Peter Angelos remembers being called to perform surgery on apatient whose life was in peril. "If I don't operate, the chance thatthe patient dies is 100 percent," said Angelos, director of endocrinesurgery at Northwestern Memorial Hospital in Chicago. "If I dointervene, the chance of his dying is still 98 percent. If thepatient dies on the table, did I cause his death, or was I justunable to save him?"
Unlike other physicians, surgeons are inextricably intertwinedwith their results. The internist is rarely blamed when the patientwith coronary artery disease has a heart attack, even if he failed toplace the patient on daily aspirin therapy, a proven way to preventcardiac events. The incident is attributed to the disease process,not to the internist's oversight.
But when a patient dies in the hands of a surgeon, the surgeon isoften viewed as an active participant in the death. As surgeon andmedical sociologist Charles Bosk writes in his book "Forgive andRemember" (University of Chicago Press, 1981): "The specific natureof surgical treatment links the action of the physician and theresponse of the patient more intimately than in other areas ofmedicine."
This link -- combined with a rising trend to gather and publishoutcome data on various medical procedures -- may affect surgeons'decisions about whether to operate on critically ill patients. Whenthe likelihood of survival is slim, it may seem more prudent, atleast from the surgeon's perspective, to deem a patient "not a goodsurgical candidate" or "too sick for surgery" and let the person dieoutside the operating room rather than on the operating table.
But of course, high-risk procedures sometimes prevent death. Howcan we ensure that publishing outcome data doesn't discouragesurgeons from taking high-risk cases?
Increasingly outcome data are made available to the public in theform of "report cards" that rate health care providers. The MarylandHealth Care Commission, for instance, publishes a hospital guide onthe Internet (http://hospitalguide.mhcc.state.md.us/index.htm). A Webenterprise called Healthgrades.com (www.healthgrades.com) gathersoutcome and performance data on hospitals, nursing homes and othercare providers. In 1996, the Pennsylvania Health Care CostContainment Council, a state agency, published a consumer guide tocoronary artery bypass graft surgery, listing each surgeon'smortality rate.
A study that appeared in the New England Journal of Medicine in1996 surveyed a large sample of Pennsylvania's cardiologists andcardiovascular surgeons to determine how the publication of thosestatistics affected the delivery of medical services.
The most disturbing finding, according to the authors, was thatcardiovascular specialists believed that access to care for very illpatients had decreased due to the publication of these report cards.Fifty-nine percent of cardiologists reported that it had become muchmore difficult to find a surgeon willing to operate on the mostseverely ill patients. Likewise, 63 percent of cardiovascularsurgeons reported that they were less willing to operate on the mostseverely ill patients.
"There are many institutions that would not touch a sick patientbecause they want to keep their mortality rates low. This happens,unequivocally, all the time," said physician Shukri Khuri, chairmanof the National Surgical Quality Improvement Program of theDepartment of Veterans Affairs (VA). "At the VA, we see thosepatients who are denied surgery [elsewhere] because they are high-risk. Programs frequently select low-risk patients in order to keeptheir mortality rates low," Khuri said.
"This will happen more often if poorly constructed outcome databecomes the norm."
Outcome data are the linchpin of "quality assurance," the movementto monitor the results of treatment delivered by individualproviders and institutions. Quality assurance is driven partly byinsurance companies hoping to deliver health care at lower cost andpartly by physicians seeking to employ a more evidence-based approachto medical care. The focus on outcomes is also endorsed by someconsumer advocates, who argue that if accurate data about outcomesare available to patients, they will be able to choose providers morewisely, thereby increasing market pressure on providers to improvethe quality of their care.
In theory, outcome data supply physicians, health plans andpatients with hard facts instead of subjective measures such asreputation or word-of-mouth. But if the outcome data arefundamentally flawed, the consequences could be enormous: Physiciansmight be deterred from taking hard cases, and patients desperatelyin need of care might have nowhere to turn.
In the world of medical statistics, there are different ways tocalculate survival. One is called absolute survival, a figure,usually cited as a percentage, that reflects how many patientsreceiving a particular procedure survive. The other, called "expectedsurvival" or "risk-adjusted survival," takes into account a patient'sunique characteristics -- such as underlying illness, age and lungfunction, for example -- that may affect his or her likelihood ofsurviving. Many experts believe surgery programs cannot be comparedproperly until all are viewed according to risk-adjusted criteria.
Robert Kotloff, director of the Program for Advanced Lung Diseaseand Lung Transplantation at the University of Pennsylvania, says lungtransplant programs must be cautious when they select patientsbecause Medicare and private insurance companies use raw survivaldata to evaluate programs.
During its Medicare review, the University of Pennsylvania had tosatisfy two markers of quality assurance. One was volume, andrequired transplanting at least 10 patients a year for twoconsecutive years. The other was to achieve a one-year and two-yearabsolute survival rate of 69 percent and 62 percent, respectively.
Absolute survival, according to Kotloff, is an inappropriate wayto evaluate medical centers. "There is a difference between a centerthat transplants a large number of patients with pulmonaryhypertension and one that primarily transplants patients withemphysema," he explained. Patients with pulmonary hypertension havepoorer survival rates because the high pressure in their pulmonaryvessels weakens the heart. After transplanting a new, more elasticlung, the heart usually bounces back, but sometimes the damage thathas occurred is irreversible. On the other hand, emphysematous lungshave flexibility; they do not place extra burden on the heart. Thesepatients have the highest survival rates of all patients withterminal lung disease. A lung transplant center could thereforeimprove its absolute survival numbers by simply transplanting morepatients with emphysema and fewer with pulmonary hypertension.
"If you are just going to look at absolute statistics," Kotloffsaid, "you are going to create a system that would favortransplanting more technically straightforward, low-risk patients."
And in fact, a program's statistics do influence treatmentdecisions, according to Kotloff. "If you see that your survival rateis suboptimal because you are being aggressive [in selectingpatients], you tend to be more conservative when you list your next20 patients."
When the University of Pennsylvania started its lung transplantprogram, Kotloff said, it accepted riskier patients than it does now.A new program often has to fill its waiting list with patients whohave been declined at other centers. "Our survival statistics earlyon were not as good as they are now," Kotloff said. "We became keenlyaware of our survival statistics to ensure Medicare approval. You arejudged by your survival statistics, so it colors your selection ofpatients, to some extent."
Kotloff says he never alters the seniority listing of his patientsto skip over high-risk patients in favor of low-risk ones. Patientsreceive transplants in order of time accrued on the waiting list. Butwhen a program feels vulnerable, the texture of a waiting list willchange: It will contain fewer high-risk patients.
To funders of medical care, the reliance on absolute survivalstatistics seemed to make sense. According to one Medicare official,when developing standards in the early 1990s agency staff felt thatscarce organs should be given to patients who had the best chance ofsurviving surgery, and a center's absolute survival statistics wouldbe an indicator of its quality. Medicare also did not want tocompensate hospitals for undertaking high-risk surgeries. It lookedskeptically upon risk adjustment, viewing it as a statisticalmanipulation to justify a program's decision to give an organ tosomeone who might die early.
Patients voiced concern to federal officials that surgicalprograms would refuse to treat severely ill patients to protect theirstatistics. And the premier transplant programs complained that ascomparative outcome data became more available on the Internet,absolute survival data would lead patients to invalid conclusionsabout a program's quality.
Over time, Medicare's approach has changed. It is now consideringrisk-adjusting outcomes for lung transplantation and is in theprocess of developing new criteria for doing so. This dramaticchange of direction will affect how lung transplant programs areevaluated by private insurance companies, which typically followMedicare's lead.
Loyola University Medical Center, the largest lung transplantcenter in Chicago, did take risks by transplanting patients at a moreadvanced stage of their illness, according to Edward Garrity, medicaldirector of the program. After Loyola's survival rate decreased, in1998 Blue Cross Blue Shield of Illinois dropped the program from itsnetwork of approved providers, leaving its 4.7 million subscriberswith no in-state lung transplant option.
Blue Cross Blue Shield had drawn a line and Loyola fell below it.Studies by the United Network for Organ Sharing show that Loyola'sone-year survival rate was 64 percent for transplants performed from1995 to 1997, a time when the survival rate across the country was 73percent. Since its inception in 1988, the Loyola program had alwayshad survival rates at or above the national average.
When patients were listed at Loyola in the early 1990s, it was theonly lung transplant program in Chicago, performing on average 30lung transplants a year. But in the mid-1990s, five other transplantprograms opened, increasing the competition for lungs at a time whenthe number of available lungs was decreasing across the country.Patients' time on Loyola's waiting list went from six months in 1994to two years by the end of 1996.
Garrity said that because patients spent more time waiting for alung, they were considerably sicker by the time surgery was possible,and therefore their absolute survival rate dropped. "We made ourclinical decisions based on potential patient benefit, not based onmanaging our statistics."
Garrity said that Loyola always reassesses its waiting list,removing patients when it becomes apparent they likely would notsurvive surgery. But this is a gray area: It is not always easy togauge when a patient is too sick to benefit.
Lung transplantation involves balancing risks and benefits. Ifdoctors predict that a patient with severe lung disease has a 75percent likelihood of being alive after two years without surgery,the patient should not be transplanted, Garrity said, because therisk of dying from transplantation is higher than the risk of dyingfrom the underlying disease. A patient can become a transplantcandidate when the risk of dying from the disease is greater than therisk of transplantation. These two lines cross, but doctors cannotalways tell where.
"How much risk are you willing to take? How many pieces of riskmake this patient undoable?" said Garrity. "That is a very hardequation to work out every day, but that's exactly what we arecharged with. If you add other illnesses to the mix, like coronaryartery disease or high blood pressure, the risks start adding up. Butthere is no cut-off number. It's not as precise as that."
In retrospect, Loyola's increase in mortality may have been atemporary aberration, not a true reflection of a decline in theprogram's quality. After 1998, Loyola's survival rates returned totheir previous levels.
A decision is only as good as the data upon which it is based. InLoyola's case, its transplantation program was penalized because thedata upon which it was judged did not reflect how sick its patientswere.
In 1986, the Health Care Financing Administration (HCFA) -- nowknown as the Centers for Medicare and Medicaid Services -- publiclyreleased raw mortality data for coronary artery bypass grafting,commonly known as bypass surgery, causing an uproar in thecardiothoracic community. The Cardiac Surgery Committee, establishedto monitor surgical care within the VA, quickly realized that the rawstatistics did not reflect the quality of care patients received. Thecommittee feared this type of data would deter surgeons fromaccepting the most challenging patients.
"If surgeons are being judged by their outcomes, and outcomes donot reflect the risks patients bring to surgery, surgeons may feelconflicted. This system creates a negative incentive to operate onhigh-risk patients whose only chance for survival may be anoperation," said Frederick Grover, a cardiovascular surgeon who haschaired the VA committee since its inception in 1985. "There is nodoubt that every surgeon should be, and usually is, committed todoing the very best for the patient independent of how their data isreported. But, in the real world, consciously or subconsciously,mortality data sometimes influences decisions."
Most cardiovascular surgeons were convinced that HCFA's treatmentof outcome data was an injustice to both patients and physicians.Surgeons would be penalized for taking high-risk patients to theoperating room and high-risk patients would consequently be deniedsurgery.
Camella Coyle, senior vice president of the American HospitalAssociation, says that HCFA's data held the potential to misinformconsumers. "If you have a rare condition, you may need to be at thatpreeminent academic facility. That academic center may have a highermortality rate, but it's because it treats people who are sicker andhave unique conditions. HCFA's data wasn't very informative. It didnot tell patients whether the higher mortality rate actually meantthe hospital was worse."
Some hospitals that fared well on HCFA's list used the data inself-serving advertisements, so in the late 1980s, the VA and theSociety of Thoracic Surgeons (STS) developed national cardiacdatabases to adjust outcome data for risk. More than 2.2 millioncardiac patients have been entered into these databases, the largestundertaking of its kind in medicine. Approximately 450 of anestimated 700 cardiovascular practices nationwide participatevoluntarily in the STS database.
The first step in this complicated process is to construct amodel that predicts outcome. The most commonly used statisticalmethod, logistic regression, produces a formula to calculate theprobability of an outcome as influenced by "predictor" variables.Today, the VA database includes 10 predictor variables, while thesurgeons' group database uses 25. A surgeon's adjusted death rate iscalculated from these models and compared with his absolute deathrate.
Michael Frank, a cardiovascular surgeon at Evanston NorthwesternHealthcare in Illinois, says the STS computation has allowed him totake on the tough cases.
Early in his career, Frank said, he made an ethical decision touse his surgical skill to improve the lives of the sickest patients.Studies show that patients who have three narrowed coronary arteries(vs. one or two), poor contraction of the heart and diabetes have themost to gain from bypass surgery, but also the most to lose becauseof possible cardiac events during and after surgery. These patientsmake up more than half of Frank's practice, a larger share than mostheart surgeons? Most young surgeons hesitate to operate on these veryill patients because too many deaths too early could impede theircareers. A high mortality rate could make it hard for a surgeon tojoin reputable programs and it could increase malpractice insurancerates. Likewise, taking on tough cases could expose a surgeon to agreater risk of litigation.
Frank's two-year absolute mortality rate was on par with thenational average. However, his risk-adjusted mortality rate indicatedhe was providing superior surgical care: His ratio of observed toexpected mortality was 0.39. In other words, only a third of Frank'spatients who, because of their risk factors, would be expected to dieactually did so.
"A good report in the risk-adjusted category empowers me tocontinue taking on high-risk patients. It is positive feedback,"Frank said.
Risk-adjusted data yield essential information that help surgeonstailor the care they provide and take the risks they are capable oftaking.
Grover, the VA committee's chairman, said surgeons can also usedatabases to identify areas for improvement. For instance, St Peter'sHospital in Albany, N.Y., had a higher than expected surgicalmortality for coronary bypass from 1990 to 1992.
A detailed analysis by the hospital revealed that the excessmortality came from patients undergoing emergency bypass surgery.Surgeons discovered that they were taking unstable patients to theoperating room too quickly. Patients who were less than six hoursfrom a heart attack or in shock did not fare well. The staffresponded by stabilizing these patients for at least 24 hours priorto surgery, resulting in no deaths the following year for emergencybypass.
The VA and STS have a tradition of using their databases forresearch. The databases offer surgeons a wealth of information thatthey can analyze to prove or disprove observations they gather in thetrenches.
Yet risk-adjusted outcome -- the holy grail of quality assurance -- does have its limitations. When the New York State Department ofHealth pioneered risk-adjusted report cards to evaluate the qualityof cardiovascular care, officials noticed that doctors suddenlystarted reporting more risk factors. Indeed, at one hospital thereported prevalence of chronic obstructive pulmonary disease (COPD)increased from 1.8 percent of the patient population to 52.9 percent,while at another hospital the diagnosis of unstable angina went from1.9 percent to 20.8 percent. While it is possible that surgeonssimply began reporting actual risk factors more thoroughly in lightof the new system, they were widely suspected of inflating riskfactors, a tactic known as "gaming," to make their results seemstronger.
Many parties use billing codes and Medicare forms to collectoutcome data, even though such sources of information have been shownto be often inaccurate and incomplete.
Databases also cannot capture every possible risk factor. They donot assess how a patient's quality of life influences mortality, eventhough surgeons know it has an impact. Some coronary bypass patientshave rare diseases, like leukemia or clotting disorders, that are toouncommon to be accounted for statistically. Likewise, in the veryhigh-risk group (patients with a predicted operative mortality of 75percent or more), there are not enough cases to make accuratepredictions.
Another drawback is that the STS database, which is not accessibleto consumers, is a costly endeavor. A surgical program or physiciangroup may pay as much as $100,000 a year to run it.
Even in light of these challenges, Coyle says the health carecommunity has an obligation to provide meaningful, comparable datathat truly reflect the performance of providers.
"Risk adjustment" she says, "makes certain we have ruled outanything else that may move an outcome in one direction or another."
Americans are fascinated by lists, an obsession that the mediafeeds by ranking every aspect of our lives, from restaurants andmovies to universities and vacation retreats. It's not surprisingthat the media ranks the "who's who" of health care providers.
In its annual "Best Doctors" issue, New York magazine teams upwith the medical research firm Castle Connolly and asks New Yorkphysicians to "choose their worthiest peers." Castle Connolly sendsquestionnaires to 8,000 physicians asking, "To whom would you send amember of your family?" Washingtonian magazine uses a similarmethodology. Nationally, reputation also earns a physician a mentionin books like "America's Top Doctors."
Outcome data that do not account for underlying illness areprobably no more accurate an indicator of treatment quality than arethese subjective surveys of peers. In fact, in its potential to rankgood doctors as bad and bad doctors as good , raw outcome data may bea good deal worse.
While it would probably be considered preposterous for arespectable health insurer to remove a hospital as a preferredprovider because it did not make U.S. News and World Report's"America's Best Hospitals" list, insurance companies do not hesitatefrom doing so based on raw outcome data.
A recent study of 44 hospitals demonstrated how centers thatranked lowest by raw mortality moved to the top of the list by risk-adjusted methods.
"The travesty is that you are not passing the right judgment,"said the VA's Khuri. "There are many organizations grading hospitalsbased on unadjusted or poorly adjusted outcomes. You thendisenfranchise quality institutions because of incorrect data. Inessence, you deny patients care at superior institutions that appearsuboptimal because of incomplete data."
Liza Iezzoni, professor of medicine at Harvard and board member ofthe National Quality Forum, a public-private organization thatfocuses on improving the quality of health care, believes outcomedata should be used constructively, not punitively.
"Outcome data is invaluable when it motivates physicians to beintrospective and evaluate processes of care. But I am concerned whenthird-party payers use outcome data to punish health care providers,because this type of data does have inherent limitations."
All of the participants in the health care system -- HMOs andthird-party insurers, physicians and patients -- require meaningfulinformation about quality of care. If the data being collected andanalyzed are incomplete, the conclusions are not meaningful, and canproduce disastrous consequences. Entire patient populations can beleft without options. Good doctors can make bad decisions tomanipulate data that is not truly connected to quality.
A movement designed to protect patients and improve the quality ofcare can wind up having precisely the opposite effects.
Jennifer Obel is a resident at a Chicago hospital. She last wrotefor the Health section about performing CPR on terminal patients.
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