Is Keeping Patients in the Dark about Adverse Events Worth the Risk?

When it comes to large-scale adverse events in the hospital setting, full disclosure is still the best strategy, according to a commentary published in the New England Journal of Medicine.

However, although many organizations have disclosure policies for individual patients, they are ill-prepared to deal with events that affect larger groups, such as faulty sterilization of surgical equipment, technology malfunctions, and poor quality control in labs, according to Denise M. Dudzinski, PhD, and colleagues.

“There are ethical reasons why institutions may hesitate to disclose large-scale adverse events to patients,” the authors wrote. “Practical, legal, and financial considerations, such as the difficulty in predicting the likelihood of harm and identifying the injured patients, may also lead well-meaning institutions to consider not disclosing large-scale adverse events.”

In the NJEM piece, Dudzinski and colleagues cited as an example the case of a Toronto teaching hospital where it was discovered that the sterility of prostate-biopsy equipment had been compromised by incomplete cleaning. Despite the fact that the risk of infectious transmission was considered very low, hospital officials could not be certain that hundreds of men had not been exposed to harmful pathogens. Still, the organization chose to inform more than 900 men of the event and offer them pathogen testing. But although infection linked to the biopsy was not detected in any of the notified patients, the hospital faced a $100 million class-action lawsuit.

According the authors, many hospitals face this dilemma: when a large-scale adverse event occurs, should they disclose it if many patients may have been harmed, or should they use discretion if the risk of harm was remote and if the disclosure would primarily cause anxiety to patients who would ultimately not be physically harmed by the event? “Whether and how to disclose such events to patients pose substantial challenges, especially when the majority are more likely to be harmed by the disclosure itself than by the event,” they wrote.

To that end, the authors provide the following recommendations for organizations seeking to establish policies for large-scale adverse events:

1. Proactively disclose all large-scale adverse events to affected patients unless a strong, ethically justifiable case can be made not to disclose. Temporary anxiety in patients involved in near-miss incidents is not a sufficient argument against disclosure. The method of disclosure may depend on the event. Initially, written notification regarding low-risk, low-harm, large-scale adverse events may be appropriate, whereas oral notification by treating physicians regarding events involving greater harm may be indicated.
2. Assume that media coverage of large-scale adverse events is inevitable. Responses to the media should demonstrate the institution’s commitment to honesty and transparency to build public trust.
3. Provide follow-up diagnostic testing and treatment to patients affected by the large-scale adverse event and address anxiety produced by the disclosure.

For more information:

• NJEM: The Disclosure Dilemna—Large-scale Adverse Events
• Archives of Internal Medicine: Disclosure of Hospital Adverse Events and Its Association with Patients’ Ratings of the Quality of Care
• Health Affairs: Hospital Disclosure Practices: Results of a National Survey