Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, April 3, 2015

Joint Replacement Patient Outcomes Registry: Proprietary!

Functional Outcomes Data for Joint Replacement Ups the Quality Ante

Cheryl Clark, for HealthLeaders Media , April 2, 2015  FiDA highlight added

Collected by an evolving roster of state registries, functional outcomes data complements data on readmissions and complications and is of value to surgeons, hospitals, and payers as well as to prospective patients.

As Medicare and state agencies increasingly turn their scrutiny to complication and readmission rates for the more than 1 million hip and knee replacement surgeries performed in U.S. hospitals annually, new provider registries are asking patients questions that will determine their HOOS/KOOS.
Come again, you say?
Yes, it's an odd phrase for such a serious subject.
HOOS/KOOS stands for hip disability and osteoarthritis outcome score and knee disability and osteoarthritis outcome score. These are 40- and 42-question surveys that ask about patients' pain levels, symptoms, stiffness, function during sports and recreational activities, and quality of life before and after joint replacement surgeries.
The surveys aim to determine whether a surgery has restored a person's ability to do what she used to do, or what she expected she'd be able to do, and whether it alleviated her suffering.
This is the sort of functional data that has so far been missing from Medicare's Hospital Compare, which recently began disclosing hospital-level rates of 30-day readmissions and serious complications for patients undergoing joint replacement surgery. Readmissions and complications are, of course, extremely significant.
But some might argue that it's also important to know whether patients got the results they anticipated, and whether they perceive that they are worse or better off months later.
Down the line, private payers may tether the price they'll pay for some procedures, at least in part, to how well a surgeon scored on these kinds of surveys. It's another form of value-based contracting.
Registries Abound
Evolving state registries to measure such fine points of patient outcomes include the California Joint Replacement Registry (CJRR), the Virginia Joint Registry, and the Michigan Arthroplasty Registry Collaborative Quality Registry (MARCQI), as well as a national network called the American Joint Replacement Registry (AJRR).
These organizations seek to answer questions about surgeon and hospital proficiency after patients have lived with their new joints for periods of time. Most of the registries use versions of HOOS/KOOS, among other quality and safety indicators.
Now, there's an even larger database on the scene, the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE TJR). I know, it too has a funny name, like a video game set in outer space.
Co-directed by Patricia Franklin, MD and David Ayers, MD, of the University of Massachusetts, FORCE TJR was funded with a $12 million grant, now expired, from the federal Agency for Healthcare Research and Quality.
To date, Franklin says, FORCE TJR has amassed pain and outcome data for 30,000 surgeries performed by 150 surgeons at 70 hospitals in 24 states. For the bulk of those surgeries, the network has collected more than two years' worth of follow-up data. All patients added to the registry are followed indefinitely.
And while the data is not public, FORCE TJR has used results from 25,000 of those surgeries to create demographically representative benchmarks so various kinds of hospitals and a representative sample of surgeons can compare their risk-adjusted scores.

Now, the network is trying to recruit more doctors to join the registry. It's been "ahead of the others in implementing this and making it mandatory for every patient" so that surgeons and hospitals that participate can't cherry pick the patients who get surveyed, Franklin says.

An important factor in creating and implementing registries is how surgeons learn from information they receive, or from those who get higher scores, especially if it shows wide variation in scores, such as infection rates.
Nationally, she says, the average 90-day all-cause complication rate from hip and knee replacement surgeries is 4.5%, but the variation is nearly four-fold, from 2.2% to 8.9%.
It's Only Good If It's Used to Improve
Reports have suggested that because surgeons are busy and lack support from their hospitals, they may not have an opportunity to learn from better performers or implement practice changes to improve their own results.
After getting less than desirable scores, a surgeon from one orthopedic practice told Franklin that now, there's someone available to answer patients' questions more promptly after they're discharged, and schedules are always rearranged to see patients "the next morning" if there's a concern about redness or swelling or pain near the incision.
Without prompt attention, a patient might go to the emergency department "and see someone who didn't know the patient or know about their surgery."
Another benefit is that results are relayed back to the hospital and surgeon every quarter, unlike data now posted on Hospital Compare, which is usually at least two years old. "Often, this is the first time that the surgeon really [has gotten] this kind of feedback," Franklin says.
In time, she imagines that the Centers for Medicare & Medicaid Services will publish FORCE TJR data, perhaps in aggregate or as a composite, either on Hospital Compare or Physician Compare.
"The question is, what data will be useful to the public? That's what Hospital Compare will have to test. I imagine we will get there in time. But it will have to be information that is meaningful to the patient," and information that will show variation as well, Franklin says.
U.S. News & World Report may soon publish names of hospitals and whether they choose to report if their orthopedic surgeons are participating in such a registry, she says. That's at least a start.
Several insurance companies are already using models to collect data like this from surgeons.
With so many aging baby boomers insisting on high levels of physical function into their senior years, hip and knee replacement procedures can only be expected to grow. In 2011, according to the National Center for Health Statistics, there were more than 710,000 knee replacements, and more than 460,000 hip replacement procedures. Their costs were $11.31 billion and $7.96 billion, respectively.
I just hope all of this quality data is available publicly if and when I need to get one.

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists. 

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