AHRQ Study Calls for Disclosing Medical Mistakes That Involve Multiple Patients

Health care organizations that experience medical mistakes affecting multiple patients should disclose the mistakes even when patents were not harmed, according to an AHRQ-funded research paper published in the Sept. 2, 2010, edition of the New England Journal of Medicine.

“It’s clear that health care organizations face a dilemma regarding disclosure of large-scale adverse events—whether these events lead to patient harm or not,” said AHRQ Director Carolyn M. Clancy, M.D. “It’s not always clear how to do that in a way that minimizes risk to the patient and the organization, but this research can help.”

Disclosure policies for adverse events that affect individual patients, although more common now, often fail to address the way to disclose these events, researchers from the University of Washington, Seattle, found in the study. The researchers considered the ethics of whether to disclose such events by reviewing instances in which health care institutions filed a report and analyzed the disclosure method and existing policies. For instance, they considered whether it was ethical to disclose an event unlikely to have harmed the patients if that disclosure could be more harmful psychologically.

The authors concluded that adverse events should be disclosed in most cases and offered the following recommendations:

• Develop an institutional policy. Organizations should establish a clear set of policies to manage the disclosure process that includes notifying the patient and the public, which should include follow-up diagnostic testing, treatment and reporting to regulatory bodies.
• Plan for disclosures. Make disclosures proactively, unless a strong, ethically justifiable argument can be made for not making the event known. Patients should be informed personally and all at the same time.
• Communicate with the public. Understand that media coverage of a large-scale adverse event is inevitable and demonstrate a commitment to honesty and transparency.
• Plan for patient follow-up. Coordinate follow-up diagnostic testing and treatment for patients affected by the event, along with addressing any anxiety caused by the disclosure. And compensate patients who have suffered physical harm from a preventable error or system failure.

“Disclosing large-scale adverse events is essential if health care organizations are to maintain patients’ and the public’s trust and ensure that affected patients receive the testing and treatment they need,” said lead author Denise Dudzinski, Ph.D., an associate professor in the department of bioethics and humanities at the University of Washington, in an AHRQ press release. “These disclosures are never easy, but it is critical that organizations invest the time and resources necessary to learn how to handle these disclosures effectively.”

The press release is available at www.ahrq.gov/news/press/pr2010/nejmstudypr.html.