Disclosing medical errors to patients.

Adverse events and medical errors are not uncommon, and otolaryngology--head and neck surgery is not immune to the systemic failures and human-factor errors inherent in the practice of medicine. In their 2004 study, Shah and colleagues looked at self-reported errors in otolaryngology and extrapolated approximately 2,600 incidents of error-related major morbidity and 165 error-related deaths in otolaryngologic patients per year. (1) When bad things happen, what are the physician's ethical and legal responsibilities to disclose them to the patient? What are the legal and financial implications for physicians and hospitals that practice a policy of "extreme honesty" with patients? And how can you improve disclosure procedures in your own practice?

What should I disclose and when?

According to the Institute of Medicine, a medical error is "the failure of a planned action to be completed as intended" [i.e., error of execution] or "the use of a wrong plan to achieve an aim" [i.e., an error of planning]. (2) An adverse event is an injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a "preventable adverse event." (2) Not all errors result in adverse events; sometimes a mistake is made but the patient does not suffer harm as a result. And not all adverse events are caused by error. For example, side effects of appropriately prescribed and administered chemotherapy are an example of adverse events not caused by error.

Medical errors should be disclosed to patients for a number of reasons. Because of their fiduciary relationship with patients, physicians have an ethical responsibility to disclose errors to them. To withhold this information undermines the public trust in medicine and damages the therapeutic relationship between physician and patient. In fact, patients may be caused additional, avoidable harm by failure to disclose because they lack information that would allow them to receive appropriate treatment should further complications arise. (3)

Talking to patients about errors

Focus-group research indicates that there is strong agreement among physicians that patients should be told about any error that has caused harm or requires follow-up testing or treatment. (4) However, physicians participating in this study expressed uncertainty about whether to disclose errors when there was no harm or when the harm was trivial. Also, physicians perceived a number of barriers to disclosing errors, including fear of litigation, fear of being reported to a public registry, and not knowing how to talk to patients about errors. (4)

Few physicians receive training in how to disclose and discuss adverse events with patients. Chan et al reviewed the literature on error disclosure and surveyed patients about their information needs related to errors, and they developed a five-point framework for effective error disclosure. (5) This framework includes: (1) an objective explanation of the medical facts related to the error, (2) honesty and truthfulness, (3) empathy, (4) a discussion of how future adverse events will be prevented for all patients, and (5) general communication skills, such as listening, responsiveness, and checking for understanding. When observing physicians in standardized error-disclosure scenarios, Chan and colleagues found that surgeons scored high on describing the medical facts and on honesty and truthfulness, but lower on characteristics of empathy and on steps that would be taken to prevent errors from occurring in the future. (5)

These weaknesses could be addressed through additional training, both in how to communicate errors and in error-prevention strategies. Also, tools are available to help physicians learn disclosure skills. For example, the Georgia Hospital Association's Partnership for Health and Accountability has a free video, Discussing Unanticipated Outcomes and Disclosing Medical Errors. The video contains advice on how to communicate with patients when disclosing errors and models error-disclosure conversations between physicians and patients.

What effect does disclosure have on liability?

Fear of liability is not a trivial concern. In a recent survey, 77% of hospitals indicated that malpractice fear was the principal barrier to error disclosure. (6) Malpractice liability and insurance costs have become so high that they have caused physicians to move their practices to other states and, in some states, institute work stoppages. (7) Although physicians may want to do the right thing by disclosing errors to patients and apologizing for harm that occurred as a result of an error, physicians fear that an apology would lead to higher malpractice premiums and be admissible in court, should the patient decide to sue. However, research on the relationship between error disclosure and malpractice liability has not found that to be true and, in fact, suggests the opposite--that a structured and compassionate error-disclosure program can reduce both the number of lawsuits and the amount of compensation paid out over time. (8) In studies that have examined the reasons given for instituting a malpractice suit, patients and families indicate suspicion of a cover-up, lack of error acknowledgment, and failure to apologize as major risk factors for malpractice suits. (7) This implies that many malpractice suits could be avoided through appropriate error-disclosure programs.

Structured disclosure and apology programs

Programs providing a structure for disclosing errors and apologizing to patients are of benefit to doctors and patients alike. This has certainly been the experience of the Veterans Administration Medical Center (VAMC) in Lexington, Kentucky. In 1987, after losing two malpractice judgments totaling more than $1.5 million, the Lexington VAMC instituted a proactive risk-management program to identify cases that seemed likely to result in liability and now actively identifies and investigates accidents and medical errors within the facility. When incidents are found to have resulted in harm to patients, the VAMC utilizes a policy of "extreme honesty." Patients are told the facts, sympathetically and directly, by the hospital's senior management and senior medical staff. The staff members accept full responsibility, including an apology, and describe what the hospital has done to prevent future incidents. The patient is advised to retain an attorney, and the hospital then negotiates a settlement with the patient or the patient's attorney.

Since implementing the program, the Lexington VAMC went from being one of the VA facilities paying the highest liability settlements to being in the lowest quartile for all VA facilities nationwide. Over a 13-year period, the hospital negotiated more than 170 incidents. Only three lawsuits went to trial, of which the hospital lost two and won one. The average settlement was $16,000--a fraction of the average pretrial settlement of $98,000 for the VA system nationally

One additional benefit of this policy of extreme honesty is that when the patient or family perceives an adverse event and the hospital investigation finds no wrongdoing on the hospital's part, the hospital politely, but firmly, refuses to settle. The incidence of frivolous lawsuits has therefore declined, since local attorneys have learned that they're not likely to win a suit when the hospital has refused to settle. (7,8)

According to the Sorry Works! Coalition, similar results are being reported by academic and private-sector institutions across the country as they implement and monitor full-disclosure policies. (9) These results are highly encouraging, since reporting and analysis of errors and adverse events are critical to improving patient safety. Open investigation and full disclosure of errors and adverse events improve patient safety by allowing physicians and hospitals to appropriately redesign systems to prevent similar errors from occurring in the future.

References

(1.) Shah RK, Kentala E, Healy GB, Roberson DW. Classification and consequences of errors in otolaryngology. Laryngoscope 2004;114;1322-35.

(2.) Kohn LT, Corrigan JM, Donaldson MS. To Err Is Human: Building a Safer Health System. Washington, D.C.: National Academy Press, 2000.

(3.) Hebert PC, Levin AV, Robertson G. Bioethics for clinicians: 23. Disclosure of medical error. Can Med Ass J 2001;164:509-13.

(4.) Gallagher TH, Waterman AD, Ebers AG, et al. Patients' and physicians' attitudes regarding the disclosure of medical errors. JAMA 2003 ;289:1001-7.

(5.) Chan DK, Gallagher TH, Reznick R, Levinson W. How surgeons disclose medical errors to patients: A study using standardized patients. Surgery 2005; 138:851-8.

(6.) Lamb RM, Studdert DM, Bohmer RMJ, et al. Hospitals' error disclosure practices: Results of a national survey. Health Affairs Mar/Apr 2003;22:73-83.

(7.) Kachalia A, Shojania KG, Hofer TP, et al. Does full disclosure of medical errors affect malpractice liability? The jury is still out. Jt Comm J Qual Saf 2003;29:503-11.

(8.) Kraman SS, Hamm G. Risk management: Extreme honesty may be the best policy. Ann Intern Med 1999;131:963-7.

(9.) Summaries of the experiences of individual hospitals and hospital systems with structured full-disclosure programs for medical errors can be found on the Sorry Works! Coalition Web site at www. sorryworks.net.

ELIZABETH W. HOY, MHA 

Manager of Quality Improvement

American Academy of Otolaryngology--Head and Neck Surgery

Alexandria, Virginia