(Reaffirmed 2013, Replaces No. 380, October 2007)
ABSTRACT: Disclosure and discussion of adverse events in health care with the patient are morally and ethically necessary to achieve the optimal goal of respecting patient autonomy. Improving the disclosure process through education, policies, programmatic training, and accessible resources will enhance patient satisfaction, strengthen the physician–patient relationship, reduce physician stress, and, most importantly, promote safe and high-quality health care.
Adverse outcomes, preventable or otherwise, are an uncomfortable reality of medical care. Thus, health care providers and institutions should understand how to best disclose and discuss adverse events with patients and their families.
Disclosing information about adverse events likely has benefits for both parties through a strengthened physician–patient relationship and a promotion of trust. Studies show that in the event of an adverse outcome, patients expect and want timely and full disclosure of the event, an acknowledgement of responsibility, an understanding of what happened, expressions of sympathy, and a discussion of what is being done to prevent recurrence (1, 2). Surveys have shown that patients are more likely to sue if they perceive that an honest disclosure of the event was absent (3, 4). In studies of patients who sued their health care providers for adverse perinatal events, 43% were driven by a suspicion of a cover-up or by the desire for revenge (5). Research demonstrates that disclosure of adverse events is associated with higher ratings of quality by patients, an improved rate of recovery, a decrease in the number of malpractice suits, and a decrease in the average settlement amount (6, 7). Additionally, disclosure of adverse events can be important for both the patient’s and the health care team’s healing process (8).
The call for health care organizations to develop processes for full disclosure is broad-based. Patient advocacy groups, patient safety experts, ethicists, policy makers, accrediting organizations, and physician groups all advocate the adoption of policies related to the disclosure and discussion of adverse events. The Institute of Medicine proposes a multifaceted approach toward reducing and managing adverse events, including the establishment of a national focus on patient safety, the creation of a mandatory reporting system, raising standards and expectations for safety improvements at the national level, and creating safety systems in health care organizations (9).
The Joint Commission requires that accredited hospitals inform patients of adverse events. According to The Joint Commission Standard RI.01.02.01, “the licensed independent practitioner responsible for managing the patient’s care, treatment, and services, or his or her designee, informs the patient about unanticipated outcomes of care, treatment, and services” (10). A similar statement is found in the ethics code of the American Medical Association, which states that in cases in which “a patient suffers significant medical complications that may have resulted from a physician’s mistake . . . the physician is ethically required to inform the patient of all the facts neces-sary to ensure understanding of what has occurred” (11).
In 2011, the Institute for Healthcare Improvement published a second edition of its white paper that provides an overall approach and tools designed to support processes for managing serious clinical adverse events (12). The American College of Obstetricians and Gynecologists supports these efforts and seeks to assist members in understanding the value of disclosure and discussion in the face of preventable and nonpreventable adverse events and to provide guidance for such conversations.
Barriers to full disclosure are many and include fear of retribution for reporting an adverse event, lack of training, a culture of blame, and fear of lawsuits (13–15). To reduce these concerns, it is recommended that health care facilities establish a nonpunitive, blame-free culture that encourages staff to report adverse events and near misses (close calls) without fear of retaliation. Removing blame, however, does not eliminate individual responsibility. Promoting a just culture enables frontline personnel to feel comfortable disclosing errors while maintaining professional accountability. A just culture recognizes that competent professionals make mistakes and acknowledges that even competent professionals may develop unhealthy norms, but has zero tolerance for reckless behavior (16).
A number of health care organizations, insurance carriers, and states have developed programs to educate physicians about disclosure. One example is the consensus statement of the Harvard Hospitals, When Things Go Wrong: Responding to Adverse Events (17). These programs can provide valuable guidance and education about the specifics of disclosure and apology. COPIC, a professional liability insurance carrier for academic and community physicians in Colorado, provides its physicians with a training program and ongoing support in error disclosure under the “3Rs Program,” which stands for recognize, respond, and resolve unanticipated medical events (18).
In addition to addressing points from this brief overview, physicians may wish to refer to other resources before meeting with a patient and her family (18, 19) (Box 1). To frame the process of a timely and accurate disclosure, understanding and remembering who, what, when, where, and how is helpful (6):
Who—The attending physician should lead the discussion. If the physician cannot be present, it is preferable to have a senior member of the health care team lead the discussion. The circumstances of the adverse event will often dictate what other members of the health care team must also be present. Whenever possible, at least two members of the health care team should be involved in any discussion of an adverse event with the patient and her family.
What—Only factual information must be communicated to the patient. Patients must be reassured that as additional, reliable information is obtained, they will be notified promptly.
When—Even if all details of the incident are not known, disclosure must be timely. Disclosure should occur as soon as reasonably possible, while emphasizing to patients that it is an ongoing process of communication.
Where—Disclosure should occur in a quiet and confidential setting that will be most comfortable to the patient.
How—Patient dignity must always be respected. A disclosure conversation should include empathy for an acknowledgment of what patients and their families have experienced.
Box 1. Discussions With Patients on Adverse Events
These general guidelines regarding disclosure conversations with a patient and/or her family may be helpful:
- If possible, before the disclosure, the facts of the error should be gathered and investigated so that only the most accurate information can be shared with the patient.
- Disclosure, especially if the event is serious, should be done as soon as possible. If all the facts are not yet known, promise to return when the facts are known.
- Confidentiality must be preserved. The meeting with the patient should take place in a private setting. Determine whether a support person or guardian should be present with the patient during the disclosure.
- The disclosure itself should be done by the treating physician or someone with whom the patient has developed a relationship and trust who can begin the conversation. Depending on the facility’s policy, the risk manager or facility’s attorney, the nurse manager, and others may be present during the disclosure.
- The focus should be on the patient’s condition, concerns, and treatment plan and the patient should be told that her treatment and care are the utmost concern.
- Try to convey the information in terms that are understandable to the patient and that minimize patient stress. Explain the known facts regarding what happened; it may not be possible to explain why it
happened. Let the family and patient know what will be done to investigate the cause of the adverse event and to prevent the error from occurring again, and work with the patient to develop a treatment plan to remedy or mitigate the effects of any injury resulting from the error.
- Make sure to express appropriate regret for the error and concern for the patient and her family.
Reproduced with the permission of Wolters Kluwer Health. Pelt JL, Faldmo LP. Physician error and disclosure. Clin Obstet Gynecol 2008;51:700–8.
It is important to understand the difference between expressions of sympathy (acknowledgement of suffering) and apology (accountability for suffering). Expressions of sympathy are always appropriate. The appropriateness of an apology, however, will vary from case to case. When considering whether an apology is appropriate, the physician should seek advice from the hospital’s risk manager and the physician’s liability carrier. Among other matters, the issue of appropriateness of recording the conversation by the patient or her family can be discussed with these entities. It is also important to be knowledgeable about the state’s laws on apology and disclosure because these laws vary and may have an effect on the way in which the disclosure is conducted.
Health care institutions should have written policies that address the management of adverse events. The Institute for Healthcare Improvement’s white paper is an excellent resource for developing or improving these policies. It contains the information necessary to form a crisis management plan, establish a crisis management team, and organize the internal and external communication needed for success (12). Once policies are developed, health care organizations should work with health care providers to assess the need for additional resources and training such as disclosure coaching, mediation, and emotional support for health care workers involved in harmful medical errors (14, 20). Individual physicians and physician practice groups may contact their local hospitals, liability carriers, specialty organizations, or medical societies for disclosure assistance training and resources available to them. Anyone involved in disclosure should be instructed not to make promises they cannot guarantee. For example, a patient should not be told that she will not incur expenses, only to later receive a bill. Rather, she should be advised that the hospital finance department or the physician office will work with her to address these charges.
Several organizations have reported on the success of their disclosure programs. One of the oldest programs advocating full disclosure of medical errors is the Veterans Affairs Medical Center in Lexington, Kentucky. In 1999, after their full disclosure policy had been in place for 10 years, they reported that their facility’s median liability payments were one fifth of the median liability settlements for the private sector (21). The University of Michigan Health System reported a 50% reduction in legal fees and actions since implementing a policy in 2001 that encouraged disclosure and apology (22–24), and the Illinois Medical Center at Chicago noted an average 50% decrease in legal costs per case (25).
Disclosure and discussion of adverse events is critical to creating and maintaining high-quality health care and the integrity of the physician–patient relationship. A commitment on the part of all health care providers to establish programs and develop the tools needed to educate patients, health care providers, and families is necessary. The American College of Obstetricians and Gynecologists strongly supports these endeavors.
- Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA 2003;289:1001–7. [PubMed] [Full Text] ⇦
- Mazor KM, Simon SR, Yood RA, Martinson BC, Gunter MJ, Reed GW, et al. Health plan members’ views about disclosure of medical errors. Ann Intern Med 2004;140:409–18. [PubMed] [Full Text] ⇦
- Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 1994;343:1609–13. [PubMed] ⇦
- Beckman HB, Markakis KM, Suchman AL, Frankel RM. The doctor–patient relationship and malpractice. Lessons from plaintiff depositions. Arch Intern Med 1994;154: 1365–70. [PubMed] ⇦
- Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA 1992;267:1359–63. [PubMed] ⇦
- Weiss PM, Miranda F. Transparency, apology and disclosure of adverse outcomes. Obstet Gynecol Clin North Am 2008;35:53–62, viii. [PubMed] ⇦
- Helmchen LA, Richards MR, McDonald TB. How does routine disclosure of medical error affect patients’ propensity to sue and their assessment of provider quality? Evidence from survey data. Med Care 2010;48(11):955–61. [PubMed] ⇦
- Allan A, McKillop D. The health implications of apologizing after an adverse event. Int J Qual Health Care 2010; 22:126–31. [PubMed] [Full Text] ⇦
- Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000. ⇦
- The Joint Commission. Comprehensive accreditation manual. CAMH for hospitals: the official handbook. Oakbrook Terrace (IL): Joint Commission; 2010. ⇦
- American Medical Association. Patient information. In: Code of medical ethics of the American Medical Asso-ciation: current opinions with annotations. 2010–2011 ed. Chicago (IL): AMA; 2010. p. 280–3. ⇦
- Conway J, Federico F, Stewart K, Campbell MJ. Respectful management of serious clinical adverse events (second edition). IHI Innovation Series white paper. Cambridge (MA): Institute for Healthcare Improvement; 2011. Available at: http://www.ihi.org/knowledge/Pages/IHIWhitePapers/RespectfulManagementSeriousClinicalAEsWhitePaper.aspx Retrieved December 7, 2011. ⇦
- Finkelstein D, Wu AW, Holtzman NA, Smith MK. When a physician harms a patient by a medical error: ethical, legal, and risk-management considerations. J Clin Ethics 1997;8:330–5. [PubMed] ⇦
- Goldberg RM, Kuhn G, Andrew LB, Thomas HA Jr. Coping with medical mistakes and errors in judgment. Ann Emerg Med 2002;39:287–92. [PubMed] ⇦
- Mello MM, Studdert DM, DesRoches CM, Peugh J, Zapert K, Brennan TA, et al. Caring for patients in a malpractice crisis: physician satisfaction and quality of care. Health Aff 2004;23:42–53. [PubMed] [Full Text] ⇦
- Marx D. Patient safety and the “just culture”: a primer for health care executives. New York (NY): Trustees of Columbia University in the City of New York; 2001. Available at: http://www.mers-tm.org/support/Marx_Primer. pdf. Retrieved August 16, 2011. ⇦
- Massachusetts Coalition for the Prevention of Medical Errors. When things go wrong: responding to adverse events. A consensus statement of the Harvard Hospitals. Burlington (MA): MCPME; 2006. Available at: http://www.macoalition.org/documents/respondingToAdverseEvents.pdf. Retrieved August 15, 2011. ⇦
- COPIC Companies. 3Rs program. Denver (CO): COPIC Companies; 2009. Available at: http://www.callcopic.com/home/what-we-offer/coverages/medical-professional- liability-insurance-ne/nebraska-pli/special-programs/ 3rs-program. Retrieved August 16, 2011. ⇦
- Woods JR, Rozovsky FA. What do I say? Communicating intended or unanticipated outcomes in obstetrics. San Fran- cisco (CA): Jossey-Bass; 2003. ⇦
- Liebman CB, Hyman CS. A mediation skills model to manage disclosure of errors and adverse events to patients. Health Aff 2004;23:22–32. [PubMed] [Full Text] ⇦
- Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med 1999;131:963–7. [PubMed] [Full Text] ⇦
- Gallagher TH, Levinson W. Disclosing harmful medical errors to patients: a time for professional action. Arch Intern Med 2005;165:1819–24. [PubMed] ⇦
- National Medical Error Disclosure and Compensation Act, S 1784, 109th Cong, 1st Sess (2005). Available at: http://www.gpo.gov/fdsys/pkg/BILLS-109s1784is/pdf/BILLS-109s1784is.pdf. Retrieved August 15, 2011. ⇦
- Boothman RC, Blackwell AC, Campbell DA Jr, Commiskey E, Anderson S. A better approach to medical malpractice claims? The University of Michigan experience. J Health Life Sci Law 2009;2:125–59. [PubMed] ⇦
- McDonald TB, Helmchen LA, Smith KM, Centomani N, Gunderson A, Mayer D, et al. Responding to patient safety incidents: the “seven pillars.” Qual Saf Health Care 2010; 19:e11. [PubMed] [Full Text] ⇦