannot answer these questions definitively, investigators must decide whether to share their uncertainty with the patient.⁴³ Institutional review boards require that investigators report adverse events and protocol violations,⁶⁵ and some institutions have formal policies regarding how these events should be disclosed to research participants. An enhancement to current practice would be to include on adverse event reporting forms information about whether and how the event was disclosed to the research participant. Collecting such information would prompt investigators to consider carefully what to say to research participants when an adverse event or error occurs, and would provide important baseline data about how such disclosure is currently taking place.

In conclusion, physicians, ethicists, and lawyers offer different perspectives on disclosure of errors to patients. Evidence about the comparative effectiveness of specific disclosure strategies is lacking, however, as is a full understanding of how disclosure affects legal liability, patient trust, satisfaction, choice of physicians or health care institutions, and quality of care. Along with proper assessment of the epidemiology and patterns of errors in clinical oncology, several research, policy, and clinical activities can lead to greater clarity and effectiveness in communicating with cancer patients (Table 2).

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The authors indicated no potential conflicts of interest.

AUTHOR CONTRIBUTIONS

Conception and design: Antonella Surbone, Michael Rowe, Thomas H. Gallagher

Collection and assembly of data: Antonella Surbone, Michael Rowe, Thomas H. Gallagher

Data analysis and interpretation: Antonella Surbone, Michael Rowe, Thomas H. Gallagher

Manuscript writing: Antonella Surbone, Michael Rowe, Thomas H. Gallagher

Final approval of manuscript: Antonella Surbone, Michael Rowe, Thomas H. Gallagher

ACKNOWLEDGMENTS

Thomas H. Gallagher, MD, is supported by career development awards from the Agency for Healthcare Research and Quality and the Greenwall Foundation.

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This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Surbone, A. Articles by Gallagher, T. H. Search for Related Content PubMed PubMed Citation Articles by Surbone, A. Articles by Gallagher, T. H. Social Bookmarking                            What's this?