A collection of hospitals in eight cities around the globe has successfully demonstrated that the use of a simple surgical checklist during major operations can lower the incidence of deaths and complications by more than one third. The year-long study was led by researchers from the Harvard School of Public Health (HSPH) in collaboration with the World Health Organization, and the results are published in the New England Journal of Medicine.
The rate of major complications in the study operating rooms fell from 11% in the baseline period to 7% after introduction of the checklist, a reduction of more than one third.
Even more dramatically, inpatient deaths following major operations fell by more than 40 percent (from 1.5% to 0.8%) with implementation of the checklist.
Similar reductions in complications were seen in both the high income and lower income sites in the study, with rates falling from 10.3 per cent to 7.1 per cent and 11.7 per cent to 6.8 per cent respectively.
The reductions were of equal magnitude in high income and lower income sites in the study. The pilot sites included one hospital in each of the following cities: Seattle, Toronto, London, Auckland, Amman, New Delhi, Manila, and Ifakara, Tanzania.
Data were collected from 7,688 patients: 3,733 before implementation of the checklist and 3,955 after the checklist was implemented. The study period ran from October 2007 to September 2008.
The pilot hospitals used a checklist developed by an expert panel convened by the World Health Organization as part of its "Safe Surgery Saves Lives" Initiative, led by Atul Gawande, Associate Professor of Health Policy and Management at HSPH and a surgeon at Brigham and Women's Hospital, Boston. The checklist is a single page that requires only a few minutes to complete at three critical junctures of operative care: before anesthesia is administered, before skin incision, and before the patient is removed from the operating room. Items on the checklist are intended to ensure safe delivery of anesthesia, appropriate preventive measures against infection, effective teamwork and other essential practices in operative care.
Four countries, the UK, Ireland, Jordan and the Philippines, have already established nationwide programs to implement the checklist in all operating rooms.
"The results are startling," said Gawande, senior author of the NEJM article. "They indicate that gaps in teamwork and safety practices in surgery are substantial in countries both rich and poor. With the annual global volume of surgery now exceeding even the volume of childbirth, the use of the WHO checklist could reduce deaths and disabilities by millions. There should be no time wasted in introducing these checklists to help surgical teams do their best work to save lives."
"The checklist had a visible impact in every site in the study," added Alex Haynes, MD, a research fellow at HSPH and the Massachusetts General Hospital, and the article's lead author. "Even many clinicians who were initially skeptical of the idea became advocates once they saw the benefits to safety and consistency of care."
The Institute for Healthcare Improvement (IHI) in the U.S. recently announced a "sprint" to introduce the checklist in all 4,000 hospitals that took part in its recent 5 Million Lives Campaign, a national effort to improve quality and safety. These hospitals represent two-thirds of American hospitals.
IHI President and CEO Donald M. Berwick said: "I cannot recall a clinical care innovation in the past 30 years that has shown results of the magnitude demonstrated by the surgical checklist. This is a change ready right now for adoption by every hospital that performs surgery."
Gawande's research team has also estimated that if the WHO Surgical Safety Checklist were implemented in all operating rooms across the U.S., the annual cost-savings from the prevention of major complications would be $15 billion to $25 billion per year.
Concluded Gawande: "Modern medicine is complex. Our findings have implications beyond surgery, indicating that checklists could increase the safety and reliability of care in numerous medical fields. The checklists must be short, extremely simple, and carefully tested in the real world. But in specialties ranging from cardiac care to pediatric care, they could become as essential in daily medicine as the stethoscope."
The checklist and other supporting materials are freely available on the WHO Safe Surgery Saves Lives site: http://www.who.int/patientsafety/safesurgery/en/
Co-authors of the NEJM paper, "A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population," (N Engl J Med 2009;360:491-9)
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