The researchers say that the checklist program works because it creates an operating room culture that focuses communication on improving overall surgical safety and care.
A report on the 5-year study - by Ariadne Labs and Harvard T.H. Chan School of Public Health, both in Boston, MA, and the South Carolina Hospital Association in Columbia - is published in the Annals of Surgery.
The researchers say that this is the first study to show a large-scale, population-wide effect of the 19-point Surgical Safety Checklist, which is based on the one that the World Health Organization (WHO) introduced in 2008.
Lead author Dr. Alex B. Haynes, a surgeon at Massachusetts General Hospital and associate director of the Safe Surgery Program at Ariadne Labs, says that their findings show that "when done right, the Surgical Safety Checklist can significantly improve patient safety at large scale."
According to a study for the WHO, the global volume of surgery in 2012 was estimated to be 312.9 million operations - an increase of 38 percent over the previous 8 years. This volume equates to an average rate of 4,469 surgical operations per 100,000 people per year.
The WHO study defines surgical operations as "procedures performed in operating theatres that require general or regional anesthesia or profound sedation to control pain."
The WHO Safe Surgery Saves Lives initiative
The WHO initiative Safe Surgery Saves Lives addresses the safety of surgery and the fact that following an operation, there is a higher risk of complications and death from hemorrhage, infection, organ failure, and other causes.
At its center is a 19-item safe surgery checklist that highlights key points of attention in three phases of surgery: "sign in" (before the administration of anesthesia); "time out" (before the incision); and "sign out" (before the patient exits the operating room).
A checklist coordinator confirms that the surgical team has completed the tasks of each phase before moving onto the next.
A pilot scheme conducted in 2008, in which eight hospitals in eight cities around the world participated, showed that implementing the WHO checklist resulted in nearly a third fewer deaths and complications in a diverse population of adult patients who underwent noncardiac surgery.
A later study, presented at the Euroanaesthesia meeting in Berlin in June 2015, concluded that, if properly implemented, the WHO Safe Surgery checklist could "save more lives worldwide than any other single known intervention."
That research, which pooled and analyzed results of many other investigations, confirmed that the checklist improved outcomes in both poorer and richer nations.
Could the checklist improve surgery safety on a large scale?
In the new study, the researchers note that despite such documented improvements, there have remained questions about whether implementing the checklist can improve surgical outcomes on a large scale in a population.
All hospitals in South Carolina were invited to take part in the voluntary Safe Surgery South Carolina program. Once enlisted as a participant, Ariadne Labs took each hospital through 12 steps to implement the program.
The 12-step implementation includes customizing the checklist for the particular hospital, carrying out initial testing on a small scale, and observing and coaching to improve use of the checklist.
Altogether, 14 hospitals completed the program. Between them, they represented nearly 40 percent of South Carolina's inpatient surgery volume. The study followed the hospitals from 2010 (before implementation) to 2013 (after implementation), and it also compared their 30-day post-surgery mortality rates to the other 44 nonparticipating hospitals in the state.
The analysis covered a wide range of surgical operations, from thoracic, neurological, and cardiac, to orthopedic and soft tissue procedures.
Significant reduction in post-surgery deaths
The results showed that in the 14 South Carolina hospitals that completed the Safe Surgery checklist program, post-surgery death rates fell from 3.38 percent prior to implementation in 2010, to 2.84 percent after implementation in 2013.
However, there was no such reduction in post-surgery death rates in the other 44 South Carolina hospitals that did not complete the program - which were 3.5 percent in 2010, and 3.71 percent in 2013.
The researchers note that this represents a 22 percent difference in post-surgery mortality between the participating and nonparticipating groups, and they conclude that their findings "may indicate that effective large-scale implementation of a team-based surgical safety checklist is feasible."
The team also suggests that the experience in South Carolina offers a model for implementing the Safe Surgery checklist program nationwide.
The reason the checklist program works, they believe, is because it creates a culture in the operating room that focuses communication on bettering overall surgical care and safety.
Co-author Dr. Atul Gawande, executive director of Ariadne Labs, also led the international team that developed the WHO Safe Surgery checklist in 2008. He concludes that:
"Safety checklists can significantly reduce death in surgery. But they won't if surgical teams treat them as just ticking a box. With this work, South Carolina has demonstrated that surgery checklists can save lives at large scale - and how hospitals can support their teams to do it."