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Checklists are helping some doctors do no harm, in keeping with their oath. The campaign to convince the others that a simple list can reduce medical errors and complications is handicapped by entrenched attitudes. The influential World Health Organization (WHO) recently became a convert, and its promotion of the checklist adds heft to the campaign.
An aviation accident over 70 years ago inspired the campaign. A Boeing Model 299, the prototype of the B-17 Flying Fortress, crashed and burned at Wright Air Field in Ohio on 30 Oct 1935 during a test. United States Air Force historians describe the plane as substantially more complex than previous aircraft. It required the pilot to attend to the four engines, a retractable landing gear, new wing flaps, electric trim tabs that needed adjustment to maintain control at different air speeds and constant-speed propellers with pitch that had to be regulated with hydraulic controls. While doing all this, the extremely experienced pilot had forgotten to release a new locking mechanism on the elevator and rudder controls. The investigation report blamed “pilot error,” but the consensus was that the new plane was too complicated to be left to the memory of any pilot, however expert. The plane was deemed, as one newspaper put it, “too much airplane for one man to fly.”
A pilot’s checklist, with step-by-step checks for takeoff, flight, landing, and taxiing, grew out of this accident. With the checklist in hand, the pilots went on to fly the Model 299 a total of 1.8 million miles without one accident.
Evolution of the Intensive Care Checklist
Atul Gawande, MD, Associate Professor of Surgery at Harvard Medical School and director of WHO’s Global Challenge for Safer Surgical Care, is one of the loudest voices in the campaign to increase the use of checklists in the medical world. He likens the demands of aviation to the demands of modern medicine. Substantial parts of what hospitals do—most notably, intensive care—are now too complex for clinicians to carry them out reliably from memory alone, the much-published campaigner said in December 2007 article in New Yorker magazine. He added that ICU life support has become too much medicine for one person to fly.
The professor pointed to the recent case in Austria of a child who was resuscitated by ICU doctors after cardiac arrest, hypothermia and suffocation. “To save this one child,” he wrote, “scores of people had to carry out thousands of steps correctly: placing the heart-pump tubing into her without letting in air bubbles; maintaining the sterility of her lines, her open chest, the burr hole in her skull; keeping a temperamental battery of machines up and running. The degree of difficulty in any one of these steps is substantial. Then you must add the difficulties of orchestrating them in the right sequence, with nothing dropped, leaving some room for improvisation, but not too much.”
A decade ago, he noted, Israeli scientists published a study in which engineers observed patient care in ICUs for 24-hour stretches. They found that the average patient required 178 individual actions per day, ranging from administering a drug to suctioning the lungs, and every one of them posed risks.
Professor Gawande observed that ICU medicine has become the art of managing extreme complexity—and a test of whether such complexity can, in fact, be humanly mastered.
Peter Pronovost, MD, a critical-care specialist at Johns Hopkins Hospital who has a Ph.D. in public health and is trained in emergency medicine, anesthesiology, and critical-care medicine, has tested the management of complexity with checklists. One of the strongest and earliest voices in the pro-checklist campaign, Dr. Pronovost started in 2001 with a checklist that tackled just one problem: line infections. To avoid the often fatal setback for a patient, doctors are supposed to wash their hands with soap, clean the patient’s skin with antiseptic, put sterile drapes over the entire patient, wear a sterile mask, hat, gown, and gloves, and put a sterile dressing over the catheter site once the line is in. Pronovost asked the nurses in his ICU to observe the doctors for a month as they put lines into patients, and record how often they completed each step. In more than a third of patients, the doctors skipped at least one.
The next month, he and his team persuaded the hospital administration to authorize nurses to intervene if doctors didn’t follow every step on the checklist.
In just one year, the 10-ten line-infection rate went from 11 percent to zero. The test period was extended by 15 months, and only two line infections occurred during the entire period.
Pronovost recruited more colleagues, and they made other checklists. One aimed to insure that nurses observe patients for pain at least once every four hours and provide timely pain medication. This reduced the likelihood of a patient’s experiencing untreated pain from 41 percent to 3 percent. They tested a checklist for patients on mechanical ventilation, making sure that, for instance, the head of each patient’s bed was propped up at least thirty degrees so that oral secretions couldn’t go into the windpipe, and antacid medication was given to prevent stomach ulcers. The proportion of patients who didn’t receive the recommended care dropped from 70 percent to 4 percent; the occurrence of pneumonias fell by a quarter; and 21 fewer patients died than in the previous year. The researchers found that simply having the doctors and nurses in the ICU make their own checklists for what they thought should be done each day improved the consistency of care to the point that, within a few weeks, the average length of patient stay in intensive care dropped by half.
In December 2006, a grander test, called the Keystone Initiative, published its findings in a landmark article in The New England Journal of Medicine. The researchers reported that within the first three months of the project, the infection rate in Michigan’s ICUs decreased by 66 percent. The typical ICU—including the ones at Sinai-Grace Hospital in Detroit—cut its quarterly infection rate to zero. Michigan’s infection rates fell so low that its average ICU outperformed 90 percent of ICUs nationwide. In the Keystone Initiative’s first 18 months, the hospitals saved an estimated 175 million dollars in costs and more than 1,500 lives. And the successes have been sustained.
The checklists provided two main benefits, the professor observed. First, they helped with memory recall, especially with mundane matters that are easily overlooked in patients undergoing more drastic events, while making the minimum, expected steps in complex processes explicit.
Time Magazine recently saluted Dr. Pronovost for “returning to the basics.” Naming him to its list of “100 Most Influential People 2008,” the article explained that he “may have saved more lives than any laboratory scientist in the past decade by relying on a wonderfully simple tool: a checklist.”
WHO Joins the Campaign
The checklist campaign received a substantial boost in 2008 when WHO released a checklist for operating theaters, along with robust recommendations for its use. Surgical complications are common and often preventable, WHO argues. “We hypothesized that a program to implement a 19-item surgical safety checklist designed to improve team communication and consistency of care would reduce complications and deaths associated with surgery.”
The checklist requires only a few minutes to complete at three critical points during operative care – before anesthesia is administered, before skin incision and before the patient leaves the operating room. It is intended to ensure the safe delivery of anesthesia, appropriate prophylaxis against infection, effective teamwork by the operating room staff and other essential practices in perioperative care.
Professor Gawande is one of the surgical checklist developers and a member of the international team of researchers who tested it on 7,688 patients—3,733 before and 3,955 after the checklist was introduced. The results of the study, by Haynes AB, et al, were published in The New England Journal of Medicine in January 2009.
Hospitals in Tanzania, Philippines, India, Jordan, United States, Canada, United Kingdom and New Zealand participated in the test. “The primary end point was the rate of complications, including death, during hospitalization within the first 30 days after the operation,” the authors wrote.
Analysis showed that the rate of major complications following surgery fell from 11 percent in the baseline period to 7 percent after introduction of the checklist, a reduction of one third. Inpatient deaths following major operations fell by more than 40 percent (from 1.5 percent to 0.8 percent.)
"The concept of using a brief but comprehensive checklist is surprisingly new to us in surgery,” Professor Gawande commented in a WHO news release on January 14. “Not everyone on the operating teams were happy to try it. But the results were unprecedented. And the teams became strong supporters."
Sir Liam Donaldson, Chair of the WHO World Alliance for Patient Safety and Chief Medical Officer for England, said the results “will make a major contribution towards our goal of having 2,500 hospitals around the world using the safe surgery checklist by the end of this year."
Entrenched Attitudes
Dr. Pronovost found few takers for his idea when he took it on the road, according to the professor. Some physicians were offended by the suggestion that they needed checklists. Others had doubts about the doctor’s evidence. Some of its critics saw the tool as impractical in the real world, where nurses and doctors are in short supply, pressed for time, overwhelmed with patients, and hardly receptive to the idea of filling out yet another piece of paper.
There were also doubts that something as simple as a checklist could be of much help in medical care. Recounting some of the arguments against checklists, the professor pointed out that a study of 41,000 trauma patients found 1,224 different injury-related diagnoses in 32,261 unique combinations for teams to attend to. He likened it to having 32,261 kinds of airplane to land safely. Mapping out the proper steps for each is not possible, he said, and physicians have been skeptical that a piece of paper with a bunch of little boxes would improve matters much.
The professor attributes some of the resistance to the medical culture. “We have the means to make some of the most complex and dangerous work we do—in surgery, emergency care, and ICU medicine—more effective than we ever thought possible,” he explained, “but the prospect pushes against the traditional culture of medicine. Its central belief is that in situations of high risk and complexity what you want is a kind of expert audacity—the right stuff. Checklists and standard operating procedures feel like exactly the opposite,” he said, “and that’s what rankles many people.”
The professor observed that Dr. Pronovost is not the first person in medicine to use a checklist, but he is among the first to recognize its power to save lives and take advantage of the breadth of its possibilities. The findings from the WHO test have implications beyond surgery, suggesting that checklists could increase the safety and reliability of care in numerous medical fields,” the professor said. “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."
Sources: United States Air Force; New Yorker; World Health Organization; Time Magazine:
A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population
Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AHS, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MCM, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA
N Engl J Med 360:491, January 29, 2009 Special Article
An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU
Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C N Engl J Med 355:2725, December 28, 2006 Original Article