NEJM: Tips for handling disclosure of large-scale adverse events

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Healthcare organizations should disclose large-scale adverse events, even if patients were not physically harmed by the event, according to an Agency for Healthcare Research and Quality (AHRQ) funded research paper published in the Sept. 2 issue of the New England Journal of Medicine.

Adverse events that affect multiple patients, known as large-scale adverse events (LSAEs) to researchers, are incidents or a series of related incidents that harm or could potentially harm multiple patients. These events, which can result from incompletely sterilized surgical equipment, poor laboratory quality control or equipment malfunctions, are often identified after care has been provided and can affect thousands of patients.

According to Denise M. Dudzinski, PhD, and colleagues from the University of Washington in Seattle, disclosure policies for adverse events that affect individual patients are becoming more common among healthcare organizations, but these policies often fail to address how to disclose LSAEs that could have affected many patients.

Researchers weighed ethical considerations of whether to disclose such events. For instance, is disclosure ethical if patients were unlikely to have been physically harmed by the event but could be harmed psychologically by the disclosure? The authors reviewed instances in which healthcare institutions disclosed an LSAE and analyzed the method of disclosure and existing disclosure policies.

They concluded that, in most cases, these events should be disclosed and offered these recommendations:

  • Develop an institutional policy: Organizations should have a clear set of procedures for managing the disclosure process, notifying patients and the public, coordinating follow-up diagnostic testing and treatment, and responding to regulatory bodies.
  • Plan for disclosures: Disclosures should be made proactively, unless a strong, ethically justifiable argument can be made not to. The method of disclosure may depend on the event, but patients should be informed personally and all at the same time.
  • Communicate with the public: Organizations should assume that media coverage of an LSAE is inevitable. To build public trust, media responses should demonstrate the organization's commitment to honesty and transparency.
  • Plan for patient follow-up: Organizations should provide follow-up diagnostic testing and treatment to patients affected by the LSAE and address any anxiety caused by the disclosure.

Patients who have suffered physical harm due to an event resulting from a preventable error or system failure should be compensated, according to the researchers.