3 thoughts on the interplay between practice, research & reimbursement

Spine

Vertebroplasty and kyphoplasty have become increasingly controversial, after several studies appeared to demonstrate that patients treated with these procedures experienced outcomes no better than those who were treated with sham surgery. However, in the push to integrate these findings into clinical practice, some physicians worry the dialogue between how research impacts clinicians, insurers and public perception has lost its nuance.

Joshua A. Hirsch, MD, FACR, FSIR, director of the NeuroInterventional Radiology at Boston-based Massachusetts General Hospital and president of the American Society of Spine Radiology, spoke with Becker's Spine Review about why he believes lack of discussion surrounding research results has stymied spinal care.

 

Here's what he had to share:

 

1. New research should be contextualized. The controversy surrounding vertebral augmentation began in 2009, after two studies were published in the New England Journal of Medicine, according to Dr. Hirsch.

 

In one of the studies, titled "A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures," the researchers concluded, based on the 78 patients in the trial, that there was "no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3 or 6 months after treatment."

 

"Unfortunately, in 2009, the discussion became very antagonistic and things really deteriorated," Dr. Hirsch said. "The result of this lack of constructive dialogue was that it hindered research. The tragedy is, a lot could have been gleaned from that experience that would have inured to the benefit of patients. Many opportunities for further study were missed.

 

"When these procedures were trialed against conservative therapy — their real-world comparator — both vertebroplasty and kyphoplasty were far superior across multiple parameters and at a host of time points. Partially reflecting those studies, the National Institute for Health and Care Excellence concluded, after a two-year exhaustive review, that these procedures should be used in patients with ongoing pain for unhealed fractures."

 

Dr. Hirsch thinks that one reason the 2009 trials did not demonstrate benefits associated with vertebroplasty over placebo treatment was the use of an "active control." In the trial's sham arm, the researchers inserted a 13-gauge needle to rest on the lamina of the affected vertebrae, and then injected large doses of local anesthetic, which may have provided a therapeutic benefit.

 

"I don't find it particularly helpful to attack those 2009 studies," he continues. "I simply believe that they need to be contextualized within the 1,500 other papers and real-world experience patients have, and lament their disproportionate impact on this space. "

 

In particular, Dr. Hirsch notes a recent study from The Lancet, which used a different sham procedure; for this study, local anesthetic was only applied in the subcutaneous tissues. This study (VAPOUR) found vertebroplasty to be more effective than placebo intervention when performed on patients with acute osteoporotic spinal fractures.

 

Dr. Hirsch notes that "the results of VAPOUR do not mean the 2009 studies were wrong; rather, that patient care benefits from clinicians and researchers having an open mind and allowing for continuous learning. Patients were denied access to these procedures based on those two trials, ignoring the vast majority of empiric case series and trial evidence that was available."

 

2. Public perception is malleable. "Groups like uptodate.com and Wikipedia jumped on these findings, and recommended against using vertebral augmentation," Dr. Hirsch says of the period following 2009. "In 2016, many physicians get their advice from places like uptodate.com."

 

As these findings concerning vertebral augmentation were translated to the general public, Dr. Hirsch asserts that they became even more simplified. As an example, he notes how a recent article in the New York Times, titled "Why 'Useless' Surgery Is Still Popular," cited the 2009 New England Journal of Medicine studies.

 

"We should be careful using terms like 'useless surgery' on something that well over a million people have been treated with," he says. "They, their family, their caregivers, the practitioners that performed the procedure, directly observe that the patients are deriving benefit."

 

One such patient, 81-year-old John R., spoke with Becker's Spine Review about his experiences with vertebral augmentation. After a steep fall, John R. broke two vertebrae, and was referred to New England Neurological Associates in Lawrence, Mass., for care, where he underwent a balloon kyphoplasty procedure.

 

"I went in with pain, and I left the same day — early afternoon — walking with a cane and with no pain," John R. says. "It's hard to believe; you go in with a pain score of eight or nine and leave with a pain score of two or three. The procedure worked, the pain is gone and I'm back to work."

 

Dr. Hirsch suggests that more nuanced discussion of the available data would serve to change public perception. "We lost five plus years since these studies when we should have been discussing 'what can we learn from this trial?' and 'what's the right population to treat?'" he says. "I hope we start doing that again."

 

3. Insurance coverage has narrowed. Given the assertion that vertebral augmentation is no more beneficial than placebo treatment, some insurers have discouraged use of these methods, according to Dr. Hirsch.

 

"Where I think the biggest challenge for vertebroplasty and kyphoplasty is when insurance companies deny these procedures, thereby denying their beneficiaries the opportunity to even consult with somebody about these procedures," he says.

 

"I don't claim vertebroplasty or kyphoplasty is right for every patient," he continues. "But I believe patients should be given the opportunity to make an informed decision.

 

"Put differently, in 2013, researchers at Johns Hopkins used claims-based data to make the point that vertebroplasty and kyphoplasty offer a survival benefit when compared with nonoperative management," he continues. "If that observation is true, the implications of denying patients access to these therapies is profound."

 

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