Disclose mistakes that affect multiple patients

Harm/benefits analysis leads researchers to conclusion

A group of researchers from the University of Washington, Seattle, led by Denise M. Dudzinski, PhD, MTS, associate professor and director of graduate studies, has concluded that it is preferable to disclose medical mistakes affecting multiple patients — even if those patients were not harmed. Their findings were published in the Sept. 2, 2010, issue of the New England Journal of Medicine.1

"We were wondering about this dilemma concerning disclosure and recognized there was not much out there [in the literature] on this, and we wanted to really analyze the ethics of disclosure and give examples of different types of large-scale events," Dudzinski explains.

Why did the researchers conclude that in most cases these events should be disclosed? "We focused on ethical analysis," Dudzinski explains. "In other words, when you do a harms/benefit analysis and consider it carefully, would this [disclosure] actually be more harmful?" Hospital administrators, she notes, may be concerned that by disclosing mistakes, knowing that a small percentage of patients were actually physically harmed, the only potential harm is to worry people.

However, says Dudzinski, the analysis showed that the magnitude of harm for the few who were physically harmed is likely greater than the harm diffused over all the people who are informed and temporarily worry.

"In addition, we also said it's important to look at what duties we have," Dudzinski continues. "There is more of a trend to disclose to individuals than to a group. But why doesn't that same duty apply to a group? Based on those issues, disclosure should be the rule."

Although Dudzinski's group endorsed disclosure in all cases, the most challenging types of disclosure they examined were prion diseases such as Creutzfeldt–Jakob disease where there was potential exposure from surgical instruments in neurosurgery. "You have a low possibility of it being passed on, but sterilization procedures for non-prion disease do not work on prions," she explains. "The World Health Organization says we need to use more robust sterilization if we suspect potential exposure." What troubles people about these cases the most, she adds, is that there's no way to actually diagnose the disease before death, and in cases where it was not suspected, patients who died were found to have been treated with the same surgical instruments as several others.

"It's still your duty," Dudzinski insists. "The patient may want to know, and if they are going to have other neurological procedures, this may amplify the risk; and if a test or treatment becomes available later, the patient can get it."

Policies and procedures recommended

Large-scale adverse events, noted the researchers, "occur frequently enough to warrant thoughtful policies and procedures." Here are several they recommend:

• 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." Such a policy, says Dudzinkski, "should be sanctioned and endorsed by leadership." Quality leaders, she adds, "might be in a perfect position to write the policy, along with clinicians." In any event, says Dudzinski, she recommends a multidisciplinary approach.

• Plans for disclosure

"Institutions should proactively (rather than reactively) disclose all large-scale adverse events to affected patients unless a strong, ethically justifiable case can be made not to disclose," the researchers wrote. What methods of disclosure should be used? "If you have to notify 1,000 people and you want everyone to know around the same time, in that case, probably a letter makes sense — as long as you have a telephone call-in center," says Dudzinski. "With a smaller number, you might consider making phone calls."

• Communication with the public

"Institutions should 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," according to the article. Potentially, says Dudzinski, this could involve a news release. "Those patients at increased risk of being exposed should be told first, and then the information you provided them can go out to the media," she advises. "Since it takes a while to find out what happened, you might initially tell the public what you know now, and what you're going to do to get more information." In addition, she says, let the patients know they will keep hearing from you as you get more information that is relevant to their health.

• Plans for patient follow-up

The article advises: "Institutions should provide follow-up diagnostic testing and treatment to patients affected by the large-scale adverse event and address anxiety produced by the disclosure." Organizations should provide follow-up diagnostic testing and treatment to patients who were affected by the event, says Dudzinski, and then address any anxiety they may have. "You need people who are well-trained to answers questions about what occurred and to address anxiety," says Dudzinski. "For patients worried about infectious disease, it may be sufficient to inform them that you will get them tested to address their concerns. For some who may be extremely worried, you may need people who are better trained."

Reference

  1. Dudzinski DM, Hebert PC, Foglia MB, and Gallagher TH. The Disclosure Dilemma — Large-Scale Adverse Events N Engl J Med 2010; 363:978-986.