With the all-consuming grind of seeing patients, it is often difficult for head and neck surgeons to sit back and ask some important questions: Just how well are we doing our jobs? Are our choices on how to approach medical problems based on good information? How do we get better? But with medicine advancing at such a fast clip, it might be more important than ever to make such assessments.
Some head and neck surgeons are asking these tough questions. And this look in the mirror has not been done without some wincing.
The level of research is poor in many areas, leaving the right approach to many medical problems in doubt. At M. D. Anderson Cancer Center in Houston, a close look at performance and quality indicators has found some room for improvement. And the M. D. Anderson system might provide a good framework for other institutions to follow.
Adding to the urgency is the specter of medical reform and the likelihood that if the surgeons themselves don’t make sweeping changes to the system, it will be done for them-by politicians-and probably won’t be done very well.
Leading surgeons took on these questions in a discussion at the annual meeting of the American Head and Neck Society, part of the Combined Otolaryngology Spring Meeting. They hoped that the issues they raised would be taken up more broadly by the head and neck surgery community as a whole.
-Jonas T. Johnson, MD
Keeping Up with Change
Jonas T. Johnson, MD, Chairman of the Department of Otolaryngology at the University of Pittsburgh School of Medicine, noted that medical advancement has an obvious upside-but there is also a downside. The problem is that you have to keep up, he said.
He used a quote by Carl Snyderman, MD, to sum it up: Everything I do today I have learned in the past five years.
It’s an immense responsibility for all of us to keep up with the changes in medicine, Dr. Johnson said. In fact, this is not a new observation. It’s been suggested that the half-life of truth in medicine might be 45 years. I’m going to guess that with the rapid expanse of new information, it might be far shorter than that.
With the advances, surgeons need evidence to ensure that their treatments are the best approach. But Johnson said the state of the evidence is poor.
In 2002, researchers examined the level of evidence in head and neck surgery, asking four leading journals about the quality of the studies published. The embarrassment was that 7 percent were randomized clinical trials, or Level I evidence, Dr. Johnson said. The overwhelming majority were descriptive, retrospective studies. The level of evidence in otolaryngology and head and neck surgery is not so hot.
Surgeons looking for solid evidence on treatment of T1 and T2 glottic cancer-on whether endoscopic resection or radiation is best-might be frustrated. There is quite a bit of evidence suggesting that radiation treatment works very well. But that doesn’t resolve the question of whether that approach or surgery is better, Dr. Johnson said, citing the 2008 book Evidence-Based Otolaryngology, by Jennifer Shin, MD, Christopher Hartnick, MD, and Gregory Randolph, MD.
The reality is that for T1 and T2 glottic cancer, there are no randomized clinical trials, Dr. Johnson said. It’s not been done. There is limited Level III evidence that suggests comparable survival. And there are no significant differences in voice or QOL [quality of life]. That’s the level of evidence today in terms how we should treat early vocal fold cancer.
For early oral cancer, the evidence is similarly thin. I would argue that in terms of disease control efficiency, comorbidity, and functional outcomes, the evidence favors surgery, Dr. Johnson said. But the evidence is based almost completely on single-institution retrospective reports.
As for whether selective neck dissection or modified radical neck dissection is best for N0 oral cancer, both Level I and Level III studies have concluded that there is no difference. But, according to Evidence-Based Otolaryngology, the evidence isn’t sufficient to notice a 5% difference, Dr. Johnson said.
The evidence is underpowered, he said. And the authors suggest you’d need at least 2000 patients to achieve a significantly powered study to answer the question.
The authors of Evidence-Based Otolaryngology write that the lack of evidence is a multifaceted problem. Although medical and surgical developments have relentlessly advanced this field, the educational and explanatory literature regarding the evidence supporting those advancements has lagged behind, they said. This deficiency is made more pronounced by burgeoning pressure from the academic medical community, third-part financiers, and members of the legal arena.
Dr. Johnson noted the sobering fact that laryngeal cancer survival in the United States has decreased over the last decade, unlike survival for other forms of cancer. The expanded use of nonsurgical treatment parallels this lower survival rate, he said.
The tendency to generalize those widely reported New England Journal articles demonstrating the effectiveness of chemoradiation therapy in some circumstances potentially could have hurt a lot of people. Is this the failure to communicate effectively with our colleagues? he said. We have to avoid this tendency to generalize studies and assume that if it works in one place it’ll work somewhere else. And we need articulate leadership.
The challenge is to remain committed to our core values, Dr. Johnson said. Obviously that includes leadership, presentations, and publications. But the reality is that it all starts with discovery, because discovery is what allows us to take translational issues to the clinic and learn how to better care for our patients.
Prospective, multicenter trials are a must, he said. There’s every opportunity now for it to be geographically diverse-in other words, we need to work together, Dr. Johnson said. The risk if we fail is immense.
M. D. Anderson Faces the Challenge
-Randal S. Weber, MD
At M. D. Anderson Cancer Center in Houston, a team of head and neck surgeons have taken a step toward this self-evaluation, developing a system for tracking performance and quality indicators, taking heed that the emerging priorities in health care for the new millennium are safety, quality, and value.
The team defined quality of care as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.
Their performance indicators-agreed upon and quantifiable measurements that reflect the critical success factors of an intervention-include whether a patient had to return to the operating room within seven days, deaths within 30 days of surgery, and hospital readmission within 30 days. The team examined the acuity of the procedure, the comorbid conditions of patients, and the surgeon ranking to see how much they influenced the results.
Randal S. Weber, MD, Hubert L. and Olive Stringer Distinguished Professor in Cancer Research in the Department of Head and Neck Surgery at M. D. Anderson, said the data uncovered some areas for improvement. I’m struck after actually reviewing my own data that with so much, we don’t always do enough or do it right, he said.
The team found a strong relationship between the acuity of the procedures and the performance indicators. High-acuity procedures were those involving reconstruction, such as mandibulectomies and pharyngolaryngectomies. Low-acuity procedures were those that did not involve reconstruction, such as lymphadenectomies, minor glossectomies, and parotidectomies.
In every area, from hospital stays to infections, results were significantly better in low-acuity cases than in high-acuity cases. The acuity of the procedure was a major determinant, as it influenced these performance measures, Dr. Weber said.
Infections within 30 days, for example, occurred at a rate of 10.5% for high-acuity cases and 1.2% for low-acuity cases. Similarly, 13.1% of high-acuity patients had to be readmitted to the hospital within 30 days of the procedure, whereas just 5.4% of the low-acuity patients had to be readmitted so soon. There were two or more negative indicators in 53.4% of the high-acuity cases, but in only 4.6% of the low-acuity cases.
At M. D. Anderson, the number of high-acuity procedures went up slightly from 2004 to 2007. In 2004, there were 63 such procedures, accounting for about 13% of the total. Three years later, there were 81, accounting for about 15%.
The team also looked at the role of comorbidities. Predictably, the high-acuity patients were significantly more likely to have some comorbid condition. Those conditions-which included cardiovascular disease, diabetes, liver disease, prior heart failure, and renal disease-also had a strong relationship to the performance measures.
For every comorbid condition reviewed, except diabetes, there were significant correlations to at least a majority of the performance indicators. Cardiovascular disease and prior heart failure were the strongest signals that problems were likely.
The team also created rankings for the physicians by tallying, for each, the number of their patients with two or more negative indicators, and then balancing that with the number of their patients who had comorbid conditions.
Overall, the risk estimate for negative surgical quality factors for a high-acuity procedure versus a low-acuity procedure was 331.0-by far the most powerful determinant of a problem following a procedure.
The acuity of the procedure had the greatest impact, Dr. Weber said. You can see the hazard ratio is very high. There was also an influence by the physician ranking, more so for the high-acuity procedures than the low-acuity procedures. And the comorbid conditions also had a significant influence.
Dr. Weber said that the data gathered will be useful outside M. D. Anderson, as well as inside the institution. Extramurally, these data may serve as a comparator between providers and institutions and serve as a resources for health care purchasers and consumers, he said.
Creating Performance Quality Parameters
Not stopping there, surgeons at M. D. Anderson also turned to early-stage tongue cancer and created performance quality parameters. They then examined their own cases to see whether those parameters were being met.
The study was a retrospective chart review covering the period from January 1998 to December 2003. The quality measures they set out were whether tumor size-lymph nodes-metastases (TNM) staging was assigned before treatment; whether the margin status was documented and acknowledged by the surgeon; whether selective neck dissection was performed when the depth of the invasion of the primary tumor was more than 4 mm; and whether referral was made to the radiation oncology department for adverse pathologic factors such as perineural invasion.
They found that, for the most part, compliance in these areas was good. Pretreatment TNM staging was documented in 90.5% of the 116 cases. The margin status was documented in the report and acknowledged by the physician in 99.1%. The guidelines for selective neck dissection were followed in 88.7% of the cases, and referral for adverse findings in the pathology report was made in 98.2%.
-Frank G. Opelka, MD
The researchers also assessed the adherence to 26 other practices. They found that smoking history was documented in 87% of the cases, the tumor size was described in 91.4%, and the tumor location was described in 96%.
In all 116 cases, the case was presented in a treatment planning conference, which Dr. Weber said was key. All our patients are presented in a multidisciplinary tumor conference, so we’ve had very good compliance with the guidelines, he said. And that’s an important quality indicator for multidisciplinary care.
On the downside, the frequency of follow-up was lacking. Only 54 percent of our patients were actually seen four times a year per protocol in the first year, so there’s room for improvement there, Dr. Weber said.
The review had proven valuable. Quality data provide a useful benchmark to evaluate the care provided to patients with early tongue cancer, he said.
Time Is Ripe for Quality Improvement Measures
Frank G. Opelka, MD, of the American College of Surgeons Health Policy and Advocacy Group and Professor of Surgery at Louisiana State University, has been working on quality improvement and patient safety measurement systems as part of the national health reform-efforts that have led to a call for national surgical clinical registries to be used to measure performance, analyze data, and generate meaningful reports for actionable quality improvement and public reporting. Such registries could merge with payer information to create robust programs for physician driven, evidence-based health care redesign, he said. Quality is a virtuous cycle that begins with measurement and moves through its various phases to create improvement, he said.
The time for change is now, he told the room of surgeons at the AHNS. The tension that we went through when we experienced top-down, Hillary-care is gone, he said. The current national efforts are multi-stakeholder collaborations [of those] who appreciate the crisis and are moving toward solutions. And we’ve actually got to move to the Beltway to join these health reform efforts and assume our leadership role.
A recent Central Budget Office report suggested that waste in the health care system totals $700 billion a year. He said institutions have to move from silos of care to becoming part of systems.
Our current care is focused on what a surgeon needs at that very moment, rather than on what the patient needs to get from a diagnosis to complete recovery, he said. We need to create the roadmap for each condition for each patient, and create reliable, standardized systems with tight coordination across all the health care providers.
Leading our profession through such challenges means we have to listen with a broad set of perspectives, he told the surgeons. Listen not only as physicians and surgeons who really represent your patients, but listen as your patient, listen as the purchaser, and listen as the payer. Because you’re the only one really capable of doing all that.
Dr. Opelka described four areas that need to be changed to get to a high-value health care delivery system. Values and goals must become patient-centric. The focus on medical conditions needs to shift from the disease of the moment to longitudinal, continuous care. Measurements of quality have to include criteria from the clinical, to claims, to cost to the experience of patients. And payment systems must shift from volume-based financial rewards to alignment with the value of the services delivered. These changes could lead to alternative payment systems such as bundled payments or accountable care organizational payments, Dr. Opelka said.
Left to the government, the results won’t be pretty, he said. It’ll be a very heavy hatchet that cuts into us, a vise that squeezes down on us, leaves us in the current system, and it just is not the answer, he said.
Medicare now spends more than it collects in taxes. It has seven or eight years before it will require new financial support, Dr. Opelka said. We must shift from a current state to a future state which is designed on the best value for the care delivered, he said.
Jeffrey Myers, MD, from M. D. Anderson noted that it is difficult to get the money to establish the kinds of registries Dr. Opelka wants to start.
Eight to ten years ago, an effort was made to start a cancer registry, but there was no enthusiasm for it because it wasn’t a Level I, sexy new drug design trial, so I think organizations like you’re with are going to have to put pressure to get funds available to get proper databases that work across organizations.
Dr. Opelka agreed with him. Recently, Congress has given funding to government agencies that can help registries spring to life. The registries that do emerge will survive if they can meaningfully contribute to defining quality improvement, reducing costs and informing patients, he said.
Progress is being made. We are very far along in this process, he said. And I’m hopeful that within this net three-to-six-month period, we will tie up a lot of these loose ends and begin to move forward.
©2009 The Triological Society