Joint replacement registry bears early fruit
Surprises in data point to unknown safety issues
There has long been a hole in the data collected on joint replacements: Patient-reported outcomes over an extended period of time were missing. In late 2012, the Agency for Healthcare Research and Quality (AHRQ) gave a $12 million grant to create the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) to attempt to plug that hole, and it is already showing signs that the money is being well spent.
Already, surprises in the data are leading orthopedists to rethink the way they consider risk and provide ammunition against those who think they are overzealous in pushing for surgery.
There had been several independent joint-related data repositories before FORCE-TJR, says David Ayers, MD, a co-lead of the program and chairman of the department of orthopedics at the University of Massachusetts Medical School in Worcester. Other countries have successfully adopted a single portal registry that naysayers said could not work in the U.S. But so far, 20,000 patients and 150 surgeons have enrolled and submitted data to the program. Thirty of those surgeons have come in post-grant.
Along with information already collected related to cost, readmissions, and complications, this includes information on function and pain, both before and after surgery, he says. That patient experience has been missing. "This is very meaningful data."
Among the big "aha" moments, says Ayers, is that more than half of joint replacement surgeries are now in people who are younger than 65. "That is the most rapidly growing segment having elective joint replacement," he says. "The assumption has been that these are young, active people who want to remain active. What we have found, though, is that there are some who fit that, but the majority do not. They are obese and they have significant medical comorbidities and significant pain as well as functional limitations."
This group mimics the over-65 age group, but they are more obese and have more comorbidities. "They may have been active once, but data shows that by the time they have joint replacement surgery, they are severely limited by arthritis and are more obese," he says. "But they have all the benefit as the seniors over 65. That they are younger equals out the obesity/comorbidity issues. They have similar adverse event profiles as older patients."
So these younger patients who might not have been on the radar for adverse events due to their age need to be because of their weight and other factors such as diabetes, he says.
Ayers says another item of surprise from the data is that there is a near exponential rise in knee surgery — more than a million a year — fuelled by advanced arthritis, not because orthopedists or patients are changing their decision-making about when to have surgery. A look at the pain and function profile of these patients, compared to studies from 10 and 25 years ago, shows there has been "no liberalizations. We are not recommending surgery at an earlier stage. These are people who are very disabled, physically limited, and in significant pain."
The Centers for Medicare & Medicaid Services (CMS) has been publishing readmission and complication rates for every hospital that does more than 25 joint replacements per year, says Ayers. They risk-adjust based purely on administrative data from Medicare. FORCE-TJR used its data to see if there is a way to use its clinical information to improve the risk-adjustment methodology for patients and providers.
"This was a collaborative project we did with the American Association of Hip and Knee Surgeons," he says. "What we found is that by adding clinical information we can significantly improve the prediction of CMS readmission data and improve their risk adjustment based on five areas."
They are:
• BMI: that it is not just above or below 40, as CMS has. Less than 40 but still high is also important, notes Patricia Franklin, MD, MPH, MBA, the other co-lead of FORCE-TJR and the director of clinical research for orthopedics and physical rehabilitation at the medical school. "It is not just the most obese who are a risk, but across the continuum."
• Pre-surgical function.
• Whether the patient is a smoker.
• The total burden of musculoskeletal disease: Ayers notes that knowing if there is arthritis in one knee is not enough. If the patient has arthritis in the other knee, the hips, the low back, that will also impact the risk of complication or readmission. "It is important to the physical function after surgery, and if you have more disease burden, it makes sense that you will have a greater likelihood of complication."
• Synergistic effect of medical comorbidities: It is not just whether you have three other comorbidities that add three more "points" of risk. They add more than that. The cumulative effect of diabetes, renal disease, and cardiac disease is more together than if you looked at each individually.
That this information is available could be a boon, says Ayers. A facility that does total joint replacements should take the CMS administrative data that it uses for risk adjustment and add those five factors to help determine which patients are most at risk. Then develop programs to ameliorate that risk.
"This is really exciting. This allows us to figure out the best practice over different pathways — anesthesia, pre-op, surgery, post-op," he says.
The registry provides quarterly executive summaries and reports on consistent risk factors for complications, as well as patient-reported outcomes, Franklin says.
"Do they have more comorbidities, are they older or heavier. These are compared to national norms for risk factors and outcomes," she says. Participants also receive a preoperative profile that includes information on severity of pain and functional disability both at the center in question and nationally. Outcomes such as readmission rates are also part of the information provided, and this has proved particularly illuminating.
Franklin notes that while many people will travel a distance to go to a good joint replacement facility, if they are having pain, shortness of breath, or other complications, they often go to a different hospital, and the original facility may not get that information. Indeed, 25% of the time, that happens. "We get the true number because we ask patients did they go to the hospital and which one."
Other data includes 90-day all-cause complications, and 6- and 12-month patient reported outcomes, for the participant and national comparison numbers.
Cost of participation depends on how much information the organization wants, says Ayers, as well as the assistance needed in terms of computer program set up.
"It is comparable to NSQIP and the programs by thoracic surgeons in terms of costs and involvement," he says. "What is new is that there has never been an option like this to be part of a quality improvement methodology for joint replacements."
Franklin also notes that FORCE-TJR is certified by CMS to submit as quality data for PQRS.
For more information on this topic, contact:
• David Ayers MD, Chairman, Department of Orthopedics and Physical Rehabilitation, University of Massachusetts Medical School, Worcester, MA. Email: [email protected].
• Patricia Franklin, MD, MPH, MBA, Director, Clinical Research, Orthopedics and Physical Rehabilitation, University of Massachusetts Medical School, Worcester, MA. Email: [email protected].
