April 30, 2016
After James Happli of Mosinee, Wisconsin, was diagnosed with pancreatic cancer, he was referred to a surgeon at a local hospital where he had been treated for lymphoma 28 years earlier. The surgeon told Happli and his wife that although she had never successfully performed a Whipple procedure — the pancreatic cancer operation widely regarded as among the most difficult in surgery — she believed she could do it with the help of a second surgeon.
But Happli’s operation had to be aborted after it proved too difficult. Several months later, the pipe fitter, now 58, traveled to Froedtert Hospital in Milwaukee, 175 miles from his home. His operation, one of 127 Whipples done at Froedtert last year, was performed successfully by chief surgeon Douglas B. Evans.
The procedure involves removing part of the pancreas and small intestine as well as the gallbladder, and reconnecting the digestive organs. It proved to be particularly complicated in Happli’s case, Evans said, because of tissue damage caused by radiation treatment for his lymphoma.
“If this patient is not getting referred [to a specialist], then who is?” asked Evans, who said he has seen a recent uptick in patients treated unsuccessfully by inexperienced surgeons at smaller hospitals.
The largely unfettered ability of surgeons with minimal expertise to perform high-risk procedures — particularly at hospitals that lack experience caring for significant numbers of patients — has been the subject of a contentious, long-running battle known as the volume-outcome debate.
A groundbreaking 1979 Stanford study found that patients who underwent operations at hospitals that did more of those surgeries had significantly lower death rates than those treated at hospitals where they were done infrequently. That finding has since been replicated repeatedly across many specialties and found to apply to surgeons as well as hospitals. Last month, a large study found that the risk of complications was far higher among surgeons who performed only one thyroid removal annually than among those who did 25 or more of the tricky procedures per year.
Recently the volume battle was reignited when a trio of prominent health systems — Johns Hopkins, Dartmouth-Hitchcock and the University of Michigan — pledged that they will require their surgeons and 20 affiliated hospitals to meet minimum annual thresholds for 10 high-risk procedures. The three systems have asked other hospital networks around the country to join them.
Under the terms of the volume pledge, believed to be the first of its kind, surgeons must perform at least five pancreatic cancer surgeries annually in hospitals where 20 such operations are done each year. For knee or hip replacements, the requirement is 25 per surgeon and 50 per hospital. There are provisions for emergency surgery and for surgeons who sometimes do not meet the threshold because they were on leave; such surgeons might be required to perform a certain number of procedures under supervision.
“There is this intractableness of patients undergoing surgical care in places that have no business doing it” or performed by “hobbyists” — surgeons who infrequently perform risky surgeries, said John Birkmeyer, chief academic officer at Dartmouth. Birkmeyer devised the pledge with Peter Pronovost, an internationally known expert who directs the Armstrong Institute for Patient Safety and Quality at Johns Hopkins.
At large teaching hospitals, Birkmeyer noted, “there are usually one or two or three surgeons who are recognized as go-to doctors” for certain procedures and do them frequently. “But there’s this tail of other surgeons who do only a few a year,” such as a shoulder surgeon who performs a handful of hip replacements or a breast cancer surgeon who occasionally attempts a Whipple.
“We decided to use volume as a pilot case, an initial foray into setting quality and safety standards,” he said. “And we wanted to do it in a way” that was not subject to the discretion of hospital officials.
As smaller community hospitals affiliate with larger ones, the questions of which surgeons should do which procedures and where are increasingly confronting health systems. Hospitals of all sizes — both large academic centers and smaller community institutions — face a variety of sometimes competing incentives: to retain lucrative surgical cases and to avoid angering surgeons, who fiercely prize autonomy and wield considerable clout because they generate substantial revenue. And while hospitals formerly reaped a financial reward if patients suffered complications and had to be readmitted, they now face penalties under the Affordable Care Act.
The Leapfrog Group, a nonprofit organization that represents large employers and purchasers of health care and seeks to advance patient safety, has focused on volume in its hospital rating system. “Volume is a really critical piece of information,” said the group’s chief executive officer, Leah Binder.
“I think every medical staff should be grappling with these volume benchmarks,” she said, endorsing the pledge. “It’s fundamental.”
Ashish K. Jha, a practicing internist and professor of health policy at Harvard’s T. H. Chan School of Public Health who has written about efforts to improve medical quality, calls the pledge “very reasonable.”
Low-volume hospitals, he said, typically lack specialized teams to care for patients as well as state-of-the-art equipment and systems designed to prevent or quickly spot complications — critical factors in improving outcomes. “None of us care about volume; we care about outcomes, and volume is a surrogate” measure of outcomes, Jha noted. “Even though we’ve been talking about this for 35 years, a ton of high-risk surgery still happens among low-volume providers.”
But surgeons’ groups and the president of the Joint Commission, the Chicago group that accredits the nation’s hospitals, have criticized the pledge as simplistic and overly prescriptive. Some officials say they fear it could unfairly penalize low-volume surgeons and smaller hospitals that have good outcomes.
“There’s room to improve in low-volume and high-volume hospitals,” said Kevin Bozic, chairman of the department of surgery at the Dell Medical School at the University of Texas at Austin, who heads the committee on research and quality for the American Academy of Orthopaedic Surgeons. “There are high-volume, low-quality hospitals” as well as the converse.
“I know Harvard may be better than McPherson, Kansas,” said Tyler Hughes, a surgeon at the 25-bed hospital in McPherson and a director of the American Board of Surgery. “But for many patients, the best possible surgery is closest to home.”
Although patient-safety experts and some insurance companies have long encouraged patients, especially those with serious illnesses or complex diagnoses, to seek care from experienced specialists at high-volume hospitals, there is little to prevent doctors and hospitals from doing whichever surgeries (other than organ transplants) they see fit, no matter how rarely they do them.
Many patients don’t know to ask a doctor about volume or outcomes or are unable to ferret out relevant information when choosing a surgeon or hospital. One reason, Leapfrog’s Binder said, is that much important information such as complication rates remains hidden. Hospitals report detailed data about surgical outcomes to registries for internal use, but the information is not publicly available.
Kerry O’Connell, 59, a Denver construction executive, said that only after a botched elbow operation that required seven corrective surgeries did he learn that his was the second such procedure his orthopedist had performed. “I went to the one clinic where the ER sent me, and the surgeon seemed like a nice guy,” he said.
“We don’t have enough transparency in health care,” Binder said. “It’s the first thing everyone wants to know: Who’s the best surgeon? And anyone in health care picks up the phone and asks their friends.”
Recently, Binder notes, there have been new efforts to inform patients. In the past year, the journalism organization ProPublica and Consumer’s Checkbook have launched databases that rate surgeons. Since 1995 New York state has published some data on heart surgeons. And Consumer Reports and the federal government’s Hospital Compare website provide hospital-specific information.
A report by Leapfrog found that in 2013, one-third of hospitals that performed procedures to remove all or part of the esophagus, a demanding surgery to treat cancer, did only one or two annually, far below the level needed to achieve proficiency. A CNN investigation of an extremely low-volume Florida heart surgery program launched in 2011 found that six babies died in a two-year period, far more than expected; the program has since closed. And a U.S. News analysis last year found that Medicare patients who had knee replacements at the lowest-volume hospitals in the country were 70 percent more likely to die than those whose surgery was performed at the highest-volume centers; for hip replacement, the figure was 50 percent.
Disparities can be seen among hospitals in the same system, Birkmeyer noted.
“One of our highest priorities is insuring consistent quality and safety” regardless of where a patient seeks treatment, he said. In the past decade, Dartmouth has grown from a single hospital in Hanover, New Hampshire, to eight in northern New England. Baltimore-based Hopkins has affiliated with smaller hospitals in Washington, D.C. and suburban Maryland.
Among the most irate reactions Birkmeyer said he encountered came from about 10 surgeons affiliated with Dartmouth’s main hospital who were told they would no longer be allowed to do procedures for which they didn’t meet annual minimums. “They said things like, ‘I’ve been credentialed to do this for 20 years and I’ve never had a complication, and now you’re telling me I can’t do it?’ ”
That anger and the months required to get the boards of hospitals and their executive committees to agree to the new rules may be among the reasons only three systems have signed on so far, Birkmeyer said. More than a dozen others have expressed interest.
Some surgeons say that the focus on volume is misguided.
The problem “is actually much more complicated than volume” said David Hoyt, executive director of the American College of Surgeons. Hoyt said that the group is drafting its own guidelines that will address volume.
To Mark Chassin, president of the Joint Commission, the pledge misses the mark. “The surgeon’s contribution to the outcomes patients experience is only one component,” he said.
“Volume should never be used by an accrediting organization as a measure of quality” because it is too imperfect a measure, Chassin added.
Patients can help protect themselves, he added, by taking “as much responsibility and interest” as possible in their care.
In the view of general surgeon Linda Halderman, doctors are the best judges of their abilities. “Every surgeon has to exercise judgment of their own capabilities” and know when to refer to a more experienced colleague, said Halderman, who is based in Selma, California.
But Harvard’s Jha disagrees. Many surgeons, he said, tell him they “have excellent results and I’ll say, ‘How do you know? Do you actually track your outcomes?’ ” Most, he said, do not.
Two months ago, Linus Linaweaver, 76, chose to undergo elective abdominal surgery in his home town of McPherson, Kansas, after robotic prostate surgery at a larger hospital in Wichita nearly killed him and left him with a colostomy.
“I wanted to be back in our town,” he said, adding that he had confidence in Tyler Hughes, his surgeon, and McPherson Hospital. His seven-hour operation went well, and Linaweaver recently said he is “almost back to normal.”
James Happli is back at work after a year’s medical leave. Following his failed Whipple surgery, the local surgeon proposed trying again. That offer was withdrawn after a second specialist refused to participate. At that point, Happli was referred to Evans in Milwaukee.
If he had it to do over again, Happli said, “I would have gone to a bigger place” and a more experienced surgeon the first time.