Predictive Modeling for Spine Surgeries in the MACRA Era
Published on the Sept. 26, 2016, Rheumatology Network website
By Whitney L. Jackson
For many patients – especially those facing spinal surgery – the specter of an unknown outcome can be frightening. Knowing their odds for a successful procedure versus a failed operation can help many individuals decide whether and what type of surgery they’d like to undergo.
And, having the data to determine those success percentages can also help surgeons and other providers make the right decisions when it comes to expenditures and recouping reimbursement.
Using this data is called predictive modeling. To understand how its affected spinal surgeries and payments associated with it, Rheumatology Network spoke with Joseph Osorio, M.D., Ph.D., a resident with the Department of Neurological Surgery at the University of California at San Francisco, about his study, “Predictive Modeling of Complications,” published recently in Current Reviews in Musculoskeletal Medicine.
Rheumatology Network: Why did you decide to study predictive modeling? What is the importance of this tactic?
Dr. Osorio: The importance really lies with the patients we operate on most frequently. It’s complex spine surgery. Patients are prone to having complications because their surgeries involve many levels, and there’s a high risk for complications. Patient satisfaction is something that we want to do well, and we wanted a tool where we could use all the data at our disposal in our practice in the clinic to give them a number they could understand. For example, they’ll have an 85 percent chance of success rather than telling them patients like them generally do well with this operation.
One of the benefits we have is the professional societies are collecting data the way we’ve been doing here at UCSF and at other centers that focus on adult spinal deformities. We have a repository of data and collect large volumes, prospectively, on patients that fall within the adult degenerative and scoliosis parameters set out in the literature. We put that information into a database and go back, retrospectively, and analyze it. There’s a huge wealth of information there to benefit us. Part of the nuts and bolts of predictive modeling is having quality data and having large volumes of it. If you don’t have quality data, then it is a limitation to the predictive model. If you do, you can apply these techniques to other conditions and settings, and achieve the same success that we have.
Rheumatology Network: How impactful has the modeling been on spinal surgery?
Dr. Osorio: I think it’s been extremely useful with aging individuals and those undergoing revision surgery. Some of them want to know because they have many options for surgery. Do they go with the larger surgery that may address the bigger problem of global spinal balance, or do they choose a less invasive one that might have a likelihood for needing another spine surgery because the bigger problem was not addressed? Are they someone who doesn’t want to take the risk of undergoing such a big operation? With this data, we can relay possible outcomes to the patient.
Rheumatology Network: What were your main findings? Why are they important?
Dr. Osorio: Some of the main findings started with one of our initial pieces of work. The first one looked at surgical complications in the adult spinal deformity patients. Those were patients we did large segment fusions on, and they returned with adjacent level disease. They come back with new pain or new neurological indications, and they need another operation. In some sense, they’ve failed the surgery and are in need of a revision operation. We were able to take 500 or so patients and look at those we had two-year follow-up data on. We look at X-rays and clinical information and we’re able to say which of all those patients — if we throw in a series of variables — are going to come back with a failed surgery. We added in variables that were strong predictors — some were based on radiographic parameters that are commonly used in the clinic to assess adult spinal deformity patients. From previous studies, we predicted that these parameters, including being over age 64, being sagittally imbalanced, and having flat back syndrome where patients develop much of their back pain by overuse of compensatory muscles, are important ones to monitor.
Rheumatology Network: Did you find anything unexpected?
Dr. Osorio: It wasn’t unexpected, but it is something that gets discussed in the literature a great deal. It’s where do we stop — at what level do we end? Do we go to the pelvis or the sacrum? Does it make a difference or not? Surgeons want to know. It seems that it does make a difference, but we need to do more studies to get a better sense of it all. At our institution, we commonly end our large spine surgeries at the pelvis. That’s something that seems to be coming out in the predictive model.
Rheumatology Network: Are there any challenges to spinal surgeries that were revealed?
Dr. Osorio: I think the biggest challenge with studies like this is that when we see patients in our clinic, we really do have an algorithm for the way we analyze each patient. Everyone receives a standing 36-inch long X-ray. We’ve essentially designed our clinic that way – we don’t see patients until they get that X-ray, so that might be a challenge for other providers who are not using this film as one of their tools in understanding a patient’s global alignment. If you start reading the literature now, you get the sense that all of us are using 36-inch X-rays to identify parameters that are important for choosing whom to operate on. In many cases, when we receive referrals from the community to see patients who have had a failed surgery, there often isn’t a record of having had a 36-inch X-ray acquired. Providers often obtain a CT scan, or an MRI of the lower back, but overlook the global alignment. We’re looking at global alignments, but the challenge in moving forward is that providers aren’t looking at the problem in a global way. We’re trying to move the field in that direction — to get providers to understand that patients often have problems that could impact more than one region. They need to think about the patient and the spine as a whole.
Rheumatology Network: How does this work fit in with MACRA?
Dr. Osorio: I would say as we move forward with this wealth of information, we’re moving toward having an abundance of information from our use of electronic heath records. Having access to this data, we’re going to have a better understanding as to what parameters most impact surgical outcomes. We can better justify an expected outcome. Are providers, when they’re offering surgeries, looking at other providers’ outcomes to get a sense as to how the field is adapting/improving? Are they actually at the mean or are they below average? Are more of the patients they’re providing surgeries to, patients they would’ve know might have failed if they’d looked at a set of high risk targets? We can provide them with these targets. We can educate providers that are going to be doing do this level of spine surgery, to pay close attention to these targets. Counsel them that it will impact their success. I think overall, MACRA is going to really try to differentiate providers that are given that kind of data and incentivize them to provide high value care. Those that are below the mean are going to suffer. This will provide them with a tool and give them a better understanding of what success is in this field.
Rheumatology Network: How can this work be used to promote better care and outcomes?
Dr. Osorio: One of the challenges we fall into, is justifying and providing large scale operations at tertiary and quarternary care centers. Operations are expensive. Smaller spine surgeries can offer immediate improvement, but if you don’t think about addressing the larger scale problem, the patient will suffer and they might be back within a year with a failed operation. This will result in the patient requiring another operation, which is something we see very often. So, in order to justify doing a larger cost operation up front, it helps to be able to look out several years in advance and predict outcomes. If you tell someone justifying cost that reimbursement for an operation is X dollars more than a smaller-scale operation, they will likely want evidence through data about why spending that much more can be justified. If they are looking at larger operations that are chosen based on the correct indications, they’ll realize over the long term that most patients aren’t returning for an initial failed surgery. In this ideal scenario, the cost is better justified for the larger operations because you need fewer surgeries overall. Ultimately, through these kinds of examples you can get an understanding how these large scale operations are justified.
I think, overall, predictive modeling and analyzing is something that’s used in the business and government worldwide. We’re simply applying it to healthcare now. We’ve been stuck in this more traditional statistical model, that is hindered because of the fundamentals that require hypotheses and assumptions. They answer a single question, but really now that we’re having an abundance of data, we’re able to better answer any questions that are patient specific and individualized to a particular problem. We can provide a number that’s easier for a patient to interpret. It’s hard to interpret an odds ratio when making a decision as to what surgery to have, but if I say you have a 96 percent chance of doing well from this surgery, that number is something that makes sense.
To read the article at its original location: http://www.rheumatologynetwork.com/news/predictive-modeling-spine-surgeries-macra-era
Romosozumab Shows Promise for Post-Menopausal Osteoporosis
Published on the Sept. 21, 2016, Rheumatology Network website
By Whitney L. Jackson
Treating post-menopausal osteoporosis patients with romosozumab could improve their long-term bone density and decrease the risk of spine and hip fractures, according to a randomized, multi-center, double-blind, placebo-controlled study.
Currently, there’s a gap in how best to treat post-menopausal women who suffer low bone density thanks to osteoporosis. Using romosozumab could help them ward off both vertebral and all other clinical fractures into older age. Romosozumab is an investigational, bone-forming, monoclonal antibody that binds sclerostin and increases bone formation and decreases bone resportion.
In a Sept. 18 presentation at the American Society of Bone Mineral Research annual conference in Atlanta, lead study author Helen Hayes Hospital rheumatologist Felicia Cosman, M.D., revealed FRAME study investigators wanted to identify a medication that could reverse bone loss and offer preventive care for the future.
The results of this study present “a unique opportunity for patients with osteoporosis who are at high risk for fractures and might be at imminent risk for future fractures. If they have a medication that rapidly increases bone strength and reduces fracture risk, it puts them in a better position for the next year and beyond,” she said.
Participants were post-menopausal women between ages 55 and 90 with osteoporosis. They had bone mineral density T-scores of < -2.5 at total hip or femoral neck. Co-primary endpoints were subject incidence of new vertebral fractures through M12 and M24. Secondary endpoint included clinical (nonvertebral plus symptomatic vertebral) and nonvertebral fracture, and bone mass density.
Of the 7,180 women, 89 percent completed the entire study. They were divided into a placebo group and one that received monthly 210 mg injections of romosozumab. Both groups received 60 mg of denosumab monthly for a year.
According to results, the romosozumab group experienced a 13-percent and 6.8-percent increase in bone density in the spine and hips, respectively, after one year. At the second year, the increase was 17.9 percent for spine and 8.8 percent for hips. Overall, romosozumab decreased new vertebral fracture risk by 73 percent and new clinical fractures by 36 percent.
To read the article at its original location: http://www.rheumatologynetwork.com/news/romosozumab-shows-promise-post-menopausal-osteoporosis
Low Protein and Osteoporosis in Men?
Published on the Sept. 21, 2016, Rheumatology Network website
By Whitney L. Jackson
Low protein intake may be responsible for fractures in older men, according to an observational study that analyzed data from the 2000-2002 Osteoporotic Fractures in Men Study.
Dietary protein is a potentially modifiable risk factor for controlling fractures among older men.
In a Sept. 18 presentation at the American Society of Bone Mineral Research annual conference in Atlanta, lead study author Lisa Langsetmo, M.D., from the University of Minnesota, discussed the investigators’ hypothesis that lower-to-moderate protein intake was associated with an increased fracture risk while high protein intake was not.
“Increased dietary protein intake may be feasible as a low-risk intervention to reduce the risk of hip fracture among older men,” she said.
The study, which included 5,875 men — average age 73.6 years — had two objectives: to assess the association of protein intake with low trauma (trauma < fall from standing height) fracture risk and to assess whether the association between protein intake and fracture risk was mediated by falls, body mass index, bone mineral density, appendicular lean mass or gait speed.
Researchers took baseline protein assessment and excluded men with < 500 kcal/d total energy intake or missing > 10 items. The median was 15.9 percent total energy intake with a range from 14.2 percent to 17.8 percent. They defined low protein intake as the bottom quartile and high intake at the top quartile, Dr. Langsetmo said.
According to the analysis, there were 808 low trauma fractures, excluding head, hands, and feet, over 15 years. Results showed a 16-percent lower hip fracture risk, and an 8-percent lower major osteoporotic fracture risk.
Low protein intake was associated with increased fracture risk (HR=1.28, 95 percent CI, 1.08-1.51) compared to those with moderate intake. High protein intake was not associated (HR=1.00, 95 percent CI, 0.84-1.19). There was a two point change in estimates when they were adjusted for falls, body mass index, appendicular lean mass and gait speed.
The protein intake-fracture risk association was dependent on skeletal site, Dr. Langsetmo said. In addition, while the hip fracture association was strong, there was no such association with vertebral fractures.
To read the article at its original location: http://www.rheumatologynetwork.com/news/low-protein-and-osteoporosis-men
Growth of Interventional Radiology
Published on the Sept. 22, 2016, DiagnosticImaging.com website
By Whitney L. Jackson
Historically, mention of interventional radiology conjured up thoughts of vascular techniques. Today, this area of radiology encompasses much more – in fact, according to industry experts, it’s growing quickly and is expanding heavily throughout health care as a whole.
But, what’s behind this extension, and how has it – and will it – affect diagnostic radiology?
These changes, said Matt Hawkins, MD, director of pediatric interventional radiology (IR) at Emory University School of Medicine, will likely change the health care landscape in the years to come.
“Interventional radiology will play a bigger role moving forward,” he said. “As we measure the overall cost and value, we can do a lot in interventional radiology that costs less and positively impacts patients.”
Interventional Radiology’s Changing Face
For many years, IR was used mainly to make cardiovascular procedures less invasive, but in recent years, these techniques have been applied to other specialty areas, as well, according to the Advisory Board. In addition to medical oncology and pediatrics, IR is gaining ground in neurology, gastroenterology, and urology.
A Transparency Market Research report indicated the most common IR procedures include angioplasty, venous access, biopsy, fibroid embolization, stents, arteriograms, and embolization.
Providers are using IR more frequently in these ways because the techniques are more cost effective, less disruptive to the body, and can be done in the outpatient setting. Based on the Advisory Board analysis, increased use of IR in research is strengthening the quantitative data to support IR’s value in radiology as a whole.
To read the remainder of the article at its original location: http://www.diagnosticimaging.com/interventional-radiology/growth-interventional-radiology
Fracture Assessment Tools Underutilized, Study Shows
Published on the Sept. 19, 2016, RheumatologyNetwork.com Website
By Whitney L. Jackson
Using the fracture assessment tool with older, community-dwelling women can help reduce their risk of hip fracture over time, according to a randomized controlled trial.
Currently, although the cost of fractures is high for both society and individuals, the use of fracture risk tools to identify at-risk patients — and potentially stave off future fractures — is relatively low. The FRAX assessment tool identifies high-risk individuals in primary care environments in an effort to reduce fracture incidence.
The FRAX study was developed by the World Health Organization to evaluate fracture risk based on individual patient models that integrate risk associated with clinical risk factors, as well as bone mineral density at the femoral neck. The FRAX algorithms provide a 10-year fracture probability.
In fact, according to a 2010 study, the National Osteoporosis Foundation Guide recommends treating patients who have a FRAX 10-year score of ≥3 percent for hip fractures or ≥ 20 percent for major osteoporotic fractures to reduce future fracture risks.
In a Sept. 19, presentation at the 2016 American Society of Bone Mineral Research conference, lead author E.V. McCloskey, M.D., from the University of Sheffield in the United Kingdom, discussed a five-year, two-arm study into the efficacy of using the FRAX tool to pinpoint women with osteoporosis who are also at high fracture risk in the community.
Of the 12,483 women identified in primary care environments, 6,233 were randomized into the study’s screening arm. In that group, 898 women (14.4 percent) were identified as high risk using the FRAX tool. By the end of the first year, exposure to osteoporosis medication was higher in the screening group compared to the control group – 15.3 percent versus 4.5 percent, respectively. High treatment uptake occurred in the high-risk group (78.3 percent) at six months.
Results showed the incidence of major osteoporosis fractures – comprising hip, waist, humerus, and clinical vertebral fractures — reduced by 12 percent (2 percent to 21 percent, p=0.018). Screening was associated with a significant reduction in hip fractures (RRR 27 percent, 10 percent – 41 percent, p=0.003).
Based on these findings, researchers wrote, a systematic, community-based screening fracture risk program that uses the FRAX tool in older women can be both feasible and effective in lowering hip fracture risk.
To read the article at its original location: http://www.rheumatologynetwork.com/news/fracture-assessment-tools-underutilized-study-shows
Hip Fractures No Longer on a Downward Trend in the U.S.
Published on the Sept. 19, 2016, RheumatologyNetwork.com Website
By Whitney L. Jackson
The 15-year trend of decreasing hip fractures due to osteoporosis is coming to a close in the United States, according to an observational study of Medicare claims data. A drop in reimbursement for a common screening technique could be to blame.
Since 2001, hip fracture rates have dropped thanks to improvements in osteoporosis evaluation and fracture predictions via dual-energy X-Ray absorptiometry (DXA), as well as new drugs, such as oral bisphosphate. DXA uses to X-ray beams to measure bone mineral density and diagnose osteoporosis.
In a Sept. 17, presentation at the 2016 American Society of Bone Mineral Research conference, lead study author E. Michael Lewiecki, M.D., of the New Mexico Clinical Research and Osteoporosis Center, discussed investigators’ analysis of hip fracture rates to determine if the downward trend still existed.
Researchers used Medicare claims and enrollment data from 2002-2014, approximately 900,000 annually, for the analysis. It was five percent sample of Medicare’s fee-for-service beneficiaries who had at least one Medicare-paid DXA scan per year. DXA providers were either office-based, free-standing or hospital-based. Analysts identified hip fractures with ICD-9 codes 820.0x, 820.2x, and 820.8x, excluding trauma-associated fractures.
While the analysis showed a downward trend in osteoporosis-caused hip fractures from 2002-2012, the data revealed a reversal, beginning in 2013. The uptick coincides with a drop in Medicare reimbursement for DXA screening. Reimbursement levels dropped to below cost, Dr. Lewiecki said in an interview with Rheumatology Network.
“The analysis suggests the downward trend for hip fractures in the United States could be over,” he said. “We can’t say that declines in DXA reimbursement are directly responsible for the higher than expected hip fractures, but it makes sense when you look at other contributing factors.”
To combat the drop in screening and, potentially, provide better treatment for osteoporosis, Dr. Lewiecki said patients should educate themselves about the benefits and risk of DXA screening. In addition, he said, patients and providers should support a bill in the U.S. Congress that would create a reimbursement floor for DXA payments that would make providing screening more profitable – or at least less costly – for doctors who have offered the service.
To read the article at its original location: http://www.rheumatologynetwork.com/news/hip-fractures-no-longer-downward-trend-us
How One Class of Bisphosphonates Could Predict Vertebral Fractures
Published on the Sept. 19, 2016, RheumatologyNetwork.com Website
By Whitney L. Jackson
Using biomarkers to assess the efficacy of existing bisphosphonate drugs in predicting fracture risk could pave the way for improved osteoporosis treatment, according to a new study.
Currently, little analysis exists into how bisphosphonate drugs can relate bone turnover markers to fracture reduction. With the cost of drug development so high — and with the time to get new drugs approved so long — researchers looked into how available drugs can help reduce fracture risk.
In a Sept. 19 presentation at the America Society of Bone Mineral Research conference, lead study author Douglas Bauer, M.D., from the University of California-San Francisco, discussed how biomarkers, such as blood and urine, can help identify how one class of bisphosphonates can predict vertebral — but not non-vertebral — fractures.
Based on the National Institutes of Health Bone Quality project, investigators analyzed data on more than 120,000 participants from 11 clinical trials, including bone turnover markers, dual-energy X-Ray absorptiometry and fracture outcomes. They recorded baseline data from 2,268 individuals with vertebral fractures, 3,286 with non-spine fractures (including 514 hip fractures), and 6,729 N-telopeptide of type 1 collagen fractures.
Researchers compared the mean effect of the bisphosphonate to the placebo over a three-to-four-year period. Results indicate there’s a high statistically-significant relationship between short-term change and bone markers for vertebral fractures compared to the placebo group (p=0.005, r=0.84). However, no such strong relationship exists for non-vertebral fractures. The findings suggest that non-fragile factors, such as falling, come into play for non-vertebral fractures.
For instance, for two hypothetical bisphosphonates with 10 percent versus 30 percent reductions in bone-specific alkaline phosphatase, the model predicted a 19 percent versus 66 percent reduction in vertebral fractures (r2-0.84, p=0.001). The relationship is weaker and not significant for non-vertebral fractures. The comparable risk reductions were 12 percent versus 21 percent (r2=0.06, p=0.27).
Ultimately, Dr. Bauer told Rheumatology Network, the study results can, hopefully, be useful in developing medications for the same bisphosphonate classes and extending the effects to other populations.
“The hope is that this overall effect can be observed in all anti-absorptive medications that will be developed in the future,” Dr. Bauer said. “Hopefully, all this data will be used to fill in predictive efficacy.”
To read the article at its original location: http://www.rheumatologynetwork.com/news/how-one-class-bisphosphonates-could-predict-vertebral-fractures
Who am I?
I’m a seasoned reporter, writer, freelancer and public relations specialist with a master’s degree in international print journalism from The American University in Washington, D.C.
I launched my journalism career as a stringer for UPI on Sept. 11, 2001, on Capitol Hill. That day led to a two-year stint as a daily political reporter in Montgomery County, Md. As a staff writer for the Association of American Medical Colleges, a public relations specialist for the Duke University Medical Center and the public relations director for the UNC-Chapel Hill School of Nursing, I’ve earned in-depth experience in covering health care, including academic medicine, health care reform, women’s health, pediatrics, radiology, and Medicare.
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