Executive Summary

Despite patients’ growing expectations that medical errors and unexpected outcomes will be disclosed openly, the practice is infrequent. To promote disclosure, bioethics experts suggest the following:

• Provide guidance as to what level of detail should be shared.

• Encourage the development of policies and procedures for disclosure.

• Use simulation to train clinicians and administrators in the process of disclosure.

 

Patients increasingly expect that medical errors and unexpected outcomes will be disclosed openly; the reality is that this practice is infrequent. “Only a very small percentage of adverse events from health care involving a significant degree of patient harm have documented evidence for institutional disclosures,” says Edward Dunn, MD, a palliative medicine physician and director of the Integrated Ethics Program at Lexington (KY) VA Medical Center.

The ethical obligation to disclose medical errors is rooted in the professional virtues of veracity and fidelity, according to Andrew G. Shuman, MD, chair of the Adult Ethics Committee and Consultation Service at University of Michigan Health System in Ann Arbor, which has pioneered a strategy of proactive disclosure of medical errors.1,2 “This approach is rooted in the underlying professional obligations of clinicians and health systems, but also in the belief that patient satisfaction and trust will be maximized in an environment that fosters open, honest disclosure,” says Shuman.

To deliberately withhold clinically relevant information or deceive individuals violates the trust inherent to the doctor-patient relationship, says Shuman — “as such, in broad strokes, honest, open disclosure of medical errors is obligatory.”

Just as patients have a right to informed consent prior to medical or surgical intervention, “they also have a right to informed understanding of a medical mistake,” says Margaret R. McLean, PhD, associate director of Markkula Center for Applied Ethics at Santa Clara (CA) University. It is well-recognized that medical errors come at a significant cost, both in terms of harm to patients and financial loss. “But there is a less obvious ethical cost as well, in the loss of patient trust in medical professionals and the health care system,” McLean says.

Dunn says it’s important to focus on poor outcomes and adverse events resulting in harm to patients. “This really isn’t about errors; humans make errors frequently, which is not particularly noteworthy,” he explains. “What matters is whether or not the patient was harmed, regardless of a mistake being made or not.”

For the majority of adverse events, it is unclear whether a medical mistake was actually made, Dunn explains. “In disclosing adverse events, we are meeting our ethical and professional responsibility to honor patient autonomy, and tell the truth about what happened during the course of their medical or surgical care,” he says.

The threshold for what constitutes an error, and what level of detail should be shared, will vary based upon the clinical circumstance and the involved protagonists, according to Shuman. “As with all clinical situations, judgment is necessary,” he says. For instance, intraoperative blood loss need not be disclosed down to the cubic centimeter. “In situations that arise within this gray zone, or in which clinicians request guidance, the involvement of patient representatives, institutional administrators, and ethics consultants can be invaluable,” says Shuman.

The content of a disclosure meeting with a patient and/or family member should never be primarily about using the “right” words, says Dunn. “That is where most physicians become stymied and fearful of making a wrong statement,” he says. “This is about open, honest, and timely disclosure in a compassionate and empathic way.”3

University of Michigan’s ethics consultants can help the involved parties in determining the appropriate next steps, ensuring that mutual trust and respect are maintained in the face of a perceived negative outcome. “This role is distinct from hospital administration, risk management, and legal counsel, who may continue to be involved,” says Shuman.

Bioethicists should be involved in “sustaining an ethical climate” through developing policies that encourage the disclosure of medical error, says McLean. “Bioethicists should assist in the creating of ethically defensible policies and procedures for error disclosure,” she says. McLean recommends that bioethicists do the following:

Encourage the development of a transparent disclosure process.

“Bioethicists can insist that, to the extent possible, both organizational and clinical decision-making and action be transparent to both professionals and patients,” says McLean.

Help to build clear institutional support for disclosure.

For instance, bioethicists can involve administrators in the creation and review of medical disclosure policies and protocols and make institutional support explicit in such policies. “Institutions should provide training in error disclosure and make certain that their policies support professionals in disclosing errors to patients,” says McLean.

Address professionals’ concerns.

Physicians are often uncomfortable in disclosing errors to patients, and may wonder, “What do I say?,” “How do I say it?,” and, “Do I apologize?” Bioethicists can assist in developing guidelines delineating the basic content of disclosure, and participate in disclosure training. “Bioethicists can also remind professionals of the duty to tell the truth, thereby providing an ethical impetus for disclosure,” says McLean.

Dunn was the principal investigator on a VA-funded grant to develop and implement a Disclosure Training Program workshop. “We have done 19 two-day interactive workshops over the past three years, using simulation methods to facilitate disclosure meetings conducted by workshop participants,” he says. Professional actors play the roles of patients and family members. “After each simulation, the facilitator leads a debriefing with participants to reflect on their performance and reinforce communication techniques grounded in compassion, empathy and improvisational communication skills,” says Dunn.4

The workshops train clinicians to disclose adverse events largely through experiential learning. “All of that was informed by our operational experience doing institutional disclosures in Lexington,” says Dunn. The team uses clinical scenarios in various clinical settings, including outpatient clinics, the emergency department, mental health, and both medical and surgical hospital cases.

“Regardless of whether a tort claim is made, it’s important for patients to understand what happened to them,” says Dunn. “The clinician has a professional and ethical responsibility to disclose what happens to his or her patient 100% of the time.” In some cases involving a significant level of unanticipated patient harm, the institution also has a duty to disclose. “The clinician cannot speak for the institution; only its leadership can meet this responsibility,” says Dunn.

During the workshops, audience response technology is used to elicit feedback from attendees to administer pre- and post-tests of knowledge, and for program evaluation by participants. Through the first 14 workshops, approximately 400 participants demonstrated a 30% improvement in a test of knowledge and submitted a 95% overall favorability rating of the workshops on several measures.4

Even with effective processes in place, clinicians find it difficult to disclose mistakes. “Our litigious society really gets in the way of that,” says Dunn. “[As a provider,] you are also worried about reputational loss in the community, and the story getting out in the news.”

Ethicists can provide much-needed support to clinicians, who often experience a crisis of confidence after a poor patient outcome, with or without evidence for a medical mistake. “It’s devastating personally when you get a suboptimal outcome. There is often nowhere, no formal place, for a clinician to go for help,” says Dunn.

Dunn recommends that ethicists take a very proactive approach to helping clinicians after a medical mistake. “This is not something you can do from a conference room or committee,” he says. “You have to be available to quickly spring into action to aid the person in need of help.”

After an adverse event occurred in the operating room which resulted in a patient’s death, a physician involved in the case was personally devastated and unable to return to work for several months. “We met with him immediately after the incident and for several months thereafter,” says Dunn. “We affirmed him as a physician and supported his emotional needs as a human being.”

The physician subsequently received help from a mental health professional. “But there is nothing more important for a clinician than to receive a timely call from a peer after his patient suffers an adverse event,” says Dunn.

References

  1. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med 2010; 153(4):213-221.
  2. Mello MM, Boothman RC, McDonald T, et al. Communication-and-resolution programs: The challenges and lessons learned from six early adopters. Health Aff 2014; 33(1):20-29.
  3. Eaves-Leanos A. and Dunn E. Open disclosure of adverse events — Transparency and safety in healthcare. Surgical Clinics of North America 2012; 92(1);163-177.
  4. Dunn E, McKinney K, Martin M. Empathic disclosure of adverse events to patients: VHA simulation-based disclosure training program. Federal Practitioner 2014; 31(5):18-21.

SOURCES

  • Edward J. Dunn, MD, ScD, Palliative Medicine Physician/Director of the Integrated Ethics Program, Lexington (KY) VA Medical Center. Phone: (502) 415-2486. Email: edwdun@gmail.com.
  • Margaret R. McLean, PhD, Associate Director, Markkula Center for Applied Ethics, Santa Clara (CA) University. Email: mmclean@scu.edu.
  • Andrew G. Shuman, MD, Chair, Adult Ethics Committee and Consultation Service, University of Michigan Health System, Ann Arbor. Phone: (734) 232-0120. Email: shumana@med.umich.edu.