By Liz Kowalczyk, Globe Staff
Deaths and complications dropped by an astounding 36 percent when operating room doctors and nurses completed a simple safety checklist before, during and after surgery, according to a study led by Harvard researchers.
The eight hospitals that participated in the study in eight countries collectively reduced complications during patients' hospital stays from 11 percent of patients before they began using the checklist to 7 percent of patients with the checklist.
The improvement means that 158 of 3,955 surgery patients whose cases included the checklist potentially avoided complications such as an infection, re-operation or death. Deaths alone dropped from 1.5 percent of patients to 0.8 percent.
"This was beyond anything we expected,'' said Dr. Atul Gawande, senior author of the Harvard School of Public Health paper and a surgeon at Brigham and Women's Hospital. "We had hoped to see a 10 percent reduction in complications.'' The impact of all the items on the checklist "put together seems to have produced these really remarkable results,'' he said.
Gawande said he hopes the results will win over surgeons and other operating room staff who are skeptical about the usefulness of checklists and believe they waste precious minutes when pressure to turn-over ORs quickly is greater than ever.
While the study was published in the New England Journal of Medicine's online edition today, the Brigham and some other US hospitals already are implementing the 19-step checklist in their operating rooms based on early word about the strength of the data. The Brigham, which was not part of the study, began using the checklist a month ago in general and cardiac surgery and plans to roll it out to other specialties over the next several months, Gawande said.
The checklist, which takes a couple of minutes to do and is based on World Health Organization guidelines, requires operating room staff to complete a series of verbal steps before giving the patient anesthesia, before the incision, and before the patient leaves the operating room. These steps include verifying out loud that an anesthesia safety check was completed and that surgeons are about to perform the correct procedure, confirming that all team members have introduced themselves by name to each other and discussed any concerns, and, at the end of the surgery, verifying that all sponges and needles are accounted for and none has been left inside the patient.
Completing the checklist out loud as a team is crucial to uncovering lapses that lead to problems, said Dr. Alex Haynes of the Harvard School of Public Health, the lead author and a surgeon at Massachusetts General Hospital. "Saying it verbally codifies things more than simply having one person check a box,'' he said. It requires more attention and "a greater sense of collective responsibility.''
The hospitals that participated in the study range in size, income level of patients and location -- Jordan, India, Tanzania, Philippines, Canada, England and New Zealand in addition to the United States -- but they all reduced their complication rates with the checklist, which does not require a large financial investment.
Use of the checklist won't completely eliminate complications, the authors said, because some are caused by the patient's underlying disease or by a more complicated set of factors. The checklist, for example, did not reduce the incidence of pneumonia.
Many doctors and nurses, however, warn that implementing safety checklists in ORs is not as simple as it sounds. Even a shorter "time out'' used by most US hospitals to help prevent operating on the wrong side, wrong patient and doing the wrong procedure has not been foolproof. Implementation is sometimes spotty, partly because a procedure can become so routine that staff just go through the motions without really checking each item.
The Joint Commission, a national organization that accredits hospitals, adopted a requirement in 2004 that hospitals perform "time outs'' to prevent these types of errors, but soon discovered the mistakes still were occurring.
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