Deadeye Deyo Takes Aim

There was a spring-time "Deyo" sighting in the Journal of the American Medical Association (JAMA) the first full week of April.

Richard Deyo, M.D., MPHRichard Deyo, M.D., MPH, either the devil or angel of the spine community, published a study that found that older patients are getting more "complex" spine surgeries and are experiencing greater complications. Deyo is consistent in his assertions that, when it comes to the spine, we operate too quickly on patients and put them at higher risks and waste money.

Deyo's study, "Trends, Major Medical Complications, and Charges Associated With Surgery for Lumbar Spinal Stenosis in Older Adults, JAMA 2010; 303: 1259-65), as usual, garnered wide attention.

Authors included: Deyo; Sohail K. Mirza, M.D., MPH; Brook I. Martin, MPH; William Kreuter, MPA; David C. Goodman, M.D., M.S.; and, Jeffrey G. Jarvik, M.D.

Innovation, Safety and Motivations

The study was about data. But the real attention was focused on Deyo's conclusions. While the study notes "it is unclear why more complex operations are increasing, " Deyo speculated that the increase in such complex surgeries can be partly attributed to good marketing, ego, and financial incentives.

The leaders of the North American Spine Society (NASS) read the study with great interest.

This could have been another confrontation between forces of innovation (surgeons) and the forces of safety (academicians). This dynamic is played out at every FDA orthopedic panel meeting and underlies the internal tension of the 510(k) program between getting treatments to patients as fast as possible, but braking for safety.

Ray Baker, M.D., President NASSNot far from Deyo in Portland, Oregon, Ray Baker, M.D., the President of NASS, was in Seattle, Washington, drafting a response. Over the next couple of days, Baker and his Executive Committee came up with an eight-point response. Baker spoke with OTW on April 7.

Regarding the motivations of surgeons, Baker said, "Association is not causation. Deyo's study points to the need for comparative effectiveness, to help determine what is effective, ” [and ultimately reimbursed].

NASS is gaining credibility with payers as a source of medical opinion to justify coverage and payment decisions. The recent reversal by several insurance carriers over XLIF coverage showed the role that NASS can play in promoting innovation.

Baker told us that, overall, NASS agrees with the evidence in Deyo's study, but questions the conclusions about financial motivations because the study wasn't designed to answer those questions.

The Deyo Study

Deyo has become almost legendary as an academic gadfly who is trying to save the spine establishment from itself.

In an interview with OTW four years ago, the kindly and calm Deyo said that he can understand why some see him as the devil and a tiny few see him as an angel. He says following the best evidence is in the best long-term financial interest of the spine community and best health interest of patients.

Deyo's team performed a retrospective cohort analysis of Medicare claims data for patients ages 65 and older with a primary diagnosis of lumbar spinal stenosis (98.2%) or spondylogenic compression of the lumbar spinal cord.

Their goal was to better define trends in the use of various surgical procedures for lumbar stenosis; see how complications vary as a function of age, comorbid conditions, previous surgery, and complexity of the surgical procedure; and identify health care use associated with stenosis surgery.

Patients were divided into three groups according to the type of surgery they received—decompression alone, simple fusion of one or two disk levels using a single surgical approach, or complex fusion of more than two disk levels.

They discovered that over a six-year period, the rate of complex procedures to treat spinal stenosis increased 15-fold, while overall procedure rates actually declined. The decline was from 137.4 procedures per 100, 000 beneficiaries in 2002 to 135.5 in 2007. The rate for complex procedures during that period went from 1.3 to 19.9 procedures per 100, 000 beneficiaries.

Increased Complications

Not surprisingly, they found that as complex procedures increase, so have the complications.

According to the study, "life threatening complications increased with increasing surgical invasiveness, from 2.3% among patients having decompression alone to 5.6% among those having complex fusions."

Photographer: Andrew HuthDeyo said the evidence generally does not show that complex operations are much more effective, if at all, and absent data showing clear superiority for more complex operations, surgeons and patients might want to identify the least invasive type of surgery that will yield good pain relief and functional outcomes.

The study noted, "This contrasts with a competing theory that surgeons should correct every anatomic abnormality, hoping to avoid future symptoms."

It wasn't just about safety. Mean hospital charges were likewise higher for the complex procedures ($80, 888 versus $23, 724).

The Deyo study acknowledged its limitations, including:

• The possibility of miscoding of diagnoses and procedures in claims data
• Incomplete information on use of implants
• The possibility that complications are not consistently recorded
• The lack of information on severity or extent of anatomic changes, patient symptoms, or functional status
• The use of hospital charges, rather than actual resource costs or reimbursements

The study was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, and the National Center for Research Resources.

NASS Responds

The NASS leadership team responded.

First, they noted the JAMA study "is in general agreement with the recommendations of the NASS Clinical Guidelines on Spinal Stenosis published in The Spine Journal in 2008, which took an enormous amount of time and effort to develop."

Those guidelines say:

• "...decompressive surgery alone is effective approximately 80% of the time"
• "...there is no evidence to support the addition of fusion" [in the absence of spondylolisthesis or instability]
• "...decompression with fusion results in better outcomes than decompression alone” [with spondylolisthesis]
• "...decompression with fusion provides better outcomes than decompression alone at greater than 2-year follow-up” [with instability]
• "...The addition of instrumentation...increases the radiographic fusion rate, but not necessarily the clinical outcomes” [with spondylolisthesis]

Registry

Second, NASS supports a spine registry to "gather data on the best treatment options" because leadership agrees that "for patients with more complex combinations of pathology the evidence is less clear and that more complex surgery is associated with more complications." 

Rising Demand

Third, NASS agrees with Deyo that "there are likely multiple factors" that have led to an increase in complex fusion rates.

Those factors include:

• "Improved surgical and [other] techniques...have made more complex surgeries feasible in sicker, older, or more complex patients"
• "Patient demands...altruism can lead to seemingly irrational behavior when a physician has a patient sitting in front of him or her and there is a lack of alternative treatments"
• "Hope that newer technologies yield superior...benefits."
• "Continued perception that solid fusion is correlated with a better outcome, despite a lack of clear scientific evidence”

Fourth, citing NASS’ most emphatic disagreement with Deyo, the group wrote, “while contributing factors...the effect of financial incentives...opinion leaders, and device marketing has on complex surgery rates is unknown." Baker emphasizes in the letter that his membership "chooses the treatment option that they honestly feel will yield the best outcome."

Value Assessments

Fifth, NASS will continue to educate its members. "It takes time to change established behavior and change long-held perceptions. The letter also noted that NASS is beginning to incorporate value assessments into its recommendations, "although the science is still lacking in most fields of medicine."

Limited Date for Analysis

Sixth, "There are limitations of the dataset which limit analysis: the lack of consistent methodology and terminology for coding (CPT and ICD), absence of standardized diagnostic category assignment, technique and technical variation that are totally opaque in this analysis really hamper any scientific arrival at causality, " stated the letter.

Baker offered that NASS is participating in a multi-stakeholder conference in July to "look at ways of classifying diagnoses and quantifying outcomes. AHRQ, NIH, CMS, and others will be at the conference."

More Funding

Seventh, lack of funding for research. "There is very little federal funding for clinical trials or basic research into the biology of spinal disorders...funding, by default, usually comes from industry." The letter specifically notes the lack of funding from NIH.

The letter points to the "significant impact" made by the well funded, $15 million SPORT study—the largest grant ever for spine care. "This level of funding pales next to the dollars going to investigate innumerable health problems of much smaller societal concern.

Grave Concerns

Eighth. NASS is "gravely concerned about overutilization of precious resources that may in fact be injurious to patients." However, Baker and colleagues are equally concerned that decisions over access for patients may be based on "very coarse" datasets and questions designed, not for therapeutic outcomes, but for expenditure outcomes.

All in all, the study, admittedly, did not offer any surprising findings. What was noteworthy was the tenor and speed of the NASS response to find common ground with Deyo.

Must be something in the water in the Great Northwest.