A new study from Canada
found that the use of surgical safety checklists was not associated with significant reductions in complications or deaths in surgery. But some U.S. experts say the findings suggest that it's still better to incorporate checklist use into physician and operating room culture, rather than have the government mandate their use.
The Ontario Ministry of Health and Long-Term Care required hospitals to implement surgical safety checklists by July 2010. To assess their effectiveness, researchers compared data from the 3 months preceding the checklist's implementation to data gathered 3 months after its mandated use and found that more than 100 Ontario hospitals had rapidly adopted checklists published by the World Health Organization
In a study published in the March 13 issue of the New England Journal of Medicine, researchers said there may be value in using checklists to enhance communication and teamwork and promote a hospital culture where safety is a high priority. But they wrote that “these potential benefits did not translate into meaningful improvements in the outcomes we analyzed.” Dr. David R. Urbach, of the Institute for Clinical Evaluative Sciences in Toronto was the study's lead author.
The findings showed that the risk of death following surgery was 0.65% before the checklists were implemented, and 0.71% after the lists were implemented. The risk of surgical complications was 3.86% before checklists were used and 3.82% afterwards. There was no significant reduction in hospital readmissions.
The Canadian example is typical of how many countries have incorporated checklists, said Dr. Peter J. Pronovost, senior vice president for patient safety and quality at the Johns Hopkins University medical school and author of the 2010 book, Safe Patients, Smart Hospitals: How One Doctor's Checklist Can Help Us Change Health Care from the Inside Out
“The reality check for checklists is that it's not a magic bullet,” Pronovost said. “Regulation is too slow to keep up with the changes in evidence-based practices. I fear that regulating [checklists] may actually anchor you into bad practices.”
But another U.S. expert wasn't sure how valid the Ontario study was in assessing the effectiveness of surgical checklists in Canadian hospitals because of the narrow timeframes within which hospitals had to implement them. Measuring outcomes 3 months after checklists were instituted probably did not give the hospitals, physicians or staff adequate time for education, engagement and demonstrable improvement, said Dr. Don Goldmann, chief medical and scientific officer for the Institute for Healthcare Improvement, Cambridge, Mass.
The IHI supports checklist use, and healthcare checklists have taken off with remarkable speed since the idea was borrowed from aviation and introduced to the industry in the early 2000s. Efforts to adapt checklists have been hailed as a big step forward for patient safety. Many hospitals across the U.S. and around the world have updated their standard procedures to include operating room checklists to help proceduralists and OR staff prevent errors, reduce infection rates, lower readmissions and reduce medical malpractice costs. Checklist use has even become law in some locations.
In 2011, Nevada became the first state to require medical facilities to adopt patient safety checklists
, and nearly 30 countries are considering using the World Health Organization's surgical safety checklist on a national scale, WHO officials said.
But some experts worry that checklists are being adopted in ineffective ways. In an editorial accompanying the checklist study in the New England Journal of Medicine entitled “The Checklist Conundrum,” Dr. Lucian Leape, adjunct professor of health policy with the Harvard School of Public Health, said regulations are often pushed by those wanting to make promising innovations widely available. But the Canadian checklist study shows the limitations of that approach.
“Regulation works best when a practice of unquestioned value has become the norm. We are not there yet,” Leape wrote. Instead, mandates and national funding should go to large-scale collaborations that motivate, train, and support local efforts to implement checklists, he said.
Experts say it's important to encourage local, even hospital-specific, checklist customization. For example, when the WHO issued its surgical safety checklist in 2008, Stanford Hospital & Clinics in California enhanced the template
to include more specific instructions for anesthesiologists, nurses and surgeons. It also added instructions explaining when the surgical team should have a verbally ordered time-out—a pause before moving to its next step—and provided an outline for surgical team post-surgery discussions.
Pronovost said that in working on quality improvement with hospitals in Michigan, he discouraged hospitals from using the checklist developed by Johns Hopkins. Instead, he encouraged staff to customize the list to ensure that it addressed the specific needs of their system. For example, each hospital team should make sure that the roles outlined in the checklist are consistent with their current staff structure and that the checklist does not conflict with other hospital procedures. “Now every one of them thinks that their checklist is the best,” he said. “And it is, for their culture.”
One of the major challenges is getting all key players on board and willing to adopt the changes in a meaningful way. “Just checking boxes is not applying the checklist in the way it is meant to be applied,” Goldmann said.
of five hospitals in Washington state found that when hospital leaders failed to explain the rationale behind a checklist's introduction and did not provide education on how it should be implemented, staff were frustrated and stopped using the list despite the hospital's mandate to incorporate it.
Leape wrote in his editorial that successful checklist implementation means creating a culture of change. “The checklist is merely a tool for ensuring that team communication happens,” he wrote. “Full implementation takes time: time for the team to get it right and time for all units in an institution to get on board.”Follow Sabriya Rice on Twitter: @MHSrice